Nasal seal, mask and respiratory interface assembly

Abstract

A nasal seal, mask or interface assembly has a seal body defining a breathing lumen. A nasal port is provided in the seal body. The nose port has a central portion with a pair of lateral portions spanning across both sides. The nose port further has an upper edge and a lower edge. The upper edge defines an inwardly projecting portion within the central portion. The lower edge defines an inwardly projecting portion within the central portion. Thus, the nose port may be generally bean-shaped or bow-shaped. The mask may include a frame having a central portion supporting the seal and a pair of arm portions extending rearward of the seal and configured for attachment to a headgear. The central portion may be more rigid than the arm portions. The mask may be configured to reduce noise transmitted through the bias vent.

Description

[0001] This application is a divisional application of the invention patent application with the application date of September 9, 2016, application number 201680062677.5 (international application number PCT / IB2016 / 055369), and invention name “Nasal seal, mask and respiratory interface assembly”.

[0002] Priority application

[0003] This application claims priority to U.S. Provisional Patent Application Nos. 62 / 381,496, filed August 30, 2016, 62 / 310,549, filed March 18, 2016, 62 / 300,578, filed February 26, 2016, and 62 / 217,656, filed September 11, 2015, the entire contents of which are hereby incorporated by reference herein and made a part of this disclosure.

[0004] background

[0005] field

[0006] The present disclosure generally relates to a nasal seal for a respiratory interface and to an interface including the nasal seal, the interface including a mask or a mask and headgear.

[0007] Description of related technologies

[0008] A respiratory interface is used to provide one or more breathing gases to a user under positive pressure, such as air in continuous positive airway pressure (CPAP) therapy.A nasal interface delivers gases to the nose.

[0009] The seal of an indirect nasal interface contacts the upper lip, the face on either side of the nose, and the bridge of the nose, and substantially surrounds the nose. The indirect nasal interface can be relatively large on the face, can exert pressure on the bridge of the nose, and the frame of the interface can include a T-piece that connects to the headgear at the wearer's forehead, which also typically interferes with wearing glasses, for example.

[0010] Direct nasal interfaces are typically smaller on the face and do not include a T-piece, and are therefore less obstructive. However, direct nasal interfaces typically include nasal pillows or the like that enter the wearer's nostrils to ensure an effective seal.

[0011] CPAP is a treatment for sleep apnea (e.g., obstructive sleep apnea). Patients who are being treated for sleep apnea with CPAP wear a full-face or nasal mask during sleep. It is desirable that the respiratory interface be comfortable to wear while maintaining a good seal between the respiratory interface and the user.

[0012] Overview

[0013] The systems, methods and devices described herein have innovative aspects, no single one of which is indispensable or solely responsible for achieving their desirable attributes.Without limiting the scope of the claims, some advantageous features will now be summarized.

[0014] In some configurations, a nasal seal includes a seal body defining a breathing chamber. A nasal port is disposed within the seal body. The nasal port includes a central portion and a pair of lateral portions spanning opposite sides. The nasal port further includes an upper edge and a lower edge. The upper edge defines an inwardly projecting portion within the central portion. The lower edge defines an inwardly projecting portion within the central portion.

[0015] In some configurations, the inwardly projecting portions of one or both of the upper edge and the lower edge are curved.

[0016] In some configurations, the nasal port is generally bean-shaped or bow-tie-shaped.

[0017] In some configurations, the nasal seal further includes a thickened rim portion extending around a portion or all of a periphery of the nasal port, the thickened rim portion having a greater wall thickness than portions of the seal immediately adjacent the thickened rim portion.

[0018] In some configurations, the seal body includes a central portion, a pair of lateral portions spanning either side, wherein, in use, the seal body is configured such that when a user applies pressure to the central portion, the lateral portions move inwardly.

[0019] In some configurations, the user-facing surface of the nasal seal includes a thinned wall portion. In some configurations, the thinned wall portion of the user-facing surface has or is equal to the minimum wall thickness of the seal body.

[0020] In some configurations, the nasal seal further comprises a pair of thickened wall portions that contact the cheeks of the user in use. In some configurations, the thickened wall portions have or are equal to the maximum wall thickness of the seal body.

[0021] In some configurations, each of the thickened wall portions includes a groove within the thickened wall portion that allows for uncoupling movement of portions of the thickened wall portion on either side of the groove.

[0022] In some configurations, the nasal seal further includes a connector configured to allow the nasal seal to be coupled to a frame, wherein the connector includes a first portion located within the seal body and a second portion located outside the seal body, wherein the first portion and the second portion are coupled to each other.

[0023] In some configurations, the first portion includes a flange and a hub, wherein the hub extends through the aperture of the seal body, and wherein the second portion is coupled to the hub of the first portion.

[0024] In some configurations, the seal body includes a rim extending partially or completely around the aperture, wherein the rim is captured between the first portion and the second portion.

[0025] In some configurations, the rim includes a generally T-shaped cross-section having a base, a first blade extending from the base in a first direction, and a second blade extending from the base in a second direction opposite the first direction.

[0026] In some configurations, each of the first portion and the second portion of the connector includes a recess configured to receive a corresponding one of the first blade and the second blade.

[0027] In some configurations, the seal and the connector include interference portions that inhibit or prevent relative rotation between the seal and the connector.

[0028] In some configurations, the seal body has a first texture on a user contacting side and a second texture on an opposite side, wherein the second texture is different from the first texture.

[0029] In some configurations, a nasal mask includes a nasal seal as described in any of the preceding paragraphs, and a frame, wherein the frame includes a central portion and a pair of arm portions extending rearwardly from the central portion, wherein the arm portions are configured for connection to a headgear.

[0030] In some configurations, the central portion of the frame is shaped to correspond to a side of the seal body that faces the central portion.

[0031] In some configurations, the central portion is more rigid than the arm portions.

[0032] In some configurations, the pair of arm portions are overmolded onto the central portion.

[0033] In some configurations, each of the pair of arm portions includes a hinge portion that allows the rear ends of the arm portions to flex relative to the central portion of the frame.

[0034] In some configurations, the central portion includes a seal connector portion configured to removably receive the seal.

[0035] In some configurations, the central portion includes a catheter connector portion that supports the catheter connector.

[0036] In some configurations, the catheter connector includes an elbow.

[0037] In some configurations, the bias flow vent is located on the catheter connector portion.

[0038] In some configurations, the nasal mask further includes an expansion portion in a flow pathway defined between an upstream end of the conduit connector portion and the breathing cavity of the seal body, wherein the bias flow vent is located upstream of the expansion portion.

[0039] In some configurations, the mask tube is coupled to the conduit connector, the upstream end of the mask tube comprising a connector configured to be connected to a gas supply conduit of an associated respiratory therapy system, wherein an interior of the connector is the same size and shape as an interior of the mask tube.

[0040] In some configurations, the end of the connector abuts the upstream end of the mask tube, and the connector and the mask tube are coupled by a coupling sleeve. In some configurations, the coupling sleeve is overmolded onto the mask tube and the connector.

[0041] In some configurations, a pad is positioned on an inwardly facing surface of each of the pair of arm portions.

[0042] In some configurations, the pad and the arm portion are joined by an overmolding process.

[0043] In some configurations, the liner includes a textured surface treatment.

[0044] In some configurations, the pad includes a fabric outer layer.

[0045] In some configurations, an interface assembly includes the nasal mask as described in any of the preceding paragraphs, and a headgear comprising an upper strap, a rear strap, and forward strap extensions connected to the arm portions of the frame.

[0046] In some configurations, at least the upper strap and the forward strap extensions are inextensible. In some configurations, the rear strap is extensible.

[0047] In some configurations, the forward strap extensions and the arm portions are adjustably connected to each other.

[0048] In some configurations, the forward strap extensions and the arm portions have discrete adjustment positions.

[0049] In some configurations, one of the forward strap extension and the arm portion includes a plurality of posts, and the other of the forward strap extension and the arm portion includes a plurality of recesses each configured to receive one of the posts.

[0050] In some configurations, an interface assembly includes a nasal mask, a frame attached to the nasal mask, a headgear, and side arms connected to the frame and the headgear. The side arms are rigid in a vertical plane and movable in a horizontal plane relative to a user's face.

[0051] In some configurations, the side arms include hinges.

[0052] In some configurations, the side arms are formed from modular segments.

[0053] In some configurations, the side arms include accordion springs.

[0054] In some configurations, the side arms have kerfs on surfaces of the side arms.

[0055] In some configurations, the ends of the side arms have hook connectors that engage toothed posts disposed on the frame.

[0056] In some configurations, the side arms include leaf springs configured to bias the frame between the side arms.

[0057] In some configurations, a central portion is connected to the ends of the side arms, and a channel is disposed on the frame. The central portion is positioned within the channel such that the frame is movably supported by the central portion.

[0058] In some configurations, the side arms are extendable.

[0059] In some configurations, the nasal seal further comprises: a seal body defining a breathing cavity; and a nasal port positioned on the seal body. The nasal port comprises a central portion, a pair of lateral portions spanning either side, the nasal port further comprising an upper edge and a lower edge. The nasal seal further comprises a flange extending from the upper edge toward the breathing cavity, wherein the flange is configured to contact the user's nose when the user's nose is inserted into the nasal port.

[0060] In some configurations, the nasal seal further includes through-holes positioned in the flange.

[0061] In some configurations, a nasal seal includes a seal body defining a breathing cavity, a nasal port positioned on the seal body, the nasal port further including an upper edge and a lower edge, and a nasal obstruction member configured to contact a user's nose inserted into the nasal port.

[0062] In some configurations, the nasal obstruction member is disposed on the nasal port and includes a woven mesh attached to and spanning the nasal port.

[0063] In some configurations, the nasal obstruction member is disposed on the nasal port and includes a through-hole extending therethrough.

[0064] In some configurations, the nasal obstruction member is disposed on the nasal port and includes a tether attached to a bottom surface of the breathing chamber.

[0065] In some configurations, the nasal obstruction member extends from a bottom surface of the breathing cavity toward the nasal port.

[0066] In some configurations, the distance between the upper edge and the lower edge is narrowest at a midpoint along the width of the nasal port.

[0067] In some configurations, wherein the nasal port includes a thickened bead positioned along the upper edge of the nasal port.

[0068] In some configurations, a nasal seal includes a seal body defining a breathing cavity and a nasal port positioned on the seal body. The nasal port further includes outer lateral portions and a central portion positioned between the outer lateral portions. The central portion of the nasal port is narrower than the outer lateral portions of the nasal port. The central portion is configured to contact a user's nose when inserted into the nasal port.

[0069] In some configurations, the distance between the upper edge of the nasal port and the lower edge of the nasal port is narrowest at a lateral midpoint of the nasal port.

[0070] In some configurations, the outer lateral portions further include oval ports, and the central portion further includes a throat portion, wherein the throat portion connects the oval ports.

[0071] In some configurations, the oval ports are angled toward each other.

[0072] In some configurations, the throat portion is closer to the lowermost edge of the oval ports than to the uppermost edge of the oval ports.

[0073] In some configurations, the throat portion is closer to the uppermost edge of the oval ports than to the lowermost edge of the oval ports.

[0074] In some configurations, the nasal port is crescent-shaped.

[0075] In some configurations, the nasal port is kidney-shaped.

[0076] In some configurations, the outer lateral portions include oval ports separated by the central portion.

[0077] In some configurations, the upper portion of the nasal port and the lower portion of the nasal port overlap.

[0078] In some configurations, the upper portion has a recess and the lower portion has a protrusion, wherein the protrusion is positioned within the recess.

[0079] In some configurations, a nasal seal includes a seal body defining a breathing cavity, a nasal port positioned on the seal body, and a marking positioned on the seal body configured to indicate a position of a user's nose over the nasal port.

[0080] In some configurations, the indicia is printed onto the seal body.

[0081] In some configurations, the indicia is scented.

[0082] In some configurations, the indicia is formed from frosted silicone.

[0083] In some configurations, the marker is deformable.

[0084] In some configurations, an interface assembly includes: a nasal mask; a frame attached to the nasal mask; a headgear; an upper connecting member rotatably connected to an upper portion of the frame and the headgear; and a lower connecting member connecting a lower portion of the frame and the headgear. Relative movement between the upper and lower connecting members causes the frame to rotate.

[0085] In some configurations, the upper connecting member and the lower connecting member are connected to the headgear by pulleys.

[0086] In some configurations, a nasal seal includes a seal body defining a breathing chamber and a downwardly deflectable upper portion that rolls in a downward direction relative to a lower portion of the seal.

[0087] In some configurations, the nasal seal further includes an upwardly deflectable lower portion.The upwardly deflectable lower portion rolls in an upward direction relative to the lower portion of the seal.

[0088] In some configurations, a nasal seal includes a seal body defining a breathing cavity, a nasal port positioned on the seal body, and a deformable nasal interfacing portion formed around the nasal port. The deformable nasal interfacing portion deforms in an inward direction into the breathing cavity and expands in an outward direction from the breathing cavity.

[0089] In some configurations, a reinforced region surrounds the nasal port. The reinforced region has a thickness greater than that of the deformable nasal interfacing portion.

[0090] In some configurations, a nasal seal includes a front wall having a rim circumferentially surrounding a gas inlet opening. The front wall extends proximally from the rim and joins a rear wall, thereby forming a breathing cavity between the front and rear walls. A central portion of the rear wall extends to first and second lateral portions of the rear wall, thereby forming a recess. A nasal orifice in the recess communicates with the breathing cavity.

[0091] In some aspects, the front wall comprises a first region having a first thickness and a second region having a second thickness, the first thickness being at least three times greater than the second thickness. In some configurations, the front wall extends to the second wall without passing through an inflection point. In some aspects, the nasal seal further comprises a connector secured to the edge of the front wall. In some configurations, the connector comprises an arm extending proximally along the front wall.

[0092] In some configurations, at least a portion of the nasal orifice is disposed closer to the distal-most point of the front wall than to the proximal-most point of the front wall. In some configurations, the entire nasal orifice is closer to the distal-most point of the front wall than to the proximal-most point of the front wall.

[0093] In some aspects, the nasal seal includes a bottom wall extending from the gas inlet opening to the recess. The bottom wall has a front portion distal to the rear portion. The rear portion has a thickness greater than the thickness of the front portion. In some embodiments, the bottom wall further includes a central portion disposed between the front portion and the rear portion. The central portion has a thickness less than the thickness of the front portion.

[0094] In some embodiments, the rear wall includes a thickened portion surrounding the nasal opening. In some configurations, the maximum width of the thickened portion extending away from the nasal opening is less than three times the maximum thickness of the thickened portion. In some configurations, the maximum width of the thickened portion extending away from the nasal opening is greater than three times the maximum thickness of the thickened portion.

[0095] In some embodiments, the gas inlet opening includes a truncated area and a non-truncated area, and a distance between a center point of the opening and the truncated area is smaller than a distance between the center point of the opening and the non-truncated area.

[0096] Other aspects of the presently disclosed subject matter, which should be considered in all its novel aspects, will become apparent to those skilled in the art upon reading the following description, which provides at least one example of a practical application of the invention.

[0097] BRIEF DESCRIPTION OF THE DRAWINGS

[0098] Reference numerals may be repeated throughout the drawings to indicate general correspondence between reference elements.The drawings are provided to illustrate the exemplary embodiments described herein and are not intended to limit the scope of the present disclosure.

[0099] Figure 1 is a diagram of a respiratory system including a flow generator, a humidifier, and a user interface.

[0100] Figure 2 Is suitable for Figure 1 A perspective view of a user interface for use with a breathing system comprising a mask and a headgear.

[0101] Figure 3 yes Figure 2 Another perspective of the user interface.

[0102] Figure 4 yes Figure 2 A perspective view of a mask for a user interface of FIG. 1 , the mask including a frame and a seal.

[0103] Figure 5 yes Figure 4 A cross-sectional view of a mask taken along the central vertical plane of the mask.

[0104] Figure 6 is a perspective view of a portion of a frame of a face mask.

[0105] Figure 7 yes Figure 6 Top view of the part of the frame.

[0106] Figure 8 is a perspective view of the mask with the Figure 6 and7 The part shown.

[0107] Figure 9 yes Figure 8 The portion of the mask shown is a cross-sectional view taken along a horizontal plane.

[0108] Figure 10 A front perspective view of a portion of a frame of a mask.

[0109] Figure 11 yes Figure 10 A rear perspective view of this portion of the frame.

[0110] Figure 12 is another perspective view of the mask showing the internal structure of the seal in dotted lines.

[0111] Figure 13 is a perspective view of the seal separated from the frame.

[0112] Figure 14 Is the seal along Figure 13 A cross-sectional view taken along line 14-14 in FIG.

[0113] Figure 15 Is the seal along Figure 13 A cross-sectional view taken along line 15-15 in FIG.

[0114] Figure 16 It is the profile of the orifice of the seal.

[0115] Figure 17 is a perspective view of a seal illustrating features of a connector configured for connection to a frame.

[0116] Figure 18 is a perspective view of the seal with a portion of the connector removed.

[0117] Figure 19 is a rear perspective view of a portion of the connector.

[0118] Figure 20 is a front perspective view of another portion of a connector configured to be connected to Figure 19 on the connector portion.

[0119] Figure 21 is a perspective view of the seal with the connector removed.

[0120] Figure 22 is a view of the connector with the seal removed, showing the upper portion of the aperture of the seal.

[0121] Figure 23 This is a perspective view of the headgear separated from the mask.

[0122] Figure 24 is a cross-sectional view of a conventional CPAP hose-mask connection.

[0123] Figure 25 is a cross-sectional view of a CPAP hose to mask connection of the present disclosure.

[0124] Figure 26A and 26B Correspondingly, here are the velocity plots for the expansion within the flow path with the diverting air holes positioned before and after the expansion.

[0125] Figure 27A and 27B Correspondingly, vector diagrams of the expansion within the flow path with the flow diversion holes positioned before and after the expansion.

[0126] Figure 28A 、 28B 28 and 28C are cross-sectional views of three different designs of the portion of the interface including the flow-biasing pores.

[0127] Figure 29 yes Figure 28A 、 28B and 28C plots of noise levels over time for the three designs.

[0128] Figure 30 is a side view of an alternative connection between a mask frame and headgear in a connected configuration.

[0129] Figure 31 Is in disconnected configuration Figure 30 Side view of the connection.

[0130] Figure 32 is a side view of another alternative connection between a mask frame and headgear in a disconnected configuration.

[0131] Figure 33 is in connected configuration Figure 32 Side view of the connection.

[0132] Figure 34 yes Figure 32 and 33 A perspective view of the entire headgear.

[0133] Figure 35 is a diagram showing horizontal and vertical planes across the user's face.

[0134] Figure 36A is a side perspective view of an interface having a side arm arrangement with hinges encased in an accordion-style covering.

[0135] Figure 36B yes Figure 36A A close-up side perspective view of the hinge of the interface.

[0136] Figure 36C is shown in a flexed and unflexed position Figure 36A A top view of the accordion cover of the interface is shown.

[0137] Figure 36D yes Figure 36A A perspective view of the accordion cover of the interface.

[0138] Figure 37A is a perspective view of an interface with a side arm arrangement having modular sections.

[0139] Figure 37B yes Figure 37A A close-up side perspective view of the modular sections of the interface.

[0140] Figure 37C yes Figure 37A A top view of the interface showing the articulation of the sidearm.

[0141] Figure 38A is a perspective view of an interface having a spring-loaded side-arm arrangement.

[0142] Figure 38B yes Figure 38A A close-up top view of the spring portion of the interface.

[0143] Figure 38C yes Figure 38A Top view of the interface showing the side arms in their undeformed shape.

[0144] Figure 38D yes Figure 38A A top view of the interface showing the articulation of the sidearm.

[0145] Figure 39A is a close-up side perspective view of an alternative spring-loaded side-arm arrangement having a resilient section and a rigid section.

[0146] Figure 39B yes Figure 39A Top view of the elastic and rigid segments in the .

[0147] Figure 40A is a perspective view of an interface having a side arm arrangement with saw cuts.

[0148] Figure 40B yes Figure 40A A top view of the interface showing the side arms in an unbent and undeformed orientation.

[0149] Figure 40C yes Figure 40A Top view of the interface showing the maximum joint motion of the side arm.

[0150] Figure 40D yes Figure 40A A close-up top view of the side arm saw cuts on the interface.

[0151] Figure 40E yes Figure 40A A close-up top view of the interface showing the articulation of the saw-cut portion.

[0152] Figure 41A is a perspective view of an interface having a hook and post connector arrangement.

[0153] Figure 41B yes Figure 41A Close-up top view of the hook and post connector in the.

[0154] Figure 41C yes Figure 41A A close-up perspective view of the hook connector in the.

[0155] Figure 42A is a top view of an interface with an offset side arm arrangement.

[0156] Figure 42B yes Figure 42A A top view of the interface showing the orientation of the side arm when the interface is positioned on a user lying against a pillow.

[0157] Figure 42C yes Figure 42A A top view of the interface showing the orientation of the side arms when the interface is positioned on a user with a crooked nose.

[0158] Figure 42D yes Figure 42A A top view of the interface showing the range of sidearm positions.

[0159] Figure 43A is a perspective view of an interface with a sliding seal arrangement.

[0160] Figure 43B yes Figure 43A A top view of the interface showing the orientation of the seal positioned in an undisturbed position on the user's face.

[0161] Figure 43C yes Figure 43A A top view of the interface showing the orientation of the seal when the interface is positioned on a user lying against a pillow.

[0162] Figure 44A is a cross-sectional perspective view of a seal having a flange to indicate to the user that the seal is not being worn correctly.

[0163] Figure 44B is correctly positioned on the user Figure 44A Cross-sectional side view of the seal in FIG.

[0164] Figure 44C is incorrectly positioned on the user Figure 44A Cross-sectional side view of the seal in FIG.

[0165] Figure 44D is a cross-sectional perspective view of a seal having a flange with blow holes to indicate to the user that the seal is not being worn correctly.

[0166] Figure 44E is correctly positioned on the user Figure 44D Cross-sectional side view of the seal in FIG.

[0167] Figure 44F is incorrectly positioned on the user Figure 44D Cross-sectional side view of the seal in FIG.

[0168] Figure 44G is a cross-sectional side view of an alternative flange arrangement having rounded flanges.

[0169] Figure 44H is a cross-sectional side view of an alternative flange arrangement having rounded edges.

[0170] Figure 44I is a cross-sectional perspective view of a seal having a flange with a recess to indicate to the user that the seal is not being worn correctly.

[0171] Figure 45A is a cross-sectional perspective view of a seal arrangement having a woven mesh over an orifice to physically prevent or inhibit a user from improperly wearing the seal.

[0172] Figure 45B is a cross-sectional perspective view of an alternative seal arrangement having a woven mesh offset from the orifice to prevent direct skin contact with the woven mesh.

[0173] Figure 45C yes Figure 45B Cross-sectional side view of the seal.

[0174] Figure 45D is a cross-sectional perspective view of an alternative seal arrangement having an aperture cover to physically prevent or inhibit a user from improperly wearing the seal.

[0175] Figure 45E Orifice covers with various hole arrangements are shown.

[0176] Figure 46A is a cross-sectional perspective view of a seal arrangement having a tether to physically prevent or inhibit a user from improperly wearing the seal.

[0177] Figure 46B yes Figure 46A Cross-sectional side view of the seal arrangement in FIG.

[0178] Figure 46C yes Figure 46A A cross-sectional side view of a seal showing the seal in an undeformed shape.

[0179] Figure 46D yes Figure 46A A cross-sectional side view of a seal showing the seal properly donned on a user.

[0180] Figure 46E is a cross-sectional perspective view of a seal arrangement having a cushioning member to physically prevent or inhibit a user from improperly wearing the seal.

[0181] Figure 46F yes Figure 46E A cross-sectional side view of a seal showing the seal properly donned on a user.

[0182] Figure 46G yes Figure 46E A cross-sectional side view of a seal illustrating the seal being improperly donned on a user.

[0183] Figure 46H Alternative buffer member arrangements are shown.

[0184] Figure 47A Alternative configurations of the orifice of the seal are shown that prevent or inhibit insertion of a user's nose into the orifice.

[0185] Figure 47B Alternative configurations of the orifice of the seal are shown that prevent or inhibit insertion of a user's nose into the orifice.

[0186] Figure 47C Alternative configurations for the orifice of the seal are shown that prevent or inhibit insertion of a user's nose into the orifice.

[0187] Figure 47D Alternative configurations of the orifice of the seal are shown that prevent or inhibit insertion of a user's nose into the orifice.

[0188] Figure 47EAlternative configurations of the orifice of the seal are shown that prevent or inhibit insertion of a user's nose into the orifice.

[0189] Figure 47F Alternative configurations of the orifice of the seal are shown that prevent or inhibit insertion of a user's nose into the orifice.

[0190] Figure 47G yes Figure 47F Cross-sectional side view of the orifice arrangement in FIG.

[0191] Figure 48A is a rear view of a nasal seal arrangement with visual markings to indicate proper nasal position.

[0192] Figure 48B Alternative marking arrangements are depicted.

[0193] Figure 48C Alternative combination markings indicating correct nasal alignment and position are depicted.

[0194] Figure 48D Alternative landmarks indicating correct nasal alignment and position are depicted.

[0195] Figure 48E is a rear view of the alternative marking arrangement.

[0196] Figure 48F is a rear view of an alternative scented marker arrangement.

[0197] Figure 48G is a rear view of a nasal seal arrangement having frosted markings to visually indicate proper nasal alignment and position.

[0198] Figure 48H is a rear view of a nasal seal arrangement having frosted markings to visually indicate correct nostril position.

[0199] Figure 48I Alternative frosted marker arrangements are depicted.

[0200] Figure 49A is a rear view of a nose seal arrangement having a depressible vortex to indicate proper nose position.

[0201] Figure 49B yes Figure 49A A cross-sectional perspective view of a nasal seal arrangement.

[0202] Figure 49C yes Figure 49A Cross-sectional side view of the nose seal arrangement to depress the location of the trapped vortex.

[0203] Figure 50A is a perspective view of an interface arrangement with a rotatable nose seal.

[0204] Figure 50B yes Figure 50A A side view of the interface arrangement illustrating the range of rotation of the rotatable nose seal.

[0205] Figure 50C and 50D is a schematic side view illustrating the extended and retracted positions of the frame rails resulting in Figure 50A The interface arrangement allows the nose seal to be rotated about a projected line of the front plane.

[0206] Figure 50E It is suitable for users with a positive nose angle. Figure 50A Cross-sectional side view of a rotatable nose seal.

[0207] Figure 50F Is designed to fit users with negative nose angles Figure 50A Cross-sectional side view of a rotatable nose seal.

[0208] Figure 51A is a perspective view of an alternative interface arrangement having pulleys to allow rotation of the nasal seal.

[0209] Figure 51B yes Figure 51A Side view of an alternative interface arrangement illustrating rotation of the nasal seal.

[0210] Figure 51C and 51D yes Figure 51A Side views of alternative interface arrangements illustrating different rotational positions of the nasal seal.

[0211] Figure 51E is a side perspective view of a geared pulley used to maintain the rotational position of the nasal seal.

[0212] Figure 51F is a side perspective view of a geared pulley having a knurled outer surface.

[0213] Figure 51G is a side perspective view of a geared pulley with a rod.

[0214] Figure 52A is a perspective view of a rolled nose seal.

[0215] Figure 52B yes Figure 52A A cross-sectional side perspective view of the rolled nasal seal in FIG. 1 showing the undeformed orientation.

[0216] Figure 52C yes Figure 52A A cross-sectional side perspective view of a rolled nose seal in FIG. 1 showing the rolled orientation.

[0217] Figure 53A is a perspective view of a rolled nasal seal having upper and lower rolling sections.

[0218] Figure 53B is a schematic side view showing the angle of the user's nose and upper lip.

[0219] Figure 53C yes Figure 53A A side view of a rolled nasal seal showing an undeformed orientation.

[0220] Figure 53D yes Figure 53A Side view of a rolled nose seal showing the rolled orientation.

[0221] Figure 53E is a perspective view of an alternative rolled nose seal having a spring steel section.

[0222] Figure 54A is a perspective view of a nasal seal having a telescoping region.

[0223] Figure 54B yes Figure 54A A cross-sectional side perspective view of a nasal seal in FIG.

[0224] Figure 54C Is to show the fit to users with longer noses and users with shorter noses Figure 54A Schematic side view of a nasal seal in FIG.

[0225] Figure 54D Is shown to fit to a user with a longer nose with a horizontal plane Figure 54A Schematic side view of a nasal seal in FIG.

[0226] Figure 54E is shown to fit users with longer noses that are angled downwards Figure 54A Schematic side view of a nasal seal in FIG.

[0227] Figure 54F Is shown to fit users with shorter noses with upward angles Figure 54A Schematic side view of a nasal seal in FIG.

[0228] Figure 54G Is shown to fit users with shorter noses with downward angles Figure 54A Schematic side view of a nasal seal in FIG.

[0229] Figure 55Is suitable for Figure 1 A perspective view of a user interface for use with a respiratory system comprising a patient interface and a headgear.

[0230] Figure 56 is a perspective view of the seal and frame of the patient interface.

[0231] Figure 57 yes Figure 56 Rear perspective view of the frame.

[0232] Figure 58A is a perspective view of an embodiment of a nasal seal.

[0233] Figure 58B is a perspective view of an embodiment of a nasal seal.

[0234] Figure 58C is a perspective view of an embodiment of a nasal seal.

[0235] Figure 59A yes Figure 58A Front view of the nose seal.

[0236] Figure 59B yes Figure 58B Front view of the nose seal.

[0237] Figure 59C yes Figure 58C Front view of the nose seal.

[0238] Figure 60A yes Figure 58A Left side view of the nasal seal.

[0239] Figure 60B yes Figure 58B Left side view of the nasal seal.

[0240] Figure 60C yes Figure 58C Left side view of the nasal seal.

[0241] Figure 61A yes Figure 58A Rear view of the nose seal.

[0242] Figure 61B yes Figure 58B Rear view of the nose seal.

[0243] Figure 61C yes Figure 58C Rear view of the nose seal.

[0244] Figure 62A yes Figure 58A Top view of a nasal seal.

[0245] Figure 62B yes Figure 58B Top view of a nasal seal.

[0246] Figure 62C yes Figure 58C Top view of a nasal seal.

[0247] Figure 63A is in use Figure 58A Left side view of the nasal seal.

[0248] Figure 63B is in use Figure 58B Left side view of the nasal seal.

[0249] Figure 63C is in use Figure 58C Left side view of the nasal seal.

[0250] Figure 64 is a perspective view of an embodiment of a nasal seal.

[0251] Figure 65A yes Figure 58C A partial cross-sectional view of a nasal seal.

[0252] Figure 65B yes Figure 58C A partial cross-sectional view of a nasal seal.

