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 filed on September 9, 2016, with application number 201680062677.5 (international application number PCT / IB2016 / 055369) and entitled "Nose seal, mask and breathing interface assembly".

[0002] Priority application

[0003] This application claims priority to the following 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 herein by reference and form part of this disclosure.

[0004] background

[0005] field

[0006] This disclosure generally relates to a nasal seal for a breathing interface, and to an interface including the nasal seal, the interface comprising a mask or a mask and headgear.

[0007] Description of related technologies

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

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

[0010] Direct nose interfaces are typically smaller on the face and do not include a T-piece, thus being less obstructive. However, direct nose interfaces typically include a nose pillow or similar device that inserts into the wearer's nostrils to ensure an effective seal.

[0011] CPAP is a treatment for sleep apnea (e.g., obstructive sleep apnea). Patients undergoing CPAP treatment for sleep apnea wear a full-face mask or nasal mask during sleep. The goal is for the breathing interface to be comfortable to wear while maintaining a good seal between the breathing interface and the user.

[0012] Overview

[0013] The systems, methods, and apparatuses described herein are innovative in that no single aspect is indispensable or can alone provide the desired properties. Without limiting the scope of the claims, some advantageous features will now be outlined.

[0014] In some configurations, a nasal seal includes a seal body defining a breathing cavity. A nasal port is provided in the seal body. The nasal port includes a central portion and a pair of lateral portions spanning both 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, these inwardly projecting portions of one or both of the upper and lower edges are curved.

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

[0017] In some configurations, the nose seal further includes a thickened edge portion extending partially or entirely around the periphery of the nose port, the thickened edge portion having a greater wall thickness than the portion of the seal immediately adjacent to the thickened edge portion.

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

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

[0020] In some configurations, the nose seal further includes a pair of thickened wall portions that contact the user's cheek during use. In some configurations, these thickened wall portions have a wall thickness equal to or greater than the maximum wall thickness of the seal body.

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

[0022] In some configurations, the nose seal further includes a connector configured to allow the nose 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 an orifice in 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 an edge that extends partially or completely around the orifice, wherein the edge is caught between the first portion and the second portion.

[0025] In some configurations, the edge 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 to the first direction.

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

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

[0028] In some configurations, the seal body has a first texture on the user contact side and a second texture on the 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 rearward from the central portion, wherein the arm portions are configured for attachment to a headgear.

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

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

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

[0033] In some configurations, each of the pair of arm sections includes a hinge portion that allows the rear ends of these arm sections 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 section that supports the catheter connector.

[0036] In some configurations, the conduit connector includes a bend.

[0037] In some configurations, the deflection vent is located on the duct connector portion.

[0038] In some configurations, the nasal mask further includes an extension within a flow passage defined between the upstream end of the duct connector portion and the breathing chamber of the sealing body, wherein the deflection orifice is located upstream of the extension.

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

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

[0041] In some configurations, the liner is positioned on the inward-facing surface of each of the pair of arm portions.

[0042] In some configurations, the liner and the arm portion are connected via an overmolding process.

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

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

[0045] In some configurations, an interface component includes a nose mask as described in any of the preceding paragraphs, and a headgear including 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 its forward extensions are non-extendable. In some configurations, the rear strap is extendable.

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

[0048] In some configurations, these forward strap extensions and these arm portions have multiple 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 of which is configured to receive one of the posts.

[0050] In some configurations, an interface component includes: a nose mask; a frame attached to the nose mask; a headband; and side arms connected to the frame and the headband. These side arms are rigid in a vertical plane and movable relative to the user's face in a horizontal plane.

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

[0052] In some configurations, these side arms are formed by modular segments.

[0053] In some configurations, these side arms include accordion-style springs.

[0054] In some configurations, these side arms have serrations on their surfaces.

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

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

[0057] In some configurations, a central section is attached to the ends of these side arms, and a channel is arranged on the frame. The central section is positioned within the channel, thus allowing the frame to be movably supported by the central section.

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

[0059] In some configurations, the nasal seal further includes: a seal body defining a breathing cavity; and a nasal port positioned on the seal body. The nasal port includes a central portion, a pair of lateral portions spanning both sides, and further includes an upper edge and a lower edge. The nasal seal also includes 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 nose seal further includes through holes positioned within 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 the nose of a user inserted into the nasal port.

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

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

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

[0065] In some configurations, the nasal obstruction member extends from the 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 the midpoint of the width along the nose port.

[0067] In some configurations, the nose port includes a thickened beaded edge positioned along the upper edge of the nose 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 these 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 the nose of a user inserted into the nasal port.

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

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

[0071] In some configurations, these oval ports face each other at an angle.

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

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

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

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

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

[0077] In some configurations, the upper portion and the lower portion of the nose 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 mark positioned on the seal body, the mark being configured to indicate the position of a user's nose above the nasal port.

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

[0081] In some configurations, the label has an odor.

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

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

[0084] In some configurations, an interface assembly includes: a nose mask; a frame attached to the nose 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 rotation of the frame.

[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 cavity; and a downwardly deflectable upper portion. The downwardly deflectable upper portion rolls in a downward direction relative to a lower portion of the seal.

[0087] In some configurations, the nose seal further includes an upwardly deflectable lower portion. This 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 interface connection portion formed around the nasal port. The deformable nasal interface connection portion deforms inward into the breathing cavity and extends outward from the breathing cavity.

[0089] In some configurations, a reinforcement region surrounds the nose port. This reinforcement region has a thickness greater than that of the deformable nose interface connection portion.

[0090] In some configurations, a nasal seal includes a front wall having a circumferentially circumferentially surrounding a gas inlet opening. The front wall extends proximally from the edge and connects to a rear wall, thereby forming a breathing cavity between the front and rear walls. A central portion of the rear wall extends to a first and a second lateral portion 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 includes 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 directly to the second wall without any inflection point. In some aspects, the nose seal further includes a connector secured to the edge of the front wall. In some configurations, the connector includes an arm extending proximally along the front wall.

[0092] In some configurations, at least a portion of the nasal opening is arranged closer to the farthest point of the anterior wall than to the nearest point of the anterior wall. In some configurations, the entire nasal opening is closer to the farthest point of the anterior wall than to the nearest point of the anterior wall.

[0093] In some aspects, the nose seal includes a bottom wall extending from the gas inlet opening to the recess. The bottom wall has a front portion distal to a rear portion. The rear portion has a greater thickness than the front portion. In some embodiments, the bottom wall further includes a central portion disposed between the front and rear portions. The central portion has a 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 region and a non-truncated region, and the distance between the center point of the opening and the truncated region is less than the distance between the center point of the opening and the non-truncated region.

[0096] Other aspects of the subject matter of this disclosure, which should be considered in all its novel aspects, will become clear to those skilled in the art upon reading the following specification (which provides at least one example of the practical application of the invention).

[0097] Brief description of the attached figures

[0098] Throughout the accompanying drawings, reference numerals may be used repeatedly to indicate general correspondences between reference elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of this disclosure.

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

[0100] Figure 2 It is suitable for and Figure 1 A perspective view of a user interface used with a respiratory system, which includes a mask and headgear.

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

[0102] Figure 4 yes Figure 2 A perspective view of the user interface face mask, which includes a frame and seals.

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

[0104] Figure 6 This is a perspective view of part of the frame of the face mask.

[0105] Figure 7 yes Figure 6 The top view of this part of the frame.

[0106] Figure 8 This is a perspective view of the face mask, in which [the mask] has been removed. Figure 6 and7 The part shown.

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

[0108] Figure 10 This is a front perspective view of part of the mask's frame.

[0109] Figure 11 yes Figure 10 The back perspective of this part of the frame.

[0110] Figure 12 This is another perspective view of the mask, which shows the internal structure of the seal with dashed lines.

[0111] Figure 13 This is a perspective view of the seal, which is separate from the frame.

[0112] Figure 14 It is along the seal. Figure 13 The cross-sectional view taken from line 14-14 in the figure.

[0113] Figure 15 It is along the seal. Figure 13 The cross-sectional view taken from line 15-15 in the figure.

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

[0115] Figure 17 This is a perspective view of the seal, showing the features configured for connection to the connector on the frame.

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

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

[0118] Figure 20 This is a front perspective view of another part of the connector, which is configured to be connected to. Figure 19 On the connector part.

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

[0120] Figure 22 This is a view with the connector seal removed, showing the upper portion of the seal's orifice.

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

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

[0123] Figure 25 This is a cross-sectional view of the CPAP hose-to-mask connection disclosed herein.

[0124] Figure 26A and 26B Correspondingly, the velocity diagram of the extension within the flow path is shown before and after the deflection orifice is positioned in the extension.

[0125] Figure 27A and 27B Correspondingly, this is a vector diagram of the extension within the flow path when the deflection vent is positioned before and after the extension.

[0126] Figure 28A , 28B The images 28C and 28C are cross-sectional views of three different designs of the interface, including the portion with deflecting air vents.

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

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

[0129] Figure 31 It is in a disconnected configuration. Figure 30 The side view of the connection.

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

[0131] Figure 33 It is in a connected configuration Figure 32 The side view of the connection.

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

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

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

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

[0136] Figure 36C They are shown as being in the bent position and the unbent position. Figure 36A A top view of the accordion-style cover of the interface shown.

[0137] Figure 36D yes Figure 36A A perspective view of the accordion-style overlay of the interface.

[0138] Figure 37A This 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 section of the interface.

[0140] Figure 37C yes Figure 37A A top view of the interface, showing the joint movement of the side arm.

[0141] Figure 38A It is a perspective view of the interface with 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 A top view of the interface, showing the side arm in its undeformed shape.

[0144] Figure 38D yes Figure 38A A top view of the interface, showing the joint movement of the side arm.

[0145] Figure 39A It is a close-up side perspective view of the alternative spring-loaded side arm arrangement with elastic and rigid sections.

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

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

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

[0149] Figure 40C yes Figure 40A A top view of the interface, which shows the maximum joint movement of the side arm.

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

[0151] Figure 40E yes Figure 40A A close-up top view of the interface, showing the joint movement of the saw cut section.

[0152] Figure 41A It is a perspective view of the interface with hook and post connector arrangement.

[0153] Figure 41B yes Figure 41A A close-up top view of the hook and post connectors.

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

[0155] Figure 42A This is a top view of the 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 on a pillow.

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

[0158] Figure 42D yes Figure 42A A top view of the interface, which shows the range of the side arm positions.

[0159] Figure 43A It 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 location 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 on a pillow.

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

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

[0164] Figure 44C It was incorrectly positioned on the user. Figure 44A A cross-sectional side view of the seal in the image.

[0165] Figure 44D This is a cross-sectional perspective view of a seal with a flange having an air vent to indicate to the user that the seal is being worn incorrectly.

[0166] Figure 44E It is correctly positioned on the user. Figure 44D A cross-sectional side view of the seal in the image.

[0167] Figure 44F It was incorrectly positioned on the user. Figure 44D A cross-sectional side view of the seal in the image.

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

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

[0170] Figure 44I This is a cross-sectional perspective view of a seal that has a flange with a recess to indicate to the user that the seal is being worn incorrectly.

[0171] Figure 45A It is a cross-sectional perspective view of a sealing arrangement having a woven mesh above the orifice to physically prevent or inhibit improper wearing of the sealing by the user.

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

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

[0174] Figure 45D This is a cross-sectional perspective view of an alternative sealing arrangement having an orifice cover to physically prevent or inhibit improper use of the seal by the user.

[0175] Figure 45E An orifice cover with multiple orifice arrangements is shown.

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

[0177] Figure 46B yes Figure 46A A cross-sectional side view of the sealing arrangement in the middle.

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

[0179] Figure 46D yes Figure 46A A cross-sectional side view of the seal, showing the seal being correctly fitted to the user.

[0180] Figure 46E This is a cross-sectional perspective view of a sealing arrangement having cushioning elements to physically prevent or inhibit improper use of the seals by the user.

[0181] Figure 46F yes Figure 46E A cross-sectional side view of the seal, showing the seal being correctly fitted to the user.

