Interface comprising rolling nasal bridge portion

Abstract

To provide an interface for use in providing positive pressure respiratory therapy.SOLUTION: An interface for positive pressure therapy includes a mask assembly, a headgear assembly, and a connection port assembly. The mask assembly comprises a seal member that has an upper portion movably connected to an integrated lower portion, where the upper portion rolls during hinging movement of the upper portion relative to the lower portion. The headgear assembly allows connection to the mask assembly in a direction substantially normal to a direction of strap tension. The connection port assembly includes a swivel elbow with a valve member that controls a flow through a port that opens toward a user.SELECTED DRAWING: Figure 11

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 61 / 476,188, filed April 15, 2011, U.S. Provisional Patent Application No. 61 / 504,295, filed July 4, 2011, and U.S. Provisional Patent Application No. 61 / 553,067, filed October 28, 2011, the entire contents of each of which are incorporated herein by reference.

[0002] The present invention relates generally to face masks that cover at least one of a user's nose and mouth and deliver breathing gas under positive pressure. More particularly, certain aspects of the invention relate to masks having a nasal bridge seal that moves relative to other sealing portions of the mask. [Background technology]

[0003] Face masks can be used to deliver breathing gas under positive pressure to a user. In a configuration that covers both the user's mouth and nose, a full face mask typically fits over the bridge of the nose. Typically, a single seal surrounds the user's nose and mouth.

[0004] Such full face masks are typically secured to the user's head by a headgear. To sufficiently reduce leakage, the headgear is typically tightened, which places high pressure on the bridge of the user's nose. In other words, as the headgear is tightened, the load exerted on the bridge of the nose by the silicone sealant typically increases gradually. The pressure can cause discomfort and, in some cases, can lead to pressure ulcers over a period of time. Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present invention to provide one or more compositions and / or methods which will at least partially ameliorate the above, or at least provide a useful option to the public or medical practitioners. [Means for solving the problem]

[0006] Accordingly, an interface for use in administering positive airway pressure therapy is provided. The interface includes a mask assembly. The mask assembly includes a mask seal and a mask base removably connected to the mask seal. The mask seal includes a mask seal clip having a higher rigidity than at least a portion of the mask seal. The mask seal clip is generally cup-shaped and has an open proximal end and a generally closed distal end. A generally pentagonal lip extends around the periphery of the proximal end. The mask seal clip includes an arcuate upper portion having an outer surface. An arc length of the mask seal clip is defined between a pair of hinge points along the outer surface adjacent an upper end of the upper portion. A hinge axis extends laterally between the hinge points of the mask assembly, and at least a portion of the upper portion of the mask seal clip is located vertically higher than the hinge axis. The upper portion of the mask seal clip includes a support surface. A generally central passageway extends through the mask clip and into a space defined by the mask seal. The mask seal includes a flexible top portion that is configured to be positioned over the nose region of a user. The top portion of the mask seal is located vertically above the hinge axis. The top portion of the mask seal includes a less stiff region disposed between two more stiff regions. The less stiff region is capable of rolling such that the top portion of the mask seal is pivotable relative to the mask seal clip. One of the two more stiff regions is positioned adjacent the small radius curvature and the other of the two more stiff regions is positioned adjacent the reinforcing component. Between the boundary defined by the small radius curvature and the reinforcing component, the top portion of the mask seal rolls while the top portion is pivoted about the pivot axis. The top portion of the mask seal has a first curved length adjacent the small radius curvature and a second curved length adjacent the reinforcing band. The first curved length can be less than the second curved length. The curved length increases as the measurement location moves away from the mask seal clip. The mask base overlaps at least a portion of the mask seal clip. The mask base includes a first pocket and a second pocket, the first and second pockets being symmetrically positioned about a central plane that substantially bisects the mask base.Each of the first pocket and the second pocket includes a vertical dimension greater than the horizontal dimension. The mask base also includes a wall defining a central opening. The wall extends into a generally central passage of the mask seal clip. The connection port assembly includes an elbow having a ball-shaped member at a terminal end. The ball-shaped member is sized and configured to be retained by the wall defining the central opening. The connection port assembly also includes a removable swivel member. The removable swivel member is secured by a lever. The lever overlaps the port. The port can be selectively covered by a flap. The flap can also close the central passage in the elbow. The port opening is generally toward the mask when the elbow is connected to the mask. The headgear assembly includes a pair of upper straps and a pair of lower straps. One of the pair of upper straps and one of the pair of lower straps are connected to a first clip. The other of the pair of upper straps and the other of the pair of lower straps are connected to a second clip. The first and second clips are securable within a pocket in the mask base, and the clips are brought into engagement within the pocket by moving the clips in a direction substantially perpendicular to the direction of strap tension.

[0007] In some configurations, the mask seal is a full face mask.

[0008] In some configurations, the mask seal clip is integral to the mask seal such that the mask seal clip is inseparable from the mask seal.

[0009] In some configurations, the mask base is removably connected to the mask seal.

[0010] In some configurations, the outer surface of the upper portion rolls onto the support surface of the mask seal clip, the support surface defining the outer surface of the upper portion of the mask seal clip.

[0011] In some configurations, the regions of lower stiffness include regions of reduced thickness as compared to the regions of higher stiffness.

[0012] In some configurations, the top of the mask seal includes an apex defined by the first and second walls, and the reinforcing component extends along at least a portion of the first wall and along at least a portion of the second wall. Preferably, the reinforcing component extends over the apex of the top of the mask seal.

[0013] In some configurations, the reinforcing components terminate at both ends generally vertically higher than the hinge points.

[0014] The mask assembly can include a mask seal. The mask seal includes an upper portion and a lower portion. The upper portion is pivotable relative to the lower portion. The upper portion includes a less stiff region located between a first boundary and a second boundary. The first boundary is defined by a stiffness greater than that of the less stiff region. The second boundary is defined by a stiffness greater than that of the less stiff region. As the first boundary is moved toward the second boundary, the less stiff region bends in one direction to define a roll of material that changes in size as the first boundary continues to move further toward the second boundary.

[0015] In some configurations, the area of ​​lower stiffness allows an upper portion of the seal member to move more easily relative to a lower portion of the seal member, preferably the upper portion includes a nasal bridge portion of the mask, and movement of the first boundary towards the second boundary allows the nasal bridge portion of the mask to move more easily relative to the lower portion of the mask.

[0016] In some configurations, the second boundary is located between the upper and lower portions. Preferably, the mask further comprises a mask seal clip having a high stiffness relative to the mask seal, and the second boundary is located along one edge of the mask seal clip. More preferably, the roll of material overlaps at least a portion of the mask seal clip.

[0017] In some configurations, the first boundary is defined along a reinforcing component. Preferably, the reinforcing component comprises a plastic band.

[0018] In some configurations, the region of lower stiffness is defined by a smaller thickness relative to the first boundary.

[0019] In some configurations, the second boundary is defined by a small radius corner.

[0020] In some configurations, the rolled portion extends over at least a portion of the mask seal.

[0021] In some configurations, the roll portion overlaps at least a portion of the mask seal clip when the first boundary is fully moved toward the second boundary.

[0022] The mask assembly may include a mask seal, the mask seal including a nasal region and a mouth region, the nasal region and the mouth region being integrally formed, the nasal region being movable relative to the mouth region, and the force exerted by the nasal region being substantially constant at a plurality of positions even as the force exerted by the mouth region increases.

[0023] The mask assembly includes a mask seal connected to a headgear assembly, the mask seal configured to encircle the nasal bridge region and the mouth region of a user, the mask seal including anti-pleat means that ensures that tightening of the headgear assembly exerts a substantially constant force on the nasal bridge region despite increasing forces exerted on the mouth region.

[0024] The mask assembly includes a seal. The seal includes a flange that contacts a user's face. The seal is removably connected to a mask base. The mask base includes a first opening and a second opening. The first opening and the second opening receive first and second clips of an associated headgear assembly. The mask base further includes a passage generally positioned between the first and second openings. The passage is adapted to receive a respiratory tube connector.

[0025] In some configurations, the mask assembly further includes a mask seal clip connected to the mask seal and removably connected to the mask base. Preferably, the mask base overlaps a substantial portion of the mask seal clip. More preferably, the mask base includes a peripheral edge and at least one recess is defined along the peripheral edge of the mask base at a location that overlaps the mask seal clip.

[0026] The mask assembly includes a mask seal. The mask seal includes a proximal flange adapted to contact a face of a user. The mask seal includes a distal facing surface. The mask base includes a peripheral edge and a cover surface extends from the peripheral edge. The cover surface of the mask base overlaps at least a portion of the distal facing surface of the mask seal such that the cover surface of the mask base is spaced distally from the distal facing surface of the mask seal such that the cover surface of the mask base and the distal facing surface of the mask seal provide an insulating effect for the mask assembly, which reduces moisture rainout.

[0027] The headgear assembly is configured to secure the mask assembly to a user's head. The headgear assembly includes a strap assembly. The strap assembly includes a rear arm, an upper arm, and a lower arm, and at least one crown arm. The upper and lower arms define an arched region shaped to at least partially encircle the user's ears. A soft edging is attached to at least a portion of the periphery of the strap assembly.

[0028] In some configurations, the strap assembly includes a semi-rigid strap, and the soft edging is butt-jointed to the semi-rigid strap and does not overlap the semi-rigid strap. In some configurations, the semi-rigid strap includes a first thickness and the soft edging includes a second thickness, the first thickness and the second thickness being substantially the same. In some configurations, the semi-rigid strap includes a thickness and the soft edging is thinner than the thickness in at least one region. In some configurations, the semi-rigid strap includes a thickness and the soft edging is thicker than the thickness in at least one region. In some configurations, the soft edging forms a bulbous end of the semi-rigid strap.

[0029] The clip assembly is configured to secure the headgear to the mask assembly. The clip assembly includes an outer cover and an inner fastener. The inner fastener is configured to be attached to the outer cover and thereby secured to one or more straps of the headgear assembly. The inner fastener includes a long slot and a circular opening. The long slot can extend along a long axis and can have a width transverse to the long axis. The circular opening can have a diameter greater than its width. The long axis extends along a transverse to the straps when attached to the outer cover and inner fastener.

[0030] The elbow assembly is configured to connect the mask assembly to the air conduit. The elbow assembly includes an elbow. The elbow includes an inner wall and an outer wall defining an air flow path therebetween. The inner wall includes a port on one side of the elbow. A sleeve is coupled to the elbow. The sleeve includes a flap. When the flap is in a first position, the flap at least partially blocks the port, allowing gas to pass from the air conduit through the elbow to a user, and when the flap is in a second position, the flap at least partially blocks the air conduit, allowing gas to flow from the user through the port and the air flow path to a location outside the sleeve. The air flow path can direct air away from the one side of the elbow.

[0031] In some configurations, the air flow passage includes two air flow passages. In some configurations, the sleeve further includes a protrusion extending around an outer surface of the sleeve and a recess adjacent the protrusion. In some configurations, the protrusion and recess are adapted to receive a swivel component incorporating a ridge that engages the protrusion.

