Patient interface

Abstract

A mask assembly can include a mask seal. In some configurations, the mask assembly can be configured to be positioned entirely below a nasal bridge of a user's face and to leave the nasal bridge of the user exposed. The mask seal can include a nose region including at least one nose opening, a first flap on a first side of the nose region, and a second flap on a second side of the nose region. The first flap can be configured to contact one side of the nose of the user and the second flap can be configured to contact the other side of the nose of the user.

Description

[0001] This application is a divisional application of the invention patent application filed on October 5, 2017, with application number 201780073731.0 (international application number PCT / IB2017 / 056136) and entitled "Patient Interface".

[0002] By incorporating any priority claim

[0003] This application claims priority to U.S. Provisional Application No. 62 / 413,604, filed October 5, 2016; U.S. Provisional Application No. 62 / 413,280, filed October 26, 2017; and U.S. Provisional Application No. 62 / 404,341, filed October 27, 2016, each of which is incorporated herein by reference in its entirety. Background of the Invention Technical Field

[0005] This disclosure relates to interface components for respiratory therapy. Specifically, this disclosure relates to subnasal interface components that do not cover the bridge of the user's nose. Background Technology

[0007] In patients with obstructive sleep apnea (OSA), the muscles that normally keep the upper airway open relax during sleep to the point that the airway is constricted or completely closed, a phenomenon often manifested as snoring. When this persists for a period of time, the patient's brain typically becomes aware of the threat of oxygen deprivation and incompletely awakens the patient to open the airway, allowing normal breathing to resume. The patient may not be aware of these awakening events, which can occur hundreds of times per sleep period. This incomplete awakening significantly reduces sleep quality, potentially leading to a variety of symptoms over time, including excessive daytime sleepiness, chronic fatigue, elevated heart rate, elevated blood pressure, weight gain, headaches, irritability, depression, and anxiety.

[0008] Obstructive sleep apnea is often treated with positive airway pressure (PAP) therapy. PAP therapy involves delivering a flow of air to the patient at a therapeutic pressure above atmospheric pressure, which reduces the frequency and / or duration of apnea, hypopnea, and / or flow restriction. This therapy is typically achieved by using a positive airway pressure device to deliver a pressurized airflow through a tube that passes through a patient interface or mask positioned on the patient's face.

[0009] A common type of patient interface assembly used in conjunction with PAP therapy or other respiratory therapies involving gas delivery includes a seal that contacts the bridge of the user's nose. The bridge of the nose is sensitive to pressure applied by the seal of the interface assembly. Recently, interface assemblies that do not contact the bridge of the nose have become available. Such interface assemblies may be referred to as "subnasal" interface assemblies. There is a need to provide improved subnasal interface assemblies with improved comfort and / or sealing performance, or to provide a useful option to the public. Summary of the Invention

[0010] The systems, methods, and apparatuses described herein are innovative in that no single aspect is essential or alone to achieve their desired properties. Without limiting the scope of the claims, some of the advantageous features will now be outlined.

[0011] In some configurations, an interface for use in providing positive pressure ventilation therapy includes a mask assembly having a mask seal. The mask assembly is configured to be positioned completely below the bridge of the user's nose and expose the user's nose. The mask seal includes a nasal region including at least one nasal opening. The mask seal includes a first flap on a first side of the nasal region and a second flap on a second side of the nasal region. The first flap is configured to contact one side of the user's nose and the second flap is configured to contact the other side of the user's nose. The first flap includes a first cutout region extending from the front side of the first flap to the rear side of the first flap. The second flap includes a second cutout region extending from the front side of the second flap to the rear side of the second flap.

[0012] In some configurations, the mask seal further includes a support structure configured to support the nasal region of the mask seal.

[0013] In some configurations, the mask seal includes a recessed front surface, which includes an upper recessed front surface configured to receive the frame flaps.

[0014] In some configurations, the first cut area includes a reduced wall thickness.

[0015] In some configurations, the first cut region includes a first concave portion positioned along the length of the first cut region, and the second cut region includes a second concave portion positioned along the length of the second cut region.

[0016] In some configurations, the first concave portion is configured to allow the first cut area to fold inward when a force is applied to the first wing, and the second concave portion is configured to allow the second cut area to fold inward when a force is applied to the second wing.

[0017] In some configurations, the mask seal includes a concave region positioned along the outer periphery of the mask seal.

[0018] In some configurations, the first cut region includes a first inner region and a first outer region. The first inner region is configured to compress toward the first outer region when a force is applied to the first inner region. The second cut region includes a second inner region and a second outer region. The second inner region is configured to compress toward the second outer region when a force is applied to the second outer region.

[0019] In some configurations, the first cut area extends across a portion of the rear side of the first wing and at least to the first side of the nose opening.

[0020] In some configurations, an interface for use in providing positive pressure ventilation therapy includes a mask assembly having a mask seal. The mask assembly is configured to be positioned completely below the bridge of the user's nose and expose the user's nose. The mask seal includes a nasal region including at least one nasal opening. The mask seal includes a first flap on a first side of the nasal region and a second flap on a second side of the nasal region. The first flap is configured to contact one side of the user's nose and the second flap is configured to contact the other side of the user's nose. The mask assembly further includes a front upper portion. The front upper portion includes a front recessed portion. In some configurations, the mask assembly further includes a stepped transition between the upper periphery of the front upper portion and the front recessed portion.

[0021] In some configurations, the stepped transition follows the curvature of the periphery of the first and second winglets.

[0022] In some configurations, the stepped transition varies in depth.

[0023] In some configurations, the stepped transition is tapered, so that the depth is minimized at the lower end of the stepped transition.

[0024] In some configurations, the depth of the stepped transition depends on the size of the mask seal.

[0025] In some configurations, the mask assembly further includes a frame. The forward recess is configured to receive at least a portion of the frame.

[0026] In some configurations, the maximum depth of the stepped transition is greater than or equal to the thickness of the frame.

[0027] In some configurations, the upper front portion further includes a first upper corner and a second upper corner formed on the front sides of the first and second winglets.

[0028] In some configurations, the stepped transition includes varying depths such that the depth of the stepped transition is greater at the first and second upper corners than at the middle portion between the first and second upper corners.

[0029] In some configurations, the interface includes a frame that is removably attached to the mask assembly.

[0030] In some configurations, the frame includes frame flaps.

[0031] In some configurations, when assembled to the mask assembly, the frame flaps are positioned to insert into and / or within the front recessed surface.

[0032] In some configurations, the outer surface of the frame flap is flush with the upper recessed surface.

[0033] In some configurations, the frame provides additional support for the nose area of ​​the seal.

[0034] In some configurations, the frame provides additional rigidity to the front nose area of ​​the seal.

[0035] In some configurations, the frame flaps provide support for the nose area.

[0036] In some configurations, the frame flaps help prevent the sealing flaps from deflecting away from the user's nose during use.

[0037] In some configurations, the frame flaps can help prevent the frame flaps from contacting or digging into the user's face if the mask seal becomes excessively deformed.

[0038] In some configurations, the recessed front surface allows for the use of a single-size frame with mask assemblies of different sizes.

[0039] According to some embodiments, an interface for use in providing positive pressure ventilation therapy may include a mask assembly and a frame. The mask assembly may include a mask seal. The mask assembly may be positioned completely below the bridge of the user's nose and expose the user's nose. The mask seal may include a nasal region. The nasal region may include at least one nasal opening.

[0040] The mask seal may include a first flap on a first side of the nasal region and a second flap on a second side of the nasal region. The first flap may contact one side of the user's nose, and the second flap may contact the other side of the user's nose. A frame may be removably coupled to the mask assembly. The mask assembly may include a housing. The housing may include an inlet and a concave front surface surrounding the inlet. The inlet may define a flow path to an internal chamber of the mask assembly.

[0041] In some configurations, the interface includes a bend that connects to the frame via a connecting feature.

[0042] In some configurations, the connection features include snap-fit ​​arrangements that allow the frame to snap into a slot in the bend.

[0043] In some configurations, the connection features include a snap-fit ​​arrangement such that the bend includes multiple ribs extending outward from the bend. The multiple ribs can form a slot to receive the frame.

[0044] In some configurations, the frame is shaped to at least partially receive the bend.

[0045] In some configurations, the bend includes a valve port that is configured to provide a flow path from the atmosphere to the interior space of the bend.

[0046] In some configurations, the valve port faces the front surface of the concave side, and the valve port and the front surface of the concave side define the flow path, such that the area of ​​the valve port forms the minimum area of ​​the flow path.

[0047] In some configurations, the mask assembly may include a biased vent that is configured to expel air exhaled by the user.

[0048] In some configurations, an interface for use in providing positive pressure ventilation therapy includes a mask assembly having a mask seal. The mask assembly is configured to be positioned completely below the bridge of the user's nose and expose the user's nose. The mask seal includes a nasal region including at least one nasal opening. The mask seal includes a first flap on a first side of the nasal region and a second flap on a second side of the nasal region. The first flap is configured to contact one side of the user's nose and the second flap is configured to contact the other side of the user's nose. The mask assembly further includes a frame removably coupled to the mask assembly, wherein the frame includes a clamp holding feature configured to connect to a headband clamp. The headband clamp includes: an upper strap slot; a lower strap slot; a pull tab; and an aperture positioned between the lateral sides of the upper and lower strap slots and the pull tab.

[0049] In some configurations, the clamp retainer features provide an opening that is configured to allow air exhaled by the user to escape.

[0050] In some configurations, the headgear clamp includes an insert that causes the pull tab to form at least a portion of the covering molding arrangement.

[0051] In some configurations, the frame includes bonding protrusions configured to engage corresponding bonding recesses of the headgear clamps.

[0052] In some configurations, the bonding protrusion is positioned on one side of the first clamp holding feature, and the bonding protrusion is configured to indicate the correct orientation for attaching the headgear clamp.

[0053] In some configurations, the frame includes at least two openings.

[0054] In some configurations, the headgear clamp includes a finger grip and a thumb grip, which form a molded grip provided to the user, wherein the finger grip is positioned laterally opposite the thumb grip along the concave surface of the headgear clamp.

[0055] In some configurations, the headgear clamp is positioned near the upper front portion of the face mask seal, preventing the face mask seal from expanding.

[0056] According to some embodiments, a breathing mask may include a mask assembly and a frame. The mask assembly may include a seal and a housing. The seal may include a nasal seal and a mouth seal. The seal may provide airflow to the user's nose and mouth. The housing and seal may form a breathing chamber. The frame may be removably coupled to the mask assembly. The frame may include: a body; an inlet opening through which pressurized air is supplied to the mask assembly; and an anti-asphyxiation valve in fluid communication with the inlet opening. The body of the frame may define at least a portion of a gas flow passage for the anti-asphyxiation valve.

[0057] In some configurations, the frame includes a tube connector that is attached to the frame body. The frame can be connected to a breathing tube. The tube connector can define an inlet opening.

[0058] In some configurations, a pipe connector can secure the valve component of the anti-suffocation valve to the body of the frame.

[0059] In some configurations, the frame may define the mask connector. The mask connector secures the mask assembly to the frame. The mask connector may define a portion of the gas flow path. The mask connector may receive gas flow from the inlet opening and the anti-asphyxiation valve. The mask connector may deliver the gas flow to the mask assembly.

[0060] In some configurations, the front wall of the frame can define a portion of the gas flow channel for the breathing mask.

[0061] In some configurations, the housing may define a recess that accommodates at least a portion of the frame, including the anti-suffocation valve.

[0062] In some configurations, the nose sealing portion may include a left nose sealing surface and a right nose sealing surface. The inner portion of each sealing surface closest to the nose opening of the seal may be generally flat.

[0063] In some configurations, the outer portion of each of the sealing surfaces may be curved. The radius of curvature of the outer portion may decrease in the rear-to-front direction within each of the outer portions.

[0064] In some configurations, the angle defined between the left and right sealing surfaces can be increased in the rear-to-front direction.

[0065] In some configurations, the mask includes an inlet tube that defines a portion of a gas flow channel and is fixed relative to the body of the frame.

[0066] In some configurations, the entrance opening is integrated with the main body of the frame.

[0067] In some configurations, the inlet pipe extends downward from the bottom region of the front wall.

[0068] In some configurations, the inlet pipe includes a front surface that defines a continuous surface with the front surface of the front wall.

[0069] In some configurations, the inlet pipe is located at least partially behind the front wall.

[0070] In some configurations, the inlet pipe includes a rear inner surface and a front inner surface. The rear inner surface may extend away from the inlet and may be angled toward the front inner surface.

[0071] In some configurations, the recess accommodates the inlet pipe.

[0072] In some configurations, the housing includes a bias vent positioned on opposite sides of the inlet orifice and below the frame on the front surface of the housing. The bias vent allows air to exit below the lower edge of the frame.

[0073] According to some embodiments, a breathing mask may include a mask assembly and a frame. The mask assembly may include a full-face seal and a housing. The housing may include a bias vent. The frame connects the mask assembly to a pressurized air supply and may include a body defining at least one headgear connector. The bias vent may be positioned on opposite sides of an inlet orifice and located below the frame on the front surface of the housing, and the bias vent may exhaust air below the lower edge of the frame. The frame may define at least a portion of a gas flow passage for an anti-asphyxiation valve.

[0074] In some configurations, the frame can define at least one valve outlet of the anti-suffocation valve.

[0075] In some configurations, the frame includes a tube connector that is attached to the frame body. The frame can be connected to a breathing tube. The tube connector can define an inlet opening.

[0076] In some configurations, a pipe connector can secure the valve component of the anti-suffocation valve to the body of the frame.

[0077] In some configurations, the frame may define the mask connector. The mask connector secures the mask assembly to the frame. The mask connector may define a portion of the gas flow path. The mask connector may receive gas flow from the inlet opening and the anti-asphyxiation valve. The mask connector may deliver the gas flow to the mask assembly.

[0078] In some configurations, the front wall of the frame can define a portion of the gas flow channel for the breathing mask.

[0079] In some configurations, the housing may define a recess that accommodates at least a portion of the frame, including the anti-suffocation valve.

[0080] In some configurations, the nose sealing portion may include a left nose sealing surface and a right nose sealing surface. The inner portion of each sealing surface closest to the nose opening of the seal may be generally flat.

[0081] In some configurations, the outer portion of each of the sealing surfaces may be curved. The radius of curvature of the outer portion may decrease in the rear-to-front direction within each of the outer portions.

[0082] In some configurations, the angle defined between the left and right sealing surfaces can be increased in the rear-to-front direction.

[0083] In some configurations, the mask includes an inlet tube that defines a portion of a gas flow channel and is fixed relative to the body of the frame.

[0084] In some configurations, the entrance opening is integrated with the main body of the frame.

[0085] In some configurations, the inlet pipe extends downward from the bottom region of the front wall.

[0086] In some configurations, the inlet pipe includes a front surface that defines a continuous surface with the front surface of the front wall.

[0087] In some configurations, the inlet pipe is located at least partially behind the front wall.

[0088] In some configurations, the inlet pipe includes a rear inner surface and a front inner surface. The rear inner surface may extend away from the inlet and may be angled toward the front inner surface.

[0089] In some configurations, the recess accommodates the inlet pipe.

[0090] In some configurations, the housing includes a bias vent positioned on opposite sides of the inlet orifice and below the frame on the front surface of the housing. The bias vent allows air to exit below the lower edge of the frame.

[0091] According to some embodiments, a breathing mask may include a mask assembly and a frame. The mask assembly may include a seal and a housing. The frame may be removably coupled to the mask assembly. The frame may include: an inlet opening through which pressurized air is supplied to the mask assembly; and an anti-asphyxiation valve in fluid communication with the inlet opening. The housing may include a valve recess that receives at least a portion of the frame including the anti-asphyxiation valve.

[0092] In some configurations, the valve recess defines a concave area.

[0093] In some configurations, the concave area is positioned below the entrance.

[0094] In some configurations, the concave region is located near the entrance.

[0095] In some configurations, the width of the valve recess is smaller than the maximum width of the inlet.

[0096] In some configurations, the valve recess can receive at least a portion of the valve.

[0097] In some configurations, the valve recess can receive at least the rear portion of the valve.

[0098] In some configurations, the valve recess may receive at least a portion of one or more valve outlets of the valve.

[0099] In some configurations, the valve recess has a curved surface that corresponds to the curvature of the valve's rear surface.

[0100] In some configurations, the valve recess is configured to allow the valve to be positioned recessed into the seal.

[0101] In some configurations, the valve recess and valve are designed to reduce the overall depth of the mask assembly and reduce the intrusiveness of the mask assembly on the user.

[0102] In some configurations, the valve recess and valve are configured to allow the valve to be positioned higher relative to the bottom edge of the seal.

[0103] In some configurations, the valve recess and the valve are designed to reduce the length of the inlet orifice. Attached Figure Description

[0104] Throughout the accompanying drawings, reference numerals may be used repeatedly to indicate the general correspondence between reference elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of this disclosure.

[0105] Figure 1 It is a front perspective view of an interface component positioned on the user's head that has certain features, aspects, and advantages described in this disclosure.

[0106] Figure 2 It is positioned on the user's head. Figure 1 A top view of the interface component.

[0107] Figure 3 It is separate from the user and has no headgear. Figure 1 The rear perspective view of the interface part of the interface component.

[0108] Figure 4 yes Figure 1 The front perspective view of the mask component of the interface component.

[0109] Figure 5 yes Figure 4 The rear view of the mask assembly shows the thickened area of ​​the mask seal.

[0110] Figure 6 yes Figure 4 A side view of the mask assembly, showing the thickened area of ​​the mask seal.

[0111] Figure 7 This is a rear view of the face mask assembly, showing the cutout area of ​​the face mask seal.

[0112] Figure 8 yes Figure 7 A top view of the mask assembly, showing the cut-out area of ​​the mask seal.

[0113] Figure 9A This is a front view of the mask assembly, showing the cut-out area of ​​the mask seal.

[0114] Figure 9B It is along Figure 9A The cross-sectional view of the mask assembly taken by line AA shows the cut area of ​​the mask seal.

[0115] Figure 9C yes Figure 9A A close-up view of the mask assembly, showing Figure 9B The incision area.

[0116] Figure 9D yes Figure 9A The rear view of the mask assembly shows the cut-out area of ​​the mask seal.

[0117] Figure 10A This is a partial top view of the mask assembly, showing the cut-out area of ​​the mask seal of the mask assembly, which is generally not compressed.

[0118] Figure 10B yes Figure 10A A top view of the mask assembly, showing the cut area of ​​the partially compressed mask seal.

[0119] Figure 10C yes Figure 10A A top view of the mask assembly, showing the cut area of ​​the partially compressed mask seal.

[0120] Figure 11A yes Figure 10A The top perspective view of the mask assembly shows the cut-out area of ​​the mask seal, which is generally not compressed.

[0121] Figure 11B yes Figure 10A A top view of the mask assembly, showing the cut area of ​​the partially compressed mask seal.

[0122] Figure 12 This is a rear view of the face mask seal of the face mask assembly, showing the cut-out area of ​​the face mask seal.

[0123] Figure 13 yes Figure 12 A partial rear view of the mask assembly, showing the cut-out area of ​​the mask seal.

[0124] Figure 14 yes Figure 12 The top and rear perspective views of the mask assembly show the cut-out area of ​​the mask seal.

[0125] Figure 15 yes Figure 12 A top view of the mask assembly, showing the cut-out area of ​​the mask seal.

[0126] Figure 16 This is a front perspective view of the face mask assembly, showing the recessed surface of the face mask assembly.

[0127] Figure 17 yes Figure 16 The front and side perspective views of the mask assembly show the recessed surface and frame of the mask assembly.

[0128] Figure 18A yes Figure 16 The rear view of the mask assembly shows the recessed surface of the mask assembly.

[0129] Figure 18B yes Figure 16The front view of the mask assembly shows the recessed surface of the mask assembly.

[0130] Figure 19A This is a front view of the face mask assembly, showing the recessed surface of the face mask assembly.

[0131] Figure 19B yes Figure 19A The front and side perspective views of the mask assembly show the recessed surface of the mask assembly.

[0132] Figure 20 yes Figure 19A Front and side perspective views of the frame of the mask assembly.

[0133] Figure 21A yes Figure 19A An exploded view of the face mask assembly shows its components.

[0134] Figure 21B yes Figure 19A An exploded view of the face mask assembly shows its components.

[0135] Figure 22A This is a front view of the face mask assembly, showing the components of the face mask frame.

[0136] Figure 22B yes Figure 22A The rear view of the mask assembly shows the components of the mask frame.

[0137] Figure 23A These are rear and side perspective views of the mask assembly, showing the components of the mask frame.

[0138] Figure 23B yes Figure 23A Rear and side perspective views of the mask assembly show the components of the mask frame.

[0139] Figure 24 This is a front view of the face mask assembly, showing the recessed surface of the face mask assembly.

[0140] Figure 25 yes Figure 24 A cross-sectional side view of the face mask assembly, showing the recessed surface of the face mask assembly.

[0141] Figure 26 This is a partial cross-sectional side view of the face mask assembly, showing the recessed surface of the face mask assembly.

