Including the interface of the roll-up nose bridge section

Abstract

An interface for positive pressure therapy includes a mask assembly, a headgear assembly, and a connection port assembly. The mask assembly includes a sealing member having an upper portion movably connected to an integral lower portion, wherein the upper portion retracts during hinged movement relative to the lower portion. The headgear assembly allows connection to the mask assembly in a direction generally perpendicular to the direction of strap tension. The connection port assembly includes a swivel elbow with a valve member controlling airflow through a port open toward the user.

Description

[0001] This application is a divisional application of the invention patent application filed on April 13, 2012, with application number 201611078802.X (parent application number 201280029072.8, international application number PCT / IB2012 / 000858) and entitled "Interface including a roll-up nose bridge portion".

[0002] Cross-reference to related applications

[0003] 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 which are incorporated herein by reference. Invention Field

[0004] The present invention generally relates to a mask that covers at least one of a user's nose and mouth to supply breathing gas under positive pressure. More specifically, certain aspects of the invention relate to masks having a bridge-of-the-nose seal that is movable relative to another sealing portion of the mask. Background Technology

[0005] A face mask can be used to provide breathing air to a user under positive pressure. In configurations that cover both the user's mouth and nose, a full-face mask typically sits over the bridge of the nose. A single seal generally surrounds the user's nose and mouth.

[0006] These full-face masks are typically secured to the user's head with a headband. To minimize air leakage, the headband is typically tightened, which results in increased pressure on the user's nose. In other words, because the headband is tightened, the silicone seal typically applies a gradually increasing load on the bridge of the nose. This pressure can be a source of discomfort and, in some cases, can lead to bedsores over time. Summary of the Invention

[0007] One objective of this disclosure is to provide one or more structures and / or methods that will at least partially improve the above problems or provide at least a useful alternative to the public or the medical community.

[0008] Therefore, an interface for providing positive pressure ventilation therapy is provided. The interface includes a mask assembly. The mask assembly includes a mask seal and a mask base removably attached to the mask seal. The mask seal includes a mask seal clamp that is more rigid than at least a portion of the mask seal. The mask seal clamp is generally cup-shaped, having an open proximal end and a generally closed distal end. A generally pentagonal lip extends around the proximal end. The mask seal clamp includes an arcuate upper portion having an outer surface. An arcuate length of the mask seal clamp is defined along the outer surface, near an upper extreme of the upper portion between a pair of hinge points. A hinge axis extends laterally across the mask assembly between the two hinge points, and at least a portion of the upper portion of the mask seal clamp is positioned vertically above the hinge axis. The upper portion of the mask seal clamp includes a support surface. A generally central channel extends through the mask clamp and into a chamber defined by the mask seal. The mask seal includes a flexible upper portion configured to be positioned on a user's nasal area. The upper portion of the mask seal is positioned vertically above the hinge axis. The upper portion of the mask seal includes a region with decreasing stiffness located between two regions with increasing stiffness. This region with decreasing stiffness is rollable to allow the upper portion of the mask seal to pivot relative to the mask seal clamp. One of the two regions with increasing stiffness is positioned adjacent to a small radius bend, and the other of the two regions with increasing stiffness is positioned adjacent to a reinforcing member. The small radius bend and the reinforcing member define two boundaries, and the upper portion of the mask seal exhibits roll-up between these two boundaries during pivoting of the upper portion about the pivot axis. The upper portion of the mask seal has a first curve length adjacent to the small radius bend and a second curve length adjacent to the reinforcing band. The length of the first curve may be less than the length of the second curve. The curve length increases as the measurement position moves away from the mask seal fixture. The mask base covers at least a portion of the mask seal fixture. The mask base includes a first recess and a second recess. The first recess and the second recess are symmetrically positioned relative to a central plane that substantially bisects the mask base. The first recess and the second recess each include a vertical dimension greater than the lateral dimension. The mask base also includes a wall defining a central opening. The wall extends into the generally central channel of the seal fixture. A connection port assembly includes an elbow terminating in a spherical member. The size of the spherical member is determined and configured to be received by the wall defining the central opening. The connection port assembly also includes a removable rotating member. The removable rotating member is secured by a lever.The lever covers a port. This port is selectively covered by a valve. The valve is also capable of closing a central channel within the elbow. When the elbow is attached to the mask, the port opening is in the general orientation of the mask. A hood assembly includes a pair of upper straps and a pair of lower straps. One of the upper straps and one of the lower straps are attached to a first clamp. The other of the upper straps and the other of the lower straps are attached to a second clamp. The first and second clamps are secured within recesses in the mask base, such that the clamps engage within these recesses by movement in a direction generally perpendicular to the strap tension direction.

[0009] In some configurations, the mask seal is a full-face mask.

[0010] In some configurations, the mask seal clamp is integrated into the mask seal, making the mask seal clamp and the mask seal inseparable.

[0011] In some configurations, the mask base is removably attached to the mask seal.

[0012] In some configurations, the upper outer surface is rolled up to the support surface of the mask seal clamp, and the support surface defines an upper outer surface of the mask seal clamp.

[0013] In some configurations, the region with reduced stiffness includes a region with reduced thickness, compared to the regions with increased stiffness.

[0014] In some configurations, the upper portion of the mask seal includes a vertex defined by a first wall and a second wall, and the reinforcing member extends along at least a portion of the first wall and at least a portion of the second wall. Preferably, the reinforcing member extends across the vertex of the upper portion of the mask seal.

[0015] In some configurations, both ends of the reinforcing member end at a position in the generally vertical direction above these hinge points.

[0016] A face mask assembly may include a face mask seal. The face 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 region with decreasing stiffness positioned between a first boundary and a second boundary. The first boundary is defined by a stiffness greater than that in the region with decreasing stiffness. The second boundary is defined by a stiffness greater than that in the region with decreasing stiffness. As the first boundary moves toward the second boundary, the region with decreasing stiffness buckles in a unidirectional direction to define a roll of material that changes size as the first boundary continues to move toward the second boundary.

[0017] In some configurations, the region with reduced stiffness facilitates movement of the upper portion of the sealing member relative to the lower portion of the sealing member. Preferably, the upper portion includes a bridge portion of the mask, and movement of the first boundary toward the second boundary facilitates movement of the bridge portion of the mask relative to the lower portion of the mask.

[0018] In some configurations, the second boundary is positioned between the upper and lower portions. Preferably, the mask further includes a mask seal clamp with increased stiffness relative to the mask seal, and the second boundary is positioned along one end of the mask seal clamp. More preferably, the material roll-up section covers at least a portion of the mask seal clamp.

[0019] In some configurations, the first boundary is defined along a reinforcing member. Preferably, the reinforcing member comprises a plastic band.

[0020] In some configurations, the region with reduced stiffness is defined as having a reduced thickness relative to the first boundary.

[0021] In some configurations, the second boundary is defined by a corner with a small radius.

[0022] In some configurations, the winding section extends over at least a portion of the mask seal.

[0023] In some configurations, the take-up section covers at least a portion of the mask seal clamp as the first boundary moves fully toward the second boundary.

[0024] A face mask assembly may include a face mask seal. The face mask seal includes a nose region and a mouth region. The nose region and the mouth region are integrally formed. The nose region is movable relative to the mouth region, such that the force exerted by the nose region at multiple locations remains relatively constant, while the force exerted by the mouth region increases.

[0025] A face mask assembly includes a face mask seal attached to a headgear assembly. The face mask seal is configured to surround a user's nose bridge region and mouth region. The face mask seal includes a wrinkle-free means for applying a substantially constant force to the nose bridge region and a gradually increasing force to the mouth region when the headgear assembly is tightened.

[0026] A face mask assembly includes a seal. The seal includes a flange that engages with a user's face. The seal is removably attached to a face mask base. The face mask base includes a first opening and a second opening. The first opening and the second opening receive a first clamp and a second clamp from an associated headgear assembly. The face mask base further includes a passage generally positioned between the first opening and the second opening. The passage is adapted to receive a breathing tube connector.

[0027] In some configurations, the mask assembly further includes a mask seal clamp attached to the mask seal and removably attached to the mask base. Preferably, the mask base covers a substantial portion of the mask seal clamp. More preferably, the mask base includes an outer peripheral edge and defines at least one recess along the outer peripheral edge of the mask base at a location covering the mask seal clamp.

[0028] A face mask assembly includes a face mask seal. The face mask seal includes a proximal flange adapted to contact a user's face. The face mask seal includes a distally facing surface. A face mask base includes an outer peripheral edge, and a covering surface extends from the outer peripheral edge. The face mask base covering surface covers at least a portion of the distally facing surface of the face mask seal, such that the face mask base covering surface is spaced apart from the distally facing surface of the face mask seal in a distal direction, thereby providing a moisture-rain-reducing barrier to the face mask assembly.

[0029] A headgear assembly is configured to secure a face mask assembly to a user's head. The headgear assembly includes a strap assembly. The strap assembly includes a rear arm, an upper arm, a lower arm, and at least one crown arm. The upper and lower arms define multiple arcuate regions shaped to at least partially encircle a user's ears. A soft trim is attached to at least a portion of the outer periphery of the strap assembly.

[0030] In some configurations, the strap assembly includes a semi-rigid strap and the flexible trim is attached to the semi-rigid strap without overlapping it. In some configurations, the semi-rigid strap includes a first thickness and the flexible trim includes a second thickness, wherein the first thickness and the second thickness are substantially the same. In some configurations, the semi-rigid strap includes a thickness and the flexible trim is thinner than the thickness in at least one region. In some configurations, the semi-rigid strap includes a thickness and the flexible trim is thicker than the thickness in at least one region. In some configurations, the flexible trim forms a bulbous end of the semi-rigid strap.

[0031] A clamping assembly is configured to secure a hood to a face mask assembly. The clamping assembly includes an outer cover and an inner catch. The inner catch is configured to attach to the outer cover, thereby securing it to one or more straps from a hood assembly. The inner catch includes an elongated slot and a circular opening. The elongated slot may extend along an elongated axis and may have a width transverse to the elongated axis. The circular opening may have a diameter greater than the width. When the straps are attached to the outer cover and the inner catch, the elongated axis extends in a direction transverse to the straps.

[0032] An elbow assembly is configured to connect a mask assembly to an air duct. The elbow assembly includes an elbow. The elbow includes an inner wall and an outer wall, defining an airflow channel between the inner and outer walls. The inner wall includes a port on one side of the elbow. A sleeve is coupled to the elbow. The sleeve includes a valve. When the valve is in a first position, the valve at least partially blocks the port and allows gas from the air duct to be delivered to a user via the elbow, and when the valve is in a second position, the valve at least partially blocks the air duct, thereby allowing gas to flow from the user through the port and the airflow channel to a location outside the sleeve. The airflow channel can direct air away from that side of the elbow.

[0033] In some configurations, the airflow channel includes two airflow channels. In some configurations, the sleeve further includes a bump extending around an outer surface of the sleeve and a recess adjacent to the bump. In some arrangements, the bump and the recess are adapted to receive a rotating component having a ridge for engaging with the bump. Attached Figure Description

[0034] These and other features, aspects, and advantages of embodiments of the present invention will be described with reference to the following accompanying drawings.

[0035] Figure 1 It is a front view of a user wearing an interface arranged and configured according to certain features, aspects and advantages of the present invention.

[0036] Figure 2 It is worn Figure 1 The user's side view of the interface.

[0037] Figure 3 yes Figure 1 A perspective view of the face mask seal and face mask seal fixture of the interface.

[0038] Figure 4 yes Figure 3 Side view of the mask seal and mask seal clamp.

[0039] Figure 5 yes Figure 3 Rear perspective view of the mask sealing fixture.

[0040] Figure 6 yes Figure 3 Rear front view of the mask sealing fixture.

[0041] Figure 7 yes Figure 3 Side front view of the mask sealing fixture.

[0042] Figure 8 yes Figure 3 A top plan view of the mask sealing fixture.

[0043] Figure 9 yes Figure 3 Front view of the face mask seal and face mask seal clamp.

[0044] Figure 10 yes Figure 3 Rear front view of the face mask seal and face mask seal clamp.