[0032] These and other features, aspects, and advantages of embodiments of the present invention are described with reference to the following drawings. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a front view of a user wearing an interface constructed and arranged in accordance with certain features, aspects, and advantages of the present invention. [Diagram 2] FIG. 2 is a side view of a user wearing the interface of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of a mask seal and a mask seal clip of the interface of FIG. 1; [Figure 4] FIG. 4 is a side view of the mask seal and mask seal clip of FIG. 3. [Diagram 5] FIG. 4 is a rear perspective view of the mask seal clip of FIG. 3. [Figure 6] FIG. 4 is a rear view of the mask seal clip of FIG. 3. [Figure 7] FIG. 4 is a side view of the mask seal clip of FIG. 3. [Figure 8] FIG. 4 is a top view of the mask seal clip of FIG. 3. [Figure 9] FIG. 4 is a front view of the mask seal and mask seal clip of FIG. 3. [Figure 10] FIG. 4 is a rear view of the mask seal and mask seal clip of FIG. 3. [Figure 11] FIG. 4 is a side view of the mask seal and mask seal clip of FIG. 3. [Figure 12A] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. [Figure 12B] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. [Figure 12C] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. [Figure 12D] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. [Figure 13] FIG. 2 is a front perspective view of the mask seal, mask seal clip and mask base of the interface of FIG. 1. [Figure 14] FIG. 14 is a cross-sectional view of the mask seal, mask clip, and mask base of FIG. 13. [Figure 15] FIG. 13 is a side view of the mask seal, mask seal clip, and mask base. [Figure 16] FIG. 14 is a top view of the mask seal, mask seal clip and mask base of FIG. 13. [Figure 17] FIG. 2 is a perspective view of the connection port assembly of FIG. 1; [Figure 18] FIG. 18 is a side view of the connection port assembly of FIG. 17. [Figure 19] FIG. 18 is a rear view of the connection port assembly of FIG. 17. [Figure 20] FIG. 18 is a side cross-sectional view of the connection port assembly of FIG. 17. [Figure 21] FIG. 18 is a cross-sectional perspective view of the connection port assembly of FIG. 17. [Figure 22] FIG. 2 is a perspective view of the clip assembly of FIG. 1. [Diagram 23] 23 is a cross-sectional view of the clip assembly of FIG. 22. [Figure 24] 13 is a cross-sectional view similar to that of FIG. 12, showing the mask seal configured to roll under a portion of the mask seal clip 112. FIG. [Diagram 25] 15 is a cross-sectional view similar to that of FIG. 14, but with the mask seal clip reduced in size. [Figure 26] FIG. 15 is a cross-sectional view similar to that of FIG. 14, but without the mask seal clip. [Figure 27] FIG. 15 is another cross-sectional view similar to that of FIG. 14, but without the mask seal clip. [Figure 28] 1 is a graph showing the relationship between mask stretch as a function of load (or force) on the user's body. [Figure 29] FIG. 3 is a perspective view of a backbone compatible with the headgear assembly of FIGS. 1 and 2; [Diagram 30] FIG. 30 is an enlarged view of the end region of the lower arm of FIG. 29. [Diagram 31] FIG. 31 is an enlarged perspective view of an end region of FIG. 30. [Diagram 32] FIG. 1 is a perspective view of a mask assembly including a mask, a clip, and a strap. [Diagram 33] FIG. 33 is a side view of one of the two clips of FIG. 32. [Diagram 34] FIG. 34 is an exploded view of the clip of FIG. 33. [Diagram 35] FIG. 34 is a top view of the inner catch of the clip of FIG. 33. [Diagram 36] FIG. 13 is a front view of a mask base having two mounting posts with one inner fastener of a clip attached to the left mounting post. [Figure 37] FIG. 13 is a front view of another configuration of a mask base having two mounting posts and an alternative configuration of a clip attached to the left mounting post of the mask base. [Figure 38] Additional configurations of clips and associated masks and mounting posts. [Figure 39] Additional configurations of clips and associated masks and mounting posts. [Diagram 40] Additional configurations of clips and associated masks and mounting posts. [Diagram 41] Additional configurations of clips and associated masks and mounting posts. [Diagram 42] Additional configurations of clips and associated masks and mounting posts. [Diagram 43] Additional configurations of clips and associated masks and mounting posts. [Diagram 44] Additional configurations of clips and associated masks and mounting posts. [Diagram 45]Additional configurations of clips and associated masks and mounting posts. [Diagram 46] Additional configurations of clips and associated masks and mounting posts. [Figure 47] Additional configurations of clips and associated masks and mounting posts. [Figure 48] FIG. 13 is a side view of another configuration of the swivel assembly. [Figure 49] FIG. 49 is an exploded view of the swivel assembly of FIG. 48. [Figure 50] FIG. 50 is a cross-sectional view taken along line 50-50 of FIG. 48. [Figure 51] FIG. 51 is a cross-sectional view taken along line 51-51 of FIG. 48. [Figure 52] FIG. 30 is a side view of the backbone of FIG. 29 worn on a user. [Figure 53] FIG. 30 is a rear perspective view of the backbone of FIG. 29 worn on a user's head. [Figure 54] FIG. 1 is a perspective view of a flexible headgear having panels for use with a mask assembly in the field of respiratory therapy. [Figure 55] FIG. 55 is an enlarged end region of the arm of FIG. 54 to which a tab having embedded hook fabric is attached. [Figure 56] FIG. 56 is a top view of the end region of FIG. [Figure 57A] FIG. 2 is a rear view of the headgear without panels as fitted to a test model, prior to application of force to the lower arms of the headgear. [Figure 57B] FIG. 57B is a rear view of the headgear of FIG. 57A showing the displacement of the rear straps of the headgear when a force is applied to the lower arms of the headgear. [Figure 58A] 55 is an alternative configuration of panels that can be used with the headgear of FIG. 54. [Figure 58B] 55 is an alternative configuration of panels that can be used with the headgear of FIG. 54. [Figure 58C] 55 is an alternative configuration of panels that can be used with the headgear of FIG. 54. [Fig. 58D]55 is an alternative configuration of panels that can be used with the headgear of FIG. 54. [Figure 59] An assembly including headgear having a wing-type buckle connector. [Figure 60] It is a piece of headgear that has a wing-type buckle connector. [Figure 61] FIG. 60 is a top view of a wing-type buckle used in the wing-type buckle connector of FIG. 59. [Figure 62] FIG. 60 is a side view of a wing-type buckle used in the wing-type buckle connector of FIG. 59. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] 1 and 2, an interface 100 is shown attached to a user U. The interface 100 comprises an interface that can be used in the field of respiratory therapy. The interface 100 is particularly useful for forms of positive pressure respiratory therapy. For example, the interface 100 can be used to deliver continuous positive airway pressure (CPAP) therapy. In addition, the interface 100 can be used to deliver variable positive airway pressure (VPAP) therapy and bilevel positive airway pressure (BiPAP) therapy. The interface can be used with any suitable CPAP system.

[0035] The interface 100 may include any suitable mask configuration. For example, certain features, aspects, and advantages of the present invention may be beneficial for nasal masks, full face masks, oral-nasal masks, or any other positive pressure mask. The illustrated mask is a full face mask. The illustrated interface 100 generally includes a mask assembly 102, a connection port assembly 104, and a headgear assembly 106.

[0036] 13, the mask assembly 102 generally includes a mask seal 110, which may include a mask seal clip 112, and a mask base 114. As described below, the mask seal clip 112 preferably connects the mask seal 110 to the mask base 114. Although the mask seal 110 and the mask seal clip 112 are shown as being formed separately and secured to one another, in some configurations, the mask seal 110 and the mask seal clip 112 may be integrated into one component. In some configurations, the mask seal 110 is formed over the mask seal clip 112 by multi-layer injection molding.

[0037] 3, the mask seal clip 112 is relatively stiffer, more rigid, or more inflexible than the mask seal 110. In some configurations, the mask seal clip 112 is formed of a polycarbonate material. In some configurations, at least a portion of the mask seal clip 112 is formed of polycarbonate or other rigid or semi-rigid material. In some configurations, the mask seal clip 112 is at least partially formed of silicone or other suitable material. In some configurations, at least the silicone portion of the mask seal clip 112 may be relatively thick compared to the more flexible portions of the mask seal 110. The mask seal clip 112 provides structural support to the mask seal 110 in the illustrated configuration.

[0038] As shown in FIG. 14, the mask seal clip 112 can define a large portion of the mask assembly 102. As shown, the mask base 114 overlaps with a majority of the mask seal clip 112. With reference to FIGS. 25-27, the mask assembly 102 can be configured in a variety of configurations as desired. For example, with reference to FIG. 25, the mask seal clip 112 extends only a limited amount from its junction with the mask seal 110. In the configuration shown in FIG. 25, the mask base 114 overlaps with at least a portion of the mask seal clip 112, while the mask seal clip 112 defines a very limited edge-like configuration around a portion of the mask seal 110. With reference to FIG. 26, the mask seal clip is eliminated altogether, and the mask seal 110 is formed directly on the mask base 114 by multi-layer injection molding. However, in some configurations, the mask seal 110 and mask base 114 can be configured to allow the two components to be separated. For example, as shown in Figure 27, the mask seal 110 may include a peripheral flange 111 while the mask base 114 may include a peripheral groove 115 that receives the peripheral flange 111, thereby allowing the mask seal 110 to be releasably secured to the mask base 114. In some configurations, other suitable methods may be used to secure the mask seal 110 to the mask base 114. Additionally, the configuration depicted in Figure 27 shows an embodiment without the mask seal clip 112, although the mask seal clip 112 and mask base 114 are integrated into the mask base 114.

[0039] With reference to Figure 5, the illustrated mask seal clip 112 includes a substantially cup-shaped configuration. A proximal end 120 defines an open end of the illustrated mask seal clip 112, while a distal end 122 defines a generally closed end of the illustrated mask seal clip 112. In the illustrated configuration, the proximal end 120 is generally surrounded by a lip 124. The lip 124 is generally pentagonal in shape when viewed from behind (see Figure 5). As shown in Figure 7, the wall 126 is generally arched forward. The arched shape of the wall 126 provides the illustrated mask seal clip 112 with a three-dimensional configuration.

[0040] 7, the upper portion 130 of the illustrated mask seal clip 112 has a generally arcuate configuration. Additionally, the generally arcuate configuration of the illustrated mask seal clip 112 is such that it can accommodate a larger nose, but does not reach as far up in an over-the-nose position as the mask seal 110, as shown in FIGS.

[0041] 3, the upper portion 130 of the illustrated mask seal clip 112 preferably includes two arc dimensions. First, an arc length 132 can be defined along an upper edge of the upper portion 130 of the illustrated mask seal clip 112. The arc length 132 can be defined between inflection points 134 found along the perimeter of the illustrated mask seal clip 112.

[0042] As shown in Figure 7, the upper portion 130 of the illustrated mask seal clip 112 also includes a side radius 136. As shown, the side radius 136 of the upper portion 130 may be slightly increasing, with the radius increasing slightly as the distance from the top increases. In some configurations, the upper portion 130 may include a substantially constant side radius 136 or a decreasing side radius. Advantageously, the slightly increasing side radius 136 provides the mask 100 with a larger volume adjacent the user's nose.

[0043] 3 and 6, the mask seal clip 112 preferably includes at least two recesses 140. In the illustrated configuration, the mask seal clip 112 includes two recesses 140 located laterally on opposite sides of a generally vertical central plane CP (see FIG. 6). The generally vertical central plane CP preferably corresponds to the midsagittal plane of the user and divides the illustrated mask seal clip 112 into two substantially mirror image halves. The two recesses 140 define two generally enclosed pockets in the illustrated mask seal clip 112. The illustrated recess 140 includes another recess 142 that is used to provide sufficient clearance for reasons described below while limiting the amount of intrusion into the nasal region of the space defined by the mask assembly 102.

[0044] The illustrated mask seal also includes a generally central passageway 144 defined by a wall 146. In the illustrated configuration, the wall 146 generally surrounds the passageway 144. Preferably, the wall 146 is of a generally cylindrical configuration and extends through the wall 126. Other configurations are possible.

[0045] 14, the mask seal 110 includes a flexible portion that extends away from the proximal end 120 of the mask seal clip 112. In the illustrated configuration, the mask seal 110 is formed on the mask seal clip 112 by multi-layer injection molding, such that the mask seal 110 and the mask seal clip 112 are joined together into a unitary, preferably inseparable, assembly. In some configurations, attempts to separate the mask seal 110 and the mask seal clip 112 may destroy the bond between the components and / or destroy one or both of the mask seal 110 and the mask seal clip 112. As previously mentioned, other assemblies may be used to connect the mask seal clip 112 to the mask seal 110. However, the illustrated configuration advantageously provides a structure that is easy to clean and maintain.