[0182] Figure 46G yes Figure 46E A cross-sectional side view of the seal, showing a seal that has been improperly fitted to the user.

[0183] Figure 46H An alternative buffer arrangement was demonstrated.

[0184] Figure 47A An alternative configuration of the orifice of the seal is shown, which prevents or inhibits the insertion of the user's nose into the orifice.

[0185] Figure 47B An alternative configuration of the orifice of the seal is shown, which prevents or inhibits the insertion of the user's nose into the orifice.

[0186] Figure 47C An alternative configuration of the orifice of the seal is shown, which prevents or inhibits the insertion of the user's nose into the orifice.

[0187] Figure 47D An alternative configuration of the orifice of the seal is shown, which prevents or inhibits the insertion of the user's nose into the orifice.

[0188] Figure 47EAn alternative configuration of the orifice of the seal is shown, which prevents or inhibits the insertion of the user's nose into the orifice.

[0189] Figure 47F An alternative configuration of the orifice of the seal is shown, which prevents or inhibits the insertion of the user's nose into the orifice.

[0190] Figure 47G yes Figure 47F A cross-sectional side view of the orifice arrangement in the diagram.

[0191] Figure 48A This is a rear view of the nose seal arrangement, which has visual markings to indicate the correct nose position.

[0192] Figure 48B The alternative marking arrangement is described.

[0193] Figure 48C Alternative combination markers are depicted to indicate the correct nose alignment and position.

[0194] Figure 48D Alternative markings indicating correct nose alignment and position are depicted.

[0195] Figure 48E This is the rear view of the alternative marker arrangement.

[0196] Figure 48F It is a rear view of the alternative odorous marking arrangement.

[0197] Figure 48G This is a rear view of the nose seal arrangement, which has frosted markings to visually indicate the correct nose alignment and position.

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

[0199] Figure 48I An alternative frosted marking arrangement is described.

[0200] Figure 49A This is a rear view of a nose seal arrangement that has a compressible vortex to indicate the correct nose position.

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

[0202] Figure 49C yes Figure 49A A cross-sectional side view of the nose seal arrangement at the location that can compress the vortex.

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

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

[0205] Figure 50C and 50D This is a schematic side view showing the extended and retracted positions of the frame track, which result in... Figure 50A The interface arrangement allows for the rotation of the front plane projection line of the rotatable nose seal.

[0206] Figure 50E It is designed for users with a straight nasal angle. Figure 50A A cross-sectional side view of a rotatable nose seal.

[0207] Figure 50F It is designed for users with a negative nasal angle. Figure 50A A cross-sectional side view of a rotatable nose seal.

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

[0209] Figure 51B yes Figure 51A A side view of the alternative interface arrangement, showing the rotation of the nose seal.

[0210] Figure 51C and 51D yes Figure 51A Side views of the alternative interface arrangement, showing different rotational positions of the nose seal.

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

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

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

[0214] Figure 52A This is a perspective view of a roll-up nose seal.

[0215] Figure 52B yes Figure 52A The undeformed orientation of the roll-type nose seal is shown in the side perspective view of the cross section.

[0216] Figure 52C yes Figure 52A A side perspective view of a cross-section showing the rolling orientation of the roll-type nose seal.

[0217] Figure 53A It is a perspective view of a roll-type nose seal having an upper roll-up section and a lower roll-up section.

[0218] Figure 53B It 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 showing the undeformed orientation of the roll-type nose seal.

[0220] Figure 53D yes Figure 53A A side view showing the rolling orientation of the roll-type nose seal.

[0221] Figure 53E This is a perspective view of an alternative spiral nose seal with a spring steel section.

[0222] Figure 54A This is a perspective view of a nose seal with a telescopic area.

[0223] Figure 54B yes Figure 54A A side perspective view of the cross-section of the nose seal.

[0224] Figure 54C It demonstrates the fit for users with longer noses and users with shorter noses. Figure 54A A schematic side view of the nose seal.

[0225] Figure 54D It is a demonstration of a user's nose that fits to a longer, more horizontal plane. Figure 54A A schematic side view of the nose seal.

[0226] Figure 54E It is designed to fit users with longer noses that are angled downwards. Figure 54A A schematic side view of the nose seal.

[0227] Figure 54F It is a demonstration of a user's nose that fits at an upward angle and has a shorter nose. Figure 54A A schematic side view of the nose seal.

[0228] Figure 54G It is a demonstration of a user's nose that fits at a downward angle and has a shorter nose. Figure 54A A schematic side view of the nose seal.

[0229] Figure 55It is suitable for and Figure 1 A perspective view of a user interface used with a respiratory system, which includes a patient interface and a headgear.

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

[0231] Figure 57 yes Figure 56 The back perspective of the frame.

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

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

[0234] Figure 58C This is a perspective view of an embodiment of the 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 nose seal.

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

[0240] Figure 60C yes Figure 58C Left side view of the nose 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 A top view of the nose seal.

[0245] Figure 62B yes Figure 58B A top view of the nose seal.

[0246] Figure 62C yes Figure 58C A top view of the nose seal.

[0247] Figure 63A In use Figure 58A Left side view of the nose seal.

[0248] Figure 63B In use Figure 58B Left side view of the nose seal.

[0249] Figure 63C In use Figure 58C Left side view of the nose seal.

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

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

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

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

[0254] Figure 66B yes Figure 58C A partial longitudinal section view of the nose seal.

[0255] Figure 66C yes Figure 58C A longitudinal section view of the nose seal.

[0256] Figure 67A yes Figure 58A A partial longitudinal section view of the nose seal.

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

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

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

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

[0261] Figure 70 yes Figure 58C A 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 This is a perspective view of an embodiment of the connector.

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

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

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

[0269] Figure 76A This is a front view of an embodiment of the nose seal.

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

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

[0272] Figure 76D yes Figure 76A A top view of the nose seal.

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

[0274] Figure 77 This is a perspective view of an embodiment of the nose seal.

[0275] Figure 78 This is a perspective view of an embodiment of the wide-nose seal.

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

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

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

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

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

[0281] Figure 82B yes Figure 82A A front perspective view of the nose seal, showing the location of different wall thickness areas on the seal.

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

[0283] Figure 84 This is a longitudinal section of an embodiment of the nose seal.

[0284] Figure 85 This is a front view of the inner surface of the rear wall of an embodiment of the nose seal, showing the thickened portion surrounding the nose opening.

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

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

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

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

[0289] Figure 90 This is a rear perspective view of an embodiment of a nasal seal with a subnasal window extending across the bottom wall of the seal.

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

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

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

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

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

[0298] Figure 93A This is a front perspective view of an embodiment of the rear flange of the 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 It is connected to Figure 93A On the rear flange Figure 92A Rear perspective view of the front flange component.

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

[0307] Figure 96 This is a longitudinal sectional view of a portion of an embodiment of a connector attached to a nose seal.

[0308] Figure 97 This is a longitudinal cross-sectional view as part of another embodiment of a connector attached to a nose seal.

[0309] Figure 98 This is a longitudinal cross-sectional view as part of yet another embodiment of a connector attached to a nose seal.

[0310] Figure 99 This is a longitudinal cross-sectional view as part of another embodiment of a connector attached to a nose seal.

[0311] Detailed description

[0312] Embodiments of systems, components, and assembly and manufacturing methods will now be described with reference to the accompanying drawings, wherein similar numerals refer to similar or analogous elements throughout. Although several embodiments, examples, and illustrations are disclosed below, it should 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 their obvious modifications and equivalents. The terminology used in the description presented herein is not intended to be interpreted simply in any limiting or restrictive manner, as the terminology is used in conjunction with the detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature alone is essential to achieving its desired properties or to practicing the invention described herein.

[0313] Certain terms used in the following description may be for reference only and are therefore not intended to be limiting. For example, terms such as “above” and “below” refer to the directions referenced in the accompanying drawings. Terms such as “front,” “rear,” “left,” “right,” “back,” and “side” describe the orientation and / or position of portions of a component or element in a consistent but arbitrary frame of reference, which is made clear by reference to the text describing these components or elements in discussion and the associated accompanying drawings. Furthermore, terms such as “first,” “second,” and “third” may be used to describe individual components. Such terms may include the words specifically mentioned above, their derivatives, and words with similar meanings.

[0314] Figure 1This is a schematic diagram of a positive airway pressure (CPAP) system 10, which provides a stream of heated and humidified air to a user U via a user-worn interface 110 connected to the CPAP system 10 via a conduit or tube 12. A humidification chamber 14 has a heat-conducting base in contact with a heating plate 16 of a humidifier 17 to humidify the air stream. A conduit 12 connects to an outlet 13 of the humidification chamber 14 to deliver humidified air to the user interface 110. The humidifier 17 includes, for example but not limited to, a controller 18 that executes computer software commands stored in associated memory, such as a microprocessor-based controller. The controller 18 receives input commands from multiple sources, including a user input interface 19, such as a dial pad or touchscreen, that enables the setting of predetermined values ​​for the 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 temperature and / or flow rate sensors 20 and 21 connected via connector 22 to communicate with the controller 18, and / or heating plate temperature sensor 23. In response to a selected humidity or temperature value, the controller 19 determines when and / or to what level the heating plate 16 should be energized to properly heat the water contained in the humidification chamber 14.

[0315] When a certain volume of water in the chamber is heated, water vapor begins to fill the chamber volume above the surface of the water. The water vapor exits the humidification chamber outlet 13 along with the airflow supplied from supply source 25 (such as blower 27) and entering the humidification chamber 30 through inlet 26. Blower 27 may be a variable speed fan or may include a variable pressure regulator. Blower 27 draws air in through inlet 28. The blower may be controlled by, for example, controller 29 or controller 18. Controller 18 or 29 may control the blower speed, regulated pressure, etc., according to any suitable criteria. For example, controller 29 may respond to inputs from controller 18 and user-set values ​​(e.g., preset values) for pressure and / or fan speed, which may be set using user interface 30 (e.g., dial pad).

[0316] The conduit 12 may include a heater (such as a heating wire) to heat the walls of the conduit in order to reduce condensation of the humidifying gas inside the conduit.

[0317] The seals and interfaces disclosed herein may be used in such CPAP systems (with or without humidification) as described, or alternatively in other forms of respiratory systems (e.g., VPAP (Variable Positive Airway Pressure) systems, BiPAP (Bilevel Positive Airway Pressure) systems), or with ventilators, and are generally described herein by way of example only with reference to CPAP therapy.

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

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

[0320] Interface 110 preferably includes a flow-limiting outlet or deflector vent 126 for providing gas flushing from interface 110. In some configurations, the deflector vent 126 is in the form of small orifices. The deflector vent 126 may be located in frame 116 (as shown), in bend 122, or elsewhere on interface 110.

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

[0322] In some configurations, frame 116 includes side arms 130 that extend outward (away from each other), backward, and upward at shallow angles, beyond the left and right ends of seal 114, and along the left and right cheeks, specifically the user's cheekbones, to connect to headband 118 to hold seal 114 to the user's face. These side arms 130 may be longer than their depth or thickness and may be resiliently and flexibly connected to the frame and / or resiliently and flexibly along their length (width rather than height). In some configurations, side arms 130 extend toward or to the location between the user's ear and eye and / or to the user's temple or nearby, where side arms 130 connect to headband 118. In some configurations, the length of side arms 130 is between approximately 100 mm and approximately 150 mm. The shape of the side arms 130 and / or the angle between them is such that the side arms 130 rest on the left and right cheeks, and specifically on the user's cheekbones, so as to help stabilize the interface 110 for rotation around the horizontal axis when worn.