[0142] Figure 27 This is a bottom view of the face mask assembly, showing the recessed surface of the face mask assembly.

[0143] Figure 28 This is an exploded view of the face mask assembly, showing... Figure 26The design of the pipe bend.

[0144] Figure 29 These are front and side perspective views of the mask assembly, showing the headgear clamps and clamp holding features.

[0145] Figure 30A yes Figure 29 The front and side perspective views of the mask assembly show the clamp holding features.

[0146] Figure 30B yes Figure 29 Front and side perspective views of the headgear clamp of the face mask assembly.

[0147] Figure 31A yes Figure 29 A top view of the mask assembly, showing the clamp holding features.

[0148] Figure 31B yes Figure 29 The front and side perspective views of the mask assembly show the clamp holding features.

[0149] Figure 32A yes Figure 29 The front view of the frame of the mask component.

[0150] Figure 32B yes Figure 29 The rear view of the frame of the mask component.

[0151] Figure 33A yes Figure 29 Front view of the headgear clamp of the face mask assembly.

[0152] Figure 33B yes Figure 29 Rear and side perspective views of the headgear clamp of the mask assembly.

[0153] Figure 33C yes Figure 29 A side view of the headgear clamp of the face mask assembly, wherein a portion of the clamp is made transparent to reveal the structure below.

[0154] Figure 33D yes Figure 29 The front view of the headgear clamp of the mask assembly, wherein a portion of the clamp is made transparent to reveal the structure below.

[0155] Figure 33E yes Figure 29 Side and rear perspective views of the headgear clamp of the mask assembly, wherein a portion of the clamp is made transparent to reveal the structure below.

[0156] Figure 34A These are the front and side perspective views of the frame component of the mask assembly.

[0157] Figure 34B yes Figure 34A The front view of the frame component of the mask component.

[0158] Figure 35A yes Figure 34A The front view of the frame of the mask component.

[0159] Figure 35B yes Figure 34A The rear view of the frame of the mask component.

[0160] Figure 36A yes Figure 34A Front view of the first headgear clamp of the mask assembly.

[0161] Figure 36B yes Figure 34A Front view of the second headgear clamp of the mask assembly.

[0162] Figure 37A yes Figure 34A Side view of the first headgear clamp of the mask assembly.

[0163] Figure 37B yes Figure 34A Side view of the second headgear clamp of the mask assembly.

[0164] Figure 37C yes Figure 34A Rear view of the second headgear clamp of the mask assembly.

[0165] Figure 37D yes Figure 34A Rear view of the first headgear clamp of the mask assembly.

[0166] Figure 38A yes Figure 34A The first clamp of the mask assembly holds the feature in a side view.

[0167] Figure 38B yes Figure 34A Side view of the first headgear clamp assembly of the face mask assembly.

[0168] Figure 39A yes Figure 34A Side view of the second headgear clamp assembly of the face mask assembly.

[0169] Figure 39B yes Figure 34A The second clamp of the mask assembly holds the feature in the external side view.

[0170] Figure 39C yes Figure 34A The second clamp of the mask assembly holds the internal side view of the feature.

[0171] Figure 40 yes Figure 34A Top view cross section of the frame component of the mask assembly.

[0172] Figure 41 yes Figure 34A The rear view of the frame component of the mask component.

[0173] Figure 42 yes Figure 34A The top and front perspective views of the frame component of the mask component.

[0174] Figure 43 yes Figure 34A The bottom and front perspective views of the frame component of the mask component.

[0175] Figure 44 This is a front view of the interface components, showing the clamp holding features and the vent features.

[0176] Figure 45 yes Figure 44 The front and side perspective views of the interface components show the clamp holding features and the vent features.

[0177] Figure 46 yes Figure 44 The front view of the interface components shows the clamp holding features and the vent features.

[0178] Figure 47 yes Figure 44 A cross-sectional view of the headgear fixture of the interface component.

[0179] Figure 48 yes Figure 44 A cross-sectional view of the headgear fixture of the interface component.

[0180] Figure 49 These are the front and top perspective views of the interface component.

[0181] Figure 50A These are front, top, and side perspective views of the mask assembly, including the air supply duct.

[0182] Figure 50B yes Figure 50A Rear, top, and side close-up perspective views of the mask assembly.

[0183] Figure 51A yes Figure 50A The front view of the frame of the mask component.

[0184] Figure 51B yes Figure 50A The rear view of the frame of the mask component.

[0185] Figure 52yes Figure 50A A side view of the frame of the mask component.

[0186] Figure 53 yes Figure 50A The frame of the mask component along Figure 51A The side view section taken from line 53-53.

[0187] Figure 54 yes Figure 50A The frame of the mask component along Figure 51A The side view section diagram taken from line 54-54.

[0188] Figure 55 yes Figure 50A The frame of the mask component along Figure 52 The front view section diagram taken from line 55-55.

[0189] Figure 56 yes Figure 50A The bottom view of the frame of the mask component.

[0190] Figure 57 yes Figure 50A Exploded perspective views of the front, bottom, and side views of the frame of the mask assembly.

[0191] Figure 58 yes Figure 50A Exploded perspective views of the rear, bottom, and side views of the frame of the mask assembly.

[0192] Figure 59 yes Figure 50A A side cross-sectional view of the frame of the mask assembly, showing the inlet axis and the buffer pad connector axis.

[0193] Figure 60 yes Figure 50A Front, top, and side perspective views of the face mask seal of the face mask assembly.

[0194] Figure 61 yes Figure 50A Rear view of the mask seal of the mask assembly.

[0195] Figure 62 yes Figure 50A Front view of the mask seal of the mask assembly.

[0196] Figure 63 yes Figure 50A Side view of the mask seal of the mask assembly.

[0197] Figure 64 yes Figure 50A A side cross-sectional view of the mask seal of the mask assembly.

[0198] Figure 65 yes Figure 50A A close-up rear view of a portion of the face mask seal of the face mask assembly.

[0199] Figure 66 yes Figure 50A A top view of the mask seal of the mask assembly.

[0200] Figure 67A yes Figure 50A The mask assembly's mask seal along Figure 66 The rear view section diagram taken from line 67A-67A.

[0201] Figure 67B yes Figure 50A The mask assembly's mask seal along Figure 66 The rear view section diagram taken from line 67B-67B.

[0202] Figure 67C yes Figure 50A The mask assembly's mask seal along Figure 66 The rear view section view taken from line 67C-67C.

[0203] Figure 67D yes Figure 50A The mask assembly's mask seal along Figure 66 The rear view section diagram taken from line 67D-67D.

[0204] Figure 67E yes Figure 50A The mask assembly's mask seal along Figure 66 The rear view section diagram taken from line 67E-67E.

[0205] Figure 67F yes Figure 50A The mask assembly's mask seal along Figure 66 The rear view section diagram taken from line 67F-67F.

[0206] Figure 68 yes Figure 50A Side view of the mask component.

[0207] Figure 69 yes Figure 50A A side cross-sectional view of the face mask assembly.

[0208] Figure 70 yes Figure 50A Front view of the mask component.

[0209] Figure 71 yes Figure 50A Bottom view of the mask assembly.

[0210] Figure 72A yes Figure 50ATop cross-sectional view of the face mask assembly.

[0211] Figure 72B yes Figure 50A Bottom view of the mask assembly.

[0212] Figure 73 This is a side view of the interface component, showing the headgear component.

[0213] Figure 74 This is an external surface view of the headgear assembly in a flat orientation.

[0214] Figure 75 It is oriented to be laid flat. Figure 74 An internal surface view of the headgear assembly. Detailed Implementation

[0215] Embodiments of systems, components, and methods of assembly and manufacture will now be described with reference to the accompanying drawings, wherein similar numerals refer to similar or analogous elements throughout. Although several embodiments, examples, and illustrations are disclosed below, it will be understood by those skilled in the art that the invention described herein extends beyond the specifically disclosed embodiments, examples, and illustrations, and may include other uses of the invention and its obvious modifications and equivalents. The terminology used in the description presented herein is not intended to be interpreted in any limiting or restrictive manner merely because the terminology is used in conjunction with the detailed description of certain particular embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature alone is essential to achieving its desired properties or to practicing the invention described herein.

[0216] Certain terms used in the following description may be for illustrative purposes only and are therefore not intended to be limiting. For example, terms such as “above” and “below” refer to directions of reference in the accompanying drawings. Terms such as “front,” “back,” “left,” “right,” “rear,” and “side” describe the orientation and / or position of portions of a component or element within a consistent but arbitrary frame of reference, which becomes clear by reference to the text describing the component or element under discussion and the associated drawings. For example, as the context may indicate, the terms “front” and / or “forward” may be used relative to a component positioned relative to or completely away from the user’s face as described herein when the user wears a mask assembly as described herein. As the context may indicate, the terms “back” and / or “rear” may be used relative to a component positioned relative to or completely close to the user’s face as described herein and / or a component forward of or in front of the mask assembly as described herein when the user wears a mask assembly as described herein. Furthermore, terms such as “first,” “second,” and “third” may be used to describe individual components. Such terms may include the words specifically mentioned above, their derivatives, and words with similar meanings.

[0217] One or more embodiments described herein address the challenges of sealing and fitting face masks to various facial (e.g., nasal) geometries. Specifically, at least some of these embodiments are for patient interfaces, such as face masks, that seal below the bridge of the user's nose and around the nostrils. However, the embodiments disclosed herein can also be adapted to other full-face masks (e.g., those that partially cover and / or seal the bridge of the user's nose).

[0218] One or more embodiments described herein address the problem of achieving a satisfactory seal with subnasal seals across a variety of facial geometries. Subnasal masks or combined nose-mouth masks, with their reduced coverage area on the user's face compared to conventional nose masks or full-face masks that contact the bridge of the nose, can make it more difficult to maintain a seal with the user's face and be configured to accommodate various facial geometries. A seal around and below the nose can be challenging due to variations in visible facial geometry between individual users. One or more embodiments illustrated herein can allow the nasal portion of the mask seal to expand, for example, in response to fitting onto a particular user or in response to pressure within the mask seal. In some configurations, the nasal portion of the mask seal can be configured to allow relatively low resistance to increased width. This arrangement can allow a single mask seal to form a satisfactory seal with users having relatively narrow noses and users having relatively wide noses. For example, when used with a user having a relatively narrow nose, the width of the nasal portion may not expand or may increase, or may only expand or increase slightly. When used with a user with a relatively wide nose, the width of the nose section can be significantly or maximally expanded or increased. However, in at least some configurations, even when expanded, the nose section does not exert an uncomfortable level of force on the user's nose. This arrangement advantageously maintains a satisfactory seal between the user's face and the mask seal.

[0219] Figures 1 to 75A mask assembly 2100 and its components are shown, positioned appropriately on and separated from the user's face. The mask assembly 2100 shown is a combined nose and mouth mask, which may be referred to herein as a nose-mouth mask. The mask assembly 2100 is designed to seal below the user's nose, along a portion of the face extending laterally to the nose, and around the user's mouth. Advantageously, the mask assembly 2100 does not need to contact the user's bridge of the nose. In the illustrated configuration, the mask assembly 2100 does not extend beyond the user's bridge of the nose. More specifically, the mask assembly 2100 does not contact the user's bridge of the nose. Even more specifically, the assembly 2100 does not contact the forward portion of the user's bridge of the nose. In some configurations, the assembly 2100 does not contact the face in an area vertically above the overall horizontal plane extending along the lower edge of the user's eyes. The mask assembly 2100 may or may not extend beyond the user's nose tip. Thus, in some configurations, the mask assembly 2100 covers the nose tip. In some configurations, the seal of the mask assembly 2100 covers the tip of the nose. In some configurations, the mask assembly 2100 preferably does not cover the tip of the user's nose. In some configurations or with certain facial geometries, the tip of the user's nose extends beyond the adjacent portion of the mask assembly 2100.

[0220] As shown in the figure, the mask assembly 2100 is preferably adapted to extend around and seal over a wing of the nose or nasal ala, the wing of the nose being open to form a circular bulge around the nostrils. The mask assembly 2100 is adapted to seal around a surface defining a nostril opening, said surface may include a portion or the entire fleshy outer end of the nasal septum (sometimes referred to as a columella). In some configurations, the mask assembly 2100 is adapted to extend upward to seal along at least a portion of the left and right dorsal sidewalls of the user's nose. In some configurations, the mask assembly 2100 is adapted to extend upward along at least a portion of the left and right dorsal sidewalls but not upward to the bridge of the user's nose. In some configurations, the primary sealing surface of the mask assembly 2100 contacts the underside of the user's nose and may also contact the upper lip and / or the transition area between the underside of the nose and the upper lip. Secondary sealing surfaces of the mask may contact the lateral surfaces of the user's nose and may also contact the cheek at some location near the nose. Such a primary and secondary sealing surface may not come into contact with all users' faces; however, this arrangement can provide a suitable seal with a relatively large range of facial geometries. The mask assembly 2100 preferably also seals around at least a portion of the user's mouth. The mask assembly 2100 may or may not be adapted to seal between the user's mouth and nose.

[0221] As shown in the figure, the mask assembly 2100 includes a mask support, such as a base, housing, or mask shell 2102 (see example). Figure 4 The face mask seal or cushioning pad 2104 may be attached to the housing 2102 such that the housing 2102 provides a certain amount of support for the face mask seal 2104. However, in other configurations, the face mask seal 2104 may not include a support and may be adapted for direct assembly to another component of an associated interface assembly. In some configurations, the housing 2102 may be substantially smaller than the housing shown. For example, the housing 2102 may define an opening that allows the face mask assembly 2100 to be attached to another component, such as a frame and / or conduit connector (e.g., a bend), and the housing 2102 may be confined to the opening without providing direct support to other parts of the face mask assembly 2100.

[0222] The mask assembly 2100 may engage with or be otherwise supported by a frame 2178, which allows connection to a head strap or headgear 2180 with any suitable arrangement. The mask assembly 2100 may be locked to the frame 2178 to allow assembly only in the correct orientation. In some configurations, the head strap or headgear 2180 may be directly coupled to the mask assembly 2100 and the frame 2178 may be used for other purposes or omitted. The conduit connector 2106 may also be attached to the housing 2102, the frame 2178, or otherwise supported relative to the mask assembly 2100 and adapted to communicate with the internal space of the mask assembly. Collectively, the frame 2178 and the headgear 2180 can support the mask assembly 2100 in the appropriate position on the user's face. Collectively, the mask assembly 2100, the frame 2178, and the headgear 2180 may be referred to as an interface assembly. The mask assembly 2100 or the mask assembly 2100 combined with the frame 2178 may be referred to as the interface.

[0223] The illustrated conduit connector 2106 can be connected to the frame 2178 and / or housing 2102 in any suitable manner (including, but not limited to, any manner discussed elsewhere herein). For example, but not limited to, connector 2106 can be connected to housing 2102 such that connector 2106 can rotate, pivot, or swivel relative to housing 2102 about a single axis or about multiple axes. In some configurations, connector 2106 may define a portion of a ball joint with frame 2178 and / or mask housing 2102, for example, but not limited to, defining another portion. The ball joint can have any suitable configuration. Connector 2106 facilitates connection to a gas conduit, such as a supply conduit, for supplying pressurized breathing gas to the interior of mask assembly 2100. Any suitable connector 2106 can be used, and in some cases, the connector may include a rotatable or rotary connection that allows relative rotation between connector 2106 and the gas conduit.

[0224] In the illustrated configuration, connector 2106 includes a bend containing an air vent, such as, but not limited to, a polycarbonate bend. In the illustrated arrangement, the air vent includes a deflector 2110. However, the air vent may include other geometries or arrangements, such as slots or controlled openings located between components. The air vent may also contain a diffusion material to reduce noise and / or small airflows. The deflector 2110 is a group of orifices configured to expel air and remove CO2 to reduce the likelihood of the user re-inhaling exhaled carbon dioxide. Although the deflector 2110 is shown as being uniquely located on connector 2106, in some configurations, the deflector 2110 may be located on housing 2102, on mask seal 2104, or on connector 2106, housing 2102 and seal 2104, or on any other component of the interface assembly or associated breathing circuit. The deflection orifice 2110 can have any suitable cross-section and can be cylindrical, hourglass-shaped, conical in any direction, fully or partially conical, fully or partially cylindrical, with a profile set to vary in cross-section, or the like.

[0225] The housing 2102 generally provides a variety of support structures for the mask assembly 2100 and more specifically for the mask seal 2104. The housing 2102 can be formed of any suitable material. In some configurations, the housing 2102 is formed of a fairly rigid material. In some configurations, the housing 2102 is formed of a plastic material, such as polycarbonate. In some configurations, the mask assembly 2100 may include a mask seal comprising a mask seal clamp that is separate from but attachable to the housing. In this configuration, the mask seal clamp connects the mask seal 2104 to the housing 2102. In such configurations, the mask seal and the mask seal clamp may be formed separately and secured together, or the mask seal and the mask seal clamp may be integrated into a single component. In some configurations, the mask seal may be overmolded onto a mask seal fixture, and in some configurations, the mask seal 2104 may be directly overmolded onto the housing 2102, the overmolding including, for example, chemical and / or mechanical overmolding.

[0226] In some configurations, housing 2102 comprises a large portion of the front wall of mask assembly 2100. This arrangement provides advantageous horizontal support to mask seal 2104. For example, housing 2102 comprises a large portion of the mouth portion of the front wall of mask assembly 2100. In some configurations, housing 2102 is generally confined to the mouth portion of mask assembly 2100 and does not extend into the nose portion of mask assembly 2100, at least to any apparent extent. This arrangement can provide support to mask seal 2104 while advantageously allowing movement or deformation of the nose portion of mask seal 2104. In other configurations, housing 2102 can extend into the nose portion to provide additional support to the nose portion if desired. In the illustrated configuration, housing 2102 flares rearward from central portion 2112 toward opposite side portions 2116. Central portion 2112 includes an aperture 2114 for receiving connector 2106. The housing 2102 may have a generally or substantially constant height throughout the central portion 2112 and the opposite side portions 2116. In other arrangements, the height of the housing 2102 may be varied, such as by forming a shape that generally mimics the front shape of the mask seal 2104. The height of the housing 2102 may be substantially equal to the height of the mouth portion of the mask seal 2104. The width of the housing 2102 may constitute a significant portion of the total width of the mouth portion of the mask assembly 2100, such as at least approximately three-quarters of the total width of the mouth portion of the mask assembly 2100. This arrangement of the housing 2102 may provide reinforcement to the central and lateral portions of the mask seal 2104. In some configurations, the housing 2102 may be extremely small, such as an annular support ring or frame.

[0227] The face mask seal 2104 is designed to seal against a user's face. The face mask seal 2104 is preferably formed of a soft material, such as, but not limited to, silicone. In some configurations, at least a portion of the face mask seal 2104 may be textured to improve user comfort. For example, in some configurations, at least several portions of the mold used to form the face mask seal 2104 may be sandblasted to provide a surface texture in areas where at least the face mask seal 2104 will contact the user's skin. Other techniques for texturing one or more surfaces of the face mask seal 2104 may be used. In some configurations, it may be desirable to avoid surface texturing and provide a smooth surface texture to at least the facial contact surface of the face mask seal 2104, which could enhance the grip of the face mask seal 2104 on the user's face and improve sealing properties.

[0228] As described above, the mask seal 2104 includes a nose-to-mouth mask seal and therefore includes at least one mouth opening 2122 and at least one nose opening 2124. In some configurations, the mask seal 2104 may include a combined mouth-to-nose opening. In some configurations, the mask seal 2104 may include more than one nose opening 2124. In some configurations, the mask seal 2104 may include a nose opening 2124 defined within an upper structure such as a nose pillow, nose fork, etc. In some configurations, the nose opening 2124 may be defined by a nose cushion or insert that may cover or otherwise secure to a base structure of the mask seal 2104. An example of such an arrangement is disclosed in Applicant Publication No. WO2014 / 062070, which is incorporated herein by reference in its entirety.

[0229] At least one mouth opening 2122 and at least one nose opening 2124 preferably communicate with a single chamber 2125 defined within a mask assembly 2100. The chamber 2125 of the mask assembly 2100 is at least partially defined by a housing 2102 and a mask seal 2104. At least one mouth opening 2122 is substantially opposite to a receiving connector 2106 or an aperture 2114 communicating with said connector. At least one nose opening 2124 may be vertically positioned above at least one mouth opening 2122. At least one nose opening 2124 may be positioned in the posterior-posterior direction of the mask assembly 2100 between the aperture 2114 for the connector 2106 and at least one mouth opening 2122. At least one nose opening may have an axis that is inclined relative to a vertical line and, in some arrangements, may generally extend through the aperture 2114 for the connector 2106.

[0230] The face mask seal 2104 preferably includes a pair of flaps 2126, which are located on the upper surface 2130 of the central portion of the face mask seal 2104 (see, for example, [reference needed]). Figure 7 The upper surface 2130 may define a line extending in the anteroposterior direction along the central surface of the nasal surface of the mask seal 2104. Such a line generally extends along the nasal septum in a direction away from the user's face. The flaps 2126 are configured to extend upward along the sides of the nostrils and, in some configurations, extend in the direction above the nostrils. The flaps 2126 may contact the edges of the nostrils and / or the sides of the nose. The portion of the flaps 2126 or the mask seal 2104 between the flaps 2126 may or may not cover the tip of the user's nose. As described herein, preferably the mask seal 2104 does not contact the bridge of the user's nose.