[0046] 4, the mask seal clip 112 is preferably constructed such that it is generally flush with an inner edge 150 of the mask seal 110. In the illustrated configuration, the mask seal 110 includes a relatively small radius portion 152 that leads to an upper portion 154. The upper portion 154 of the mask seal 110 is configured to cover the nasal region of a user. In some configurations, the upper portion 154 is configured to cover the nasal bridge region of a user U.

[0047] The upper portion 154 is connected to a lower portion 156 of the seal member 110. The lower portion 156 extends laterally outward from the mask seal clip 112, as shown in FIG. 9. Additionally, the lower portion 156 bends backwards and inward, as shown in FIGS. 4 and 10, respectively. Proximal to the full-face mask assembly 102, the upper portion 154 and the lower portion 156 jointly define a face-contacting flange 160, as shown in FIG. 10. The face-contacting flange 160 is configured to be positioned under the user's lower lip, extend along the outside of the mouth, extend upward along the cheekbones, and extend across the bridge of the user's nose. The illustrated face-contacting flange 160 thus defines a generally teardrop-shaped opening 162. When the mask assembly 102 is placed on the user's face, the flange 160 is positioned to cover the bridge of the user's nose, cheekbones, the outside of the mouth, and under the lower lip. When supplied with positive air pressure, the mask seal 110 expands and seals tightly against the user's face, reducing or eliminating the possibility of leakage between the flange 160 and the user's face.

[0048] As shown by the dashed lines in FIG. 11 , the top 154 ​​of the mask seal 110 is designed to roll over onto the outer surface 170 of the mask assembly 102. In the illustrated configuration, the outer surface of the mask seal 110 rolls smoothly into contact with the outer surface of the mask seal clip 112, which then forms a support surface. In some configurations, the outer surface 170 over which the top 154 ​​rolls includes at least a portion of the outer surface of the mask seal clip 112. In some configurations, the outer surface 170 over which the top 154 ​​rolls includes almost exclusively the outer surface of the mask seal clip 112. In some configurations, the top 154 ​​rolls over another portion of the mask seal 110. In some configurations, the top 154 ​​rolls over the mask seal base 114.

[0049] 12, to aid in the roll of the top 154, the thickness of the top 154 ​​may be varied or the stiffness may be varied. In the configuration shown in FIG. 12, the top 154 ​​includes a thick / thin / thick configuration. In other words, a less stiff region 172 may be incorporated to induce the top 154 ​​to roll in the area between the face-contacting flange 160 and the small radius portion 152 proximate the mask seal clip 112. In the illustrated configuration, the less stiff region 172 is incorporated into the mask seal 110. The less stiff region 172 reduces or eliminates the possibility of the mask seal 110 bending or deforming adversely in areas other than the area desired to roll.

[0050] Although the illustrated configuration utilizes thinner regions, other means for providing the less stiff regions 172 can be used to induce the seal member 110 to roll. For example, the material of the seal member 110 can be configured to reduce stiffness through material selection or material properties. Additionally, material composition can be utilized to provide regions of lower bending stiffness or regions of lower torsional rigidity. Additionally, any suitable combination of techniques can be used. Nevertheless, the illustrated thinner configured regions 172 provide a simple way to achieve the less stiff regions 172. Additionally, by adjusting the stiffness of the less stiff regions 172, the force required to induce the regions 172 to roll can be controlled, which controls the force applied to the user's nose. For example, by varying the stiffness, the resistance to movement can be increased or decreased throughout the range of movement.

[0051] When the upper portion 154 includes a less stiff region 172, the upper portion 154 of the mask seal 110 tends to expand outwardly under internal pressure, such as that experienced during positive pressure therapy, and this expansion is believed to occur due to the less stiff region 172 defining a large area of ​​silicone without significant structure. With reference to FIGS. 4 and 12, to prevent the upper portion 154 from expanding too much and to improve the structure of the upper portion 154, a reinforcing component such as a band 174 can be attached along at least a portion of the upper portion 154. The band 174 can be a component formed of a material characterized as being stiffer than or stiffer relative to the silicone or other material forming the mask seal 110. For example, if the less stiff region 172 is formed of the same material forming the mask seal 110, a significantly thicker region relative to that region can be used to increase the stiffness of the reinforcing component.

[0052] In some configurations, the band 174 may be a separately formed component that is at least partially enveloped by the material of the mask seal 110. In the illustrated configuration, the band 174 may be a co-molded plastic component, or the mask seal 110 may be formed by multi-layer injection molding over the band 174. In some configurations, the band 174 may be defined by a portion of the upper portion 154 that is stiffer than the surrounding areas. For example, but not limited to, the band 174 may be defined by a thicker portion, a portion of different material or material properties to increase stiffness, or otherwise.

[0053] 9, the band 174 extends along at least a portion of the top 154 ​​of the mask seal 110. The top 154 ​​of the mask includes an apex 180 when viewed from the front. The apex 180 may be defined as the tip, top and angled peak of the mask seal 110, which is positioned adjacent the user's nose in use. A first wall 182 and a second wall 184 converge at the apex 180 in the illustrated configuration.

[0054] In some configurations, at least a portion of first wall 182 and at least a portion of second wall 184 are reinforced by one or more components or structures, such as, for example, band 174. In the illustrated configuration, a reinforcing component, such as, for example, band 174, reinforces at least a portion of first wall 182 and at least a portion of second wall 184. In some configurations, a reinforcing component, such as, for example, band 174, reinforces at least a portion of first wall 182 and at least a portion of second wall 184 and apex 180.

[0055] 9, the illustrated band 174 has a first end 186 and a second end 188 opposite the first end 186. In some configurations, the band 174 may be formed separately from the mask seal clip 112 and attached to the mask seal clip 112 by one or more flexible components. In some configurations, the band 174 may be connected to the mask seal clip 112 by a mechanical hinge structure. In the illustrated configuration, the first end 186 and the second end 188 are located on the same side of the hinge axis H as the apex 180. Preferably, the first end 186 and the second end 188 are spaced from the hinge axis H toward the apex 180.

[0056] As shown in FIG. 12, the bend 152 and stiffer regions (e.g., regions of thicker cross section) adjacent the less stiff region 172 help initiate the roll of the less stiff region 172. In other words, the less stiff region 172 bends in a controlled manner with the assistance of the stiffer adjacent portions. In addition, positioning the edge of the relatively stiffer mask seal clip 112 near the bend 152 further helps guide the roll of the less stiff region 172. In some configurations, the less stiff region 172 is bounded by a first boundary and a second boundary, the first boundary and the second boundary having a higher stiffness relative to the less stiff region. For example, in the illustrated configuration, the first boundary is defined by or along the band 174 and the second boundary is defined by or along the bend 152. In some configurations, the second boundary can be defined by or along the edge of the stiffer mask seal clip 112. In some configurations, the second boundary may be defined along a portion of the mask seal 110 positioned between the mask seal clip 112 and the less stiff region 172 .

[0057] As the top 154 ​​of the mask seal 110 moves about the hinge axis H, the roll becomes larger. In other words, as the first boundary moves toward the second boundary initially, the roll is created in the mask seal 110. As the first boundary continues to move toward the second boundary, the roll continues to increase. Thus, in the configuration shown in FIG. 11, the roll defined in the top 154 ​​starts at zero and gradually increases as the top 154 ​​moves, as shown by the dashed line. Preferably, the roll between the first boundary and the second boundary creates a single bend or bend between the first boundary and the second boundary. The single bend provides a leg approaching the bend location that increases as the first boundary moves toward the second boundary. In other words, the roll created by the first boundary moving toward the second boundary does not result in a fan-like appearance, such as a pleated configuration.

[0058] 3, the mask seal 110 may be shaped to help facilitate continued roll of the less stiff regions 172 after roll has begun. The arc length may generally be defined as ranging from a first intersection of the hinge axis H with the mask seal 110 upwardly, through the top 154 ​​of the mask seal 110, and back downwardly to a second intersection of the hinge axis H with the mask seal 110.

[0059] As shown in FIG. 3, the illustrated mask seal 110 includes at least a first arc length A (shown in dashed lines), a second arc length B (shown in dashed lines), and a third arc length C (shown along the base of the band 174). The first arc length A is preferably longer than the arc length of the mask seal clip 112 immediately adjacent the first mask arc length A. The second arc length B is positioned between the first arc length A and the third arc length C, and the second arc length B is preferably shorter than the third arc length C and longer than the first arc length A. In some configurations, the arc length steadily increases from the curved portion 152 or other region proximal to the outer surface 170 toward the band 174 in a proximal direction. In other words, as the angle α (see FIG. 4) from the first arc length A increases, the arc length generally increases. In some configurations, the arc length can be substantially constant from front to back (i.e., as angle α increases), but by increasing the arc length away from where the roll begins, as apex 180 moves further distally, mask seal 110 continues to roll over onto itself and over outer surface 170, as shown in FIG. 11.

[0060] Referring again to Figure 4, the top portion 154 of the illustrated mask seal 110 also includes varying radii when viewed from the side. As shown, R1>R2>R3. Thus, in the illustrated mask seal 110, the radii decrease from proximal to distal with increasing angle. In some configurations, the radii may not decrease in this manner, however, it is believed that the decrease in radius assists in the roll of the mask seal 110.

[0061] Additionally, the radius r1 of the mask seal clip 112 from the hinge point H is preferably less than the radius R3 of the mask seal 110. However, given the pliable nature of the mask seal 110, the radii r1 and R3 could be substantially the same and still allow the mask seal 110 to roll over onto the mask seal clip 112. However, in the illustrated configuration, the difference between radii r1 and R3 creates a step. This step allows the side radius 136 to be slightly larger, as previously discussed, without significantly affecting the ability of the mask seal 110 to roll over onto the mask seal clip 112. Without the step, the ability to increase the side radius 136 would be very limited.

[0062] As previously mentioned, the flange 160 surrounds a generally teardrop-shaped opening 162. As is well known, circumferential stress can be defined as the stress in the circumferential direction in a cylindrical part resulting from internal pressure. Thus, circumferential stress increases as the rings attempt to expand. It is believed that circumferential stress resulting from wearing a respiratory mask can cause some discomfort to the user, particularly in the nasal bridge area. The lower portion 156 of the illustrated mask assembly 102 is generally fixed in place, while the nasal or upper portion 154 moves relative to the user's nose. The above-mentioned rolling action causes the illustrated full face mask assembly 102 to roll away from the nose, thereby reducing the occurrence of circumferential stress buildup, particularly around the nasal bridge. Thus, the rolling mask configuration provides a means to maintain or reduce circumferential stress during mask wearing.

[0063] As mentioned above, as shown in Figure 11, the top 154 ​​of the illustrated mask seal 110 rolls over onto the outer surface 170 in the illustrated configuration. Such rolling over the mask outer surface takes advantage of the positive pressure present within the full face mask, as increased air pressure increases the mask seal's ability to roll onto itself (i.e., it reduces the surface tension between the two surfaces of the mask seal that slide against each other during rolling), and the slight expansion effect helps reduce the likelihood that the mask seal 110 will bend, wrinkle, or fold unnecessarily. Additionally, depending on the configuration, the outward rollover can provide a visual cue as to the degree or angle of movement of the top 154 ​​of the mask seal 110 relative to the bottom 156 of the mask seal 110.

[0064] A visual indicator may also be utilized to provide a user with a better understanding of the extent to which the upper portion 154 of the mask has rolled. For example, in some configurations, graduations may be printed, embossed, or otherwise disposed on or near the less stiff region 172. In some configurations, the graduations may be located along the portion of the mask 100 where the less stiff region 172 rolls over. For increased fidelity, the graduations are preferably located in a central location to maximize the extent to which the less stiff region 172 rolls. The graduations may be, for example, but are not limited to, a numbered graduation or a color gradient graduation.