[0323] The side arm may be resiliently flexible toward and away from the user's face in an approximately horizontal plane (when worn) to accommodate different face sizes, but may be relatively inflexible in an approximately vertical plane. The side arm 130 shown is solid, but other types of side arms may include one or more openings or cutouts extending along the length of the side arm to increase the resilient flexibility of the side arm 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 may include a softer material on or around at least a portion of the user-facing surface of the side arm 130 to soften contact between the side arm 130 and the user's face. If desired, the inner surface of the side arm 130 may include a pad 132 facing and / or contacting the user's face, such as... Figure 3 As shown. Pad 132 may be removable for cleaning or replacement. Pad 132 and side arm 130 may be joined by overmolding or welding processes. Pad 132 may have a textured and / or fabric outer surface. Textured surfaces may increase friction to keep the side arm 130 in place on the user's face, and fabric materials may improve comfort.

[0325] At the outer end or free end of the side arm 130, the side arm includes a connector portion 134 for detachably connecting the side arm 130 to the headgear 118. In some configurations, each of the connector portions 134 includes a recess or receiving portion 136 configured to receive a complementary connector 138 of the headgear 118. The connector 138 of the headgear 118 can be held within the receiving portion 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 receiving portion 136 has an orientation feature. The orientation feature allows 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 features may allow the left side of the headgear 118 to connect to the right side arm 130 and the right side of the headgear 118 to connect to the left side arm 130, simply by causing the headgear 118 to fold inward. In the illustrated arrangement, each connector portion 134 includes at least one protrusion or latching member 140, such as a pair of latching members 140 respectively positioned on opposite sides of the receiving portion 136. The latching members 140 may retain the connector 138 within the receiving portion 136 in at least one direction, such as in a direction of outward movement away from the connector portion 134 and in a rotational direction. When, for example, the connector 138 is inserted from its end, the latching members 140 may guide the connector 138 into a 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 outward from the outer surface of the receiving portion 136 and engages a complementary opening of the connector 138 of the headgear 118 to retain the connector 138 within the receiving portion 136 in response to a force that tends 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 facilitate clamping the connector 138 into place.

[0326] In some configurations, the side arms 130 may be integrally formed with another portion or the remainder of the frame 116 by injection molding from, for example, 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 the connector 146 may be permanently or removably coupled to each other. In some configurations, each of the side arms 130 may include its own connector 146, which may be separately attached to the base 144.

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

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

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

[0330] In some configurations, the laterally outward or rearward portion of the central portion 148 can be configured to support the side arm 130 in a spaced-out relationship with the base 144 and / or the seal 114. In the illustrated arrangement, the laterally outward or rearward portion of the central portion 148 has a greater wall thickness in a direction perpendicular to the inner surface 154 compared to the center of the central portion 148. The wall thickness gradually increases in the front-rear direction of the laterally outward or rearward portion of the central portion 148. Therefore, the front end of the side arm 130 is spaced outward from the inner surface 154, the base 144, and / or the seal 114 by a distance 158. The distance 158 can be, for example, between 3-15 mm, 5-10 mm, or about 5 mm. The attachment point of the central portion 148 to the base 144, defined by, for example, a protrusion 150, can define a hinge or articulation point of the frame assembly, which increases the flexibility of the side arm 130 relative to the central portion 148 and / or the base 144. The reduced thickness of the front end of the side arm 130 relative to the rear portion of the central portion 148 can contribute to the flexibility of the side arm 130 relative to the central portion 148 and / or the base 144.

[0331] In some configurations, the protrusion 150 is located at or near the end of the laterally outward or rearward portion of the central portion 148. In this arrangement, the central portion 148 of the connector 146 is coupled to the base 144, while the side arm 130 is not directly coupled to the base 144 and is free to move or flex relative to the base 144. In some configurations, the connector 146 is overmolded to the base 144, or the connector 146 and the base are otherwise connected by an overmolding process. In other arrangements, the connector 146 may be coupled to the base 144 in other ways, preferably at the central portion 148, such that the side arm 130 is 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 material of the side arm 130 of the connector 146. Alternatively, the side arm 130 may be configured to have lower rigidity compared to the base 144 in other ways, such as by reducing material thickness, hinges, cutouts, or other suitable arrangements. In some configurations, on each side of the mask 112, the central portion 148 terminates before the rearward edge of one or both of the base 144 and the seal 114. Therefore, the portion of the side arm 130 in front of the rearward edge of one or both of the base 144 and the seal 114 may move or flex relative to the base 144 and / or the seal 114.

[0332] In some configurations, on each side of the face shield 112, the terminating point of the central portion 148 is spaced 160 from the rearward edge of the base 144 and 162 from the rearward edge of the seal 114, as measured along the central axis 164 extending in the front-rear direction and bisecting the face shield 112. The distance 160 may be between one-quarter and one-half of the total length 166 of the face shield 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 face shield 112. The distance 162 may 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 may be at least as long as, at least 1.5 times, or at least twice the total length 166 of the mask 112, as measured along the central axis 164, depending on where the tip of the side arm 130 is located relative to the mask 112. This arrangement provides desired horizontal support to the base 144 and the seal 114 while allowing desired horizontal movement of the side arm 130 to accommodate various facial geometries.

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

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

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

[0336] Preferably, the seal 114 and base 144 include an alignment or keying arrangement such that the seal 114 and base 144 can only be assembled in the correct orientation relative to each other. Any suitable arrangement can be used. In the illustrated arrangement, the seal connector 172 includes a recess 180 configured to receive a key or protrusion 182 of the seal 114. Figure 17 The recess 180 and protrusion 182 shown are 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 may also be reversed. Furthermore, other suitable arrangements may be used, such as connectors 172 and apertures 176 with non-circular shapes.

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

[0338] In the illustrated arrangement, the deflector vent 126 is defined by the frame 116. Specifically, the deflector vent 126 is defined by a bend connector 174 of the base 144 of the frame 116. The illustrated bend connector 174 includes a diameter-enlarged portion closest to the U-shaped body of the base 144, which defines a surface or shoulder 188 facing or contacting the end surface of the bend 122. The deflector vent 126 includes a plurality of openings or vents 190 that extend radially in a generally radial direction through the diameter-enlarged portion of the bend connector 174. Therefore, when the bend 122 is attached to the base 144, the bend 122 does not cover the vents 190, and the vents 190 are located between the bend 122 and the U-shaped body of the base 144. In the illustrated arrangement, the longitudinal axis of the individual vent 190 is tilted or angled in the forward direction when moved along the axis from the inside of the bend connector 174 toward the outside of the bend connector 174. This arrangement can guide the exhaust gas flow away from the user's face. Alternatively, the deflector vent 126 can be located on the bend 122, the frame 116, or at another suitable location.

[0339] Figure 12-15 Features that allow the face shield 112 to transfer force from the seal 114 to the frame 116 are illustrated. The face shield 112 shown includes a seal support, which may be, for example, a base, housing, shell, or 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 face shield 112 to be attached to the frame 116. The connector 202 shown is generally annular in shape and, in at least some configurations, does not cover most of the forward-facing surface of the seal 114.

[0340] Connector 202 can be constructed from relatively rigid, semi-rigid, or rigid materials, such as polycarbonate. Therefore, in at least some configurations, connector 202 is more rigid than seal 114. The material forming the thin-walled, flexible central portion of at least seal 114 can be a flexible, stretchable material, such as silicone or TPE (thermoplastic elastomer). In some configurations, seal 114 is a one-piece component, all described components and portions of which are integrally formed, for example, by injection molding. However, in alternative arrangements, only the wearer side of seal 114 can be formed of this material and can be bonded to or integrally formed with a more rigid housing (rather than connector 202) attached to or with the interface frame 116. Alternatively or additionally, seal 114 can be a foam or gel-filled seal.

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

[0342] The mask 112 may or may not extend over the tip of the user's nose. Therefore, 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 mask 112 preferably does not cover the tip of the user's nose. In some configurations, or in cases of certain 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), thus allowing the interface to accommodate various nose lengths.

[0343] As shown, the mask 112 is preferably adapted to extend around or seal over wings of the nose or nasal wing, which are flared to form a circular bulge around the nostrils. The mask 112 is adapted to seal around a surface defining an opening to the nostrils, which may include part or all of the fleshy outer end of the nasal septum (sometimes called a 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 upward to the area of ​​the user's nasal bridge. In some configurations, the primary sealing surface of the mask 112 contacts the lower side of the user's nose, the upper lip, and / or the transition area between the lower side of the nose and the upper lip. The secondary sealing surface of the mask may contact the lateral surface of the user's nose, possibly along with the cheek at a location near the nose. Such primary and secondary sealing surfaces may not come into contact with all users' faces; however, this arrangement can provide a suitable seal with a relatively wide range of face geometries.

[0344] As described above, the seal 114 includes at least one nose opening or aperture 128. In some configurations, the seal 114 may include more than one nose aperture 128. In some configurations, the seal 114 may include a nose aperture 128 defined within an upper structure, such as a nose pillow, fork, or the like. In some configurations, the nose aperture 128 may be defined by a nose cushion or insert that may be overmolded or otherwise attached to the base structure of the seal 114. Examples of suitable arrangements of the seal 114 are disclosed in the applicant’s publication WO 2014 / 077708, the entire contents of which are incorporated herein by reference.

[0345] The seal 114 includes an inwardly or rearwardly 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 inwardly facing surface and a rearwardly facing surface. That is, each of the inner lateral portions 206 can roll toward or toward the rearwardly facing surface of the seal 114 from the inwardly facing surface of the seal 114. The outer lateral portions 208 may include both a rearwardly facing surface and an outwardly facing surface. The rearwardly facing surface of the outer lateral portions 208 can contact the user's face during use of the mask 112. The seal 114 may also include a nose opening support or thickened edge 210 that partially or completely surrounds and provides support to the nose opening 128. Preferably, the outer lateral portion 208 is not connected to the frame 116, such that the outer lateral portion 208 and / or the inner lateral portion 206 can move inward in response to pressure applied by the user to the central portion 204 of the seal 114. This arrangement allows the lateral portions of the seal 114 to move inward to facilitate a seal with the user's face.

[0346] Seal 114 may include regions with varying thicknesses to provide different properties or characteristics to 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 a 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 thickness of the central portion 204 is 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 a lower thickness may lead to wrinkling or increase the likelihood of wrinkling due to certain facial geometries and / or under certain operating gas pressures. Maintaining a thickness of 0.3 mm or higher in most or all of the central portion 204 may reduce the incidence of wrinkling over a significant range of operating pressures (which may include the entire normal operating pressure range).

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

[0348] The lateral portions 212 of the face 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. Paddle 212 can refer to any portion of the interface seal positioned beside the user's nose during use of the interface. Paddle 212 is disclosed herein in the context of a subnasal interface, but may be used for other types of interfaces, including those that contact, cover, or abut against the user's bridge of the nose for sealing, unless otherwise specified.

[0349] The outer lateral portion 208 may include features that help maintain the shape of the seal 114. In some configurations, the outer lateral portion 208 includes regions of increased thickness, stiffness, or rigidity that help maintain the shape of the seal 114; these regions are referred to herein as support structures 214. The support structures 214 of the mask 112 may inhibit or prevent excessive or undesirable expansion of the lateral end portions of the seal 114, which could lead to leakage and / or result in undesirable pressure exerted on the user's nose by the central portion 204 of the seal 114. The support structures 214 may also inhibit or prevent at least a portion of the mask seal 112 from collapsing during use when engaging with the user's nose. For example, the support structures 214 may inhibit or prevent collapse of the nasal region or the central portion 204 of the mask seal 112.

[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 of the seal 114 or the user contact surface 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 the 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 the surface overlapping the frame 116 or other support structures. However, as noted above, the support structure 214 can provide structure to the seal 114 and can be used to provide such support without transmitting force.

[0351] In some configurations, 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 seal 114 and may be referred to herein as wing covers 216. The lateral portions or wing covers 216 may be aligned with or overlap with the portion of seal 114 that includes the support structure 214, such that the support structure 214 can transfer loads to the lateral portions 216 of frame 116.