[0045] Figure 11 yes Figure 3 Side front view of the face mask seal and face mask seal clamp.

[0046] Figure 12 is Figure 3 An enlarged cross-sectional view of a portion of the face mask seal and face mask seal clamp.

[0047] Figure 13 yes Figure 1 The front perspective view of the face mask seal, face mask seal fixture, and face mask base.

[0048] Figure 14 yes Figure 13 Cross-sectional views of the mask seal, mask seal fixture, and mask base.

[0049] Figure 15 yes Figure 13 Side and front views of the mask seal, mask seal fixture, and mask base.

[0050] Figure 16 yes Figure 13 A top plan view of the mask seal, mask seal fixture, and mask base.

[0051] Figure 17 yes Figure 1 A perspective view of the connection port component.

[0052] Figure 18 yes Figure 17 Side front view of the connection port component.

[0053] Figure 19 yes Figure 17 Rear front view of the connection port component.

[0054] Figure 20 yes Figure 17 A cross-sectional side front view of the connection port component.

[0055] Figure 21 yes Figure 17 A cross-sectional perspective view of the connection port component.

[0056] Figure 22 yes Figure 1 A perspective view of the fixture assembly.

[0057] Figure 23 yes Figure 22 A cross-sectional view of the fixture assembly.

[0058] Figure 24 It is a cross-sectional view similar to that in Figure 12, showing a face mask seal configured for winding under a portion of the face mask seal clamp 112.

[0059] Figure 25 It is similar to Figure 14 A cross-sectional view of a face mask seal fixture with reduced dimensions.

[0060] Figure 26 It is similar to Figure 14 A cross-sectional view of the face mask sealing fixture, which is omitted.

[0061] Figure 27 It is similar to Figure 14 Another cross-sectional view of the cross-section view, in which the mask sealing fixture is omitted.

[0062] Figure 28It is a graphical representation showing the functional relationship between the load (or force) on the user's body and the amount of mask extension.

[0063] Figure 29 Is with Figure 1 and Figure 2 A perspective view of a skeleton compatible with the headgear components.

[0064] Figure 30 yes Figure 29 An enlarged view of the end region of a lower arm.

[0065] Figure 31 yes Figure 30 An enlarged cross-sectional view of the end region.

[0066] Figure 32 It is a perspective view of a mask assembly including a mask, multiple clamps, and multiple straps.

[0067] Figure 33 yes Figure 32 Side view of one of the two clamps.

[0068] Figure 34 yes Figure 33 Exploded view of the fixture.

[0069] Figure 35 yes Figure 33 A top view of the inner locking mechanism of the clamp.

[0070] Figure 36 This is a front view of a mask base with two mounting posts, and an inner latch of a clamp is attached to the left mounting post.

[0071] Figure 37 This is a front view of an alternative configuration of a mask base, which has two mounting posts, and a clamp of the alternative configuration is mounted to the left mounting post of the mask base.

[0072] Figures 38 to 47 It includes various other configurations of clamps, related face shields, and mounting posts.

[0073] Figure 48 This is a side view of another configuration of a rotating component.

[0074] Figure 49 yes Figure 48 The exploded view of the rotating component.

[0075] Figure 50 It is along Figure 48 The cross-sectional view taken from line 50-50.

[0076] Figure 51 It is along Figure 48 The cross-sectional view taken from line 51-51.

[0077] Figure 52 It is attached to a user's head. Figure 29 Side view of the skeleton.

[0078] Figure 53 It is attached to a user's head. Figure 29 Rear perspective view of the skeleton.

[0079] Figure 54 This is a perspective view of a flexible headgear that has a panel for use with mask components in the field of respiratory therapy.

[0080] Figure 55 yes Figure 54 An enlarged view of the end region of the arm, which has an embedded fabric hook-and-loop tab attached thereto.

[0081] Figure 56 yes Figure 55 A plan view of the end region.

[0082] Figure 57A This is a rear view of a hood before force is applied to its multiple lower arms; the hood is not attached to the test model.

[0083] Figure 57B yes Figure 57A The rear view of the hood shows the displacement of a rear strap portion of the hood when a force is applied to one of the lower arms of the hood.

[0084] Figures 58A to 58D It is compatible with and Figure 54 Multiple alternative configurations of the insert used together with the headgear.

[0085] Figure 59 It is a component that incorporates a headgear with winged buckle connections.

[0086] Figure 60 It is part of a headgear with a wing-type buckle connection.

[0087] Figure 61 It is used for Figure 59 A top view of one of the wing buckles in a wing buckle connection.

[0088] Figure 62 It is used for Figure 59 A side view of the wing buckle in the wing buckle connection. Detailed Implementation

[0089] First refer to Figure 1 and Figure 2 The diagram illustrates an interface 100 positioned on a user U. Interface 100 includes an interface that can be used in the field of respiratory therapy. Interface 100 is particularly useful for various forms of positive airway pressure (CPAP) therapy. For example, interface 100 can be used to administer continuous positive airway pressure (“CPAP”) therapy. Furthermore, interface 100 can be used for variable positive airway pressure (“VPAP”) therapy and bilevel positive airway pressure (“BiPAP”) therapy. This interface can be used with any suitable CPAP system.

[0090] Interface 100 may include any suitable mask configuration. For example, certain features, aspects, and advantages of the invention may be applied to nasal masks, full-face masks, oronasal masks, or any other positive pressure masks. The mask shown is a full-face mask. The shown interface 100 generally includes a mask assembly 102, a connection port assembly 104, and a headgear assembly 106.

[0091] Reference Figure 13 The mask assembly 102 generally includes a mask seal 110 and a mask base 114, the mask seal including a mask seal holder 112. As will be described, the mask seal holder 112 preferably attaches the mask seal 110 to the mask base 114. Although the mask seal 110 and mask seal holder 112 shown are formed separately and secured together, in some configurations, the mask seal 110 and mask seal holder 112 may be integrated into a single component. In some configurations, the mask seal 110 is overmolded onto the mask seal holder 112.

[0092] Reference Figure 3 The face mask seal clamp 112 is relatively more rigid, stiffer, or less flexible than the face mask seal 110. In some configurations, the face mask seal clamp 112 is formed of a polycarbonate material. In some configurations, at least a portion of the face mask seal clamp 112 is formed of a polycarbonate material or other rigid or semi-rigid material. In some configurations, the face mask seal clamp 112 is at least partially formed of silicone or another suitable material. In such configurations, at least the silicone portion of the face mask seal clamp 112 can be formed relatively thicker compared to the more flexible portion of the face mask seal 110. In the illustrated configuration, the face mask seal clamp 112 provides structural support to the face mask seal 110.

[0093] like Figure 14 As shown, the mask seal clamp 112 can define a large portion of the mask assembly 102. As illustrated, the mask base 114 covers a significant portion of the mask seal clamp 112. (See reference...) Figures 25 to 27 As desired, the mask assembly 102 can be configured to have a variety of different structures. For example, refer to Figure 25 The mask seal clamp 112 extends a limited distance from its interface with the mask seal 110. Figure 25 In the configuration shown, the mask base 114 covers at least a portion of the mask seal clamp 112, and the mask seal clamp 112 defines a very limited rim shape configuration around a portion of the mask seal 110. (See reference...) Figure 26 In some configurations, the mask seal fixture is omitted entirely, and the mask seal 110 is directly overmolded onto the mask base 114. However, in some configurations, the mask seal 110 and the mask base 114 can be configured such that the two components are separable. For example, as... Figure 27 As shown, the mask seal 110 may include an outer peripheral flange 111, and the mask base 114 may include an outer peripheral groove 115 receiving the outer peripheral flange 111, such that the mask seal 110 can be removably 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, although... Figure 27 The configuration shown illustrates an embodiment without the mask seal clamp 112, but the mask seal clamp 112 and the mask base 114 have been combined into the mask base 114.

[0094] Reference Figure 5 The mask seal clamp 112 shown includes a generally cup-shaped configuration. A proximal end 120 defines an open end of the mask seal clamp 112, while a distal end 122 defines a generally closed end of the mask seal clamp 112. In the shown configuration, the proximal end 120 is generally surrounded by a lip 124. When viewed from the rear, the lip 124 is generally pentagonal (see [reference]). Figure 5 ).like Figure 7 As shown, a wall 126 generally sweeps forward in an arc. The arc shape of the wall 126 provides a three-dimensional configuration for the mask seal clamp 112 shown.

[0095] Continue to refer to Figure 7 The upper portion 130 of the illustrated mask seal clamp 112 has a generally arcuate configuration. Furthermore, this generally arcuate configuration of the illustrated mask seal clamp 112 is configured to accommodate a larger nose, but does not extend upwards over the nose as much as the extension of the mask seal 110, as... Figure 1 and Figure 2 As shown in the figure.

[0096] First refer to Figure 3 The upper portion 130 of the illustrated face mask seal clamp 112 preferably includes two arcuate dimensions. First, an arc length 132 can be defined along the upper extreme of the upper portion 130 of the illustrated face mask seal clamp 112. The arc length 132 can be defined between two inflection points 134 found along the circumference of the illustrated face mask seal clamp 112.

[0097] like Figure 7 As shown, the upper portion 130 of the illustrated mask sealing clamp 112 also includes a side profile radius 136. As shown, the upper portion 130 may have a slightly increasing side profile radius 136, such that the radius increases slightly with increasing distance from the upper end. In some configurations, the upper portion 130 may include a substantially constant side profile radius 136 or a decreasing side profile radius. Advantageously, this slightly increasing side profile radius 136 provides an increased volume within the mask 100, near the user's nose.

[0098] Reference Figure 3 and Figure 6 The face mask seal clamp 112 preferably includes at least two recesses 140. In the illustrated configuration, the face mask seal clamp 112 includes two recesses 140 arranged on either side of a generally vertical central plane CP (see [reference]). Figure 6 The generally vertical central plane CP preferably corresponds to the user's midsagittal plane and divides the illustrated mask seal clamp 112 into two generally mirror-image halves. These two recesses 140 define two generally enclosed recesses within the illustrated mask seal clamp 112. The illustrated recesses 140 include a plurality of additional recesses 142 to provide sufficient clearance for reasons discussed below, while limiting the amount of intruder entering the nasal region of a cavity defined by the mask assembly 102.

[0099] The illustrated face mask seal also includes a generally central channel 144 defined by a wall 146. In the illustrated configuration, wall 146 generally surrounds channel 144. Preferably, wall 146 is generally cylindrical and extends through wall 126. Other configurations are possible.

[0100] Reference Figure 14The face mask seal 110 includes a flexible portion extending away from the proximal end 120 of the face mask seal holder 112. In the illustrated configuration, the face mask seal 110 is overmolded onto the face mask seal holder 112 such that the face mask seal 110 and the face mask seal holder 112 combine to form an integrated and preferably inseparable assembly. In some configurations, attempts to separate the face mask seal 110 and the face mask seal holder 112 may result in damage to the interface between these components, and / or damage to one or both of the face mask seal 110 and the face mask seal holder 112. As described above, other components may also be used to attach the face mask seal holder 112 to the face mask seal 110. However, the illustrated configuration advantageously produces a structure that is easy to clean and maintain.

[0101] Reference Figure 4 The mask seal clamp 112 is preferably arranged such that it is generally flush with an inner rim 150 of the mask seal 110. In the illustrated configuration, the mask seal 110 includes a relatively small radius portion 152 connecting to an upper portion 154. The upper portion 154 of the mask seal 110 is configured to extend across the user's nasal region. In some configurations, the upper portion 154 is configured to extend across a bridge of the nose region of the user U.