[0065] In some configurations, a pawl or locking mechanism can be incorporated into the mask so that the less rigid region 172 can be set at a predetermined roll position. For example, a pawl mechanism having a series of teeth that engage a closure member (e.g., a zip-tie locking pawl) can be used. As the top 154 ​​of the mask moves around the hinge point, the locking mechanism can ensure that the top 154 ​​is held in that position when the mask 100 is removed from the face of the user U. Preferably, the locking mechanism allows the locked position to be easily released if needed so that the top can be loosened and returned to a better fitting position if the mask is moved too far. Thus, the user can set the extent to which the top 154 ​​rolls once, and then it will have the same level of roll with every use.

[0066] By rolling, the upper portion 154 (i.e., the portion of the seal member that contacts the bridge of the nose) moves as pressure from the mask flange 160 on the user's face increases. As a result of this movement, the force applied by the upper portion 154 to the bridge of the nose is substantially constant over a wide range of pressures that the lower portion 156 applies to other parts of the user's face. Similarly, the force required for the upper portion 154 to move is also substantially constant. As shown in FIG. 28, with the configuration shown, the increase in force associated with the range of movement is less than about 0.5N as the position of the upper portion changes over 25mm. Because the force on the nose is generally constant over the range of angles and associated upper portion movement, the force on the bridge of the nose does not change significantly at various headgear tension levels. Again, such a result is shown in FIG. 28, where the total change in force over a range of movement of the apex 180 from 5mm to 25mm results in a change in force of about 0.2N. Additionally, the force on the nose is generally constant over a range of angles, allowing the mask to be adjusted to improve fitting with a variety of face shapes while limiting pressure on the sensitive nose bridge area.

[0067] The use of a rolled configuration provides significant improvements when compared to configurations featuring a pleated configuration. First, by rolling outward instead of pleating, the possibility of the mask seal material infiltrating into the space designed to accommodate the user's nose is reduced or eliminated. Rolling outward therefore reduces the possibility of contacting the user's nose in that space as the upper portion 154 moves relative to the lower portion 156. Second, it is believed that rolling outward instead of pleating improves the user's perception of the full face mask compared to a pleated assembly by providing a cleaner appearance and reducing the number of exterior cavities.

[0068] Referring to Fig. 24, the mask seal 110 shown rolls over onto the outer surface 170, however the mask seal can be configured to roll on the inside of the mask assembly. In other words, an inward rollover can be used in some configurations. An inward rollover is less preferred than an outward rollover because positive pressure tends to interfere with the rolling and the rolling action tends to intrude into the nose receiving space. In contrast, an inward rollover provides a cleaner appearance than an outward rollover because any expansion of the seal member is contained within the mask seal clip.

[0069] 1 and 2, the mask assembly 102 includes a mask base 114, which is more rigid than the mask seal 110. The mask base 114 may be formed from any suitable material. In some configurations, the mask base 114 is formed from a polycarbonate material, such that it is able to flex when connecting with the mask seal 110 and / or the mask seal clip 112.

[0070] 14, the mask assembly 102 is shown having a mask base 114 secured to a mask seal 110. More particularly, in the configuration shown, the mask base 114 is secured to a mask seal clip 112, which is attached to the mask seal 110 in any suitable manner. In some configurations, the mask base 114 and the mask seal 110 or the mask seal clip 112 are releasably connected. In some configurations, the mask base 114 is snap-fitted together with one or both of the mask seal 110 and the mask seal clip 112. Preferably, the mask seal 110 and the mask seal clip 112 can be removed from the mask base 114, and a snap-fit ​​connection secures the mask seal clip 112 to the mask base 114.

[0071] 14 and 15, the mask base 114 in the figures overlaps at least a portion of the mask seal clip 112. In some configurations, the mask base 114 almost completely covers the mask seal clip 112. In some configurations, the mask base 114 extends over more than half of the mask seal clip 112. When the mask base 114 overlaps a majority of the mask seal clip 112 or mask seal 110, a two-layer effect occurs (e.g., mask seal clip 112 and mask base 114). The two-layer effect improves insulation when a majority of the mask base 114 overlaps a majority of the mask seal clip 112 or mask seal 110. The improved insulation allows the inner portions (e.g., mask seal 110 and / or mask seal clip 112) to be warmer, resulting in less moisture rainout during use. Preferably, at least a portion of the mask seal clip 112 is exposed from underneath the mask base 114, resulting in the mask base 114 being more easily separated from the mask seal clip 112. 15, the mask base 114 shown includes a peripheral surface 200 at a proximal end to facilitate separation of the mask base 114 from the underlying mask seal 110 and / or mask seal clip 112. The mask base 114 is recessed inwardly to accommodate the underlying components. In other words, the mask base 114 is arm-shaped in the distal direction relative to the proximal peripheral surface 200.

[0072] The peripheral surface 200 includes one or more recesses 202. Preferably, the recesses 202 include at least two recesses 202 that are positioned on opposite sides of the mask base 114. The recesses 202 are configured to receive a thumb and index finger so that the mask base 114 can be more easily removed from the front of the mask seal clip 112 underneath. The recesses 202 may define a means for gripping the assembly underneath the mask base 114 when removing the mask base, although other configurations may be used, such as, but not limited to, outwardly extending tabs, protrusions, or the like. In addition, while the recesses 202 shown are located on both lateral sides of the mask base 114, the recesses 202 may be located on the top and bottom, or in other areas, as desired.

[0073] As shown in FIG. 13, the mask base 114 preferably includes an opening 210 defined by a wall 212. Referring to FIG. 14, which is a cross-section through the mask seal 110, the mask seal clip 112, and the mask base 114, the wall 212 defining the opening 210 through the mask base 114 preferably fits within the wall 146 defining the passageway 144 through the mask seal clip 112. As shown in FIG. 14, the wall 212 may be axially coextensive with the wall 146. In addition, the walls 146, 212 may be sized and shaped such that the walls interact with each other to reduce relative sliding between the walls 146 and 212 and to reduce the likelihood of the mask seal base 114 becoming separated from the mask seal clip 112, which may be disadvantageous. In some configurations, the walls 146, 212 fit together to reduce the likelihood of leakage from the joint between the walls. Preferably, the walls 146, 212 are secured together with a taper lock.

[0074] With further reference to FIG. 14, the wall 212 includes a contoured inner surface 214. The radius of the contoured surface 214 may be such that it can receive a ball end 220 of a swivel elbow 222, such as that shown in FIG. 17. As better shown in FIG. 18, the ball end 220 has a contoured surface 224 that can snap into the contoured surface 214 formed on the mask base 114. The connection between the two contoured surfaces 214, 224 allows the surfaces to slide relatively freely relative to one another, thereby allowing the position of the swivel elbow 222 to be easily changed. In some configurations, the elbow 222 can be configured to rotate or pivot without having a ball and socket arrangement.

[0075] 13, the mask base 114 also includes at least two pockets 230. The illustrated mask base 114 includes two pockets 230. The pockets 230 are recessed into the mask base 114 and protrude rearwardly therefrom. The pockets 230 are received in recesses 140 in the mask seal clip 112. An opening 232 defined by a peripheral wall 234 overlies another recess 142 formed in the mask seal clip 112.

[0076] The illustrated pockets 230 are formed such that one pocket 230 is formed on each lateral side of the mask base 114. The pockets 230 may be positioned symmetrically about a central plane CP, which plane substantially bisects the mask base 114. In some configurations, the pockets 230 have a vertical dimension 240 that is greater than a lateral dimension 242, as shown in Figure 15. Similarly, the openings 232 have a vertical dimension 244 that is greater than a lateral dimension 246, as shown in Figure 15.

[0077] In the illustrated mask base 114, the laterally inward portion of each pocket 230 includes a support wall 250. The support wall 250 is positioned toward the central plane CP relative to a normal to the base surface 248 of the pocket 230. Each of the pockets 230 is configured to receive a clip 252 (see FIG. 22). When the clip 252 is installed in the pocket 230, the support wall 250 helps to limit rotation of the clip 252 relative to the pocket 230. Additionally, the increased vertical dimension helps the user position the pocket 230 with the clip 252 during installation.

[0078] Referring to FIG. 22, the clips 252 may be configured in two parts: an outer cover 254 and an inner fastener 256. The straps 260 may be secured to each clip 252 in any suitable manner. One suitable configuration is shown in FIG. 2. In some configurations, the straps 260 may be sandwiched between the outer cover 254 and the inner fastener 256. In some configurations, the clips 252 may have loops or openings or holes through which the straps 260 may be threaded. Preferably, one clip 252 may be connected to both the upper and lower straps of the headgear assembly 106. Such a configuration allows the headgear assembly 106 to be easily connected to and removed from the full face mask assembly 102.

[0079] 23, the clip 252 includes an angled surface 262. The angled surface 262 may be provided on the outer cover 254. The angled surface 262, in cooperation with the support wall 250, helps to orient the clip 252 relative to the pocket 230 of the mask base 114.

[0080] The clip 252 includes an interlocking means 264 that is configured to be inserted into an opening 232 defined in the pocket 230 of the mask base 114. The interlocking means 264 is capable of snap-fit ​​engagement with a tab 236 defined along a wall 234 that defines the opening 232 of the mask base 114, as shown in Figure 13. Other methods of interlocking the clip 252 into the pocket 230 may also be used.

[0081] 23, the interlocking means 264 of the illustrated clip 252 includes a U-shaped component 268 having a release lever 266 at its end. The U-shaped end 268 protrudes a sufficient distance to allow connection with the tab 236, but not so far that the bottom of another recess 142 of the mask seal clip 112 prevents further proper insertion of the interlocking means 264 into the opening 232. The U-shaped end 268 first contacts the wall of the opening 232 during connection of the clip 252 to the mask base 114. In the illustrated configuration, the U-shaped end 268 contacts the wall 234 of the opening 232 during insertion, which guides the clip 252 into position within the pocket 230. The opening 232, or one or more surfaces defining the opening 232, generally aligns the clip 252 with respect to the mask base 114 during connection of the clip 252 to the mask base 114.

[0082] An end of the release lever 266 extends through an opening 270 defined by a wall 272. Preferably, the end of the release lever 266 projects from the opening 270 a sufficient distance to allow the release lever 266 to be easily manipulated. By moving the release lever 266 in a manner to close the U-shape of the interlocking means 264, the interlocking means 264 is disengaged from engagement with a tab 236 in the wall 234 that defines the opening 232 in the mask base 114.

[0083] 32-39 show alternative configurations of clip assemblies 252 configured to secure the mask assembly 102 to the head of a user. For example, the clips 252 of FIGS. 32 and 33 have raised edges 400 (sometimes referred to as finger tabs 400) that allow a user to easily remove the headgear 106 from the mask assembly 102. The raised edges 400 are oriented such that a user can simply pull rearward on the raised edges 400 to disengage the clips 252 so that they pop out from the mask base 114. By disengaging one or more clips 252 from the mask base 114, the mask assembly 102 is easily removed from the user's head. The raised edges 400 provide a gripping point during attachment and removal of the headgear 106 from the mask assembly 102. For example, a user may support either side of the raised edges 400 with their thumb and index finger to disengage the clips 252 from the mask assembly 102. Additionally, the user may grasp and hold the clip 252 while fitting the mask, eliminating the need to hold the strap 260 during assembly. This also allows the user to attach, remove, and reinstall the clip 252 while holding the raised edge 400.

[0084] FIG. 34 shows an exploded view of the clip 252 of FIGS. 32 and 33. The clip 252 includes an outer cover 254 and an inner catch 256. The inner catch 256 includes one or more slots 402 that receive the distal ends of the headgear straps 260. The inner catch 256 may also include a number of pressure protrusions, such as those shown in connection with the configurations of FIGS. 38 and 39. The pressure protrusions apply additional pressure to the outer cover 254 and the inner catch 256, thereby securing them together. In one configuration, the headgear straps 260 can be removed from the clip 252 in an assembled state.