[0352] Support members 214 may generally extend from the rear surface or user contact surface of seal 114 toward the lateral portion of the cover 216 of their corresponding frame 116. In some configurations, each of the supports 214 extends generally or substantially in the longitudinal direction of seal 114. Support members 214 may generally extend parallel to each other or may be closer together at the front end than at the rear end. In other words, supports 214 may converge in a direction of movement from the rear surface or user contact surface of seal 114 toward the front portion of seal 114. However, in other configurations, supports 214 may converge from rear to 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 viewed from the side, each support structure 214 may comprise an overall C-shaped shape (or an inverted C-shaped shape) including a rear portion 218 and an upper extension or leg 220 and a lower extension or leg 222 extending forward from the rear portion 218. In the illustrated arrangement, the support structures 214 are thickened areas of the seal 114, each of these areas projecting inward into the interior space of the seal 114. Either or both of the extensions 220, 222 may 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 connector 202 from the rear. However, in other configurations, this arrangement may be reversed.

[0354] Each of the illustrated support structures 214 includes a cut or notch 224 that provides a region within the support structure 214 with less thickness, stiffness, or rigidity. In the illustrated arrangement, the notch 224 is a region with less thickness relative to other portions of the support structure 214. When viewed from the side, the illustrated notch 224 also includes an overall C-shaped shape (or an inverted C-shaped shape). In some configurations, the notch 224 also follows part or all of the peripheral edge of the associated outer lateral portion 208. However, preferably, the notch 224 is spaced apart from 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 allows portions of the support structure 214 to move relative to each other. Accordingly, the notch 224 allows corresponding portions of the seal 114 to move relative to each other. Therefore, the portion of the support structure 214 and the seal 114 behind the notch 224 can move toward the portion of the support structure 214 and the seal 114 in front of the notch 224.

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

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

[0357] As described, the face contact side or wearer side of the seal 114 includes a soft, lower nasal receiving concave central portion, the shape of which is configured 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 an orifice 128 for gas flow below the wearer's nostrils. Figure 5 and 16As shown, the soft central portion of the lower nose receiving part 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 below the wearer's nose, and a left and right wall portion for contacting the lower left and lower right sides of the wearer's nose, the left and right wall portions being defined by the previously described inner lateral portion 206. The lower wall portion 232 below the outlet orifice 128 is positioned behind the upper wall portion 230, or closer to the left and right rearmost ends of the seal 114 compared to the upper wall portion.

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

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

[0360] Figure 5A cross-sectional view of the face shield 112 taken along its vertical central plane is shown. The portion of the upper wall portion 230 above and adjacent to the orifice 128 may define a line 240 lying in the central plane. Similarly, the portion of the lower wall portion 232 below and adjacent to the orifice 128 may define a line 242 lying in the central 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 is located in the central plane and extends through a point on the lower edge 236 of the orifice and a point on the upper edge 234 of the orifice 128. Figure 16 An orifice 128 is shown as viewed from behind the seal 114 perpendicular to line 246. As described above, the orifice 128 can be bean-shaped or bow-shaped, wherein the central portion 250 has a height 252 smaller than the height 254 of the lateral portions 256. The orifice 128 can be symmetrical about a central vertical axis. In the arrangement shown, each lateral portion 256 is generally elliptical in shape, wherein the major axis of the elliptical shape is 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 point 260 of the lateral portion 256 is closer to each other and to the central axis than the lowest point 262. The highest point 260 defines a horizontal distance or width 264 between them, which is less than the horizontal distance or width 266 between the lowest points 262. Each of the distances 264 and 266 may be equal to or greater than one-half and less than or equal to three-quarters of the total width 268 of the aperture 128. 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 orifice 128 defines a vertical distance 270 between its highest point 260 and its lowest point 272 within the central portion 250, which may be located on the central axis. This vertical distance 270 can also be referred to as the depth of the central portion 250 on the upper edge 234. Similarly, the lower edge 236 of the orifice 128 defines a vertical distance 274 between its lowest point 262 and its highest point 276 within the central portion 250, which may be located on the central axis. This vertical distance 274 can also be referred to as the depth of the central portion 250 on the lower edge 236. In some configurations, the vertical distances 270 and 274 may differ from each other. In some configurations, the vertical distance 270 is less than the vertical distance 274. In some configurations, the vertical distance 270 is between one-third and two-thirds of the vertical distance 274, or approximately one-half of the 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 edges 234 is between 8-12 mm, between 9-11 mm, or approximately 10 mm. In some configurations, the distance 266 between the lowest point 262 of the lower edge 236 is between 15-20 mm, between 16-18 mm, or about 17 mm.

[0365] For details, please refer to the following: Figure 5 , 10 And 17-22, as described above, the illustrated face shield 112 includes a connector 202 for attaching a seal 114 to a frame 116. The connector 202 includes a first portion 300 and a second portion 302 therebetween for capturing the seal 114. The first portion 300 and the second portion 302 can be coupled to each other to hold the seal 114 between the first portion 300 and the second portion 302. In some configurations, the first portion 300 can be attached to the second portion 302 via a snap-fit ​​arrangement; this connection can be permanent or removable.

[0366] In the illustrated arrangement, the first portion 300 of connector 202 includes a hub portion 304 and a flange portion 306. The hub portion 304 includes an annular wall extending in the axial direction and defining an orifice 175 that receives the connector 172 of the base 144 portion of the frame 116. The flange portion 306 includes an annular wall extending outwardly from the hub portion 304. In some configurations, the flange portion 306 is in the radial direction and therefore perpendicular to the hub portion 304. In the illustrated arrangement, the second portion 302 is an annular member whose size and shape are determined for mating with the hub portion 304 of the first portion 300.

[0367] As described above, the first portion 300 and the second portion 302 of 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 the 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 the circumferential direction and is configured to be received by the recess 308 of the first portion 300. In other configurations, this arrangement may be reversed, such that the protrusion 310 may be on the first portion 300 and the recess 308 may be on the second portion 302.

[0368] The first portion 300 and the second portion 302 may also be keyed together to ensure that the first portion 300 and the second portion 302 can only be connected relative to each other in a single rotational orientation, and / or that relative rotation is suppressed or prevented once connected. In some configurations, one of the first portion 300 and the second portion 302 includes a key or protrusion, and the other of the first portion 300 and the second portion 302 includes a slot or recess configured to receive the key or protrusion. In the illustrated arrangement, the hub portion 304 of the first portion 300 includes a slot or recess 312, and the second portion 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 the protrusion 314 are located on the upper portion of the corresponding one of the first portion 300 and the second portion 302 of the connector 202. However, in other configurations, this position can vary. Furthermore, the positions of the recess 312 and the protrusion 314 can be reversed between the first portion 300 and the second portion 302 of the connector 202, as shown.

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

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

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

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

[0373] In some configurations, at least some portions of the headband 118 are rigid, semi-rigid, inelastic, or substantially non-stretchable in response to normal or anticipated forces acting on the headband 118, while other portions of the headband 118 are elastic or stretchable in response to normal or anticipated forces. In some configurations, one or more of the upper strap portion 350, the connecting portion 354, and the forward-extending strap 356 are rigid, semi-rigid, inelastic, or substantially non-stretchable. In the configuration shown, each of the upper strap portion 350, the connecting portion 354, and the forward-extending strap 356 is rigid, semi-rigid, inelastic, or substantially non-stretchable. In the configuration shown, the rear strap portion 352 is elastic or stretchable. This arrangement allows the rear strap portion 352 to stretch to adjust the circumferential length of the headband 118. The stretch of the rear strap portion 352 can be limited, and therefore, the rear strap portion 352 can also be length-adjustable. In some configurations, circumferential length adjustment preferably occurs at the rear of the user's head, making it less prone to lengthening in response to blow-out forces. The rigid, semi-rigid, inelastic, or substantially non-stretchable nature of the connecting portions 354 located on the side and front portions of the user's head and the forward-extending strap 356 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 the headgear 118 from moving or lengthening in response to blow-out forces. However, in other arrangements, the rear strap portion 352 can be rigid, semi-rigid, inelastic, or substantially non-stretchable, and in such cases, it can be length-adjustable.

[0374] The upper strap portion 350 may include a length adjustment arrangement. In the illustrated arrangement, the upper strap portion 350 includes a first portion 358 and a second portion 360 that are separate from each other and adjustablely connected to each other. The free end of the first portion 358 includes a loop 362 through which the second portion 360 can pass. Thus, the first portion 358 and the second portion 360 can slide relative to each other to change the overlap distance of portions 358, 360, and thus change the length of the upper strap portion 350. The second portion 360 can be coupled to the first portion 358 to secure the upper strap portion 350 in a desired adjustable length. In the illustrated arrangement, the inner surface of the second portion 360 may include the hook portion of a hook-and-loop fastener, and the outer surface of the first portion 358 may include the loop portion of a hook-and-loop fastener. This arrangement may also be reversed. In some configurations, the material of the 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 the upper strap portion 350.

[0375] Under the arrangement described above, for a specific user, the upper strap portion 350 can be adjusted to an appropriate length, such that the connecting portion 354 and / or the forward-extending strap 356 sit above the user's ears. Once adjusted, the upper strap portion 350 can remain in the adjusted position during the putting on and taking off of the headgear 118 and the associated interface 110. In other words, preferably, the first portion 358 and the second portion 360 do not need to be separated from each other to facilitate the user putting on or taking off the interface 110. Instead, the headgear 118 allows the interface 110 to be put on ('like wearing a hat') by holding the frame 116 at or near the seal 114 (just as people would hold a hat at 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 allows the headgear 118 to be wrapped around the user's head without opening the headgear 118 by separating portions 358, 360 of the upper strap portion 350 or by 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 undressed by a reverse action.

[0376] In the illustrated configuration, the rear strap portion 352 is connected to each of the connecting portions 354 by an end portion of the rear strap portion 352, the end portion passing through a loop 364 carried by the connecting portion 354 and folding back onto itself. The end portion of the rear strap portion 352 can be engaged to a relatively more central portion of the rear strap portion 352 by a suitable fastener, such as a hook-and-loop fastener. The rear strap portion 352 can be adjustable at one or both ends.

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

[0378] The seals and face shields disclosed herein can be used with headwear in other forms, such as headwear with two straps (attached to either side of the face shield), i.e., headwear including upper and lower straps on the left and right sides. The frame of such an interface embodiment may or may not include side arms as described above. The upper left and right straps may pass downwards (when the headwear is worn) between the wearer's eyes and ears, and the lower left and right straps may extend from the lower back of the head and below the ears to the face shield (and attach to the face shield, each side below the upper straps). Alternatively, the upper and lower straps may be connected, for example, with a stiffer yoke before attachment to the face shield frame, or may be integral with the face shield frame. Such a headwear may have buckles and tongues, loops and tongues, or other adjustments in the upper or lower straps or on either side, partially along their length, or at the junction of the straps and the face shield. In a preferred embodiment, the upper strap may be attached to the top of a T-shaped piece extending upwards from the frame to the wearer's forehead. In another embodiment, again, the headgear may include a single strap that wraps around or loops around the back of the head from one side of the mask and returns to the other side of the mask. This headgear strap may be elastic or resiliently stretchable, and / or may have length adjustment devices (e.g., buckles and tongues, loops and tongues, etc.) in the back, on the side, or at the connection between the headgear and one or both sides of the mask. Variations of this headgear may also include a top head strap.

[0379] Other suitable materials or configurations for the headgear 118 may also be used. For example, in some configurations, the headgear may be formed at least partially from a soft, flexible material, such as a foam material covered with fabric, like BREATH-O-PRENE. The headgear 118 may be formed by cutting it from a sheet of material, 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 opposite outer surfaces of the headgear toward each other at the edges and thermally bond them together. This can be done simultaneously with, for example, cutting the headgear to form, or in the same tool: cutting the outline of the headgear shape in a sheet of material in one operation and thermoforming to define the rounded edges of the headgear, or alternatively cutting the headgear first and then rounding the edges in a second operation. Rounded edges or any joints in the headgear can be alternatively formed by, for example, ultrasonic or radio frequency welding.