[0102] The upper part 154 is connected to the lower part 156 of the sealing member 110. For example... Figure 9 As shown, the lower part 156 extends outward from the side of the mask sealing clamp 112. Furthermore, as shown in... Figure 4 and Figure 10 As shown, the lower portion 156 wraps backward and inward. On the proximal side of the full-face mask assembly 102, the upper portion 154 and the lower portion 156 combine to define a flange 160 that contacts the face. Figure 10 The flange 160 that contacts the face is shown. The flange 160 is configured to lie below the user's lower lip, extend along the outer side of the mouth, extend upward along the cheekbone, and extend across the user's nose. Therefore, the flange 160 defined by the flange 160 defines a generally teardrop-shaped opening 162. When the mask assembly 102 is placed on the user's face, the flange 160 will lie flat on the user's nose, cheekbone, outer side of the mouth, and below the lower lip. When positive pressure air is supplied, the mask seal 110 will expand and seal against the user's face to reduce or eliminate the possibility of air leakage between the flange 160 and the user's face.

[0103] like Figure 11As shown by the dashed lines, the upper portion 154 of the face mask seal 110 is designed to be wound onto an outer surface 170 of the face mask assembly 102. In the illustrated configuration, the outer surface of the face mask seal 110 is smoothly wound to abut against the outer surface of the face mask seal clamp 112, such that the outer surface of the face mask seal clamp 112 forms a support surface. In some configurations, the outer surface 170 to which the upper portion 154 is wound includes at least a portion of the outer surface of the face mask seal clamp 112. In some configurations, the outer surface 170 to which the upper portion 154 is wound includes almost only the outer surface of the face mask seal clamp 112. In some configurations, the upper portion 154 is wound onto another portion of the face mask seal 110. In some configurations, the upper portion 154 is wound onto the face mask seal base 114.

[0104] Referring to Figure 12, to assist in the winding of the upper portion 154, the upper portion 154 can have varying thickness or varying stiffness. In the configuration shown in Figure 12, the upper portion 154 includes a thick / thin / thick configuration. In other words, to cause the upper portion 154 to wind up in a region between the flange 160 of the contact surface and the small radius 152, near the face mask seal clamp 112, a stiffness-reducing region 172 can be incorporated. In the illustrated configuration, the stiffness-reducing region 172 is incorporated into the face mask seal 110. The stiffness-reducing region 172 reduces or eliminates the possibility of the face mask seal 110 curling or adversely deforming in areas other than the desired winding area.

[0105] Although the illustrated configuration uses a region with reduced thickness, other means of providing a region 172 with reduced stiffness can be used to induce the sealing member 110 to retract. For example, the material of the sealing member 110 can be configured to have reduced stiffness through material selection or material properties. Furthermore, a composite material can be used to provide a region with reduced stiffness or rigidity. Additionally, any suitable combination of techniques can be used. However, the illustrated region 172 configured with reduced thickness provides a simple way to achieve the region 172 with reduced stiffness. Furthermore, by adjusting the stiffness of the region 172 with reduced stiffness, the force required to induce the region 172 to retract can be controlled, which controls the force applied to the user's nose. For example, by changing the stiffness, movement within the range of motion can become progressively or progressively restricted.

[0106] When the upper portion 154 includes a region 172 with reduced stiffness, under internal pressure, such as that encountered in positive pressure therapy protocols, the upper portion 154 of the mask seal 110 tends to expand outwards. This expansion is believed to be caused by this region 172 with reduced stiffness, which defines a large area of ​​silicone without a clearly defined structure. (See reference...) Figure 4As shown in Figure 12, to reduce expansion propagation in the upper portion 154 and to provide a reinforced structure within the upper portion 154, one or more reinforcing members, such as a band 174, may be positioned along at least a portion of the upper portion 154. The band 174 may be a member formed of a material with greater stiffness or increased stiffness characteristics relative to silicone or other materials forming the faceplate seal 110. For example, a region with significantly increased thickness relative to a region 172 with reduced stiffness (where this region is formed of the same material forming the faceplate seal 110) may be used to increase the stiffness of this reinforcing member or these reinforcing members.

[0107] In some configurations, the band 174 may be a separately formed component at least partially covered by the material of the face mask seal 110. In the illustrated configurations, the band 174 may be a co-molded plastic component, or the face mask seal 110 may be overmolded onto the band 174. In some configurations, the band 174 may be defined by a portion of an upper portion 154 that has increased stiffness relative to the surrounding area. For example, but not limited to, the band 174 may be defined by a portion having increased thickness, a portion having a different material or different material properties that produce increased stiffness, etc.

[0108] Reference Figure 9 The band 174 extends along at least a portion of the upper portion 154 of the mask seal 110. When viewed from the front, the upper portion 154 of the mask includes a vertex 180. The vertex 180 can be defined as a tip, a top, and an angled apex of the mask seal 110, and is located near the user's nose during use. In the illustrated configuration, a first wall 182 and a second wall 184 converge at the vertex 180.

[0109] In some configurations, at least a portion of the first wall 182 and at least a portion of the second wall 184 are reinforced by one or more components or structures (such as a hoop 174). In the illustrated configuration, this reinforcing component or these reinforcing components (such as a hoop 174) reinforce at least a portion of the first wall 182 and at least a portion of the second wall 184. In some configurations, this reinforcing component or these reinforcing components (such as a hoop 174) reinforce at least a portion of the first wall 182, at least a portion of the second wall 184, and apex 180.

[0110] Continue to refer to Figure 9The illustrated band 174 has a first end 186 and a second end 188 opposite to the first end 186. In some configurations, the band 174 may be formed separately from the mask seal clamp 112 and attached to the mask seal clamp 112 by one or more flexible members. In some configurations, the band 174 may be attached to the mask seal clamp 112 by a mechanical hinge structure. In the illustrated configuration, the first end 186 and the second end 188 are positioned on the same side of the hinge axis H as the vertex 180. Preferably, the first end 186 and the second end 188 are spaced apart from the hinge axis H toward the vertex 180.

[0111] As shown in Figure 12, the bend 152 and the harder region (e.g., a region with a thicker cross-section) adjacent to the region 172 with reduced stiffness help to induce coiling in the region 172 with reduced stiffness. In other words, controlled coiling of the region 172 with reduced stiffness occurs with the assistance of these adjacent harder portions. Furthermore, positioning an edge of the relatively more rigid mask seal clamp 112 adjacent to the bend 152 further helps to induce coiling in the region 172 with reduced stiffness. In some configurations, the region 172 with reduced stiffness is defined by a first boundary and a second boundary, wherein the first boundary and the second boundary have increased stiffness relative to the region with reduced stiffness. For example, in the configuration shown, the first boundary is defined by or abuts the band 174, while the second boundary is defined by or abuts the bend 152. In some configurations, the second boundary may be defined by or against an edge of the more rigid face mask seal clamp 112. In some configurations, the second boundary may be defined along a portion of the face mask seal 110 positioned between the face mask seal clamp 112 and the region 172 with reduced stiffness.

[0112] As the upper portion 154 of the face mask seal 110 shifts about the hinge axis H, the size of the take-up section increases. In other words, as the first boundary begins to move toward the second boundary, a take-up section is formed in the face mask seal 110. As the first boundary continues to move toward the second boundary, the size of the take-up section continues to increase. Therefore, in Figure 11In the illustrated configuration, during the displacement of the upper portion 154 (as shown by the dashed lines), the coiling segment defined in the upper portion 154 starts from nothing and gradually increases. Preferably, the coiling between the first boundary and the second boundary creates a single bend or zigzag between the first boundary and the second boundary. This single bend creates a leg near the bend whose size increases as the first boundary moves toward the second boundary. In other words, the coiling resulting from the movement of the first boundary toward the second boundary preferably does not produce a fan-like appearance, such as a pleated configuration.

[0113] Refer again Figure 3 The faceplate seal 110 may have a geometry that helps to promote the continued winding of the region 172 with reduced stiffness after winding begins. Generally, multiple arc lengths can be defined from a first intersection of the hinge axis H and the faceplate seal 110, upward and across the upper part 154 of the faceplate seal 110, and downward back to a second intersection of the hinge axis H and the faceplate seal 110.

[0114] like Figure 3 As shown, the mask seal 110 includes at least one 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 clamp 112 and directly adjacent to the first arc length A. The second arc length B lies between the first arc length A and the third arc length C, and is preferably shorter than the third arc length C and longer than the first arc length A. In some embodiments, these arc lengths steadily increase from the bend 152 or from another region near the outer surface 170 toward the proximal side of the band 174. In other words, with angle α (see...) Figure 4 As the first arc length A increases, the arc length generally increases. In some configurations, these arc lengths can be approximately constant from front to back (i.e., as angle α increases); however, by increasing these arc lengths away from the beginning of the take-up segment, further movement of the vertex 180 in the distal direction results in continued take-up of the mask seal 110 on itself and on the outer surface 170, as... Figure 11 As shown in the image.

[0115] Refer again Figure 4 When viewed from the side profile, the upper portion 154 of the illustrated face mask seal 110 also includes a variable radius. As shown, R1>R2>R3. Therefore, in the illustrated face mask seal 110, the radius decreases from near to far as the angle increases. In some configurations, this radius does not need to decrease in this way; however, a gradually decreasing radius is considered to facilitate the winding of the face mask seal 110.

[0116] Furthermore, the radius r1 of the face mask seal clamp 112, starting from the hinge point H, is preferably smaller than the radius R3 of the face mask seal 110. However, considering the bendable nature of the face mask seal 110, the radii r1 and R3 can be approximately the same, while still allowing the face mask seal 110 to be wound onto the face mask seal clamp 112. However, in the configuration shown, the difference between the radii r1 and R3 creates a compensation. This compensation provides the ability to slightly increase the side profile radius 136 (as described above) without significantly affecting the ability of the face mask seal 110 to be wound onto the face mask seal clamp 112. Without this offset, the ability to increase the side profile radius 136 would be very limited.

[0117] As discussed above, flange 160 surrounds the generally teardrop-shaped opening 162. As is known, ring stress can be defined as the circumferential stress generated within a cylindrical portion due to internal pressure. Therefore, ring stress increases as a ring attempts to expand. It is believed that ring stress resulting from the placement of a breathing mask can be a source of discomfort for the user, particularly in the nasal region. The lower portion 156 of the illustrated mask assembly 102 is generally fixed in place, while the nose or upper portion 154 moves relative to the user's nose. Due to the aforementioned retraction action, the illustrated full-face mask assembly 102 retracts away from the nose, reducing the occurrence of increasing ring stress, especially around the nasal bridge. Therefore, this retractable mask configuration provides a means of maintaining or reducing ring stress during mask placement.

[0118] As discussed above and as Figure 11 As shown, in the illustrated configuration, the upper portion 154 of the illustrated face mask seal 110 is rolled up on the outer surface 170. This rolling up on the outer surface of the face mask utilizes the positive pressure present within the full-face mask assembly. The increased air pressure enhances the face mask seal's ability to roll up on itself (i.e., during rolling, the air pressure reduces the surface tension between the two surfaces of the face mask seal that slide relative to each other), and the slight expansion helps reduce the likelihood of the face mask seal 110 curling, wrinkling, or undesirable folding. Furthermore, in some configurations, this external rolling up can provide a visual cue to the degree or angle of displacement of the upper portion 154 of the face mask seal 110 relative to the lower portion 156 of the face mask seal 110.

[0119] To provide the user with an enhanced indication of the degree to which the upper part 154 of the mask has been rolled up, a visual indicator may be employed. For example, in some configurations, a scale may be embossed, decal, or otherwise arranged on or near the area of ​​reduced stiffness 172. In some configurations, a scale may be positioned along a portion of the mask 100 where the area of ​​reduced stiffness 172 will be rolled up. For improved accuracy, the scale is preferably positioned in a central location such that the degree of rollup in the area of ​​reduced stiffness 172 can be maximized. For example, but not limited to, the scale may be a digital scale or a color gradient scale.

[0120] In some configurations, a ratchet or locking mechanism can be integrated with the mask, allowing the reduced stiffness area 172 to be positioned at a desired retraction point. For example, a ratchet mechanism (e.g., a zipper ratchet) with a series of teeth engaging a closing member can be used. The locking mechanism allows the upper portion 154 of the mask to be held in place when the mask 100 is removed from the user's face as the upper portion 154 shifts about the hinge point. Preferably, the locking mechanism allows for easy release of the locked position as desired, so that if the mask is moved too far, the upper portion can be loosened to a better fit. Therefore, the user can set the degree of retraction of the upper portion 154 only once, and each subsequent use will produce the same level of retraction.