[0231] In some configurations, each of the flaps 2126 includes an air pocket that is in direct fluid communication through the mask assembly 2100 with an air path from the connector 2106 to at least one nasal opening 2124 and at least one mouth opening 2122. The flaps 2126 can be configured such that their volume expands and / or flexes inward in response to increased pressure within the mask seal 2104 to accommodate various facial and nasal geometries and facilitate a sealing contact with the user's face. The expansion of the flaps 2126 can aid in sealing against the user's face, particularly along varying contours on and around the user's nose. The inward flexing of the flaps 2126 allows the central portion (e.g., the upper surface 2130) to move downward with less constraint or less material stretch of the mask seal 2104, allowing the mask seal 2104 to better conform to various nasal geometries. Similarly, as described in more detail below, the cutout area 2202 of the support structure 2163 can advantageously allow the mask seal to maintain a sealed contact with the user's face in response to increased pressure within the mask seal 2104.

[0232] The height of the flap 2126 above the upper surface 2130 can be selected to provide a desired balance between stability (e.g., vertical stability) of the mask seal 2104 on the user's face and the ability to accommodate a range of nasal geometries or reduce visual interference caused by the flap 2126. Generally, a higher flap 2126 tends to provide additional vertical stability to the mask assembly 2100, while a lower flap 2126 tends to provide a better fit for a wider range of users and result in less visual interference. In some configurations, the flap height 2126 is between about 10 mm and about 30 mm, or between about 15 mm and about 25 mm. In some configurations, the flap height 2126 is between about 15 mm and about 22 mm, or between about 18 mm and about 20 mm, including any value or subrange within the aforementioned ranges. In some configurations, the flap height is about 18.5 mm.

[0233] The face mask seal 2104 may also include a support structure or support member 2163 for the flap 2126, which may be in the form of a suspension member or spring, providing mechanical rigidity and structure to maintain the shape of the flap 2126 when the face mask seal 2104 is worn by a user. The support member 2163 may include a thickened area of ​​sealing material. The support member 2163 is preferably sized, shaped, and / or otherwise configured to transfer forces from the rear surface of the flap 2126 or the user contact surface toward or toward the front surface of the flap 2126. In some configurations, the interface may include a support portion or cover for the flap 2126, and the support member 2163 may transfer forces from the rear surface of the flap 2126 to the front surface of the flap 2126 or the face mask seal 2104, or other portions that contact or face the support portion or cover. In some configurations, support 2163 can transfer forces from the rear surface of flap 2126 toward or towards another support portion of the faceplate seal 2104 or interface (e.g., housing 2102). Support 2163 can resist or prevent collapse of flap 2126 or other associated or adjacent portions of faceplate seal 2104, thereby facilitating fitting to the user and providing feedback to the user, such as in response to applied forces (e.g., headgear forces). In some configurations, support 2163 can resist or prevent collapse of flap 2126 or other associated or adjacent portions of faceplate seal 2104 in the absence of significant internal gas pressure.

[0234] The support member 2163 can help maintain the shape of the flaps 2126 of the mask seal 2104 and / or help maintain the separation between the rear wall (which defines the face contact surface) of the mask seal 2104 and the front wall of the mask seal 2104, at least in response to forces experienced during normal use. Additionally, the support member 2163 can provide support to the nasal region or the nasal sealing portion 2168. Specifically, the support member 2163 can provide structure to the nasal region 2168 and / or the upper front portion 2150 and inhibit or prevent them from wrinkling, creasing, or collapsing. As mentioned above, the nasal region 2168 and / or the upper front portion 2150 are preferably relatively thin to allow these portions of the mask seal 2104 to conform to the user's nose. The relatively thin nasal region 2168 and / or the upper front portion 2150 can unfold and seal around the user's nose. The support member 2163 provides a rigid portion or element of the seal 2104 adjacent to or near the relatively thin nasal region 2168 and / or the upper front portion 2150 to suppress or prevent collapse when the user engages his or her nose into the mask assembly 2100. The upper rear portion 2156 may help prevent collapse of the nasal region 2168 and / or the upper front portion 2150.

[0235] In some configurations, support 2163 helps reduce the likelihood of wrinkling or creases in the face contact portion of flap 2126 during use, while allowing the lateral interior portion to be as thin as desired within practical constraints, such as those described above. Support 2163 can help suppress or prevent flap 2126 from collapsing or maintain the desired shape of flap 2126. For example, support 2163 can help maintain the desired front-to-back shape and / or lateral or side shape of flap 2126. The level of support provided can vary in different directions. In some configurations, support 2163 can be formed as a separate portion or component from the sealing material and can be the same or different materials. Such a separate support 2163 can be coupled to flap 2126 or other portions of mask seal 2104 when needed. The support 2163 disclosed herein can be particularly useful in subnasal type mask assemblies (including nasal masks and combined naso-mouth masks). However, support 2163 can also be used in other types of mask assemblies or interfaces, including, but not limited to, those that cover, contact, or abut against the user's nose for sealing and / or include T-shaped elements or other types of forehead supports. Support 2163 can be used or modified for any location where the interface may be desired to provide support against collapse and / or support against over-expansion. Such locations may be at or near the portion of the seal that contacts the user's nose or extends lateral to the user's nose, or may be at other locations.

[0236] In the illustrated arrangement, at least a portion of the support member 2163 extends generally along the flap 2126 in the front-rear direction. Specifically, the support member 2163 may extend along the upper edge of the flap 2126 or along the region or ridge connecting the lateral outer surface portion and the lateral inner surface portion of the flap 2126. The support member 2163 may extend along a portion of the side of the nose region 2168. The support member 2163 may include a generally thin, elongated shape. When viewed from above, the support member 2163 may include a generally triangular shape, with the base of the triangle positioned behind the apex or vertex of the triangle. Other shapes are possible to achieve a desired level of support or for other design considerations (such as a desired shape for adjacent or nearby structures). The support member 2163 may have additional portions to provide other levels of support or to provide support in other directions. For example, the support member 2163 may be connected to each other, such as along one or both of the front or rear sides of the nose opening 2124. In some configurations, the support 2163 can extend completely through the fin 2126, for example, as if it extends into the housing 2102.

[0237] like Figures 7 to 18BAs shown, each of the flaps 2126 (or, for example, support 2163) may include a thinned and / or cutout region 2202. The cutout region 2202 may extend rearward and be positioned below the nose region of each of the flaps 2126. In some configurations, the cutout region 2202 extends rearward and is positioned adjacent to the nose region of each of the flaps 2126. However, in other configurations, the cutout region 2202 extends rearward and is positioned laterally offset from the nose region of each of the flaps 2126. The cutout region 2202 may extend from the upper front portion 2150 of the mask seal 2104 to the upper rear portion 2151 of the mask seal 2104, such that the cutout region 2202 wraps around the lateral side portion 2210 of each of the flaps 2126. Thus, in some configurations, the cutout region 2202 is typically curved, straight, and / or has a variable curvature. In some configurations, the cut area 2202 may slope from the upper front portion 2150 to the upper rear portion 2151 and / or from the upper rear portion 2151 to the upper front portion 2150. In some other configurations, the cut area 2202 is substantially flat or has minimal slope.

[0238] As shown in the configuration, the cut area 2202 extends across at least a portion of the upper front portion 2150 and at least a portion of the rear portion 2151. For example, the cut area 2202 may extend around the lateral side portion 2110 of the mask seal 2104 and across the rear portion 2151 toward the approximate center of the upper rear portion above the mouth opening 2122. In some configurations, the cut area 2202 extends across approximately 1 / 16, 1 / 8, 1 / 4, and / or 1 / 2 or more of the upper rear portion and / or the upper front portion. In some configurations, the cut area 2202 extends across the upper rear portion 2151 a distance that does not reach the lateral side of the nose opening 2124 of the nose region 2200.

[0239] In the illustrated configuration, the cutout region 2202 is located below the nose region of the flap 2126. However, in other configurations, the cutout region 2202 may be located above the nose region of the flap 2126 and / or in the same plane as the nose region. For example, the cutout region 2202 may be located approximately 0.1 mm to 0.5 mm, 0.5 mm to 1 mm, 1 mm to 10 mm, 10 mm to 50 mm, 50 mm to 1 cm, 1 cm to 2 cm, and / or 2 cm to 3 cm or more below the nose region of the flap 2126. In some configurations, the cutout region 2202 is located almost adjacent to the upper side of the mouth opening 2122. In other configurations, the cutout region 2202 is located above, below, and / or in plane with the nose opening 2124. However, in some configurations, the cutout region 2202 extends along the lateral side of the flap 2126. In this configuration, the cutout region 2202 may not extend across a portion of the upper front portion 2150 and / or a portion of the upper rear portion 2151, and may be confined to the wing 2126 or terminate within the nose region 2200.

[0240] The face mask seal 2104 of the face mask assembly 2100 includes a thickness range and thickness configuration, such as Figures 7 to 18B As shown. The thicknesses are varied to utilize different characteristics in different regions of the illustrated face mask seal 2104 or to provide different characteristics in different regions. For example, the thickness in different regions can be selected to achieve desired characteristics in the regions and / or the entire face mask seal 2104. Such characteristics may include, for example: allowing the face mask seal 2104 to conform to the user's facial geometry to enhance sealing properties or comfort; supporting the shape of the face mask seal without significant internal gas pressure to facilitate fit, and / or supporting the shape of the face mask seal in response to internal gas pressure and / or external pressure (e.g., caused by headwear forces); or providing strength or durability.

[0241] As described above, the face mask seal 2104 may include various regions of different thicknesses. An example of this arrangement is disclosed in the applicant's publication number WO2015 / 193821A1, which is incorporated herein by reference in its entirety. Generally, the outer surface of the face mask seal 2104 is defined as a relatively smooth shaped or curved surface without abrupt changes in direction. The different thicknesses arise from significant variations in wall thickness on the inner surface of the face mask seal 2104 or from variations in the shape of the inner surface of the face mask seal.

[0242] Support member 2163 may have a different thickness than other portions of vane 2126, and may have a greater thickness than other portions of vane 2126. In some configurations, support member 2163 may have the maximum thickness of or be within the maximum thickness of mask seal 2104. In some configurations, a portion or all of support member 2163 may have a thickness between about 1.5 mm and about 3.5 mm. In the configuration shown, a portion or all of support member 2163 may have a thickness of about 2.5 mm. The thickness of support member 2163 may be constant or variable.

[0243] In some configurations, the support structure 2163 for the wing is thicker than the nose region 2168 and the upper front portion 2150. In some configurations, there is a relatively abrupt thickness transition between the nose region 2168 and the upper front portion 2150 and the wing 2126. In contrast, the thickness transition between the outer peripheral portion 2162, the wing 2126, and the upper rear portion 2151 is more gradual. Furthermore, in at least some configurations, the thickness transition between the outer peripheral portion 2162, the upper rear portion 2151, and the mouth opening 2122 is relatively gradual. The different portions of the mask seal 2104 are further described below.

[0244] To reduce the incidence of wrinkling in at least some of the face contact areas of the face mask seal 2104 during use, it has been found that the outer peripheral portion 2162 of the face mask seal 2104 (which generally proximates some or all of the face contact portions of the face mask seal 2104) provides desirable performance when the outer peripheral portion 2162 is relatively rigid or relatively rigid compared to adjacent or other portions of the face mask seal 2104. In the illustrated arrangement, the outer peripheral portion 2162 extends along a generally vertically extending portion of the rear of the face mask seal 2104 and is slightly rolled inward at the bottom of the rear of the face mask seal 2104. Additionally, the outer peripheral portion 2162 is rolled inward from the rearward side of the face mask seal 2104 toward at least a portion of the lateral side of the face mask seal.

[0245] In the illustrated arrangement, the outer peripheral portion 2162 is located on each lateral side of the opening 2122. In some configurations, the outer peripheral portion 2162 extends along the entire height of the opening 2122. The upper end of the outer peripheral portion 2162 may extend at least to the vicinity of the upper end of the opening 2122. The lower end of the outer peripheral portion 2162 may extend below the lower end of the opening 2122. As described above, in some configurations, the outer peripheral portion 2162 is rolled inward in the direction below the opening 2122, such that a portion of the outer peripheral portion 2162 is vertically positioned below a portion of the opening 2122.

[0246] The relatively increased thickness of the outer peripheral portion 2162 can help resist or prevent the mask seal 2104 from collapsing in the absence of significant internal gas pressure, thereby facilitating fit to the user and providing feedback to the user, such as in response to applied forces (e.g., headwear forces). The outer peripheral portion 2162 can help maintain the curved shape of the lateral sides of the mask seal 2104 and / or help maintain the separation between the rear wall (which defines the inner surface of face contact) and the front wall of the mask seal 2104, at least in response to forces experienced during normal use. In some configurations, the thickness of a portion or entirely of the outer peripheral portion 2162 may be between about 1.0 mm and about 2.0 mm. In the illustrated configuration, a portion or entirely of the outer peripheral portion 2162 preferably has a thickness of about 1.5 mm. The thickness of the outer peripheral portion 2162 may be constant or variable within the boundaries of the outer peripheral portion 2162.

[0247] In some configurations, the cutout region 2202 has a reduced wall thickness compared to the surrounding sealing surface (e.g., support structure 2163). For example, in at least some embodiments, some or all of the cutout region 2202 may have a reduced wall thickness compared to the surrounding sealing surface, all or a portion of which may be defined by all or a portion of the support structure 2163. In some configurations, the surrounding sealing surface includes a wall thickness of approximately 3 mm. As described above, some or all of the surrounding sealing surface including the outer peripheral portion 2162 may have a thickness between approximately 1.0 mm and approximately 2.0 mm. However, for example, the cut-out region 2202 of the support structure 2163 may have a wall thickness between about 0.1 mm and 0.2 mm, 0.2 mm and 0.3 mm, 0.3 mm and 0.4 mm, 0.4 mm and 0.5 mm, 0.5 mm and 0.6 mm, 0.6 mm and 0.7 mm, 0.7 mm and 0.8 mm, 0.8 mm and 0.9 mm and / or 0.9 mm and 1.0 mm or greater. In the illustrated configuration, a portion or all of the cut-out region 2202 preferably has a wall thickness of about 0.3 mm. The thickness of the cut-out region 2202 may be constant or variable within the boundaries of the cut-out region 2202.

[0248] The reduced wall thickness of the cutout region 2202, compared to the surrounding sealing surface, can desirablely provide a more deformable and / or compressible area than the surrounding sealing surface. For example, the cutout region may be less rigid and / or more deployable than the surrounding sealing surface. This may be desirable, for example, when applying lateral forces to the flap 2126 (such as those applied by a wider nose). Therefore, the cutout region 2202 may be more compressible than a flap 2126 without the cutout region 2202 and / or with or without the support structure 2163, in order to better accommodate lateral forces applied to the nose region of the flap 2126. Instead of maintaining rigidity, the cutout region 2202 will allow the flap 2126 to compress while maintaining the structural integrity of the mask sealing assembly (see, for example...). Figures 10A to 10C , Figures 11A to 11B This configuration may be more comfortable for patients wearing a face mask sealing assembly.

[0249] In some configurations, the cutout region 2202 of the support structure 2163 of the mask seal 2104 includes a concave profile 2204. For example, Figure 8 The cutout region 2202 is shown to include a concave profile 2204 at its rear portion 2160. In the illustrated configuration, the relatively low point of the concave profile 2204 is located approximately at the center of the rear portion 2160 of each cutout region 2202. However, in other configurations, the concave profile is located closer to one side. In other configurations, the concave profile 2204 of the cutout region 2202 is located closer to the nose region of the flap 2126.

[0250] In some configurations, the cutout region 2202 includes a concave profile 2204 along a portion or the entire length of the cutout region 2202. In the illustrated configuration, the relatively low point of the concave profile 2204 is located approximately at the center of the width of each cutout region 2202. However, in other configurations, the concave profile is located closer to one side. In other configurations, the concave profile 2204 of the cutout region 2202 is located closer to the nose region of the flap 2126. Figure 8 As shown, the concave profile 2204 smoothly transitions inward along the rear portion 2160 of the cut-out region 2202. In some configurations, the concave profile 2204 extends inward toward the upper front portion 2150 of the mask seal 2104 by a relatively short distance. In some configurations, the concave profile 2204 extends inward toward the upper front portion 2150 of the mask seal 2104 by a greater amount of distance. In some configurations, the concave profile 2204 extends downward along the rear portion 2160 of the cut-out region 2202.

[0251] Typically, the deployment of the flaps 2126 helps to create a seal against the user's face, particularly around the user's nose, along the varying surface contours 2206. For example, as Figure 8As shown, the nasal region 2168 includes a surface contour 2206. The surface contour 2206 may extend along the inner side of the nasal region 2168. The surface contour 2206 may extend generally inward from the upper rear portion of the mask seal 2104 toward the center of the upper front portion 2150 of the mask seal 2104. The surface contour 2206 may desirably increase patient comfort and help ensure a seal with the user's face, while allowing the nasal region 2168 to move outward when adaptation to a particular user is required.

[0252] Figures 9A to 9D A close-up view of the concave profile 2204 of the cutout region 2202 of the support structure 2163 is shown. As shown in the configuration, the concave profile 2204 can extend vertically downward (relative to...). Figures 9A to 9D (as shown in the orientation) and extends inward toward the interior of the mask seal 2104. Therefore, when sufficient force is applied to the flap 2126, the concave profile 2204 can allow the cutout area 2202 to fold inward toward the interior of the mask seal 2104.

[0253] Typically, reduced thickness of the walls of the concave contour 2204, surface contour 2206, and / or cut area 2202 can help reduce material usage. This can desirablely reduce volume and increase patient comfort. In some configurations, the concave contour 2204 can cause the walls of the cut area 2202 to fold inward toward the internal chamber 2125 of the mask seal assembly. This can advantageously reduce volume when the mask seal 2104 folds against the patient's face. Similarly, when the user wears the mask seal 2104, the concave contour 2204 of the cut area 2202 can help minimize leakage by forming a better seal with the user's face. For example, instead of unfolding outward and / or bulging outward when the mask seal 2104 unfolds laterally, the cut portion 2202 can advantageously fold inward to maintain engagement with the user's face and prevent the mask seal 2104 from shifting to an undesirable position.

[0254] In some configurations, the concave profile 2204 allows for better compression of the cut-out region 2202 when a force is applied to the wing 2126. As described above, when a lateral force is applied to the wing 2126, the concave profile 2204 can allow the cut-out region 2202 to fold laterally and / or vertically and inwardly.

[0255] For example, Figures 10A to 10C and 11A to Figure 11BA top view of the mask assembly is shown, illustrating the cutout region 2202 of the mask seal 2104. In this example, a constant lateral force 2400 is applied to the nose region 2402 of the flap 2126. In some configurations, the lateral force 2400 is generated by the user's nose, which is wider than the neutral width of the nose region 2402 (e.g., when no lateral force is applied to the nose region 2402 or when a minimal lateral force is applied). However, in other configurations not shown, forces can be applied in any direction and / or the forces can be varied. As shown in the example illustrated, the cutout region 2202 can be compressed when force 2400 is applied to the flap 2126. Figure 10A An exemplary configuration is shown when no force is applied or a very small force is applied. As shown, the support structure 2163 includes an inner region 2404 and an outer region 2406, which cooperate to define a cutout region 2202. In this configuration, the cutout region 2202 separates the inner region 2404 from the outer region 2406. When no force is applied to the flap 2126 or a very small force is applied, the outer ends of the inner region 2404 and the outer region 2406 are spaced apart by a gap 2408. Figure 10B The configuration of the mask seal 2104 is shown when a lateral force 2400 is applied to the nose region of the flap 2126. As shown in the configuration, the inner region 2404 is compressed toward the outer region 2406 of the cutout region 2202. In the illustrated configuration, the outer region 2406 remains relatively fixed when a lateral force 2400 is applied to the nose region of the flap 2126. Figure 10B As shown, when the inner region 2404 of the cutout region 2202 is compressed, the size of the gap 2408 decreases. When the flap 2126 is compressed, the inner region 2404 moves toward the outer region 2406. In some configurations, depending on the amount of force applied to the nose region, the inner region 2404 of the cutout region 2202 does not contact and / or overlap with the outer region 2406. However, as... Figure 10C As shown, the inner region 2404 may contact and / or at least partially overlap with the outer region 2406.

[0256] In some configurations, the mask seal 2104 provides flexibility in its nasal sealing surface to accommodate various nasal geometries and different nasal area sizes, particularly various nasal widths. In some such configurations, the seal 2104 described herein improves the seal with the user's lower nasal surface by clamping inwardly to the outer side of the user's nose.