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

[0381] Inspiratory noise can be defined as the increased level of noise caused by the inhalation or exhalation of a user wearing a CPAP mask. Inspiratory noise is common with CPAP masks, especially smaller nasal masks or nasal pillow masks. Static bias noise can be defined as a constant noise in the absence of flow caused by the patient's breathing and is generally associated with the geometry of the bias orifice, and can be reduced by several different orifice shapes, patterns, and configurations. Dynamic inspiratory noise (generally more pronounced during inhalation) can be caused by geometry other than the bias orifice. However, it is believed that this inspiratory noise is transmitted or heard through the bias orifice and is therefore closely associated with bias flow. When a patient breathes with a CPAP machine, the flow rate in the CPAP tubing increases during his or her inhalation, thus maintaining a nearly constant pressure within the mask. This results in the bias flow being nearly constant during inhalation and exhalation, and therefore the flow rate through the bias orifice changes only with pressure.

[0382] Dynamic noise, and specifically inspiratory noise, occurs during patient inhalation, and therefore occurs when the flow rate from the CPAP is at its maximum. It is therefore believed that increased flow rate causes inspiratory noise. The following discusses methods for minimizing the noise generated during inspiration. The noise is caused by a constraint in the breathing circuit upstream of the deflection orifice. This constraint results in increased velocity and turbulence, which in turn generates noise. The noise is heard through the deflection orifice. It has been determined that a diameter of less than approximately 15 mm within the breathing circuit can lead to significant inspiratory noise. Therefore, when designing a mask system with reduced, minimal, or no inspiratory noise issues, maintaining a diameter greater than approximately 15 mm within the breathing circuit may be desirable, taking into account other factors, if possible or practically.

[0383] Besides maintaining a minimum diameter or cross-sectional area within the breathing circuit, another factor is the consideration of vortices. The noise generated in the airflow itself contributes to the noise, which is subsequently heard by the patient. Sudden expansions in the tubing cause changes in tubing velocity, vortices, and therefore noise. Expansions can be abrupt (where the expansion angle is equal to 180 degrees) or more gradual (where the expansion angle is greater than 0 degrees and less than 180 degrees). To reduce noise, the velocity at which the fluid slows down can be reduced (i.e., by using a shallow, gradual expansion) or the velocity at which the air travels can be reduced. To reduce head loss, the expansion should preferably have an angle of θ < 30°, or alternatively, 120°θ < 180° or 150°θ < 180°.

[0384] In practice, noise can be reduced by designing the cross-section to reduce or minimize peak air velocity; and / or by designing the geometry to reduce or eliminate abrupt changes in geometry that induce eddies and thus noise. In some configurations, noise reduction can be achieved by carefully considering the diameters of the tubes and connectors within the breathing circuit. For example, Figure 24 The image shows a standard CPAP hose to mask tube connection. The actual CPAP hose or breathing circuit is not shown in the image. Figure 24 As shown in (however, see also) Figure 1 The conduit 12) is connected to the upstream end of the CPAP hose adapter 400. The CPAP hose adapter 400 is connected to the connector 124 of the mask tube 120. The connector 124 shown on the mask tube 120 is a swivel connector including a male swivel portion 402 and a female swivel portion 404. The male swivel portion 402 is connected to the mask tube 120 and the female swivel portion 404 is connected to the CPAP hose adapter 400. Figure 24 As can be seen, there are several restraints and one extension in the connection between the CPAP hose and the mask tube. These restraints cause an increase in air velocity, which then creates increased turbulence as the air passes through the extension. These restraints are caused by several male-to-female connections between the swivel rings 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 way the male swivel 402 is connected to the mask tube 120. Specifically, in Figure 25In the illustrated configuration, the male swivel ring 402 does not extend within the mask tube 120. Instead, the male swivel ring 402 has a minimum diameter equal to or substantially equal to the inner diameter of the mask tube 120. In some configurations, this can be achieved by using a connecting sleeve 406 or other suitable coupling to attach the male swivel ring 402 to the mask tube 120. The connecting sleeve 406 can be formed, for example, by overmolding a material that will chemically bond to both the male swivel ring 402 and the mask tube 120 onto a portion of both the swivel ring 402 and the tube 120. This arrangement reduces the size of the constraint portion within the male swivel ring 402 and also removes or substantially eliminates the extension from the male swivel ring 402 to the mask tube 120. In the illustrated arrangement, the diameters of the different components are marked as follows 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 may differ from the values ​​above, but the proportions between two or more of these diameters may be the same or substantially the same. Furthermore, the differences between two or more of these diameters may be the same as, substantially the same as, or smaller than the values ​​above.

[0392] In some applications or at certain locations within a CPAP system (e.g., interface 110), avoiding abrupt changes in geometry can be difficult or impractical. For example, to prevent abrupt changes in cross-sectional area, small wall angles (e.g., less than 30°) are desirable. Such small wall angles require the transition between diameters or cross-sectional areas to occur over a larger length compared to more abrupt transitions, which can increase the overall size of the mask. In many cases, for user comfort, it may be desirable for the mask to be as small or as inconspicuous as possible. Therefore, abrupt changes may be desirable with respect to the smallest permissible mask geometry.

[0393] To reduce the noise generated within the unavoidable transition section (extension) from the smaller diameter to the larger diameter, the location of the deflector orifice can be chosen to reduce the flow rate across the transition section. In practice, deflection, which is generally associated with noise generation, can be used to reduce noise. By having deflection on the side of the extension section with the smallest cross-sectional area (before the extension section), intake noise can be reduced because the flow rate and therefore velocity within the extension section are now reduced. This arrangement produces weaker vortices, as shown in Figures 26 and 27. Figure 26A and27A This demonstrates the flow at the extension section when the deflection orifice is located before or upstream of the extension section. Figure 26A It is speed drawing and Figure 27A It is a vector drawing. Figure 26B and 27B This demonstrates the flow at the extension section when the deflector is located behind it. Similarly, Figure 26B It is speed drawing and Figure 27B It's a vector drawing. (Comparison) Figure 26A and 26B It is clear that the deflection vent is located before the expansion section. Figure 26A When the velocity at the extension section is located behind the deflection orifice relative to the extension section, Figure 26B The velocity is lower at the expansion section. The dark areas in the relatively upstream portion of these flows represent areas of higher velocity. Therefore, when the deflector is located before the expansion section, the velocity is lower, and therefore, the noise is lower. Figure 27A and 27B It also indicates that the deflection vent is located after the expansion section. Figure 27B Compared to the scenario where the deflection vent is located before the expansion section, Figure 27A When the recirculation flow is smaller, there is less recirculation flow. Smaller recirculation flow means smaller eddies, which means less noise.

[0394] Figure 28A , 28B Different design options (A, B, and C) are shown in 28C, demonstrating how this principle is implemented in the face mask 112. Figure 29 The diagram illustrates the sound levels produced in 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 between Design C and Design A. Each sample has the same minimum inner diameter D. In the design shown, the deflector vent 126 is implemented in the bend connector 174. However, in other arrangements, the deflector vent 126 may also be located in other locations. For example, in some configurations, the deflector vent 126 may be located in the bend 122, among other possible locations.

[0395] In design A, the vent 190 of the deflector vent 126 is located after an abrupt change in geometry. Therefore, during intake, a high flow rate of air exists within the abrupt expansion section, which causes turbulence and noise.

[0396] In design B, the vent 190 of the deflector vent 126 is located after the geometrically gradual transition. The angle of the geometrically gradual transition is greater than 30°. Therefore, during intake, due to the high fluidity within the gradual extension, the flow separates to some extent from the wall of the flow path. This flow separation causes vortices, which in turn cause noise.

[0397] In design C, the vent 190 of the deflector 126 is located before or upstream of an abrupt change in geometry. This reduces the flow rate and thus the velocity of the air passing through the abrupt expansion. Since head or pressure loss is proportional to the square of velocity, it is clear that velocity significantly affects the amount of head loss, eddies, and therefore noise that occur when fluid flows within a change in cross-section. This illustrates the effect of the location of the deflector 126 on the generated noise and eddies. Because of the reduced velocity passing through the expansion, the noise in design C is significantly lower than that observed in design A.

[0398] In an alternative arrangement, the principles illustrated in Design C can be applied to Design B by positioning the deflector 126 before or at the beginning of the gradual expansion. Due to the reduced flow within the gradual expansion, results similar to those in Design C are expected.

[0399] The position of the vent 190 of the deflector 126 relative to the abrupt expansion has a greater impact on noise than reducing the angle of the wall at the expansion. This is desirable because optimizing the expansion angle in an actual mask may be impractical, as the desired (small) angle would require an increased transition length to achieve the change in cross-sectional area, potentially resulting in an oversized mask. To reduce dynamic (inhalation) noise, eddies generated within the air supply flow path can be reduced or minimized by avoiding, reducing, or minimizing constraints in the flow path from the CPAP machine to the patient, where possible or practical. Alternatively, the inner diameter (or cross-sectional area) of the loops, bends, and / or other sections of the flow path can be increased or maximized, or these inner diameters can be made as close as possible or practically as possible to the inner diameter (or cross-sectional area) of the air supply (CPAP) hose. This arrangement minimizes flow velocity and therefore eddies, resulting in less noise. If desired, the transition from a smaller to a larger cross-section is preferably located between the deflector vent and the patient (after the deflection), thus reducing the volumetric flow rate within the transition. If desired, the transition from a smaller to a larger cross-section is preferably designed to minimize the flow head loss within the transition. The flow path from the smaller to the larger cross-section is preferably a gradually expanding section with a wall angle of less than 30 degrees. If this arrangement is impractical, an abrupt transition with a wall angle of 180° is preferred.

[0400] Figure 30 and 31 Alternative connection arrangements between the headgear 118 and the frame 116 (or other parts of the face mask 112) are shown. In the shown arrangement, the forward-extending strap 356 of the headgear 118 overlaps with the side arm 130 of the frame 116. In the shown arrangement, the forward-extending strap 356 can be positioned inside the side arm 130; however, in other arrangements, this arrangement can be reversed, and the forward-extending strap 356 can be positioned outside the side arm 130.

[0401] In some configurations, the position of the headband 118 relative to the frame 116 is adjustable, allowing adjustment of the amount of overlap between the forward-extending straps 356. This adjustment changes the effective circumferential length of the interface 110. In some configurations, the headband 118 and frame 116 are adjustable to one of two or more discrete adjustment positions. Any suitable connection arrangement between the headband 118 and frame 116 can be used. In the illustrated arrangement, the headband 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 headband 118 includes two posts 410 on each side, and each side arm 130 of the frame 116 includes three openings 412. Thus, the headband 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 structurally and functionally similar to a baseball cap-style size adjustment arrangement. Each of the posts 410 includes a shaft 414 and a head or cap 416. The posts 410 shown are generally T-shaped; however, other shapes may be used, such as a cylindrical shaft 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 through, at least in response to normal or anticipated forces, and to retain the post 410 once it has passed through the opening 412. However, the posts 410 may be intentionally removed from the openings 412 to allow the headgear 118 and the frame 116 to be separated. The passage of the posts 410 through the openings 412 may be achieved by a variation of one or both of the posts 410 and the openings 412. In other words, the head 416 of the post 410 can be flexed or otherwise deformed, and the opening 412 can be stretched or enlarged to facilitate the passage of the head 416 of the post 410.

[0403] In the illustrated arrangement, openings 412 are elongated and each includes a recessed flange 418 spaced from the inner side of the outer surface of the side arm 130 of frame 116. The recessed flanges 418 may extend partially or entirely around the periphery of the opening 412. The recessed flanges 418 may be continuous or discontinuous. For example, recessed flanges 418 may include portions at each end of the elongated opening 412, wherein those portions are separate from each other. The recessed flanges 418 may be configured to contact and retain the head 416 of the associated post 410.

[0404] The post 410 can be formed or attached to the headgear 118 in any suitable arrangement. For example, the post 410 can be integrally formed with the base member 420 and attached to the headgear 118 by means such as stitching, RF welding, adhesive, or other suitable connection arrangements. In some configurations, the post 410 can be integrally formed with the plastic core of the headgear 118.