[0253] Figure 66A yes Figure 58C Partial rear view of the nose seal.

[0254] Figure 66B yes Figure 58C A partial sagittal cross-sectional view of a nasal seal.

[0255] Figure 66C yes Figure 58C A longitudinal cross-sectional view of a nasal seal.

[0256] Figure 67A yes Figure 58A A partial longitudinal sectional view of the nasal seal.

[0257] Figure 67B yes Figure 58B A partial longitudinal sectional view of the nasal seal.

[0258] Figure 67C yes Figure 58C A partial longitudinal sectional view of the nasal seal.

[0259] Figure 68 is a rear view of an embodiment of a nasal seal.

[0260] Figure 69 yes Figure 58B Partial rear view of the nose seal.

[0261] Figure 70 yes Figure 58C Partial rear view of the nose seal.

[0262] Figure 71A yes Figure 58A Rear view of the nose seal.

[0263] Figure 71B yes Figure 58B Rear view of the nose seal.

[0264] Figure 71C yes Figure 58C Rear view of the nose seal.

[0265] Figure 72 is a perspective view of an embodiment of a connector.

[0266] Figure 73 yes Figure 72 A perspective view of the connector on the nose seal.

[0267] Figure 74 is a front perspective view of an embodiment of a connector attached to a nasal seal.

[0268] Figure 75 is a front perspective view of an embodiment of a connector attached to a nasal seal.

[0269] Figure 76A is a front view of an embodiment of a nasal seal.

[0270] Figure 76B yes Figure 76A Left side view of the nasal seal.

[0271] Figure 76C yes Figure 76A Rear view of the nose seal.

[0272] Figure 76D yes Figure 76A Top view of a nasal seal.

[0273] Figure 76E yes Figure 76A Bottom view of the nasal seal.

[0274] Figure 77 is a perspective view of an embodiment of a medium size nasal seal.

[0275] Figure 78 is a perspective view of an embodiment of a wide size nasal seal.

[0276] Figure 79A yes Figure 76A Left side view of the nasal seal.

[0277] Figure 79B yes Figure 76A Left side view of the nasal seal.

[0278] Figure 80 is positioned on the user's nose Figure 76A Side view of the nasal seal.

[0279] Figure 81 yes Figure 76A Front view of the nose seal.

[0280] Figure 82A is a front perspective view of an embodiment of a nasal seal.

[0281] Figure 82B yes Figure 82A A front perspective view of a nose seal illustrating the location of areas of varying wall thickness on the seal.

[0282] Figure 83 is a partial cross-section of an embodiment of a nasal seal.

[0283] Figure 84 is a longitudinal cross-section of an embodiment of a nasal seal.

[0284] Figure 85 is a front view of the inner surface of the rear wall of an embodiment of a nasal seal illustrating the thickened portion surrounding the nasal orifice.

[0285] Figure 86 is a bottom view of an embodiment of a nasal seal having a subnasal window.

[0286] Figure 87 is a cross-sectional top view of an embodiment of a nasal seal having a subnasal window.

[0287] Figure 88 is a bottom view of an embodiment of a nasal seal having a subnasal window extending across a bottom wall of the seal.

[0288] Figure 89 is a cross-sectional top view of an embodiment of a nasal seal having a subnasal window extending across a bottom wall of the seal.

[0289] Figure 90 is a rear perspective view of an embodiment of a nasal seal having an under-the-nose window extending across a bottom wall of the seal.

[0290] Figure 91 is a cross-sectional top view of an embodiment of a nasal seal having a separated subnasal window.

[0291] Figure 92A is a front perspective view of an embodiment of a front flange of a connector.

[0292] Figure 92B yes Figure 92A Rear perspective view of the front flange.

[0293] Figure 92C yes Figure 92A Front view of the front flange.

[0294] Figure 92D yes Figure 92A Left side view of the front flange.

[0295] Figure 92E yes Figure 92A Rear view of the front flange.

[0296] Figure 92F yes Figure 92A Top view of the front flange.

[0297] Figure 92G yes Figure 92A Bottom view of the front flange.

[0298] Figure 93A is a front perspective view of an embodiment of a rear flange of a connector.

[0299] Figure 93B yes Figure 93A Rear perspective view of the rear flange.

[0300] Figure 93C yes Figure 93A Front view of the rear flange.

[0301] Figure 93D yes Figure 93A Left side view of the rear flange.

[0302] Figure 93E yes Figure 93A Rear view of the rear flange.

[0303] Figure 93F yes Figure 93A Top view of the rear flange.

[0304] Figure 93G yes Figure 93A Bottom view of the rear flange.

[0305] Figure 94 is connected to Figure 93A On the rear flange Figure 92A Rear perspective view of the assembly of the front flange.

[0306] Figure 95is a longitudinal cross-sectional view of an embodiment of a connector attached to a nasal seal.

[0307] Figure 96 is a longitudinal cross-sectional view of a portion of an embodiment of a connector attached to a nasal seal.

[0308] Figure 97 is a longitudinal cross-sectional view of a portion of another embodiment of a connector attached to a nasal seal.

[0309] Figure 98 is a longitudinal cross-sectional view of a portion of yet another embodiment of a connector attached to a nasal seal.

[0310] Figure 99 is a longitudinal cross-sectional view of a portion of yet another embodiment of a connector attached to a nasal seal.

[0311] Detailed description

[0312] Embodiments of the systems, components, and methods of assembly and manufacture will now be described with reference to the accompanying drawings, wherein like numerals refer to like or similar 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 obvious modifications and equivalents thereof. The terms used in the descriptions presented herein are not intended to be interpreted simply in any restricted or limiting manner, as the terms are used in conjunction with the detailed descriptions of certain specific embodiments of the invention. In addition, 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.

[0313] Certain terms may be used in the following description for reference purposes only and are therefore not intended to be limiting. For example, terms such as "above" and "below" refer to directions referenced in the accompanying drawings. Terms such as "front," "rear," "left," "right," "rear," and "side" describe the orientation and / or position of parts of a component or element in a consistent but arbitrary reference system that is made clear by reference to the text and associated drawings describing the components or elements in question. In addition, terms such as "first," "second," and "third" may be used to describe individual components. Such terminology may include the words specifically mentioned above, their derivatives, and words of similar meaning.

[0314] Figure 1Schematic diagram of a positive pressure respiratory therapy system in the form of a continuous positive airway pressure (CPAP) system 10 for providing a heated and humidified air flow to a user U via an interface 110 worn by the user and connected to the CPAP system 10 via a conduit or tube 12. A humidification chamber 14 has a thermally conductive base that contacts a heating plate 16 of a humidifier 17 to humidify the air flow. A conduit 12 is connected to an outlet 13 of the humidification chamber 14 to deliver the humidified air to the user interface 110. The humidifier 17 includes, for example, but not limited to, a controller 18, such as a microprocessor-based controller, that executes computer software commands stored in an associated memory. The controller 18 receives input commands from a plurality of sources, including a user input interface 19, such as a dial or touch screen, that enables setting predetermined values ​​for humidity, temperature, or other characteristics of the humidified air supplied to the user U. The controller 18 may also receive input from one or more other sources, such as, for example, temperature and / or flow rate sensors 20 and 21, and / or a heater plate temperature sensor 23, connected via connector 22 for communication with the controller 18. In response to the selected humidity or temperature value, the controller 19 determines when and / or to what level the heater plate 16 should be energized to appropriately heat the water contained in the humidification chamber 14.

[0315] In one embodiment, the water of the present invention is heated to a certain volume in the chamber. When the water of a certain volume in the chamber is heated, water vapor begins to fill the chamber volume above the surface of the water. Water vapor leaves the outlet 13 of the humidification chamber together with the air flow that is provided from a supply source 25 (such as, blower 27) and enters the humidification chamber 30 through inlet 26. Blower 27 can be a variable speed fan, or a variable pressure regulator can be included. Blower 27 draws air through inlet 28. Blower can be controlled by, for example, controller 29 or controller 18. Controller 18 or 29 can control blower speed, regulated pressure etc. according to any applicable standard. For example, controller 29 can respond to the user setting value (for example, preset value) of input and pressure and / or fan speed from controller 18, and this setting value can be set by user interface 30 (for example, dial).

[0316] The conduit 12 may include a heater, such as, for example, a heating wire, to heat the walls of the conduit to reduce condensation of the humidified gas within the conduit.

[0317] The seals and interfaces of the present disclosure may be used as described in such CPAP systems (whether humidified or not), or alternatively in other forms of respiratory systems (e.g., VPAP (variable positive airway pressure) systems, BiPAP (bi-level positive airway pressure) systems), or in conjunction with a ventilator, and are generally described herein with reference to CPAP therapy by way of example only.

[0318] Figure 2 and 3 yes Figure 1 1 is a perspective view of an example of an interface assembly or interface 110 of the system 10. The interface 110 includes a mask 112, which, in some configurations, includes a seal 114 and a frame assembly or frame 116. The interface 110 also includes a headgear 118 for securing the mask 112 to a user. In a preferred embodiment, the interface 110 does not include a T-piece extending upward from the frame 116 (when worn) to connect to the headgear 118 at the user's forehead. However, if desired, aspects, features, or components of the disclosed interface 110 can be used in designs incorporating a T-piece.

[0319] In some configurations, the interface 110 also includes a short, flexible supply conduit or tube 120 extending from the mask 112 (e.g., from a central connection on the front of the mask 112), which connects to the supply conduit 12 of the CPAP system 10 or other respiratory system. The conduit 120 connects to the mask 112 directly or via a suitable connector, such as a hollow elbow 122. In some configurations, the elbow 122 can rotate relative to the mask 112 about one or more axes of rotation so that the path of the conduit 120 relative to the positioning of the mask 112 on the user's face can be adapted to the user's sleeping position. However, in other arrangements, the elbow 122 can be integral or monolithic with the mask 112. The end of the conduit 120 opposite the elbow 122 can include a connector 124 suitable for connecting the conduit 120 to the supply conduit 12. In some configurations, the connector 124 can be or include a swivel connector that allows relative rotation between the conduit 120 and the supply conduit 12.

[0320] The interface 110 preferably includes a restricted flow outlet or bias flow vent 126 for providing a gas flush from the interface 110. In some configurations, the bias flow vent 126 is in the form of a number of small orifices. The bias flow vent 126 can be provided in the frame 116 (as shown), in the elbow 122, or elsewhere on the interface 110.

[0321] As described above, the mask 112 can include a seal 114 and a frame 116. In some configurations, the frame 116 (and the elbow 122, if desired) can be more rigid than at least a portion of the seal 114 (such as the portion defining the user contact surface). In some configurations, the seal 114 is removably coupled to the frame 116 around a passageway extending from the interior of the elbow 122 through the frame 116. Thus, the seal 114 and the frame 116 together form an enclosure having a gas flow inlet from the CPAP system 10 and an orifice 128 through the seal 114 to the user.

[0322] In some configurations, the frame 116 includes side arms 130 that extend outward (away from each other), backward, and upward at a shallow angle, past the left and right ends of the seal 114, and along the left and right cheeks, and specifically the user's cheekbones, to connect to the headgear 118 to secure the seal 114 to the user's face. Such side arms 130 can be longer than their depth or thickness and can be resiliently flexible to the frame and / or resiliently flexible along their length (widthwise rather than heightwise). In some configurations, the side arms 130 extend toward or to a position between the user's ears and eyes and / or to or near the user's temples, where they connect to the headgear 118. In some configurations, the length of the side arms 130 is between about 100 mm and about 150 mm. The shape of the side arms 130 and / or the angles therebetween are such that the side arms 130 rest on the left and right cheeks, and specifically the cheekbones of the user, to help stabilize the interface 110 against rotation about a horizontal axis when worn.

[0323] The side arms can be resiliently flexible toward and away from the user's face in an approximately horizontal plane (when worn) to accommodate different face sizes, but can be relatively inflexible in an approximately vertical plane. The illustrated side arms 130 are solid, but other versions of the side arms may include one or more apertures or cutouts extending along the length of the side arms to increase the resilient flexibility of the side arms toward and away from the user's face, but retain relative inflexibility in an approximately horizontal plane (when worn).

[0324] In some configurations, the side arm 130 can include a softer material on at least a portion or all of the user-facing surface of the side arm 130, or completely around the side arm 130, to soften the contact of the side arm 130 with the user's face. If desired, the inner surface of the side arm 130 can include a cushion 132 that faces and / or contacts the user's face, such as Figure 3 As shown. The pad 132 can be removable for cleaning or replacement. The pad 132 and side arm 130 can be connected through an overmolding or welding process. The pad 132 can have a textured and / or fabric outer surface. The textured surface can increase friction to keep the side arm 130 in place on the user's face, and the fabric material can improve comfort.

[0325] At the outer or free ends of the side arms 130, the side arms include connector portions 134 for removably connecting the side arms 130 to the headgear 118. In some configurations, each of the connector portions 134 includes a recess or receiver 136 configured to receive a complementary connector 138 of the headgear 118. The connector 138 of the headgear 118 can be retained within the receiver 136 of the side arm 130 by any suitable mechanism, such as a snap-fit ​​arrangement. In some configurations, the connector 180 has an orientation feature. In some configurations, the receiver 136 has an orientation feature. The orientation feature can allow the left side of the headgear 118 to connect only to the left side arm 130 and the right side of the headgear 118 to connect only to the right side arm 130. In some configurations, the orientation feature can allow the left side of the headgear 118 to connect to the right sidearm 130 and the right side of the headgear 118 to connect to the left sidearm 130 only in a manner that turns the headgear 118 inside out. In the illustrated arrangement, each connector portion 134 includes at least one protrusion or latch member 140, such as a pair of latch members 140, each positioned on opposite sides of the receiving portion 136. The latch members 140 can retain the connector 138 within the receiving portion 136 in at least one direction, such as an outward movement away from the connector portion 134 and a rotational direction. When the connector 138 is inserted from the end, for example, the latch members 140 can guide the connector 140 into the connected position. In some configurations, the connector portion 134 includes one or more additional retaining elements, such as protrusions or bosses 142. In the illustrated arrangement, the boss 142 extends outwardly from the outer surface of the receiver 136 and engages a complementary opening in the connector 138 of the headgear 118 to retain the connector 138 within the receiver 136 in response to forces tending to move the connector 138 rearward or in the longitudinal direction of the side arm 130. In some configurations, the boss 142 has a chamfer on one side (not shown in the figures) to help clip the connector 138 into place.

[0326] In some configurations, the side arms 130 can be integrally formed with another portion or the remainder of the frame 116 by, for example, injection molding of a plastic material. However, in the illustrated arrangement, the frame 116 includes a central or base portion (referred to herein as the "base") 144 that supports the seal 114 and a connector portion or connector 146 that includes the side arms 130. The base 144 and connector 146 can be permanently or removably coupled to each other. In some configurations, each of the side arms 130 can include its own connector 146 that can be detachably attached to the base 144.

[0327] The illustrated connector 146 is a generally U-shaped member (from a top view) that includes side arms 130 and a central portion 148 that connects the two side arms 130 to each other. In the illustrated arrangement, the central portion 148 passes under the elbow 122 and extends upward to a corresponding one of the side arms 130 on each side. The central portion 148 can also be configured to connect to the base 144 via, for example, a snap-fit ​​connection. In the illustrated arrangement, the central portion 148 includes a pair of spaced-apart protrusions 150 that engage corresponding ones of a pair of complementary slots 152 of the base 144. In other configurations, this arrangement can be reversed, or other suitable connection arrangements can be utilized. The central portion 148 can be removable from the base 144. That is, the protrusions 150 can be removable from the slots 152. In other configurations, the central portion 148 and / or the side arms 130 may be integrated with the base 144 through a process such as, for example, a two-shot or overmolding process.

[0328] Central portion 148 includes an inner surface 154 that faces or rests against base 144. In some configurations, central portion 148 includes a shelf or shoulder 156 against which base 144, or another portion of frame assembly 116, or seal 114, rests. In the illustrated arrangement, the lower edge of base 144 rests on shoulder 156, such that the portion of connector 146 below shoulder 156 is positioned below base 144. The illustrated shoulder 156 is curved in shape, with the outer end lower than the central portion relative to the orientation of mask 112 in use. In other arrangements, shoulder 156 may have other shapes, such as being curved in opposite directions (i.e., concave) or flat. Furthermore, the forward-facing surface of base 144 defines a recess 157 that accommodates central portion 148 of connector 146. Recess 157 may extend partially or entirely between slots 152 in base 144.

[0329] The laterally outward or rearward portions of the central portion 148 of the connector 138 are connected to the side arms 130. In the illustrated arrangement, the side arms 130 are integrally formed with the central portion 148. However, in other arrangements, the side arms 130 may be formed separately from the central portion 148 from the same or different material and coupled to the central portion via a process such as, for example, mechanical fasteners, adhesives, welding, or by a two-shot molding process (e.g., overmolding).

[0330] In some configurations, the laterally outward or rearward portions of the central portion 148 can be configured to support the side arm 130 in a spaced relationship from the base 144 and / or the seal 114. In the illustrated arrangement, the laterally outward or rearward portions of the central portion 148 have a greater wall thickness perpendicular to the inner surface 154 than the center of the central portion 148. The wall thickness gradually increases in the fore-aft direction of the laterally outward or rearward portions of the central portion 148. As a result, the front ends of the side arms 130 are spaced outward from the inner surface 154, the base 144, and / or the seal 114 by a distance 158. Distance 158 can be, for example, between 3-15 mm, 5-10 mm, or approximately 5 mm. The attachment points of the central portion 148 to the base 144, defined by, for example, protrusions 150, can define hinges or articulation points of the frame assembly, which enhances the flexibility of the side arms 130 relative to the central portion 148 and / or the base 144. The reduced thickness of the front ends of the side arms 130 relative to the greater wall thickness of the rear portions of the central portion 148 may facilitate flexibility of the side arms 130 relative to the central portion 148 and / or the base 144 .

[0331] In some configurations, the protrusions 150 are located at or near the ends of the laterally outward or rearward portions of the central portion 148. With this arrangement, the central portion 148 of the connector 146 is coupled to the base 144, while the side arms 130 are not directly coupled to the base 144 and are free to move or flex relative to the base 144. In some configurations, the connector 146 is overmolded onto the base 144, or the connector 146 and base are otherwise joined by an overmolding process. In other arrangements, the connector 146 can be coupled to the base 144 in other ways, preferably at the central portion 148, such that the side arms 130 are free to flex or move relative to the base 144. In some configurations, the base 144 is constructed of a material that is more rigid than the material of the connector 146, or at least more rigid than the side arms 130 of the connector 146. Additionally or alternatively, the side arms 130 can be configured to be less rigid than the base 144 in other ways, such as by reduced material thickness, hinges, cutouts, or other suitable arrangements. In some configurations, the central portion 148 terminates forward of the rearward edge of one or both of the base 144 and the seal 114 on each side of the mask 112. Thus, the portion of the side arms 130 forward of the rearward edge of one or both of the base 144 and the seal 114 can move or flex relative to the base 144 and / or the seal 114.

[0332] In some configurations, the termination point of the central portion 148 is spaced a distance 160 from the rearward edge of the base 144 and a distance 162 from the rearward edge of the seal 114 on each side of the mask 112, as measured along a central axis 164 of the mask 112 extending in the anterior-posterior direction and bisecting the mask 112. The distance 160 can be between one-quarter and one-half of the total length 166 of the mask 112, as measured along the central axis 164. In some configurations, the distance 160 is between one-third and three-eighths of the total length 166 of the mask 112. The distance 162 can be between one-third and five-eighths of the total length 166, or between two-fifths and nine-sixteenths of the total length 166. In some configurations, the length 168 of the side arm 130 can be at least as long, at least 1.5 times longer, or at least twice as long as the overall length 166 of the mask 112, as measured along the central axis 164, depending on where the front end of the side arm 130 is located relative to the mask 112. This arrangement provides a desired level of support to the base 144 and seal 114 while allowing a desired level of movement of the side arm 130 to accommodate a variety of facial geometries.

[0333] In an alternative arrangement, instead of having side arms 130 as shown (or having shorter side arms), the ends of the headgear 118 can be attached to both sides (left and right) of the mask frame 116 (or shorter side arms) via stiffer strap ends that terminate at the mask 112 by an attachment mechanism that allows movement in an approximately horizontal plane but not in an approximately vertical plane, such as a hook that engages in a vertical upstanding slot (e.g., slot 152) on the mask frame 116 (e.g., base 144).

[0334] As described above, in some configurations, seal 114 is removably coupled to frame 116. Seal 114 can be configured to surround a passageway through frame 116 from the interior of elbow 122. Thus, seal 114 and / or frame 116 can form a chamber having an inlet for gas flow from CPAP system 10 and an orifice 128 through seal 114 to the user. In the illustrated arrangement, base 144 of frame 116 defines a generally U-shape when viewed from above. A central portion of base 144 defines an orifice 170 through which gas can flow. A first annular wall surrounds orifice 170 and projects in a rearward direction to define a support or connector 172 for seal 114. A second annular wall surrounds the orifice and projects in a forward direction to define a support or connector 174 for elbow 122.

[0335] The seal 114 defines an orifice 175 that is configured to receive the connector 172 of the base 144. The seal 114 and the base 144 can be removably coupled by any suitable arrangement such as a friction fit or a snap fit. In the illustrated arrangement, the connector 172 includes one or more recesses 176 that are configured to receive corresponding protrusions 178 of the seal 114 so as to form a snap fit engagement between the seal 114 and the base 144. However, this arrangement can also be reversed. In addition, the entire arrangement between the seal 114 and the base 144 can be reversed so that the seal 114 can include a male connector portion and the base 144 can include a corresponding female connector portion.

[0336] Preferably, the seal 114 and base 144 include an alignment or key arrangement such that the seal 114 and base 144 can only be assembled in the correct orientation relative to each other. Any suitable arrangement may be used. In the illustrated arrangement, the seal connector 172 includes a recess 180 configured to receive a key or protrusion 182 ( Figure 17 ). The recess 180 and protrusion 182 are shown located on the upper central portion of the aperture 170; however, other locations along the periphery of the aperture 170 may also be used. This arrangement can also be reversed. In addition, other suitable arrangements may also be used, such as, for example, non-circular shapes of the connector 172 and aperture 176.

[0337] The elbow 122 can be connected to the elbow connector 174 in any suitable manner. In the illustrated arrangement, the elbow 122 is removably connected to the elbow connector 174 so that the elbow 122 can be removed, such as for cleaning. In the illustrated arrangement, the elbow 122 and the elbow connector 174 are coupled by a snap-fit ​​connection; however, other suitable connections (e.g., friction fit) may also be used. In some configurations, the elbow connector 174 includes a recess 184 that is configured to receive a protrusion 186 of the elbow 122. In the illustrated arrangement, the recess 184 is an annular recess that extends around the entire circumference of the elbow connector 174 so that the elbow 122 is rotatable on the elbow connector 174 relative to the frame 116. The protrusion 186 of the elbow 122 can be annular or intermittent around the circumference of the elbow 122. This arrangement can also be reversed. In an alternative arrangement, the connection of the elbow 122 to the frame 116 can provide for both rotation and pivoting of the elbow 122 relative to the frame 116. For example, the connection can include a ball joint connection to the frame 116 such that the elbow 122 can pivot about multiple axes parallel to and perpendicular to its connection to the frame 116. The elbow 122 can include a ball end that snaps into a socket opening in the frame 116. The elbow 122 preferably defines an angle between the flow in the conduit 120 and the flow through the orifice 170 of between 0° and 90°, or between 30° and 60°. Alternatively, as described above, the elbow 122 can be integrally or unitarily formed with the frame 116. In other configurations, the elbow 122 can be omitted entirely, and the tube 120 or other breathing circuit can be connected directly to the frame 116.

[0338] In the illustrated arrangement, the bias flow aperture 126 is defined by the frame 116. Specifically, the bias flow aperture 126 is defined by the elbow connector 174 of the base 144 of the frame 116. The illustrated elbow connector 174 includes an enlarged diameter portion proximate the U-shaped body of the base 144 that defines a surface or shoulder 188 that faces or contacts the end surface of the elbow 122. The bias flow aperture 126 includes a plurality of openings or vents 190 that extend in a generally radial direction through the enlarged diameter portion of the elbow connector 174. Thus, when the elbow 122 is connected to the base 144, the elbow 122 does not cover the vents 190, and the vents 190 are located between the elbow 122 and the U-shaped body of the base 144. In the illustrated arrangement, the longitudinal axes of the individual vents 190 are inclined or angled in a forward direction as one moves along the axis from the interior of the elbow connector 174 toward the exterior of the elbow connector 174. This arrangement can direct the exhaust gas flow away from the user's face. Alternatively, the bias flow vents 126 can be located on the elbow 122, the frame 116, or at another suitable location.

[0339] Figure 12-15 Features are shown that allow the mask 112 to transfer forces from the seal 114 to the frame 116. The illustrated mask 112 includes a seal support, which can be, for example, a base, a housing, a shell, or a connector 202. The seal 114 is attached to the connector 202 such that the connector 202 provides a certain amount of support for the seal 114. The connector 202 allows the mask 112 to be connected to the frame 116. The illustrated connector 202 is generally annular in shape and, in at least some configurations, does not cover a substantial portion of the forward-facing surface of the seal 114.

[0340] Connector 202 can be by relatively rigid, semi-rigid or rigid material, such as polycarbonate construction.Therefore, in at least some configurations, connector 202 has more rigidity than seal 114.The material forming the thin-walled soft central portion of at least seal 114 can be a soft stretchable material, such as silicone material or TPE (thermoplastic elastomer).In some configurations, seal 114 is a one-piece component, and all described parts and parts of this one-piece component are formed as a whole by, for example, injection molding. However, in an alternative arrangement, only the wearer side of seal 114 can be formed by this material, and can be bonded on a more rigid shell (rather than connector 202), which is coupled to the frame 116 of the interface or is formed as a whole with it.Alternatively or additionally, seal 114 can be a seal filled with foam or gel.

[0341] The illustrated mask 112 has a hollow interior filled with air at positive pressure and is configured to seal beneath the user's nose, along a portion of the face extending transversely to the nose, and along the user's upper lip. Advantageously, the mask 112 does not require contact with the user's nose bridge. In the illustrated configuration, the mask 112 does not extend over the user's nose bridge. More specifically, the illustrated mask 112 does not contact the user's nose bridge.

[0342] The mask 112 may or may not extend over the tip of the user's nose. Thus, in some configurations, the mask 112 covers the tip of the nose. In some configurations, the seal 114 of the mask 112 covers the tip of the nose. In some configurations, the illustrated mask 112 preferably does not obscure the tip of the user's nose. In some configurations or with some facial geometries, the tip of the user's nose extends over an adjacent portion of the mask 112. In some configurations, the frame 116 and other portions of the mask 112 can accommodate deflection of the seal 114 caused by portions of the user's nose (e.g., the tip), such that the interface can accommodate a variety of nose lengths.

[0343] As shown, the mask 112 is preferably adapted to extend around or seal on the ala of the nose, or the wing of the nose, which flares out to form a circular ridge around the nostrils. The illustrated mask 112 is adapted to seal around the surface defining the opening to the nostrils, which can include part or all of the fleshy outer end of the nasal septum (sometimes called the columella). In some configurations, the mask 112 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 112 is adapted to extend upward along at least a portion of the left and right dorsal sidewalls, but not to the area of ​​the user's nose bridge. In some configurations, the primary sealing surface of the mask 112 contacts the underside of the user's nose, the upper lip, and / or the transition area between the underside and upper lip of the nose. The secondary sealing surface of the mask may contact the side surfaces of the user's nose, possibly along with the cheeks at a location near the nose. Such primary and secondary sealing surfaces may not contact the faces of all users; however, such an arrangement may provide a suitable seal with a relatively wide range of facial geometries.

[0344] As described above, the seal 114 includes at least one nasal opening or orifice 128. In some configurations, the seal 114 may include more than one nasal orifice 128. In some configurations, the seal 114 may include the nasal orifices 128 defined within an upper structure, such as nasal pillows, fork tubes, or the like. In some configurations, the nasal orifice 128 may be defined by a nasal cushion or insert that may be overmolded or otherwise secured to the base structure of the seal 114. Examples of suitable arrangements for the seal 114 are disclosed in Applicant's publication No. WO 2014 / 077708, the entire contents of which are incorporated herein by reference.

[0345] The seal 114 includes an inward-facing or rearward-facing central portion 204 that faces or contacts the user during use of the mask 112. The seal 114 also includes a pair of opposing inner lateral portions 206 and a pair of opposing outer lateral portions 208. The inner lateral portions 206 are configured to contact the sides of the nose and / or portions of the user's face on either side of the nose. The inner lateral portions 206 may include both an inward-facing surface and a rearward-facing surface. In other words, each of the inner lateral portions 206 may roll from the inward-facing surface of the seal 114 toward or toward the rearward-facing surface of the seal 114. The outer lateral portions 208 may include both a rearward-facing surface and an outward-facing surface. The rearward-facing surface of the outer lateral portions 208 may contact the user's face during use of the mask 112. The seal 114 may also include a nose opening support or thickened rim 210 that partially or completely surrounds and provides support to the nasal orifice 128. Preferably, the outer lateral portions 208 are not connected to the frame 116, such that the outer lateral portions 208 and / or the inner lateral portions 206 can move inwardly in response to pressure applied by a user on the central portion 204 of the seal 114. This arrangement allows the lateral portions of the seal 114 to move inwardly to facilitate sealing with the user's face.

[0346] The seal 114 may include regions of varying thickness to provide different properties or characteristics to the seal 114 in different regions. For example, the central portion 204 may have a relatively low thickness to allow the central portion 204 to conform to the user's specific facial geometry. In some configurations, the relatively low thickness may allow the central portion 204 to stretch. In some configurations, the central portion 204 may have a thickness between 0.3 mm and 0.5 mm or 0.6 mm. In some configurations, the central portion 204 has a thickness of 0.3 mm. If desired, the central portion 204 may have a thickness as low as 0.15 mm. However, it has been determined that lower thicknesses may lead to, or increase the likelihood of, wrinkling with certain facial geometries and / or at certain operating gas pressures. Maintaining a thickness at or above 0.3 mm throughout most or all of the central portion 204 may reduce the incidence of wrinkling within a significant range of operating pressures (which may include the entire normal operating pressure range).

[0347] The inner lateral portions 206 may have a thickness greater than that of the central portion 204. In some configurations, the thickness of the inner lateral portions 206 may be between 0.4 mm and 0.6 mm. In some configurations, the thickness of the inner lateral portions 206 is 0.5 mm. The nasal opening support 210 may have a thickness greater than that of one or both of the central portion 204 and the inner lateral portions 206. The relatively greater thickness may protect the seal 114 from tearing at the nasal orifice 128 and may help the nasal orifice 128 maintain an open shape. In some configurations, the thickness of the nasal opening support 210 is between 1 mm and 2.5 mm. In some configurations, the thickness of the nasal opening support 210 is 1.2 mm. The thickness may be constant or variable within any of the central portion 204, the inner lateral portions 206, or the nasal opening support 210.