[0257] like Figures 12 to 15As shown, compared to other mask seals, the mask seal may include a reduced nose region width 2410. The reduced nose region width 2410 may desirablely provide an increased feel of reliable engagement with the sides of the user's nose. For example, the nose region width 2410 may be approximately half the width of the upper portion of the mask seal 2104. In some configurations, the nose region width 2410 is approximately one-quarter the width of the upper portion of the mask seal 2104. In some configurations, the nose region width 2410 may extend outward from the center of the mask seal 2104 toward the outer peripheral portion 2162 of the mask seal 2104 by a distance less than the lateral width of the mouth opening 2122. In some configurations, the nose region width 2410 extends outward from the center of the mask seal 2104 toward the outer peripheral portion 2162 of the mask seal 2104 by a distance approximately the same as and / or greater than the lateral width of the mouth opening 2122. In some configurations, the width 2410 of the nose region extends outward from the center of the mask seal 2104 to the cutout region 2202.

[0258] In some configurations, the total nasal region width 2412 is approximately 20 mm to 25 mm, 25 mm to 30 mm, 30 mm to 35 mm, 35 mm to 40 mm, 40 mm to 45 mm, 45 mm to 50 mm, and / or 50 mm or more. Preferably, the total nasal region width 2412 is approximately 40 mm.

[0259] In some configurations, the reduced total nose area width 2412 results in increased engagement with the sides of the user's nose during wear. Therefore, as described above, the mask seal 2104 can provide a better seal to the user's face. Such configurations allow the user to feel that the mask seal 2104 is properly positioned and / or properly seals against the user's nose. In some configurations, the flaps 2126 of the mask seal 2104 can clamp inwardly onto the user's nose by increasing the sealing force applied to the user's nose.

[0260] In some configurations, the mask assembly includes a front portion 2420. The front portion 2420 may include a recessed front surface 2430 and one or more fan-shaped lateral sides 2440. For example, Figure 16An example of a face mask assembly 2100 is shown, the face mask assembly including a recessed front surface 2430 formed by a housing or face mask housing 2102. The recessed surface 2430 may be positioned on the front portion of a face mask seal 2104 and may be configured as a receiving frame 2178. The recessed front surface 2430 may be formed along a portion or all of the periphery of the housing or face mask housing 2102, wherein it engages with the seal 2104. In the illustrated example, the recessed front surface 2430 forms a step in the surface of the front portion 2420. The recessed front surface 2430 generally extends along the sides and lower edge of the periphery of the housing 2102.

[0261] In some configurations, the depth of the step gradually decreases along its length, such that there is no step or a very small step along the upper edge of the periphery of the housing 2102, and the seal 2104 is flush with the upper edge of the periphery of the housing 2102.

[0262] The depth of the step can depend on the size of the seal 2104. For example, the seal 2104 can be provided in a range of sizes to accommodate users with a range of face sizes and facial geometries. In some configurations, the seal 2104 engages with a single-sized housing 2102. In some configurations, the size difference between the seal 2104 and the housing 2102 determines the depth of the step. In some configurations, the recessed front surface 2430 is recessed at a constant depth or a varying depth. For example, the depth of the recessed front surface 2430 can be constant across the entire surface of the recessed front surface 2430. However, in some configurations, the upper recessed surface 2432 (described in more detail below) is recessed to a depth less than and / or greater than the depth of the remaining area of ​​the recessed front surface 2430.

[0263] In some configurations, the front portion 2420 includes an upper recessed surface 2432 formed within the seal 2104. The upper recessed surface 2432 may be positioned at the front upper portion 2150. In the illustrated configuration, the upper recessed surface 2432 is positioned along the front side of the flap 2126. The upper recessed surface 2432 may extend along the outer peripheral portion 2162 of the front side 2422 of the mask seal 2104. The upper recessed surface 2432 may extend rearward around the side of the mask seal 2104. In some configurations, the upper recessed surface 2432 substantially wraps around the outer peripheral portion 2162 of the mask seal 2104. In some configurations, the upper recessed surface 2432 is positioned only on a portion of the outer peripheral portion 2162. For example, the upper recessed surface 2432 may extend downward on each side of the seal 2104 for approximately half the height of the front side 2422. In some configurations, the upper recessed surface 2432 extends downward less than half the length of the front side 2422, and in some cases, extends downward about one-third of the length of the front side 2422.

[0264] In some configurations, the upper recessed surface 2432 forms a stepped transition between the upper periphery of the upper front portion 2420 and the lower periphery, extending along the curvature of the periphery or upper edge of the flap 2126. In some configurations, the stepped transition extends with a constant or varying depth. For example, the depth of the stepped transition may be constant throughout the stepped transition between the upper periphery of the upper front portion 2420 and the recessed front surface 2430. However, in some configurations, the stepped transition varies. For example, the stepped transition may be tapered. In this arrangement, the depth may be minimum at the lower or lateral end of the stepped transition. However, in some embodiments, the depth is minimum at the upper end of the stepped transition.

[0265] The depth of the stepped transition can depend on many factors, including the size of the mask seal. For example, the depth of the tapered transition can be greater for larger mask seals or less for smaller mask seals. In some configurations, the upper front portion 2420 includes multiple upper corners. For example, the upper front portion 2420 may include a first upper corner and / or a second upper corner. Multiple upper corners may be formed on the front portion of the flap 2126. Multiple upper corners may define all or part of the periphery of the upper recessed surface 2432 extending along the periphery of the upper front portion 2420.

[0266] In some configurations, the depth of the stepped transition and / or the taper of the stepped transition is greater at multiple corners compared to the upper central portion that is typically located between the upper corners (e.g., between the first and second upper corners).

[0267] In some configurations, the recessed front surface 2430 and / or the upper recessed surface allow the frame 2178 to be inserted into the face mask seal 2104. For example, the upper recessed surface 2432 may receive all or part of the frame 2178. Thus, in some configurations, the stepped transition of the upper recessed surface 2432 has a maximum depth greater than or equal to the thickness of the frame. Similarly, the recessed front surface 2430 may receive all or part of the frame 2178. These configurations can advantageously provide a slightly flush surface finish, which is more aesthetically pleasing to the user. In some configurations, the visual size of the face mask seal 2104 can be reduced and / or the amount of material used in the face mask seal can be reduced. Thus, in some configurations, the face mask seal 2104 is smaller and / or less obtrusive to the user (e.g., see...). Figure 17 ).

[0268] In some configurations, the upper recessed surface 2432 may be provided only for certain seal cushion sizes. For example, the upper recessed surface 2432 may be provided only on certain medium or large face mask seals 2104. In some configurations, the upper recessed surface 2432 is provided in certain small or medium-sized face mask seals 2104. In some configurations, the upper recessed surface 2432 may be present in face mask seals 2104 of all sizes. The depth of the upper recessed surface 2432 may vary depending on the size of the face mask seal 2104. In some configurations, the depth of the upper recess may be substantially the same as the thickness of the frame 2178 for small and / or medium-sized face mask seals 2104, and the depth may be greater than the thickness of the frame 2178 for large face mask seals 2104 (e.g., larger in size than small and / or medium-sized face mask seals 2104). In such configurations, this could result in the mask seal 2104 hanging on and / or extending beyond the frame 2178. In some configurations, the upper recessed surface 2432 is configured to allow a single-size frame to be used with multiple mask seals 2104 of different sizes, without the frame 2178 being too large or too small for the multiple mask seals 2104.

[0269] In some configurations, the recessed surface 2432 provides better support for the nose sealing surface. For example, Figure 17 A frame 2178 and frame flap 2179 are shown, inserted into and / or positioned within an upper recessed surface 2432. As shown in the configuration illustrated, the frame flap 2179 can be positioned within the upper recessed surface 2432. In this configuration, the outer surface of the frame flap 2179 is flush with the upper recessed surface 2432. This arrangement provides additional support to the nasal sealing surface by providing additional rigidity to the front side 2422 of the mask seal 2104 and the flap 2126. In some configurations, the frame flap 2179 desiccably provides support for the sealing flap 2126. In such configurations, the frame flap 2179 helps prevent the sealing flap 2126 from deflecting away from the user's nose during use. In some configurations, this arrangement can help prevent the frame flap 2179 from contacting or digging into the user's face in the event that the mask seal 2104 becomes excessively deformed. Therefore, in some configurations, the recessed front surface 2430 can advantageously allow the face mask seal 2104 to maintain its structure over time and can increase the durability of the face mask seal 2104. In some configurations, the recessed front surface 2430 allows for the use of a single-size frame 2178 with face mask seals 2104 of different sizes. Therefore, in some configurations, the recessed front surface 2430 reduces the manufacturing cost of the face mask assembly.

[0270] Figure 18A and Figure 18BAn example of a face mask seal 2104 including a fan-shaped lateral side 2440 is shown. The fan-shaped lateral side 2440 can advantageously reduce the amount of material in the face mask seal 2104 and can provide a more aesthetically pleasing or visually smaller face mask seal 2104. As shown in the configuration illustrated, the outer wall of the face mask seal 2104 transitions smoothly along the outer peripheral portion 2162 of the face mask seal 2104. However, in other configurations, the outer peripheral portion 2162 may include at least three distinct segments (e.g., an upper portion, a central portion, and a lower portion), and the outer peripheral portion 2162 may not transition smoothly between each segment.

[0271] In the illustrated configuration, the fan-shaped lateral side 2440 forms a concave portion along the side of the mask seal 2104. The fan-shaped lateral side 2440 may be positioned below the wing 2126 along the outer peripheral portion 2162 of the mask seal 2104. In some configurations, the fan-shaped lateral side 2440 is positioned to at least partially overlap the bottom of the wing 2126. In some configurations, the fan-shaped lateral side 2440 is positioned completely below the wing 2126. In some configurations, the center 2442 of the concave portion of the fan-shaped lateral side 2440 is generally aligned with the top of the mouth opening 2122. In some configurations, the center 2442 of the concave portion is positioned above the mouth opening 2122 but below the nose region 2168. In some configurations, the center 2442 of the concave portion is positioned above the nose region 2168.

[0272] In some configurations, the fan-shaped lateral side 2440 extends about half of the outer peripheral portion 2162 of the mask seal 2104. In some configurations, the fan-shaped lateral side 2440 extends about 1 / 8, 1 / 4, 1 / 3, 3 / 4 or more of the outer peripheral portion 2162 of the mask seal 2104.

[0273] As shown in the configuration, the fan-shaped lateral side 2440 can provide additional vertical support for the nose region 2168. For example, the fan-shaped lateral side 2440 can provide additional support when lateral forces are applied to the nose region and / or when pressure increases within the mask seal 2104. For example, the fan-shaped lateral side 2440 can advantageously contribute to transferring load from the cheek to the frame 2178 on the side of the mask seal 2104 in other parts of the mask seal 2104, which helps maintain engagement with the user's face. Therefore, the fan-shaped lateral side 2440 can provide an improved seal between the user's nose and the mask seal 2104.

[0274] Figure 19A and Figure 19BAn example of a face mask assembly 2100 is shown, which includes a recessed front surface 2430 formed by a housing or face mask shell 2102. The recessed front surface 2430 can be positioned on the front of a face mask seal 2104 and can receive various configurations of a frame 2178. For example, as Figure 19A and Figure 19B As shown, frame 2178 and frame flap 2179 are positioned to insert into and / or within an upper recessed surface 2432, which may be wholly or partially defined by a seal 2104.

[0275] In some configurations, housing 2102 may include a bias vent 2502. The bias vent 2502 may include multiple orifices configured to expel air and remove CO2 to reduce the likelihood of the user re-inhaling exhaled carbon dioxide. While only the orifices of the bias vent 2502 are shown on housing 2102, in some configurations, the bias vent 2502 may be located on mask seal 2104, bend 2520, or other conduit connectors, or on any combination of housing 2102, mask seal 2104, bend 2520, or on any other component of the interface assembly or associated breathing circuit. The orifices may have any suitable cross-section and may be cylindrical, hourglass-shaped, tapered in any direction, wholly or partially tapered, wholly or partially cylindrical, with a profile configured to vary in cross-section, or the like. The cross-section of the orifice may increase or decrease the amount of air expelled through it.

[0276] In some configurations, frame 2178 may be attached to and / or otherwise include bend 2520. Although Figure 19A and Figure 19B An example of a mask assembly 2100 with a bend 2520 attached to a frame 2178 is shown, but in some configurations, the bend is directly attached to the mask housing 2102 and / or the mask seal 2104, as well as other mask components. The bend may be removable and / or permanently attached to the frame 2178 and / or the housing 2102. The bend 2520 may form a non-horizontal connector. For example, the bend 2520 may include a bend. In some configurations, the bend 2520 is bent at angles of approximately 10 to 20 degrees, 20 to 30 degrees, 30 to 40 degrees, 40 to 50 degrees, 50 to 60 degrees, 60 to 70 degrees, 70 to 80 degrees, and / or 80 to 90 degrees, and other ranges. This configuration may desirablely reduce the volume of the mask assembly, reduce material usage, and / or redirect airflow in a desired direction. In some configurations, the bend 2520 is horizontal, vertical, or straight.

[0277] The bend 2520 may include an upper portion and a lower portion. The upper and lower portions may be separated by the bend, as discussed above. The bend 2520 may include various connection features, such as a frame connection slot 2532, a retaining notch 2534, and an inlet connector 2530, etc. The inlet connector 2530 may form the upper portion of the bend 2520, such that the inlet connector 2530 can be connected to the inlet 2510 of the face mask housing 2102. The inlet connector 2530 may removably connect the bend 2520 to the inlet 2510 by a snap-fit, press-fit, interference fit, and / or other mating configuration. Therefore, in some configurations, the bend 2520 may be connected to a gas supply conduit (not shown) at one end (e.g., the lower portion), and an inlet connector 2530 located at the other end (e.g., the upper portion) of the bend 2520 provides a flow path through which pressurized gas is supplied to the user via the internal chamber 2125 of the mask seal 2104.

[0278] The frame connection slot 2532 can be formed by a slot or cutout in the bend 2520. In some configurations, the frame connection slot 2532 can be formed by multiple protrusions, such as ribs extending outward from adjacent surface portions of the bend 2520. For example, as... Figure 26 and Figure 28 As shown, the bend 2520 includes two ribs extending outward from the bend 2520 to receive and / or retain the bend connector 2516 of the frame 2178. Figure 21A and Figure 21B As shown, the frame connecting slot 2532 can be positioned offset from the end of the upper portion of the bend 2520. In some configurations, the frame connecting slot 2532 is positioned on one side of the bend, on the lower portion of the bend 2520. The frame connecting slot 2532 can be completely wrapped around the bend 2520. In some configurations, as shown, the frame connecting slot 2532 extends only around a portion of the bend 2520.

[0279] In some configurations, the bend 2520 may include an anti-asphyxiation (AA) valve 2522. The AA valve 2522 provides a flow path through which ambient air can enter the mask 2100. For example, in certain situations, if the flow generator fails to supply gas to the mask, the valve 2522 allows the user to use ambient air.

[0280] Valve 2522 may include a valve disc 2524, a valve seat or retainer 2526, and a valve port 2536, as well as other components. The valve port 2536 may include one or more openings to provide a path for airflow from the macroscopic flow to the internal chamber 2125 of the faceplate seal 2104. The valve port 2536 may be positioned at one end of a bend 2520. For example, the valve port 2536 may be positioned on the rear side 2540 of the lower portion of the bend 2520 such that the valve port 2536 forms an opening generally facing the faceplate seal 2104 or the front concave surface 2508 of the faceplate seal 2104 (as described below). In some configurations, the valve port 2536 is positioned below the inlet connector 2530 of the bend 2520. In some configurations, the valve port 2536 is generally parallel to the front concave surface 2508 of the faceplate seal 2104. In some configurations, the valve port 2536 is angled downward toward the concave surface 2508 of the mask seal 2104.

[0281] Valve disc 2524 may be positioned to engage within bend 2520 and / or within at least a portion of valve seat 2526. Valve disc 2524 may open and close valve port 2536 to allow airflow through valve port 2536. For example, when the flow generator supplies airflow to the user through mask seal 2104, valve disc 2524 opens relative to valve seat 2526, thereby closing valve port 2536. When the flow generator does not supply airflow to mask seal 2104, valve disc 2524 closes relative to valve seat 2526, and valve port 2536 opens to allow the user to draw in ambient air through valve port 2536. Valve seat 2526 may support valve disc 2524 in an operable position. In some configurations, valve seat 2526 defines a stop that prevents valve disc 2524 from reversing or extending downward out of bend 2520. As described in more detail below, in some configurations, the bend 2520 including valve 2522 can be positioned in front of the recessed front surface of mask seal 2104.

[0282] Figure 20 An exemplary frame 2178 is shown that can be implemented in a face mask assembly 2100 and connected to a housing 2102 described herein. The frame 2178 can be attached to the housing 2102 in various arrangements. For example, the frame 2178 can slide into a face mask seal 2104, and / or be attached to the face mask seal 2104 by snap-fit ​​or press-fit and other suitable attachment arrangements. As described above, the frame 2178 can be fitted into a front recessed surface 2430 of the face mask seal 2104, including an upper recessed surface 2432. In some configurations, the frame 2178 is configured to be repeatedly removable from the face mask seal 2104 to allow one or both of the face mask seal 2104 and the frame 2178 to be interchangeable. However, in some configurations, the frame 2178 can be permanently attached to the face mask seal 2104.

[0283] In some configurations, frame 2178 may include at least one headgear connector 2512, a vent 2514, and / or a bend connector 2516, as well as other features or components. At least one headgear connector 2512 can be connected to and / or receive a headgear. In some configurations, the headgear connector 2512 may be formed within frame 2178. For example, frame 2178 may include one, two, three, four, five, and / or six or more headgear connectors 2512. Figure 20 As shown, the frame 2178 includes a pair of opposing headgear connectors 2512 that form slots for receiving at least a portion of the headgear (such as connector clamps of the headgear).

[0284] At least one headgear connector 2512 may be positioned along the front side of the frame 2178. For example, at least one headgear connector 2512 may extend outward (e.g., forward and / or laterally outward) from the front side of the frame 2178 and at least partially define the boundary of an opening in the frame 2178 for connecting a headgear. Figure 20 As shown, the headgear connector 2512 may extend only a portion of the front side of the frame 2178 in the height and / or width directions. The headgear connector 2512 may extend vertically or at an angle between the top and bottom sides of the frame 2178. In the illustrated arrangement, the upper end of the headgear connector 2512 is positioned forward and / or inward relative to the lower end of the headgear connector 2512. The headgear connector 2512 may be positioned at least partially below the nose region of each flap 2126 and / or the frame 2178. In some configurations, the headgear connector 2512 may be positioned on the housing 2102 or other parts of the mask assembly 2100.

[0285] like Figure 20 As shown, frame 2178 may include a vent 2514, the shape of which is configured to receive or accommodate a bias vent 2502. Thus, in some configurations, the vent 2514 is aligned with the bias vent 2502. As described above, some arrangements can advantageously allow exhausted air to pass through frame 2178 to the atmosphere. For example, the bias vent 2502 may preferably be located within housing 2102 and communicate with or be aligned with any opening in frame 2178 and / or headgear. In some configurations, the bias vent 2502 is located within at least a portion of housing 2102 not covered by frame 2178, or within the space defined between frame 2178 and housing 2102. In some configurations, the bias vent 2502 is at least partially covered by frame 2178. Such arrangements may affect the flow rate if exhausted air contacts frame 2178.

[0286] In some configurations, when frame 2178 is connected to mask seal 2104, bias vent 2502 may extend at least partially through vent 2514 of frame 2178 (see example...). Figure 19A and Figure 19B In some configurations, when the offset vent 2502 is positioned within the vent 2514, the offset vent 2502 is positioned flush with the frame 2178.

[0287] In some configurations, frame 2178 may include a bend connector 2516. Bend connector 2516 may receive and / or connect to bend 2520, such as... Figures 22A to 23B As shown. The bend connector 2516 may be defined by or include a cutout located on the lower edge of the frame 2178, the cutout being configured to receive at least a portion of the bend 2520. For example, the cutout of the bend connector 2516 may connect to the bend 2520 such that the frame 2178 is fitted into the frame connection slot 2532 of the bend 2520.

[0288] In some configurations, the bend connector 2516 can be connected to the bend 2520 via snap-fit, press-fit, interference fit, and / or other mating configurations. For example, the bend connector 2516 may preferably include a pair of retaining protrusions 2518. The retaining protrusions 2518 may be positioned opposite each other at the lower corner of the bend connector 2516. The retaining protrusions 2518 may engage with corresponding connection features of the bend 2520, such as retaining recesses 2534. The retaining recesses 2534 may be positioned at the lower end of the frame connection slot 2532 of the bend 2520. In some configurations, the frame 2178 may be permanently connected to the bend 2520 by connection means such as welding, overmolding, and / or adhesives.

[0289] As described above, bend 2520 can be connected to frame 2178. In some configurations, such as... Figures 22A to 23B As shown, before the frame 2178 is connected to the face mask seal 2104, the bend 2520 can be connected to the frame 2178. For example, the bend can slide into a cutout in the bend connector 2516, such that the bend connector 2516 aligns with the frame connection slot 2532. When the bend connector 2516 slides into the frame connection slot 2532, the retaining protrusion 2518 can align with the corresponding retaining recess 2534. Therefore, the bend 2520 can be retained by the frame 2178 to form a sub-assembly, which is then coupled to the face mask seal 2104.