[0405] Figure 32 and 33 Another alternative connection arrangement between the headgear 118 and the frame 116 (or other parts of the face mask 112) is shown. In the arrangement shown, the forward-extending strap 356 of the headgear 118 overlaps with the side arm 130 of the frame 116. In the arrangement shown, the forward-extending strap 356 can be positioned inside the side arm 130; however, in other arrangements, this arrangement can be reversed, and the forward-extending strap 356 can be positioned outside the side arm 130.

[0406] In the illustrated configuration, when the frame 116 is attached 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, thus allowing adjustment of the effective circumferential length of the interface 110. Any suitable connection 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 a 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 columns 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 arrangement shown, the rear column 410a is generally rectangular in shape, and the front column 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. Furthermore, the shapes of the different columns and / or openings may be the same or different.

[0407] Similar to Figure 30 and 31 The arrangement Figure 32 and 33 The posts 410a, 410b and openings 412a, 412b are structurally and functionally similar to a baseball cap-style size adjustment arrangement. Each of the posts 410a, 410b includes a pole (not shown, but similar to...). Figure 30 and 31Similar to the rod portion 414) and the head or cap (visible portion of the posts 410a, 410b). Openings 412a, 412b are defined in size, shape, and / or otherwise configured to allow the head of the posts 410a, 410b to pass through, at least in response to normal or anticipated forces, and to retain the posts 410a, 410b once they have passed through the openings 412a, 412b. However, posts 410a, 410b may be intentionally removed from openings 412a, 412b to allow separation of the headgear 118 and the frame 116. The passage of posts 410a, 410b through openings 412a, 412b can be achieved by deformation of one or both of the posts 410a, 410b and openings 412a, 412b. In other words, the heads of the columns 410a and 410b can be flexed or otherwise deformed, and the openings 412a and 412b can be stretched or enlarged to facilitate the passage of the heads of the columns 410a and 410b.

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

[0409] The posts 410a and 410b can be formed or attached to the headgear 118 in any suitable arrangement. For example, the posts 410a and 410b can be integrally formed with the base component and attached to the headgear 118 by means such as stitching, RF welding, adhesive, or other suitable connection arrangements. In some configurations, the posts 410a and 410b can be integrally formed with the plastic core of the headgear 118.

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

[0411] The rear strap portion 352 wraps around the back of the user's head and, in some configurations, sits 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 arrangement shown, the upper strap portion 350 and the rear strap portion 352 are connected to each other at a connecting portion 354 on each side of the headgear 118. Each of a pair of forward-extending straps 356 extends forward from the connecting portion 354 toward and connects to the corresponding side arm of the side arm 130 of the frame 116.

[0412] In some configurations, at least some portions of the headband 118 are rigid, semi-rigid, inelastic, or substantially non-stretchable in response to normal or anticipated forces acting on the headband 118, while other portions of the headband 118 are elastic or stretchable in response to normal or anticipated forces. In some configurations, one or more of the upper strap portion 350, the connecting portion 354, and the forward-extending strap 356 are rigid, semi-rigid, inelastic, or substantially non-stretchable. In the configuration shown, each of the upper strap portion 350, the connecting portion 354, and the forward-extending strap 356 is rigid, semi-rigid, inelastic, or substantially non-stretchable. In the configuration shown, the rear strap portion 352 is elastic or stretchable. This arrangement allows the rear strap portion 352 to stretch to adjust the circumferential length of the headband 118. The amount of stretching of the rear strap portion 352 may be limited.

[0413] In some configurations, the rear strap portion 352 may also be length-adjustable. In some configurations, circumferential length adjustment preferably occurs at the rear of the user's head, making it less prone to lengthening in response to blow-out forces. The rigid, semi-rigid, inelastic, or substantially non-stretchable nature of the connecting portions 354 positioned on the side and front portions of the user's head and the forward-extending strap 356 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 the headgear 118 from moving or lengthening in response to blow-out forces. However, in other arrangements, the rear strap portion 352 may be rigid, semi-rigid, inelastic, or substantially non-stretchable, and in such cases, it may be length-adjustable.

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

[0415] Under the arrangement described above, for a specific user, the upper strap portion 350 can be adjusted to an appropriate length, such that the connecting portion 354 and / or the forward-extending strap 356 sit above the user's ears. Once adjusted, the upper strap portion 350 can remain in the adjusted position during the putting on and taking off of the headgear 118 and the associated interface 110. In other words, preferably, the first portion 358 and the second portion 360 do not need to be separated from each other to facilitate the user putting on or taking off the interface 110. Instead, the headgear 118 allows the interface 110 to be put on ('like wearing a hat') by holding the frame 116 at or near the seal 114 (just as people would hold a hat at 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 allows the headgear 118 to be wrapped around the user's head without opening the headgear 118 by separating portions 358, 360 of the upper strap portion 350 or by 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 undressed by a reverse action.

[0416] In the illustrated configuration, the rear strap portion 352 is connected to each of the connecting portions 354 by an end portion of the rear strap portion 352, the end portion passing through a loop 364 carried by the connecting portion 354 and folding back onto itself. The end portion of the rear strap portion 352 can be engaged to a relatively more central portion of the rear strap portion 352 by a suitable fastener, such as a hook-and-loop fastener. The rear strap portion 352 can be adjustable at one or both ends.

[0417] Figures 36A to 40C Interface arrangements with alternative side arm arrangements are shown, which are rotatable or compliant along a horizontal plane (i.e., horizontally across the user's face) and substantially rigid along a vertical plane (i.e., vertically across the user's face). Figure 35The diagram illustrates the horizontal and vertical planes across the user's face. Side arms providing conformability along the horizontal plane allow them to conform to the geometry of the user's face and / or change shape when external horizontal forces are applied to them, such as when the user is sleeping on their side (e.g., a pillow contacts the side arm and applies force thereon), so as not to impede the positioning of the seal on the user's face. Furthermore, side arms providing conformability along the horizontal plane allow the seal to disengage from the side arms and frame, thus ensuring the seal is properly positioned on the user's face and does not move due to movement of the side arms. That is, external forces are not directly transmitted to the seal, allowing it to be maintained in the correct operating position. The interface arrangement shown below provides side arms that are substantially rigid across the vertical plane to resist or suppress rotation or wobbling of the seal relative to the side arms, headgear, and user's face caused by blowout forces, thereby ensuring a seal against the user's nose. Furthermore, Figures 36A to 40C The side arm arrangement also restricts or inhibits the torsion of the side arms, which restricts or inhibits the interface arrangement relative to the user's face (i.e., along an axis that is generally parallel to both the horizontal and vertical planes, such as...). Figure 35 (As shown) rotation. More precisely, the side arms can be substantially rigid, such that each side arm resists torsional bending along its length (i.e., about the axis defined by the longitudinal direction of the side arm). In some configurations, the side arms may allow a limited range of twisting or rotation of the interface arrangement relative to the user's face in order to provide a amount of compliance that can improve user comfort while ensuring a seal between the interface and the user's face.

[0418] Figures 36A to 36D An interface 500 with a side arm arrangement is shown, which has hinges 510 that allow the side arm 130 to rotate along a horizontal plane while remaining substantially rigid along a vertical plane (i.e., resisting bending caused by vertical forces). The side arm 130 can be formed from injection-molded plastic material and is shown to have a rectangular cross-sectional shape. The rectangular cross-sectional shape of the side arm 130 has a height significantly greater than its thickness, such that the resistance to bending in the direction parallel to the height direction is significantly greater than the resistance to bending in the direction parallel to the thickness direction. Therefore, in Figures 36A to 36D In the illustrated configuration and orientation of the side arm 130, the side arm 130 is substantially rigid along the vertical plane relative to the user and semi-rigid along the horizontal plane relative to the user (i.e., due to its rectangular cross-sectional shape). In some configurations, the side arm 130 may be rigid in both the vertical and horizontal planes relative to the user. Furthermore, the geometry, cross-sectional shape, and type of material used to form the side arm can be configured to restrict or inhibit torsion of the side arm, thereby limiting or preventing rotation of the interface arrangement relative to the user's face.

[0419] like Figure 36A and 36B As shown, the side arm 130 has a two-piece design, wherein the sealing 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 sealing 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 sealing connection portion 130A can be permanently or removably coupled to the frame 116, such that the seal 114 is rigidly attached to the sealing connection portion 130A. In this arrangement, the seal 114 is unlikely to rotate or wobble relative to the sealing connection portion 130A. The sealing connection portions 130A on the left and right sides of the seal 114 can be formed as a single integral part 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 connection portion 130B can be permanently or removably attached to the headgear using any of the previously disclosed side arm and headgear connection arrangements.

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

[0421] Hinge 510 and a portion of side arm 130 are covered by accordion cover 550. In some configurations, accordion cover 550 provides resistance to rotation, thus maintaining the relative rotational position of seal connection portion 130A and headgear connection portion 130B. Accordion cover 550 may be formed of semi-rigid plastic and have a deformable accordion-like geometry with ridges and bellows formed along its length. Accordion cover 550 may have a length that covers a portion of both seal connection portion 130A and headgear connection portion 130B. Accordion cover 550 has an inner cavity 552 through which side arm 130 extends. Accordion cover 550 may have a similar size, shape, and geometry to side arm 130, thus tightly wrapping around hinge 510 and side arm 130. The inner ridge 554 of the inner cavity 552 can have a tight fit or interference fit with the side arm 130 so as to contact the outer surface of the side arm 130 and tightly wrap around the outer surface. Thus, by wrapping the accordion cover 550 around the side arm 130 and positioning it above the hinge 510, the accordion cover 550 resists rotation between the sealing connection portion 130A and the headgear connection portion 130B until a predetermined threshold amount of force is applied to the side arm 130, which causes the accordion cover 550 to fold and deform so as to allow the sealing 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 tenon joint hinge having an inner joint 512 positioned within an outer joint 514. However, those skilled in the art will appreciate that hinge 510 may include different joints and / or hinge arrangements. Furthermore, those skilled 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. Even further, the illustrated arrangement is not limited to hinge arrangements with pins. Other hinge arrangements may be used, such as protrusions that engage a receiving portion and rotate about it.

[0423] Figures 37A to 37C An interface 600 with a side arm arrangement is shown, the side arm arrangement having a side arm 130 formed by modular sections 610A, 610B, 610C that interlock similarly to those on a watch strap. Similar to... Figures 36A to 36D The side arm arrangement, with multiple interlocking modular sections 610A, 610B, and 610C, allows the side arm 130 to rotate along the horizontal plane while remaining substantially rigid along the vertical plane. More specifically, sections 610A, 610B, and 610C allow the side arm 130 to have incremental articulation and conform to the shape of the user's face when an external horizontal force is applied, such as... Figure 37CAs depicted. Additionally, the multiple sections 610A, 610B, 610C allow for localized shape variations in the side arm 130, enabling it to conform to facial features or markings on the user's face. Similar to interface 500, sections 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 it. Sections 610A, 610B, 610C can be formed from injection-molded plastic material and have a... Figures 36A to 36D The side arm 130 has 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 sealing frame 116 or the connector 146 at one end. Segment 610A has a male connection portion 620 including an inner joint 622 positioned at the end opposite to 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 at the end opposite to the headgear 118, including an outer joint 632 defining a slot 616 therebetween. In some configurations, segments 610A and 610B are joined together by one or a series of segments 610C. Each segment 610C has a male connection portion 620 at one end and a female connection portion 630 at the other end in the longitudinal direction of segment 610C. The inner joint 622 of the male connecting portion 620 of each segment 610A, 610C is positioned within a slot 616 located between the outer joint 632 of the female connecting portion 630 of segments 610B, 610C. The male connecting portion 620 and the female connecting portion 630 are connected by a pin 612, which engages within a through hole 614 extending through both the male connecting portion 620 and the female connecting portion 630. Figure 37B As shown, pin 612 and hole 614 are aligned with the height direction of the rectangular section of side arm 130, which is also substantially aligned with the vertical plane relative to the user.