[0121] By retracting, the upper portion 154 (i.e., the part of the sealing member that contacts the bridge of the nose) moves as the flange 160 of the mask applies increasing pressure to the user's face. Due to this movement, the force exerted by the upper portion 154 on the bridge of the nose is substantially constant over a wide range of pressure applied by the lower portion 156 to the rest of the user's face. Similarly, the force required to cause the upper portion 154 to move is substantially constant. Figure 28 As shown, the configuration exhibited produces a complete 25mm change in the position of the upper part, while the force associated with this range of movement increases by less than approximately 0.5N. Since the force applied to the nose is generally constant across a range of angles and the associated upper displacement, the force applied to the bridge of the nose does not change significantly at different headgear tension levels. Again, Figure 28 The results demonstrate that, at the apex 180°, within a movement range of 5 mm to 25 mm, the total change in force produces a force change of approximately 0.2 N. Furthermore, since the force applied to the nose is generally constant across a range of angles, the mask can be adjusted to improve fit to various facial geometries while limiting pressure applied to the sensitive bridge of the nose area.

[0122] The use of a roll-up configuration offers significant improvements when compared to structures characterized by pleats. First, the external roll-up, rather than pleats, reduces or eliminates the possibility of material from the mask seal intruding into the chamber designed to contain the user's nose. Therefore, the external roll-up reduces the likelihood of contact between the upper part 154 and the user's nose within this chamber during movement of the upper part 154 relative to the lower part 156. Second, the external roll-up provides a clean appearance and reduces the number of external cavities, which is believed to improve the user's perception of the full-face mask assembly compared to pleated components.

[0123] Reference Figure 24 Although the mask seal 110 shown is rolled up on the outer surface 170, it can be configured for internal rolling up within the mask assembly. In other words, internal rolling up can be used in some configurations. Internal rolling up is less desirable than external rolling up because positive pressure tends to impede rolling up and because the rolling action tends to intrude into the receiving nasal cavity. On the other hand, internal rolling up provides a cleaner appearance than external rolling up because any expansion of the sealing member is contained within the mask seal clamp.

[0124] Now refer to Figure 1 and Figure 2 The mask assembly 102 includes a mask base 114 that is more rigid than the mask seal 110. The mask base 114 can be formed of any suitable material. In some configurations, the mask base 114 is formed of a polycarbonate material, which allows it to flex for connection with the mask seal 110 and / or the mask seal clamp 112.

[0125] Now refer to Figure 14 The image shows a mask assembly 102, in which a mask base 114 is secured to a mask seal 110. More specifically, in the illustrated configuration, the mask base 114 is secured to a mask seal clamp 112, which is attached to the mask seal 110 in any suitable manner. In some configurations, the mask base 114 is removably connected to either the mask seal 110 or the mask seal clamp 112. In some configurations, the mask base 114 snaps onto one or both of the mask seal 110 and the mask seal clamp 112. Preferably, the mask seal 110 and the mask seal clamp 112 can be removed from the mask base 114, and the snap-fit ​​connection secures the mask seal clamp 112 to the mask base 114.

[0126] Reference Figure 14 and Figure 15The mask base 114 shown covers at least a portion of the mask seal clamp 112. In some configurations, the mask base 114 almost completely covers the mask seal clamp 112. In some configurations, the mask base 114 extends across more than half of the mask seal clamp 112. When the mask base 114 covers a substantial portion of the mask seal clamp 112 or the mask seal 110, a double-layer effect is created (e.g., mask seal clamp 112 and mask base 114). This double-layer effect provides increased insulation when a significant portion of the mask base 114 overlaps with a significant portion of the mask seal clamp 112 or the mask seal 110. This increased insulation provides a warmer interior (e.g., mask seal 110 and / or mask seal clamp 112), resulting in less moisture condensation during use. Preferably, at least a portion of the mask seal clamp 112 is exposed below the mask base 114, making it easier to separate the mask base 114 from the mask seal clamp 112. Figure 15 As shown, to assist in the separation of the mask base 114 from the mask seal 110 and / or mask seal clamp 112 below, the illustrated mask base 114 includes an outer peripheral surface 200 on its proximal end. The mask base 114 is concave on its inner side to accommodate the underlying components. In other words, the mask base 114 is cup-shaped in the distal direction relative to the proximal outer peripheral surface 200.

[0127] The outer peripheral surface 200 includes one or more recesses 202. Preferably, the recesses 202 include at least two recesses 202 positioned on opposite sides of the mask base 114. The recesses 202 are configured to receive a thumb and a finger, thereby making it easier to remove the mask base 114 from the front of the mask seal clamp 112 below. While the recesses 202 may define means for gripping components below the mask base 114 to remove the mask base, a variety of other configurations may be used, such as, but not limited to, outwardly extending tabs, protrusions, etc. Furthermore, although the recesses 202 shown are arranged on opposite sides of the mask base 114, these recesses 202 may also be positioned on the top and bottom or other areas as desired.

[0128] like Figure 13 As shown, the mask base 114 preferably includes an opening 210 defined by a wall 212. (Refer to...) Figure 14 (A cross-section passing through the mask seal 110, the mask seal clamp 112, and the mask base 114), this wall 212 defining the opening 210 through the mask base 114 preferably fits within this wall 146 defining the channel 144 through the mask seal clamp 112. For example... Figure 14 As shown, wall 212 and wall 146 may extend axially together. Furthermore, the dimensions and shapes of walls 146 and 212 allow them to interact to reduce relative slippage between them and to reduce the likelihood of unintentional separation between the mask seal base 114 and the mask seal clamp 112. In some configurations, walls 146 and 212 fit together, reducing the possibility of air leakage through the interface between the two walls. Preferably, a conical lock secures walls 146 and 212 together.

[0129] Still refer to Figure 14 The wall 212 includes a profiled inner surface 214. The radius of the profiled surface 214 can be determined to receive a ball end 220 of a swivel elbow 222, such as... Figure 17 The one shown in the image. For example... Figure 18 As better illustrated, the ball joint 220 has a profiled surface 224 that can be snap-fitted into a profiled surface 214 formed in the mask base 114. The connection between these two profiled surfaces 214, 224 allows these surfaces to slide freely relative to each other, thus making it easy to change the position of the swivel elbow 222. In some configurations, the elbow 222 can be configured to rotate or swivel without a ball joint configuration.

[0130] Refer again Figure 13 The mask base 114 also includes at least two recesses 230. The mask base 114 shown includes two recesses 230. The recesses 230 are retracted into and extend rearward from the mask base 114. The recesses 230 are received within a recess 140 of the mask seal holder 112. A plurality of openings 232 cover these additional recesses 142 formed in the mask seal holder 112, these openings being defined by a peripheral wall 234.

[0131] The recesses 230 shown are formed such that one recess 230 is formed on each side of the mask base 114. These recesses 230 can be positioned symmetrically with respect to the central plane CP, which approximately bisects the mask base 114. In some configurations, such as Figure 15 As shown, the recess 230 has a vertical dimension 240 that is enlarged relative to a lateral dimension 242. Similarly, as Figure 15 As shown, the opening 232 has a vertical dimension 244 that is enlarged relative to a lateral dimension 246.

[0132] In the mask base 114 shown, the laterally inward portion of each recess 230 includes a support wall 250. The support wall 250 is positioned relative to the normal of a base surface 248 of the recess 230 toward the central plane CP. Each of the two recesses 230 is configured to receive a clamp 252 (see...). Figure 22 Once the clamp 252 has been installed within the recess 230, the support wall 250 helps restrict the rotation of the clamp 252 relative to the recess 230. Furthermore, this large vertical dimension helps the user position the recess 230 and clamp 252 together during installation.

[0133] Reference Figure 22 The clamp 252 may have a two-part structure: an outer cover 254 and an inner latch 256. The strap 260 may be secured to each clamp 252 in any suitable manner. Figure 2 A suitable configuration is shown. In some configurations, the strap 260 can be clipped between the outer cover 254 and the inner latch 256. In some configurations, multiple loops, openings, or holes can be provided on the clamp 252 through which the strap 260 will pass. Preferably, a clamp 252 can be simultaneously attached to an upper strap and a lower strap of the hood assembly 106. Such a configuration facilitates easy attachment and disengagement of the hood assembly 106 to the full-face mask assembly 102.

[0134] like Figure 23 As shown, the clamp 252 includes an inclined surface 262. The inclined surface 262 can be positioned on the outer cover 254. The inclined surface 262 cooperates with the support wall 250 to help orient the clamp 252 relative to the recess 203 of the mask base 114.

[0135] The clamp 252 includes an interlocking feature 264. The interlocking feature 264 is configured to insert into an opening 232 defined in a recess 230 of the mask base 114. The interlocking feature 264 can engage in a snap-fit ​​manner with a tab 236 defined along a wall 234 that defines the opening 232 in the mask base 114, such as... Figure 13 As shown in the diagram. Other methods of interlocking the clamp 252 with the recess 230 can also be used.

[0136] Reference Figure 23The interlocking feature 264 of the shown clamp 252 includes a U-shaped portion 268 terminating at a release lever 266. The U-shaped end 268 extends a sufficient distance to allow engagement with the tab 236, but does not extend far enough to allow the bottom of an additional recess 142 in the mask seal clamp 112 to prevent proper insertion of the interlocking feature 264 into the opening 232. During the attachment of the clamp 252 to the mask base 114, the U-shaped end 268 initially contacts a wall of the opening 232. In the shown configuration, the U-shaped end 268 contacts the wall 234 of the opening 232 during insertion, and the wall 234 guides the clamp 252 into place within the recess 230. During the attachment of the clamp 252 to the mask base 114, the opening 232, or one or more surfaces defining the opening 232, generally aligns the clamp 252 relative to the mask base 114.

[0137] The end of the release lever 266 extends through an opening 270 defined by a wall 272. Preferably, the end of the release lever 266 extends through the opening 270 a sufficient distance to allow easy manipulation of the release lever 266. Moving the release lever 266 in a manner that closes the U-shape of the interlocking feature 264 allows the interlocking feature 264 to be removed from engagement with the tab 236, which is located in the wall 234 defining the opening 232 in the mask base 114.

[0138] Figures 32 to 39 Several other configurations of the clamp assembly 252 are shown, which are configured to secure the mask assembly 102 to a user's head. For example, Figure 32 and Figure 33 The clamp 252 has a raised edge 400 (sometimes referred to as a finger-like tab 400) that allows the user to easily separate the headgear 106 from the mask assembly 102. The raised edge 400 can be oriented such that the user can detach the clamp 252 from the mask base 114 simply by pulling it back. Removing one or more clamps 252 from the mask base 114 allows the mask assembly 102 to be easily removed from the user's head. The raised edge 400 provides a gripping point during the attachment and removal of the headgear 106 relative to the mask assembly 102. For example, during the removal of the clamp 252 from the mask assembly 102, the user's thumb and forefinger can be placed on opposite sides of the raised edge 400. Furthermore, the user can hold the clamp 252 and maintain this grip throughout the mask engagement process. This eliminates the need to blindly grip the strap 260 during assembly. It also allows the user to attach the clamp 252 while maintaining a grip on the raised edge 400, remove it, and reattach it.

[0139] Figure 34 Showing Figure 32 and Figure 33 An exploded view of the clamp 252. The clamp 252 includes an outer cover 254 and an inner latch 256. The inner latch 256 includes one or more slots 402 to receive the distal end of the headgear strap 260. The inner latch 256 may also include several pressure bulges, as per [the description of the clamp 252]. Figure 38 and Figure 39 The configurations shown are as described above. These pressure bulges provide additional pressure on the outer cover 254 and the inner latch 256, thus securing them to each other. In one configuration, the headgear strap 260 is removable from the assembled clamp 252.