[0348] The lateral portions 212 of the mask 112 (including part or all of the inner lateral portion 206 and the outer lateral portion 208) may be referred to herein as paddles. The paddles 212 may refer to any portion of the interface seal that is positioned beside the user's nose during use of the interface. The paddles 212 are disclosed herein in the context of an under-the-nose interface, but may be used with other types of interfaces, including those that contact, cover, or seal against the bridge of the user's nose, unless otherwise indicated.

[0349] The outer lateral portions 208 can include features that help maintain the shape of the seal 114. In some configurations, the outer lateral portions 208 include regions of increased thickness, stiffness, or hardness that help maintain the shape of the seal 114, which are referred to herein as support structures 214. The support structures 214 of the mask 112 can inhibit or prevent over-expansion or undesirable expansion of the lateral end portions of the seal 114, which could result in leaks and / or cause undesirable pressure to be applied to the user's nose by the central portion 204 of the seal 114. The support structures 214 can also inhibit or prevent at least a portion of the mask seal 112 from collapsing when engaged with the user's nose during use. For example, the support structures 214 can inhibit or prevent the nasal region or central portion 204 of the mask seal 112 from collapsing.

[0350] The support structure 214 can also transfer forces from one portion of the seal 114 to another portion of the seal 114. For example, the support structure 214 can transfer forces applied to the rear portion of the seal 114 to the front portion of the seal 114. In some configurations, the support structure 214 can transfer forces applied by the user's face to the rearward-facing surface of the seal 114 to another portion of the seal 114 that can resist some or all of the transferred forces. In some configurations, the support structure 214 transfers forces from the rearward-facing surface or user-contacting surface of the seal 114 to the frame 116 or other structures supporting the seal 114 (e.g., connector 202). Thus, in some configurations, the support structure 214 extends between the rearward-facing surface of the seal 114 and a surface of the seal 114 that contacts or overlaps with the frame 116 or other support structures for the seal 114. Preferably, these support structures extend from the rearward-facing surface to a surface that overlaps with the frame 116 or other support structures. However, as noted above, the support structure 214 may provide structure to the seal 114 and may be used to provide such support without transmitting forces.

[0351] In some configurations, the frame 116 includes a central portion and lateral portions on each side of the central portion. The lateral portions can function to provide support to the support structure 214 of the seal 114 and can be referred to herein as wing covers 216. The lateral portions or wing covers 216 can align with or overlap the portion of the seal 114 that includes the support structure 214, such that the support structure 214 can transfer loads to the lateral portions 216 of the frame 116.

[0352] The supports 214 can extend generally from the rear surface or user contact surface of the seal 114 toward the lateral portion of the cover 216 of its corresponding frame 116. In some configurations, each of the supports 214 extends generally or substantially in the longitudinal direction of the seal 114. The supports 214 can extend generally parallel to each other or can be closer together at the front end than at the rear end. In other words, the supports 214 can converge in a direction moving from the rear surface or user contact surface of the seal 114 toward the front portion of the seal 114. However, in other configurations, the supports 214 can converge from the back to the front.

[0353] In the illustrated arrangement, each support structure 214 is shaped or otherwise configured to follow a portion or all of the peripheral edge of the associated outer lateral portion 208. When the seal 114 is viewed from the side, each support structure 214 can include an overall C-shape (or an inverted C-shape) comprising a rear portion 218 and upper and lower extensions or legs 220, 222 extending forward from the rear portion 218. In the illustrated arrangement, the support structures 214 are thickened regions of the seal 114, each of which protrudes inwardly into the interior space of the seal 114. Either or both of the extensions 220, 222 can extend to and / or contact the connector 202. In the illustrated configuration, only the lower extension 220 extends to the connector 202, while the upper extension 220 is spaced apart from the rear of the connector 202. However, in other configurations, this arrangement can be reversed.

[0354] Each of the illustrated support structures 214 includes a cutout or notch 224 that provides an area of ​​less thickness, hardness, or rigidity within the support structure 214. In the illustrated arrangement, the notch 224 is an area of ​​less thickness relative to other portions of the support structure 214. When the seal 114 is viewed from the side, the illustrated notch 224 also includes an overall C-shape (or an inverted C-shape). In some configurations, the notch 224 also follows a portion or all of the peripheral edge of the associated outer lateral portion 208. However, preferably, the notch 224 is spaced inboard of the peripheral edge of the outer lateral portion 208. In at least some configurations, the notch 224 is completely contained within the support structure 214. The notch 224 can allow portions of the support structure 214 to move relative to each other. Accordingly, the notch 224 can allow corresponding portions of the seal 114 to move relative to each other. Thus, the portion of the support structure 214 and seal 114 behind the notch 224 may move toward the portion of the support structure 214 and seal 114 in front of the notch 224 .

[0355] The support structure 214 can have varying thicknesses to provide different levels of support to the seal 114. For example, the upper extension 220 and / or the lower extension 222 can have a thickness that is less than the thickness of at least a portion of the rear portion 218. In some configurations, the portion of the rear portion 218 that is rearward of the notch 224 and / or located on or adjacent to the rearward-facing surface of the seal 114 has a thickness that is greater than the portion of the rear portion 218 that is forward of the notch 224. The notch 224 can have a thickness that is less than both the portion of the rear portion 218 that is forward of the notch 224 and the portion of the rear portion 218 that is rearward of the notch 224. Additionally, the portion of the outer lateral portion 208 that is located outside (e.g., forward of) the support structure 214 can have a thickness that is less than the thickness of any portion of the support structure 214. In some configurations, the portion of the outer lateral portion 208 that is located outside the support structure 214 has a thickness that is equal to or substantially equal to the thickness of the notch 224.

[0356] In some configurations, the rear portion 218 has a thickness between 2mm and 5mm behind the notch 224 and / or on the rearward surface of the seal 114 or adjacent to the rearward surface. In some configurations, this thickness is 4mm. In some configurations, the portion of the rear portion 218 in front of the notch 224 has a thickness between 1.5mm and 3mm. In some configurations, this thickness is 2mm. In some configurations, the notch 224 has a thickness between 0.3mm and 0.6mm. In some configurations, this thickness is 0.5mm. In some configurations, the portion of the outer lateral portion 208 outside the support structure 214 can have a thickness between 0.3mm and 0.6mm. In some configurations, this thickness is 0.5mm. The seal 114 can also have a thickness proportional to those disclosed herein, without having any or all of the specific thicknesses disclosed.

[0357] As described, the face contacting side or wearer side of the seal 114 includes a soft, lower nose receiving concave central portion shaped to form a seal on the wearer's face by receiving and sealingly contacting the tip, underside and base of the nose and sealingly contacting the upper lip, and positioning the orifices 128 for gas flow below the wearer's nostrils. Figure 5 and 16As shown, the lower nose-receiving soft central portion includes an upper wall portion 230 for contacting the tip of the wearer's nose, a lower wall portion 232 for contacting the upper lip under the wearer's nose, and left and right side wall portions for contacting the lower left and right sides of the wearer's nose, the left and right side wall portions being defined by the previously described inner lateral portion 206. The lower wall portion 232, below the outlet orifice 128, is positioned rearward of the upper wall portion 230, or closer to the left and right rearmost extremities of the seal 114 than the upper wall portion.

[0358] The left side wall portion and the right side wall portion limited by the inner lateral portion 206 extend away from each other from the orifice 128. The angle between the left side wall portion and the right side wall portion 206 can be, for example, between about 20 and about 60 degrees or between about 30 and about 50 degrees. Typically, seal 114 has a width dimension that is larger than the wall height dimension. In at least some embodiments, seal 114 can have a total width between 5cm and 10cm or 6cm and 8cm. In at least some embodiments, seal 114 can have a total height that is less than 5cm, less than 4.5cm or less than 4cm. Seal 114 can have a first texture on the user contact side and have a second texture on the opposite side, and this second texture can be different from this first texture. For example, the texture on the user contact side can promote sealing with the user's face, improve friction to the user's face or improve the comfort of the user's face. The texture on the opposite side can be configured to interact with the base 144 of the frame 116 to increase friction so as to inhibit relative movement between the seal 114 and the frame 116, reduce friction so as to promote relative movement between the seal 114 and the frame 116, or reduce adhesion between the seal 114 and the frame 116 so that the lateral portions of the seal 114 can move freely away from the frame 116 and out of contact therewith.

[0359] The aperture 128 can be elongated in the width direction of the seal 114. When viewed from the rear, the aperture 128 can be somewhat bean-shaped or bow-tie-shaped. In the illustrated configuration, the central portion of the aperture 128 has a smaller height than the lateral portions of the aperture 128. Furthermore, because the lower wall portion 232 is positioned rearward of the upper wall portion 230, when the seal 114 is worn by a user with the user's head in an upright orientation, the lower edge 236 of the aperture 128 is spaced rearward relative to the upper edge 234 of the aperture 128 in the depth direction of the seal 114.

[0360] Figure 5A cross-sectional view of the mask 112 taken along a vertical center plane of the mask 112 is shown. The portion of the upper wall portion 230 above and adjacent to the orifice 128 can define a line 240 that lies within the center plane. Similarly, the portion of the lower wall portion 232 below and adjacent to the orifice 128 can define a line 242 that lies within the center plane. Lines 240 and 242 define an angle 244 therebetween. In some configurations, angle 244 is greater than or equal to 90 degrees and less than 180 degrees. In some configurations, angle 244 is between 120 and 150 degrees. In some configurations, angle 244 is 135 degrees.

[0361] The seal 114 may also define a line 246 that lies in the central plane and extends through a point on the lower edge 236 of the aperture and a point on the upper edge 234 of the aperture 128 . Figure 16 The aperture 128 is shown viewed from behind the seal 114 perpendicular to line 246. As described above, the aperture 128 can have a bean or bowtie shape, with the central portion 250 having a height 252 that is less than the height 254 of the lateral portions 256. The aperture 128 can be symmetrical about a central vertical axis. In the illustrated arrangement, each lateral portion 256 is generally elliptical in shape, with the major axes of the elliptical shapes angled inward or toward each other in a direction from the lower edge 236 toward the upper edge 234. The central portion 250 defines a curved, concave transition between the elliptical shapes of the lateral portions 256 on each of the lower edge 236 and the upper edge 234.

[0362] Each lateral portion 256 defines a highest point 260 and a lowest point 262. The highest points 260 of the lateral portions 256 are closer to each other and to the central axis than the lowest points 262. The highest points 260 define a horizontal distance or width 264 therebetween that is less than the horizontal distance or width 266 between the lowest points 262. Each of the distances 264, 266 can be equal to or greater than one-half of the total width 268 of the aperture 128 and less than or equal to three-quarters of the total width. In some configurations, the distance 264 is between one-third and two-thirds of the width 268, or one-half of the width 268. In some configurations, the distance 266 is between one-half and seven-eighths of the width 268, or three-quarters of the width 268.

[0363] The upper edge 234 of the aperture 128 defines a vertical distance 270 between its highest point 260 and its lowest point 272 within the central portion 250, which can be located on the central axis. Vertical distance 270 can also be referred to as the depth of the central portion 250 above the upper edge 234. Similarly, the lower edge 236 of the aperture 128 defines a vertical distance 274 between its lowest point 262 and its highest point 276 within the central portion 250, which can be located on the central axis. Vertical distance 274 can also be referred to as the depth of the central portion 250 above the lower edge 236. In some configurations, vertical distances 270 and 274 can differ from each other. In some configurations, vertical distance 270 is smaller than vertical distance 274. In some configurations, vertical distance 270 is between one-third and two-thirds of vertical distance 274, or approximately one-half of vertical distance 274. In some configurations, the vertical distance 270 is less than the height 252 of the central portion 250 , and / or the height 252 of the central portion 250 is equal to or less than the vertical distance 274 .

[0364] In some configurations, the total width 268 of the orifice 128 is between 20-25 mm, between 21-23 mm, or approximately 22 mm. In some configurations, the total height 254 of the orifice 128 is between 10-14 mm, between 11-13 mm, or approximately 12 mm. In some configurations, the height 252 of the central portion 250 of the orifice 128 is between 4-6 mm, or approximately 5 mm. In some configurations, the distance 270 is between 1.5-2.5 mm, or approximately 2 mm. In some configurations, the distance 274 is between 4-6 mm, or approximately 5 mm. In some configurations, the distance 264 between the highest points 260 of the upper edge 234 is between 8-12 mm, between 9-11 mm, or approximately 10 mm. In some configurations, the distance 266 between the lowest points 262 of the lower edge 236 is between 15-20 mm, between 16-18 mm, or approximately 17 mm.

[0365] Specific reference Figure 5 、 10 17-22, as described above, the illustrated mask 112 includes a connector 202 that couples the seal 114 to the frame 116. The connector 202 includes a first portion 300 and a second portion 302 that capture the seal 114 therebetween. The first portion 300 and the second portion 302 can be coupled to each other to retain the seal 114 between the first portion 300 and the second portion 302. In some configurations, the first portion 300 can be connected to the second portion 302 by a snap-fit ​​arrangement, which can be a permanent or removable connection.

[0366] In the illustrated arrangement, the first portion 300 of the connector 202 includes a hub portion 304 and a flange portion 306. The hub portion 304 includes an annular wall extending in an axial direction and defining an aperture 175 that receives the connector 172 of the base 144 portion of the frame 116. The flange portion 306 includes an annular wall extending outward from the hub portion 304. In some configurations, the flange portion 306 is in a radial direction and is therefore perpendicular to the hub portion 304. In the illustrated arrangement, the second portion 302 is an annular member sized and shaped to fit over the hub portion 304 of the first portion 300.

[0367] As described above, the first portion 300 and the second portion 302 of the connector 202 are configured to interlock with each other in the axial direction. In the illustrated arrangement, the outer surface of the end portion of the hub portion 304 of the first portion 300 defines a recess 308 that extends partially or completely around the hub portion 304 in a circumferential direction. The inner surface of the second portion 302 defines a protrusion 310 that extends partially or completely around the second portion 302 in a circumferential direction and is configured to be received by the recess 308 of the first portion 300. In other configurations, this arrangement can be reversed so that the protrusion 310 can be on the first portion 300 and the recess 308 can be on the second portion 302.

[0368] The first and second parts 300, 302 may also be keyed to each other to ensure that they can only be connected in a single rotational orientation relative to each other and / or to inhibit or prevent relative rotation once connected. In some configurations, one of the first and second parts 300, 302 includes a key or protrusion, and the other includes a slot or recess configured to receive the key or protrusion. In the illustrated arrangement, the hub portion 304 of the first part 300 includes a slot or recess 312, and the second part 302 includes a key or protrusion 314 configured to engage the slot or recess 312. The slot or recess 312 is semi-cylindrical in shape, and the key or protrusion 314 includes a complementary semi-cylindrical shape. In the illustrated arrangement, the slot 312 and protrusion 314 are located on the upper portion of the first and second parts 300, 302 of the connector 202. However, in other configurations, this position may vary. Additionally, the positions of the recess 312 and the protrusion 314 may be reversed between the first portion 300 and the second portion 302 of the connector 202 from the positions shown.

[0369] The seal 114 defines an aperture 316 that receives the first portion 300 and the second portion 302 of the connector 202. When the connector 202 is assembled to the seal 114, the flange portion 306 of the first portion 300 is positioned within the interior of the seal 114 and the hub portion 304 extends through the aperture 316. The second portion 302 of the connector 202 is positioned on the exterior of the seal 114. The seal 114 may include an annular rim 318 that surrounds the aperture 316 and is configured to be captured by the first portion 300 and the second portion 302 of the connector 202. Specifically, the rim 318 includes a generally T-shaped cross-section having a narrow base 320, a first blade 322 extending from the base 320 in a first axial direction, and a second blade 324 extending from the base 320 in a second axial direction, the second axial direction being opposite the first axial direction. First portion 300 defines an annular recess 326 configured to receive first vane 322, and second portion 302 defines an annular recess 328 configured to receive second vane 324. Base 320 extends between first and second portions 300, 302 toward a main portion of seal 114.

[0370] In the illustrated arrangement, the connector 202 and the seal 114 include interference portions configured to inhibit or prevent rotational movement between the seal 114 and the connector 202. Specifically, the hub portion 304 of the first portion 300 includes a first protrusion 330, and the second portion 302 includes a second protrusion 332. The first protrusion 330 and the second protrusion 332 face each other with a space therebetween configured to receive a portion of the annular rim 318 therebetween. This portion of the annular rim 318 defines a first recess 334 and a second recess 336 configured to receive the first protrusion 330 and the second protrusion 332, respectively. In the illustrated arrangement, each of the protrusions 330, 332 and the recesses 334, 336 comprises a generally cuboidal shape. The protrusions 330, 332 and the recesses 334, 336 are located on the lower portions of the first and second portions 300, 302 of the connector 202. However, in other configurations, these positions may vary.

[0371] In some configurations, the connector 202 and the seal 114 further include a second set of interference portions configured to inhibit or prevent rotational movement between the seal 114 and the connector 202. Specifically, the first portion 300 includes a third protrusion 338, and the seal 114 includes a third recess 340 and a fourth recess 342. The third recess 340 is configured to receive the third protrusion 338. In the illustrated configuration, a portion of the key or protrusion 314 extends into the fourth recess 342. The third protrusion 338, the third recess 340, and the fourth recess 342 are located on an upper portion of a corresponding one of the connector 202 and the seal 114, and / or are opposite the protrusions 330, 332 and the recesses 334, 336. However, in other configurations, the third protrusion 338, the third recess 340, and the fourth recess 342 may be located elsewhere.

[0372] refer to Figure 3 and 23 In the illustrated arrangement, the headgear 118 may include a bifurcated headgear arrangement having a top or upper strap portion 350 and a rear strap portion 352. The upper strap portion 350 is configured to pass across the top of the user's head from side to side. In some configurations, the upper strap portion 350 is a top strap positioned above the parietal bone or at or near the junction between the parietal and frontal bones. In other configurations, the upper strap portion 350 may include a forehead strap positioned above the user's frontal bone. The rear strap portion 352 passes around the back of the user's head and, in some configurations, is positioned above the user's occipital bone. However, in other configurations, the rear strap portion 352 may be positioned higher or lower on the user's head and / or neck. In the illustrated arrangement, the upper strap portion 350 and the rear strap portion 352 are connected to each other at a junction 354 on each side of the headgear 118. Each of a pair of forwardly extending straps 356 extends forwardly from the joint 354 toward and is connected to a corresponding one of the side arms 130 of the frame 116 .

[0373] In some configurations, at least some portions of the headgear 118 are rigid, semi-rigid, inelastic, or substantially inextensible in response to normal or expected forces acting on the headgear 118, while other portions of the headgear 118 are elastic or extensible in response to normal or expected forces. In some configurations, one or more of the upper strap portion 350, the connection portion 354, and the forward-extending strap 356 are rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, each of the upper strap portion 350, the connection portion 354, and the forward-extending strap 356 is rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, the rear strap portion 352 is elastic or extensible. This arrangement allows the rear strap portion 352 to stretch to adjust the circumferential length of the headgear 118. The amount of stretch that the rear strap portion 352 can experience can be limited, and therefore, the rear strap portion 352 can also be adjustable in length. In some configurations, circumferential length adjustment preferably occurs at the rear of the user's head, where it is less susceptible to lengthening in response to blowout forces. The rigid, semi-rigid, inelastic, or substantially inextensible nature of the attachment portions 354 and the forward-extending strap 356 positioned on the side and front portions of the user's head helps maintain the desired circumferential length of the headgear 118, regardless of the elastic nature of the rear strap portion 352. In some cases, friction between these portions of the headgear 118 and the side and front portions of the user's head inhibits movement or lengthening of the headgear 118 in response to blowout forces. However, in other arrangements, the rear strap portion 352 can be rigid, semi-rigid, inelastic, or substantially inextensible, and in such cases, can be adjustable in length.

[0374] Upper strap portion 350 may include a length adjustment arrangement. In the illustrated arrangement, upper strap portion 350 includes a first portion 358 and a second portion 360 that are separate from each other and adjustably connectable to each other. The free end of first portion 358 includes a loop 362 through which second portion 360 can pass. Thus, first portion 358 and second portion 360 can slide relative to each other to change the overlap distance between portions 358 and 360 and, therefore, the length of upper strap portion 350. Second portion 360 can be coupled to first portion 358 to secure upper strap portion 350 at a desired adjusted length. In the illustrated arrangement, the inner surface of second portion 360 may include the hook portion of a hook-and-loop fastener, and the outer surface of first portion 358 may include the loop portion of the hook-and-loop fastener. This arrangement can also be reversed. In some configurations, the material of upper strap portion 350 may define the loop portion of the hook-and-loop fastener. In other words, the loop portion may not be a discrete element of upper strap portion 350.

[0375] With the arrangement described above, the upper strap portion 350 can be adjusted to an appropriate length for a particular user so that the connection portion 354 and / or the forward-extending strap 356 rest over the user's ears. Once adjusted, the upper strap portion 350 can remain in the adjusted position during the process of donning and doffing the headgear 118 and the associated interface 110. In other words, preferably, the first portion 358 and the second portion 360 do not have to be separated from each other to facilitate the user donning or removing the interface 110. Instead, the headgear 118 allows the interface 110 to be donned ('like a hat') by holding the frame 116 at or near the seal 114 (as one would hold a hat by the brim) and moving the rear strap portion 352 over and to the back of the user's head. The stretchable or extendable rear strap portion 352 can facilitate positioning the headgear 118 around the user's head without having to open the headgear 118 by separating the portions 358, 360 of the upper strap portion 350 or separating one or both ends of the rear strap portion 352 from the remainder of the headgear 118. The headgear 118 can be removed or doffed by the reverse motion.

[0376] In the illustrated configuration, rear strap portion 352 is connected to each of links 354 by an end portion of rear strap portion 352 that passes through a loop 364 carried by link 354 and folds back upon itself. The end portions of rear strap portion 352 may be coupled by suitable fasteners, such as, for example, hook and loop fasteners, to a relatively more central portion of rear strap portion 352. Rear strap portion 352 may be adjustable at one or both ends.

[0377] In some configurations, the rigid, semi-rigid, inelastic, or substantially inextensible portion of the headgear 118 can be constructed by introducing molten plastic material into a space defined by a textile or fabric outer cover and allowing it to cool to form a plastic core. The plastic material can be adhered to or coupled to the textile or fabric material to form a unitary structure. The textile or fabric material can be, for example, a tubular structure or a separate layer of material. Headgear structures having a plastic core and a textile or fabric outer cover, and methods for producing such headgear structures, are disclosed in applicant's U.S. Provisional Application Nos. 62 / 050,925, 62 / 159,857, and 62 / 198,104, the entire contents of which are incorporated herein by reference and form a part of this disclosure. In some arrangements, some or all of the connector 138 and the rings 362 and 264 are formed as an integral structure with the plastic core of the headgear 118.

[0378] The seals and masks disclosed herein can be used with headgear in other forms, such as a headgear with two straps (these straps are attached to either side of the mask), i.e., a headgear including left and right upper and lower straps. The frame of such an interface embodiment may or may not include side arms as described above. The left and right upper straps can pass downward (when the headgear is worn) between the wearer's eyes and ears, and the left and right lower straps can extend from the lower back of the head and below the ears to the mask (and be attached to the mask, each side below the upper straps). Alternatively, the upper and lower straps can be connected, for example, with a stiffer yoke before being attached to the mask frame, or be integral with the mask frame. Such a headgear can have buckles and tongues, loops and tongues, or other adjustment members in the upper or lower straps or both, partially along their length, or at the connection between the straps and the mask. In a less preferred embodiment, the upper strap may be attached to the top of a T-piece that extends from the frame up to the wearer's forehead. In another embodiment, again, the headgear may include a single strap that passes from one side of the mask around or around the back of the head and back to the other side of the mask. Such headgear straps may be elastic or resiliently stretchable and / or may have length adjustment features (e.g., buckle and tongue, loop and tongue, etc.) in the back or on the sides or at the connection between the headgear and one or both sides of the mask. Variants of such headgear may also include an overhead strap.

[0379] Other suitable materials or configurations for the headgear 118 may also be used. For example, in some configurations, the headgear may be at least partially formed from a soft, flexible material, such as a cloth-covered foam material, such as a BREATH-O-PRENE material. The headgear 118 may be formed by cutting the headgear 118 from a sheet of material to shape, for example, by blade cutting or radio frequency cutting. In one embodiment, the edges of the headgear are thermoformed (i.e., compressed under heat) to form rounded edges. That is, heat and pressure are applied along the edges of the headgear to compress the opposing outer surfaces of the headgear toward each other at the edges and thermally bond them together. This can be accomplished simultaneously or in the same tool as, for example, cutting the headgear to shape by cutting the outline of the headgear shape from the sheet of material in one operation and thermoforming to define the rounded headgear edges, or alternatively, by first cutting the headgear to shape and then rounding the edges in a second operation. The rounded edges or any joints in the headgear may alternatively be formed by, for example, ultrasonic or radio frequency welding.

[0380] As described above, the mask 112 includes a bias flow vent 126 that allows exhaled air from the user to be vented from the interface 110. In the illustrated arrangement, the bias flow vent 126 is defined by the frame 116. Specifically, the bias flow vent 126 is defined by the elbow connector 174 of the base 144 of the frame 116. The vent 190 of the bias flow vent extends in a generally radial direction through the elbow connector 174 between the elbow 122 and the U-shaped body of the base 144. The location of the vent 190 can reduce the noise generated by the interface 110. In addition, other features of the interface 110 can help reduce noise. Examples of such features and arrangements are specifically referenced. Figure 24-29 Disclosure.

[0381] Inspiratory noise can be defined as the noise that increases in level due to inhalation or inspiration by a user wearing a CPAP mask. Inspiratory noise is common with CPAP masks, particularly smaller nasal or nasal pillow masks. Static bias noise can be defined as constant noise in the absence of flow generated by the patient's breathing and is generally associated with the geometry of the bias flow holes. It can be reduced using a number of different hole shapes, patterns, and configurations. Dynamic inspiratory noise (generally more severe during inhalation) can be caused by geometries other than the bias flow holes. However, it is believed that this inspiratory noise is transmitted or heard through the bias flow holes and is therefore closely related to bias flow. When a patient breathes through a CPAP machine, the flow rate in the CPAP tubing increases as he or she inhales, maintaining a nearly constant pressure within the mask. This results in a nearly constant bias flow during inhalation and exhalation, and thus the flow through the bias flow holes varies only with pressure.

[0382] Dynamic noise, and specifically inhalation noise, occurs when the patient inhales, and therefore occurs when the flow from the CPAP is at a maximum. It is therefore believed that increased flow causes inhalation noise. Methods for minimizing the noise caused during inspiration are discussed below. The noise is caused by a restriction in the breathing circuit upstream of the bias flow. The restriction causes increased velocity and vortex, which in turn creates noise. The noise is heard through the bias flow holes. It has been determined that having a diameter within the breathing circuit that is less than approximately 15 mm can result in significant inhalation noise. Therefore, when designing a mask system with reduced, minimal, or no inhalation noise issues, it may be desirable to maintain a diameter greater than approximately 15 mm within the breathing circuit, where possible or practical to consider other factors.

[0383] In addition to maintaining a minimum diameter or cross-sectional area in the breathing circuit, another factor is the consideration of eddy currents. The noise generated in the airflow itself causes noise, which is then heard by the patient. The sudden expansion in the pipeline causes changes in pipeline velocity, eddy currents and therefore noise. The expansion can be a sudden expansion (wherein the expansion angle is equal to 180 degrees) or a more gradual expansion (wherein the expansion angle is greater than 0 degree and less than 180 degrees). In order to reduce noise, the rate at which the fluid slows down can be reduced (that is, using a shallow gradual expansion) or the speed at which the air travels can be reduced. In order to reduce head loss, the expansion should preferably have an angle of θ<30°, or alternatively an angle of 120°θ<180° or 150°θ<180°.

[0384] In practice, noise reduction can be achieved by designing cross-sections to reduce or minimize peak air velocities and / or designing geometry to reduce or eliminate sudden changes in geometry that induce vortices and, therefore, noise. In some configurations, noise reduction can be achieved by carefully considering the diameters of tubing and connectors within the breathing circuit. For example, Figure 24 A conventional CPAP hose to mask tubing connection is shown in FIG. The actual CPAP hose or breathing circuit is not shown. Figure 24 (However, see Figure 1 12), but will be coupled to the upstream end of the CPAP hose adapter 400. The CPAP hose adapter 400 is coupled to the connector 124 of the mask tube 120. The illustrated connector 124 of the mask tube 120 is a swivel connector that includes a male swivel portion 402 and a female swivel portion 404. The male swivel portion 402 is coupled to the mask tube 120 and the female swivel portion 404 is coupled to the CPAP hose adapter 400. Figure 24 As can be seen in the diagram, there are several restrictions and one expansion in the connection between the CPAP hose and the mask tubing. These restrictions cause the air velocity to increase, which in turn causes increased turbulence as the air passes through the expansion. These restrictions are caused by the several male-to-female connections between the swivels 402, 404 and the tube or hose.

[0385] refer to Figure 25 , the improved CPAP hose to mask tube connection reduces one or more of these constraints, such as by reducing or minimizing the wall thickness of the swivel component and changing the manner in which the male swivel 402 is attached to the mask tube 120. Specifically, in Figure 25In the illustrated configuration, the male swivel 402 does not extend within the mask tube 120. Instead, the male swivel 402 has a minimum diameter that is equal to or substantially equal to the inner diameter of the mask tube 120. In some configurations, this can be achieved by coupling the male swivel 402 to the mask tube 120 using a coupling sleeve 406 or other suitable coupling. The coupling sleeve 406 can be formed by, for example, overmolding a material that will chemically bond to the male swivel 402 and the mask tube 120 onto a portion of both the swivel 402 and the tube 120. This arrangement reduces the size of the constraint within the male swivel 402 and also removes or substantially eliminates the extension from the male swivel 402 to the mask tube 120. In the illustrated arrangement, the diameters of the various components are labeled and may be as follows:

[0386] Approximate diameter:

[0387] D1≈22mm

[0388] D2≈D3≈19mm

[0389] D4≈17mm

[0390] D5≈D6≈15mm

[0391] In other configurations, these diameters can be different from the above values, but the ratio between two or more of these diameters can be the same or substantially the same. In addition, the difference between two or more of these diameters can be the same, substantially the same, or smaller than the above values.