[0290] In some configurations, such as Figure 21A and Figure 21BAs shown, for example, bend 2520 is directly connected to inlet 2510 of housing 2102 via inlet connector 2530 of bend 2520. In some configurations, bend 2520 may be connected to housing 2102 before or after frame 2178 is connected to bend 2520. However, in other configurations, bend 2520 must first be connected to frame 2178, and then the bend 2520 / frame 2178 sub-assembly may be connected to housing 2102. In some configurations, bend 2520 may provide a connection between housing 2102 and frame 2178. For example, in such configurations, frame 2178 may not be connected to housing 2102 without the connection provided by bend 2520. In some configurations, bend 2520 is connected to and / or disconnected from housing 2102 in a direction angled downward from plane 2506, which is substantially perpendicular to the sealing surface 2504 of mask seal 2104. For example, plane 2506 may be substantially perpendicular to the direction in which bend 2520 connects to frame 2178. In some configurations, plane 2506 may be substantially perpendicular to the direction in which frame 2178 connects to bend 2520. Bend 2520 may be removably attached to housing 2102 via multiple connection arrangements (such as snap-fit ​​arrangements).

[0291] When the bend 2520 is connected to the housing 2102, the bend 2520 may be non-rotatable. For example, when the frame 2178, bend 2520, and housing 2102 are assembled, the frame 2178 may not be able to rotate relative to the housing 2102. In some configurations, the connection arrangement between the housing 2102 and the bend 2520 advantageously allows the hose drag force generated by the CPAP hose to be isolated from the mask. In such configurations, a flexible conduit (not shown) may form an intermediate component connecting the CPAP hose to the bend 2520. In some configurations, the connection arrangement between the housing 2102 and the bend 2520 is deliberately angled to provide a low-profile mask assembly 2100 that is less obtrusive to the user. Therefore, the bend 2520 may not extend as far from the user's face when worn as a conventional mask assembly. Such configurations can reduce the torque arm generated by the bend 2520 and the potential hose drag force on the mask assembly 2100.

[0292] In some configurations, the housing 2102 includes a concave surface 2508 that at least partially surrounds the inlet 2510 (see, for example, see...). Figure 21B and Figure 24For example, the concave surface 2508 may be offset relative to the inlet 2510 such that a portion of the concave surface 2508 below the inlet 2510 is larger than a portion of the concave surface 2508 above the inlet 2510. In some configurations, the area of ​​the portion of the concave surface 2508 below the lowest point of the inlet 2510 is at least two, three, four, and / or five times larger than the area of ​​the portion of the concave surface 2508 above the center of the inlet 2510. In some configurations, the area of ​​the portion of the concave surface below the inlet 2510 is larger than the area of ​​the portion of the concave surface on the side of the inlet 2510.

[0293] The concave surface can advantageously aid in the alignment of the mask assembly 2100, such that the concave surface guides the bend 2520 and / or frame 2178 into the inlet 2510 of the housing 2102 during assembly.

[0294] During assembly, such as Figures 26 to 28 As shown, for example, the concave surface 2508 is spaced apart from the rear side 2540 of the bend 2520. Therefore, a gap is formed between the rear side 2540 of the bend 2520 or the inner surface of the frame 2178 on one side and the outer casing 2102 on the other side. In some configurations, this gap provides a flow path for air to enter and exit the internal mask breathing chamber when the valve port 2536 is in the open position. Figure 26 and Figure 27 As shown, for example, the cross-sectional area of ​​the gap is larger than the area of ​​the valve port 2536. Therefore, in some configurations, the flow path through the valve port 2536 defines the minimum area through which ambient air passes from the gap, through the valve port 2536, and into the interior of the bend 2520. This arrangement can desirablely ensure that the airflow through the AA valve is unrestricted. Therefore, this arrangement allows sufficient ambient air to flow into the internal mask breathing chamber and allows CO2 to be adequately flushed out of the internal mask breathing chamber, thereby preventing constricted airflow.

[0295] In some configurations, the concave surface 2508 may desiccate the airflow from the port 2536 away from the user. For example, air may flow through the port 2536 to the concave surface 2508, causing the air to be laterally dispersed along the concave surface 2508 and / or reflected from the concave surface 2508 and away from the gap formed between the bend and the housing 2102, away from the user and reaching the atmosphere.

[0296] In some configurations, this arrangement allows the bend 2520 to be closer to the user's face during use than a typical mask assembly. For example, the concave surface 2508 can reduce the depth of the housing 2102 and position the inlet 2510 closer to the sealing surface 2504 of the mask seal 2104. Simultaneously, this arrangement allows a sufficient amount of airflow through the valve port 2536.

[0297] Similarly, the bend 2520 can be at least partially positioned within the space defined by the front concave surface 2508 of the housing 2102. The arrangement described herein allows the bend to include a wall (e.g., rear side 2540) that is angled downward relative to a portion of the bend 2520 connected to the housing 2102 (e.g., inlet connector 2530). Thus, such an arrangement can reduce the distance by which the bend 2520 extends outward from the housing 2102.

[0298] By reducing or minimizing the distance the bend 2520 extends outward from the housing 2102 relative to an arrangement without the concave surface 2508, the arrangement described herein can desirablely reduce the hose drag force on the mask assembly 2100 generated by the CPAP hose, as described above. Excessive hose drag force can undesirably cause the mask seal 2104 to detach from the user's face during wear, resulting in partial or complete loss of treatment. Typically, hose drag force can be counteracted by a headband comprising headband straps to maintain the engagement between the mask assembly 2100 and the user's face with sufficient force. However, if a greater hose drag force is generated by excessive material and by the bend extending too far from the mask housing 2102, the force exerted by the headband straps can cause user discomfort. Therefore, the arrangement described herein can advantageously alleviate user discomfort by limiting excessive force exerted on the user by the headband straps and / or by reducing or minimizing hose drag force.

[0299] In some configurations, the arrangements described herein can reduce the moment arm applied to the bend 2520, as described above. Similarly, the concave surface 2508 can minimize the overall size of the housing 2102 or the mask assembly 2100 by providing a less obtrusive mask assembly.

[0300] Such as at least Figures 21B to 23B and Figure 27As shown, frame 2178 includes a protective surface 2181. The protective surface 2181 surrounds the bend connector 2518 and forms the front boundary of the flow path formed between frame 2178 and the front concave surface 2508 of housing 2102. The protective surface 2181 may be formed by a truncated portion or a concave portion of the front surface of frame 2178. In some configurations, when frame 2178 is attached to housing 2102, the protective surface 2181 is offset from the front concave surface 2508 of housing 2102. For example, when frame 2178 and housing 2102 are assembled, the protective surface 2181 may be planar and positioned substantially parallel to the concave surface 2508 of housing 2102. This arrangement can advantageously reduce the overall size of the mask assembly 2100 to allow the mask assembly 2100 to be less obtrusive to the user and to provide adequate support for bend 2520. This arrangement can facilitate the diffusion and / or guidance of airflow through and / or out of valve port 2536.

[0301] Figures 29 to 33E The configuration of a face mask assembly 2100 is shown. For example, the face mask assembly 2100 may include a full-face mask that forms a seal below at least a portion of the user's nose and / or around at least a portion of the user's mouth. Figures 29 to 33E As shown, the mask assembly 2100 may include a mask seal 2104, a housing 2102, a frame 2178, at least one headgear clamp 2600, and a bend 2520 or other type of inlet conduit connector.

[0302] In some configurations, the mask seal 2104 may be permanently engaged or coupled to the housing 2102, for example, by overmolding. The housing 2102 may be positioned in front of the mask seal 2104 and may, alone or together with the seal 2104, define a breathing chamber around at least a portion of the user's mouth and / or nose (e.g., the user's nostrils). In some configurations, the housing 2102 may include a biased vent 2502 as described herein.

[0303] As described above, the mask assembly 2100 can be engaged with or otherwise supported by a frame 2178, which allows connection to a head strap or headgear 2180 with any suitable arrangement (see above). Figure 1In some configurations, the head strap or headgear 2180 may be directly coupled to at least a portion of the mask assembly 2100 and / or frame 2178. For example, frame 2178 may include at least one clamp holding feature 2550. Preferably, frame 2178 may include a pair of clamp holding features 2550 positioned on opposite lateral sides of frame 2178. For example, clamp holding features 2550 may be positioned on the side of the central portion of frame 2178. Frame 2178 may include frame flaps 2179 to support flaps 2126 of mask seal 2104. In some configurations, frame 2178 may include a vent 2514 through which a biased vent 2502 can discharge from internal chamber 2125 (see [link to relevant documentation]). Figure 5 ) exhaust gas.

[0304] In some configurations, the mask assembly 2100 includes at least one headgear clamp 2600. Preferably, the mask assembly 2100 may include a pair of headgear clamps 2600. The headgear clamps 2600 may be connected to clamp holding features 2550 on opposite sides of the mask frame 2178. As described in more detail below, the headgear clamps 2600 may provide a connection between at least a portion of the headgear 2180 (such as headgear straps) and the frame 2178.

[0305] In some configurations, the bend 2520 may be attached to the housing 2102, frame 2178, or otherwise supported and adapted to communicate with the internal chamber 2125 of the mask assembly 2100. As described herein, the bend 2520 may be connected to an air supply duct to supply pressurized air, for example, to the internal chamber 2125. Commonly, the frame 2178 and headgear 2180 support the mask assembly 2100 in a suitable position on the user's face.

[0306] Figure 30A and Figure 30B The configuration of the face mask assembly 2100 is shown, illustrating the clamp holding feature 2550 and the headgear clamp 2600. In some configurations, such as Figure 30A and Figure 30B As shown, the headband clip 2600 can be removably attached to the frame 2178. For example, the headband clip 2600 can be removably clamped and / or snapped or otherwise attached to the clip holding feature 2550 of the frame 2178. In some configurations, the headband clip 2600 can be adjustably attached to the headband 2180. For example, the headband clip 2600 may include an aperture 2606 that can engage with a corresponding holding feature 2550 of the frame 2178 and / or slide backward or toward the user's face during wear, such that the clip holding feature 2550 grips the headband clip 2600.

[0307] For example, Figure 30B An example of a headgear clamp 2600 is shown. The headgear clamp 2600 may include at least one strap slot, such as an upper strap slot 2602 and a lower strap slot 2604. The headgear 2180 may include at least one headgear strap for attachment to each of the upper strap slot 2602 and the lower strap slot 2604. For example, the headgear 2180 (such as...) Figure 1 (As shown) may include an upper strap connected to an upper strap slot 2602 and a lower strap connected to a lower strap slot 2604. In some configurations, the headgear straps may be adjustablely attached to the upper strap slot 2602 and the lower strap slot 2604 of the headgear clamp 2600.

[0308] Figure 31A and Figure 31B An additional example of a face mask assembly 2100 is shown, which includes a face mask seal 2104 connected to a face mask frame 2178 and a bend 2520. Advantageously, the headgear clamp 2600 of the face mask assembly 2100 can connect at least one and / or preferably two headgear straps in a single action. This configuration allows for easy assembly and / or disassembly of various components of the interface assembly, such as the frame 2178, the headgear clamp 2600, and the headgear 2180. In such configurations, the user may have limited and / or restricted visibility when assembling and / or disassembling the interface assembly. In some configurations, the arrangement described herein allows the user to assemble and / or disassemble the interface assembly with one hand. As described herein, the headgear clamp 2600 and / or frame 2178 may provide various features to guide the headgear 2180 to the frame 2178, such that the headgear 2180 and / or headgear clamp 2600 are properly positioned within the interface assembly during assembly and / or the interface assembly is not accidentally disconnected during use.

[0309] Figure 32A and Figure 32B Various configurations of the frame 2178 of the mask assembly 2100 are shown. For example... Figure 32A and Figure 32B As shown, frame 2178 may include a plurality of clamping features 2550 and vents 2514. The clamping features 2550 may be positioned along the lateral sides of frame 2178. For example, the clamping features 2550 may be laterally offset from the central portion of frame 2178. In some configurations, the clamping features 2550 are positioned along and / or extend from the lateral outermost edge of frame 2178. As shown in the configuration illustrated, the clamping features 2550 may be at least partially positioned below the flaps 2179 of frame 2178.

[0310] In some configurations, such as Figure 32A and Figure 32B As shown, the clamp holding feature 2550 may include a raised wall 2554 and at least one support member 2552. The raised wall 2554 may be offset forward or laterally from an adjacent portion of the mask frame 2178. For example, the raised wall 2554 may provide the front of the clamp holding feature 2600 such that the raised wall 2554 is positioned forward from an adjacent portion of the front surface 2560 of the frame 2178. In some configurations, the raised wall 2554 may follow the contour of the front surface 2560 of the frame 2178. For example, the raised wall 2554 may be substantially flat and / or curved to conform to the shape of the frame 2178. In such configurations, the raised wall 2554 may extend substantially parallel to the mask frame 2178 and may extend from the lateral side of the frame 2178 toward the central portion of the mask frame 2178. In some configurations, the raised wall 2554 extends from the bottom region of the flap 2179 toward or toward the lower region of the mask frame 2178. For example, in some configurations, the raised wall 2554 extends along the entire lateral side of the visor frame 2178 below the visor 2179. If desired, the raised wall 2554 may extend along the entire lateral side or substantially the entire lateral side of the visor frame 2178.

[0311] In some configurations, the raised wall 2554 is connected to the frame 2178 via at least one support member 2552. Preferably, each clamp holding feature 2550 may include at least two supports 2552 spaced apart from each other on, for example, the upper and lower edges of the raised wall 2554. The supports 2552 may connect the raised wall 2554 to the frame 2178 along the upper, lower, and / or lateral sides of the raised wall 2554. In some configurations, the supports 2552 extend outward from the mask frame 2178 to connect to the raised wall 2554 in a direction substantially perpendicular to the front surface 2560 of the frame 2178. Thus, the supports 2552 may support the raised wall 2554 at a position offset forward of the front surface 2560 of the frame 2178. Thus, a gap 2558 may be formed within the clamp holding feature 2550 and the frame 2178. The gap 2558 may provide an opening in the frame 2178 to receive at least a portion of the headgear 2180 and / or at least a portion of the headgear clamp 2600. As shown in the configuration illustrated, the gap 2558 may be defined by the front edge 2556 of the raised wall 2554, the support 2552, and the front surface 2560 of the frame 2178. In some configurations, the front edge 2556 of the raised wall 2554 extends forward from the support 2552 to form a lip. In use, the lip may desirably engage and / or retain the headgear clamp 2600.

[0312] Figures 33A to 33EAn exemplary configuration of a headgear clamp 2600 is shown. The headgear clamp 2600 may include an upper strap slot 2602, a lower strap slot 2604, an opening 2606, a step 2608, a pull tab 2630, and a front surface 2620. In some configurations, the headgear clamp 2600 may be formed in a generally "D" shape. For example, the opening 2606 may be centrally located within the headgear clamp 2606. In some configurations, the opening 2606 may be laterally positioned between the pull tab 2630 and the upper strap slot 2602 and the lower strap slot 2604. In some configurations, the maximum height of the opening 2606 may be greater than the maximum width of the opening 2606.

[0313] In this configuration, the clamp holding feature 2550 can extend fully through the aperture 2606 during assembly of the face mask assembly 2100. For example, the aperture 2606 can be formed in at least a portion of the headgear clamp 2600. In some configurations, the aperture 2606 is formed through the insert 2614 of the headgear clamp 2600 (described in more detail below). In some configurations, the headgear clamp 2600 can clamp, attach, and / or snap onto a corresponding clamp holding feature 2550 of the frame 2178. For example, the aperture 2606 can receive at least a portion of the clamp holding feature 2550. During assembly, the aperture 2606 can extend beyond the clamp holding feature 2550 of the frame 2178 and can slide rearward into a gap 2558 formed at the front of the clamp holding feature 2550. In this configuration, the forward portion of the periphery formed by the orifice 2606 can be located between the protruding wall 2554 of the clamp holding feature 2550 and the front surface 2560 of the frame 2178. Therefore, the forward portion of the periphery of the orifice 2606 can be held below the lip formed at the front edge 2556 of the clamp holding feature 2550.

[0314] like Figures 33C to 33E As shown, the headgear connector 2600 may include an overmolding arrangement. For example, the headgear connector 2600 may include an insert 2614. In some configurations, the insert 2614 may be formed of plastic. For example, the plastic of the insert 2614 may be substantially rigid. The insert 2614 may be overmolded using a relatively flexible and / or soft material such as silicone or TPE. In some configurations, the overmolded portion may form a tab 2630.

[0315] In some configurations, the opening 2606 and / or the upper strap slot 2602 and lower strap slot 2604 may be formed through and / or within the insert 2614. In some configurations, the insert 2614 may provide structure for the headband clamp 2600. For example, the insert 2614 may provide a substantially rigid connection between the headband straps of the headband 2180 and the frame 2178. As shown in the illustrated example, the upper strap slot 2602 and the lower strap slot 2604 may be spaced apart to allow the upper and lower headband straps to connect to the frame 2178. For example, the upper strap slot 2602 may be positioned offset above the lower strap slot 2604. When worn, this arrangement allows the upper strap of the headband 2180 to pass over the user's ears and the lower strap of the headband 2180 to pass below the user's ears. This configuration can desirablely improve the stability of the mask when the interface components are worn on the user's face.

[0316] As shown in the arrangement, the overmolded portion may surround at least a portion of the insert 2614. In some configurations, the overmolded portion forms a periphery around substantially the entire insert 2614 or the entire insert 2614. The overmolded arrangement may desirably provide a surface that is soft to be touched and / or easily gripped by a user. For example, the overmolded arrangement may provide flexibility to at least a portion of the headgear clamp 2600 (e.g., pull tab 2030). The overmolded arrangement may provide at least some rigidity to support the connection between the frame 2178 and the headgear 2180.

[0317] In some configurations, the overmolded portion may form a pull tab 2630 and a rotary lock 2616. In some configurations, the rotary lock 2616 may include a protrusion extending rearward from the rear surface 2624 of the headgear clamp 2600. In some configurations, the protrusion may be generally L-shaped. However, in some configurations, the protrusion may be formed in various shapes. The protrusion may extend along at least a portion of the rear edge and / or lower edge of the headgear clamp 2600. For example, the protrusion may extend along at least a portion of the lower portion of the insert 2614. The protrusion may extend laterally beyond the lateral edge of the lower portion of the insert 2614. In some configurations, the protrusion extends vertically along the rear surface of the headgear clamp 2600. In some configurations, the rear surface of the protrusion extends generally parallel to the rear surface 2624 of the headgear clamp 2600.

[0318] Rotary lock 2616 may be positioned abutting and / or adjacent to the lower edge of frame 2178. In some configurations, rotary lock 2616 may be positioned abutting and / or adjacent to the support 2552 of clamp holding feature 2550. In the configuration described herein, rotary lock 2616 may desirably prevent headgear clamp 2600 from rotating about an axis extending substantially perpendicular to the protruding wall 2554 of clamp holding feature 2550.

[0319] In some configurations, the vertical portion of the rotary lock 2616 of the headgear clamp 2600 may include an upper strap slot 2602 and a lower strap slot 2604, which form openings through the protrusion. For example... Figure 33B As shown, the upper strap slot 2602 and lower strap slot 2604 may include strap guides 2612. Strap guides 2612 may have cutouts formed in the rear edge 2622 of the rotary lock 2616. In some configurations, strap guides 2612 may provide a smooth surface. For example, strap guides 2612 may desirably align and / or guide the headband straps into appropriate arrangements within the upper strap slots 2602 and lower strap slots 2604 of the headband connector 2600. Such configurations can advantageously help reduce the volume generated during assembly by the connection of the headband straps to the headband connector 2600 and / or the depth of the headband straps. For example, strap guides 2612 may allow the headband straps to lie substantially flat on the headband clamp 2600.

[0320] In some configurations, the rotary lock 2616 includes a keyed portion to indicate the proper position for connection to the faceplate frame 2178. For example, the rotary lock 2616 can prevent the left headgear connector 2600 from connecting to the right clamp holding feature 2550 and / or prevent the right headgear connector 2600 from connecting to the left clamp holding feature 2550. Similarly, the rotary lock 2616 can prevent the headgear connector 2600 from being positioned in an incorrect vertical arrangement.

[0321] In some configurations, the pull tab 2630 includes a front surface that may have a portion extending above and / or below an opening 2606 formed in the headgear clamp 2600. The front surface of the pull tab 2630 may bulge outward and / or extend relative to at least a portion of the front surface of the headgear clamp 2600. For example, the front surface of the pull tab 2630 may bulge outward and / or extend relative to a portion of the front surface of the headgear clamp 2600 surrounding and / or adjacent to the opening 2616.