[0085] The inner catch 256 includes a long slot 404 as shown in FIG. 35. The slot 404 includes a circular opening 406 having a diameter greater than the width of the slot 404. The slot 404 and the circular opening 406 may include chamfered recesses that aid in aligning the clip 252 with the mask assembly 102. The circular opening 406 facilitates attachment and detachment of the clip 252 to and from the mask assembly 102, as will be described in more detail below. Two grooves 408 extend parallel to the sides of the slot 404, thereby defining slot walls 410 (sometimes referred to as clip levers) on either side of the slot 404. The grooves 408 are sized such that the slot walls 410 flex sufficiently during attachment and detachment of the clip 252 to and from the mask assembly 102. Additionally, the slot walls 410 extend up and down along the longest dimension of the inner catch 256, thereby allowing for a longer slot wall 410 to be utilized. The longer slot walls 410 reduce the stress levels placed on the slot walls when the clip is attached to the mounting post.

[0086] One configuration of a mask base 114 suitable for use with the clip 252 of Figures 32-35 is shown in Figure 36. The mask base 114 includes two recesses 140 symmetrically positioned on either side of the mask base 114. A mounting post 412 extends from within each recess 140 in the body of the mask base 114. The mounting post 412 may be integrally formed with the mask base 114 or may be formed separately and secured to the mask base 114. The mounting post 412 may have a mushroom-shaped configuration that secures the clip 256 to the mask base 114 when the user snaps the clip 256 into place. The rounded top of the bulbous mushroom-shaped post 412 helps to position and orient the central hole 406. When the clip 252 is fitted into the post 412, the slot walls 410 bend outward, away from the post 412. Once the head of the post 412 clears the edge of the slot wall 410, the slot wall 410 snaps back into its original position, thereby providing tactile, and sometimes audible, feedback that the clip 252 is properly attached to the mask assembly 102.

[0087] The mounting post 412 may also include a long, oval raised portion 414 (sometimes called a lug or wing) that is sized to mate with a long slot 404 in the inner catch 256. The long raised portion 414 includes a chamfered edge, which helps to properly align the headgear 106 with the mask assembly 102. The portion 414 prevents the clip 252 from rotating with respect to the mask assembly 102. This helps to ensure that there is constant tension on the headgear straps 260 while the user is sleeping.

[0088] 37 shows a partial assembly of an alternative configuration for securing the clip 252 to the mask base 114 of the mask assembly. The clip 252 fits within a recess 140 in the mask base 114. A cylindrical, button-headed post 412 extends from within the recess 140 in the surface of the mask base 114. The post 412, due to its cylindrical shape, allows the clip 252 attached thereto to rotate slightly. However, as shown in FIGS. 38 and 39, the slot 404, groove 408 and slot walls 410 extend along the shorter planar direction of the inner catch 256 toward its front and rear ends.

[0089] The inner catch 256 also includes a number of pressure protrusions 414. As previously discussed, the pressure protrusions further apply pressure to the outer cover 254 and the inner catch 256, such that they are secured together.

[0090] Alternative configurations of clip 252 are shown in Figures 40-47. Clip 252 of Figure 40 includes three long oval slots 404 and a finger tab 400. The finger tab 400 is used to act as a lever to release clip 252 from mask assembly 102. The central slot 404 is sized to receive a mounting post 412 extending from the outer surface of the mask body. One such suitable mounting post 412 is shown in Figure 43. Mounting post 412 includes a head 414 and two slots 416. When clip 252 is fitted onto mounting post 412, the outer portions of post 412 bend towards each other due to the gap provided by slot 416. When head 414 exits the top surface of clip 252, mounting post 412 snaps back into its original position and head 414 locks clip 252 in place.

[0091] A similar configuration is shown in Figures 44-47. Clip 252 of Figure 45 does not include finger tabs and its central opening 404 is more round, more oval in shape than the elongated slot of Figures 40-44.

[0092] All of the above configurations simplify the procedure for securing the mask assembly 102 to the user's head. For example, the clips 252 open the headgear 106 so that it is no longer a closed loop. By opening, the headgear 106 may be wrapped around the head without the user having to force their head into it.

[0093] 2, in addition to the strap 260, the headgear assembly 106 also includes a back strap 280 and a top strap 282. Other headgear assemblies may also be used. The back strap 280 is wrapped around the back of the head of the user U to a position generally above the nape of the neck but generally below the occipital protuberance. At a position behind the user's ear, the back strap 280 bifurcates into an upper arm 284 and a lower arm 286. The upper arm 284 bends upward to a position above the user's ear and then bends downward to a position generally in front of the user's ear. The lower arm 286 bends downward to a position generally below the user's ear and extends slightly forward of the ear.

[0094] The strap 260 may be connected to the back strap 280 in any suitable manner. In the illustrated configuration, the strap 260 is connected to an upper arm 284 and a lower arm 286, respectively. Preferably, the upper arm 284 and the lower arm 286 are stiffer than the strap 260, such that the arms 284, 286 generally maintain their shape during wear of the headgear assembly 106. In some configurations, the upper arm 284 and the lower arm 286 each support their own weight. In some configurations, the upper arm 284 and the lower arm 286 each are structured to avoid entanglement during wear. For example, the arms 284, 286 have sufficient torsional stiffness to reduce the likelihood of twisting during wear.

[0095] Preferably, the strap 260 is connected to at least one of the upper arm 284 and the lower arm 286 at a location in front of the ears. Such a configuration helps the user to position the strap 260 without too much difficulty. Additionally, because the strap 260 in the illustrated configuration is embedded in the clip 252, the ends of the upper arm 284 and the lower arm 286 may include slots 290, 292 so that the strap 260 can be threaded through the slots 290, 292. Additionally, the strap 260 may include an adjustment mechanism 294, such as a Velcro or buckle configuration. The adjustment mechanism 294 allows the force between the mask seal 110 and the face of the user U to be adjusted. Any suitable adjustment mechanism 294 may be used.

[0096] 2, the top strap 282 is preferably flexible and has an adjustable length. The top strap 282 is connected to the upper arm 284 through a slot 296 to reduce the chance of the upper arm 284 slipping off the user's head and contacting the user's ear. Preferably, the top strap 282 is connected to the upper arm 284 at a location generally above the user's ear.

[0097] Advantageously, as shown in Figures 1 and 2, when the strap 260 is connected to the mask base 114, it exerts a force in the direction of arrow F by moving it in direction C, which is generally perpendicular to the direction of force F. In other words, the strap 360 is tensioned by pulling it forward, and the clip 252 is connected to the mask base 114 by moving it in a direction perpendicular to the forward pull. Such a configuration facilitates securing the interface 100 to a user's face.

[0098] In another configuration, the headgear assembly 106 includes semi-rigid headgear 380 (shown in FIG. 29 ), which secures the mask assembly 102 to the user's head. The semi-rigid headgear 380 is formed as a composite structure including semi-rigid straps 382 coupled to soft edging 384. For example, the soft edging 384 can be coupled to the semi-rigid straps 382 by multi-layer injection molding of plastic or by use of adhesive. As shown in FIG. 29 , the soft edging 384 can be butt-jointed to the semi-rigid straps 382, ​​such that the soft edging 384 does not overlap the semi-rigid straps 382, ​​thereby maintaining a continuous shape of the semi-rigid headgear 380. The semi-rigid straps 382 define the shape of the semi-rigid headgear and maintain that shape when tension is applied from the straps 260 to pull the mask assembly 102 towards the user's head. In other words, the semi-rigid strap 382 has sufficient stiffness along its planar axis to prevent its upper and lower arms 284, 286 from deforming excessively under tension. The semi-rigid strap 382 can be made of a variety of rigid or semi-rigid materials, such as plastic or metal. In some configurations, the semi-rigid strap 382 is made from PVC.

[0099] In particular, for semi-rigid headgear assemblies, it has been found that the shape-retaining or self-supporting nature of the headgear assemblies results in an overall assembly that can be intuitively fitted. In particular, where the connectors and / or headgear members are self-supporting and retain their three-dimensional shape, the headgear can be fitted in the correct orientation with very little, if any, instruction. In a self-supporting structure, straps tend not to get tangled, reducing the time it takes to fit the entire assembly.

[0100] As used herein, the term "semi-rigid" means that the headgear assembly is sufficiently rigid to be able to assume a three-dimensional shape that approximates the dimensions of the patient's head that the headgear assembly 380 is designed to fit, while being flexible enough to generally conform to the patient's physical shape. For example, some of the other components of the headgear assembly 380 (e.g., arms and straps) may also be partially or entirely "semi-rigid," such that these components can retain a substantially free-standing three-dimensional shape. A "semi-rigid" headgear assembly does not mean that the individual components of the headgear assembly must be semi-rigid. For example, the substantially free-standing three-dimensional shape that the headgear assembly 380 can assume may be primarily relative to the back and top of the headgear assembly 380. In addition, the semi-rigid headgear assembly 380 may include semi-rigid regions that extend in front of and above the ears when placed on the patient's head.

[0101] The left and right upper and lower arms 284, 286 may also be formed from a semi-rigid material, as used herein, which may include molded plastic or sheet materials, such as, but not limited to, homogeneous plastic materials and bonded non-woven fibrous materials.

[0102] In some configurations, one or more of the arms or straps are formed of a substantially inelastic material. The arms or straps can be formed of a semi-rigid, self-supporting material, such that the semi-rigid headgear assembly 380 can assume a substantially three-dimensional shape and generally does not tangle. In some configurations, the material can include, for example, but is not limited to, a laminated structure having both conformable and semi-rigid portions. The semi-rigid straps 382 can be made of a self-supporting, resilient, substantially inelastic material, such as, but not limited to, Santoprene, polyolefin, polypropylene, polyethylene, expanded polyolefin, nylon, or non-woven polymeric materials. In some configurations, the semi-rigid straps 382 are formed from a polyethylene or polypropylene system. The material can be made of a low density polyethylene, such as Dowlex 2517, which is a linear low density polyethylene with a tensile yield strength of 9.65 MPa, a tensile strength at break of 8.96 MPa, and a -2% secant flexural modulus of 234 MPa. The semi-rigid straps 382 are preferably formed from a material that allows the semi-rigid headgear 380 to substantially maintain its shape under its own weight regardless of its orientation. In some configurations, the semi-rigid straps 382 do not stretch more than about 6 mm under a tensile load of 30 N. In some configurations, the semi-rigid straps 382 do not stretch more than about 3 mm under a tensile load of 30 N.

[0103] In some configurations, the semi-rigid straps 382 are formed from a non-woven polyolefin (NWP) that is bonded to the polyolefin (e.g., by multi-layer injection molding or lamination). In such configurations, the multi-injection molded polyolefin material provides shape retention properties. Additionally, the softer NWP material is adapted to contact the skin and provide desired comfort. Additionally, the NWP material can assist in providing desired load-bearing properties, such as desired tensile load-bearing properties.

[0104] The semi-rigid headgear 380 is generally formed of a semi-rigid material. As used herein, a semi-rigid material may include molded plastic or sheet materials, including, but not limited to, similar plastic materials and bonded non-woven fibrous materials. The upper and lower arms 284, 286 also include such semi-rigid materials, since the arms 284, 286 are integrally formed with and part of the semi-rigid headgear 380. Preferably, the left and right lower arms 286 are formed as a unitary component that wraps around the back of the patient's head and over the neck in use.

[0105] The soft edging 384 covers or is attached to at least a portion of the periphery of the semi-rigid straps 382. In one configuration, the soft edging 384 does not cover the front or back of the semi-rigid straps 382. For example, the thickness of the soft edging 384 and the semi-rigid straps 382 can be the same at the location where they are joined to one another.