[0392] In some applications or at some locations within a CPAP system (such as, for example, the interface 110), it may be difficult or impractical to avoid abrupt changes in geometry. For example, to prevent abrupt transitions in cross-sectional area, small wall angles (e.g., less than 30°) are desirable. Such small wall angles require that transitions between diameters or cross-sectional areas occur over a greater length than more abrupt transitions, which can increase the overall size of the mask. In many cases, for user comfort, it may be desirable to have a mask that is as small and unobtrusive as possible or practical. Therefore, abrupt transitions may be desirable in order to allow for a smaller mask geometry.

[0393] To reduce the noise generated within the inevitable transition from smaller diameter to larger diameter (the expansion), the position of the bias flow holes can be selected to reduce the flow rate across the transition. In fact, the bias flow, which is generally associated with noise generation, can be used to reduce noise. By having the bias flow on the side of the expansion with the smallest cross-sectional area (before the expansion), the induction noise can be reduced because the flow rate, and therefore the velocity, within the expansion is now reduced. This arrangement produces weaker vortices, as shown in Figures 26 and 27. Figure 26A and27A The flow at the expansion is shown when the biasing orifice is located before or upstream of the expansion. Figure 26A is the velocity plot and Figure 27A It is a vector drawing. Figure 26B and 27B shows the flow at the extension when the biasing air hole is located after the extension. Figure 26B is the velocity plot and Figure 27B is a vector drawing. Figure 26A and 26B , it is clear that the bias flow hole is located before the expansion part ( Figure 26A ), the velocity at the extension part is relative to the deflection hole located behind the extension part ( Figure 26B ) at the expansion. The dark areas in the relatively upstream portion of these flows represent areas of higher velocity. Thus, with the bias flow holes located before the expansion, the velocity is lower, and therefore, the noise is lower. Figure 27A and 27B It also shows that: the bias flow hole is located behind the expansion part ( Figure 27B ) is compared with the situation when the bias flow pore is located before the expansion part ( Figure 27A ), there is a smaller recirculation flow. Smaller recirculation flow means smaller vortex, which means less noise.

[0394] Figure 28A 、 28B Different design options (A, B, and C) illustrating how this principle may be implemented in a mask 112 are shown in 28A and 28C. Figure 29 The plot in Figure 2 shows the sound levels produced by each design option over three breaths. Design C has the lowest peak inspiratory noise and Design A has the highest peak inspiratory noise, while Design B has a peak inspiratory noise level between Design C and Design A. Each sample has the same minimum inner diameter D. In the illustrated design, the bias flow vent 126 is implemented in the elbow connector 174. However, in other arrangements, the bias flow vent 126 can also be located in other locations. For example, in some configurations, the bias flow vent 126 can be located in the elbow 122, among other possible locations.

[0395] In design A, the vent 190 of the bias flow aperture 126 is located after the sudden change in geometry. Therefore, during inhalation, there is a high flow rate of air in the sudden expansion, which causes turbulence and noise.

[0396] In Design B, the vent hole 190 of the bias flow hole 126 is located after the geometrically gradual transition. The angle of the geometrically gradual transition is greater than 30°. Therefore, during inhalation, the high flow rate within the gradual transition causes some separation of the flow from the flow path walls. This flow separation causes vortices, which in turn cause noise.

[0397] In Design C, the vent holes 190 of the bias flow holes 126 are located before or upstream of the sudden change in geometry. This reduces the flow rate and, therefore, the velocity of the air passing within the sudden expansion. Because head, or pressure loss, is proportional to the square of velocity, it is clear that velocity significantly affects the amount of head loss, eddy currents, and, therefore, noise that occurs when fluid flows within a change in cross-section. This illustrates the impact that the location of the bias flow holes 126 has on the noise and eddy currents generated. Because of the reduced velocity passing within the expansion, the noise in Design C is significantly lower than that observed in Design A.

[0398] In an alternative arrangement, the principles presented in Design C can be applied to Design B by positioning the biasing air holes 126 before or at the beginning of the gradual expansion. Similar results to those in Design C are expected due to the reduced flow within the gradual expansion.

[0399] The position of the vent 190 of the bias flow vent 126 relative to the abrupt expansion has a greater impact on noise than reducing the wall angle at the expansion. This is desirable because optimizing the expansion angle in a real mask may be impractical because using the desired (small) angle requires an increased transition length to achieve the change in cross-sectional area, which may result in an overly large mask. To reduce dynamic (inhalation) noise, vortices generated within the air supply flow path can be reduced or minimized by avoiding, reducing, or minimizing restrictions in the flow path from the CPAP machine to the patient, where possible or practical. Additionally or alternatively, the inner diameter (or cross-sectional area) of swivels, elbows, and / or other portions of the flow path can be increased or maximized, or made as close to the inner diameter (or cross-sectional area) of the air supply (CPAP) hose as possible or practical. This arrangement minimizes flow velocity, and therefore vortices, resulting in less noise. If necessary or desired, the design of the transition from the smaller cross-section to the larger cross-section is preferably located between the bias flow vent and the patient (after the bias flow) so that the volume flow rate in the transition section is reduced. If necessary or desired, the design of the transition from the smaller cross-section to the larger cross-section is preferably such that the flow head loss in the transition section is minimized. The flow path from the smaller cross-section to the larger cross-section is preferably a gradual expansion section with a wall angle of less than 30 degrees. If this arrangement is impractical, an abrupt transition section with a wall angle of 180° is preferred.

[0400] Figure 30 and 31 An alternative connection arrangement between the headgear 118 and the frame 116 (or other portion of the mask 112) is shown. In the illustrated arrangement, the forward-extending straps 356 of the headgear 118 overlap the side arms 130 of the frame 116. In the illustrated arrangement, the forward-extending straps 356 can be positioned on the inside of the side arms 130; however, in other arrangements, this arrangement can be reversed, and the forward-extending straps 356 can be positioned on the outside of the side arms 130.

[0401] In some configurations, the position of the headgear 118 relative to the frame 116 is adjustable, allowing the amount of overlap between the forward-extending straps 356 to be adjusted. This adjustment changes the effective circumferential length of the interface 110. In some configurations, the headgear 118 and frame 116 are adjustable to a selected one of two or more discrete adjustment positions. Any suitable coupling arrangement between the headgear 118 and frame 116 may be used. In the illustrated arrangement, the headgear 118 includes one or more posts 410 located on the forward-extending straps 356, and the frame 116 includes one or more corresponding openings 412 located on the side arms 130 and configured to removably receive the posts 410. In the illustrated arrangement, the headgear 118 includes two posts 410 on each side, and each side arm 130 of the frame 116 includes three openings 412. Thus, the headgear 118 and frame 116 have two different length adjustment positions. However, in other arrangements, other numbers of adjustment positions may be provided.

[0402] The posts 410 and openings 412 are similar in structure and function to a baseball cap-style sizing arrangement. Each of the posts 410 includes a stem 414 and a head or cap 416. The posts 410 shown are generally T-shaped; however, other shapes may be used, such as, for example, a cylindrical stem 414 and a disc-shaped or spherical head 416. The openings 412 are sized, shaped, and / or otherwise configured to allow the head 416 of the post 410 to pass therethrough in response to at least normal or expected forces and to retain the post 410 once through the openings 412. However, the post 410 may be intentionally removed from the openings 412 to allow the headgear 118 and frame 116 to be separated. Passage of the post 410 through the openings 412 may be achieved by deformation of one or both of the post 410 and the openings 412. That is, the head 416 of the post 410 may flex or otherwise deform, and the opening 412 may stretch or expand to facilitate passage of the head 416 of the post 410 .

[0403] In the illustrated arrangement, the openings 412 are elongated and each include a recessed flange 418 spaced inwardly from the outer surface of the side arms 130 of the frame 116. The recessed flange 418 may extend around a portion or all of the periphery of the opening 412. The recessed flange 418 may be continuous or discontinuous. For example, the recessed flange 418 may include portions at each end of the elongated opening 412, wherein those portions are separated from one another. The recessed flange 418 may be configured to contact and retain the head 416 of the associated post 410.

[0404] The posts 410 can be formed or connected to the headgear 118 by any suitable arrangement. For example, the posts 410 can be integrally formed with the base member 420 and coupled to the headgear 118 by, for example, stitching, RF welding, adhesives, or other suitable coupling arrangements. In some configurations, the posts 410 can be integrally formed with the plastic core of the headgear 118.

[0405] Figure 32 and 33 Yet another alternative connection arrangement between the headgear 118 and the frame 116 (or other portion of the mask 112) is shown. In the illustrated arrangement, the forward-extending straps 356 of the headgear 118 overlap the side arms 130 of the frame 116. In the illustrated arrangement, the forward-extending straps 356 can be positioned on the inside of the side arms 130; however, in other arrangements, this arrangement can be reversed, and the forward-extending straps 356 can be positioned on the outside of the side arms 130.

[0406] In the illustrated configuration, when the frame 116 is connected to the headgear 118, the position of the headgear 118 relative to the frame 116 is fixed or non-adjustable. In an alternative arrangement, the position of the headgear 118 relative to the frame 116 can be adjustable, such that the effective circumferential length of the interface 110 can be adjusted. Any suitable coupling arrangement between the headgear 118 and the frame 116 can be used. In the illustrated arrangement, the headgear 118 includes one or more posts 410 located on the forward-extending strap 356, and the frame 116 includes one or more corresponding openings 412 located on the side arms 130 and configured to removably receive the posts 410. In the illustrated arrangement, the headgear 118 includes two posts 410a, 410b on each side, and each side arm 130 of the frame 116 includes two complementary openings 412a, 412b. In some configurations, the two posts 410a and 410b differ from each other at least in shape. Similarly, the two openings 412a and 412b differ from each other at least in shape. In the illustrated arrangement, the rear post 410a is generally rectangular in shape, and the front post 410b is generally circular in shape. Similarly, the rear opening 412a is generally rectangular in shape, and the front opening 412b is generally circular in shape. However, other suitable shapes may also be used. In addition, the shapes of the different posts and / or openings may be the same or different.

[0407] Similar to Figure 30 and 31 arrangements, Figure 32 and 33 The posts 410a, 410b and openings 412a, 412b are similar in structure and function to a baseball cap-style sizing arrangement. Each of the posts 410a, 410b includes a stem (not shown, but similar to the Figure 30 and 31412b). The openings 412a, 412b are sized, shaped, and / or otherwise configured to allow the heads of the posts 410a, 410b to pass therethrough in response to at least normal or expected forces and to retain the posts 410a, 410b once through the openings 412a, 412b. However, the posts 410a, 410b may be intentionally removed from the openings 412a, 412b to allow the headgear 118 and the frame 116 to be separated. The passage of the posts 410a, 410b through the openings 412a, 412b may be accomplished by deformation of one or both of the posts 410a, 410b and the openings 412a, 412b. That is, the heads of the posts 410a, 410b may flex or otherwise deform, and the openings 412a, 412b may stretch or expand to facilitate passage of the heads of the posts 410a, 410b.

[0408] In some configurations, each of the openings 412a, 412b may include a recessed flange that is spaced apart from the inner side of the outer surface of the side arm 130 of the frame 116. The recessed flange may extend around a portion or all of the periphery of the openings 412a, 412b. The recessed flange may be continuous or discontinuous. For example, the recessed flange 418 may include portions on each end of the elongated openings 412a, 412b, wherein those portions are separated from each other. The recessed flange may be configured to contact and hold the heads of the associated posts 410a, 410b. In other configurations, the heads of the posts 410a, 410b may rest against the outer surface of the side arm 130 (or other portions of the frame 116) adjacent to the openings 412a, 412b instead of the recessed flange.

[0409] The posts 410a, 410b can be formed or connected to the headgear 118 by any suitable arrangement. For example, the posts 410a, 410b can be integrally formed with the base member and coupled to the headgear 118 by, for example, stitching, RF welding, adhesives, or other suitable coupling arrangements. In some configurations, the posts 410a, 410b can be integrally formed with the plastic core of the headgear 118.

[0410] Figure 34 An alternative arrangement of headgear 118 is shown which may be similar in many respects to Figure 3 and 23 Therefore, aspects of the headgear 118 not specifically described below can be assumed to be the same as Figure 2 and 23 The headgear 118 may be the same or similar to the headgear 118, or may have any other suitable arrangement. Figure 34In an arrangement, the headgear 118 includes a bifurcated headgear arrangement having a top or upper strap portion 350 and a rear strap portion 352. The upper strap portion 350 is configured to pass across the top of the user's head from side to side. In some configurations, the upper strap portion 350 is a top strap that is positioned above the parietal bone or at or near the junction between the parietal bone and the frontal bone. In other configurations, the upper strap portion 350 can include a forehead strap that is positioned above the user's frontal bone.

[0411] The rear strap portion 352 passes around the back of the user's head and, in some configurations, is positioned above the user's occipital bone. However, in other configurations, the rear strap portion 352 can be positioned higher or lower on the user's head and / or neck. In the illustrated arrangement, the upper strap portion 350 and the rear strap portion 352 are connected to each other at a connection 354 on each side of the headgear 118. Each of a pair of forward-extending straps 356 extends forward from the connection 354 toward and is connected to a corresponding one of the side arms 130 of the frame 116.

[0412] In some configurations, at least some portions of the headgear 118 are rigid, semi-rigid, inelastic, or substantially inextensible in response to normal or expected forces acting on the headgear 118, while other portions of the headgear 118 are elastic or extensible in response to normal or expected forces. In some configurations, one or more of the upper strap portion 350, the connection portion 354, and the forward-extending strap 356 are rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, each of the upper strap portion 350, the connection portion 354, and the forward-extending strap 356 is rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, the rear strap portion 352 is elastic or extensible. This arrangement allows the rear strap portion 352 to stretch to adjust the circumferential length of the headgear 118. The amount of stretch of the rear strap portion 352 can be limited.

[0413] In some configurations, the rear strap portion 352 may also be adjustable in length. In some configurations, circumferential length adjustment preferably occurs at the rear of the user's head, where it is less susceptible to lengthening in response to blowout forces. The rigid, semi-rigid, inelastic, or substantially inextensible nature of the attachment portions 354 and the forward-extending strap 356 positioned on the side and front portions of the user's head helps maintain the desired circumferential length of the headgear 118, regardless of the elastic nature of the rear strap portion 352. In some cases, friction between these portions of the headgear 118 and the side and front portions of the user's head inhibits movement or lengthening of the headgear 118 in response to blowout forces. However, in other arrangements, the rear strap portion 352 may be rigid, semi-rigid, inelastic, or substantially inextensible, and in such cases, may be adjustable in length.

[0414] Upper strap portion 350 may include a length adjustment arrangement. In the illustrated arrangement, upper strap portion 350 includes a first portion 358 and a second portion 360 that are separate from each other and adjustably connectable to each other. The free end of first portion 358 includes a loop 362 through which second portion 360 can pass. Thus, first portion 358 and second portion 360 can slide relative to each other to change the overlap distance of portions 358, 360 and, therefore, the length of upper strap portion 350. Second portion 360 can be coupled to first portion 358 to secure upper strap portion 350 at a desired adjusted length. In the illustrated arrangement, an inner surface of second portion 360 may include at least one protrusion (not shown), which may be similar to any of posts 410; and an outer surface of first portion 358 may include a plurality of openings 370 configured to removably receive the protrusions to provide a plurality of discrete adjustment positions. This arrangement can also be reversed.

[0415] With the arrangement described above, the upper strap portion 350 can be adjusted to an appropriate length for a particular user so that the connection portion 354 and / or the forward-extending strap 356 rest over the user's ears. Once adjusted, the upper strap portion 350 can remain in the adjusted position during the process of donning and doffing the headgear 118 and the associated interface 110. In other words, preferably, the first portion 358 and the second portion 360 do not have to be separated from each other to facilitate the user donning or removing the interface 110. Instead, the headgear 118 allows the interface 110 to be donned ('like a hat') by holding the frame 116 at or near the seal 114 (as one would hold a hat by the brim) and moving the rear strap portion 352 over and to the back of the user's head. The stretchable or extendable rear strap portion 352 can facilitate positioning the headgear 118 around the user's head without having to open the headgear 118 by separating the portions 358, 360 of the upper strap portion 350 or separating one or both ends of the rear strap portion 352 from the remainder of the headgear 118. The headgear 118 can be removed or doffed by the reverse motion.

[0416] In the illustrated configuration, rear strap portion 352 is connected to each of links 354 by an end portion of rear strap portion 352 that passes through a loop 364 carried by link 354 and folds back upon itself. The end portions of rear strap portion 352 may be coupled by suitable fasteners, such as, for example, hook and loop fasteners, to a relatively more central portion of rear strap portion 352. Rear strap portion 352 may be adjustable at one or both ends.

[0417] Figures 36A to 40C Interface arrangements are presented having alternative side-arm arrangements that are rotatable or compliant along the horizontal plane (i.e., horizontally across the user's face) and substantially rigid along the vertical plane (i.e., vertically across the user's face). Figure 35, there are shown a horizontal plane and a vertical plane across the user's face. Providing side arms that are compliant along the horizontal plane allows the side arms to conform to the geometry of the user's face and / or change shape so as not to interfere with the positioning of the seal on the user's face when external horizontal forces are applied to the side arms, such as when the user is sleeping on their side (e.g., a pillow contacts the side arms and applies a force thereon). Further, providing side arms that are compliant along the horizontal plane allows the seal to be decoupled from the side arms and the frame so that the seal can be properly positioned on the user's face and not moved due to movement of the side arms. That is, external forces are not transmitted directly to the seal, which allows the seal to be maintained in the correct operating position. The interface arrangement shown below provides side arms that are substantially rigid across the vertical plane so as to resist or inhibit rotation or shaking of the seal relative to the side arms, the headgear, and the user's face caused by blow-off forces, thereby ensuring a seal against the user's nose. Additionally, Figures 36A to 40C The side arm arrangement in the embodiment also limits or inhibits twisting of the side arms, which limits or inhibits movement of the interface arrangement relative to the user's face (i.e., along an axis generally parallel to a plane perpendicular to both the horizontal and vertical planes, as shown in FIG. Figure 35 More specifically, the side arms can be substantially rigid such that each side arm resists torsional flexing along its length (i.e., about an axis defined by the longitudinal direction of the side arm). In some configurations, the side arms can allow for a limited range of twisting or rotation of the interface arrangement relative to the user's face so as to provide an amount of compliance that can enhance user comfort while ensuring that the interface seals against the user's face.

[0418] Figures 36A to 36D An interface 500 is shown having a side arm arrangement with hinges 510 that allow the side arms 130 to rotate along the horizontal plane while remaining substantially rigid along the vertical plane (i.e., resisting flexing due to vertical forces). The side arms 130 may be formed from an injection molded plastic material and are shown having a rectangular cross-sectional shape. The rectangular cross-sectional shape of the side arms 130 has a height that is significantly greater than the thickness, such that the resistance to flexing in a direction parallel to the height direction is significantly greater than the resistance to flexing in a direction parallel to the thickness direction. Thus, in Figures 36A to 36D In the illustrated configuration and orientation of the side-arm 130 in FIG, the side-arm 130 is substantially rigid along a vertical plane relative to the user and semi-rigid along a horizontal plane relative to the user (i.e., due to the rectangular cross-sectional shape). In some configurations, the side-arm 130 can be rigid in both the vertical plane and the horizontal plane relative to the user. Additionally, the geometry, cross-sectional shape, and type of material used to form the side-arm can be configured to limit or inhibit twisting of the side-arm, such that rotation of the interface arrangement relative to the user's face can be limited or prevented.

[0419] like Figure 36A and 36B As shown, the side arm 130 has a two-piece design, wherein the seal connection portion 130A of the side arm 130 is connected to the headgear connection portion 130B of the side arm 130 by a hinge 510. The seal connection portion 130A is connected to the frame 116 of the seal 114, and the headgear connection portion 130B is connected to the headgear (not shown). The seal connection portion 130A can be permanently or removably coupled to the frame 116 so that the seal 114 is rigidly attached to the seal connection portion 130A. In this arrangement, the seal 114 is less likely to rotate or shake relative to the seal connection portion 130A. The seal connection portion 130A on both the left and right sides of the seal 114 can be formed as a single integral component with the frame 116. The seal 114 can be connected to the frame 116 using any of the previously disclosed seal and frame connection arrangements. Similarly, the headgear connecting portion 130B can be permanently or removably coupled to the headgear using any of the previously disclosed side arm and headgear connection arrangements.

[0420] like Figure 36B As shown, the hinge 510 includes a pin 512 that extends through a hole 514 located in the ends of the seal connection portion 130A and the headgear connection portion 130B. The end of the headgear connection portion 130B has a female connection portion 530 that includes an outer joint 532 that defines a slot 516 therebetween. The seal connection portion 130A has a male connection portion 520 that includes an inner joint 522 that is positioned within the slot 516 between the outer joints 532. Figure 36A As shown, the pin 512 and the hole 514 are aligned with the height direction of the rectangular cross-section of the side arm 130, which is also substantially aligned with a vertical plane relative to the user. In this way, the seal connection portion 130A and the headgear connection portion 130B rotate relative to each other about the pin 512. In other words, the seal connection portion 130A and the headgear connection portion 130B are rotatable in a horizontal direction across the user's face.

[0421] The hinge 510 and a portion of the side arm 130 are covered by an accordion cover 550. In some configurations, the accordion cover 550 provides resistance to rotation, so that the seal connection portion 130A and the headgear connection portion 130B maintain their relative rotational position. The accordion cover 550 can be formed from semi-rigid plastic and have a deformable accordion-like geometry with ridges and bellows formed along its length. The accordion cover 550 can have a length that covers a portion of both the seal connection portion 130A and the headgear connection portion 130B. The accordion cover 550 has an inner cavity 552 through which the side arm 130 extends. The accordion cover 550 can have a size, shape, and geometry similar to the side arm 130, so that the accordion cover 550 is tightly wrapped around the hinge 510 and the side arm 130. The inner ridge 554 of the inner cavity 552 can have a close fit or interference fit with the side arm 130 so as to contact and tightly wrap around the outer surface of the side arm 130. Thus, by wrapping the accordion cover 550 around the side arm 130 and positioning it over the hinge 510, the accordion cover 550 resists rotation between the seal connection portion 130A and the headgear connection portion 130B until a predetermined threshold amount of force is applied to the side arm 130, causing the accordion cover 550 to flex and deform so as to allow the seal connection portion 130A and the headgear connection portion 130B to rotate relative to each other.

[0422] Hinge 510 is depicted as a butt-joint or mortise-and-tenon hinge having an inner joint 512 positioned within an outer joint 514. However, one of ordinary skill in the art will appreciate that hinge 510 may include different joints and / or hinge arrangements. Further, one of ordinary skill in the art will appreciate that the illustrated arrangement is not limited to a single hinge and may include multiple hinges and accordion-style covers. Still further, the illustrated arrangement is not limited to a hinge arrangement having a pin. Other hinge arrangements may be used, such as a protrusion that engages a receiving portion and rotates about it.

[0423] Figures 37A to 37C An interface 600 is shown having a side arm arrangement with side arms 130 formed from modular sections 610A, 610B, 610C that interlock similarly to a watch band. Figures 36A to 36D In the side arm arrangement of FIG, a plurality of interlocking modular segments 610A, 610B, 610C allow the side arm 130 to rotate along the horizontal plane while remaining substantially rigid along the vertical plane. More specifically, the segments 610A, 610B, 610C allow the side arm 130 to articulate incrementally and conform to the shape of the user's face when external horizontal forces are applied, such as Figure 37CAdditionally, the plurality of segments 610A, 610B, 610C allow for localized shape changes in the side arm 130 such that the side arm 130 conforms to facial features or landmarks on the user's face. Similar to the interface 500, the segments 610A, 610B, 610C of the side arm 130 resist rotation or shaking of the seal 114 caused by vertical forces (e.g., blow-off forces) acting on the seal 114. The segments 610A, 610B, 610C may be formed of an injection molded plastic material and have a Figures 36A to 36D The side arms 130 in the embodiment have a similar rectangular cross-sectional shape.

[0424] like Figure 37A As shown, segment 610A can be permanently or removably coupled to the connector portion of the seal frame 116 or connector 146 at one end. Segment 610A has a male connection portion 620 including an inner joint 622 positioned on the end opposite the frame 116. Similarly, segment 610B can be permanently or removably coupled to the headgear 118 at one end and has a female connection portion 630 on the end opposite the headgear 118, including an outer joint 632 defining a slot 616 therebetween. In some configurations, segments 610A and 610B are connected together by one or a series of segments 610C. Each segment 610C has a male connection portion 620 on one end and a female connection portion 630 on the other end, along the length of the segment 610C. The inner joint 622 of the male connection portion 620 of each segment 610A, 610C is positioned within the slot 616 located between the outer joints 632 of the female connection portion 630 of the segments 610B, 610C. The male connection portion 620 and the female connection portion 630 are connected by a pin 612, which fits within a through hole 614 extending through the male connection portion 620 and the female connection portion 630. Figure 37B As shown, the pin 612 and hole 614 are aligned with the height direction of the rectangular cross-section of the side arm 130, which is also substantially aligned with a vertical plane relative to the user.

[0425] Similar to a watch band, the pin 612 may be removable to allow for the addition or removal of segments 610C, thereby allowing for adjustment of the length of the side arm 130. One of ordinary skill in the art will appreciate that the segments are not limited to having male and female connecting portions 620, 630 with pins inserted through the inner and outer joints 622, 632, and may include alternative modular and interlocking connection arrangements.

[0426] Figures 38A to 38DAn interface 700 is shown having a side arm arrangement with spring-loaded side arms 130 that deform or deflect to provide a temporary shape change when a transient external horizontal force is applied to the side arms 130. When the transient external horizontal force is removed, the side arms 130 return to or toward their undeformed shape. Furthermore, the spring-loaded side arms 130 are extendable to expand or contract, allowing the interface 700 to accommodate a wider range of facial geometries and to account for blow-off forces in the mask. The side arms 130 have a spring portion 710 positioned between a seal connection portion 130A and a headgear connection portion 130B. The seal connection portion 130A can be permanently or removably coupled to the frame 116 so that the seal 114 is rigidly attached to the seal connection portion 130A, thereby preventing the seal 114 from rotating or rocking relative to the seal connection portion 130A. Similarly, the headgear connection portion 130B can be permanently or removably coupled to the headgear. The seal connection portion 130A, the headgear connection portion 130B, and the spring portion 710 can be integrally formed as a one-piece, one-piece side arm. The side arm 130 can be formed of an injection molded plastic material and have a Figures 36A-36D Rectangular cross-sectional shape similar to the side arm arrangement in 37A-37C.

[0427] like Figure 38B As shown, the spring portion 710 is shown as a linear accordion-style flat spring that is compressible, expandable, and horizontally rotatable. The spring portion 710 is formed as a series of straight sections 712 connected by bends 714. The bends 714 can form acute angles between the straight sections 712 to allow the spring portion 710 to bend, shorten in length, or expand in length. Figure 38C and 38D The spring portion 710 is shown to flex, shorten, and lengthen along a horizontal plane when a transient external horizontal force is applied to the side arm 130 to allow the side arm 130 to move relative to the seal 114. The spring portion 710 absorbs at least a portion of the transient external horizontal force rather than transferring all of the transient external horizontal force to the seal 114, so that the position of the seal 114 on the user's face remains undisturbed or less disturbed than in the case of other frame designs. The spring portion 710 can have an undeformed shape (i.e., when no transient external horizontal force is applied), wherein the seal connection portion 130A and the headgear connection portion 130B are substantially coaxial or parallel in the length direction on average. However, the spring portion 710 can be formed to have an undeformed shape that is curved or nonlinear in the length direction on average.

[0428] Similar to Figures 38A to 38D , Figure 39A and39B An alternative spring loaded side arm arrangement is shown which also deforms to provide a temporary shape change when a brief external horizontal force is applied to the side arm 130. However, unlike Figures 38A to 38D Compared to the side arms 130 in FIG, the seal connection portion 130A and the headgear connection portion 130B are connected to elastic sections 810, which provide a spring-loaded action similar to the spring portion 710. The elastic sections 810 can be formed from rubber or thermoplastic polyurethane (TPU). The elastic sections 810 are positioned between the seal connection portion 130A and the headgear connection portion 130B and separated by a rigid section 812. The seal connection portion 130A and the headgear connection portion 130B are also rigid. Thus, the elastic sections 810 flex and deform to allow the side arms 130 to be compliant in the horizontal plane, thereby allowing the side arms 130 to move relative to the seal 114 when a transient external horizontal force is applied. In other words, the elastic sections 810 absorb at least a portion of the transient external horizontal force rather than transmitting the entire transient external horizontal force to the seal 114, thereby allowing the seal 114 to remain in position on the user's face undisturbed or less disturbed than with other frame designs. Further, when the transient external horizontal force is removed, the elastic segments 810 return to their neutral, undeformed shape.

[0429] like Figure 39B As shown, the elastic section 810 has a male connection portion 820 on each end, and the rigid section 812 has a female connection portion 830 on each end. The elastic section 810 is connected to the rigid section 812 by positioning the male connection portion 820 into the female connection portion 830. The male connection portion 820 has a shape and size corresponding to the female connection portion 830, so that the male connection portion 820 and the female connection portion 830 are connected by a tight fit or an interference fit. The seal connection portion 130A and the headgear connection portion 130B each have a female connection portion 830 positioned on the end facing the rigid section 812. The rigid section 812 has female connection portions 830 positioned on both ends. In some configurations, additional elastic sections 810 and rigid sections 812 can be added or removed to adjust the length of the side arm 130. Further, the male connection portion 820 is depicted as a cylindrical post and the female connection portion 830 is depicted as a cylindrical slot. One of ordinary skill in the art will appreciate that the male and female connection portions 820, 830 are not limited to cylindrical posts and slots and may include alternative connection arrangements.

[0430] Figures 40A to 40EAn interface 900 is shown having a side arm arrangement having flexible side arms 130 that deform to provide a temporary shape change when a transient external horizontal force is applied to the side arms 130 while remaining substantially rigid along a vertical plane. The side arms 130 have one or both of an outer kerf 910 and an inner kerf 920 along the length of the side arms 130. The outer kerf 910 is positioned on an outer surface of the side arms 130 (i.e., facing away from the user) and is positioned closest to the seal 114. The inner kerf 910 is positioned on an inner surface of the side arms 130 (i.e., facing toward the user) and is positioned closest to the headgear 118. The side arms 130 are formed of an injection molded plastic material, and the kerfs 910, 920 can be integrally and monolithically formed into the side arms 130. Alternatively, the kerfs 910, 920 may be formed by cutting, molding, or otherwise forming vertical slots into the side arms 130. As shown, the side arms 130 have a Figures 36A-36D The side arm arrangement of FIG37A-37D has a rectangular cross-sectional shape similar to that of FIG37A-37D. The cheek pad 950 can be attached to the inner kerf 920 of the side arm 130 to prevent the inner kerf 920 from contacting the user's face. The cheek pad 950 can be formed of a soft padding material.