[0322] like Figure 33AAs shown, for example, the raised front surface 2620 of the pull tab 2630 can form a step 2608. Step 2608 can form a front surface and can form at least a portion of the periphery surrounding the aperture 2616. During assembly of the mask assembly 2100, step 2608 can desirably prevent the headgear clip 2600 from being incorrectly attached and / or aligned with the frame 2178. For example, by providing a surface offset from the aperture 2616, step 2608 can prevent the headgear clip 2600 from being incorrectly attached to the frame 2178 in a back-to-front orientation. That is, the current side (in...) Figure 33A (As can be seen) When positioned inward against or adjacent to frame 2178 rather than in the correct outward orientation, step 2608 prevents clamp 2600 from engaging clamp holding feature 2550. This configuration prevents orifice 2616 from sliding below and / or receiving the corresponding clamp holding feature 2550 of frame 2178.

[0323] In some configurations, the pull tab 2630 may be slightly elastic and / or flexible. For example, the pull tab 2630 may be formed of a substantially flexible material that allows the pull tab 2630 to extend and / or bend when a force is applied to it. For example, the pull tab 2630 may extend when pulled to disengage the headgear clamp 2600 from the corresponding clamp holding feature 2550. This arrangement can support a peeling action for disengaging the headgear clamp 2600 from the clamp holding feature 2550. Such an arrangement can ensure that the user properly disengages the clamp 2600 from the clamp holding feature 2550. For example, such an arrangement can ensure that the user does not unintentionally remove and / or disconnect the clamp 2600 from the clamp holding feature 2550 and / or can minimize the risk of the user doing so. In some configurations, the pull tab 2630 may provide sufficient tension to allow only a portion of the headgear clamp 2600 to bend laterally.

[0324] like Figures 33C to 33E As shown, for example, the overlay molding may not form the upper strap slot 2602 and lower strap slot 2604. For example, in some configurations, the upper strap slot 2602 and lower strap slot 2604 may be formed of a material having a greater thickness and / or stiffness than the surrounding surface (which may be the insert 2614). Such an arrangement can provide a low-friction surface finish to allow the headband straps to pass through the upper strap slot 2602 and lower strap slot 2604 for easy adjustment and / or sliding within them.

[0325] Figures 34A to 35BThe configuration of the face mask assembly 2100 is shown. The face mask assembly 2100 may include a frame 2178 and a first headwear clamp 2600A and a second headwear clamp 2600B. From the perspective of the wearer of the face mask assembly 2100, the first headwear clamp 2600A and the second headwear clamp 2600B may be defined as the right headwear clamp 2600A and the left headwear clamp 2600B. Figure 34A and Figure 34B An exemplary configuration of a first headgear clamp 2600A and a second headgear clamp 2600B connected to a frame 2178 is shown.

[0326] like Figure 35A and Figure 35B As shown, frame 2178 may include at least one clamp holding feature 2550 and at least one vent 2514. For example, frame 2178 may include at least two vents. In some configurations, frame 2178 may include at least three openings. The clamp holding feature 2550 may at least partially form a vent 2514 extending through frame 2178. Vent 2514 may provide an opening in frame 2178 to receive at least a portion of headgear clamp 2600. Vent 2514 may be generally rectangular, circular, and / or elliptical. For example, vent 2514 may include a top side, a bottom side, and at least one lateral side. Figure 35A and Figure 35B As shown, the top and bottom sides of the vent 2514 may be curved. In some configurations, the top and bottom sides of the vent 2514 may be concave and may face the central portion of the frame 2178. For example, the concave top and bottom sides of the vent 2514 may typically face the apex of the bend connector 2516.

[0327] In some embodiments, the connection feature 2550 may include a raised edge 2572. The raised edge 2572 may be formed from the most lateral side of the aperture of the connection feature 2550 located near the outermost lateral side of the frame 2178. For example, the raised edge 2572 may extend outward from the pre-formed surface 2560 of the frame 2178. The raised edge 2572 may include an increased thickness relative to the portion of the frame 2178 surrounding the raised edge 2572.

[0328] In some configurations, the raised edge 2572 extends along the length of the transverse edge of the vent 2514, thereby forming a connection point for the headgear clamp 2600. For example, the raised edge 2572 may form a post 2576 for connection to the hook 2654 of the headgear clamp 2600 (see example). Figure 40This arrangement provides a clearance for the hook 2654 of the headgear clamp 2600 to pass through the opening. This configuration allows the headgear clamp 2600 to be easily aligned with and / or attached to the frame 2178.

[0329] For example, the raised edge 2572 can form an alignment feature 2574 that properly aligns the headgear clamp 2600 with the frame 2178 (see example). Figure 35B Therefore, the raised edge 2572 may form a stepped area and / or recess on the rear surface of the frame 2178. In some configurations, the alignment feature 2574 may receive at least a portion of the hook 2654 of the headgear clamp 2600. In some configurations, the alignment feature 2574 may have a varying wall thickness. For example, the wall thickness may be greater at the raised edge 2572, such as at the post 2576, compared to the surrounding surfaces (including the surface adjacent to the post 2576 and the surrounding transverse surfaces of the rear surface of the frame 2178). In such configurations, the alignment feature 2574 may abut the hook 2654 of the headgear clamp 2600 to desirably minimize and / or prevent rotation about an axis substantially perpendicular to the front surface 2560 of the frame 2178 near the clamp holding feature 2550. Such an arrangement may prevent the clamp from disengaging from the clamp holding feature 2550 when the headgear is pulled up, down, and / or away from the mask assembly 2100. Alignment feature 2574 may desirably provide an anti-slip or non-slip surface. Therefore, alignment feature 2574 can prevent headgear clamp 2600 from sliding along the post 2576 of clamp holding feature 2550. This arrangement can provide a more secure connection between headgear 2180 and mask assembly 2100. Similarly, this arrangement can provide greater stability to the connection between headgear 2180 and mask assembly 2100.

[0330] like Figures 34A to 35BAs shown, frame 2178 may include a bonding protrusion 2570. In some configurations, the bonding protrusion 2570 may be formed in frame 2178 adjacent only to one of the clamp holding features 2550. In some configurations, the bonding protrusion 2570 may be formed in frame 2178 and positioned adjacent to multiple clamp holding features 2550. For example, the bonding protrusion 2570 may allow headgear clamp 2600 to be bonded to frame 2178 to allow assembly only in the appropriate orientation. In some configurations, the bonding protrusion 2570 may extend outward from the front surface 2560 of the left lateral side of frame 2178. The bonding protrusion 2570 may preferably be positioned laterally offset from the left clamp holding feature 2550 toward the outermost lateral edge of frame 2178. For example, the bonding protrusion 2570 may be aligned with a corresponding bonding notch 2650 on the second and / or left headgear clamp 2600B. In some configurations, the bonding protrusion 2570 may desirablely prevent incorrect headgear clip 2600 (in this example, right headgear clip 2600A) from being attached to the left side of frame 2178. In some configurations, the bonding protrusion 2570 may desirablely prevent headgear 2180 from being attached to frame 2178 in incorrect horizontal alignment, vertical alignment, and / or front-to-back alignment. Therefore, the bonding protrusion 2570 may enhance the usability of mask assembly 2100 and / or allow for easy assembly and / or disassembly of mask assembly 2100.

[0331] Figures 36A to 43 Configurations of a first head-mount clamp 2600A and a second head-mount clamp 2600B, and / or a first head-mount clamp 2600A and a second head-mount clamp 2600B connected to a frame 2178, are shown. The first head-mount clamp 2600A and the second head-mount clamp 2600B are similar or identical in many respects to other instances of the head-mount clamp 2600 discussed above. As shown in the illustrated configurations, the first head-mount clamp 2600A and the second head-mount clamp 2600B include orifices that can clamp onto and / or receive at least a portion of a corresponding clamp holding feature 2550 of the frame 2178 (e.g., post 2576). In some configurations, the first head-mount clamp 2600A and the second head-mount clamp 2600B are formed of a substantially rigid material, such as nylon, polycarbonate, and / or polypropylene, among others. Therefore, the first headgear clamp 2600A and the second headgear clamp 2600B can desirablely provide support for the headgear 2180 and / or maintain the connection between the headgear 2180 and the frame 2178.

[0332] The first headgear clamp 2600A and the second headgear clamp 2600B may include an opening 2606, a thumb grip 2640, a finger grip 2642, an upper strap slot 2602, a lower strap slot 2604, an overmolded grip 2644, a hook 2654, and a bonding notch 2650. For example, the first headgear clamp 2600A and the second headgear clamp 2600B may form a generally arcuate ring around the opening 2606. Thus, the opening 2606 can be centrally positioned within the first headgear clamp 2600A and the second headgear clamp 2600B. In some configurations, the opening 2606 may receive at least a portion of the clamp holding feature 2550 of the frame 2178 (e.g., a raised lip 2652). For example, when the first headgear clamp 2600A and the second headgear clamp 2600B are connected to the frame 2178 via the clamp holding feature 2550, the first headgear clamp 2600A and the second headgear clamp 2600B can be substantially flush with the front surface 2560 of the frame 2178.

[0333] In some configurations, the first headgear clamp 2600A and the second headgear clamp 2600B may include a thumb grip portion 2640. The thumb grip portion 2640 may be defined by a protruding tab positioned relative to a central plane extending vertically between the first headgear clamp 2600A and the second headgear clamp 2600B, along the lateral outer edge of the first headgear clamp 2600A and the second headgear clamp 2600B. Such configurations may desirablely provide a grip for the user's thumb. For example, the user may rest their thumb against the thumb grip portion 2640. In some configurations, the thumb grip portion 2640 may have a greater thickness than its surrounding portion. Such configurations may desirablely provide an increased contact area for the user's thumb to grip, thereby allowing the user to easily connect and / or disconnect the first headgear clamp 2600A and the second headgear clamp 2600B from the corresponding clamp holding feature 2550.

[0334] Such as at least Figure 36A and Figure 36B As shown, the first head-mounted clamp 2600A and the second head-mounted clamp 2600B form concave surfaces along at least a portion of the first head-mounted clamp 2600A and the second head-mounted clamp 2600B (e.g., along a portion of the lateral outer edges of the first head-mounted clamp 2600A and the second head-mounted clamp 2600B). For example, a thumb grip portion may be centrally positioned along the lateral outer edges of the first head-mounted clamp 2600A and the second head-mounted clamp 2600B. The concave surface of the thumb grip portion 2640 can provide a comfortable gripping surface for the user. In some configurations, the concave surface can provide a visual indicator that can indicate to the user that the surface of the thumb grip portion 2640 should be gripped by the user.

[0335] In some configurations, the first head-mount clamp 2600A and the second head-mount clamp 2600B include a finger grip portion 2642. The finger grip portion 2642 may be defined by a raised tab positioned along the lateral inner edge of the first head-mount clamp 2600A and the second head-mount clamp 2600B. Such configurations may desirably provide gripping for one or more fingers of a user. For example, a user may rest their fingers against the finger grip portion 2642. In some configurations, the finger grip portion 2642 may have a greater thickness than its surrounding portion. This configuration may desirably provide an increased contact area for the user's fingers to grip, thereby allowing the user to easily connect and / or disconnect the first head-mount clamp 2600A and the second head-mount clamp 2600B from the corresponding clamp holding feature 2550.

[0336] Such as at least Figure 36A and Figure 36B As shown, the finger grip portions 2642 of the first head-mounted clamp 2600A and the second head-mounted clamp 2600B form concave surfaces along at least a portion of the first head-mounted clamp 2600A and the second head-mounted clamp 2600B (e.g., along a portion of the lateral inner edges of the first head-mounted clamp 2600A and the second head-mounted clamp 2600B). For example, the finger grip portions 2642 may be centrally positioned along the lateral inner edges of the first head-mounted clamp 2600A and the second head-mounted clamp 2600B. The concave surfaces of the finger grip portions 2642 can provide a comfortable gripping surface for the user. In some configurations, the concave surfaces may provide visual indicators that can indicate to the user that the surface of the finger grip portions 2642 should be gripped by the user.

[0337] In some configurations, the finger grip 2642 may be positioned along the lateral edges of the first headband clamp 2600A and the second headband clamp 2600B opposite to the thumb grip 2640. For example, the finger grip 2642 and the thumb grip 2640 may be positioned on opposite sides of the opening 2606. Such configurations encourage the user to grip the first headband clamp 2600A and the second headband clamp 2600B with their fingers toward the front edges of the clamps. Such configurations improve the user's control over the angle of the first headband clamp 2600A and the second headband clamp 2600B during assembly and / or disassembly, thereby allowing the first headband clamp 2600A and the second headband clamp 2600B to be easily connected to the clamp holding feature 2550. For example, the first headband clamp 2600A and the second headband clamp 2600B can be more easily aligned with the clamp holding feature 2550. In some configurations, the positioning and / or shape of the finger grip portion 2642 relative to the thumb grip portion 2640 may prompt the user to grip the first outer side and the second outer side of the first headgear clamp 2600A and the second headgear clamp 2600B.

[0338] In some configurations, the first headgear clamp 2600A and the second headgear clamp 2600B may include an upper strap slot 2602 and a lower strap slot 2604. The upper strap slot 2602 and the lower strap slot 2604 may be similar or identical in many respects to other instances of the upper strap slot 2602 and the lower strap slot 2604 discussed above. Therefore, the upper strap slot 2602 and the lower strap slot 2604 may receive corresponding upper and lower headgear straps of the headgear 2180.

[0339] In some configurations, the overmolded gripping portions 2644 of the first headgear clamp 2600A and the second headgear clamp 2600B may extend around at least a portion of the first headgear clamp 2600A and the second headgear clamp 2600B. For example, the overmolded gripping portions 2644 may extend around the periphery of the first headgear clamp 2600A and the second headgear clamp 2600B. Figure 36A and Figure 36B As shown, the overmolded grip portion 2644 may form at least a portion of the concave surface of the thumb grip portion 2640 and / or the finger grip portion 2642. In some configurations, the overmolded grip portion 2644 may form the concave surface of the thumb grip portion 2640 and / or the finger grip portion 2642.

[0340] In some configurations, the overmolded grip portion 2644 may comprise various materials, such as elastomeric materials. For example, the overmolded grip portion 2644 may comprise silicone and / or TPE, as well as other materials. The overmolded grip portion 2644 can provide a soft tactile finish, thereby providing a more comfortable grip on the first headgear clamp 2600A and the second headgear clamp 2600B. In some configurations, the overmolded grip portion 2644 can provide a grip for the user. In such configurations, the overmolded grip portion 2644 may have a higher coefficient of friction than the surrounding portions of the first headgear clamp 2600A and the second headgear clamp 2600B.

[0341] like Figure 37A and Figure 37B As shown, the first headgear clamp 2600A and the second headgear clamp 2600B may include a hook 2654. The hook 2654 may form a tongue that projects rearwardly and laterally from the rear portion of the finger grip portion 2642 toward the center of the aperture 2606. For example, the hook 2654 may extend inwardly into the aperture 2606. In some configurations, during assembly, the hook 2654 may slide beneath at least a portion of the clamp holding feature 2550 (e.g., raised edge 2572). In some configurations, the hook 2654 may include a raised lip 2652. The raised lip 2652 may extend along the inner edge of the hook 2654. The raised lip 2652 may engage with at least a portion of the clamp holding feature 2550 (e.g., post 2576). Therefore, hook 2654 can secure the first headgear clamp 2600A and the second headgear clamp 2600B to frame 2178.

[0342] In some configurations, at least one of the first headgear clamp 2600A and the second headgear clamp 2600B includes a bonding notch 2650. The bonding notch 2650 may be formed as a recess along, for example, the edge of at least one of the first headgear clamp 2600A and the second headgear clamp 2600B. For example, the bonding notch 2650 may be positioned along the rear surface of at least one of the first headgear clamp 2600A and the second headgear clamp 2600B. The bonding notch 2654 may correspond to and / or receive a bonding protrusion 2570 of the frame 2178 such that when the headgear clamp is attached to the frame 2178, the headgear clamp is substantially flush with the front surface of the frame 2178. For example, as... Figure 36BAs shown, the left head-mount clamp may include a bonding notch 2650. The bonding notch 2650 may correspond to a bonding protrusion 2570 located on the lateral left side of the frame 2178. For example, the bonding notch 2650 may indicate to the user that the head-mount clamp 2600 is the left head-mount clamp 2600B or the right head-mount clamp 2600A. In such a configuration, the bonding notch 2650 may desirably prevent the head-mount clamp 2600 from engaging with the incorrect clamp holding feature 2550.

[0343] Figures 44 to 45 An example of an interface component is shown. For example... Figures 44 to 45 As shown, the interface may include a headgear assembly 2180 and a face mask assembly 2100. The face mask assembly 2100 may include a face mask seal 2104, a frame 2178, and an air supply duct 2520A. As shown in the example illustrated, the frame 2178 may include a duct connector 2700. The duct connector 2700 may provide a direct connection between the frame 2178 and the air supply duct 2520A. For example, the duct connector 2700 may form a substantial portion of the lower region of the housing 2102. For example, the duct connector 2700 may extend substantially laterally between opposing clamping features 2550. In some configurations, the duct connector 2700 may be angled downwards away from the frame 2178.

[0344] like Figures 44 to 45 As shown, the frame may include at least one vent 2514. For example, the vent 2514 may preferably be disposed within the mask assembly 2100 such that the vent 2514 is aligned with an opening in the frame 2178 and / or with various components of the mask assembly 2100. For example, the vent 2514 may be disposed between the frame 2178 and headgear clamps 2600A, 2600B. In some configurations, the vent 2514 defines an opening disposed between the frame 2178 and the headgear clamps 2600A, 2600B. In some configurations, the vent 2514 may form at least a portion of the clamp holding feature 2550 (e.g., at least a portion of the opening of the clamp holding feature 2550). For example, the vent 2514 may define a portion of the opening of the clamp holding feature 2550 that is not covered by the headwear clamp 2600 when the headwear clamp 2600 is attached to the frame 2178. Such a configuration may desirably disperse the exhausted air over a larger area and in at least two directions away from the user's face in order to reduce small bursts of airflow against the user's face during wear.

[0345] In some arrangements, as described above, the vent 2514 can advantageously allow exhausted air to pass through the frame 2178 to reach the atmosphere. In some configurations, the vent 2514 can be positioned along the lateral side of the mask frame 2178 and can face outwards away from the central portion of the frame 2178. For example, as... Figure 45 As shown, when a user wears the mask assembly 2100, the exhausted air can pass through the frame 2178 and move laterally away from the user. As described above, this configuration can desirably disperse the exhausted air over a larger area and in at least two directions away from the user's face in order to reduce small bursts of airflow against the user's face when worn.

[0346] Figures 46 to 48 Embodiments of interface components are illustrated, which include features and / or components that are similar to or identical in many respects to the interface components discussed above. For example... Figures 46 to 48 As shown, the vent 2514 can be centrally positioned within the frame 2178, as described above. In some configurations, the vent 2514 can be formed in at least a portion of the conduit connector 2700. For example, the vent 2514 can be formed in the upper portion of the conduit connector 2700. Figure 46 As shown, for example, the conduit connector 2700 can be integrally formed with the frame 2178. In some configurations, the conduit connector 2700 can be formed directly in the housing 2102.

[0347] In some configurations, such as Figure 46 As shown, the headgear clamp 2600 can provide support for the face mask seal 2104. In this configuration, the frame 2178 may not provide support for the flaps 2126 of the face mask seal 2104. For example, the headgear clamp 2600 can be positioned on the front surface of the face mask seal 2104 such that it provides sufficient mechanical rigidity and structure to maintain the shape of the face mask seal 2104 when the user wears it. For example, the headgear clamp 2600 can help prevent the face mask seal 2104 from swelling. Figure 46 As shown, the headgear clamp can extend vertically along the lateral side of the face mask seal 2104. For example, the headgear clamp 2600 can extend along a substantial portion of the lateral side of the face mask seal 2104. When attached to the frame 2178, the headgear clamp 2600 can extend upward along the front surface of the face mask seal 2104 and can cover at least a portion of the face mask seal 2104. This configuration can desirablely support the face mask seal 2104 and can reduce the overall size of the frame 2178. Therefore, this configuration can reduce the volume of the face mask assembly 2100.

[0348] Figure 47 and Figure 48Various configurations of the headgear clamp 2600 are shown. In some configurations, the headgear clamp 2600 may have a circular and / or elliptical cross-section (see [reference]). Figure 48 In such configurations, the circular surface of the headgear clamp 2600 can provide a more aesthetically pleasing appearance to the user. For example, the circular surface of the headgear clamp 2600 can allow the headgear clamp 2600 to appear smaller to the user and / or reduce the overall volume of the headgear clamp 2600. In some configurations, the headgear clamp 2600 may include a square and / or substantially rectangular cross-section (see...). Figure 47 In this configuration, the square surface of the headgear clamp 2600 can provide a more grippy surface compared to cross-sections of other shapes.