[0140] like Figure 35 As shown, the inner locking latch 256 includes an elongated slot 404. 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 multiple chamfered recesses to aid in aligning the clamp 252 with the mask assembly 102. The circular opening 406 facilitates attaching and removing the clamp 252 to and from the mask assembly 102, as will be discussed in more detail below. Two grooves 408 extend parallel to both sides of the slot 404, thereby defining a slot wall 410 (sometimes referred to as a clamp lever) on either side of the slot 404. The grooves 408 are sized to allow sufficient flexural flexibility of the slot wall 410 during attachment and removal of the clamp 252 from the mask assembly 102. Furthermore, the slotted wall 410 extends towards the top and bottom along the longest dimension of the inner latch 256, which allows for a longer slotted wall 410. The longer slotted wall 410 reduces the stress level on the slotted wall when the fixture is assembled onto the mounting post.

[0141] Figure 36 The text demonstrates suitability and... Figures 32 to 35A configuration of a mask base 114 used in conjunction with the clamp 252. The mask base 114 includes two recesses 140 symmetrically positioned on opposite sides of the mask base 114. Within each recess 140, a mounting post 412 extends from the body of the mask base 114. The mounting post 412 may be integrally formed with the mask base 114 or separately formed and secured to the mask base 114. The mounting post 412 may have a mushroom-shaped configuration so that the clamp 256 is secured to the mask base 114 once the user snaps the clamp 256 into place. The dome of the bulbous mushroom-shaped post 412 facilitates the positioning and orientation of the central hole 406. When the clamp 252 is pressed against the post 412, the slot wall 410 offsets outward away from the post 412. Once the head of the post 412 passes the edge of the slotted wall 410, the slotted wall 410 snaps back to its original position, thus providing tactile feedback and sometimes auditory feedback that the clamp 252 has been properly attached to the mask assembly 102.

[0142] Mounting post 412 may also include an elongated, oval, raised portion 414 (sometimes referred to as a lug or wing) sized to match the elongated slot 404 of the inner locking buckle 256. This elongated, raised portion 414 includes a chamfered edge to aid in proper alignment of the headgear 106 relative to the mask assembly 102. This portion 414 also prevents the clamp 252 from rotating relative to the mask assembly 102. This helps ensure constant tension on the headgear strap 260 when the user is asleep.

[0143] Figure 37 A partial assembly with yet another configuration for securing a clamp 252 to a mask base 114 of a mask assembly is shown. The clamp 252 is located within a recess 140 of the mask base 114. Within the recess 140, a cylindrical, round-headed post 412 extends from the surface of the mask base 114. When the clamp 252 is attached to the post 412, the post, due to its cylindrical configuration, allows for slight rotation of the clamp. However, as... Figure 38 and Figure 39 As shown, the slot 404, groove 408, and slot wall 410 extend toward the front and rear ends of the inner latch 256 along the shorter planar direction.

[0144] The inner latch 256 also includes several pressure protrusions 414. As discussed above, these pressure protrusions provide additional pressure on the outer cover 254 and the inner latch 256, thus securing them to each other.

[0145] Figures 40 to 47 Several other configurations of clamp 252 are shown. Figure 40The clamp 252 includes three elongated, elliptical slots 404 and a finger-shaped tab 400. The finger-shaped tab 400 is used to create a lever for releasing the clamp 252 from a mask assembly 102. The central slot 404 is sized to receive a mounting post 412 extending from the outer surface of the mask body. Figure 43 The image shows a suitable mounting post 412. The mounting post 412 includes a ridge 414 and two slots 416. When the clamp 252 is pressed against the mounting post 412, the outer portions of the post 412 flex towards each other due to the spacing provided by the slots 416. Once the ridge 414 has passed the upper surface of the clamp 252, the mounting post 412 snaps back to its original position, and the ridge 414 locks the clamp 252 in place.

[0146] Figures 44 to 47 A similar configuration is shown in the figure. Figure 45 The clamp 252 does not include a finger-shaped tab and its central opening 404 has a larger diameter than the one shown in the previous section. Figures 40 to 44 These elongated slots are more rounded or elliptical in shape.

[0147] All of these aforementioned configurations simplify the procedure of securing the mask assembly 102 to the user's head. For example, the clamp 252 allows the headgear 106 to be opened so that it is not a closed loop. By opening, the headgear 106 can be wrapped around the head instead of forcing the user to pull their head through the headgear.

[0148] Reference Figure 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 wraps around the back of the user's head, generally above the back of the neck, but generally below the occipital protuberance. At a position behind the user's ear, the back strap 280 forks into an upper arm 284 and a lower arm 286. The upper arm 284 curves upward to a position above the user's ear and then curves downward to a position generally in front of the user's ear. The lower arm 286 curves downward to a position generally below the user's ear and extends slightly in front of the ear.

[0149] The strap 260 can be attached to the back strap 280 in any suitable manner. In the illustrated configuration, the strap 260 is attached to the upper arm 284 and the lower arm 286, respectively. Preferably, the upper arm 284 and the lower arm 286 are more rigid than the strap 260, such that the arms 284 and 286 substantially maintain their shape when the headgear assembly 106 is worn. In some configurations, the upper arm 284 and the lower arm 286 each support their own weight. In some configurations, the upper arm 284 and the lower arm 286 are each constructed to be tangle-free during wear. For example, the arms 284 and 286 have sufficient torsional stiffness to reduce the possibility of twisting when worn.

[0150] Preferably, the strap 260 is attached to at least one of the upper arm 284 and lower arm 286 at a location in front of the ear. This configuration helps the user position the straps 260 without much difficulty. Furthermore, since the strap 260 in the illustrated configuration is embedded in the clamp 252, the ends of the upper arm 284 and lower arm 286 may include slots 290 and 292, allowing the strap 260 to pass through them. Additionally, the strap 260 may include an adjustment mechanism 294, such as a Velcro or buckle configuration. The adjustment mechanism 294 allows adjustment of the force between the face shield seal 110 and the user's face. Any suitable adjustment mechanism 294 can be used.

[0151] like Figure 2 As shown, the top strap 282 is preferably flexible and has an adjustable length. The top strap 282 is attached to the upper arm 284 via a slot 296, reducing the likelihood of the upper arm 284 sliding down from the user's head and contacting the user's ear. Preferably, the top strap 282 is attached to the upper arm 284 at a location approximately above the user's ear.

[0152] Advantageously, such as Figure 1 and Figure 2 As shown, the straps 260 apply a force in the direction of arrow F, and these straps are connected to the mask base 114 by movement in the C direction, which is generally perpendicular to the direction of force F. In other words, the straps 360 are tensioned by pulling forward, and the clamps 252 are connected to the mask base 114 by movement in a direction perpendicular to this forward pull. This configuration facilitates securing the interface 100 to the user's face.

[0153] In another configuration, the hood assembly 106 includes a semi-rigid hood 380 (e.g., Figure 29(As shown) for securing the face mask assembly 102 to the user's head. The semi-rigid headgear 380 is formed as a composite structure including a semi-rigid strap 382 attached to a soft trim 384. For example, the soft trim 384 can be molded by plastic overlay or bonded to the semi-rigid strap 382 using an adhesive. Figure 29 As shown, a flexible trim 384 can be attached to a semi-rigid strap 382 without overlapping, to maintain the continuous profile of the semi-rigid headgear 380. When tension is applied from the strap 260 to pull the mask assembly 102 toward the user's head, the semi-rigid strap 382 defines and maintains the shape of the semi-rigid headgear. In other words, the semi-rigid strap 382 is sufficiently rigid along its planar axis to prevent excessive deformation of its upper arm 284 and lower arm 286 under tension. The semi-rigid strap 382 can be made of a variety of rigid or semi-rigid materials, including plastic or metal. In some configurations, the semi-rigid strap 382 is made of PVC.

[0154] In particular, with regard to semi-rigid hood assemblies, it has been found that shape-retaining or self-supporting properties can produce an intuitively fitting integral assembly. Specifically, where these connections and / or these hood components are self-supporting, allowing them to maintain their three-dimensional form, the hood can be assembled in the correct orientation with little (if any) instruction. In a self-supporting arrangement, the tendency of these straps not to tangle also reduces the time required to assemble the entire assembly.

[0155] As used herein, the term "semi-rigid" indicates that the headgear assembly is rigid enough that the headgear assembly 380 can present a three-dimensional shape having a size approximation to the patient's head to which the headgear is designed to fit, while being flexible enough to generally conform to the patient's anatomy. For example, some of the other components of the headgear assembly 380 (e.g., arms or straps) may also be partially or fully "semi-rigid," allowing these components to maintain a generally self-supporting three-dimensional form. A "semi-rigid" headgear assembly is not intended to mean that every and all components of the headgear assembly must be semi-rigid. For example, the generally three-dimensional form that a self-supporting headgear assembly 380 may present may primarily involve the rear and top of the headgear assembly 380. Furthermore, when placed on a patient's head, a semi-rigid headgear assembly 380 may include multiple semi-rigid areas extending in front of and above the ears.

[0156] The upper arms 284 and lower arms 286 on the left and right sides can also be formed of a semi-rigid material. When used here, the semi-rigid material can include a variety of molded plastic or sheet materials, including but not limited to homogeneous plastic materials and bonded nonwoven fiber materials.

[0157] In some configurations, one or more of these arms or straps are formed of a substantially inelastic material. These arms or straps may be formed of a semi-rigid, self-supporting material, allowing the semi-rigid headgear assembly 380 to have a generally three-dimensional shape and to be largely tangle-free. In some configurations, for example, but not limited to, the material may include a layered structure with compliant and semi-rigid portions. For example, but not limited to, the semi-rigid strap 382 may be made of a self-supporting, elastic, substantially inelastic material such as Santoprene, polyolefins, polypropylene, polyethylene, foamed polyolefins, nylon, or nonwoven polymers. In some configurations, the semi-rigid strap 382 is formed of polyethylene or a series of polypropylenes. This material may be a low-density polyethylene, such as Dowlex 2517, which is a linear low-density polyethylene with a yield tensile 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 strap 382 is preferably formed of a material that allows the semi-rigid headgear 380 to maintain approximately its shape under its own weight regardless of its orientation. In some configurations, the semi-rigid strap 382 stretches no more than about 6 mm under a tensile load of 30 N. In some configurations, the semi-rigid strap 382 stretches no more than about 3 mm under a tensile load of 30 N.

[0158] In some configurations, the semi-rigid strap 382 is formed from a nonwoven polyolefin (NWP) bonded (e.g., overmolded or laminated) with a polyolefin. In such configurations, the overmolded polyolefin material provides the primary shape-maintaining properties. Furthermore, a softer NWP material is adapted for contact with the skin and to provide a desired level of comfort. Additionally, the NWP material can assist in providing desired load-bearing properties, such as desired tensile load-bearing properties.

[0159] The semi-rigid headgear 380 is generally formed of a semi-rigid material. When used herein, the semi-rigid material may include a variety of molded plastic or sheet materials, including but not limited to homogeneous plastic materials and bonded nonwoven fiber materials. The upper arms 284 and lower arms 286 also include this type of semi-rigid material, as arms 284 and 286 are integrally formed with the semi-rigid headgear 380 and are multiple parts of the semi-rigid headgear. Preferably, the right and left lower arms 286 are formed as a single, integral component that will wrap around the back of the patient's head and extend above the neck during use.

[0160] A flexible trim 384 covers or is attached to at least a portion of the outer periphery of the semi-rigid strap 382. In one configuration, the flexible trim 384 does not cover the front or back of the semi-rigid strap 382. For example, the flexible trim 384 and the semi-rigid strap 382 may have the same thickness at their joint location.

[0161] The soft trim 384 provides a soft and comfortable interface between the outer periphery of the semi-rigid strap 382 and the user's skin. The soft trim 384 can be made of a variety of soft materials, including but not limited to plastics, elastomers, silicones, or thermoplastic polyurethane (TPU). The soft trim 384 can have a Shore stiffness in the range of 10 Shore A to 80 Shore A.

[0162] As used herein with respect to headbands and harnesses, "soft" is used to describe the feel of a material, meaning the quality of the material as assessed by the response obtained through touch. Furthermore, as used herein with respect to headbands and harnesses, "comfortable" is used to describe the ability of a material to conform to the anatomical features of a patient (e.g., around a facial feature). Specifically, a harness comprising at least one element made of a "soft" and / or "comfortable" material may also be "semi-rigid" and / or axially inelastic.