[0431] like Figure 40D and 40E As shown, the kerfs 910, 920 are formed by a series of living hinges or slots 930 recessed into the side arm 130 along the thickness of the side arm 130. The slots 930 extend across the entire width of the side arm 130. Therefore, the thickness of the side arm 130 is thinner at the portion having the slots 930 than at the portion located between the slots 930. As a result, when a brief external horizontal force is applied to the side arm 130, the side arm 130 is able to flex and rotate about the slots 930. Further, when the brief external horizontal force is removed, the kerfs 910, 920 allow the side arm 130 to return to or toward the undeformed shape. Figure 40DAs shown, the slots 930 have a depth X, a width Y, and are spaced apart by a spacing distance Z. The return force (i.e., the amount of resistance to flexing) that urges the side arm 130 to return to or toward its undeformed neutral shape is at least partially or primarily controlled by the depth X of the slots 930 (i.e., relative to the thickness of the side arm 130). Slots 930 having a greater depth X result in the side arm 130 having a thinner thickness T at the location where the slots 930 are located. Consequently, the thinner thickness T provides less resistance to flexing and a smaller return force for returning the side arm 130 to its undeformed shape than slots 930 having a smaller depth X. The maximum amount of flexing provided by the slots 930 is at least partially or primarily controlled by the width Y of the slots 930. Overall, slots 930 having a larger width Y allow for a greater amount of flexing of the side arm 130 about the slots 930. The maximum amount of flexure permitted by the slot 930 occurs when the slot 930 narrows in width until the sidewalls 932 of the slot 930 contact each other (e.g., Figure 40E Thus, providing the slot 930 with a greater width Y provides a greater distance between the side walls 932. However, the amount of flexure can be limited to prevent the side arms 130 from contacting the user's face or detaching from the headgear 118. Figure 40C Shows relative to Figure 40B The undeformed shape shown provides the maximum amount of flexion provided by both the inner and outer kerfs 920, 910. The flexion rate of the side arm 130 (i.e., gradual or acute flexion) is at least partially or primarily controlled by the spacing distance Z and the number of slots 930. Tightly spaced slots 930 with a narrow spacing distance Z will allow for a greater flexion rate of the side arm 130 than widely spaced slots 930 with a wider spacing distance Z. Thus, the amount and rate of flexion of the side arm 130 are determined by the depth X, width Y, and spacing distance Z of the slots 930. Further, while the side arm 130 is depicted as having geometrically identical slots 930, in some configurations, the slots 930 may have varying depths X, widths Y, and spacing distances Z along the length of the side arm 130, thereby allowing the side arm 130 to have varying amounts and rates of flexion and return forces along its length. Further, the slot 930 is not limited to a rectangular shape and may include a variety of shapes, such as a trapezoidal, curved, or semicircular shape.

[0432] Figures 41A to 41CAn interface 1000 is shown having a hook and post connector arrangement that allows rotation between the seal 114 and the side arms 130 of the headgear 118 and maintains the rotational position therebetween. In the illustrated configuration, the headgear 118 is detachable from the seal 114. The headgear 118 has a hook connector 1020 on each end of the side arms 130. The hook connector 1020 can be integrally formed with the side arms 130. The side arms 130 and hook connector 1020 can be formed of an injection molded plastic material and have the same Figures 36A-36D 37A-37D . The connector 146 of the frame 114 has a post 1010 on each end. The seal 114 is connected to the headgear 118 by attaching a hook connector 1020 to the post 1010. The hook connector 1020 has a cavity 1022 that receives the post 1010 so that the hook connector 1020 wraps over and around the post 1010. In other words, the post 1010 is positioned within the cavity 1022. In the illustrated configuration, the connector 146 has an opening 1012 adjacent to the post 1012, through which the hook connector 1020 extends so as to wrap around the post 1010.

[0433] like Figure 41BAs shown, the post 1010 has teeth 1014 extending radially outward from the post 1010. The hook connector 1020 has detents 1024 extending in a direction toward the cavity 1022. The detents 1024 engage valleys 1016 located between adjacent teeth 1014 such that rotation of the post 1010 within the cavity (i.e., rotation between the post 1010 and the hook connector 1020) is inhibited or blocked by the detents 1024. The detents 1024 are semi-rigid and deflectable to permit rotation of the hook connector 1020 about the post 1010 (i.e., including rotation of the side arm 130 in a horizontal plane) when an external horizontal force is applied to the side arm 130. That is, when an external horizontal force applied to the side arm 130 overcomes the yield strength of the pawl 1024, the pawl 1024 deforms as the hook connector 1020 rotates about the post 1010 and slides upward from the valley 1016 along the teeth 1014. The pawl 1024 slides upward along and over the teeth 1014 and slides downward along the adjacent valley 1016. The shape, thickness, and geometry of the teeth 1014 and pawl 1024 can be varied to customize the force profile for allowing the post 1010 to rotate relative to the hook connector 1020. Further, because the teeth 1014 extend radially outward from the post 1010, the hook connector 1020 can rotate clockwise or counterclockwise relative to the post 1010. In the illustrated configuration, the teeth 1014 are formed only on the side or portion of the post 1010 that faces the headgear 118, providing the post 1010 with a corresponding smooth surface for contact with the inner surface of the hook connector 1020. In alternative configurations, the teeth 1014 can be formed completely around the post 1010. The hook-and-post connector arrangement provides rotational resistance between the post 1010 and the hook connector 1020, allowing the user to put on and take off the interface using a traditional broken-loop donning and doffing method. Furthermore, the hook-and-post connector arrangement can also allow for alternative donning and doffing methods, such as a swing-fit type donning and doffing method, in which one end of the headgear / frame is connected to the mask, and the other end of the headgear / frame is swung around the head and connected to the mask. The hook-and-post connector arrangement accommodates a variety of donning and doffing methods to increase the usability of the interface.

[0434] Figures 42A to 42DAn alternative interface assembly or interface 1100 is shown having a seal 1114 that rotates horizontally (i.e., across the user's face) relative to the side arms 1130 and is biased by a leaf spring 1140 to a rotationally centered position between the side arms 1130. The rotating seal 1114 and leaf spring 1140 allow the interface 1100 to absorb external horizontal forces to inhibit or prevent the seal 1114 from moving down the user's nose, for example, when the user is sleeping on their side and a pillow contacts the interface 1100. Figure 42B Further, the rotating seal 1114 allows the interface 1110 to accommodate users with crooked noses, such as Figure 42C Similar to the interfaces disclosed above, the interface 1100 prevents or inhibits the seal 1114 from rotating along the vertical plane (ie, vertically across the user's face). Further, the leaf spring 1140 centers the seal 1114 when the external horizontal force is removed.

[0435] Similar to Figures 1 to 11 11. The interface 110 in FIG. 11 includes a seal 1114 attached to a frame assembly or frame 1116. Frame 1116 supports seal 1114. A connector portion or connector 1146, including side arms 1130, is attached to frame 1116. Frame 1116 and connector 1146 can be formed from a relatively rigid, semi-rigid, or rigid material, such as, for example, polycarbonate. Thus, in at least some configurations, frame 1116 and connector 1146 are more rigid than seal 1114.

[0436] Similar to Figures 1 to 11 The connector 146 in FIG. 1 is a generally U-shaped member (when viewed from a top-down perspective) that includes side arms 1130 and a central portion 1148 that connects the two side arms 1130 to each other. That is, the side arms 1130 can be integrally formed as a single piece with the connector 1146, which provides greater vertical stability (i.e., resists vertical movement of the seal across the user's face). Figures 1 to 11 Compared to connector 146 in FIG, connector 1146 is pivotally attached to frame 1116 to allow frame 1116 to rotate about a vertical axis relative to connector 1146, such that frame 1116 rotates along a horizontal plane. Connector 1146 can be pivotally connected to frame 1116 by a pivot mechanism, such as a cylindrical post positioned vertically within the socket.

[0437] As shown, the side arms 1130 extend outward (away from each other), backward, and upward at a shallow angle, past the left and right ends of the seal 1114, and along the left and right cheeks, and specifically the user's cheekbones, to connect to a headgear (not shown) to secure the seal 1114 to the user's face. At the outer or free ends of the side arms 1130, the side arms include connector portions 1134 for removably connecting the side arms 1130 to a headgear (not shown). The side arms 1130 are relatively inflexible in the horizontal and vertical planes (when worn).

[0438] like Figure 42A As shown, each side arm 1130 has a leaf spring 1140 attached to and extending from an inner surface 1132 of the side arm 1130. The leaf springs 1140 extend toward the frame 1116 a distance so as to be in sliding contact with an outer surface 1118 of the frame 1116 when the frame 1116 is centered between the side arms. The leaf springs 1140 are positioned along the inner surface 1132 so that when the frame 1118 is rotationally centered between the side arms 1130, both leaf springs 1140 contact the outer surface 1118 of the frame 1116. The leaf springs 1140 act as cantilever springs to bias the frame 1116 away from the side arms 1130. In other words, the leaf springs 1140 bias the frame 1116 to rotationally center the seal 1114 relative to the connector 1146. Figure 42D (Center) shows the neutral position of the frame 1116 relative to the side arms 1130, maintained by the leaf springs 1140. When the frame 1116 is centered between the side arms 1130, the leaf springs 1140 can be slightly in contact with the frame 1116 so as to be unloaded. However, in some configurations, when the frame 1116 is centered between the side arms 1130 or slightly biased toward one of the side arms 1130, the two leaf springs 1140 can be preloaded.

[0439] When the seal 1114 and frame 1116 are rotated from a centered position relative to the connector 1146, the leaf spring 1140 provides a return force to center the seal 1114 and frame 1116. Figure 42D(Left and right) The seal 1114 and frame 1116 are shown rotated from a centered position relative to the connector 1146. The leaf spring 1140 toward which the frame 1116 rotates deflects and applies a return force to center the seal 1114 and frame 1116. In the illustrated configuration, the leaf spring 1140 is in sliding contact only with the frame 1118. That is, the leaf spring 1140 is not fixed to the frame 1118. Thus, the leaf spring 1140 away from which the frame 1116 rotates does not contact the frame 1116 and remains undeflected. In some configurations, the leaf spring 1140 can be attached to both the connector 1146 and the frame 1116, such that both leaf springs 1140 apply a return force to the frame 1116 to center it relative to the connector 1146. The leaf spring 1140 can have a smoothly curved shape and a sliding surface to reduce sliding friction between the leaf spring 1140 and the frame 1116. 1140 .

[0440] Figures 43A to 43C An alternative interface assembly or interface 2100 is shown having a seal 2114 that slides horizontally or laterally between side arms 2130 (ie, across the user's face). Figures 42A to 42D Compared to the interface 1100 in FIG. 1 , the seal 2114 slides horizontally or laterally across the user's face, as opposed to rotating horizontally about an axis across the user's face. Sliding the seal 2114 horizontally between the side arms 2130 allows the interface 2100 to absorb and adjust to external horizontal forces, such as to inhibit or prevent the seal 2114 from moving down the user's nose when the user sleeps on their side and a pillow contacts the interface 2100, as in FIG. Figure 43B and 43C Similar to the interfaces disclosed above, the interface 2100 prevents or inhibits the seal 1114 from rotating or flexing along a vertical plane (ie, vertically across the user's face).

[0441] like Figure 43AAs shown, the side arms 2130 are connected to each other by a bridge or central portion 2148. That is, each side arm 2130 is connected to the central portion 2148 at its end, thereby forming a closed loop with the headgear 2118. The side arms 2130 can be permanently or removably coupled to the headgear 2118. The side arms 2130 can be integrally formed as a single piece with the connector 2146 from a material such as polycarbonate, so that the side arms 2130 and the central portion 2148 are rigid. Similar to the interface disclosed above, the side arms 2130 and the central portion 2148 have an elongated cross-section with a height significantly greater than the thickness, so that the side arms 2130 and the central portion 2148 resist vertical rotation (i.e., vertically across the user's face). The side arms 2130 and the central portion 2148 are connected to the frame 2116 by a connector portion or connector 2146. The connector 2146 has a channel 2150 through which the central portion 2148 slides. The channel 2150 has a shape and size corresponding to the side arms 2130 and the central portion 2148, so that the side arms 2130 and the central portion 2148 can slide within and move through the channel 2150. In operation, when a user sleeps on their side and a pillow (applying force to the side arms 2130) contacts the interface 2100, the side arms 2130 and the central portion 2148 are displaced and pushed through the channel 2150 of the connector 2146, so that the seal 2114 does not move and the position of the seal 2114 on the user's nose is not disturbed.

[0442] In some configurations, the range of travel between the side arms 2130 can be limited by changing the cross-sectional size and shape of the central portion 2148 or the side arms 2130 such that the enlarged area of ​​the central portion 2148 or the side arms 2130 cannot enter the connector 2146. For example, the height and / or thickness of the end portions of the central portion 2148 can be increased such that the end portions of the central portion 2148 are larger than the height and / or width of the channel 2150. As a result, the range of travel of the frame 2116 will be limited between the ends of the central portion 2148. In alternative configurations, protrusions extending from the surface of the central portion 2148 or the side arms 2130 can be used to obstruct the central portion 2148 or the side arms 2130 from entering the connector 2146, thereby limiting the range of travel.

[0443] Figures 44A to 49C A nasal seal is presented that has features that inhibit or preferably prevent improper donning of the nasal seal and also indicate to the user that the seal is being donned incorrectly. A common donning error for users is inserting their nose into the nasal port of the seal. As a result, the seal will not properly seal around the user's nose, and the mask may not function properly. Furthermore, the mask may become uncomfortable to wear, and the user may be discouraged from continuing to wear the mask. Figures 42A to 49C The feature of the nasal seal indicates to the user that the nasal seal is not being worn correctly, prevents or inhibits the user from wearing the nasal seal incorrectly, or provides guidance to the user on how the nasal seal should be worn properly.

[0444] Figures 44A to 44D The illustrated configuration depicts a nasal seal 114 that provides physical feedback to the user indicating that the seal 114 is not being worn correctly, which discourages the user from continuing to wear the seal 114 incorrectly. Figure 1-22 The seal described herein is a mask that is not intended to be worn by a user, and therefore, redundant descriptions of similar structures will be largely omitted. The seal 114 has an inwardly or rearwardly facing central portion 204 that faces or contacts the user during use of the mask 114. The central portion 204 has a nasal opening or orifice 128 defined by an upper edge 234, a lower edge 236, and a plurality of side edges 238. As shown, the seal 114 has a thickened flange 1210 that causes the flange 1210 to be harder than the central portion 204 of the seal 114. The flange 1210 is formed along the upper portion of the orifice 128 to define the upper edge 234 of the orifice 128 and extends toward the interior or dead space 228 of the seal 114 when the seal is not being worn by the user and is not deformed. The ends of the flange 1210 can be extended to connect to the side edges 238, which can also increase the hardness of the flange 1210. In some configurations, the flange 1210 can extend to include a lower edge 236, thereby substantially or completely surrounding the nasal orifice 128. The flange 1210 has a greater thickness than along the central portion 204 of the seal 114, making the flange harder and more rigid than the central portion 204. The flange 1210 is shown as having a constant thickness, but the thickness of the flange 1210 can vary along its length. The flange 1210 can be integrally formed with the seal 114. The flange 1210 extends downwardly into the dead space 228 of the seal 114. In some configurations, the nasal orifice 128 has a rim that includes a thickened bead at the upper edge 234 of the nasal orifice 128.

[0445] Figure 44B 1 shows the seal 114 properly donned on a user. As shown, the user's nose is positioned on top of the seal 114 so that the orifice 128 is positioned below the user's nostrils and the tip of the user's nose is in contact with the central portion 204 of the seal. Further, when the seal 114 is properly donned on the user, the flange 1210 does not contact the user. Rather, the flange 1210 is positioned below the user's nostrils and extends away from the nose and into the seal 114.

[0446] Figure 44C The seal 114 is shown being improperly donned on a user. Figure 42B In contrast, the user's nose extends through the orifice 128 and is positioned within the seal 114. With the user's nose extending through the orifice 128, the flange 1210 is positioned on top of the user's nose, such that the bottom edge 1212 of the flange 1210 presses into the tip, end, or bridge of the user's nose. The stiffness of the flange 1210 (i.e., due to its thickness and the fact that the end is attached to the side edge 238 of the orifice 128) prevents the flange 1210 from deforming inward or collapsing into the seal 114 due to the force of the user's nose pushing into the orifice 128. In this way, the user will physically feel the flange 1210 pressing against their nose and causing discomfort, which will provide tactile feedback or an indication to the user that the seal is not being worn correctly. In other words, the discomfort felt by the user caused by the flange 1210 will be perceived as an indication that the seal 114 is not being worn correctly. The flange 1210 also prevents blow-off because the flange 1210 is formed from thicker silicone and, therefore, is stiffer and better able to retain its shape under the application of a blow-off force.

[0447] Figures 44D to 44F An alternative flange configuration is shown including a flange 1210 having through holes or blow holes 1214 extending through the flange 1210. The blow holes 1214 provide a path for pressurized air to escape from the interior of the seal to the exterior of the seal. Figure 44B , when the seal 114 is properly worn by the user, as Figure 44E As shown, the user's nose is positioned on top of the seal 114 and the flange 1210 does not contact the user when the seal 114 is properly donned on the user. Figure 44F As shown, when the seal 114 is not properly worn on the user, the user's nose is pressed into the orifice 128, so that the bottom edge 1212 of the flange 1210 is pressed into the user's nose, which is similar to Figure 44CIn operation, when seal 114 is filled with air under positive pressure, pressurized air will flow through blow holes 1214. Flange 1210 and blow holes 1214 are positioned slightly above the user's nose so that the user will feel the pressurized air flow blowing through blow holes 1214. Therefore, in addition to the discomfort of flange 1210 pressing into the user's nose, the user will also feel the air flow escaping the seal just above their nose. In some configurations, the blow holes can be positioned and / or angled so that the blow holes 1214 direct the pressurized air flow toward the user's eyes. Furthermore, the size and shape of blow holes 1214 can be tuned to provide an audible sound, thereby providing the user with an audible indicator that seal 114 is not being worn correctly. One of ordinary skill in the art will appreciate that blow holes 1214 are not limited to a circular cross-section and can be formed with different cross-sectional shapes and sizes.

[0448] Figure 44G and 44H An alternative flange configuration is shown including a flange 1210 having a rounded bottom edge 1212. Similar to Figures 44A-44F When the user's nose is pressed into the orifice 128, the flange 1210 presses into the user's nose and the blow holes 1214 direct the pressurized air toward the user's eyes to indicate to the user that the seal 114 is not worn correctly. Figures 44A-44F Compared to the flange 1210 in FIG. 1 , the rounded bottom edge 1212 can provide a wider and rounded surface that can contact the user's nose without leaving marks or indentations on the user's nose. Figure 44G A flange 1210 is shown having a semicircular cross-section. Figure 44H A flange 1210 is shown having an upper portion that is rectangular in cross-section and a rounded bottom portion of the flange. The rectangular upper portion allows the flange 1210 to flex so that the force of the flange 1210 pressing down on the user's nose is distributed over a larger area so as not to leave marks or indentations on the user's nose.

[0449] Figure 44I Shown includes an alternative having recess 1216 Figures 44D-44F 128 and 129. An alternative flange configuration for the flange 1210 that provides an air hole 1214 in the flange 1210 may be provided. A recess 1216 may be formed into the bottom edge 1212 of the flange 1210 such that when the user's nose is pressed into the orifice 128 and the seal 114 is pressurized (i.e., the seal 114 is not properly donned on the user), pressurized air will flow through the recess 1216.

[0450] Figures 45A to 45CThe illustrated configuration depicts a nasal seal 114 that physically prevents or inhibits a user from improperly wearing the seal 114. More specifically, the seal 114 obstructs insertion of the user's nose into the seal 114 through the aperture 128. The nasal seal 114 is similar to Figure 1-22 and Figures 44A-44I The seal described herein is the same as that of the seal described herein, and therefore, redundant descriptions of similar structures will be largely omitted. Figure 45A As shown, seal 114 has a woven mesh 1310 that is overmolded or otherwise attached to upper edge 234, lower edge 236, and side edge 238 of orifice 128 such that woven mesh 1310 is flush with the sealing surface of seal 114. Woven mesh 1310 spans and covers orifice 128. Woven mesh 1310 allows air to flow through orifice 128 while preventing or inhibiting a user from inserting their nose into orifice 128. Woven mesh 1310 can be overmolded onto orifice 128 from a silicone material. Woven mesh 1310 can be elastic so as to conform to the shape of orifice 128 and deform with seal 114. However, woven mesh 1310 can be tensioned so as to prevent or inhibit a user's nose from entering seal 114. Further, the strand width and thickness or fineness of the woven mesh 1310 may be varied to provide strength to withstand the force of a user's nose pushing into the orifice 128 while also maintaining any pressure drop caused by the woven mesh 1310 restricting the flow of air through the orifice 128.

[0451] Figure 45B and 45C An alternative configuration of the nasal seal 114 is shown having a woven mesh 1310 offset inwardly into the seal 114 by an offset flange 1320. Figure 45C As shown, the outer edges of the offset flange 1320 can be attached to the upper edge 234, the lower edge 236, and the side edges 238 of the orifice 128, and the offset flange 1320 extends inwardly in a direction toward the interior of the seal 114. The inner edge of the offset flange 1320 is attached to the woven mesh 1310. The offset flange 1320 positions the woven mesh 1310 away from the sealing surface so that when the user's nose is positioned over the orifice 128, the user's nose does not make direct skin contact with the woven mesh 1310.

[0452] Figure 45D and 45E An alternative configuration of the nasal seal 114 is shown that hinders insertion of the user's nose into the seal 114 through the aperture 128. Figures 45A-45CIn contrast to the woven mesh 1310, the seal 114 has an orifice cover 1410 having an array of apertures 1420 extending therethrough. Similar to the woven mesh 1310, the orifice cover 1410 hinders insertion of the user's nose into the seal 114 through the orifice 128. The orifice cover 1410 is attached to the upper edge 234, lower edge 236, and side edges 238 of the orifice 128 such that the orifice cover 1410 is flush with the sealing surface of the seal 114. The orifice cover 1410 can be integrally or unitarily formed with the seal 114. The apertures 1420 extend through the orifice cover 1410 and are evenly distributed across the orifice cover. The apertures 1420 allow air to flow through the orifice cover 1410 while preventing or inhibiting the user from inserting their nose into the orifice 128. The diameter and spacing of the holes 1420 can be configured to minimize noise and pressure drop. One of ordinary skill in the art will appreciate that the holes 1420 can include an unlimited combination of holes having different shapes, sizes, and arrangements. Figure 45E Examples of holes 1420 arranged on the aperture cover 1410 are shown, such as a combination of large and small holes, holes in a polygonal shape, wide holes across the aperture, and holes arranged in a fan configuration across the aperture.

[0453] Figures 46A to 46D Also shown is an alternative configuration of the nasal seal 114 that obstructs insertion of the user's nose into the seal 114 through the aperture 128. Figures 45A-45C woven mesh 1310 and Figures 45D-45E In contrast to the orifice cover 1410 of the orifice 128, the orifice 128 has a series of tethers 1510 attached to the periphery of the orifice 128 along the upper edge 234, lower edge 236, and side edges 238 of the orifice 128. When a user attempts to insert his / her nose into the orifice 128, the user's nose will contact one or more of the tethers 1510, which will indicate to the user that the seal 114 is not properly donned. If the user continues to insert his / her nose into the orifice 128, the tethers 1510 will block or hinder the user from advancing further into the orifice 128.

[0454] Tethers 1510 extend downwardly into seal 114 and are attached to an inner surface 1520 of the bottom wall of the seal. Tethers 1510 are elongated, string-like strands of silicone that are bonded or integrally molded with components of seal 114 or seal 114 itself. Tethers 1510 are evenly spaced around the perimeter of orifice 128.

[0455] like Figure 46CAs shown, when the seal 114 is undeformed (i.e., the seal 114 is not worn on a user), the tether 1510 is tensioned (i.e., there is tension in the tether 1510). Thus, the tether 1510 anchors the central portion 204 of the seal 114 to the inner surface 1520 at the bottom of the seal 114, which allows the seal 114 to maintain its undeformed shape. In this way, the undeformed position of the edge of the orifice 128 can be controlled and maintained. Figure 46D As shown, when the seal 114 is properly donned on a user, the tether 1510 is slack (i.e., there is no tension in the tether 1510). That is, when the seal 114 is donned by the user, the seal 114 is compressed, which reduces the distance between the aperture 128 and the inner surface 1520 at the bottom of the seal 114. As a result, the tether 1510 is compressed and becomes slack.

[0456] Figures 46E to 46H Another alternative configuration of the nasal seal 114 is shown that hinders insertion of the user's nose into the seal 114 through the aperture 128. Figures 46A-46D In contrast to the tether 1510 of the seal 114, the seal 114 has a buffer 1610 attached to an inner surface 1620 at the bottom of the seal 114 and positioned immediately below the orifice 128. Figure 46F As shown, when the user attempts to insert his / her nose into the orifice 128, the seal 114 will compress and the user's nose will contact the cushion 1610. When contacting the cushion 1610, the user is provided with feedback so that the user can realize that the user should not insert his / her nose into the orifice 128 and will try to put the seal 114 back on so that the user's nose is positioned outside the orifice 128.

[0457] The buffer includes vertical struts 1612 and lateral crossbars 1614. Struts 1612 are positioned below the aperture 128 and attached to an inner surface 1620 at the bottom of the seal 114. Struts 1612 extend vertically upward toward the aperture 128. The upper ends of struts 1612 are attached to crossbars 1614. Crossbars 1614 have an elongated shape that extends laterally across the width of the aperture 128.

[0458] The support 1612 has a certain height so that when the seal 114 is properly donned on the user, the crossbar 1614 is positioned a certain distance below the orifice 128, such as Figure 46CAs shown. In other words, when seal 114 is properly donned on the user, crossbar 1614 does not contact the user's nose. Seal 114 may be slightly compressed due to the force required to provide an airtight seal around the user's nose. However, pillars 1612 have a certain height so that crossbar 1614 does not contact the user's nose even though seal 114 is compressed. Pillars 1612 and crossbar 1614 can be formed from a silicone material so that they are flexible and do not cause pain or damage when they come into contact with the user's nose. Pillars 1612 and crossbar 1614 can be integrated with or integrally molded into components of seal 114 or seal 114 itself. Furthermore, pillars 1612 can have a curved shape so that the shape of pillars 1612 can provide a certain amount of flexibility so that pillars 1612 deform when they come into contact with the user's nose.

[0459] The crossbar 1614 is shown as having a straight, elongated cylindrical shape. However, one of ordinary skill in the art will appreciate that the crossbar 1614 can have one of a variety of shapes that hinder the passage of a user's nose or other object through the aperture 128 and deeper into the seal 114. Further, in some configurations, the seal 114 can have the posts 1612 without the crossbar 1614 attached to the upper ends of the posts 1612. Figure 46H A strut arrangement is shown with struts 1612 but without cross beams.

[0460] Figures 47A to 47GAn alternative configuration of the orifice 128 for a seal (not shown) is shown that inhibits or prevents insertion of a user's nose into the orifice 128 by providing different locations for the user's left and right nostrils above the orifice 128. As shown, the upper and lower edges 234, 236 of the orifice 128 narrow at a lateral midpoint of the orifice 128 to form a narrow central portion 1710 of the orifice 128, which is positioned between the left and right nostril portions 1712. The widest distance between the upper and lower edges 234, 236 of the orifice 128 at the narrow central region 1710 is significantly narrower than the widest distance between the upper and lower edges 234, 236 at the left and right nostril portions 1712. Thus, the narrow central portion 1710 defines distinct left and right nostril portions 1712, such that the user can intuitively and visibly recognize that his / her nostrils should be positioned over the left and right nostril portions 1712 because the user will recognize that the orifice 128 is too narrow at the narrow central portion 1710 for inserting his / her nose. Further, if the user attempts to insert his / her nose into the orifice 128, the portion of the seal 114 surrounding the narrow central portion 1710 will contact the tip or septum of the user's nose, thereby hindering or blocking insertion into the orifice 128. The left and right nostril portions 1712 can be oval in shape. The orifice 128 can be formed in a variety of shapes, such as, but not limited to, a kidney shape ( Figures 47A-47D ) or crescent shape ( Figure 47E ). The left and right nostril portions 1712 can be angled toward each other such that the uppermost edges of the left and right nostril portions 1712 are closer together than the lowermost edges of the left and right nostril portions 1712. In some configurations, the left and right nostril portions 1712 can be angled away from the narrow central region 1710. Each of the left and right nostril portions 1712 can have a certain shape such that the width of the uppermost portion of the left and right nostril portions 1712 is narrower than the width of the lowermost portion of the left and right nostril portions 1712. In some configurations, the narrow central region 1710 can be positioned closer to the upper edge 234 of the orifice 128, such as Figure 47A 、 47C In other configurations, the narrow central region 1710 can be positioned closer to the lower edge 236 of the orifice 128, as shown in FIG. Figure 47B shown.

[0461] like Figures 47A to 47FAs shown, the position, shape, and size of the narrow central region 1710 between the upper edge 234 and the lower edge 236 of the orifice 128 can vary depending on the size and shape of the user's nose and nostrils. Similarly, the size and shape of the left and right nostril portions 1712 can also vary depending on the size and shape of the user's nose and nostrils. Figure 47F and 47G The orifice 128 is shown with overlapping upper and lower edges 234, 236. As shown, the lower edge 236 extends above the upper edge 234, thereby completely separating the left and right nostril portions 1712. The separated left and right nostril portions 1712 provide a clearly distinct location above the orifice 128 for the user's left and right nostrils.

[0462] In some configurations, the seal 114 can be configured such that the aperture 128 having the overlapping upper and lower edges 234, 236 provides a flush sealing surface for the nose of a user to be seated thereon. Figure 47G As shown, upper portion 1730 of seal 114 can have a recess 1732 that receives lower portion 1740 of seal 114 such that the seating surface at the intersection of upper portion 1730 and lower portion 1740 is substantially flat. The substantially flat seating surface at the intersection of upper portion 1730 and lower portion 1740 inhibits or prevents a portion of a user's nose from being squeezed between upper portion 1730 and lower portion 1740. Lower portion 1740 can also have a protrusion 1742 having a shape corresponding to recess 1732 such that when seal 114 is donned on a user, upper portion 1730 and lower portion 1740 interlock and provide a substantially flat seating surface.