[0349] Figures 49 to 75 An example of an interface component is shown. For example... Figure 49 As shown, the interface assembly may include a headgear assembly 2180, a frame 2178, a face mask assembly 2100, and an air supply duct 2520A, as well as other possible components. The headgear assembly 2180 may include straps, such as one or more upper side straps 2804, one or more lower side straps 2802, and / or a top head strap 2808, as well as other components (see [link to documentation]). Figures 73 to 75The mask assembly 2100 may include a mask housing 2012 and a mask seal 2104 forming a breathing chamber, as well as other possible components. As shown in the illustrated example and explained in more detail below, the frame 2178 may include an anti-asphyxiation (AA) valve assembly 2522B. In some configurations, the valve assembly 2522B may be received by a valve recess 2726, as described below. As described in more detail below, the valve assembly 2522B may include a valve housing 2522 (referred to herein as "valve 2522"). The valve 2522 may be integrally formed with the frame 2178. As described below, the valve assembly 2522B may include at least a portion of the frame 2178, valve 2522, valve element or valve component (such as valve disc 2524), and / or pipe connector 2711, as well as other possible components. The valve 2522 may be located within the frame 2178, adjacent to the gas supply conduit 2520A. In some embodiments, the valve 2522 of the valve assembly 2522B may include an inlet tube 2522A. The inlet tube 2522A may be positioned posterior to the front wall of the frame 2178. In some embodiments, the inlet tube 2522A may define at least a portion of an airflow passage. In some configurations, integration of the valve 2522 with the frame 2178 may allow the air supply conduit 2520A to extend from the lower front portion of the frame 2178 in a generally downward direction. Such configurations can reduce the overall volume of the patient interface. For example, in such configurations, the conduit 2520A may be positioned closer to the user during use. The gas flow passage is provided by the gas supply conduit 2520A, the valve assembly 2522B, and the cushion connector 2708. The gas flow passage provides a channel through which pressurized gas is delivered via the mask assembly 2100 to the user's nose and / or mouth.

[0350] Figures 50A to 50B An example of a mask assembly 2100 is shown. As described above, the mask assembly 2100 may include a mask seal 2104 and a housing 2012, and is assembled to a frame 2178 and / or an air supply duct 2520A, as well as other components. The frame 2178 is typically bendable in the lateral and / or vertical directions.

[0351] In some embodiments, the frame 2178 may be disposed on the front side of the face mask seal 2104. In some embodiments, the frame 2178 may cover a substantial portion of the front side of the face mask seal 2104, such as a substantial portion of the housing 2102 of the face mask seal 2104. In some embodiments, the frame 2178 is centered in the lateral direction along the front surface of the face mask seal 2104. For example, the entire front surface of the frame 2178 may be positioned in front of the face mask seal 2104.

[0352] Figures 51A to 59An embodiment of frame 2178 is shown. In some embodiments, frame 2178 may include a cushioning connector 2708, an inlet or inlet opening 2706, a valve 2522, at least one upper strap connector 2702, at least one lower strap connector 2704, and / or a flap 2179.

[0353] In some embodiments, the cushioning connector 2708 may be positioned on the rear side of the frame 2178. In some embodiments, the cushioning connector 2708 is integral with the frame 2178 and extends rearward from the rear surface of the front wall of the frame 2178. The cushioning connector 2708 may provide a fluid connection between the inlet 2706 and the mask assembly 2100.

[0354] In some embodiments, the cushioning connector 2708 may be shaped to fit into at least a portion of the mask assembly 2100 to connect the frame 2178 to the mask assembly 2100. For example, the cushioning connector 2708 may fit into at least a receiving portion of the mask housing 2102 portion of the mask assembly 2100. The cushioning connector 2708 may include a slightly rounded 'D' shape, a circular trapezoidal shape, a circular shape, an elliptical shape, and / or an egg shape, as well as other possible shapes.

[0355] In some embodiments, the buffer connector 2708 is in the form of a protruding wall that forms a sleeve or collar. The protruding wall may extend rearward and / or upward from the rear side of the front wall portion 2701 of the frame 2178. The buffer connector 2708 may be positioned above the AA valve 2522 along the rear side of the frame 2178. The buffer connector 2708 may be positioned adjacent to the AA valve 2522 along the rear side of the frame 2178. In some configurations, the inlet 2706, the AA valve 2522, and the buffer connector 2708 cooperate to form a gas flow passage defined by the frame 2178. In the illustrated arrangement, each of the inlet 2706, the AA valve 2522, and the buffer connector 2708 includes a substantially enclosed space (other than a specific and intentional opening) defining a portion of the entire gas flow passage. In some configurations, the front wall portion 2701 of the frame 2178 defines at least a portion of the gas flow passage. In the arrangement shown, the front wall portion 2701 of the frame 2178 defines a portion of the gas flow passage for one or both of the AA valve 2522 and the buffer pad connector 2708. This arrangement allows the frame 2178 to have a reduced depth compared to a design in which the entire gas flow passage is defined by a dedicated structure.

[0356] In some embodiments, the cushioning connector 2708 may include alignment features, such as an alignment notch 2710. The alignment notch 2710 may be formed in a portion of the cushioning connector 2710. For example, the alignment notch 2710 may be formed in the upper wall portion of the cushioning connector 2708. The alignment notch 2710 may guide the connection between the frame 2178 and the mask assembly 2100. For example, the alignment notch 2710 may correspond to a feature on the mask assembly 2100 to allow the frame 2178 and the mask assembly 2100 to be connected in a proper orientation. In some embodiments, the alignment notch 2710 has a generally trapezoidal shape, a rectangular shape, and / or a square shape, as well as other possible shapes. In some embodiments, the alignment notch 2710 may have a width at the outer edge of the upper wall of the cushioning connector 2708, said width being wider than the width of the alignment notch 2710 at a location closer to the rear side of the frame 2178.

[0357] In some embodiments, frame 2178 may include inlet 2706. Inlet 2706 may be defined by pipe connector 2711, which may be a separate structure coupled to frame 2178. In some embodiments, inlet 2706 may provide a fluid flow path or gas flow channel through which pressurized air can be supplied to mask assembly 2100. In some embodiments, pressurized air may be supplied to mask assembly 2100 via or through AA valve 2522 via inlet 2706. As explained in more detail below, AA valve 2522 allows the use of atmosphere when there is no pressurized air source or when the pressure within mask assembly 2100 is otherwise reduced to below atmospheric pressure.

[0358] In some embodiments, frame 2178 may include at least one upper strap connector 2702 and at least one lower strap connector 2704. In the illustrated arrangement, frame 2178 includes a pair of upper strap connectors 2702 and a pair of lower strap connectors 2704, each of which may be positioned on an opposing lateral side of frame 2178. In some embodiments, upper strap connector 2702 may slidably receive a corresponding upper headband strap 2802 of headgear 2180 (e.g., see...). Figure 49 The head-mount connector 2702 may include a post 2703A and an aperture 2703B. The post 2703A may be spaced apart from the front surface of the frame 2178. The post 2703A may be positioned approximately at the center of the aperture 2703B. In some embodiments, the post 2703A may be positioned offset from the center of the aperture 2703B. In some embodiments, the post 2703A may be positioned offset in front of the front wall of the frame 2178.

[0359] Such as at least Figure 49 and Figure 73 As shown, post 2703A can help secure the upper strap 2802 to the upper headgear connector 2702. In some embodiments, post 2703A, together with the front surface of frame 2178, can define a slot through which the corresponding upper strap 2802 can pass. For example, the upper strap 2802 can pass through the slot formed between post 2703A and aperture 2703B. For example, once the upper strap 2802 passes through the slot, it can wrap around the outside of post 2703A and fold itself. In some embodiments, aperture 2703B can provide additional space to allow the upper strap 2802 to pass behind post 2703A. In some configurations, aperture 2703B can help reduce the distance between post 2703A and the front surface of frame 2178 necessary to accommodate the thickness of the strap 2802. In some embodiments, the upper strap connector 2702 can secure (e.g., removably secure) a headgear clamp that can be attached to the upper side strap 2802.

[0360] In some embodiments, the lower strap connector 2704 may receive and / or secure the lower side strap 2802 and / or the lower headgear clamp 2600 (see [link]). Figure 49 ). For example, at least Figures 51A to 54 As shown, the lower strap connector 2704 may include a lower post 2705A. The lower post 2705A may be positioned along a side edge of the frame 2178. The lower post 2705A may be spaced apart from a portion of the frame 2178 to define an aperture 2705B. In some embodiments, the lower post 2705A forms a lateral lower edge of the frame 2178. In some embodiments, the aperture 2705B may be shaped to receive at least a portion of the lower head-mount clamp 2600. In some embodiments, the aperture 2705B may be substantially D-shaped, among other possible shapes. In some embodiments, the post 2705A may be received within and / or retain a portion of the corresponding lower head-mount clamp 2600 (such as a hook portion of the clamp 2600). The lower post 2705A may provide a removable connection between the lower side strap 2802 and the frame 2178 and / or between the lower head-mount clamp 2600 and the frame 2178.

[0361] In some embodiments, frame 2178 may include frame flaps 2179. As described above, flaps 2179 may define an upper support member that, upon assembly, provides support to the forward-facing lateral side (sealing flap 2126) of the nose region 2168 of the mask seal 2104. Flaps 2179 may help minimize deflection of the mask seal 2104. In some embodiments, flaps 2179 may help maintain contact between the nose region 2168 and the user's nose. For example, flaps 2179 may help prevent the nose region 2168 of the mask seal 2104 and the sealing flap 2126 from expanding away from and / or disengaging from the user's nose.

[0362] Figures 52 to 58 Some parts of valve 2522 are shown in more detail. For example, at least... Figures 52 to 54 As shown, valve 2522 may include valve elements or valve components, such as valve disc 2524. Valve 2522 may also include pipe connector 2711 and other possible components. In some embodiments, valve 2522 may include a vent passage 2722 and / or an outlet 2720. As shown, at least a portion or some components of valve 2522 may be integrally formed with frame 2178. For example, the main body portion defining the gas flow passage of valve 2522 is integrally formed with frame 2178. Some configurations may desirablely reduce assembly time and / or reduce the number of components required for manufacturing, cleaning, and / or replacement. Some such configurations may desirablely reduce the likelihood of pressurized air leaking from the component.

[0363] Figure 53 and Figure 54 They respectively showed along Figure 51A The side cross-sectional view of frame 2178 obtained by lines 53-53 and 54-54 shown. Figure 55 Showing Figure 52 The figure shows a front cross-sectional view of the frame 2178. As shown, the frame 2178 can accommodate the valve disc 2524. In some embodiments, the frame 2178 completely surrounds the valve disc 2524. Therefore, the valve disc 2524 can be positioned within the gas flow passage of the valve 2522 in the frame 2178.

[0364] In some embodiments, the tube connector 2711 may define an inlet opening 2706 that directs pressurized air through the valve 2522 to the user via the mask assembly 2100. In some embodiments, the tube connector 2711 may be elliptical, circular, and / or oval, among other shapes. Preferably, the inlet 2706 is smaller in the longitudinal direction than in the transverse direction. This provides additional space to accommodate the valve 2522 in the longitudinal direction compared to a design where the inlet 2706 is circular, without increasing the longitudinal dimensions of the frame 2178 or causing the inlet 2706 to move further away from the user's face. The tube connector 2711 may include a convex portion received by a corresponding concave connector. The concave connector may be attached to the conduit 2520A. In some embodiments, the tube connector 2711 may allow the conduit 2520A to be disconnected by twisting it relative to the frame 2178 and / or the tube connector 2711. In some embodiments, the conduit 2520A is connected to the tube connector 2711 via a snap-fit ​​configuration and other possible configurations. For example, pipe connector 2711 may include one or more pipe connector recesses 2712. Pipe connector recesses 2712 may engage corresponding features on conduit 2520A via a snap-fit ​​configuration.

[0365] In some embodiments, the valve disc 2524 may be secured within the frame 2178 via a pipe connector 2711. In some embodiments, the pipe connector 2711 may be permanently connected to the lower end of the defined valve 2522 of the frame 2178 via various configurations such as welding, adhesive and / or snap-fit ​​configurations, and other possible configurations. In some embodiments, the pipe connector 2711 may surround and / or secure a tab of the valve disc 2524 between the lower end of the frame 2178 and the flange of the pipe connector 2711. In some embodiments, the valve disc 2524 may be positioned adjacent to the inner end 2711A of the pipe connector 2711 within the frame 2178. In some embodiments, the valve disc 2524 may be constructed wholly or partially of a flexible elastomer such as silicone, and other materials.

[0366] Valve disc 2524 can open and close different flow paths within valve 2522 to allow airflow through a desired one of the different flow paths within valve 2522. For example, when the flow generator supplies positive pressure air to the user through mask assembly 2100, valve disc 2524 can pivot about a hinge or otherwise move in response to pressurized air entering inlet 2706. In this position, valve disc 2524 is open relative to inlet 2706 of pipe connector 2711 and closed relative to valve 2522 and / or venting path 2722 of valve 2522. Some configurations can help ensure that all or substantially all of the positive pressure airflow is directed to the user with little or no airflow leakage from venting path 2722 of valve 2522. When the flow generator does not supply airflow to the mask assembly 2100 or the pressure inside the mask assembly 2100 drops to below atmospheric pressure in other ways, the valve disc 2524 closes relative to the inlet 2706 of the pipe connector 2711, and the ventilation path 2722 of the AA valve 2522 opens to allow the user to inhale ambient air through the valve 2522.

[0367] The pipe connector 2711 can support the valve disc 2524 in an operable position relative to the valve 2522 portion of the frame 2178. In some configurations, the pipe connector 2711 defines a stop that prevents the valve disc 2524 from reversing or extending downward out of the inlet 2706 of the frame 2178 (see, for example...). Figure 53 In some configurations, the tube connector 2711 may include a flap support 2724. In some embodiments, the tube connector 2711 may include at least three flap supports 2724 (see...). Figure 56 In some embodiments, the tube connector 2711 may include at least two, three, four, five, or six or more flap supports 2724. The flap supports 2724 may extend radially inward from the inner surface of the peripheral wall of the tube connector 2711 into the inlet 2706 of the tube connector 2711.

[0368] In some embodiments, the valve support 2724 may be positioned adjacent to the upper edge of the tube connector 2711. In some configurations, the valve support 2724 may prevent the valve disc 2524 from reversing or extending downward into the inlet 2706.

[0369] Such as at least Figure 55As shown, valve 2522 (alone or in combination with frame 2178) may include various venting paths and valve outlets to allow air to flow into and out of mask assembly 2100 when valve disc 2524 is in the closed position. For example, in some embodiments, the flow path is configured to pass through venting path 2722 and valve outlet 2720 of valve assembly 2522B and cushion connector 2708. In some embodiments, valve 2522 may include at least two venting paths 2722 and / or at least two lateral valve outlets 2720.

[0370] In some embodiments, the venting path 2722 may extend rearward away from the inlet 2706 toward the outlet 2720. In some embodiments, the venting path 2722 may extend through the inner wall of the valve 2522 toward the outlet 2720. In some embodiments, the venting path 2722 may extend from the pipe 2520A through the inner wall of the valve 2522 toward the outlet 2720. In some embodiments, the venting path 2722 may extend rearward and downward into the outlet 2720. In some embodiments, the central axis of the venting path 2722 is parallel to the central axis 2706A of the inlet 2706 (e.g., ...). Figure 59 (As shown) forms an acute angle.

[0371] In some embodiments, outlet 2720 may define an opening to allow exhausted air to leave the patient interface or inhaled air to enter the patient interface via ventilation path 2722 when valve disc 2524 is in the closed position. Figure 54 As shown, valve 2522 may include a rear wall 2523, which is rearwardly spaced from the outlet 2720 away from the venting path 2722, and together with the inner wall defines the outlet 2720. This configuration can provide space for guiding exhaust air in the lateral direction, such as... Figure 51B As shown by the arrow, the rear wall of valve 2522 allows exhausted air to be directed away from the user. In some embodiments, the lateral orientation can help minimize contact between the exhausted air and the user. Some configurations can help reduce discomfort to the patient caused by the exhausted air. In some embodiments, outlet 2720 may extend below the lower surface of housing 2102 during assembly (see...). Figures 68 to 70 In this configuration, the exhaust air is not blocked by the outer casing 2102.

[0372] Figure 57 and Figure 58An exploded view of frame 2178 is shown, illustrating a portion of valve 2522. In some embodiments, valve disc 2524 may include an outer periphery 2524A and an inner rib 2524B. The outer periphery 2524A may include a lip. The lip may define a thickened region extending along the outer periphery 2524A. In some embodiments, rib 2524B may be positioned along the underside of valve disc 2524. Rib 2524B may be positioned generally along the central axis of valve disc 2524. In some embodiments, rib 2524B may define a thickened region along the center of valve disc 2524. In some embodiments, outer periphery 2524A and / or rib 2524B may provide rigidity to valve disc 2524. Outer periphery 2524A and / or rib 2524B may help suppress expansion and / or deformation of valve disc 2524 caused by pressurized airflow during use. Some configurations may help provide an effective seal around venting path 2722 when valve 2522 is in the open position.

[0373] In some embodiments, the tube connector 2711 may define an inlet 2706 that directs pressurized air through valve 2522 into the breathing chamber. Inlet 2706 may be angled downwards during use. For example, as... Figure 59 As shown, the central axis 2706A of the inlet 2706 can form an angle with the central axis 2708A of the cushion connector 2708. In some embodiments, the angle is approximately 125 degrees. In some embodiments, the angle is greater than or less than 125 degrees. In some embodiments, the angle is approximately 124.4 degrees. In some embodiments, the angle is greater than or less than 124.4 degrees. Some configurations may help keep the catheter 2520A away from the user. Some configurations may desirably minimize the volume of the patient interface, such as at the front of the mask assembly 2100.

[0374] Figures 60 to 72B An embodiment of a mask assembly 2100 coupled to a frame 2178 is shown. As previously described herein, the mask assembly 2100 may include a housing 2102 and a mask seal 2104. The housing 2102 may be located on the front side of the mask seal 2104. In some embodiments, the housing 2102 may be substantially rigid. In some embodiments, the housing 2102 may include a frame connector 2730, at least one biased vent 2502, and / or an AA valve recess 2726.

[0375] Figure 62A front view of the face mask assembly 2100 is shown, illustrating the housing 2102. In some embodiments, the housing 2102 may include one, two, three, four, or five or more bias vents 2502. The bias vents 2502 may be positioned in the bottom region of the housing 2102. In some embodiments, the bias vents 2502 may be positioned on a generally forward-facing surface of the housing 2102. For example, the bias vents 2502 may be positioned adjacent to the lower edge of the housing 2102. In some configurations, the openings of the bias vents 2502 may be positioned close to and / or adjacent to the lower edge of the frame 2178 during assembly. Preferably, the bias vents 2502 are positioned below the lower edge of the frame 2178. Such configurations can minimize contact between exhausted air and the frame 2178. Such configurations can help reduce noise and / or unwanted small airflows or air leaks.

[0376] Figure 62 An example of a housing 2102 including two biased vents 2502 is shown. The biased vents 2502 may include multiple holes. These holes may be arranged in a generally triangular pattern, as well as other possible patterns. The biased vents 2502 may be positioned on opposite lateral sides of the inlet 2732 and / or valve recess 2726 of the mask seal 2104. In some embodiments, at least a portion of the biased vents 2502 is positioned below at least a portion of the inlet 2732, and at least a portion of the biased vents 2502 is positioned beyond the side of the inlet 2732. In such a configuration, only a portion of the biased vents 2502 is positioned laterally beyond the inlet 2732. In some embodiments, the biased vents 2502 are positioned completely beyond the side of the inlet 2732. The biased vents 2502 may help disperse exhaust air. Such a configuration may reduce disturbances caused by exhaust air to the user and / or the user's bed partner, such as gusts of air and / or noise.

[0377] In some embodiments, the biased vent 2502 is positioned such that air is exhausted below the frame 2178 (see [link]). Figures 68 to 70 For example, the offset vent 2502 is positioned directly below and / or near the lower edge of the frame 2178. This configuration allows exhaust air to pass through the frame 2178 with minimal airflow disturbance. As described above, this configuration can help disperse exhaust air, reduce noise, and / or minimize disturbance to the user and / or the user's bed partner caused by exhaust air.

[0378] In some embodiments, housing 2102 includes a valve recess 2726. The valve recess 2726 may define a concave region. The concave region may be located below and / or near inlet 2732. In some embodiments, the width of the valve recess 2726 may be less than the maximum width of inlet 2732.

[0379] In some embodiments, the valve recess 2726 may receive at least a portion of the valve assembly 2522B, such as the rear portion of the valve 2522 and / or the valve outlet 2720. In some embodiments, the valve recess 2726 has a curved surface, the curved surface including a curvature that adapts to or matches the curvature of the rear surface / wall 2523 of the valve 2522. In at least some embodiments, the valve recess 2726 allows the valve 2522 to be positioned recessed into the mask assembly 2100 and / or below at least a portion of the mask seal 2104 (such as the upper front portion of the mask seal 2104 and / or the nasal region 2168). In at least some embodiments, the valve recess 2726 and / or the valve 2522 may desirably reduce the overall depth of the patient interface. This can help reduce the intrusiveness of the patient interface on the user and reduce hose pulling. In at least some embodiments, the valve recess 2726 and / or valve 2522 may allow the valve 2522 to be positioned higher relative to the bottom of the mask seal 2104 and / or the inlet 2732 to be shorter. This can help reduce the overall size of the mask assembly 2100.