[0163] The flexible trim 384 may have a uniform thickness or, in some configurations, a non-uniform thickness. For example, in some configurations, the flexible trim 384 has the same thickness as the semi-rigid band 382. In other configurations, the flexible trim 384 is thinner than the semi-rigid band 382, ​​forms a bulbous end of the semi-rigid band 382, ​​or is simply thicker than the semi-rigid band 382. Figure 29 The image shows multiple cross-sectional views of the semi-rigid headgear 380. Each cross-sectional view (A-A' to F-F') shows one possible configuration of the thickness of the semi-rigid strap 382 and the soft trim 384, which can be combined as desired. For example, any particular thickness and shape of the soft trim 384 can be applied to a portion or the entirety of the semi-rigid strap 382, ​​or can be combined with... Figure 29 Combine any other specific cover thickness and shape shown.

[0164] Many other thickness configurations are also available. Furthermore, the material thickness can be applied symmetrically or asymmetrically to the semi-rigid strap 382. For example, cross-sectional views C-C' and F-F' are shown asymmetrically; however, in other configurations, the thickness at either end of the soft trim 384 is applied symmetrically to the semi-rigid strap 382. In some configurations, the semi-rigid strap 382 is selectively thickened to provide additional stiffness and support. For example, the second of the two configurations shown as cross-sectional view F-F' has such a thickening. Finally, in some configurations, the entire semi-rigid headgear 380 (as in the semi-rigid strap 382, ​​such as...) is thickened... Figure 29 As shown in the figure, or on the soft trim 384, multiple ventilation holes 396 are provided to provide ventilation and sweat management.

[0165] like Figure 29 As shown, when laid flat, the semi-rigid headgear 380 defines three C-shaped arcuate regions 386, 388, and 390. Two regions 386 and 388 surrounding the ears are defined by upper arms 284 and lower arms 286, while a rear region 390 is defined by multiple lower arms 286 and the rear strap 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 regions 386 and 388 surrounding the ears at least partially surround or encircle the user's ears, and the rear region 390 at least partially surrounds or encircles the back of the user's head above the neck.

[0166] The curvature of each arm 280, 284, 286 can be selected to provide a comfortable fit and facilitate the application or removal of the semi-rigid headgear 380 from the user's head. For example, in the illustrated configuration, the upper arms 284 have a concave curvature relative to the openings in the upper arcuate regions 386, 388 surrounding the ears, and the lower arms 286 have a convex curvature. The back strap portion 280 and the lower arms 286 all have a concave curvature relative to the openings in the arcuate region 390 surrounding the neck. These curvatures facilitate the application and removal of the semi-rigid headgear 380 from the user's head by, for example, providing multiple openings to these arcuate regions, the size and orientation of which are determined for easy fitting around the user's neck and ears.

[0167] Figure 29The configuration employs an integrated crown strap including a first crown arm 392 and a second crown arm 394 for securing the semi-rigid headgear 380 to the user's head. Once the semi-rigid headgear 380 is positioned partially around the user's head, the first crown arm 392 and the second crown arm 394 engage with each other to secure the semi-rigid headgear 380 in place. Any of a variety of mechanisms can be provided to the first crown arm 392 and the second crown arm 394 to enable them to attach to each other. For example, in some configurations, hook-and-loop fabric (e.g., Velcro) or one or more snaps or clips can be used to attach the first crown arm 392 and the second crown arm 394 to each other.

[0168] These coronal bands extend laterally, collinear with the ears, on the top of the skull. When these coronal bands extend in this manner and the arcuate regions 386, 388 are positioned to partially encircle the user's ears, the rear band 280 of the semi-rigid headgear 380 should be positioned above or below the occipital protuberance. The user's occipital protuberance is the most prominent projection of the occipital bone in the posteroinferior portion of the skull. In other words, the occipital protuberance is the highest point of the external occipital protuberance. The semi-rigid headgear 380 can be positioned on the user's head according to any of the various configurations described in the appendix, which forms an integral part of this disclosure and is incorporated herein in its entirety.

[0169] For example, the back strap portion 280 is adapted to engage with the back of the user's head. Preferably, the back strap portion 280 is adapted to engage with the head at a location on or below the external occipital protuberance. The back strap portion 280 spans a distance around the back of the head and extends to each side of the head. In some configurations, the back strap portion 280 includes a longitudinal center that is adapted to be located approximately 25 degrees below a horizontal plane extending through the patient's ear canal.

[0170] On either side of the head, the semi-rigid headgear 380 extends upward and downward to form a left and right side region, which together form arcuate regions 386 and 388. These two side regions are adapted to extend behind the patient's ears. Preferably, these two side regions are also adapted to extend behind the patient's mastoid process. The left and right side regions of the semi-rigid headgear 380 each extend into or include an arched portion 386 and 388. The arched portions 386 and 388 curve forward. The arched portions 386 and 388 are adapted to extend around the corresponding ear of the patient. Preferably, the arched portions 386 and 388 each terminate at a corresponding termination portion. These termination portions are preferably adapted to be located in front of the patient's ears. In some configurations, these side regions and arched portions 386 and 388 of the semi-rigid headgear 380 do not include a soft internal padding portion, but may include a self-supporting elastic material in direct contact with the patient's head / hair.

[0171] The top portion of the semi-rigid headgear 380 connects the arched portions 386 and 388 together. In some configurations, this top portion may be positioned in front of the ears. Preferably, the top portion is positioned to rise generally from the ears. More preferably, the longitudinal center of the top portion is adapted to be spaced back by more than 13 mm, preferably between 13 mm and 100 mm, from a vertical plane intersecting the ear canal. In some configurations, the top portion includes a first segment 392 and a second segment 394, wherein the first segment 392 and the second segment 394 combine to form the top portion. The first segment 392 extends upward from a apex of the left arched portion 386, while the second segment 394 extends upward from a apex of the right arched portion 388. Preferably, the top portion is formed of a self-supporting and semi-rigid material. In some configurations, the top portion does not include any backing (including a soft, padded backing layer).

[0172] The upper arm 284 and lower arm 286 each include a slot 292, 290 near the end of each arm. Each slot is configured to receive a strap 260 from the mask assembly 102, such as... Figure 2 As shown in the diagram. Furthermore, the portion 398 of the semi-rigid headgear 380 covered by the strap 260 is thinner than the corresponding arms 284 and 286 to accommodate the thickness of the strap 260. For example, as... Figure 30 and Figure 31 As shown, the semi-rigid headgear portion 398 is thinner than the arm 286. The dimensions of portion 398 are determined such that when the strap 260 is inserted into the slot 290 and tightened, its thickness will not exceed that of the arm 286. By keeping the thickness of the strap 260 and portion 398 less than the thickness of the arm 286, the strap 260 will not irritate the user when worn.

[0173] Furthermore, the upper arm 284 is configured to extend downwards from a position above the user's ear, such that the adjustable top strap 260 extends to a distance of at least approximately 10 mm from the user's eyes during wear. The lower arm 286 is configured to detach from the user's neck when the head is tilted up and down, and the termination point of the lower arm 286 is generally located below the user's ear, such that the lower strap attached to the lower arm 286 rises at an angle from the termination point 290 to the face mask assembly 120. In this configuration, as... Figure 52 and Figure 53 As shown, the lower straps and the upper straps form a triangle, and the space between the lower straps and the upper straps on the mask is smaller than the space between the lower straps and the upper straps on the headgear, thereby stabilizing the mask assembly 120 to prevent it from moving up and down.

[0174] Refer again Figure 17 Elbow 222 is connected to conduit 300 via a detachable rotating assembly 302. For example... Figure 20 As shown in the cross-sectional view, elbow 222 includes a post 304, which includes an inner wall 306 at its base. The inner wall 306 includes a recess 308.

[0175] A sleeve 310 includes a flange 312 received within a recess 308. The sleeve 310 can be secured in place within the elbow 222 using any suitable technique. The sleeve 310 includes a generally cylindrical outer wall 314. The flange 312 includes a section extending outwardly and connecting to a lever 316. Preferably, the flange 312 and the lever 316 are integrally formed. (See reference...) Figure 21 The lever 316 includes an inwardly extending lower latch 320 and is pivotable about the section that connects the lever 316 to the flange 312. Therefore, pressing inward on an upper portion 322 of the lever 316 causes the latch 320 to move away from the generally cylindrical outer wall 314 of the sleeve 310.

[0176] A swivel 330 includes a generally cylindrical inner wall 332. The inner wall 332 slides on the outer wall 314 of the sleeve 310, thereby creating a sliding fit between the swivel 330 and the sleeve 310. An upper portion 334 includes a shoulder 336. A latch 320 of a lever 316 can engage with the shoulder 336 to secure the swivel 330 in an axial position on the sleeve 310. When the upper portion 322 of the lever 316 is pressed, the latch 320 moves away from the shoulder 336, allowing the swivel 330 to be removed from the sleeve 310.

[0177] A valve disc 350 can be mounted between the rod 304 and the sleeve 310. In the illustrated configuration, the valve disc 350 extends from a base 354 sandwiched between the rod 304 and the sleeve 310 into a flow channel 352. The valve disc 350 can be positioned around the X-axis (see [reference]). Figure 21 ) Upward pivot (e.g.) Figure 20 As shown in the diagram (see arrow P), the valve 350 moves away from the sleeve 310, allowing the flow from a positive pressure generator to continue generally unobstructed to the user through the interface 100. The valve 350 pivots downwards to contact the sleeve 310 to seal the flow channel 352 should the positive pressure source cease supplying pressurized airflow. In some configurations, the valve 350 will not fully contact the sleeve 310. In some configurations, the valve 350 does not seal the channel 352 when in the downposition position.

[0178] Reference Figure 21A port 360 is defined at a location above the valve disc 350 via the bend 222. The port 360 is preferably positioned along a portion of the bend 222 near the axis X. In some configurations, the port 360 is positioned to be substantially shielded by the valve disc 350, isolating the intake airflow. In other words, as air causes the valve disc 350 to pivot away from the sleeve 310, the valve disc 350 is moved to a location that at least partially or completely covers the port 360.

[0179] In some configurations, port 360 extends through a wall of elbow 222, including a generally flat inner wall 362. As the valve disc moves upward away from flange 312 of sleeve 310, the generally flat inner wall 362 helps valve disc 350 to generally seal port 360.

[0180] In some configurations, lever 316 covers most of port 360, causing port 360 to be largely obscured during observation. However, as... Figure 20 As shown, a gap 364 preferably surrounds at least a portion of the lever 316 such that a relatively free flow of air can pass through the port 360 when the valve disc 350 is not covering it. Furthermore, in some configurations, the port 360 and the lever 316 are positioned on the same side of the elbow 222 as an opening 370 defined within the ball end 220, which is positioned within the mask assembly 102 when the connecting port assembly 104 is assembled to the mask assembly 102. Advantageously, this positioning places the port 360 in a user-facing position on the elbow 222. During use, such a position further obscures the port 360 from view, resulting in a more aesthetically pleasing configuration. Moreover, since the flow through the port 360 is very sparse, arranging the port 360 towards the user will not cause any noticeable discomfort to the user.

[0181] Although not shown, elbow 222 may also include one or more deflection vents. Preferably, these deflection vents are positioned in a forward orientation so that any deflection does not directly impact the user.

[0182] Figures 48 to 51 Another configuration of the elbow assembly 302 is shown in the image. For example... Figure 49As shown, elbow assembly 302 includes an elbow 222, a sleeve 310, and / or a swivel 330. In some configurations, elbow assembly 302 includes only elbow 222 and sleeve, omitting swivel 330. The swivel can be permanently or removably attached to sleeve 310 and elbow 222; in some configurations, swivel 330 is integrally formed with the end of the delivery conduit. A valve disc 350 is positioned on sleeve 310 such that the valve disc at least partially blocks the flow channel 352 of the sleeve. Elbow assembly 302 and Figures 17 to 21 The elbow assembly 302 serves a similar function; however... Figures 48 to 51 The elbow assembly 302 provides the additional benefit of guiding gas away from the patient when the valve disc 350 descends to its closed position (e.g., Figure 50 and Figure 51 (as shown in the image).