[0425] Similar to a watch strap, pin 612 may be removable to allow the addition or removal of segment 610C, thus enabling adjustment of the length of side arm 130. Those skilled in the art will appreciate that these segments are not limited to male connecting portions 620 and female connecting portions 630 having pins inserted through inner joint 622 and outer joint 632, but may include alternative, modular, and interlocking connection arrangements.

[0426] Figures 38A to 38DAn interface 700 with a side arm arrangement is shown, comprising spring-loaded side arms 130 that deform or deflect to provide a temporary shape change when a brief external horizontal force is applied to the side arms 130. When the brief external horizontal force is removed, the side arms 130 return to or toward an undeformed shape. Furthermore, the spring-loaded side arms 130 are extendable to extend or retract, allowing the interface 700 to adapt to a wider range of facial geometries and take into account blow-out forces within the mask. The side arms 130 have a spring portion 710 positioned between a sealing connection portion 130A and a headgear connection portion 130B. The sealing connection portion 130A can be permanently or removably coupled to a frame 116, such that a seal 114 is rigidly attached to the sealing connection portion 130A, preventing the seal 114 from rotating or wobbling relative to the sealing connection portion 130A. Similarly, the headgear connection portion 130B can be permanently or removably attached to the headgear. The sealing connection portion 130A, the headgear connection portion 130B, and the spring portion 710 can be integrally formed into a single-piece side arm. The side arm 130 can be formed from injection-molded plastic material and has the same characteristics as... Figures 36A-36D It has a rectangular cross-sectional shape similar to the side arm arrangement in 37A-37C.

[0427] like Figure 38B As shown, the spring portion 710 is presented as a compressible, extendable, and horizontally rotatable linear accordion-style flat spring. The spring portion 710 is formed as a series of straight segments 712 connected by bends 714. The bends 714 may form acute angles between the straight segments 712 to allow the spring portion 710 to bend, shorten in length, or extend in length. Figure 38C and 38D A spring portion 710 is shown that bends, shortens, and lengthens along a horizontal plane when a brief external horizontal force is applied to the side arm 130 to allow movement of the side arm 130 relative to the seal 114. The spring portion 710 absorbs at least a portion of the brief external horizontal force, rather than transmitting the entire force to the seal 114, thus keeping the seal 114 undisturbed or less disturbed in position on the user's face compared to other frame designs. The spring portion 710 can have an undeformed shape (i.e., when no brief external horizontal force is applied), wherein the seal connection portion 130A and the headgear connection portion 130B are substantially coaxial or parallel in the longitudinal direction. However, the spring portion 710 can be formed with an undeformed shape that bends in the longitudinal direction or is non-linear.

[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 side arm 130. However, compared to... Figures 38A to 38D Compared to the side arm 130, the sealing connection portion 130A and the headband connection portion 130B are connected to the resilient section 810, which provides a spring-loaded effect similar to that of the spring portion 710. The resilient section 810 may be formed of rubber or thermoplastic polyurethane (TPU). The resilient section 810 is positioned between the sealing connection portion 130A and the headband connection portion 130B and is separated by a rigid section 812. The sealing connection portion 130A and the headband connection portion 130B are also rigid. In this way, the resilient section 810 flexes and deforms to allow the side arm 130 to be compliant in the horizontal plane, thereby allowing the side arm 130 to move relative to the seal 114 when a brief external horizontal force is applied. That is, the resilient section 810 absorbs at least a portion of the brief external horizontal force rather than transferring the entire brief external horizontal force to the seal 114, thus keeping the position of the seal 114 on the user's face undisturbed or less disturbed compared to other frame designs. Furthermore, when the brief external horizontal force is removed, the elastic segments 810 return to their neutral, undeformed shape.

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

[0430] Figures 40A to 40EAn interface 900 with a side arm arrangement is shown, which has flexible side arms 130 that deform to provide a temporary shape change when a brief 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 saw 910 and an inner saw 920 along their length. The outer saw 910 is positioned on the outer surface of the side arm 130 (i.e., away from the user) and is positioned closest to the seal 114. The inner saw 910 is positioned on the inner surface of the side arm 130 (i.e., facing the user) and is positioned closest to the headgear 118. The side arms 130 are formed from injection-molded plastic material, and the saw 910, 920 can be integrally and monolithically formed into the side arms 130. Alternatively, the kerfs 910 and 920 can be formed by cutting, molding, or otherwise forming the vertical slots into the side arm 130. As shown, the side arm 130 has... Figures 36A-36D It has a rectangular cross-sectional shape similar to the side arm arrangement in 37A-37D. The cheek pad 950 can be attached to the inner saw 920 of the side arm 130 to prevent the inner saw 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 and 920 are formed by a series of movable hinges or slots 930 recessed into the side arm 130 along its thickness direction. 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 portions with the slots 930 than at the portions 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 around the slots 930. Furthermore, when the brief external horizontal force is removed, the kerfs 910 and 920 allow the side arm 130 to return to or toward its undeformed shape. Figure 40DAs shown, the slot 930 has a depth X, a width Y, and is spaced apart by a spacing distance Z. The return force (i.e., the amount of resistance to bending) for causing the side arm 130 to return to or toward its undeformed neutral shape is controlled at least partially or primarily by the depth X of the slot 930 (i.e., relative to the thickness of the side arm 130). A slot 930 with a greater depth X results in the side arm 130 having a thinner thickness T at the location of the slot 930. Therefore, the thinner thickness T provides less resistance to bending and a smaller return force for causing the side arm 130 to return to its undeformed shape compared to a slot 930 with a smaller depth X. The maximum amount of bending provided by the slot 930 is controlled at least partially or primarily by the width Y of the slot 930. Overall, a slot 930 with a greater width Y allows for a greater amount of bending of the side arm 130 around the slot 930. The maximum allowable bending of 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 This occurs when (as shown). Therefore, providing a greater distance between the sidewalls 932 by providing a slot 930 with a greater width Y. However, the amount of bending can be limited to prevent the side arm 130 from contacting the user's face or detaching from the headgear 118. Figure 40C Showing relative to Figure 40B The undeformed shape shown is maximized by both the inner saw 920 and the outer saw 910. The rate of bending (i.e., gradual or acute bending) of the side arm 130 is controlled at least partially or primarily by the spacing Z and the number of slots 930. A closely spaced slot 930 with a narrow spacing Z will allow for a greater rate of bending of the side arm 130 compared to a widely spaced slot 930 with a wider spacing Z. Thus, the amount and rate of bending of the side arm 130 are determined by the depth X, width Y, and spacing Z of the slots 930. Furthermore, although the side arm 130 is depicted as having slots 930 with identical geometry, in some configurations, the slots 930 may have varying depth X, width Y, and spacing Z along the length of the side arm 130, thus allowing the side arm 130 to have variable amounts and rates of bending and return forces along its length. Furthermore, the slot 930 is not limited to a rectangular shape, but can include a variety of shapes, such as trapezoidal, curved or semi-circular shapes.

[0432] Figures 41A to 41CAn interface 1000 with a hook and post connector arrangement is shown, which allows rotation between a seal 114 and a side arm 130 of a headgear 118 and maintains that rotatable position. In the shown configuration, the headgear 118 and the seal 114 are separable. The headgear 118 has a hook connector 1020 at each end of the side arm 130. The hook connector 1020 can be integrally formed with the side arm 130. The side arm 130 and the hook connector 1020 can be formed from injection-molded plastic material and have a... Figures 36A-36D The side arm arrangement is similar to that in 37A-37D, with a rectangular cross-sectional shape. The connector 146 of frame 114 has a post 1010 at each end. Seal 114 is connected to headgear 118 by attaching a hook connector 1020 to the post 1010. The hook connector 1020 has a cavity 1022 for receiving the post 1010, such that the hook connector 1020 wraps around and around the post 1010. In other words, the post 1010 is positioned within the cavity 1022. In the illustrated configuration, connector 146 has an opening 1012 adjacent to post 1012, through which the hook connector 1020 extends to wrap around 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 a pawl 1024 extending in a direction toward the cavity 1022. The pawl 1024 engages a valley 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 impeded by the pawl 1024. The pawl 1024 is semi-rigid and deflectable so as to allow rotation of the hook connector 1020 about the post 1010 (i.e., including rotation of the side arm 130 in the horizontal plane) when an external horizontal force is applied to the side arm 130. In other words, when an external horizontal force applied to the side arm 130 overcomes the yield strength of the pawl 1024, the pawl 1024 will deform as the hook connector 1020 rotates around the post 1010 and slide upward from the valley 1016 along the tooth 1014. The pawl 1024 slides upward along and past the tooth 1014 and downward along the adjacent valley 1016. The shape, thickness, and geometry of the tooth 1014 and the pawl 1024 can be varied to customize the force distribution curve that allows the post 1010 to rotate relative to the hook connector 1020. Furthermore, since the tooth 1014 extends 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 one side or part of the post 1010 facing the headgear 118, to provide a corresponding smooth surface to the post 1010 that contacts the inner surface of the hook connector 1020. In an alternative configuration, the teeth 1014 may be formed entirely 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 or remove the interface using conventional broken-loop methods. Furthermore, the hook and post connector arrangement can also allow alternative types of put-on and take-off methods, such as a swing-fit type, where one end of the headgear / frame is attached to the face mask, and the other end of the headgear / frame is swinged around the head and attached to the face mask. The hook and post connector arrangement accommodates a variety of put-on and take-off methods to improve interface usability.

[0434] Figures 42A to 42DAn alternative interface assembly or interface 1100 is shown, featuring 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 rotatably central 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 shifting under the user's nose, for example, when the user is sleeping on their side and the pillow is in contact with the interface 1100. Figure 42B As shown. Furthermore, the rotary seal 1114 allows the interface 1110 to mate with a user having a crooked nose, such as... Figure 42C As shown. Similar to the interface disclosed above, interface 1100 prevents or inhibits the seal 1114 from rotating along a vertical plane (i.e., vertically across the user's face). Furthermore, when an external horizontal force is removed, leaf spring 1140 centers the seal 1114.

[0435] Similar to Figures 1 to 11 The interface 110 includes a seal 1114 attached to the frame assembly or frame 1116. The frame 1116 supports the seal 1114. A connector portion, including a side arm 1130, or connector 1146, is attached to the frame 1116. The frame 1116 and connector 1146 may be formed of relatively rigid, semi-rigid, or rigid materials, such as polycarbonate. Therefore, in at least some configurations, the frame 1116 and connector 1146 are more rigid than the seal 1114.

[0436] Similar to Figures 1 to 11 Connector 1146, a generally U-shaped component (viewed from top to bottom), includes side arms 1130 and a central portion 1148 connecting the two side arms 1130 to each other. That is, the side arms 1130 can be integrally formed with connector 1146 as a single piece, providing greater vertical stability (i.e., resisting vertical movement of the seal across the user's face). Figures 1 to 11 Compared to connector 146, connector 1146 is pivotally attached to frame 1116 to allow frame 1116 to rotate about a vertical axis relative to connector 1146, thus allowing frame 1116 to rotate along a horizontal plane. Connector 1146 may be pivotally connected to frame 1116 by a pivoting mechanism, such as a cylindrical post vertically positioned within a 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, specifically the user's cheekbones, to connect to a headwear (not shown) to hold the seal 1114 to the user's face. At the outer or free end of the side arm 1130, the side arm includes a connector portion 1134 for detachably connecting the side arm 1130 to the headwear (not shown). The side arms 1130 are relatively inflexible in both 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 the inner surface 1132 of the side arm 1130. The leaf spring 1140 extends toward the frame 1116 by a distance such that it is in sliding contact with the 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 such that both leaf springs 1140 contact the outer surface 1118 of the frame 1116 when the frame 1118 is rotatably centered between the side arms 1130. 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 such that the seal 1114 is rotatably centered relative to the connector 1146. Figure 42D (Center) The neutral position of the frame 1116, held by leaf springs 1140, relative to the side arms 1130 is shown. When the frame 1116 is centered between the side arms 1130, the leaf springs 1140 may be in slight contact with the frame 1116 so that they are unloaded. However, in some configurations, both leaf springs 1140 may be preloaded when the frame 1116 is centered between the side arms 1130 or slightly biased toward one of the side arms 1130.