[0463] Figures 48A to 48D An alternative configuration of the nasal seal 114 is shown that provides visual guidance to the user as to how the seal 114 should be properly fitted to the nose. Figure 48AAs shown, the seal 114 has a marking 1810 to visually indicate to the user where to position his / her nose over the orifice 128. The marking 1810 is depicted as a circular target with a central "bull's eye." The marking 1810 is positioned on the central portion 204 of the seal 114 at a location where the user's nose should be positioned. The marking 1810 can be printed with ink on the inner or outer surface of the seal 114. In some configurations, the ink can be a water-based washable ink that can be removed with water, so that once the user learns how to properly wear the seal 114, the marking 1810 can be removed. In other configurations, the marking 1810 can be a sticker applied to or on the inner surface of the seal 114 within the dead space using an adhesive, so that the marking 1810 is visible through the surface of the seal 114. Figure 48B An alternative targeted marker 1810 is shown. Figure 48C A combination of markings is shown including a marking 1810A indicating the alignment of the user's nose on the seal 114 and a marking 1810B indicating the position of the underside of the user's nose on the orifice 128 . Figure 48D Indicia 1810 is shown that depicts the outline of the user's nose to indicate both the alignment of the user's nose on the seal 114 and the position of the user's nose over the orifice 128 .

[0464] Rather than explicit images indicating the precise location, placement, and / or alignment of the user's nose, the indicia 1810 may include fun or comical images to convey the location of the seal 114 on the user's face. Figure 48E Depicted is an indicia 1810 in the form of a mustache printed onto the central portion 204 of the seal 114 below the orifice 128, which is positioned below the user's upper lip. The image of the mustache provided by the indicia 1810 will indicate to the user where his / her upper lip should be positioned. Similarly, Figure 48F Depicted are indicia 1810 in the form of flowers that are printed onto the central portion 204 of the seal 114 above the orifice 128, which is positioned under the user's nose. In some configurations, the indicia 1810 may also be scented (e.g., floral) to further indicate how the seal 114 should be worn. In other configurations, the indicia 1810 may be a sticker applied to the seal 114 using an adhesive. In other configurations, the indicia 1810 may be applied using an ink or sticker that changes color based on temperature, such that an area of ​​the seal 114 may change color (e.g., red or green) when the seal 114 is worn incorrectly or correctly. The changing color may provide positive or negative feedback about the user's behavior.

[0465] Compared to the printed mark 1810, Figures 48G to 48I Indicia 1910 is shown formed as frosted silicone. Indicia 1910 may be integrally and unitarily molded into seal 114 to provide frosted silicone indicia 1910 having an opaque appearance that contrasts with the translucent appearance of the remainder of seal 114. Similar to Figure 48D , Figure 48G Frosted silicone markings 1910 are shown that indicate both the position and alignment of the user's nose on the seal 114 and the position of the user's nostrils on the orifice 128 . Figure 48H Frosted silicone markers 1910 are shown that indicate the location of the user's nostrils on the orifice 128 by outlining the shape of the user's nostrils in frosted silicone. Figure 48A , Figure 48I Target-style markings 1910 in frosted silicone are shown that may indicate where the tip of the user's nose should be positioned on the seal 114 .

[0466] As an alternative to printed markings, Figures 49A to 49C A deformable marker or depressible vortex 2010 is shown that deforms to indicate that the seal 114 is properly donned on the user. Similar to the target or "bull's eye" shaped marker 1810, the vortex 2010 is positioned on the central portion 204 of the seal 114 at a location where the user's nose should be positioned. Figure 49C As shown, when depressed, the vortex 2010 deforms inwardly toward the interior cavity or dead space of the seal 114. Thus, when the tip of the user's nose is positioned over the vortex 2010, the vortex 2010 will deform inwardly to provide the user with tactile positive feedback that the seal 114 is correctly positioned. The vortex 2010 may also create an audible "pop" noise as it deforms inwardly. When the seal 114 is removed from the user's face, the vortex 2010 can be reset to extend outwardly (i.e., away from the interior or dead space of the seal 114), such that the vortex 2010 is repositioned for the next wear. As deformable vortices are also used on consumer products (e.g., takeout coffee lids), the vortex 2010 provides an easily identifiable mechanism for indicating where the user's nose should be placed on the seal 114.

[0467] The trapped vortex 2010 can also be used to indicate whether the seal 114 is sufficiently tight against the user. For example, a force profile or a threshold amount of force required to deform the trapped vortex 2010 can be determined based on the appropriate tightness of the seal 114 against the user's nose or face. Thus, the trapped vortex 2010 will not deform unless a threshold force is applied that will indicate to the user whether the seal 114 is sufficiently tight against the user's nose or face.

[0468] Figures 50A to 50F An alternative configuration of an interface 3110 is shown that adjusts the angle of the nasal seal 3114 based on the angle of the user's nose so as to comfortably fit the user's nose over a wide range of upward or downward angles and minimize the amount of force applied to the user's under-nose area. In general, the user's under-nose area is sensitive to the upward force applied by the seal. However, in order to inhibit or prevent the seal from leaking, the seal must apply an upward force to the user's nose that is greater than the blow-off force. The blow-off force varies based on the upward or downward angle of the user's nose. Thus, a seal that comfortably fits a user with an upwardly angled nose (i.e., by applying a minimal amount of force to the user's under-nose area) may be uncomfortable for a user with a downwardly angled nose because the seal will not be aligned with the blow-off force, thereby applying a greater amount of force to the user's under-nose area. Therefore, in order to reduce or minimize the amount of force applied to the under-nose area, the interface 3110 provides the following seal 3114, which is rotatable according to the upward or downward angle of the user's nose so as to provide a sealing force that is aligned with and directly opposite to the user's blowing force, thereby reducing or minimizing the amount of force applied to the under-nose area of ​​the user.

[0469] exist Figure 50A In FIG. 3 , the interface 3110 has a seal 3114 attached to a frame 3116. The seal 3114 and the frame 3116 are similar to Figure 1-22The seal 114 and frame 116 described above are similar to those described above, and therefore, redundant descriptions of similar structures will be largely omitted. The frame 3116 is rotatably attached to the upper frame rail 3122 at the upper connecting portion 3152 and is rotatably attached to the lower frame rail 3124 at the lower connecting portion 3154. That is, the frame 3116 rotates relative to the upper frame rail 3122 around the upper connecting portion 3152, and the frame 3116 also rotates relative to the lower frame rail 3124 around the lower connecting portion 3154. The upper frame rail 3122 and the lower frame rail 3124 can be formed of a relatively rigid, semi-rigid or rigid material, such as polycarbonate. The ends of the upper frame rail 3122 and the lower frame rail 3124 are attached to the forward strap 3140 of the headgear 3118. That is, the ends of the upper frame rails 3122 are attached to the upper headgear strap 3142, and the ends of the lower frame rails 3124 are attached to the lower headgear strap 3144. In this way, the seal 3114 is supported by the headgear 3118 at the upper connecting portion 3152 and the lower connecting portion 3154.

[0470] The upper frame rail 3122 and the lower frame rail 3124 can be attached to the upper headgear strap 3142 and the lower headgear strap 3144 by the connecting mechanism 3160, so that the upper frame rail 3122 and the lower frame rail 3124 can be extended or retracted relative to the headgear 3118, as shown. Figure 50B More specifically, extension or retraction of the upper and lower frame rails 3122, 3124 changes the relative positions of the upper and lower connecting portions 3152, 3154, which results in rotation of the seal 3114 and allows for rotational adjustability of the seal 3114 within a range of angular rotation. Figure 50B The rotational position of the seal 3114 is depicted by a dotted line.

[0471] To demonstrate, Figure 50C and 50DThe following is a schematic side view of the upper frame rail 3122 and the lower frame rail 3124, illustrating the corresponding positions of the upper connecting portion 3152 and the lower connecting portion 3154 when the upper frame rail 3122 and the lower frame rail 3124 are extended or retracted from the upper headgear strap 3142 and the lower headgear strap 3144. As shown in the figure, the length L1 is measured as the distance between the upper connecting portion 3152 and the end of the upper headgear strap 3142. Similarly, the length L2 is measured as the distance between the lower connecting portion 3154 and the end of the lower headgear strap 3144. Therefore, extending or retracting the upper frame rail 3122 or the lower frame rail 3124 relative to the upper connecting portion 3152 and the lower connecting portion 3154 changes the lengths L1 and L2. To further illustrate the effect of extending or retracting the upper headgear strap 3142 and the lower headgear strap 3144, a front plane projection line FP defined by the upper connecting portion 3152 and the lower connecting portion 3154 represents the front plane of the frame 3116. Thus, the angle of the front plane projection line FP changes depending on the lengths L1 and L2 of the upper frame rail 3122 and the lower frame rail 3124.

[0472] When compared Figure 50C and 50D When Figure 50C and 50D The length L1 does not change. However, from Figures 50C to 50D , the length L2 increases. That is, Figure 50D The length L2 in Figure 50C Therefore, the lower connecting portion 3154 is positioned larger than in Figure 50C Further away from the headgear 3118 (which causes the seal 3114 to rotate downward), as shown by Figure 50D 124. The seal 3114 is rotated in a clockwise manner relative to the front plane projection line FP in FIG. 125. Similarly, although not depicted, extension of the upper frame rail 3122 and retraction of the lower frame rail 3124 will cause the seal 3114 to rotate upward and cause the front plane projection line FP to rotate counterclockwise. The range of angular rotation provided by the upper frame rail 3122 and the lower frame rail 3124 can depend on the amount or range of extension and retraction provided to both the upper frame rail 3122 and the lower frame rail 3124 by the connection mechanism 3160. Thus, rotation of the seal 3114 within the range of angular rotation allows the seal 3114 to comfortably fit the nose of a user over a wide range of positive or negative nasal angles so as to minimize the amount of force applied to the under-nose region of the user.

[0473] To demonstrate the rotational adjustability of seal 3114 provided by interface 3110, Figure 50E shows a cross-sectional view of the seal 3114 fitted to the nose of a user having a positive nose angle, and Figure 50FA cross-sectional view of a seal 3114 fitted to the nose of a user having a negative nose angle is shown. The nose angle is determined based on the angle σ between the base plane BP of the user's nose and a horizontal reference plane H. A positive nose angle is defined as an angle σ above the horizontal reference plane H. A negative nose angle is defined as an angle σ below the horizontal reference plane H. Figures 50E-50F Also depicted are the blow-off force vectors BOF for positive and negative nose angles. As shown, the blow-off force vector BOF for positive nose angles is angled closer to the horizontal plane than the blow-off force vector BOF for negative nose angles. Figures 50E-50F Also depicted is a front plane projection line FP, which is defined by the connecting portion 3152 and the lower connecting portion 3154 and represents Figures 50A-50D The front plane of the illustrated frame 3116. The interface 3110 accommodates the different angles of the blow-off force vector BOF resulting from positive and negative nose angles by allowing the seal 3114 to rotate according to nose angle so that the front plane projection line FP is perpendicular to the blow-off force vector BOF. Aligning the front plane projection line FP perpendicular to the blow-off force vector BOF minimizes the amount of force applied to the user's under-nose area.

[0474] like Figure 50E As shown, with seal 3114 fitted to a negative nose angle ( Figure 50F ), the seal 3114 fitted to the positive nose angle is rotated clockwise such that the front plane projection line FP is perpendicular to the blow-off force. Thus, the amount of force applied to the user's under-nose area in order to seal the seal 3114 against the user's nose is minimized. Figure 50F In, with Figure 50E Compared to the seal 3114 fitted to the positive nose angle in FIG, the seal 3114 fitted to the negative nose angle is rotated counterclockwise so that the front plane projection line FP is also perpendicular to the blow-off force. Therefore, the amount of force applied to the user's under-nose area to provide a seal against the user's nose is minimized. To further illustrate the difference in the rotation angle of the front plane projection line FP, the angle θ between the front plane projection line FP and the vertical reference plane V is shown. As shown in the figure, Figure 50E The angle θ of the front plane projection line FP of the seal 3114 that fits into the positive nose angle is less than Figure 50F Angle θ of the front plane projection line FP of the seal 3114 that fits to the negative nose angle.

[0475] The seal 3114 can be rotatably attached to the upper and lower frame rails 3122, 3124 by any connection arrangement that allows the frame 3116 to rotate. In other words, the upper and lower connection portions 3152, 3154 can include any of a variety of connection arrangements that allow the frame 3116 to rotate. In some configurations, the frame 3116 can have rings or through-holes located on the front portion of the frame 3116 through which the upper and lower frame rails 3122, 3124 pass, thereby allowing the frame 3116 to rotate about the upper and lower frame rails 3122, 3124.

[0476] The connection mechanism 3160 can include any connection mechanism arrangement between the headgear 3118 and the upper frame rail 3122 and the lower frame rail 3124 that provides for extension and retraction of the upper frame rail 3122 and the lower frame rail 3124 such that the seal 3114 is rotatable through a range of angular rotation. The connection mechanism 3160 can include a rigidity adjustment mechanism as described in U.S. Provisional Patent Application 61 / 261,715, which is incorporated herein by reference.

[0477] Figures 51A to 51G An alternative connection mechanism is shown that allows the seal 3114 to be rotated through a range of angular rotation. Figures 51A-51B A connection mechanism 3260 is shown that includes a circulating or closed-loop cable 3220 and a pulley 3230. The closed-loop cable 3220 has an upper loop portion 3222 and a lower loop portion 3224. Similar to the upper and lower frame rails 3122, 3124, the closed-loop cable 3220 is connected to the frame 3116 at an upper connection portion 3152 and a lower connection portion 3154. The upper and lower connection portions 3152, 3154 may include loops or through-holes located on the front portion of the frame 3116 through which the closed-loop cable 3220 passes, thereby allowing the frame 3116 to rotate about the upper and lower frame rails 3222, 3224.

[0478] like Figures 51A-51B As shown, the closed-loop cable 3220 is wrapped around a pulley 3230. The pulley 3230 is attached to the forward strap 3240 of the headgear 3118. Rotating the pulley 3230 clockwise or counterclockwise allows the upper and lower ring portions 3222 and 3224 to increase or decrease in length, thereby rotating the seal 3114. In other words, rotating the pulley 3230 pulls the upper and lower connecting portions 3152 and 3154 closer to the headgear 3118. Thus, the user can rotate the pulley 3230 to rotate and adjust the seal 3114 until the seal 3114 is comfortably fitted.

[0479] In some configurations, the pulley 3230 can have a recessed groove around its perimeter to receive the closed-loop cable 3220. Additionally, the user can don and doff the seal 3114 by detaching the closed-loop cable 3220 from the pulley 3230. Furthermore, the pulley 3230 can be adjustably attached to the forward strap 3240 of the headgear 3118 to allow adjustment of the slack within the closed-loop cable 3220 and, therefore, the tightness of the seal 3114 against the user's face. More specifically, the position of the pulley 3230 can be moved along the forward strap 3240 (i.e., closer to or further away from the frame 3114), thereby adjusting the tightness of the seal 3114 against the user's face. Alternatively, the closed-loop cables 3220 can be provided with different lengths, thereby adjusting the tightness of the seal 3114 against the user's face.

[0480] Figures 51C-51D Shown is an alternative connection mechanism comprising an upper yoke 3322 and a lower yoke 3324 attached to a pulley 3330. Compared to the closed-loop cable 3220, the upper yoke 3322 and the lower yoke 3324 have fixed lengths and can be rigid or semi-rigid in construction. Therefore, the rigidity of the upper yoke 3322 and the lower yoke 3324 can be sufficient to resist yielding to vertical forces, such as the vertical component of the blow-off force. The upper yoke 3322 and the lower yoke 3324 are rotatably attached to the pulley 3230 to allow the upper yoke 3322 and the lower yoke 3324 to rotate relative to the pulley 3230. As shown, the user can rotate the pulley 3230 to rotate the seal 3114 in a clockwise or counterclockwise direction. More specifically, rotation of the pulley 3230 can push or pull the upper yoke 3322 and the lower yoke 3324, which pushes or pulls the upper connecting portion 3152 and the lower connecting portion 3154 further away from or closer to the headgear 3118. As a result, the seal 3114 rotates upward or downward.

[0481] like Figure 51E As shown, the pulley 3430 can have a gear 3460 positioned on one side of the pulley 3430. The gear 3460 can engage teeth 3462 attached to the headgear 3118. The teeth 3462 engage the teeth of the gear 3460 to inhibit or prevent the pulley 3430 from rotating, thereby maintaining the rotational orientation of the seal 3114. In some configurations, the pulley 3460 can have a toothed outer periphery. The pulley 3430 and the teeth 3462 can be formed from a plastic such as thermoplastic polyurethane (TPU).

[0482] Figure 51F A pulley 3430 is shown having a knurled outer periphery 3470. The texture provided by the knurled outer periphery 3470 provides increased gripping force to allow a user to overcome the retaining force of the teeth 3462 and rotate the pulley 3430. Similarly, Figure 51G The pulley 3430 is shown with a rod 3480 extending radially outward from the periphery of the pulley 3430. Thus, the pulley 3430 can be rotated by turning the rod 3480.

[0483] Figures 52A to 52C An alternative configuration of a rolled seal 4114 is shown that deforms to comfortably fit the user's nose over a wide range of upward or downward angles to minimize the amount of force applied to the user's under-nose region. Rather than a mechanism that rotates the seal upward or downward to align with the angle of the user's nose, seal 4114 deforms and rolls downward onto itself, allowing seal 4114 to conform to the shape and angle of the user's nose. More specifically, seal 4114 includes regions of varying thickness or hardness, such that when force is applied to seal 4114, deformation of seal 4114 can be controlled and provided in predetermined regions of seal 4114, thereby minimizing the amount of force applied to the user's under-nose region. When seal 4114 is removed, upper peripheral region 4250 reverts to its undeformed shape.

[0484] The seal 4114 has an orifice 4128 surrounded by an inwardly or rearwardly facing central portion 4204 that faces or contacts a lower portion of a user's nose during use of the mask 4114. The central portion 4204 is connected to an upper peripheral region 4250 that surrounds the central portion 4204 and extends along a lateral portion of the periphery of the seal 4114. A lower peripheral region 4252 is positioned below the upper peripheral region 4250 and also extends along a lower lateral portion of the periphery of the seal 4114. The upper peripheral region 4250 is connected to an inner upper edge of the lower peripheral region 4252 that is adjacent to the dead space 4206 of the seal 4114. A seal port 4172 may be formed at a central midpoint of the lower peripheral region 4252.

[0485] Figure 52B A vertical cross-section of the seal 4114 is shown. As shown, the thickness of the lower peripheral region 4252 (i.e., the thickness of the wall of the seal 4114 at the lower peripheral region 4252) is much greater than the thickness of the upper peripheral region 4250. Therefore, the lower peripheral region 4252 has a significantly greater hardness and stiffness than the upper peripheral region 4250. In some configurations, the lower peripheral region 4252 can be formed from a rigid plastic material over which the silicone portion of the seal 4114 is overmolded. Thus, when a downward force is applied to the central portion 4204 of the seal 4114 (i.e., if the user has a downwardly angled nose), the upper peripheral region 4250 rolls inwardly and downwardly onto itself and / or the lower peripheral region 4252, as shown in FIG. Figure 52CMore specifically, in response to the applied force, central portion 4204 moves downward and / or inward into dead space 4206 of seal 4114, causing upper peripheral region 4250 to collapse and roll inward into dead space 4206 of seal 4114 and downward onto itself and / or lower peripheral region 4252. This rolling of upper peripheral region 4250 allows seal 4114 to move downward and / or inward to conform to the shape and angle of the bottom plane of the user's nose, thereby reducing the force applied to the user's lower nose area. Furthermore, by adjusting the thickness and hardness of upper peripheral region 4250, the force required to cause the upper peripheral region 4250 to roll, thereby controlling the force applied against the user's nose, can be controlled. For example, by gradually varying the thickness or hardness, the rolling of upper peripheral region 4250 can be increasingly or increasingly resisted within its range of motion.

[0486] The seal 4114 can include a reinforcement portion or thickened band 4240 positioned between the upper peripheral region 4250 and the central portion 4204. The band 4240 can extend along the inner wall of the seal 4114 along the upper outer edge of the central portion 4204. The band 4240 reduces the incidence of bulging and provides additional structure between the upper peripheral region 4250 and the central portion 4204 to inhibit or prevent rolling of the central portion 4204 and promote rolling of the upper peripheral region 4250. The band 4240 can be formed of a material that is more rigid than the silicone or other material forming the seal 4114, or characterized by increased hardness relative to the silicone or other material.

[0487] The seal 4114 can also include a thickened or reinforced orifice region 4242 surrounding the orifice 4128. The reinforced orifice region 4242 can extend around or encircle the orifice 4128 to inhibit or prevent the edges of the orifice 4128 from deforming and collapsing into the dead space 4206 of the seal 4114. Additionally, the reinforced orifice region 4242 can also help transfer downward forces exerted by the user's nose to the upper peripheral region 4250. Similar to the band 4240, the reinforced orifice region 4242 can be a component formed from a material that is more rigid than, or characterized by increased hardness relative to, the silicone or other material forming the seal 4114.

[0488] In the illustrated configuration, the thickness of the upper peripheral region 4250 can be similar in thickness to the central portion 4204 and other areas of the seal 4114 (except for the significantly thicker lower peripheral region 4252). However, in this case, the central portion 4204 is reinforced by the thickening band 4240 to inhibit or prevent collapse or rolling of the central portion 4204. In some configurations, the thickness of the seal 4114 along the upper peripheral region 4250 can be thinner than all other portions of the seal 4114 to provide a region of reduced stiffness relative to all other areas of the seal 4114, such that deformation and rolling are limited to only the upper peripheral region 4250.

[0489] While the illustrated configuration utilizes regions of varying thickness, other methods for providing regions of varying hardness may be used to induce rolling of seal 4114. For example, the material of seal 4114 may be configured to include regions of relatively increasing or decreasing hardness through material selection or material properties. Furthermore, composites of multiple materials may be used to provide regions of varying hardness or stiffness. Furthermore, any combination of suitable techniques may be used. However, upper peripheral region 4250 configured to have a decreasing thickness provides a simple means of achieving regions of decreasing and increasing hardness.

[0490] Figures 53A to 53D An alternative configuration of a roll seal 5114 is shown that deforms to accommodate users with a wide range of subnasal angles, which is a combination of the user's nose angle and upper lip angle. Figures 52A-52C , seal 5114 has an upper peripheral region 5250 that rolls downwardly onto itself to accommodate a user with a negative nose angle. However, seal 5114 also has a lower peripheral region 5252 that rolls upwardly onto itself to accommodate a user with a convex upper lip angle. That is, upper peripheral region 5250 and lower peripheral region 5252 roll downwardly and upwardly, respectively, such that seal 4114 is compressed to fit the space between the user's nose and upper lip. When seal 4114 is removed from the space between the user's nose and upper lip, upper peripheral region 5250 and lower peripheral region 5252 return to their undeformed shapes.

[0491] The upper peripheral region 5250 and the lower peripheral region 5252 can be separated by a rigid frame portion 5260. The rigid frame portion 5260 can be formed from thick silicone so that the rigid frame portion 5260 is substantially inflexible. Alternatively, the rigid frame portion 5260 can be formed from a rigid plastic material, and the upper peripheral region 5250 and the lower peripheral region 5252 can be overmolded with a flexible material such as silicone. The seal port 5172 can be formed at a central midpoint area of ​​the front region of the rigid frame portion 5260. The rigid frame portion 5260 is shown as being recessed inward relative to the outer peripheries of the upper peripheral region 5250 and the lower peripheral region 5252. However, in some configurations, a person of ordinary skill in the art will appreciate that the rigid frame portion 5260 can be flush with or protrude from the outer peripheries of the upper peripheral region 5250 and / or the lower peripheral region 5252.

[0492] The seal 5114 having a rolled upper peripheral region 5250 and a lower peripheral region 5252 accommodates users having a wide range of inferior nasal angles (ie, a combination of the nose angle and the upper lip angle). Figure 53B is a comparative illustration showing the side profile of a user with a positive nose angle and a shallow upper lip angle superimposed on the side profile of a user with a negative nose angle and a convex upper lip angle. The lower nose angle is measured between the lower nose area and the upper lip. The user with the positive nose angle and the shallow upper lip angle is shown as having a value of θ 最大 A user with a negative nose angle and a convex upper lip angle is shown as having a nose angle of θ 最小 In other words, the lower nose angle is greater for a user with a positive nose angle and a shallow upper lip angle than for a user with a negative nose angle and a convex upper lip angle.

[0493] Seal 5114 is adapted to have a 最小 to θ 最大 The range of the nose angle of the user. Figure 53C is configured to fit a nose having a lower angle θ 最大 5250 and the lower peripheral region 5252 are not deformed, so that the seal 5114 can span the nose angle θ. 最大 and seals against the user's nose. Figure 53D is configured to fit a nose having a lower angle θ 最小 In contrast, the upper peripheral region 5250 and the lower peripheral region 5252 deform and roll onto themselves, such that the seal 5114 conforms to fit the lower nose angle θ. 最小and seals against the user's nose while minimizing the amount of force applied to the user's under-nose area.

[0494] The upper peripheral region 5250 and the lower peripheral region 5252 can be substantially similar in structure to the upper peripheral region 4250 and to each other. Thus, the upper peripheral region 5250 and the lower peripheral region 5252 can deform similarly under similar forces. Consequently, the seal port 5172 is balanced between the upper peripheral region 5250 and the lower peripheral region 5252. Furthermore, as the upper peripheral region 5250 and the lower peripheral region 5252 roll and reach equilibrium in their new positions, they absorb sustained vertical external forces. Temporary vertical external forces, such as those caused by accidental hose tugs, are absorbed by the upper peripheral region 5250 and the lower peripheral region 5252, and the upper peripheral region 5250 and the lower peripheral region 5252 will return toward or to their equilibrium positions. In some configurations, the upper peripheral region 5250 and the lower peripheral region 5252 can have different sizes, geometries, and / or structures such that the upper peripheral region 5250 can provide a different force distribution curve than the lower peripheral region 5252.

[0495] Similar to seal 4114, a reinforcement portion or thickened band 5240 extends on the inner wall of seal 5114 around the uppermost outer edge of upper peripheral region 5250 and the lowermost outer edge of lower peripheral region 5252. In addition, seal 5114 may also include a thickened or reinforced orifice region 5242 surrounding orifice 5128. Band 5240 and reinforced orifice region 5242 help transfer forces applied by the user's nose and upper lip to upper peripheral region 5250 and lower peripheral region 5252. Figure 53E An alternative to the reinforcing band 5240 is shown. As shown, the seal 5114 can have a spring steel strip 5340 onto which the upper peripheral region 5250 and the lower peripheral region 5252 are overmolded. The spring steel strip 5340 promotes rolling of the upper peripheral region 4250 by inhibiting or preventing rolling at other areas of the seal 5114.

[0496] Figures 54A to 54G An alternative configuration of a seal 6114 is shown having a flex region 6202 that allows the seal 6114 to adjust to fit a range of nose lengths. The flex region 6202 is a deformable region of the seal 6114 that receives the user's nose and deforms to accommodate the length and shape of the user's nose and expands outwardly and / or upwardly to relieve and reduce the amount of force acting against the user's nose. Figures 54A-54BAs shown, the telescoping region 6202 is a flexible region formed by the thin-walled portion of the seal 6114. The telescoping region 6202 can have the thinnest wall thickness compared to all other portions of the seal 6114, such that deformation occurs only in the telescoping region 6202. The thin wall thickness provides flexibility that allows the telescoping region 6202 to change shape by deforming inward and expanding outward. The telescoping region 6202 can include a central portion 6204, such that the telescoping region 6202 surrounds the orifice 6128. Additionally, the telescoping region 6202 can extend to include a portion of the upper peripheral region 6250. The seal 6114 can also include a thickened or reinforced orifice region 6242 surrounding the orifice 6128. That is, the orifice 6128 can have a thickened or reinforced orifice region 6242 (i.e., relative to other portions of the seal 6114) formed of thickened silicone such that the orifice 6128 is reinforced and strengthened to inhibit or prevent the seal 6114 from collapsing around the orifice 6128. Thus, the reinforced orifice region 6242 can ensure that the telescoping region 6202 of the seal 6114 deforms (completely different from the area surrounding the orifice 6128) when the seal 6114 is fitted to a user.

[0497] Figure 54C is a comparative illustration showing a cross-sectional side view of a seal 6114 fitted to a user with a longer nose, superimposed on a cross-sectional side view of a seal 6114 fitted to a user with a shorter, upwardly angled nose. As illustrated, a longer nose extends deeper into the seal 6114 than a shorter nose. Therefore, the telescoping region 6202L deforms inward to accommodate the longer nose. Furthermore, the telescoping region 6202L bulges outward in the forward and upward directions to increase the volume within the seal 6114, thereby minimizing pressure buildup within the seal 6114. Consequently, the amount of force acting against the longer nose is reduced, which increases the comfort of the seal 6114. Furthermore, the thin surface provided by the telescoping region 6202L extending upward along the user's nose improves the comfort of the seal 6114 because the force is distributed over a larger area of ​​contact with the nose. In contrast, the telescoping region 6202S bulges or extends toward the user to accommodate a shorter nose. The shorter nose does not extend deep into the seal 6114. Thus, the telescoping region 6202S does not bulge outwardly in the forward and upward directions as does the telescoping region 6202L.

[0498] Figure 54D Seal 6114 is shown fitted to a user having a longer nose with a horizontal nose angle. Figure 54EThe seal 6114 is shown fitted to a user having a longer nose with a negative nose angle. As shown, the telescoping region 6202 of the seal 6114 bulges outward in the forward and upward directions to accommodate both nose angles. Similarly, Figure 54F Seal 6114 is shown fitting to a user having a shorter nose with a positive nose angle. Figure 54G A seal 6114 is shown fitted to a user with a shorter nose having a negative nose angle. As shown, the telescoping region 6202 of the seal 6114 extends in an upward direction to accommodate both nose angles. In some configurations, the thickness and hardness along the telescoping region 6202 can vary so that the seal 6114 can initially expand or bulge upward along the user's nose to improve the comfort of the seal 6114 against the user's nose. After a threshold pressure or force is applied, the telescoping region 6202 can then expand or bulge forward to relieve pressure within the seal 6114.

[0499] By avoiding protrusion of the nasal seal into the user's nostrils, the comfort of a nasal pillow seal can be improved. A nasal seal that does not protrude into the user's nostrils can form a seal with the user by having a surface that compresses against the lower portion of the user's nose and upper lip. This can give the nasal seal a larger profile than seals that protrude into the patient's nostrils. A problem with large-profile nasal pillow seals is that the seal can become dislodged if it comes into contact with another surface, such as when the user changes their position to their side. Reducing the profile of the nasal seal can reduce the perceived forcefulness of the seal and reduce the negative effects experienced when sleeping on one's side. Because a low-profile respiratory interface is smaller, it is less likely to come into contact with a pillow or other surface associated with sleeping, which could dislodge the respiratory interface and disrupt the seal on the patient's nose. However, a low-profile respiratory interface may have less surface area to form a seal with the user's skin. The respiratory interface disclosed herein provides a low-profile nasal seal that is comfortable to wear and maintains a good seal between the interface and the user.