[0183] Reference Figure 49 The sleeve 310 preferably includes two or more cut-out areas or recesses 356. These recesses 356 can have any suitable shape, and in the illustrated configuration, these recesses 356 include a semi-circular shape extending upward into the sleeve 310. The sleeve 310 also includes at least one protrusion 357, and preferably two or more protrusions 357. Preferably, each protrusion 357 extends about an arc of about 70 degrees. More preferably, each protrusion 357 is generally located between two recesses 356 and each protrusion 357 extends about 70 degrees around an outer surface of the sleeve 310.

[0184] The preferred configuration of the rotating body 330 is generally cylindrical. For example... Figure 49 As shown, the rotating body 330 has an inwardly extending ridge 358. The ridge 358 preferably surrounds the entire inner surface. In some configurations, the ridge 358 may be interrupted. However, preferably, the ridge 358 does not have an interruption large enough to accommodate the entire raised portion 357, so that the ridge 358 and the raised portion 357 can assist in holding the rotating body 330 mounted on the sleeve 310. When the rotating body 330 is assembled onto the sleeve 310, the recess 356 allows the raised portion 357 to deflect inwards so that the raised portion 357 can slide over the ridge 358 and then snap back outwards to secure the raised portion 357 beneath the ridge 358.

[0185] The elbow 222 includes multiple openings 420 on its side, which are in fluid communication with an air vent 422. Figure 50 and Figure 51 As shown, the air ventilation channel 422 is formed by the gap between the inner wall 362 and the outer wall 424 of the elbow.

[0186] like Figure 50 and Figure 51 As shown, when valve disc 350 descends to its closed position, the user's exhaled air enters the opening 370 of elbow 222. The exhaled air flows through port 360 in the inner wall 362 of elbow and through ventilation passage 422 until it exits elbow 222 via opening 420.

[0187] Figures 48 to 51 The configuration provides a reduced overall length and improves the product's aesthetics by eliminating an unsightly hole positioned at the front of elbow 222. Furthermore, Figures 48 to 51 The configuration improves patient comfort by preventing air from being directed toward the user. Instead, multiple openings 420 direct air away from the patient from these sides with bends 222.

[0188] Reference Figure 54 For example, but without limitation, a flexible headgear assembly 500 can be used to secure a mask assembly to a user's head for respiratory therapy. The flexible headgear assembly 500 shown can be used with any suitable mask assembly, including but not limited to any of the mask configurations disclosed herein.

[0189] The illustrated flexible headgear assembly 500 includes a back strap portion 502. At least a portion of the back strap portion 502 is connected to an insert 504. In the illustrated configuration, the back strap portion 502 is configured to span a distance around the back of the user's head and is configured to extend toward each side of the user's head.

[0190] Continue to refer to Figure 54 A pair of upper arms 506 and a pair of intermediate arms 510 extend generally laterally from a top edge 512 of the rear strap portion 502. A pair of lower arms 514 extend generally laterally from a lower edge 516 of the rear strap portion 502. In some configurations, the lower arms 514 extend downward and away from the rear strap portion 502, such that a lower edge of the lower arms 514 is positioned below the bottom edge of the rear strap portion 502. In some configurations, the intermediate arms extend upward and away from the rear strap portion 502, such that the intermediate arms 510 have an upper edge positioned above the upper edge of the rear strap portion.

[0191] In the illustrated configuration, the lower arm 514 and the middle arm 510 terminate at end 520. End 520 may include securing portions 522, which may be formed of hook or loop components for a hook-and-loop fastening arrangement. Preferably, and as will be described in more detail below, these securing portions 522 include at least a hook portion that can engage with material of another portion of the headgear assembly 500. Each upper arm 506 may also terminate in an area including a securing portion 524.

[0192] When positioned on a user's head, the back strap portion 502 is located on or below the external occipital protuberance and above the back of the user's neck. These upper straps 506 can be joined together in any suitable manner. In some configurations, a clamp secures these upper straps 506 to a fixing portion 522 that is folded in half and secured to another portion of the upper strap 506. Thus, the upper straps 506 can generally extend across the top of the user's head to limit downward movement of the rest of the headgear assembly 500.

[0193] The intermediate arm 510 and lower arm 514 can be attached to a clamp (not shown) or to another part of the mask assembly, such that the intermediate arm 510 and lower arm 514 directly or indirectly (e.g., with a clamp, such as but not limited to) hold the headgear assembly 500 in place (e.g., with a clamp, such as but not limited to) Figure 40 (The one shown) is fixed to the mask. The ends 520 of the intermediate arm 510 and lower arm 514 can pass through the loops or other structures on the mask assembly and be folded in half along a crease. The overlapping parts can be secured in any suitable manner. For example, but not limited to, a hook-and-loop fastening arrangement can be used (e.g., Fasteners are used to secure these overlapping parts.

[0194] Reference Figure 55 At least one of the ends of the upper arm 506, the intermediate arm 510, and the lower arm 514 may include an enlarged end 520. Preferably, the enlarged end 520 is formed at least on the intermediate arm 510 and the lower arm 514 of the flexible headgear 500. In some configurations, the enlarged end 520 may appear on one or more arms attached to the mask assembly. The enlarged end 520 may be integrally formed with the main portion of the arm 510 or the arm 514.

[0195] As described above, the arm 526 can be integrally formed with the enlarged end 520. The enlarged 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 enlarged 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 enlarged end 520 and the arm width e 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 enlarged end 520 and the arm width e is about 6 mm. Because the width d of the enlarged end 520 is greater than the width e of the arm 526, the edge of the enlarged end 520 can be more easily positioned so that the portion used to secure the end 520 to the arm can be more easily positioned to re-engage the arm 526 (e.g., to tighten, loosen, remove, or otherwise reposition the flexible headgear 500).

[0196] Furthermore, when the width d of the enlarged end 520 is greater than the width e of the arm 526, a neck 536 can be formed at a location between the enlarged end 520 and the arm 526. When secured to the user's head, the neck 536 can reduce the likelihood of the enlarged end 520 slipping out of the attachment portion on the mask assembly. For example, an opening in the attachment portion on the mask assembly can be about 16 mm to about 18 mm wide, while the enlarged end 520 can be about 22 mm and the arm 526 can be about 16 mm. Therefore, the possibility of the enlarged end 520 accidentally being pulled through the opening is greatly reduced.

[0197] The geometry of the neck 536 can further reduce the possibility that the enlarged end 520 may be unintentionally pulled through the opening. Any suitable transition section can be used. Figure 56 As shown, the neck 536 can be curved when desired to facilitate removal of the arm from the mask assembly. The neck can 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. In some configurations, the neck 536 can be a more abrupt transition or a less abrupt transition. The more abrupt the transition, the less likely the arm is to accidentally detach from the mask assembly.

[0198] The neck 536 forms part of the geometry of the enlarged end 520. In some configurations, the enlarged end 520 may be generally oval. In some configurations, the enlarged end 520 may be configured to resemble a variety of shapes, including, for example, a parallelogram, an ellipse, a circle, a triangle, or any other suitable shape.

[0199] Continue to refer to Figure 55 Each extended end 520 may include an embedded insert 522 having a hook or similar feature. The insert 522 may be positioned on the extended end 520 such that, when the arm has been folded over itself, the extended end 520 can be secured to another portion of the corresponding arm. The embedded insert 522 may include a hook-fabric (e.g., Therefore, the hook material of the enlarged end 520, and specifically the insert 522, can be fastened to another part of the corresponding arm to secure the headgear assembly 500 to the mask assembly.

[0200] Insert 522 can be attached to the ends of these arms in any suitable manner. In some configurations, insert 522 is attached to the enlarged end 520 by ultrasonic welding. For example, insert 522 can be positioned at a desired location along the arm, and then the ultrasonic welding process can effectively fuse the two materials together. (See reference...) Figure 56 When an enlarged fabric hook insert 522 is attached to an enlarged end 520 using ultrasonic welding, a weld edge 530 with a width α is formed around the outer periphery of the enlarged fabric hook insert 522. Due to the ultrasonic welding process in the illustrated configuration, the width α of the weld edge 530 is approximately 3 mm. Because the ultrasonic welding process melts or otherwise deforms the fabric hook, the area of ​​the fabric hook insert 522 including the weld edge 530 typically does not engage with the material of the receiving hook. Therefore, the functional surface area of ​​the fabric hook insert 522 is reduced to a surface area equal to that of the weld edge.

[0201] The weld edge 530 may be defined by a flexible edge 532, which includes a breathable composite material of the receiving hooks of the extended end 520 and has a width b. Preferably, the weld edge 530 is recessed below the surface of the flexible edge 532. The projection of the width e of the arm 526 may extend through the weld edge 530 such that the flexible edge 532 will be positioned slightly outward from the projected segment of the width e of the arm 526.

[0202] The width b of the soft edge can be from about 0.5 mm to about 4 mm, from about 1 mm to about 3 mm, or preferably about 2 mm. An effective hook portion 534 can be adjacent to the welded edge 530 and has a width c. The width c of the effective hook portion can be slightly narrower than the width e of the arm 526. By increasing the width c, the functional surface area of ​​the fabric hook material can be increased, thus improving shear resistance and durability. By making the width c smaller than the width e of the arm 526, the arm 526 reduces the likelihood of the effective hook portion 534 contacting the user's skin. The width c of the effective fabric hook portion 534 can be from about 8 mm to 16 mm, from about 10 mm to about 14 mm, and preferably about 12 mm. The width d of the enlarged end allows for an increase in the width c of the functional surface area. In other words, the end of the arm has been enlarged to increase the width of the effective hook portion 534, which provides a more secure attachment of the enlarged end to the surface of the arm.

[0203] The flexible hood assembly 500 can be formed from any suitable material. In some configurations, the flexible hood assembly 500 may be at least covered with a breathable composite material that receives hooks, or at least a portion thereof may be formed from that material. In some configurations, the flexible hood assembly 500 may be at least partially made of nylon / Lycra. Material Formation. In some embodiments, when a material sample measuring 150 mm in length and 20 mm in width is subjected to an axial load of 10 N, the sample elongates to approximately 207 mm, meaning the 10 N axial load results in an elongation of approximately 38%. Therefore, the material is preferably quite elastic. In some embodiments, the headgear assembly 500 may include one or more rounded edges. These rounded edges may be formed in any suitable manner. In some configurations, these rounded edges are formed by applying heat and pressure to the edges of the headgear assembly 500. In some configurations, these rounded edges are formed in a manner similar to that described in U.S. Patent No. 3,295,529, the entire contents of which are incorporated herein by reference.

[0204] As described above, the back strap portion 502 of the illustrated flexible headgear assembly 500 preferably includes at least one relatively inelastic insert 504. This insert can be formed from a relatively low-stretch material, such as, but not limited to, polyester. Material. In some embodiments, when a material sample measuring 150 mm in length and 20 mm in width is subjected to an axial load of 10 N, the sample elongates to approximately 160 mm, meaning the 10 N axial load results in an elongation of approximately 7%. Therefore, this material is preferably quite inelastic or non-stretchable compared to the more elastic material of the flexible portion.

[0205] Because the insert 504 is formed of a material less elastic than the surrounding portion of the headgear assembly 500, the insert 504 resists stretching in at least a portion of the headgear assembly 500. By resisting elongation of at least a portion of the elastic headgear assembly, the insert helps maintain the headgear 500 in a desired shape and helps hold the headgear 500 in a desired position relative to the back of the user's head.

[0206] Tests have shown that, without using insert 504, when an increasing load is applied to these lower straps, elongation in the back of the headgear assembly 500 can cause the headgear assembly to elongate and move downward toward the user's neck. Figure 57A and Figure 57B The effect of applying an increasing force to the lower arm 514 of a flexible hood 540, which has a back strap portion 544 made entirely of an elastic material, is shown. Figure 57A and 57B The configuration shown does not have the characteristics of block 504.