[0106] The soft edging 384 provides a soft, comfortable contact between the perimeter of the semi-rigid strap 382 and the user's skin. The soft edging 384 can be made of a variety of soft materials, including, but not limited to, plastic, elastomer, silicone, or thermoplastic polyurethane (TPU) plastic. The shore hardness of the soft edging 384 can be in the range of 10 to 80 (Shore A).

[0107] As used herein with respect to headgear and straps, "soft" is used to describe the feel of the material, which refers to the quality of the material as assessed by the response obtained by the sense of touch. Additionally, as used herein with respect to headgear and straps, "conformable" is used to describe the ability of the material to conform to the patient's physical characteristics (e.g., around facial features). In particular, straps that include at least one element of "soft" and / or "conformable" material may also be "semi-rigid" and / or axially inelastic.

[0108] The soft edging 384 can be of uniform thickness, or in some configurations, can be of non-uniform thickness. For example, in some configurations, the soft edging 384 is the same thickness as the semi-rigid straps 382. In other configurations, the soft edging 384 is thinner than the semi-rigid straps 382, ​​forms a bulbous end of the semi-rigid straps 382, ​​or is simply thicker than the semi-rigid straps 382. Various cross-sectional views of the semi-rigid headgear 380 are shown in FIG. 29. Each cross-sectional view (A-A' through F-F') shows one possible configuration of the thickness of the semi-rigid straps 382 and the soft edging 384, which may be combined as desired. For example, any one particular soft edging 384 thickness and shape may be applied to some or all of the semi-rigid straps 382, ​​or may be combined with other particular coating thicknesses and shapes as shown in FIG. 29.

[0109] Many other thickness configurations may be provided. Additionally, the thickness of material may be applied symmetrically or asymmetrically to the semi-rigid straps 382. For example, cross sections C-C' and F-F' are shown asymmetrically, while in other configurations, the thickness of both ends of the soft edging 384 is applied symmetrically to the semi-rigid straps 382. In some configurations, the semi-rigid straps 382 are selectively thickened to provide extra stiffness and support. For example, the two configurations shown as cross section F-F' have such thickness configurations. Finally, in some configurations, ventilation through-holes 396 are provided throughout the semi-rigid headgear 380 (e.g., on the semi-rigid straps 382 or on the soft edging 384 as shown in FIG. 29) to allow for ventilation and sweat management.

[0110] 29, when laid flat, the semi-rigid headgear 380 defines three C-shaped arched regions 386, 388, 390. The two ear surrounding regions 386, 388 are defined by the upper and lower arms 284, 286, and the rear region 390 is defined by the lower arm 286 and the backstrap portion 280. The semi-rigid headgear 380 is flexible enough to bend to conform to the shape of the user's head such that the ear surrounding regions 386, 388 at least partially surround or encircle the user's ears and the rear region 390 at least partially surrounds or encircles the user's back head at a location above the ears.

[0111] The curvature of each arm 280, 284, 286 can be selected to provide a comfortable fit and allow the semi-rigid headgear 380 to be easily placed on and removed from a user's head. For example, in the illustrated configuration, the upper arm 284 has a concave curvature and the lower arm 286 has a convex curvature relative to the openings in the upper ear arched regions 386, 388. The backstrap portion 280 and the lower arm 286 all have a concave curvature relative to the opening in the neck arched region 390. These curvatures allow the semi-rigid headgear 380 to be easily placed on and removed from a user's head, for example, by providing openings in the arched regions sized and oriented to easily fit over the user's neck and ears.

[0112] The configuration of Figure 29 utilizes a unitary crown strap that includes first and second crown arms 392, 394 to secure the semi-rigid headgear 380 to the user's head. When the semi-rigid headgear 380 is positioned partially around the user's head, the first and second crown arms 392, 394 contact one another to secure the semi-rigid headgear 380 in place. The first and second crown arms 392, 394 may be provided with any of a variety of mechanisms that allow them to be attached to one another. For example, in some configurations, the first and second crown arms 392, 394 may be attached to one another using hook-and-loop fabric (e.g., Velcro®) or one or more snaps or clips.

[0113] The crown straps are wrapped laterally around the top of the skull at ear level. With the crown straps so extended and positioned such that the arched regions 386, 388 partially encircle the user's ears, the back straps 280 of the semi-rigid headgear 380 should be located at or below the inion. A user's inion is the most prominent prominence of the occipital bone at the rear-inferior part of the skull. In other words, the inion is the highest point of the external occipital protuberance. The semi-rigid headgear 380 may be placed on the user's head according to any of the configurations shown in the accompanying Appendix, which is a part of this application and is incorporated herein in its entirety.

[0114] For example, back strap portion 280 is adapted to engage the back of the user's head. Preferably, back strap portion 280 is adapted to engage the head at or below the external occipital protuberance. Back strap portion 280 extends on either side of the head for a distance that wraps around the back of the head. In some configurations, back strap portion 280 includes a vertical center that is adapted to be positioned approximately 25 degrees below a horizontal plane that extends through the patient's ear canal.

[0115] On either side of the head, the semi-rigid headgear 380 extends upwardly and downwardly into left and right lateral regions forming arched regions 386, 388. The lateral regions are adapted to extend behind the patient's ears. Preferably, the lateral regions are also adapted to extend behind the patient's mastoid processes. Each of the left and right lateral regions of the semi-rigid headgear 380 extends into or includes an arched portion 386, 388. The arched portions 386, 388 curve forward. The arched portions 386, 388 are adapted to extend around each of the patient's ears. Preferably, each of the arched portions 386, 388 terminates in a respective terminal end. The terminal end is preferably adapted to be located in front of the patient's ear. In some configurations, the lateral regions and arched portions 386, 388 of the semi-rigid headgear 380 do not include soft inner padding, but may include a self-supporting elastic material that is in direct contact with the patient's head / hair.

[0116] The top of the semi-rigid headgear 380 interconnects the arched portions 386, 388. In some configurations, the top can be positioned forward of the ears. Preferably, the top is positioned generally perpendicular to the ears. More preferably, the vertical center of the top is spaced greater than 13 mm, preferably between 13 and 100 mm, behind a vertical plane intersecting the ear canal. In some configurations, the top includes a first segment 392 and a second segment 394, which together form the top. The first segment 392 extends upwardly from the apex of the left arched portion 386, and the second segment 394 extends upwardly from the apex of the right arched portion 388. Preferably, the top is formed of a self-supporting semi-rigid material. In some configurations, the top does not include any backing, including a softly padded backing layer.

[0117] Each of the upper and lower arms 284, 286 includes a slot 292, 290 near the end of each arm. Each slot is configured to receive a strap 260 of the mask assembly 102, as shown in FIG. 2. Additionally, the portion 398 of the semi-rigid headgear 380 that is covered by the strap 260 is thinner than the corresponding arm 284, 286 to accommodate the thickness of the strap 260. For example, as shown in FIGS. 30 and 31, the semi-rigid headgear portion 398 is thinner than the arm 286. The portion 398 is dimensioned such that when the strap 260 is inserted into the slot 290 and tensioned, its thickness is no greater than that of the arm 286. By keeping the thickness of the strap 260 and portion 398 thinner than the thickness of the arm 286, the strap 260 does not irritate the user when worn.

[0118] Additionally, the upper arms 284 are configured to extend downward from a position above the user's ears, such that the adjustable upper straps 260 are positioned no closer than approximately 10 mm to the user's eyes when worn. The lower arms 286 are configured to retain the straps on the user's neck when tilted up or down, and the ends of the lower arms 286 are positioned generally below the user's ears, such that the lower straps, when attached to the lower arms 286, slope upward from ends 290 to the mask assembly 120. In this configuration, the lower and upper straps form a triangle, as shown in Figures 52 and 53, and the space between the lower and upper straps on the mask is smaller than the space between the lower and upper straps on the headgear, thereby stabilizing the mask assembly 120 against upward and downward movement.

[0119] Referring again to Figure 17, elbow 222 is connected to a conduit 300 through a disconnectable swivel assembly 302. As shown in cross-section in Figure 20, elbow 222 includes a stem 304 that includes an inner wall 306 at its base. The inner wall 306 includes a recess 308.

[0120] The sleeve 310 includes a flange 312 that is received in the recess 308. The sleeve 310 can be fixed in position within the elbow 222 in any suitable manner. The sleeve 310 includes a generally cylindrical outer wall 314. The flange 312 includes an outwardly extending portion that connects to a lever 316. Preferably, the flange 312 and the lever 316 are integrally formed. Referring to FIG. 21 , the lever 316 includes a lower, inwardly extending catch 320 that allows the lever 316 to pivot about the portion that connects the lever 316 to the flange 312. Thus, by squeezing the upper portion 322 of the lever 316 inwardly, the catch 320 moves away from the generally cylindrical outer wall 314 of the sleeve 310.

[0121] The swivel 330 includes a generally cylindrical inner wall 332 that slides around the outer wall 314 of the sleeve 310, providing a slidable fit between the swivel 330 and the sleeve 310. The upper portion 334 includes a shoulder 336. A catch 320 on the lever 316 can engage the shoulder 336 to secure the swivel 330 in an axial position on the sleeve 310. Depressing the upper portion 322 of the lever 316 moves the catch 320 away from the shoulder 336, thereby disengaging the swivel 330 from the sleeve 310.

[0122] The flap 350 may be attached between the stem 304 and the sleeve 310. In the illustrated configuration, the flap 350 extends into the flow passage 352 from a base 354 that is sandwiched between the stem 304 and the sleeve 310. The flap 350 may be pivoted upward (as shown in FIG. 20, arrow P) about an axis X (see FIG. 21) and away from the sleeve 310, so that flow from the positive pressure generator may continue through the interface 100 and to the user generally unobstructed. The flap 350 may be pivoted downward into contact with the sleeve 310 and seal the flow passage 352 when the positive pressure source stops providing pressurized air flow. In some configurations, the flap 350 does not fully contact the sleeve 310. In some configurations, the flap 350 does not seal the flow passage 352 when in the down position.

[0123] 21 , a port 360 is defined through the elbow 222 at a location above the flap 350. The port 360 is preferably positioned along a portion of the elbow 222 near the axis X. In some configurations, the port 360 is positioned such that it is substantially blocked from the intake air flow by the flap 350. In other words, as air rotates the flap 350 away from the sleeve 310, the flap 350 moves to a position that at least partially or completely covers the port 360.

[0124] In some configurations, the port 360 extends through a wall of the elbow 222, which includes a generally flat inner wall 362. The generally flat inner wall 362 helps the flap 350 generally seal the port 360 when the flap is moved upward, away from the flange 312 of the sleeve 310.

[0125] In some configurations, the lever 316 overlaps a majority of the port 360, such that the port 360 is generally not visible. However, as shown in FIG. 20, a gap 364 preferably surrounds at least a portion of the lever 316, such that relatively free airflow can pass through the port 360 when the flap 350 does not overlap the port 360. In addition, in some configurations, the port 360 and lever 316 are positioned on the same side of the elbow 222 as an opening 370 defined within the ball end 220, which opening is positioned within the mask assembly 102 when the connection port assembly 104 is attached to the mask assembly 102. Advantageously, such positioning positions the port 360 on the elbow 222 facing the user. Such positioning also renders the port 360 invisible during use, resulting in a more aesthetically pleasing configuration. Additionally, there is little flow from the port 360, and the port 360 may be positioned toward the user without causing much discomfort to the user.

[0126] Although not shown, the elbow 222 may also include one or more bias flow ventilation holes that are preferably positioned in a forward facing direction so that no bias flow is directed at the occupant.