[0380] As described above, housing 2102 may include frame connector 2730. For example... Figure 60 As shown, the frame connector 2730 can form a collar. The collar can protrude inward from the front surface of the housing 2102 toward or into the interior of the mask assembly 2100. The frame connector 2730 can extend all or part of the periphery of the inlet 2730. In some embodiments, the frame connector 2730 can receive and / or retain the cushion connector 2708 of the frame 2178.

[0381] In some embodiments, the frame connector 2730 may include a retaining feature for engaging the cushion connector 2708 of the frame 2178. For example, the frame connector 2730 may include at least one connector protrusion 2734 (e.g., a pair of connector protrusions 2734) or other retaining or alignment features. The connector protrusion 2734 may be positioned along a portion of the inner surface of the frame connector 2730. The connector protrusion 2734 may engage with a corresponding engagement feature 2715 of the cushion connector 2708. The engagement feature 2715 may include a notch, recess, or other engagement feature. The engagement feature 2715 may be positioned on the outer surface of the cushion connector 2708. In some embodiments, the connector protrusion 2734 may engage with the engagement feature 2715 of the cushion connector 2708 via a snap-fit ​​arrangement and other engagement arrangements. In some embodiments, the cushion connector 2708 includes a pair of laterally opposed recesses 2715 configured to receive and / or retain a corresponding pair of connector protrusions 2734 on the frame connector 2730. This configuration allows the frame 2178 to be secured to the mask seal 2104.

[0382] Such as at least Figure 61 As shown, in some embodiments, the frame connector 2730 may include a lip 2738 (see Figure 1). Figure 69 The lip 2738 may define the upper wall of the valve recess 2726. In some configurations, the lip 2738 may be positioned recessed relative to the front side of the housing 2102. In some embodiments, the lip 2738 may form at least a portion of the frame connector 2730 and / or the inlet 2732. When assembled, the lip 2738 may be positioned above the valve outlet 2720.

[0383] In some embodiments, the frame connector 2730 may include an alignment feature 2714. The alignment feature 2739 may project radially into an inlet and / or front portion of the rear edge of the frame connector 2730. The alignment feature 2714 may engage with an alignment notch 2710 of the cushioning connector 2708 of the frame 2178. This configuration may facilitate the alignment and / or securing of the frame 2178 to the face mask seal 2104.

[0384] In some embodiments, the mask seal 2104 is substantially resilient. In some embodiments, the mask seal 2104 may include a nasal region 2168 and a mouth sealing portion. The nasal region 2168 may include a nasal opening 2124 and a left nasal sealing surface 2124A and a right nasal sealing surface 2124B. The left nasal sealing surface 2124A and the right nasal sealing surface 2124B may extend outwardly from the nasal opening 2124. In some embodiments, the mouth sealing portion may include a mouth opening 2122 (see...). Figure 61 ).

[0385] Such as at least Figures 61 to 62 As shown, the mask seal 2104 may include an inlet 2732. The inlet 2732 may form an opening in the mask seal 2104 to allow air to flow into and out of the breathing chamber. In some embodiments, the inlet 2732 may include a non-circular periphery. In some embodiments, the periphery of the inlet 2732 is typically oval, elliptical, square, and / or rectangular, among other shapes. In some embodiments, the inlet 2732 includes a generally circular 'D' shape and / or a circular trapezoidal shape, among other shapes. An inlet 2732 with a non-circular periphery may desirablely facilitate easier assembly and / or alignment of the frame 2178 and the mask seal 2104. Such a configuration may help prevent the seal 2104 from being incorrectly assembled to the frame 2178. Such a configuration may help suppress or limit rotation of the frame 2178 relative to the seal 2104 during assembly. In some embodiments, the non-circular periphery of the inlet 2732 may allow at least a portion of the valve 2522 to be positioned closer to the center of the inlet 2732 than a design with a circular inlet 2732. This non-circular configuration can desirablely create additional space for valve 2522, thereby reducing the overall size (e.g., height) of mask assembly 2100 during assembly compared to a mask with a circular inlet.

[0386] As described above, the mask seal 2104 may include a nose region 2168. The nose region 2168 may include a left sealing surface 2124B and a right sealing surface 2124A. In some embodiments, each of the left sealing surface 2124B and the right sealing surface 2124A may define a convex region. As previously described herein, the left sealing surface 2124B and the right sealing surface 2124A cooperate to define a concave region configured to receive the user's nose. The convex regions of the left sealing surface 2124B and the right sealing surface 2124A may generally be flat. For example, a flat convex region may extend from the top of the left sealing surface 2124B and the right sealing surface 2124A toward the nose opening 2124. As the left sealing surface 2124B and the right sealing surface 2124A extend from their highest point toward the nose opening 2124, the flat convex region may have a generally linear profile. For example, when the nasal region 2168 engages with the user's nose during use, the flat sealing surfaces 2124B, 2124A can help prevent or limit the formation of creases in the sealing surfaces 2124B, 2124A. Some configurations can help minimize leakage around the user's nose during use.

[0387] Figure 65A close-up rear view of a portion of the nasal region 2168 is shown. Although the left nasal sealing surface 2124B is shown and described, the right nasal sealing surface 2124A may include similar features and is preferably a mirror image of the left nasal sealing surface 2124B. As shown, the nasal sealing surface 2124B may be relatively flat laterally near the nasal opening 2124. In some embodiments, the curvature of the nasal sealing surface 2124B may be relatively low (e.g., nearly linear) as the nasal sealing surface 2124B extends radially outward from the nasal opening 2124 towards its highest point. In some embodiments, the curvature of the nasal sealing surface 2124B may be relatively low as it extends radially outward from the nasal opening 2124 towards approximately its midpoint 2725, as indicated by curvature lines 2727A, 2727B, 2727C, 2727D, and 2727E. In some embodiments, the curvature of the nose sealing surface 2124B increases as the nose sealing surface 2124B extends radially outward beyond the midpoint 2725 (e.g., at the outer nose sealing surface region). As shown in graph 2728 and described in more detail below, the radius of curvature of the outer nose sealing surface region decreases along the surface of the outer nose sealing surface region in the rearward to forward direction. For example, in some embodiments, the radius of curvature of the outer nose sealing surface region at the rear portion of the nose sealing surface 2124B is greater than the radius of curvature of the outer nose sealing surface region at the front portion of the nose sealing surface 2124B. That is, the nose sealing surface 2124B can become more curved from less curved when moving in the rearward to forward direction.

[0388] Figure 66 A top view of the face mask seal 2104 is shown. Figures 67A to 67FThis is a cross-sectional view viewed from the rear of the mask seal 2104. As shown, in some embodiments, the left nasal sealing surface 2124B and the right nasal sealing surface 2124A may be angled away from each other in at least two dimensions. For example, when viewed from the front or rear, the left nasal sealing surface 2124B and the right nasal sealing surface 2124A may extend upward at an angle away from the nasal region 2168 to form a generally V-shape. In some embodiments, when viewed from the top, the left nasal sealing surface 2124B and the right nasal sealing surface 2124A may be angled away from each other in a direction from the front 2740 to the rear 2742 of the mask seal 2104 or sealing assembly 2100. In such configurations, the nasal region 2168, including the left nasal sealing surface 2124B and the right nasal sealing surface 2124A, may form a generally triangular shape. Such configurations can desirablely adapt to or generally match the geometry of the user's nose. This can provide the user with greater stability and / or comfort. This configuration can help reduce air leakage from the mask seal 2104.

[0389] Figure 67A Showed along Figure 66 The rear view section diagram taken from line AA. Figure 67B Showed along Figure 66 The rear view section diagram taken from line BB. Figure 67C Showed along Figure 66 The rear view section diagram taken from line CC. Figure 67D Showed along Figure 66 The rear view section diagram taken from line DD. Figure 67E Showed along Figure 66 The rear view section diagram taken from the EE line. Figure 67F Showed along Figure 66 The rear view section diagram taken by line FF. (See figure) Figures 67A to 67FAs shown, the left nasal sealing surface 2124B and the right nasal sealing surface 2124A of the nasal region 2168 may be spaced apart from each other in a bottom-to-top direction and angled outward and upward from a central vertical plane. In some embodiments, the angle between the left nasal sealing surface 2124B and the right nasal sealing surface 2124A increases in a rear-to-front direction. In some embodiments, the depth of the nasal region 2168 decreases in a rear-to-front direction. For example, angle 2744A may be approximately 57 degrees, angle 2744B may be approximately 60 degrees, angle 2744C may be approximately 64 degrees, angle 2744D may be approximately 71 degrees, angle 2744E may be approximately 77 degrees, angle 2744F may be approximately 88 degrees, and the angles between them are within this range. This configuration allows the nasal region 2168 to engage with the user's nose in use without extending onto the tip of the user's nose. This configuration can desirablely and better match the geometry of the user's nose. This can provide the user with greater stability and / or comfort. This configuration can help reduce air leakage from the mask seal 2104.

[0390] Figure 73 A side view of the patient interface is shown, illustrating an embodiment of the headgear 2180. Figure 74 An external plan view of the outer surface of the headgear 2180 is shown, and Figure 75 An internal view of the inner surface of headgear 2180 is shown, wherein headgear 2180 is in Figure 74 and Figure 75 Both are laid flat. As described above, the headgear 2180 may include at least two upper side straps 2804, at least two lower side straps 2802, a back panel 2806 and / or a top head strap 2808, and other components. For example, at least... Figure 74 and Figure 75 As shown, the upper strap 2804 can be connected to the top strap 2808 at an angle X. For example, the angle X between the upper strap 2804 and the top strap 2808 can be approximately 144 degrees. In some embodiments, the angle X is 130 degrees, 135 degrees, 140 degrees, 145 degrees, or 150 degrees or greater. The angle X allows the upper strap 2804 to extend downwards above the user's ears to the frame 2178 during use.

[0391] In use, the upper strap 2804 can be positioned on opposite sides of the headgear 2180 and can extend downward from the top strap 2808 toward the face mask assembly 2100. In some embodiments, the upper strap 2804 can be configured to extend across the user's cheeks when worn. In some embodiments, the upper strap 2804 can be adjustably and / or directly connected to the frame 2178, such as at the upper strap connector 2702 of the frame 2178.

[0392] In some embodiments, the lower side straps 2802 may be positioned on opposite sides of the headgear 2180. In use, the lower side straps 2802 may extend generally horizontally below the user's ears. The lower side straps 2802 may extend from the rear panel 2806 toward the face mask assembly 2100. In some embodiments, the lower side straps 2802 may be configured to extend across the user's face when worn, such as typically extending along the user's jawline. In some embodiments, the lower side straps 2802 may be adjustably connected to the frame 2178. The connection between the frame 2178 and the lower side straps 2802 may include a direct connection and / or an indirect connection. For example, the lower side straps 2802 may be indirectly connected to the frame 2178 via headgear clips 2600. Figures 73 to 75 As shown, the upper strap 2804 and the lower strap 2802 can be connected via the rear panel 2806. The connection between the upper strap 2804 and the lower strap 2802 at the rear panel 2806 allows for positioning behind the user's ears during use. This configuration provides stability and support for the headgear 2180. This configuration also provides greater comfort and / or a more aesthetically pleasing appearance for the user when worn.

[0393] In some embodiments, the back panel 2806 may be positioned approximately at the center of the headgear 2180. The back panel 2806 may be configured to contact the rear portion of the user's head when worn. In some embodiments, the back panel 2806 may include at least two or more portions. The back panel 2806 may include a first portion 2806A and a second portion 2806B. The first portion 2806A may be integrally formed with the upper side strap 2804 and the lower side strap 2802. In some embodiments, the second portion 2806B may be positioned approximately at the center of the back panel 2806. The second portion 2806B may be at least partially made of spacer fabric. Examples of such spacer fabric are disclosed in the applicant's publication number WO 2017021836, which is incorporated herein by reference in its entirety. Spacer fabric can provide additional comfort to the user. For example, spacer fabric may be desirablely lightweight, breathable, and / or form a cushioned area at the back of the user's head. In some embodiments, the spacer fabric of the second portion may extend inwardly from the first portion 2806A of the rear panel 2806. In some embodiments, the spacer fabric may comprise two layers of spacer fabric. For example, each layer may be stacked on top of the other layer.

[0394] In some embodiments, the headgear 2180 includes a top head strap 2808. The top head strap 2808 may include a right portion 2810 and a left portion 2812. In some embodiments, the left portion 2812 and the right portion 2810 may form a strap that extends across the upper region of the user's head, such as the top of the user's head.

[0395] In some embodiments, the left portion 2812 and the right portion 2810 may be adjustablely connected. In some embodiments, the left portion 2812 and the right portion 2810 may be adjustablely connected by a buckle. In some embodiments, the left portion 2812 includes an opening 2813. The opening 2813 may be positioned near the end of the left portion 2812 of the head strap 2808. In some embodiments, the opening 2813 may receive at least a portion of the right portion 2810 of the head strap 2808. In some embodiments, the opening 2813 allows the left portion 2812 and the right portion 2810 to be adjustablely connected. For example, the left portion 2812 and the right portion 2810 may be slidably adjustable relative to each other. In some embodiments, the right portion 2810 includes a first recessed region 2811A and a second recessed region 2811B. The first recessed region 2811A and the second recessed region 2811B may be formed along opposite sides of the right portion 2810. The first recessed region 2811A and the second recessed region 2811B may be aligned with each other and positioned offset from the end of the right portion 2810. In some embodiments, the first recessed region 2811A and the second recessed region 2811B define a region with a reduced width. The region with a reduced width may slide through the aperture 2813. In some embodiments, the region with a reduced width may slide through the aperture 2813, wherein the left portion 2812 and / or the right portion 2810 is undeformed or has very little deformation.

[0396] Although certain embodiments have been described, such as a left portion 2812 having an aperture 2813 and a right portion 2810 having a first recessed region 2811A and a second recessed region 2811B, other configurations are contemplated. For example, the right portion 2810 may include the aperture 2813, and the left portion 2812 may include the first recessed region 2811A and the second recessed region 2811B.

[0397] In some embodiments, the upper strap 2804, lower strap 2802, and / or head strap 2808 may include fastening features 2820. Fastening features 2820 may include one or more of hook-and-loop fasteners and other features. Fastening features 2820 may allow the headgear to be adjusted to various lengths, such as user-defined lengths. In some embodiments, the fastening features 2820 of the lower strap 2802 and / or upper strap 2804 may allow the straps 2802, 2804 to be easily adjusted and / or removed from the face mask assembly 2100.

[0398] Unless the context clearly requires otherwise, the words “comprise”, “comprising,” etc., used throughout this specification and claims should be interpreted in an open sense (as opposed to a closed or exhaustive sense), that is, meaning “including but not limited to.” Conditional language used herein, such as “can,” “could,” “might,” “may,” “e.g.,” etc., unless specifically stated otherwise or otherwise understood in the context as used, is generally intended to convey that certain embodiments include certain features, elements, and / or states that are not included in other embodiments. Therefore, such conditional language is not intended in general to imply that features, elements, and / or states are required by any means in one or more embodiments, or that one or more embodiments necessarily include logic for determining whether such features, elements, and / or states are included in any particular embodiment or will be implemented in that embodiment, with or without author input or prompting.

[0399] The term "a plurality of" refers to two or more items. The enumeration of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should be understood as if the terms "about" or "approximately" precede the quantities, dimensions, sizes, formulas, parameters, shapes, or other characteristics. The terms "about" or "approximately" mean that quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics need not be precise, but may be approximate and / or larger or smaller as needed, reflecting acceptable tolerances, conversion factors, rounding, measurement errors, and other factors known to those skilled in the art. The enumeration of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should also be understood as if the term "substantially" precedes the quantities, dimensions, sizes, formulas, parameters, shapes, or other characteristics. As used herein, the terms "approximately," "about," and "substantially" mean quantities that are close to the stated quantity and still perform the desired function or achieve the desired result. For example, in some embodiments, as the context may indicate, the terms "approximately," "about," and "substantially" may refer to quantities less than or equal to 10% of the stated quantity. As used herein, the term “generally” means that a value, quantity, or characteristic primarily includes or tends to include a particular value, quantity, or characteristic. For example, as the context may indicate, the term “generally linear” may mean approximately deviating from exact parallelism by less than or equal to 15°.

[0400] Numerical data may be expressed or presented in range format in this document. It should be understood that this range format is used merely for convenience and brevity, and therefore should be flexibly interpreted to include not only the numerical values ​​explicitly listed as the limits of the range, but also all individual numerical values ​​or subranges covered within the range, as if each numerical value and subrange were explicitly listed. For example, the numerical range “1 to 5” should be understood to include not only the explicitly listed values ​​of approximately 1 to approximately 5, but also the individual values ​​and subranges within the indicated range. Thus, this numerical range includes individual values ​​such as 2, 3, and 4, and subranges such as “1 to 3,” “2 to 4,” and “3 to 5.” The same principle applies to ranges that list only one numerical value (e.g., “greater than 1”), and should apply regardless of the breadth of the range or the characteristics described.

[0401] For convenience, multiple items may be presented in a common list. However, such lists should be interpreted as if each member of the list were independently identified as a separate and unique member. Therefore, unless otherwise indicated, individual members of such lists should not be considered solely based on their actual equivalent to any other member in the same group that is interpreted as being in the same list. Furthermore, when the terms “and” and “or” are used in conjunction with a list of items, they should be interpreted broadly, as any one or more of the listed items can be used individually or in combination with other listed items. Unless the context explicitly indicates otherwise, the term “alternatively” refers to selecting one of two or more alternatives and is not intended to limit the selection to only the listed alternatives or to only one of the listed alternatives at a time.

[0402] Any reference to prior art in this specification is not and should not be construed as an admission or in any way implying that such prior art is part of common general knowledge in the relevant field in any country of the world.

[0403] The invention can also be broadly defined as the components, elements, and features individually or collectively mentioned or indicated in the specification of this application, and any or all combinations of two or more of said components, elements, or features.

[0404] In the foregoing description, reference has been made to components in whole or in part having known equivalents thereof, which are incorporated herein as if described separately.

[0405] It should be noted that various variations and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its advantages. For example, various components may be repositioned as needed. Therefore, such variations and modifications are contemplated to be included within the scope of the invention. Furthermore, not all features, aspects, and advantages are essential for practicing the invention. Therefore, the scope of the invention is intended to be defined solely by the appended claims.

Claims

1. A nose-to-mouth mask seal for an interface assembly, comprising: The mouth sealing portion includes: Mouth opening; and The nasal region includes: - Nose opening. - Right nostril sealing surface, and -Left nasal sealing surface - The right nasal sealing surface and the left nasal sealing surface extend outward from the nasal opening, and in: When viewed from the front or rear of the nose-to-mouth mask seal, the left and right nose sealing surfaces form a V-shape, and the angle between the left and right nose sealing surfaces increases from the rear to the front. When viewed from the top of the nose-to-mouth mask seal, the left nose sealing surface and the right nose sealing surface are angled away from each other in the direction from the front to the rear of the nose-to-mouth mask seal.

2. The nose-mouth mask seal for an interface assembly according to claim 1, wherein the nose regions of the left and right nose sealing surfaces form a generally triangular shape, the generally triangular shape being configured to adapt to or substantially match the geometry of the user's nose.

3. The nose-mouth mask seal for an interface assembly according to claim 1 or 2, wherein the angle between the left nose sealing surface and the right nose sealing surface increases from about 57 degrees to about 88 degrees in the rear-to-front direction.

4. The nose-mouth mask seal for an interface assembly according to any one of claims 1 to 3, wherein the depth of the nose region decreases in the direction from rear to front.

5. A nose-to-mouth mask seal for an interface assembly according to any of the preceding claims, wherein the left nose sealing surface and the right nose sealing surface are laterally relatively flat near the nose opening.

6. A nose-to-mouth mask seal for an interface assembly according to any one of the preceding claims, wherein the left nose sealing surface and the right nose sealing surface are angled away from each other in a bottom-to-top direction and outward and upward from the central vertical plane of the nose-to-mouth mask seal.

7. A nose-mouth mask seal for an interface assembly according to any one of the preceding claims, wherein the curvature of the left nose sealing surface and the right nose sealing surface is substantially linear as the left nose sealing surface and the right nose sealing surface extend radially outward from the nose opening toward the highest point of the left nose sealing surface and the right nose sealing surface, respectively.

8. A nose-mouth mask seal for an interface assembly according to any of the preceding claims, wherein the curvature of the left nose sealing surface and the right nose sealing surface is relatively low when the left nose sealing surface and the right nose sealing surface extend radially outward from the nose opening to approximately the midpoint of the left nose sealing surface and the right nose sealing surface.

9. The nose-mouth mask seal for an interface assembly according to claim 7 or 8, wherein the curvature of the left nose sealing surface and the right nose sealing surface increases as the left nose sealing surface and the right nose sealing surface extend radially outward beyond approximately the midpoint of the left nose sealing surface and the right nose sealing surface.

10. A nose-to-mouth mask seal for an interface assembly according to any one of claims 7 to 9, wherein the curvature of the left nose sealing surface and the right nose sealing surface increases in a direction from the rear to the front of the nose-to-mouth mask seal.

Images