[0207] As described above, when the back strap portion 544 is positioned on or below the external occipital protuberance and above the back of the user's neck, the back strap portion is positioned in a desired location. Figure 57A The image shows the rear strap portion 544 in a more preferred position. To aid in visualizing the movement, multiple position markers 546 are shown on the test model 542. (See image for details.) Figure 57B As shown, when an increasing load is applied to the lower arm 514, the elastic nature of the back strap portion 544 allows it to stretch and deform, which allows the back strap portion 544 to move downwards along the user's neck. This movement is illustrated with reference to these position marks 546. With downward movement, a greater force from the back strap portion 544 is applied to the neck rather than the head, which is less desirable. Since the flexible headgear 540 may be worn for minutes to hours, or even hours to days, when used for respiratory therapy, the lowered positioning of the back strap portion 544 may cause discomfort to the user.

[0208] To reduce the elongation of the back strap portion 502 when increasing forces are applied to the lower arm 514, a less elastic insert 504 can be attached to the back strap portion 502. In some configurations, the insert 504 may include a substantially non-stretchable insert 560. The insert 560 can be attached to the back strap portion 502, for example, by over-lock stitching, by ultrasonic welding, by using glue or other adhesives, or by any other method known to those skilled in the art. When the insert 560 is attached to the back strap portion 502, it can provide greater tensile strength, which allows greater forces to be applied to the lower arm 514 when attaching and using the flexible headgear 500. Therefore, the insert 560 can advantageously reduce deformation of the back strap portion 502 and help hold the back strap portion in a desired position relative to the user's head and neck.

[0209] like Figures 58A to 58D As shown, the non-stretchable inserts 560, 562, 564, and 566 can be configured into various shapes, including but not limited to... Figures 58A to 58D As shown in the diagram. Preferably, the non-extendable inserts 560, 562, 564, 566 abut or cover at least the rear strap portion 502. In some configurations, the non-extendable inserts 562, 564 abut or cover at least a portion of the lower arms 514. In some configurations, the non-extendable inserts 562, 564 abut or cover at least a portion of the connection area between the lower arms 514 and the rear strap portion 502. In some configurations, the non-extendable insert 564 abuts or covers at least a portion of the intermediate arms 510. In some configurations, the non-extendable insert 564 abuts or covers at least a portion of the connection area between the intermediate arms 510 and the rear strap portion 502. In some configurations, the height of the non-extendable insert 560 is at least about half the height h of the rear strap portion 502. In some configurations, the height of the non-extendable insert 560 is preferably more than about half the height h of the rear strap portion 502. By making a portion of the back strap portion 502 into a more elastic material, the back strap portion 502 is able to stretch and deform to a limited extent, but beyond what a back strap portion made entirely of a less elastic material could possibly have.

[0210] The non-stretchable insert 560 can be configured to have any suitable surface area. The non-stretchable insert 560 can be configured to extend along varying lengths of the lower edge 516 of the rear strap portion 502. In some configurations, the non-stretchable insert 560 extends more than half of the lower edge 516 of the rear strap portion 502. Preferably, the non-stretchable insert 560 extends substantially the entire lower edge 516 of the rear strap portion 502. Other configurations are possible.

[0211] Now refer to Figure 59 The illustration shows an assembly including a hood 600 having two or more straps that can be connected to a wing-type buckle 602. Like other hoods described herein, the hood 600 can be used with any suitable mask assembly, including but not limited to any of the mask configurations disclosed herein. Furthermore, the illustrated configuration includes multiple straps connected by a wing-type buckle 602, and this configuration can be used (e.g., but not limited to) any hood disclosed herein.

[0212] exist Figure 59 In the illustrated configuration, the headgear assembly 600 includes at least a pair of upper arms 606. Each upper arm 606 may terminate at an end 608. In some configurations, at least one of the upper arms 606 includes a securing portion, as described elsewhere. In the illustrated configuration, each upper arm 606 includes a securing portion. Preferably, these securing portions are at least partially positioned at the end 608. In some configurations, these securing portions may be formed of hook or loop components for a hook-and-loop fastening arrangement. Preferably, these securing portions at least include a hook portion that can engage with material of another portion of the headgear assembly 600.

[0213] Reference Figure 59 For example, but without restriction, these upper arms 606 can be connected via wing-type buckles 602. Figure 61 As shown, the wing-type buckle 602 may include a body 610 that defines at least one slot 612, preferably at least two slots 612. The at least one slot 612 receives the ends 608 of the straps 606 such that the ends 608 of the straps 606 can pass through the at least one slot 612 and then be folded and secured in place with the fastening portion as described above.

[0214] The body 610 of the buckle 602 shown includes a sliding connector portion 614 and a pair of flaps 616. Therefore, the at least one slot 612 can be defined by the sliding connector portion 614. However, in some configurations, the at least one slot 612 can be formed by one or more of the following (including one or more of a plurality of the following components): a ring, a square ring, a D-ring, an oval ring, a non-slip buckle, a ladder lock, or the like.

[0215] The wing 616 advantageously provides support for the strap 606, thus enabling (as...) Figure 59 The hood assembly 600 (shown as an example) including the strap 606 can generally maintain its three-dimensional shape. In some configurations, a buckle without flaps would allow the hood assembly, and more specifically the strap 606, to fold and fall around the buckle, which could cause the hood assembly to essentially not maintain its three-dimensional shape. Therefore, flaps 616 have been found to enhance the usability of the hood assembly 600.

[0216] Reference Figure 62 The lateral outward extension 618 of the wing 616 extends downward beyond a lower surface 620 of the connector portion 614. By extending the lateral extension 618 below the lower surface 620, the buckle 602 can better conform to and / or follow the crown shape of the user's head compared to a flat buckle. However, in some configurations, the lateral outward extension 618 may not extend downward below the lower surface 620, and / or the bottom of the buckle (including the wing pieces) may be generally flat or rounded.

[0217] The buckle 602 can be formed from any suitable material. In some configurations, the buckle 602 may incorporate two or more different materials, allowing the connector portion 614 to be formed from a more rigid material, while at least the flaps 616 can be formed from a softer material. The softer flaps 616 improve comfort, while the more rigid connector 614 allows the buckle 602 to withstand the loads expected to be experienced in the headgear assembly 602.

[0218] In some configurations, the two or more different materials may be overmolded or co-molded to form the buckle 602. In some configurations, the two or more different materials may be mechanically joined (e.g., snap-fit, keying, etc.) or connected by attachment, adhesive, etc. In some configurations, for example, but not limited to, at least the flaps 616 may be formed of a thermoplastic elastomer or an impact-modified polyethylene. In some configurations, for example, but not limited to, the connector portion 614 may be formed of nylon, etc. In some configurations, the connector portion and the flaps may be formed of multiple materials having the same matrix material (e.g., materials with suitable chemical relationships to allow these materials to connect).

[0219] Still refer to Figure 62 These flaps 616 preferably taper in thickness generally from the region near the connector portion 614 toward these lateral extensions 616. While any suitable tapering profile can be used, the reduction in thickness promotes the flexural capacity of the flaps 616, enabling them to better conform to the user's anatomy. In other words, the reduced thickness of the flaps 616 at the laterally outward location from this portion adjacent to the connector portion 614 produces a weaker flexural strength, which helps to conform to the user's anatomy.

[0220] Refer again Figure 61 The flap 616 has multiple inwardly tapering sidewalls 622. In the illustrated configuration, the inwardly tapering sidewalls 622 connect to an end wall 624 with a rounded corner 626. The rounded corner 626 improves user comfort, while the tapering sidewalls 622 reduce the width of the flap 616. The reduced width at least at the end of the flap 616 facilitates securing the flap 616 within the folding area of ​​the strap 606, below the end 608, which... Figure 59 and Figure 60 The details are best illustrated here. In some configurations, the folded end 608 and / or the adjacent portion of the strap 606 define a recess that receives the tapered ends of the flaps 616. In some configurations, the strap 606 may be widened in a region as discussed above. 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 the opening 612 defined in the connector portion 614, while the tapering of the flaps 616 allows the strap 606 to cover and / or enclose the flaps 616.

[0221] In some configurations, the flap 616 extends away from the connector portion 604 by a length L2, which is greater than twice the thickness L1 of the wall of the connector portion 604 defining the slot 612. Other configurations are also possible. As discussed above, the extension length L2 of the flap 616 reduces the flipping of the strap 606 when connected to the wing buckle 602. The flap 616 may have a length L2 smaller than the length of the connector portion of these ends 608, such that the lateral extension 618 of the flap 616 can be covered by the connector portion of these ends 608.

[0222] While the invention has been described with respect to one embodiment, other embodiments will be apparent to those skilled in the art and are also within the scope of the invention. Therefore, various changes and modifications can be made without departing from the spirit and scope of the invention. For example, the components can be repositioned as desired. Furthermore, not all features, aspects, and advantages are necessary for practicing the invention. Therefore, the scope of the invention is intended to be defined solely by the following claims.

Claims

1. An elbow assembly configured to connect a face mask assembly to an air duct, the elbow assembly comprising: An elbow and a sleeve, the elbow including an inner wall and an outer wall and defining an air vent between the inner wall and the outer wall, the inner wall defining a flow channel through the elbow, the inner wall including a port located in a user-facing position, the elbow also including two openings on the side of the elbow in fluid communication with the air vent, and the sleeve being connected to the elbow; A valve disc, wherein when the valve disc is in a first position, the valve disc at least partially blocks the port and allows gas from the air duct to be delivered to the user via a flow channel through the elbow, and when the valve disc is in a second position, the valve disc at least partially blocks the flow channel, thereby allowing gas to flow from the user to a location outside the elbow assembly via the port and the air vent channel, wherein the air vent channel guides air away from the user.

2. The elbow assembly according to claim 1, wherein, The sleeve also includes a raised portion extending around the outer surface of the sleeve and a recess adjacent to the raised portion.

3. The elbow assembly according to claim 2, wherein, The raised portion and the recess are adapted to receive a rotating component, the rotating component including a ridge on the inner surface of the rotating component for engaging with the raised portion.

4. The elbow assembly according to claim 2 or 3, wherein, The sleeve includes two or more recesses.

5. The elbow assembly according to claim 2, wherein, The recess or recesses are semi-circular in shape and extend upward into the sleeve.

6. The elbow assembly according to claim 1, wherein, The sleeve includes two or more ridges, and / or each ridge extends around an arc of approximately 70 degrees, and / or each ridge is centered between two recesses.

7. The elbow assembly according to claim 1, wherein, The inner wall includes a recess, and the sleeve includes a flange, which is fixed within the recess of the inner wall.

8. The elbow assembly according to claim 3, wherein, The elbow assembly includes a lever, the lever including an inwardly extending lower latch, and The upper portion of the rotating component includes a shoulder. The inwardly extending lower latch secures the rotating component in an axial position on the sleeve by engaging with the shoulder platform. When the upper portion of the lever is pressed down, the inwardly extending lower latch moves away from the shoulder platform to allow the rotating component to be removed from the sleeve.

9. The elbow assembly according to claim 8, wherein, The sleeve includes an outwardly extending section for connection with a lever.

10. The elbow assembly according to claim 9, wherein, The sleeve is integrally formed with the lever.

11. The elbow assembly according to claim 8, wherein, The lever is placed over the port, which obscures the port as a whole when viewed.

12. The elbow assembly according to claim 1, wherein, The valve disc extends from the base, which is sandwiched between the elbow and the sleeve, into the flow channel.

13. The elbow assembly according to claim 1, wherein, In the second position, the valve disc pivots downward and contacts the sleeve to block the flow passage.

14. The elbow assembly according to claim 1, wherein, In the first position, the valve disc completely covers the port.

15. The elbow assembly according to claim 1, wherein, The port extends through the wall of the elbow, the wall of which includes a flat inner wall.

16. The elbow assembly according to claim 1, wherein, The elbow includes one or more deflection vents.

17. The elbow assembly according to claim 16, wherein, The one or more deflection vents are positioned in a forward-oriented orientation so that any deflection does not directly impact the user.

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