[0127] Another configuration of the elbow assembly 302 is shown in Figures 48-51. The elbow assembly 302 includes an elbow 222 and a sleeve 310 and / or a swivel 330, as shown in Figure 49. In some configurations, the elbow assembly 302 includes only the elbow 222 and sleeve, and does not include the swivel 330. The swivel may be permanently or removably attached to the sleeve 310 and elbow 222, and in some configurations, the swivel 330 is integrally formed with the end of the delivery conduit. A flap 350 is positioned over the sleeve 310 such that it at least partially blocks the flow path 352 of the sleeve. The elbow assembly 302 functions similarly to the elbow assembly 302 of Figures 17-21, however, the elbow assembly 302 of Figures 48-51 provides the added benefit of diverting gas away from the patient when the flap 350 is lowered to its closed position (as shown in Figures 50 and 51).

[0128] 49, the sleeve 310 preferably includes two or more cut out areas or recesses 356. The recesses 356 may be of any suitable shape, and in the illustrated configuration the recesses 356 include a semi-circular configuration and extend upwardly into the sleeve 310. The sleeve 310 also includes at least one protrusion 357, and preferably two or more protrusions 357. Preferably, each of the protrusions 357 extends along an arc of approximately 70 degrees. More preferably, each of the protrusions 357 is generally centered between two recesses 356, and each of the protrusions 357 extends approximately 70 degrees around the exterior surface of the sleeve 310.

[0129] Swivel 330 is preferably generally cylindrical in shape. As shown in FIG. 49, swivel 330 has an inwardly extending ridge 358. Ridge 358 preferably circumscribes the entire inner surface. In some configurations, ridge 358 may be interrupted. However, preferably, ridge 358 does not have an interruption large enough to accommodate entire projection 357, such that ridge 358 and projection 357 cooperate to keep swivel 330 mounted on sleeve 310. When swivel 330 is assembled to sleeve 310, recess 356 allows projection 357 to bend inwardly so that projection 357 slides over ridge 358 and then snaps back outwardly to secure projection 357 beneath ridge 358.

[0130] The elbow 222 includes an opening 420 on its side in fluid communication with a ventilation passage 422. The ventilation passage 422 is formed by the space between the inner and outer walls 362, 424 of the elbow, as shown in Figures 50 and 51.

[0131] 50 and 51, when the flap 350 is lowered to its closed position, exhaled air from the user enters the opening 370 in the elbow 222. The exhaled air flows through the port 360 in the inner wall 362 of the elbow, through the ventilation passage 422, and finally exits the elbow 222 through the opening 420.

[0132] 48-51 reduces the overall length and improves the aesthetics of the product by eliminating the blind hole located in front of the elbow 222. In addition, the configuration of Figures 48-51 improves patient comfort by preventing air from being directed at the user. Instead, the opening 420 directs the airflow out the side of the elbow 222 and away from the patient.

[0133] 54, a flexible headgear assembly 500 may be used to secure a mask assembly to a user's head for, for example, but not limited to, respiratory therapy. The illustrated flexible headgear assembly 500 may be used with any suitable mask assembly, including, but not limited to, any of the mask configurations disclosed herein.

[0134] The illustrated flexible headgear assembly 500 includes a back strap portion 502. At least a portion of the back strap portion 502 is coupled with a panel 504. In the illustrated configuration, the back strap portion 502 is configured to span a distance around the back of a user's head and extend toward either side of the user's head.

[0135] 54, the pair of upper arms 506 and the pair of central arms 510 can extend generally laterally from an upper edge 512 of the backstrap portion 502. The pair of lower arms 514 can extend generally laterally from a lower edge 516 of the backstrap portion 502. In some configurations, the pair of lower arms 514 extend downwardly, away from the backstrap portion 502, such that the lower edges of the lower arms 514 are positioned lower than the lower edge of the backstrap portion 502. In some configurations, the pair of central arms extend upwardly, away from the backstrap portion 502, such that the upper ends of the central arms 510 are positioned higher than the upper edge of the backstrap portion.

[0136] In the illustrated configuration, the lower arms 514 and central arms 510 terminate with ends 520. The ends 520 can include fastening portions 522, which can be formed with hook or loop elements for hook-and-loop fastening means. Preferably, as described in more detail below, the fastening portions 522 include at least a hook portion, which can engage material in another portion of the headgear assembly 500. Each of the upper arms 506 can include a fastening portion 524 at its terminal end.

[0137] When positioned on a user's head, the back strap portion 502 is positioned at or below the external occipital protuberance and above the nape of the user's neck. The upper straps 506 may be connected to each other in any suitable manner. In some configurations, a clip secures the upper straps 506 with a fastener 522 that is folded back and secured to another portion of the upper strap 506. Thus, the upper straps 506 may extend generally above the top of the user's head, thereby limiting downward movement of the remainder of the headgear assembly 500.

[0138] The central arm 510 and the lower arms 514 may be connected to a clip (not shown) or another portion of the mask assembly such that the central arm 510 and the lower arms 514 secure the headgear assembly 500 to the mask directly or indirectly (for example, but not limited to, by a clip as shown in FIG. 40). Ends 520 of the central arm 510 and the lower arms 514 are threaded through loops or other structures on the mask assembly and folded back once. The overlapped portions may be secured in any suitable manner. For example, but not limited to, the overlapped portions may be secured with a hook-and-loop type fastener (e.g., a Velcro fastener).

[0139] 55, at least one of the ends of the upper arm 506, the central arm 510, and the lower arm 514 can include an extended end 520. Preferably, the extended end 520 is formed on at least the central arm 510 and the lower arm 514 of the flexible headgear 500. In some configurations, the extended end 520 is found on one or more of the arms that are connected to the mask assembly. The extended end 520 can be formed integrally with a main portion of the arms 510, 514.

[0140] As discussed above, the arm 526 can be integrally formed with the extended end 520. The extended end 520 shown has a width d, while the arm 526 has a width e. The width e of the arm 526 can be between about 12 mm and about 20 mm, between about 14 mm and about 18 mm, or preferably about 16 mm. The width d of the extended end 520 can be between about 18 mm and about 26 mm, between about 20 mm and about 24 mm, or preferably about 22 mm. In some embodiments, the difference between the maximum width d of the extended end 520 and the width e of the arm is between about 3 mm and about 10 mm, or between about 5 mm and about 8 mm. In some configurations, the difference between the maximum width d of the extended end 520 and the width e of the arm is about 6 mm. Because the width d of the extended end 520 is greater than the width e of the arm 526, the edge of the extended end 520 can be more easily positioned and, as a result, the portion used to secure the end 520 to the arm can be more easily positioned when refitting the arm 526 (e.g., to tighten, loosen, remove, or otherwise reposition the flexible headgear 500).

[0141] Furthermore, when the width d of the extended end 520 is greater than the width e of the arm 526, the neck portion 536 can be formed at a position between the extended end 520 and the arm 526. The neck portion 536 can reduce the possibility that the extended end 520 will slip out of the mounting portion of the mask assembly when fixed to the user's head. For example, the opening of the mounting portion of the mask assembly may be about 16 mm to about 18 mm wide, while the extended end 520 may be about 22 mm and the arm 526 may be about 16 mm. Thus, the possibility that the extended end 520 will unintentionally slip out of the opening is greatly reduced.

[0142] The shape of the neck 536 may further reduce the likelihood of the extension end 520 being unintentionally removed from the opening. Any suitable transition may be used. As shown in FIG. 56, the neck 536 may be curved to facilitate removal of the arm from the mask assembly, if desired. The neck may extend at an angle between about 0 degrees and about 90 degrees relative to the arm. Preferably, the neck 536 extends at an angle between about 20 degrees and about 60 degrees. Depending on the configuration, the neck 536 may have a steeper or more gradual transition. The steeper the transition, the less likely the arm will be unintentionally separated from the mask assembly.

[0143] The neck 536 forms part of the shape of the enlarged end 520. In some configurations, the enlarged end 520 can be substantially elliptical. In some configurations, the enlarged end 520 can be configured to approximate a variety of shapes, such as a parallelogram, an oval, a circle, a triangle, or any other suitable shape.

[0144] 55, each of the extended ends 520 includes a recessed panel 522 having a hook fastener or the like. The panel 522 can be mounted on the extended end 520 such that the extended end 520 can be secured to another portion of a corresponding arm when the arm is folded back. The recessed panel 522 can be constructed of a hook fabric (e.g., Velcro®). Thus, the hook material of the extended end 520, and particularly the panel 522, can be secured to another portion of a corresponding arm to secure the headgear assembly 500 to a mask assembly.

[0145] The panel 522 may be attached to the end of the arm in any suitable manner. In some configurations, the panel 522 is attached to the extended end 520 by ultrasonic welding. For example, the panel 522 may be positioned at a desired location along the arm, and then an ultrasonic welding process may be used to effectively melt the two materials together. Referring to FIG. 56, when the extended hook fabric panel 522 is attached to the extended end 520 using ultrasonic welding, a weld edge 530 of width a is formed along the periphery of the extended hook fabric panel 522. Due to the ultrasonic welding procedure in the illustrated configuration, the width a of the weld edge 530 is approximately 3 mm. The area of ​​the hook fabric panel 522 that includes the weld edge 530 is generally not functional in the ultrasonic welding procedure to melt or otherwise deform the hooks of the hook fabric to engage the hook receiving material. Therefore, the functional surface area of ​​the hook fabric panel 522 is reduced by a surface area equivalent to that of the weld edge.

[0146] The welded edge 530 may be bordered by a soft edge 532 of width b made of the hook-receiving breathable composite material of the extended end 520. Preferably, the welded edge 530 is recessed below the surface of the soft edge 532. A projection of width e of the arm 526 may extend through the welded edge 530, with the soft edge 532 being positioned slightly outside the projection of width e of the arm 526.

[0147] The width b of the soft edge can be about 0.5 mm to about 4 mm, about 1 mm to about 3 mm, or preferably about 2 mm. The effective hook portion 534 is adjacent to the welded edge 530 and can have a width c. The width c of the effective hook portion is slightly narrower than the width e of the arm 526. By increasing the width c, the functional surface area of ​​the hook fabric can be increased, and therefore the shear strength and durability are improved. By making the width c smaller than the width e of the arm 526, the arm 526 reduces the possibility that the effective hook portion 534 will come into contact with the skin of the user. The width c of the effective hook fabric portion 534 can be about 8 mm to 16 mm, about 10 mm to about 14 mm, or preferably about 12 mm. The width d of the extended end can increase the width c of the functional surface area. In other words, the end of the arm is extended to increase the width of the effective hook portion 534, which allows the extended end to be more securely attached to the surface of the arm.

[0148] The flexible headgear assembly 500 can be made of any suitable material. In some configurations, the flexible headgear assembly 500 can have at least a portion coated with or formed from a hook fastener-receiving breathable composite material. In some configurations, the flexible headgear assembly 500 can be made at least in part from a nylon / Lycra Breath-O-Prene® material. In some embodiments, a 150 mm long by 20 mm wide sample of the material can be stretched to approximately 207 mm when subjected to an axial load of 10 N, which is approximately 38% elongation at an axial load of 10 N. Thus, the material is preferably fairly elastic. In some embodiments, the headgear assembly 500 can include one or more rounded edges. The rounded edges can be formed in any suitable manner. In some configurations, the rounded edges are formed by applying heat and pressure to the edges of the headgear assembly 500. In some configurations, the rounded edges are formed in a manner similar to the technique described in US Pat. No. 3,295,529, which is incorporated herein by reference in its entirety.

[0149] As previously mentioned, the back strap portion 502 of the illustrated flexible headgear assembly 500 preferably includes at least one relatively inelastic panel 504. This panel may be formed of a relatively low stretch material, such as, but not limited to, polyester Breath-O-Prene® material. In some embodiments, a sample of the material 150 mm long by 20 mm wide will stretch to approximately 160 mm when subjected to an axial load of 10 N, which is approximately a 7% elongation at an axial load of 10 N. Therefore, the material is preferably fairly inelastic or non-stretchy when compared to the more highly elastic material of the flexible portion.