[0500] Figure 55 It can be with Figure 1 A perspective view of another example of an interface assembly or respiratory mask system 110 for use with or incorporated into the system 10 is provided. The mask system 110 may be similar in at least some respects to Figure 2-22The present invention provides a mask system 110 and is described in the context of its differences relative to the previous mask system 110. Components or features of the present mask system 110 that are not described in detail may be the same as or similar to corresponding components or features of the previous mask system 110, or may have another suitable arrangement. Therefore, in some instances, the same reference numerals are used to refer to identical, corresponding, or similar components or features. The respiratory mask system 110 includes a mask 112, which, in some configurations, includes a seal 114 and a frame assembly or frame 116. The seal 114 can be connected to the frame 116 by a connector 7222. The respiratory mask system 110 also includes a headgear 118 for securing the patient interface 112 to the user. The headgear 118 can include a yoke 127 extending along the front of the patient interface 112. The yoke 127 can be integrally formed with the headgear 118. In some embodiments, the yoke 127 is removably connected to the frame 116. In some variations, the yoke 127 is integrated with the frame 116. In the illustrated embodiment, the headgear 118 forms a closed loop from the back of the user's head to the front of the frame 116 and / or from the front of the frame 116 to the top of the user's head. In a preferred embodiment, the respiratory mask system 110 does not include a T-piece extending upward from the frame 116 (when worn) to connect to the headgear 118 at the user's forehead. However, if desired, the aspects, features, or components of the disclosed respiratory mask system 110 can be used in the design of the T-piece. The seal 114 does not rest on the bridge of the nose, thereby reducing the size and profile of the seal and making the seal less mandatory. In addition, by not resting on the bridge of the nose, the seal 114 is adapted to reduce any chance of causing pressure damage on the sensitive bridge of the nose area.

[0501] In some configurations, the respiratory mask system 110 also includes a short flexible tube or gas delivery conduit 120 that allows fluid communication with the interior of the seal 114 and connects to the supply conduit 12 of the CPAP system 10 or other respiratory system. The gas delivery conduit 120 is connected to the mask 112 directly or via a suitable connector (such as a hollow connector 122), which can have any desired or suitable shape, such as curved or bent (e.g., an elbow) or straight. In some configurations, the connector 122 can rotate relative to the mask 112 about one or more rotational axes so that the path of the gas delivery conduit 120 relative to the positioning of the mask 112 on the user's face can be adapted to the user's sleeping position. However, in other arrangements, the connector 122 can be integral or unitary with the mask 112. In the illustrated embodiment, the connector 122 is not present, and the gas delivery conduit 120 is fixedly connected to the frame 116. The end of the gas delivery conduit 120 opposite the connector 122 can include a connector 124 suitable for connecting the gas delivery conduit 120 to the supply conduit 12. In some configurations, the connector 124 can be or include a swivel connector that allows relative rotation between the gas delivery conduit 120 and the supply conduit 12.

[0502] The respiratory mask system 110 preferably includes a restricted flow outlet or bias flow vent 126 for providing a gas flush from the respiratory mask system 110. In some configurations, the bias flow vent 126 is in the form of a number of small orifices. The bias flow vent 126 can be provided in the frame 116 (as shown), in the connector 122, or elsewhere on the respiratory mask system 110.

[0503] In some configurations, the mask 112 can include a seal 114, a frame 116, and a connector 122. In some configurations, the frame 116 (and the connector 122, if desired) can be more rigid than at least a portion of the seal 114 (such as the portion that defines the user contact surface). In some configurations, the seal 114 is removably coupled to the frame 116 around a passage through the frame 116 from the interior of the connector 122. In the illustrated embodiment, the frame 116 acts as a hub or connector between the seal 114, the gas delivery conduit 120, and the headgear 118. The frame 116 also provides rigid support to the seal 114 and / or the connector 122. The frame 116 is preferably rigid or semi-rigid and can also be formed from thickened silicone or other plastic material. Thus, the seal 114 and frame 116 can together form a closure having a gas flow inlet from the CPAP system 10 and an orifice 7128 (see, e.g., FIG. 1 ) through the seal 114 to the user. Figure 58A ).

[0504] In some configurations, the headgear 118 includes side arms 130 that extend outward (away from each other), backward, and upward at a shallow angle, past the left and right ends of the seal 114, and along the left and right cheeks, and specifically the user's cheekbones, to connect to the headgear 118 so as to hold the seal 114 on the user's face. Such side arms 130 can be longer than their depth or thickness and can be resiliently flexibly connected to the frame and / or resiliently flexible along their length (widthwise rather than heightwise). In some configurations, the side arms 130 extend toward or to a position between the user's ears and eyes and / or to or near the user's temples. In some embodiments, the side arms 130 extend along the cheeks and upward toward the top of the head to form a closed-loop headgear 118.

[0505] Figure 56 An embodiment of the seal 114 and frame 116 is shown. For clarity, the yoke 127 retaining structure is not shown. The yoke 127 extends across the front or distal-facing surface of the frame 116. In the illustrated arrangement, the frame 116 defines a generally U-shape when viewed from above. As discussed below, a connector 7222 can connect the seal 114 to the frame 116. The connector 7222 can function to provide support to the seal 114 and can resist deformation of the seal 114 when the seal 114 is under pressure during use.

[0506] Figure 57 A non-limiting embodiment of the frame 116 is depicted. Figures 58A-58C A non-limiting embodiment of a seal 114 is depicted. Figure 57 The central portion of the frame 116 defines an orifice 7170 through which gas can flow. A first annular wall surrounds the orifice 7170 and projects in a rearward direction to define a support or connector 7172 for the seal 114. A second annular wall of the frame 116 (containing the biasing air holes 126 and Figure 56 ) surrounds the aperture 7170 and projects in a forward direction so as to define a support for the connector 122. Figures 58A-58C, the seal 114 defines a gas entry orifice 7175 that is configured to receive a connector 7172 of the frame 116. The seal 114 and the frame 116 may be removably coupled by any suitable arrangement such as, for example, a friction fit or a snap fit. In the illustrated arrangement, the connector 7172 includes one or more recesses 7176 that are configured to receive corresponding protrusions (not shown) of the seal 114 so as to form a snap fit engagement between the seal 114 and the frame 116. However, this arrangement can also be reversed. In addition, the entire arrangement can be reversed between the seal 114 and the frame 116 such that the seal 114 may include a male connector portion and the frame 116 may include a corresponding female connector portion. In some configurations, the seal 114 may include, for example, Figure 72 and 73 The connector 7222 shown is formed around the gas inlet orifice 7175 of the seal 114. The connector 7222 can be formed of a rigid plastic (e.g., polycarbonate). The connector 7222 can be formed as part of the seal 114. For example, the seal 114 can be overmolded onto the connector 7222. In some embodiments, the connector 7222 is adhered to the seal 114 using an adhesive, or is connected to the seal 114 using a coupling or fastener. In some configurations, the connector 7222 includes a plurality of parts that capture the seal 114 therebetween. The connector 7222 allows for connection between the frame 116 and the seal 114. In some embodiments, the frame 116 does not provide structural support for the seal 114. Instead, the frame 116 acts as a manifold that enables the headgear 118, the gas delivery conduit 120, and the seal 114 to be combined with the connector 7222 into the respiratory mask system 110. Structural support for seal 114 is provided by connector 7222 on the distal side of seal 114 .

[0507] Preferably, the seal 114 and the frame 116 include an alignment or key arrangement so that the seal 114 and the frame 116 can only be assembled in the correct orientation relative to each other. Any suitable arrangement can be used. For example, the seal connector 7172 may include a recess 7180 that is configured to receive a key or protrusion (not shown) of the seal 114. The recess 7180 and the protrusion can be located at the upper central portion of the orifice 7170 and / or at other locations along the periphery of the orifice 7170. This arrangement can also be reversed. In addition, other suitable arrangements can also be used, such as connectors 7172 and gas inlet orifices 7175 that are non-circular in shape. In some embodiments, the gas inlet orifice 7175 can have an overall D-shape, wherein the bottom portion of the gas inlet orifice 7175 is flattened, or is closer to the center point of the gas inlet orifice 7175 than other portions of the gas inlet orifice 7175. The frame 116 can include a D-shaped seal connector 7172 that mates with a D-shaped gas inlet aperture 7175 to ensure proper alignment of the seal 114 relative to the frame 116 and prevent rotation of the seal relative to the frame. The D-shaped or non-circular gas inlet aperture 7175 can also reduce the overall height of the respiratory mask system 110, making the respiratory mask system 110 less cumbersome and more desirable to use.

[0508] exist Figure 58A In some embodiments, the gas inlet orifice 7175a of the seal 114a is generally circular in shape, having a diameter of approximately 29.7 mm, to accommodate a circular gas delivery conduit. In some variations, the gas inlet orifice 7175a is between 28-34 mm. Figure 58B In the embodiment of FIG. 5 , the gas inlet orifice 7175b is generally circular in shape, having a diameter of approximately 26.5 mm, but the lower edge of the gas inlet orifice 7175b includes a truncated portion 7177 ( FIG. 5 ) having a slightly reduced diameter. Figure 59B This truncated portion 7177 may provide a seal connector as discussed below ( Figure 72 and 73 ) is a visual indication of the orientation of the gas inlet orifice 7175. The truncated portion 7177 can be located on either or both of the lateral edges, the upper edge, or anywhere around the perimeter of the gas inlet orifice 7175. In some variations, the gas inlet orifice 7175b is between 26-30 mm. Figure 58C In an embodiment, the gas inlet orifice 7175c is generally circular in shape, having a diameter of approximately 28.4 mm. The lower edge of the gas inlet orifice 7175c includes the truncated portion 7177 discussed above. In some variations, the gas inlet orifice 7175c is between 28-32 mm.

[0509] The seal 114 has a hollow interior filled with air under positive pressure and is configured to seal under the user's nose, along a portion of the face extending transversely to the nose, and along the user's upper lip ( Figures 63A-63C ). Figures 58A-58C A non-limiting embodiment of the seal 114 is depicted. The seal 114 includes at least one nose opening or orifice 7128. The nose orifice 7128 is located between the hollow interior of the seal 114 and the rear wall 7202 ( Figures 66A-66C ) are communicated between the base structure of the seal 114. The gas inlet orifice 7175 provides an opening between the hollow interior of the seal 114 and the front wall 7212 of the seal 114. In some configurations, the seal 114 may include more than one nasal orifice 7128. In some configurations, the seal 114 may include a nasal orifice 7128 defined within an upper structure, such as a nasal pillow, a fork tube, or the like. In some configurations, the nasal orifice 7128 may be defined by a nasal cushion or insert that may be overmolded or otherwise secured to the base structure of the seal 114. Examples of suitable arrangements of the seal 114 are disclosed in Applicant's publication No. WO 2014 / 077708, the entire contents of which are incorporated herein by reference.

[0510] As discussed in detail below, the seal 114 can be designed so that the seal has a low profile and maintains good sealing characteristics under positive pressures up to and including 18-20 mm H2O. The profile of the seal 114 can be characterized by the distance that the seal 114 extends beyond the user's nose. In general, Figure 58C The seal 114 and Figure 58A The seal 114 in FIG. 1 has a lower profile than the seal 114 in FIG. Figure 58B The profile of the seal 114 is between Figure 58A and 58C in the middle of the seal's profile.

[0511] Figures 59A-59C Shown Figures 58A-58C 14. The seal 114 may have an overall height 7140 and an overall width 7142, as shown. Figures 59A-59C shown. Figures 60A-60C Shown Figures 59A-59C The seal 114 can have a total depth 7144, such as Figures 60A-60CAs shown. In some embodiments, the profile of the seal 7144 can be reduced by reducing one or more of the overall height 7140, overall width 7142, and / or overall depth 7144 of the seal 114. Although specific dimensions are discussed herein, ratios of specific dimensions relative to one another are also considered within the scope of this disclosure. For example, disclosure of height and depth includes disclosure of the ratio of height to depth.

[0512] exist Figure 59A and 60A In the illustrated embodiment, the total height 7140a is 42.1 mm, the total width 7142a is 75.8 mm, and the total depth 7144a is 45.6 mm. In some configurations, the total height 7140a is between 37-47 mm, between 40-44 mm, or approximately 42 mm. In some configurations, the total width 7142a of the seal 114a is between 72-82 mm, between 75-77 mm, or approximately 76 mm. In some embodiments, the total depth 7144a is between 40-50 mm, between 44-48 mm, or approximately 46 mm.

[0513] exist Figure 59B and 60B In the embodiment shown, the total height 7140b is 41.0mm, the total width 7142b is 59.0mm, and the total depth 7144b is 43.0mm. In some configurations, the total height 7140a is between 36-46mm, between 39-43mm, or about 41mm. In some configurations, the total width 7142b of the seal 114b is between 54-64mm, between 57-61mm, or about 59mm. In some embodiments, the total depth 7144 is between 38-48mm, between 41-45mm, or about 43mm.

[0514] exist Figure 59C and 60C In the illustrated embodiment, the overall height 7140c is 35.6 mm, the overall width 7142c is 59.0 mm, and the overall depth 7144c is 43.2 mm. In some configurations, the overall height 7140c is between 30-40 mm, between 33-37 mm, or approximately 35 mm. In some configurations, the overall width 7142c of the seal 114c is between 54-64 mm, between 57-61 mm, or approximately 59 mm. In some embodiments, the overall depth 7144c is between 38-48 mm, between 41-45 mm, or approximately 43 mm.

[0515] In some configurations, the seal 114 is sized to fit different nasal structures. For example, the seal 114 can be provided in small, medium, large, and wide sizes. In some embodiments, the seal 114 can be sized to fit nasal structures of different races (e.g., Caucasian, Asian, African American). The ranges of the overall height 7140, width 7142, and depth 7144 described above can represent Figures 59A-59C The different embodiments shown are M. Figure 59C In the illustrated embodiment, the overall width 7142c can be from about 45 mm for the small size to about 80 mm for the large size. Figure 59C The tuba of the embodiment may have Figure 59C The medium ones shown have similar heights 7140c and depths 7144c. In some variations, Figure 59C In the example of the L with Figure 59C The medium size shown has a greater height 7140c and / or depth 7144c. Figure 59C The trumpet of the embodiment can be used with Figure 59C The medium size shown has a similar width of 7142c. In some variations, the Figure 59C The small size has a smaller width 7142c, height 140c and / or depth 7144c than the medium size shown. Figure 59C The wide number of the embodiments in can have a width 7142c between 70-80 mm, between 73-77 mm, or approximately 75 mm. Figure 59C The wide number of the embodiment may have Figure 59C The medium ones shown have similarly greater heights 7140c and / or depths 7144c.

[0516] refer to Figures 60A-60C , when the bottom wall of the seal 114 is horizontal, the highest point 7182 of the gas inlet orifice 7175 can be arranged distal to the lowest point 7184 of the gas inlet orifice 7175. As illustrated, a line passing through the highest point 7182 and the lowest point 7184 of the gas inlet orifice 7175 can form an angle 7186 with a vertical line passing through the lowest point 7184. This angle 7186 can be referred to as a gas entry angle 7186. Figure 60A In the embodiment of FIG, the gas entry angle 7186a is 8.75°, and the highest point 7182a is 4.65 mm distal to the lowest point 7184a. Figure 60B In the embodiment of FIG, the gas entry angle 7186b is 13.2°, and the highest point 7182b is 7.1 mm distal to the lowest point 7184b. Figure 60C In the embodiment, the gas entry angle 7186c is 15.5°, and the highest point 7182c is 8.1 mm distal to the lowest point 7184c.

[0517] In some configurations, the gas entry angle 7186 can range from 5° to 30°, from 7° to 20°, or from 8° to 16°. In some variations, the gas entry angle 7186 can be selected to reduce the volume within the hollow interior space of the seal 114. Reducing the volume within the hollow interior space of the seal 114 can reduce the force of the seal 114. The volume within the hollow interior of the seal 114 can also be referred to as dead space. Reducing dead space can improve the washout of exhaled air and carbon dioxide. The gas entry angle 7186 can be selected to tilt the gas entry orifice 7175 (and the gas delivery conduit protruding from the gas entry orifice) toward a horizontal axis. Angling the gas delivery conduit protruding from the mask 112 toward the horizontal axis can allow the gas delivery conduit 120 to be connected to the supply conduit 12 without using an elbow connector. Angling the gas delivery conduit 120 toward the horizontal axis can reduce hose pull.

[0518] In addition to reducing the overall height 7140 , width 7142 , and depth 7144 dimensions of the seal 114 , the profile of the seal 114 may also be reduced by changing the shape of the seal 114 . Figures 61A-61C Shown Figures 58A-58C A rear view of the seal 114 is shown. Figures 61A-61C ,and Figure 61A and 61B Compared with the rear surfaces 7202a and 7202b of the embodiment, Figure 61C The rear wall 7202c of the embodiment has a more triangular shape. Figures 61A-61C As shown, the rearward projection of the rear wall 7202 can define a perimeter that circumferentially surrounds the nasal opening 7128. This perimeter can be referred to as a rear perimeter. Figure 61C The seal 114 shown has Figure 61A The rear perimeter of the seal shown is smaller than the rear perimeter.In some variations, the profile of the seal 114 can be reduced by reducing the rear perimeter of the seal 114.

[0519] The nasal opening 7128 of the seal 114 is arranged in the central portion of the rear wall 7202. The central portion of the rear wall 7202 is distal to the lateral portions of the rear wall 7202, thereby forming a nasal recess 7214. In use, the nasal recess 7214 receives the tip of the user's nose. The seal 114 has a bottom wall 7216 that extends upwardly and proximally to meet the rear wall 7202. Figure 61B and 61CIn the embodiment of FIG. 7 , the bottom walls 7216b, 7216c and the rear walls 7202b, 7202c meet near the bottom of the nose recess 7214 to form shelves 7218b, 7218c. Figure 61A The seal shown has a less well-defined shelf. As described below, a more defined shelf 7218 can reduce the profile of the seal 114 by allowing the bottom portion of the seal 114 to tilt closer to the user's face, such as Figures 63A-63C The well-defined shelf 7218 can allow the volume of the hollow interior of the seal 114 to be reduced, thereby reducing the profile of the seal 114. The shelf 7218 can also improve the stability of the seal 114, thereby allowing the size of the seal 114 to be reduced while maintaining good performance (e.g., sealing) of the seal 114.

[0520] Figures 62A-62C Shown Figures 58A-58C A top view of the seal 114 is shown. Figures 62A-62C , Figure 62C The rear wall 7202c of the embodiment is Figure 62A and 62B The rear surfaces 7202a, 7202b of the embodiment extend further distally. When the seal 114 is viewed from the top, Figure 62C The orifice 7128c of the seal 114c is shown closer to the farthest point 7230c of the seal 114c than to the closest point 7232c of the seal 114c. Figure 62A In the embodiment of FIG. 7 , the orifice 7128a is closer to the most proximal point 7232a of the seal 114a than to the most distal point 7230a of the seal 114a. Figure 62A In the embodiment shown, Figure 62B and 62C As shown, the front surfaces 7212b, 7212c of the seals 114b, 114c flare more as the front wall 7212a extends in the rearward direction. As the front surfaces 7212b, 7212c extend in the rearward direction, the front surfaces 7212b, 7212c maintain a parabolic form and, in some configurations, may curve continuously in one direction without an inflection point. In contrast, the front wall 7212a of the seal 114a has an inflection point 7201, as shown in FIG. Figure 62A In some configurations, the proximal-most point of the posterior surface 7202c is located halfway along the seal 114c in the distal direction, or less than halfway along the seal 114c in the anterior-posterior direction from the distal-most point 7230c to the proximal-most point 7232a. In some configurations, the proximal-most point of the posterior surface 7202c is located approximately 30-50% or approximately 40% of the distance from the distal-most point 7230c to the proximal-most point 7232a.

[0521] Figures 63A-63C is positioned on the user's face during use Figures 58A-58C The seal 114 is advantageously not required to come into contact with the bridge of the user's nose. In the illustrated configuration, the seal 114 does not extend beyond the bridge of the user's nose. More specifically, the illustrated seal 114 does not contact the bridge of the user's nose.

[0522] Continue to refer Figures 63A-63C , the profile of the seal 114 can be reduced by aligning the seal 114 along the base of the user's nose within the space between the user's nose and cheek. Figure 63C In the embodiment, Figure 63A and 63B The lateral portions of seal 114c tuck further into the space between the cheeks and nose of the user than the lateral portions of the illustrated embodiments of seals 114a, 114b. Additionally or in the alternative, the lower portions of seals 114b and 114c are positioned closer to the user's face (e.g., upper lip) during use than the lower portion of seal 114a (wherein the lower portion of seal 114c is closer than the lower portion of seal 114b). This arrangement may provide a favorable orientation or angle of the gas delivery tube or conduit and / or frame or headgear. The orientation of the gas entry orifice 7175 may be characterized by an angle 7240, also referred to as the use angle 7240. The use angle 7240 is the angle between the horizontal axis and a line that is orthogonal to a line extending between the highest point 7182 and the lowest point 7184 of the gas entry orifice 7175 when the nasal orifice 7128 is directed toward the nasal passage of the user. Figure 63A In an embodiment of the seal 114a, the use angle 7240a is about 30.0°. Figure 63B and 63C In other arrangements, such as embodiments of the present invention, angles 7240b, 7240c are used that are greater than about 35° or greater than about 40°. Figure 63B In the embodiment, the angle 7240b is about 43.7°. Figure 63C In the embodiment of FIG. 7 , the engagement angle 7240c is approximately 45.6°. Due to the diversity of nasal shapes among the human population, there can be significant variation in the engagement angle 7240 for a given seal. For example, the engagement angle 7240 can vary from approximately 0° to approximately 70°. However, it may be advantageous for the engagement angle 7240 to be relatively large in order to reduce the negative effects of hose pull. In some variations, the engagement angle 7240 can range from approximately 70° to approximately 90°.

[0523] The seal 114 may have an effective taper defined as the depth 7144 ( Figures 60A-60C ) to the projected area of ​​the lateral portion of the front wall 7212. In calculating the effective taper, the front wall 7212 is considered to extend to a line extending between the highest point 7182 and the lowest point 7184 of the gas inlet orifice 7175. Figure 63A In the embodiment of , the effective taper has a value of about 0.37. Figure 63C In an embodiment of the present invention, the effective taper has a value of about 0.39. In some variations, the profile of the seal 114 is reduced by increasing the use angle 7240 and / or by increasing the effective taper of the seal 114.

[0524] refer to Figure 64 , seal 114 can have a variable wall thickness. The thickened wall portion can be designed to provide a support structure that helps seal 114 maintain contact with the user's skin when seal 114 is in use. In some variations, the thickened wall portion helps seal 114 resist deformation when seal 114 is in use. The thickened wall portion can allow seal 114 to be made of less material, thereby reducing the profile of seal 114. The thickened wall portion can extend into the hollow interior of the seal. For example, the thickened wall portion can extend from the front wall 7212 toward the proximal side and / or from the rear wall 7202 toward the distal side.

[0525] The seal 114 may include regions of varying thickness. For example, each lateral side portion of the seal 114 may have a top region 7302, a back region 7304, a front region 7306, and a center region 7308. Figure 11 The areas on the other side may be mirror images of the illustrated areas. The rear region 7304 may have a greater thickness than all other areas. The top region 7302 and / or the central region 7308 may have a lesser thickness than all other areas. In the illustrated embodiment, the top region 7302 and the central region 7308 have a thickness of approximately 0.3 mm, the front region 7306 has a thickness of approximately 2.6 mm, and the rear region 7304 has a thickness of approximately 3.9 mm.

[0526] Figure 65A and 65B Shown Figure 58C The embodiment of seal 114c shown has a thickened wall portion or area. Figure 65A and 65B The area shown can be Figure 64 The areas shown are the same or similar. The thickened wall portion extends into the hollow interior of the seal 114c. Figure 65A, for clarity, the outline of the seal 114c profile is shown. The top region 7302c and the central region 7308c have a thickness of approximately 0.3 mm, and the front region 7306c has a thickness of approximately 1.0 mm. The rear region 7304c has a variable thickness, with a maximum thickness of approximately 1.45 mm. In some variations, the thickness of the top region 7302c and the central region 7308c is between approximately 0.2 mm and approximately 0.4 mm. The thickness of the front region 7306c is between approximately 0.7 mm and approximately 1.3 mm. The maximum thickness of the rear region 7304c is between approximately 1.2 mm and approximately 1.7 mm.

[0527] like Figure 65A and 65B As shown, the rear region 7304c is U-shaped, with the bottom of the U positioned near the proximal point of the front wall 7212. The front region 7306c extends across the top of the U-shaped structure formed by the rear region 7304c. The central region 7308c is surrounded by the front region 7302c and the rear region 7304c. The top region 7302c extends from the rear region 7304c away from the central region 7308c.

[0528] and Figure 58A Compared to those shown for seal 114a, Figure 58C The thickness of the thickened wall portion in seal 114c is shown to have been reduced. Reducing the thickness of the wall portion helps reduce the weight and / or rigidity of seal 114. The thickness of the thickened wall portion can be increased to increase rigidity and friction between seal 114 and frame 116. In some variations, the thickness of the thickened wall portion is increased to increase the vertical stability of seal 114.

[0529] Figures 66A-66C A longitudinal cross-sectional view of the seal 114 is shown. Specifically, Figures 66A-66C Seal 114c is shown; however, certain features may be found in other arrangements of seals 114, such as seals 114a and 114b. Figures 67A-67C 14a, 114b, and 114c are shown in FIG. The thickness of the bottom wall 7216 of the seal 114 can vary. The bottom wall 7216 can have a distal thickness 7316 near the front wall 7212. The bottom wall 7216 can have a proximal thickness 7318 near the rear wall 7202. The bottom wall 7216 can have a central thickness 7320 disposed within a longitudinally central portion of the bottom wall 7216. In some arrangements, two or more of the distal thickness 7316, the proximal thickness 7318, and the central thickness 7320 vary relative to one another.

[0530] Figures 67A-67C Shown Figures 58A-58CA longitudinal cross-sectional view of the depicted seal embodiment. Figure 67A The seal 114a is shown to have a distal thickness 7316a of approximately 1.5 mm and a central thickness 7320a of approximately 0.3 mm. Figure 67B The seal 114b is shown to have a distal thickness 7316b of approximately 2.4 mm and a central thickness 7320b of approximately 0.5 mm, and a proximal thickness 7318b of approximately 2.9 mm. Figure 67C The seal 114c shown has a distal thickness 7316c of about 1.35 mm and a central thickness 7320c of about 0.5 mm, and a proximal thickness 7318c of about 3.1 mm. As mentioned above, Figure 67B and 67C The seals 144b, 144c shown have a distinct difference between the bottom wall 7216 and the rear wall 7202, thereby forming a shelf 7218 in the form of a rounded edge on the proximal side of the bottom wall 7216. Figure 67A The seal 144a in has a curved bottom wall 7216a that does not have a clearly defined interface with the rear wall 7202a.

[0531] Continue to refer Figures 67A-67C , the back wall 7202 can have a thickened portion 7330 surrounding the nasal orifice 7128. The thickened portion 7330 can extend distally from the distal-facing surface of the back wall 7202 and can have a maximum thickness 7332. The thickened portion 7330 can be adapted to prevent the edges of the orifice 7128 from deforming (e.g., "blowing open") when the seal 114 is under pressure during use. Deformation of the orifice 7128 can reduce the effectiveness of the seal 114 and increase user discomfort. The thickened portion 7330 can increase the effectiveness of the seal 114.

[0532] Figure 67A The seal 114a in FIG. 1 has an oval, cushion-like thickened portion 7330a. The thickened portion 7330a has a maximum thickness 7332a of about 1.5 mm. As the thickened portion 7330a extends away from the nasal opening 7128, the thickened portion gradually tapers. Figure 67B The seal 114b has the same Figure 67A The thickened portion 7330a of the seal 114a is shown as similar to the thickened portion 7330b.

[0533] refer to Figure 68, seal 114b can include a thickened ridge 7340 extending distally from the distal-facing surface of rear wall 7202b by about 1.0 mm. The ridge 7340 can be arranged at the interface between the thickened portion 7330b and the top area 7302b of seal 114b. In some variations, the ridge 7340 reinforces seal 114b to prevent seal 114b from wrinkling as the air pressure in the hollow interior of seal 114b increases. In some embodiments, when seal 114b bulges, the thickened portion 7330 can contribute to some distortion of the seal. The ridge 7340 can allow seal 114b to bulge smoothly. In some embodiments, seal 114 with the thickened portion 7330 can bulge smoothly when seal 114 does not have the ridge 7340. In certain variations, a seal 114c having a thickened portion 7330c that closely matches the nasal opening 7128 may be smoothly bulged without the seal 114c having a raised ridge 7340 .

[0534] Figure 69 Shown in more detail Figure 68 The thickened portion 7330b of the seal 114b in the nose opening 7128 extends a maximum distance 7334b of about 7.9 mm from the edge of the nose opening 7128. The thickened portion extends from the distally facing surface of the rear wall 7202 to a maximum thickness 7332b of about 1.5 mm.

[0535] Figure 70 Shown Figure 67C A detailed front view of the thickened portion 7330c of the seal 114c is shown. The thickened portion 7330c is thicker than Figure 67A and 67B The thickened portions 7330a, 7330b are shown to more closely match the periphery of the nasal opening 7128. The thickened portion 7330c extends distally from the rear wall 7202c into the hollow interior of the seal 114c. The thickened portion 7330c has a maximum width of approximately 3.3 mm.

[0536] In many embodiments, the surface portion of the seal 114 surrounding or defining the nasal orifice 7128 is not in direct contact with the user's nose. Instead, a volume of air separates the surface portion of the seal 114 surrounding or defining the nasal orifice 7128 from the portion of the user's nose located in the nasal recess 7214 of the seal 114. This separation between the seal 114 and the user's nose allows the area of ​​the nasal orifice 7128 to be reduced without the user feeling that flow through the orifice 7128 is restricted. Figures 71A-71CThe area of ​​the nasal opening 7128 can be assessed by comparing the area of ​​the rearward projection of the nasal opening 7128. The rearward projection of the nasal opening 7128 can have a minimum height 7342, a maximum height 7344, and an overall width 7346. Figure 71A The seal 144a in has a minimum height 7342a of approximately 4.0 mm, a maximum height 7344a of approximately 12.0 mm, and an overall width 7346a of approximately 18.8 mm. Figure 71B The seal 144b in has a minimum height 7342b of approximately 4.0 mm, a maximum height 7344b of approximately 11.0 mm, and an overall width 7346b of approximately 17.1 mm. Figure 71C The seal 144c in has a minimum height 7342c of about 4.5 mm, a maximum height 7344c of about 11.0 mm, and a total width 7346c of about 16.9 mm. In some variations, each of these minimum height 7342, maximum height 7344, and total width 7346 can be increased or decreased by at least 20%.