[0150] Because the panels 504 are formed of a less elastic material than the surrounding portions of the headgear assembly 500, the panels 504 resist stretching of at least a portion of the headgear assembly 500. By resisting stretching of at least a portion of an otherwise elastic headgear assembly, the panels help maintain the headgear 500 in a desired shape and help maintain the headgear 500 in a desired position relative to the back of the user's head.

[0151] Testing has revealed that without the use of panel 504, rear extension of the headgear assembly 500 can cause the headgear assembly to stretch and move downwardly toward the user's neck as the load on the lower straps increases. Figures 57A and 57B show the effect of increasing force being applied to the lower arms 514 of a flexible headgear 540, where the back strap portions 544 are constructed entirely of elastic material. The configuration shown in Figures 57A and 57B does not feature panel 504.

[0152] As previously mentioned, the back strap portion 544 is positioned in the desired position when it is positioned at or below the external occipital protuberance and above the nape of the neck of the user. In FIG. 57A, the back strap portion 544 is shown in a more preferred position. To facilitate visualization of the movement, the test model 542 is provided with a position marker 546. When an increased force is applied to the lower arm 514, the elasticity of the back strap portion 544 allows it to stretch and deform, which causes the back strap portion 544 to move downward along the neck of the user, as shown in FIG. 57B. The movement can be seen by reference to the position marker 546. When moved downward, the back strap portion 544 exerts more force on the neck rather than the head, which is less desirable. Because the flexible headgear 540 may be worn for periods of minutes to hours, or, if used for respiratory therapy, for periods of hours to days, a lower position of the back strap portion 544 may cause discomfort to the user.

[0153] A low modulus panel 504 may be attached to the back strap portion 502 to reduce the degree of stretching of the back strap portion 502 when increased forces are applied to the lower arms 514. In some configurations, the panel 504 may comprise a substantially non-elastic insert 560. The insert 560 may be attached to the back strap portion 502, for example, by overlock stitching, by ultrasonic welding, or by the use of glue or other adhesives, or by other methods known to those skilled in the art. When the insert 560 is attached to the back strap portion 502, it may provide greater tensile strength, which may allow greater forces to be applied to the lower arms 514 when the flexible headgear 500 is installed and used. The insert 560 may therefore advantageously reduce deformation of the back strap portion 502 and help it remain positioned in a desired position relative to the user's head and neck.

[0154] As shown in FIGS. 58A-58D, the non-elastic inserts 560, 562, 564, 566 can be configured in a variety of shapes, including, but not limited to, those shown in FIGS. 58A-58D. Preferably, the non-elastic inserts 560, 562, 564, 566 are adjacent to or cover at least the back strap portion 502. In some configurations, the non-elastic inserts 562, 564 are adjacent to or cover at least a portion of the lower arm 514. In some configurations, the non-elastic inserts 562, 564 are adjacent to or cover at least a portion of the junction between the lower arm 514 and the back strap portion 502. In some configurations, the non-elastic inserts 564 contact or cover at least a portion of the central arm 510. In some configurations, the non-elastic inserts 564 are adjacent to or cover at least a portion of the junction between the central arm 510 and the back strap portion 502. In some configurations, the height of the non-elastic insert 560 is at least about half the height h of the backstrap portion 502. In some configurations, the height of the non-elastic insert 560 is preferably greater than about half the height h of the backstrap portion 502. By leaving a portion of the backstrap portion 502 formed from a more highly elastic material, the backstrap portion 502 is able to stretch and conform to a limited extent to a greater extent than would be possible with a backstrap portion formed entirely from a less elastic material.

[0155] The non-elastic insert 560 may be configured to have any suitable surface area. The non-elastic insert 560 may be configured to extend along various lengths of the lower edge 516 of the backstrap portion 502. In some configurations, the non-elastic insert 560 extends along more than half of the lower edge 516 of the backstrap portion 502. Preferably, the non-elastic insert 560 extends along substantially the entire lower edge 516 of the backstrap portion 502. Other configurations are possible.

[0156] 59, there is shown an assembly including headgear 600 having two or more straps connectable by wing-shaped buckles 602. As with other headgear described herein, the headgear 600 may be used with any suitable mask assembly, including, but not limited to, any of the mask configurations disclosed herein. Additionally, the illustrated configuration includes straps connected by wing-shaped buckles 602, and such configuration may be used with, for example, but not limited to, any of the headgear disclosed herein.

[0157] In the configuration shown in FIG. 59, the headgear assembly 600 includes at least a pair of upper arms 606. Each of the upper arms 606 can terminate in an end 608. In some configurations, at least one of the pair of upper arms 606 includes a fastening portion, such as any of the fastening portions disclosed elsewhere. In the illustrated configuration, each of the upper arms 606 includes a fastening portion. Preferably, the fastening portion is located at least partially at the end 608. In some configurations, the fastening portion can be formed of a hook or loop element for a hook-and-loop fastener. Preferably, the fastening portion includes at least a hook portion, which can engage with material of another portion of the headgear assembly 600.

[0158] 59, the upper arm 606 can be connected by, for example, but not limited to, a wing-type buckle 602. As shown in FIG. 61, the wing-type buckle 602 can include a body 610 defining at least one slot 612, and preferably at least two slots 612. The at least one slot 612 can receive an end 608 of a strap 606 such that the end 608 of the strap 606 can be threaded through the at least one slot 612 and then folded back and secured in place with a fastener as previously described.

[0159] The body 610 of the illustrated buckle 602 includes a tri-glide slide connector portion 614 and a pair of wings 616. Thus, at least one slot 612 may be defined by the tri-glide slide connector portion 614. However, depending on the configuration, the at least one slot 612 may be defined by one or more of a loop, a square ring, a D-ring, an oval ring, a slip lock buckle, a ladder lock, or the like (including multiples of one or more of these components).

[0160] The wings 616 advantageously support the straps 606 such that the headgear assembly 600 including the straps 606 can maintain a substantially three-dimensional shape, as shown in Fig. 59. In some configurations, a buckle without wings would prevent the headgear assembly from maintaining a substantially three-dimensional shape because the headgear assembly, and more particularly the straps 606, would bend around the buckle and potentially collapse. Thus, it has been found that the wings 616 improve the usability of the headgear assembly 600.

[0161] 62, the laterally outward extensions 618 of the wings 616 extend downwardly below the underside 620 of the connector portion 614. By extending the lateral extensions 618 below the underside 620, the buckle 602 may better conform to and / or follow the top of the user's head as compared to a flat buckle. However, in some configurations, the laterally outward extensions 618 may not extend downwardly below the underside 620 and / or the bottom of the buckle, including the wings, may be substantially flat or rounded.

[0162] The buckle 602 can be formed of any suitable material. In some configurations, the buckle 602 can include two or more different materials, such that the connector portion 614 can be formed of a stiffer material while at least the wings 616 can be formed of a softer material. The softer wings 616 can provide increased comfort while the stiffer connectors 614 can allow the buckle 602 to support the loads that the headgear assembly 602 is expected to experience.

[0163] In some configurations, the buckle 602 can be formed by multi-layer injection molding or co-molding of two or more different materials. In some configurations, the two or more different materials can be mechanically connected (e.g., snap-fit, keyed, or otherwise) or can be bonded, glued, or otherwise joined. In some configurations, at least the wings 616 can be formed of, for example, but not limited to, a thermoplastic elastomer or impact resistant polyethylene. In some configurations, the connector portion 614 can be formed of, for example, but not limited to, nylon, or otherwise. In some configurations, the connector portion and wings can be formed of materials having the same matrix (e.g., materials having an appropriate chemical relationship that allows the materials to bond).

[0164] 62, the wings 616 preferably taper generally in thickness from the area adjacent the connector portion 614 to the lateral extension 618. While any suitable taper shape may be used, a reduction in thickness facilitates the curvature of the wings 616 being able to better conform to the patient's anatomy. In other words, the thickness of the wings 616 decreases in a location laterally outward from adjacent the connector portion 614, thereby reducing bending strength, which aids in conforming to the user's anatomy.

[0165] Referring again to FIG. 61, the wings 616 have inwardly tapered side walls 622 which, in the illustrated configuration, are joined to end walls 624 having rounded corners 626. The rounded corners 626 improve comfort for the user while the tapered side walls 622 reduce the width of the wings 616. The reduced width at least at the ends of the wings 616 aids in trapping the wings 616 under the ends 608 of the straps 606 in the folded region, best seen in FIGS. 59 and 60. In some configurations, the folded ends 608 and / or adjacent portions of the straps 606 define pockets that receive the respective tapered ends of the wings 616. In some configurations, the straps 606 can have wider areas as previously described. In the illustrated configuration, the connector portion 614 of the buckle 602 is wider than at least a portion of the strap 606 such that the strap 606 can extend through an opening 612 defined in the connector portion 614, while the wings 616 are tapered such that the strap 606 can rest on and / or surround the wings 616.

[0166] In some configurations, the wings 616 extend a length L2 from the connector portion 604 that is greater than twice the thickness L1 of the wall of the connector portion 604 that defines the slot 612. Other configurations are also possible. As previously discussed, increasing the length L2 of the wings 616 reduces the flop over of the strap 606 when connected to the wing-type buckle 602. The length L2 of the wings 616 can be less than the length of the connector portion of the end 608, thereby allowing the lateral extensions 618 of the wings 616 to be surrounded by the connector portion of the end 608.

[0167] Although the present invention has been described with respect to specific embodiments, other embodiments that are apparent to those skilled in the art are also within the scope of the present invention. Accordingly, various modifications and improvements may be made without departing from the subject matter and scope of the present invention. For example, various components may be arranged in different configurations as desired. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is to be defined only by the following claims.

Claims

1. 1. A mask assembly comprising: a seal member including a seal member inlet and a face-contacting flange portion configured to be positioned against contours of a user's face about at least one breathing orifice in use; a mask clip attached to the seal member, the mask clip including a mask clip inlet flange defining a passage into the mask clip and a peripheral clip wall extending outwardly from the mask clip inlet flange; It is mask-based, a mask base flange configured to extend into the mask clip inlet flange; a peripheral base wall extending outwardly from the mask base flange; at least a first headgear engagement portion; A mask base including: a mask assembly comprising:

2. The mask assembly of claim 1 , wherein the mask base collar includes an outer collar surface configured to fit within the mask clip inlet collar in an axially coaxial orientation.

3. The mask assembly of claim 1 , wherein the peripheral base wall includes an inner base wall surface, and the mask base collar projects proximally from the inner base wall surface.

4. The mask assembly of claim 1 , wherein the peripheral base wall includes a concave inner base wall surface.

5. The mask assembly of claim 1 , wherein the mask clip inlet collar projects proximally from the peripheral clip wall.

6. 2. The mask assembly of claim 1, in combination with a headgear assembly configured to extend around the back of the user's head and support the seal member against the user's face in use, the headgear assembly configured to be connectable with the first headgear engagement portion.

7. 2. The mask assembly of claim 1, further comprising a second headgear engagement portion and configured to extend around a rear of the user's head to support the seal member against the user's face in use, the headgear assembly including a first end configured to be connectable with the first headgear engagement portion and a second end configured to be connectable with the second headgear engagement portion.

8. 2. The mask assembly of claim 1, wherein at least one of the outer collar surface and the mask clip inlet collar includes a tapered portion configured to releasably secure the mask base inlet collar to the mask clip inlet collar, and wherein the outer collar surface and the mask clip inlet collar interact to reduce relative sliding movement therebetween.

9. The mask assembly of claim 1 , wherein the mask base collar further comprises an inner collar surface contoured with a radiused surface configured to form a snap fit with a ball end of a swivel elbow connector.

10. The mask assembly of claim 1 , wherein the peripheral base wall extends across a substantial portion of the peripheral clip wall, such as more than half of the peripheral clip wall.

11. The mask assembly of claim 10, wherein the peripheral base wall provides a bi-layer construction having an insulating effect configured to reduce rainout, in use.

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