[0537] Compare Figures 71A-71C Another way in which the nose opening 7128 of the seal 114 is reduced in size is by comparing Figure 71A The orifice 7128a shown is Figure 71C The surface area variation between the orifices 7128c is shown. The surface area of ​​the orifices 7128 may be measured along the curved surface of the nose recess 7214 to obtain a more accurate measurement than that obtained from the 2D rearward protrusion data discussed above. For the seal 114a in 71A, the surface area of ​​the orifices 7128a along the curved surface of the nose recess 7214a is approximately 161 mm 2 For seal 114c in 71C, the surface area of ​​orifice 7128c along the curved surface of nose recess 7214c is approximately 141 mm 2 In some configurations, the surface area of ​​the orifice 7128 is less than or equal to about 160 mm 2 , less than or equal to about 150mm 2 , or less than or equal to approximately 141 mm 2 or 140mm 2 .

[0538] refer to Figure 72 and 73The seal 114 may include a connector 7222 (also referred to as a seal clamp) coupled to the seal 114. In some embodiments, the connector 7222 may be part of the frame 116. For example, the connector 7222 may be a portion of the frame 116 that is permanently integrated with the seal 114 (e.g., the seal 114 is overmolded onto the connector 7222 portion of the frame 116). In certain embodiments, the connector 7222 includes a clamp portion that allows connection to another frame 116, or to the yoke 127 or headgear 118. The connector 7222 may be configured to provide lateral support to the seal 114. The connector 7222 may have a front flange 7224, a rear flange 7226, and a hub portion 7228 disposed between the front and rear flanges 7224, 7226. The connector 7222 may be configured to capture a portion of the seal 114 between the front and rear flanges 7224, 7226. In some embodiments, the connector 7222 is overmolded onto the seal 114. In some embodiments, the seal 114 is overmolded onto the connector 7222. In some configurations, the front flange 7224 can be connected to the rear flange 7226 by a snap-fit ​​arrangement, which can be a permanent or removable connection.

[0539] When the connector 7222 is assembled to the seal 114, the rear flange 7226 is positioned within the interior of the seal 114 and the hub portion 7228 extends through the gas inlet aperture 7175 of the seal 114. The front flange 7224 of the connector 7222 is positioned on the exterior of the seal 114. The seal 114 may include an annular rim that surrounds the gas inlet aperture 7175 and is configured to be captured by the front flange 7224 and the rear flange 7226 of the connector 7222.

[0540] The connector 7222 can have a central opening 7250 that aligns with the gas inlet orifice 7175 of the seal 114 when the connector 7222 is attached to the seal 114. The central opening 7250 can be configured for coupling to the frame 116, the gas delivery conduit 120, the elbow connector 122, or other suitable means for connecting the connector 7222 to a CPAP system.

[0541] The connector 7222 can have side arms 7252 extending proximally and laterally from the central opening 7250. The side arms 7252 can be configured to have greater resistance to lateral deformation than the seal 114. The side arms 7252 can provide lateral support for the seal 114. The connector 7222 can ensure that the seal 114 maintains its shape under pressure, thereby enabling the seal 114 to effectively enclose the patient's nose. In some variations, the front wall 7212 of the seal 114 can include a recess for receiving the side arms 7252 of the connector 7222. The profile of the seal 114 can be reduced by positioning the side arms 7252 to sit within the recess on the front wall 7212 of the seal 114. In some embodiments, the side arms 7252 can be overmolded, chemically bonded, or otherwise attached to the seal 114. The side arms 7252 prevent the seal 114 from over-expanding and losing its seal with the patient's nose. The side arms 7252 may prevent the seal 114 from being severely deformed due to bulging caused by pressure from gas flowing through the patient interface 112 .

[0542] Figure 74 Another embodiment of seal 114d is shown, except that it is similar to seals 114, 144a, 114b, 114c, as described below. The features of seal 114d can be combined with or included in any other embodiment discussed herein, such as seal 114 or other embodiments. The illustrated embodiment has a connector 7222d attached to seal 114d. Except that it is described below, connector 7222d is similar to connector 7222. As discussed, connector 7222d has side arms 7252d that extend proximally and laterally from central opening 7250d and provide lateral support to seal 114d. Connector 7222d has a rear flange 7226d positioned within the interior of seal 114d. In the illustrated embodiment, rear flange 7226d has a blue color and is visible through seal 114d. The color of the rear flange 7226d can help guide the user to properly connect the seal 114d to another component of the interface (e.g., the gas delivery conduit 120). For example, the color of the rear flange 7226d can match the color of a portion of the gas delivery conduit 120, making the connection of the gas delivery conduit 120 to the connector 7222d intuitive to the user. In some embodiments, coloring is intended to be used as an indicator of the components in the seal 114. For example, the front flange 7224d can be completely transparent, while the rear flange 7226d can be colored a transparent blue.

[0543] Figure 75Another embodiment of a connector 7222e attached to a seal 114e is shown. Except as described below, seal 114e is similar to seal 114 or any other embodiment discussed herein. Except as described below, connector 7222e is similar to connector 7222 or any other embodiment discussed herein. The features of seal 114e and connector 7222e can be combined with or included in seal 114, or connector 7222, or any other embodiment discussed herein. In the illustrated embodiment, the front wall 7254e of connector 7222e is substantially flush with the front wall 7212e of seal 114e. In some embodiments, at least a portion of the front wall 7254e of connector 7222e can protrude laterally and / or distally beyond the front wall 7212e of seal 114e. In some embodiments, at least a portion of the front wall 7212e of seal 114e can protrude laterally and / or distally beyond the front wall 7254e of connector 7222e.

[0544] As discussed above, the seal 114 can be made in different sizes to allow at least one of the seals 114 to fit a wider variety of nasal structures. For example, the seal 114 can be made in four different sizes: small, medium, large, and wide. The four sizes of the seal 114 can be configured to allow one or more of the available seals 114 to be suitable for a wide variety of users. In some configurations, the four seal sizes can allow the seal 114 to be feasible for a large or very large portion of the population. The seal 114 can be made in more than four different sizes (e.g., extra large, medium wide, extra small).

[0545] Figures 76A-76E Shown Figure 75 Different views of the medium seal 114e are shown. Figure 76A is a front view of seal 114e and is similar to Figures 59A-59C Views are shown for seals 114a-114c. Figure 76B is a left side view of seal 114e and is similar to Figures 60A-60C Views are shown for seals 114a-114c. Figure 76C is a rear view of seal 114e and is similar to Figures 61A-61C Views are shown for seals 114a-114c.

[0546] Figure 76D is a top view of seal 114e and is similar to Figures 62A-62C Views are shown for seals 114a-114c. Figure 76E is a bottom view of the seal 114e.

[0547] like Figure 76A As shown, the seal 114e can be symmetrical about a vertical axis 7256. The vertical axis 7256 passes through the centerline of the seal 114e and is aligned with a longitudinal plane extending from the front of the seal to the back of the seal 114e. As discussed above, the front wall 7212e of the seal 114e can have a recessed portion 7258e. The recessed portion 7258e can be configured to receive a portion of the connector 7222e. For example, the recessed portion 7258e can receive the front flange 7224 of the connector 7222. Figures 76A-76B , the seal 114e may have the same Figures 59A-59C The seals 114a-114c shown in FIG. 1 are similar to those described in total height 7140e, total width 7142e, and total depth 7144e. Table 1 below shows examples of approximate dimensions of total height 7140, total width 7142, and total depth 7144 of the different sizes (e.g., small, medium, large, wide) of seal 114. In some embodiments, the variation of one or more of the dimensions of seal 114 can be ± 10% of the dimensions listed in Table 1. The present disclosure includes ratios that can be derived from the dimensions disclosed herein. For example, the present disclosure not only includes the disclosed total widths of small and large seals, but also includes the ratio of the width of small seals to the width of large seals and any other ratios that can be derived from the dimensions disclosed herein.

[0548] Table 1. Approximate dimensions for small, medium, large, and wide seal sizes.

[0549] Seal size Total height (mm) Total width (mm) Total depth (mm) small 36.2 59.0 43.2 Medium 38.0 58.6 41.2 large 38.0 72.0 42.7 Wide 38.0 72.0 43.9

[0550] In some embodiments, the small and medium seals 114 are designed to fit approximately the same nose width (also referred to herein as wide width) and are experimentally tailored to the appropriate size based on the nose-to-pronasal measurement. For example, the small seal 114 has a larger width than the medium seal 114 because users of the small seal 114 tend to have noses of similar width or wider than users of the medium seal 114. However, in the embodiment presented in Table 1, the difference in total width 7142 between the small and medium seals 114 is minimal (0.4 mm).

[0551] Figure 77 Shown Figure 76A A perspective view of a medium seal 114e is shown. Figure 78 A perspective view of an embodiment of a wide code seal 114f is shown. Figure 77 and 78As shown, the recessed portion 7258e of the medium seal 114e is more blunt than the recessed portion 7258f of the wide seal. For example, in the illustrated embodiment, the recessed portions 7258e, 7258f of the medium and wide seals 114e, 114f can be said to have a height dimension measured parallel to the vertical axis 7256. The height dimension of the wide seal 114f decreases more gradually toward the lateral surfaces 7260e, 7260f of the recessed portions 7258e, 7258f than the height dimension of the medium seal 114e.

[0552] Figures 79A-79B yes Figure 77 The left and right side views of the middle seal 114e are shown. Figure 79A The gas entry angle 7186e can be determined by a line passing through the highest point 7182e and the lowest point 7184e of the gas entry orifice 7175e when the vertical axis 7256 and the bottom wall 7216e are aligned to be approximately horizontal (as described above with respect to FIG. Figures 60A-60C 82 is formed by a plurality of flanges 142a and 142b, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively, and wherein the flanges 142a and 142b are formed by a plurality of flanges 142b and 142c, respectively.

[0553] Figure 79B Another way to characterize the size or shape of the seal 114 relative to the gas inlet orifice 7175 is shown. Figure 79B , seal 114e is rotated to align the highest point 7182e and the lowest point 7184e of gas inlet orifice 7175e along vertical axis 7256. Vertical distance 7262e (or another way to characterize the depth of seal 114e) can be defined as the distance between the proximal-most point 7232e of seal 114e and vertical axis 7256. In the illustrated embodiment, vertical distance 7262e is 35.2 mm. In some embodiments, vertical distance 7262e can be a value other than 35.2 mm.

[0554] Table 2 shows a comparison of the approximate vertical distances 7262 of seals 114 of different sizes (e.g., small, medium, large, wide). In some embodiments, one or more of the dimensions of the seal 114 may vary by ±10% of the dimensions listed in Table 2. As discussed above, the present disclosure includes ratios that can be derived from the dimensions disclosed herein. As shown in Table 1 above, due to the anthropometric data set used, the medium seal 114 may have a slightly smaller vertical distance 7262 than the small seal 114.

[0555] Table 2. Approximate front wall displacement for small, medium, large, and wide seal sizes.

[0556] Seal size Anterior wall displacement (mm) small 36.2 Medium 35.2 large 37.0 Wide 37.2

[0557] Figure 80 A side view of the seal 114e is depicted positioned on the user's face in use. Figures 63A-63C As depicted, the orientation of the gas inlet orifice 7175e can be characterized by a use angle 7240e. Use angle 7240e can characterize the angle at which the seal 114 sits on the user's nose relative to the transverse plane of the user's head. In the illustrated embodiment, use angle 7240e is approximately 45°. In other embodiments, the gas inlet orifice 7175e can be oriented differently. In some variations, the orientation of the gas inlet orifice 7175e can depend on the size and physical characteristics of the user's nose.

[0558] Figure 81 Shown Figure 76A A front view of seal 114e is shown. Figure 81 The front view shown is oriented differently than Figure 76A The front view of the seal 114e is shown because Figure 81 The view shown is aligned with a plane perpendicular to the axial direction of the gas entry orifice 7175e. As discussed in detail below, the seal 114e can include a connector engagement structure or connector retention structure 7262e surrounding the gas entry orifice 7175e. Other embodiments of the seal 114 disclosed herein can also include a connector retention structure 7262 similar to the connector retention structure 7262e described below. The connector retention structure 7262e defines the gas entry orifice 7175e and provides a method of allowing the connector 7222 (in the embodiment of the present invention) to be engaged with the gas entry orifice 7175e. Figure 72 ) is connected to the structure on the body of the seal 114.

[0559] The gas inlet orifice 7175e may include a truncated portion 7177e, as described with respect to Figure 59B and 59CThe truncated portion 7177e can provide a visual indication of the orientation of the connector 7222 of the seal 114. In the illustrated embodiment, the truncated portion 7177e is positioned on the bottom edge of the connector retaining structure 7262e. In some embodiments, the truncated portion 7177e can be positioned on the top edge of the connector retaining structure 7262e, on either or both of the lateral edges of the connector retaining structure 7262e, or any combination thereof.

[0560] Because of the truncated portion 7177e of the connector retaining structure 7262e, the gas inlet orifice 7175e can have a vertical dimension 7264e that is different from the lateral dimension 7266e of the gas inlet orifice 7175e. Figure 81 7. In the embodiment shown, the truncated portion 7177e is positioned on the bottom edge of the connector retaining structure 7262e, so that the vertical dimension 7264e of the gas inlet orifice 7175e is smaller than the lateral dimension 7266e of the gas inlet orifice 7175e. In the illustrated embodiment, the gas inlet orifice 7175e has a vertical dimension 7264e of 26.5 mm and a lateral dimension 7266e of 31.17 mm. However, these dimensions are merely illustrative and are not intended to be limiting. In some embodiments, the vertical dimension 7264e has a value other than 26.5 mm, and the lateral dimension 7266e has a value other than 31.17 mm.

[0561] The seal 114e may include regions of varying thickness, as described above with respect to Figure 64 described. Figure 82A An isometric view of seal 114e is shown. Figure 82B 1. The seal 114e is shown to have a tip region 7268e, a core region 7270e, and an intermediate region 7272e disposed between the tip region 7268e and the core region 7270e. The tip region 7268e of the seal 114e can have a thickness of approximately 0.3 mm. In the illustrated embodiment, the thickness of the tip region 7268e is similar to that of other embodiments of the seal 114e (e.g., Figure 64 In the illustrated embodiment, the reduced thickness of the tip region 7268e increases the degree to which the seal 114e can flex and be compressed during use. Reducing the thickness of the tip region 7268e can reduce the force exerted by the seal 114 on the user's face when the seal 114 is in use.

[0562] Continue to refer Figure 82B, the thickness of the middle region 7272e can be non-constant. In some embodiments, as the seal 114e traverses laterally along the middle region 7272e from a first point 7276e near the top of the seal 114e to a second point 7278e near the bottom of the seal 114e, the thickness of the middle region 7272e can increase non-linearly. In the illustrated embodiment, the thickness of the middle region 7272e is approximately 0.3 mm at the first point 7276e and approximately 3.4 mm at the second point 7278e. In some embodiments, the thickness of the middle region 7272e can simply vary between approximately 0.3 mm and approximately 3.8 mm at different locations along the profile of the middle region 7272e (e.g., increasing and decreasing multiple times along the path between the first point 7276e and the second point 7278e). In the illustrated embodiment, the core region 7270e corresponds to the recessed portion 7258e of the front wall 7212e and has a wall thickness of approximately 1.00 mm. The thicknesses indicated above are the seal thickness as measured in a direction normal to the surface of the seal 114e. In some embodiments, one or more of the thicknesses noted above may vary by ±10% of these stated values.

[0563] Figure 83 A left side view of a cross section of a lateral portion of seal 114e is shown. Figure 83 , the front portion of the seal 114e is shown in light shading to indicate the position of the selected cross section relative to the remainder of the seal 114e. Figure 83 Shown is an inner surface 7274e of the front wall 7212e of the seal 114e. The inner surface 7274e faces the hollow interior space of the seal 7114e. The different thicknesses of the top region 7268e, the core region 7270e, and the middle region 7272e are observable in the cross section of the front wall 7212e. The thickness distribution of the front wall 7212e of the seal 114e shown allows the seal 114e to perform better when in use, as discussed below. The thin area of ​​the seal 114e allows the seal 114e to deform when it is needed to better fit the user's nose. The thick area of ​​the seal 114e provides and transmits a reinforcing force that keeps the seal 114e from being blown open when the seal 114e is under pressure during use.

[0564] Figure 84 As shown above Figures 66A-67C The seal 114e is depicted as a left side view of a longitudinal section. The seal 114e may include a thickened portion 7330e surrounding the nasal opening 7128e, as described above with respect to Figure 69 and 70 described.

[0565] Figure 85A front view of the inner surface of the rear wall of the seal 114e is shown. In the illustrated embodiment, the thickened portion 7330e can closely follow the contours of the nose opening 7128e at the lateral edges of the nose opening 7128e and extend further away from the nose opening 7128e at the middle portion of the nose opening 7128e. As discussed above, the thickened portion 7330e can help prevent the seal 114e from blowing open when the seal 114e is under pressure during use.

[0566] review Figure 84 In the illustrated embodiment, the thickened portion 7330e has a maximum thickness of 1.8 mm and is located on the central axis of the seal 114e, proximate to the nasal opening 7128e. In some embodiments, the maximum thickness of the thickened portion 7330e is greater than 1.8 mm. In some embodiments, the maximum thickness of the thickened portion 7330e is less than 1.8 mm. The ratio of the maximum thickness of the thickened portion 7330e to the adjacent portion of the rear wall 7202e can be 1.8:0.3 or 6:1.

[0567] Continue to refer Figure 84 , the bottom wall 7216e of the seal 114e has a front portion 7280e, a rear portion 7282e, and a central portion 7284e between the front portion 7280e and the rear portion 7282e. The front portion 7280e is characterized by a region of relatively high thickness adjacent to the connector retention structure 7262e. As discussed below, at least a portion of the central portion 7284e can be characterized by a region of relatively low thickness. The region of the central portion 7284e characterized by the region of relatively low thickness is referred to herein as the under-nose window 7285e (at Figure 87 ). The rear portion 7282e is characterized by a region of relatively high thickness relative to the central portion 7284e. In the illustrated embodiment, the rear portion 7282e forms a distinct difference between the bottom wall 7216e and the rear wall 7202e. In the illustrated embodiment, the thickness of the front portion 7280e is 2.7 mm, the thickness of the central portion 7284e is 0.3 mm, and the thickness of the rear portion 7282e is 2.7 mm, where the thickness is measured along a direction normal to the outer surface of the bottom wall 7216e. In some embodiments, one or more of the aforementioned thicknesses may vary by ±10% of these stated values.

[0568] The subnasal window 7285e of the central portion 7284e (at Figure 877216e. In some embodiments, the central portion 7284e can include a band of reduced thickness along a portion of the surface of the bottom wall 7216e that faces the hollow interior of the seal 114e. In the illustrated embodiment, the central portion 7284e is recessed approximately 2.4 mm relative to the front portion 7280e and the rear portion 7282e at the central axis of the seal 114e. In some embodiments, the entire central portion 7284e can be recessed a constant dimension relative to the front portion 7280e and the rear portion 7282e.

[0569] Reducing the thickness of the central portion 7284e can improve the comfort of the seal 114e during extended use. A problem that can arise with some nasal seal designs or some users is discomfort under the nose after extended use. It has been discovered that reducing the thickness of the central portion 7284e of the bottom wall 7216e improves the comfort of the seal 114e. As mentioned, reducing the thickness of the central portion 7284e creates a subnasal window 7285e between the thickened front portion 7280e and rear portion 7282e of the bottom wall 7216e. The subnasal window 7285e allows for increased deformation of the bottom wall 7216e of the seal 114e during use without compromising the effectiveness of the seal 114e. The increased thickness of the front portion 7280e and rear portion 7282e of the bottom wall 7216e increases the structural integrity of the seal 114e and allows for a nearly airtight seal to be formed with the user's face. The rear portion 7282e of the bottom wall 7216e helps to form an airtight seal against the user's lips and / or under-nose area.

[0570] In some variations, the degree to which the central portion 7284e is recessed can vary. For example, the central portion 7284e can be recessed the most at the central axis (at Figure 84 ) and is recessed a minimum amount at the lateral ends of the central portion 7284e. In some embodiments, the central portion 7284e may include a combination of adjacent regions having increasing or decreasing thicknesses, thereby forming a plurality of regions that are recessed to varying degrees relative to the front portion 7280e and the rear portion 7282e. The boundaries between these adjacent regions may be similar to a stepped function (e.g., a sudden change in thickness). The boundaries between these adjacent regions may be smooth curves that transition from one recessed level to another in a continuous manner. In some embodiments, as the central portion 7284e extends laterally away from the central axis, the central portion 7284e may have an undulating thickness. For another example, the central portion 7284e may include a plurality of raised ridges that extend laterally parallel to each other and away from the central axis.

[0571] Figure 86A bottom view of an embodiment of a seal 114g is shown that is similar to seal 114 or any other embodiment discussed herein, except as described differently below. The subnasal window 7285g of the seal 114g can have a proximal dimension 7286g extending from the distal-most point of the subnasal window 7285g to the proximal-most point of the subnasal window 7285g along the mid-surface of the seal 114g, as shown. Figure 86 The subnasal window 7285g can have a lateral dimension 7288g extending from the rightmost point of the subnasal window 7285g to the leftmost point of the subnasal window 7285g, as shown. Figure 86 As shown. In the illustrated embodiment, seal 114g includes a subnasal window 7285g having a proximal dimension 7286g of approximately 15.72 mm and a lateral dimension 7288g of approximately 32.45 mm. The overall depth 7144g of seal 114e is 41.2 mm, resulting in a ratio of 1:2.6 between the proximal dimension 7286g and the overall depth 7144g of the illustrated embodiment. The proximal dimension 7286g accounts for approximately 38% of the overall depth 7144g of seal 114g. The overall width 7142g of seal 114g is 58.6 mm, resulting in a ratio of 1:1.8 between the lateral dimension 7288g and the overall width 7142g of seal 114g. The lateral dimension 7288g accounts for approximately 55% of the overall width 7142g of seal 114g. These dimensions are illustrative and are not intended to be limiting. In some embodiments, these dimensions and ratios may vary depending on the size of seal 114.

[0572] Figure 87 Shown Figure 76A The top view of the cross section of the seal 114e is shown. The top view is taken along a plane perpendicular to the longitudinal plane. Thus, the surface of the bottom wall 7216e facing the hollow interior of the seal 114e is Figure 87 As shown, the subnasal window 7285e can have a first width 7290e that is a measurement of the length of the subnasal window 7285e as intersected by a proximal axis 7292 that extends from the front wall 7212e to the rear wall 7202e of the seal 114e along the midline of the seal 114e. Figure 87 As shown, a reference line 7296e can be defined as being orthogonal to the proximal axis 7292 and passing through the most lateral point of the subnasal window 7285e on the proximal axis 7292. The subnasal window 7285e can have a second width 7294e that is a measurement of the width of the subnasal window 7285e at the most lateral point of the subnasal window 7285e on the reference line 7296e, wherein the second width 7294e is aligned to span the subnasal window 7285e at the shortest possible distance, as shown. Figure 87As shown. In the illustrated embodiment, the first width 7290e is approximately 5.9 mm and the second width 7294e is approximately 7.1 mm, such that the ratio of the first width 7290e to the second width 7294e is 1.0:1.2. These dimensions correspond to a medium seal 114 and are intended to be illustrative and non-limiting. In some embodiments, these dimensions and ratios may vary depending on the size of the seal 114 (e.g., small, medium, large, wide).

[0573] In some embodiments, the second width 7294e can be the maximum width of the subnasal window 7285e. As discussed, the second width 7294e can be measured at a point of the subnasal window 7285e that is laterally displaced from the proximal axis 7292. In some embodiments, the subnasal window 7285e can maintain approximately the same width as the subnasal window 7285e extends laterally away from the proximal axis 7292.

[0574] Figure 88 A bottom view of an embodiment of a seal 114h is shown that is similar to seal 114 or any other embodiment discussed herein, except as described differently below. The embodiment shown is a wide code seal 114h. Figure 88 In the seal 114h shown, the under-nose window 7285h spans the bottom wall 7216h of the seal 114h. When compared to the under-nose window 7285 that only partially spans the length of the bottom wall 7216h (e.g., Figure 87 7285e), having the under-the-nose window 7285h extend across the entire length of the bottom wall 7216h can be beneficial because the under-the-nose window 7285h having a longer lateral profile allows a longer length of the seal 114h to be compressed when in use. Thus, this can help further reduce potential under-the-nose discomfort.

[0575] Figure 89 A top view of a cross section of an embodiment of a wide code seal 114i is shown. The top view is taken along a plane perpendicular to the longitudinal plane. Thus, the surface of the bottom wall 7216i that faces the hollow interior of the seal 114i is Figure 89 is visible. Figure 89 The seal 114i is shown to have a first width 7290i that is greater than Figure 87 The seal 114e is shown with a first width 7290e. In the illustrated embodiment, the first width 7290i may be approximately 6.9 mm. Figure 89As shown, the under-nose window 7285i spans the length of the bottom wall 7216i. Except as described differently below, the seal 114i is similar to the seal 114e or any other embodiment discussed herein. The features of the seal 114i can be combined with or included in the seal 114e or any other embodiment discussed herein. Thus, the under-nose window 7285i can have similar absolute dimensions and / or ratios and / or configurations as those described for the under-nose window 7285e or any other embodiment discussed herein.

[0576] Figure 90 A rear perspective view of an embodiment of a mid-size seal 114j is shown. Figure 90 The nose window 7285j shown is Figure 89 The illustrated subnasal window 7285h is similar in that the subnasal window 7285j spans the length of the bottom wall 7216j. It can be seen that the recessed portion 7285j of the central portion 7284j (also referred to herein as the subnasal window 7285j) extends laterally along the bottom wall 7216j and into the area between the front wall 7212j and the rear wall 7202j of the seal 114j. Thus, the subnasal window 7285j can be said to extend laterally beyond what can technically be referred to as the bottom wall 7216j of the seal 114j.

[0577] Figure 91 A top view of a cross section of an embodiment of seal 114k is shown. The top view is taken along a plane substantially perpendicular to the longitudinal plane. Thus, the surface of bottom wall 7216k that faces the hollow interior of seal 114i is substantially perpendicular to the longitudinal plane. Figure 91. In the illustrated embodiment, the central portion 7284k includes three subnasal windows 7285k characterized by the reduced wall thickness of the bottom wall 7216k of the seal 114k. In the illustrated embodiment, the three subnasal windows 7285k are separated by two pillars 7287k characterized by an area with increased thickness. The separated subnasal windows 7285k can improve the behavior of the seal 114k when the seal 114k is under compression. When the seal 114k is worn, the subnasal windows 7285k (i.e., the area with reduced thickness) can be compressed, thereby reducing the pressure imposed on the user's upper lip. The pillars 7287k (i.e., the thickened portion) can improve the ability of the seal 114k to maintain its shape when deformed in the distal to proximal direction around the user's nose. In the illustrated embodiment, the pillars 7287k have the same wall thickness as the adjacent front portion 7280k and rear portion 7282k. In some embodiments, the struts 7287k can have a wall thickness that is different from the wall thickness of the adjacent front portion 7280k and rear portion 7282k. For example, the struts 7287k can have a wall thickness that is greater than or less than the wall thickness of the adjacent front portion 7280k and rear portion 7282k. In some embodiments, the wall thickness of the subnasal window 7285k can vary across the subnasal window 7285k. For example, the wall thickness of the subnasal window 7285k can gradually increase over the length of the subnasal window 7285k such that the area of ​​the subnasal window 7285k adjacent to the struts 7287k has the same wall thickness as the struts 7287k. Thus, as Figure 91 As shown in the embodiment of the present invention, the transition in wall thickness between the under-nose window 7285k and the support 7287k can be gradual, rather than stepped, over the length of the bottom wall 7216k. The illustrated embodiment has three under-nose windows 7285k. However, some embodiments may have four or more under-nose windows 7285k. In addition, the support 7287k of the illustrated embodiment has an approximately constant width (e.g., the dimensions of the front wall 7212k of the support 7287k adjacent to the seal 114k are approximately the same as the dimensions of the rear wall 7202k of the support 7287k adjacent to the seal 114k). In some embodiments, the width of the support 7287k may not remain approximately constant. For example, the dimensions of the support 7287k adjacent the front wall 7212k of the seal 114k can be smaller than the dimensions of the support 7287k adjacent the rear wall 7202k of the seal 114k (e.g., the width of the support 7287k increases when moving from the front wall 7212k of the seal 114k to the rear wall 7202k along the bottom wall 7216k of the seal 114k). In some embodiments, the opposite may also be true (e.g., the width of the support 7287k decreases when moving from the front wall 7212k of the seal 114k to the rear wall 7202k along the bottom wall 7216k of the seal 114k).

[0578] As mentioned above about Figure 55 As discussed, the seal 114 can be attached to the connector 7222, which helps provide structure to the seal 114 when the seal 114 is under pressure during use. In addition, the connector 7222 can provide a means for connecting the seal...

Claims

1. A nasal seal, comprising: a seal body defining a breathing chamber; a nasal port located in the seal body, the nasal port comprising a central portion, a pair of lateral portions spanning across the nasal port, the nasal port further comprising an upper edge and a lower edge; wherein the upper edge defines an inwardly protruding portion within the central portion, and wherein the lower edge defines an inwardly protruding portion within the central portion.

2. The nasal seal of claim 1, wherein: The inwardly projecting portions of one or both of the upper edge and the lower edge are curved.

3. A nasal seal according to claim 1 or claim 2, wherein: The nose port is generally bean-shaped or bow-tie-shaped.

4. A nasal seal as described in any of the preceding claims, further comprising a thickened rim portion extending around part or all of the periphery of the nasal port, the thickened rim portion having a greater wall thickness than a portion of the seal immediately adjacent the thickened rim portion.

5. A nasal seal as claimed in any one of the preceding claims, wherein: The seal body comprises a central portion, a pair of lateral portions spanning either side, wherein, in use, the seal body is configured such that when a user applies pressure to the central portion, the lateral portions move inwardly.

6. A nasal seal as claimed in any one of the preceding claims, wherein: The user-facing surface of the nasal seal includes a thinned wall portion.

7. The nasal seal of claim 6, wherein: The thinned wall portion of the user facing surface has or is equal to the minimum wall thickness of the seal body.

8. A nasal seal as claimed in any preceding claim, further comprising a pair of thickened wall portions which contact the cheeks of the user in use.

9. The nasal seal of claim 8, wherein: The thickened wall portions have or are equal to the maximum wall thickness of the seal body.

10. A nasal seal as claimed in claim 8 or claim 9, wherein: Each of the thickened wall portions includes a groove within the thickened wall portion that allows for uncoupling movement of portions of the thickened wall portion on either side of the groove.

Images