[0439] When the seal 1114 and the frame 1116 rotate from their centered position relative to the connector 1146, the leaf spring 1140 provides a return force to center the seal 1114 and the frame 1116. Figure 42D(Left and right sides) Show the seal 1114 and frame 1116 rotated from a centered position relative to connector 1146. Frame 1116 rotates toward leaf spring 1140, deflecting it and applying a return force to center seal 1114 and frame 1116. In the shown configuration, leaf spring 1140 only slides against frame 1118. That is, leaf spring 1140 is not fixed to frame 1118. Thus, leaf spring 1140, which is turned away from by frame 1116, does not contact frame 1116 and remains undeflected. In some configurations, leaf spring 1140 may be attached to both connector 1146 and frame 1116, such that both leaf springs 1140 apply a return force to frame 1116 to center frame 1116 relative to connector 1146. Leaf spring 1140 may have a smooth curved shape and sliding surface to reduce sliding friction between leaf spring 1140 and frame 1116. Furthermore, the leaf spring 1140 may also be curved or include rounded corners or arched walls at its connection with the inner surface 1132 of the side arm 1130 to enhance the connection between the side arm 1130 and the leaf spring 1140. Further still, the shape and geometry of the leaf spring 1140 can be modified to provide different force distribution curves for biasing the frame 1116. Moreover, those skilled in the art will understand that various spring types can be used to absorb forces and bias the frame 1116. In other words, the interface 1100 is not limited to using only the leaf spring 1140 and can employ alternative biasing arrangements such as coil springs or elastically deformable cushions, air bags, pads, etc.

[0440] Figures 43A to 43C An alternative interface assembly or interface 2100 with a seal 2114 is shown, which slides horizontally or laterally between side arms 2130 (i.e., across the user's face). Figures 42A to 42D Compared to the interface 1100, the seal 2114 slides horizontally or laterally across the user's face, which is entirely different from horizontal rotation about an axis across the user's face. Allowing the seal 2114 to slide horizontally between the side arms 2130 allows the interface 2100 to absorb and adjust to external horizontal forces, such as when the user is sleeping on their side and the pillow is in contact with the interface 2100, to inhibit or prevent the seal 2114 from moving off the user's nose. Figure 43B and 43C As shown. Similar to the interface disclosed above, interface 2100 prevents or inhibits the seal 1114 from rotating or flexing along a vertical plane (i.e., vertically across the user's face).

[0441] like Figure 43AAs shown, the side arms 2130 are connected to each other by a bridge or a central portion 2148. That is, each side arm 2130 is connected to the central portion 2148 at its end, thus forming a closed loop with the headgear 2118. The side arms 2130 can be permanently or removably attached to the headgear 2118. The side arms 2130 and connector 2146 can be integrally formed as a single piece from a material such as polycarbonate, making the side arms 2130 and the central portion 2148 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 their thickness, thus preventing 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 connector portions or connector 2146. Connector 2146 has a channel 2150 in which a central portion 2148 slides. Channel 2150 has a shape and size corresponding to the side arm 2130 and the central portion 2148, allowing the side arm 2130 and the central portion 2148 to slide and pass through the channel. In operation, when the user lies on their side and the pillow (applying force to the side arm 2130) contacts the interface 2100, the side arm 2130 and the central portion 2148 are displaced and pushed through the channel 2150 of connector 2146, thus preventing the seal 2114 from moving and ensuring its position on the user's nose remains undisturbed.

[0442] In some configurations, the travel range between the side arms 2130 can be limited by altering the cross-sectional size and shape of the central portion 2148 or the side arms 2130, preventing the enlarged areas of the central portion 2148 or the side arms 2130 from entering the connector 2146. For example, the height and / or thickness of the end portion of the central portion 2148 can be increased, making the end portion of the central portion 2148 larger than the height and / or width of the channel 2150. Therefore, the travel range of the frame 2116 will be limited to 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 also be used to obstruct the entry of the central portion 2148 or the side arms 2130 into the connector 2146, thus limiting the travel range.

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

[0444] Figures 44A to 44D The illustrated configuration depicts a nose seal 114 that provides physical feedback to the user indicating that the seal 114 is being worn incorrectly, thus preventing the user from continuing to wear the seal 114 incorrectly. The nose seal 114 is similar to... Figure 1-22 The seal described herein, and therefore, will omit much of the redundant description of similar structures. 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 nose 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, which results in the flange 1210 being 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 unused space 228 of the seal 114 when the seal is not worn by the user and is not deformed. The ends of the flange 1210 may extend to connect to the side edges 238, which may also increase the rigidity of the flange 1210. In some configurations, the flange 1210 may extend to include a lower edge 236, thereby substantially or completely surrounding the nose opening 128. The flange 1210 has a greater thickness than the central portion 204 along the seal 114, making the flange stiffer and more rigid than the central portion 204. The flange 1210 is shown to have a constant thickness, but the thickness of the flange 1210 may vary along its length. The flange 1210 may be integrally formed with the seal 114. The flange 1210 extends downward into the ineffective space 228 of the seal 114. In some configurations, the nose opening 128 has an edge including a thickened bead at the upper edge 234 of the nose opening 128.

[0445] Figure 44B The seal 114 is shown being correctly fitted onto the user. As shown, the user's nose is positioned on top of the seal 114 such that the opening 128 is positioned below the user's nostrils and the tip of the user's nose contacts the central portion 204 of the seal. Further, when the seal 114 is correctly fitted onto the user, the flange 1210 does not contact the user. More precisely, the flange 1210 is positioned below the user's nostrils and extends in a direction away from the nose into the seal 114.

[0446] Figure 44C This demonstrates that the seal 114 was improperly worn onto the 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 the top of the user's nose such that the bottom edge 1212 of the flange 1210 is pressed into the tip, nasal tip, or bridge of the user's nose. The rigidity of the flange 1210 (i.e., due to its thickness and the side edges 238 that attach the end to 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 being pushed into the orifice 128. Thus, the user will physically feel the flange 1210 pressing against his / her nose and causing discomfort, which will provide the user with tactile feedback or indication that the seal is not worn correctly. In other words, the discomfort felt by the user due to the flange 1210 will be perceived as an indication that the seal 114 is not worn correctly. Flange 1210 also prevents blow-out because it is formed from a thicker silicone, and therefore is rigider and better able to maintain its shape under blow-out force.

[0447] Figures 44D to 44F An alternative flange configuration including flange 1210 is shown, which has a through-hole or vent 1214 extending through flange 1210. Vent 1214 provides a pathway for pressurized air to escape from the interior of the seal to the exterior of the seal. Similar to Figure 44B When the seal 114 is correctly fitted to the user, such 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 fitted onto the user. Figure 44F As shown, when the seal 114 is improperly worn onto the user, the user's nose is pressed into the orifice 128, causing the bottom edge 1212 of the flange 1210 to be pressed into the user's nose, which is similar to... Figure 44CIn operation, when the seal 114 is filled with air under positive pressure, pressurized air will flow through the air vent 1214. The flange 1210 and the air vent 1214 are positioned slightly above the user's nose, so that the user will feel the pressurized airflow being blown through the air vent 1214. Therefore, in addition to the discomfort of the flange 1210 pressing into the user's nose, the user will also feel the airflow escaping from the seal just above his / her nose. In some configurations, the air vent may be positioned and / or angled such that the air vent 1214 directs the pressurized airflow toward the user's eyes. Furthermore, the size and shape of the air vent 1214 can be tuned to provide an audible sound, thus providing the user with an audible indicator that the seal 114 is being worn incorrectly. Those skilled in the art will understand that the air vent 1214 is not limited to a circular cross-section and can be formed in different cross-sectional shapes and sizes.

[0448] Figure 44G and 44H An alternative flange configuration is shown, including a flange 1210 with a rounded bottom edge 1212. Similar to... Figures 44A-44F The flange 1210 is pressed into the user's nose when the user's nose is pressed into the orifice 128, and the air inlet 1214 directs pressurized air toward the user's eyes to indicate to the user that the seal 114 is not worn correctly. However, with Figure 44A-44F Compared to the flange 1210, 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 Flange 1210 with a semi-circular cross section is shown. Figure 44H A flange 1210 is shown, which has an upper portion that is rectangular in cross-section, while the lower portion of the flange is rounded. The rectangular upper portion allows the flange 1210 to flex, so that the force exerted by the flange 1210 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 Showing an alternative including one with a recess 1216 Figure 44D-44F An alternative flange configuration to the flange 1210 of the air vent 1214. A recess 1216 may be formed in 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 improperly worn on the user), pressurized air will flow through the recess 1216.

[0450] Figures 45A to 45CThe illustrated configuration depicts a nose seal 114 that physically prevents or inhibits improper wearing of the seal 114 by the user. More specifically, the seal 114 obstructs the insertion of the user's nose into the seal 114 through the orifice 128. The nose seal 114 is similar to... Figure 1-22 and Figure 44A-44I The seals described will therefore omit much of the redundant description of similar structures. For example... Figure 45A As shown, the seal 114 has a braided mesh 1310 that is overmolded or otherwise attached to the upper edge 234, lower edge 236, and side edges 238 of the orifice 128, such that the braided mesh 1310 is flush with the sealing surface of the seal 114. The braided mesh 1310 spans and covers the orifice 128. The braided mesh 1310 allows airflow through the orifice 128 while preventing or inhibiting the user from inserting his / her nose into the orifice 128. The braided mesh 1310 may be overmolded onto the orifice 128 from a silicone material. The braided mesh 1310 may be elastic to conform to the shape of the orifice 128 and deform with the seal 114. However, the braided mesh 1310 may be taut to prevent or inhibit the user's nose from entering the seal 114. Furthermore, the width and thickness or fineness of the strands of the braided mesh 1310 can be varied to provide strength to withstand the force of a user's nose being pushed into the orifice 128, while also maintaining any pressure drop caused by the braided mesh 1310 restricting the flow of air through the orifice 128.

[0451] Figure 45B and 45C An alternative configuration of the nose seal 114 is shown, which has a braided mesh 1310 offset inwardly into the seal 114 by an offset flange 1320. (See diagram) Figure 45C As shown, the outer edge of the offset flange 1320 can be attached to the upper edge 234, lower edge 236, and side edge 238 of the orifice 128, and the offset flange 1320 extends inward in a direction toward the interior of the seal 114. The inner edge of the offset flange 1320 is attached to the braided mesh 1310. The offset flange 1320 positions the braided 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 have direct skin contact with the braided mesh 1310.

[0452] Figure 45D and 45E An alternative configuration of the nose seal 114 is shown, which prevents the user's nose from being inserted into the seal 114 through the orifice 128. Figure 45A-45CCompared to the braided mesh 1310, the seal 114 has an orifice cover 1410 having an array of holes 1420 extending through it. Similar to the braided mesh 1310, the orifice cover 1410 prevents the user's nose from being inserted into the seal 114 through the orifice 128. The orifice cover 1410 is attached to the upper edge 234, lower edge 236, and side edge 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 may be formed integrally or integrally with the seal 114. The holes 1420 extend through the orifice cover 1410 and are evenly distributed across it. The holes 1420 allow airflow through the orifice cover 1410 while preventing or inhibiting the user from inserting his / her nose into the orifice 128. The diameter and spacing of the aperture 1420 can be configured to minimize noise and voltage drop. Those skilled in the art will understand that the aperture 1420 can include an unlimited combination of apertures with different shapes, sizes, and arrangements. Figure 45E Examples of holes 1420 arranged on the orifice cover 1410 are shown, such as combinations of large and small holes, polygonal holes, wide holes spanning the orifice, and holes arranged in a fan configuration across the orifice.

[0453] Figures 46A to 46D An alternative configuration of the nasal seal 114 is also shown, which prevents the user's nose from being inserted into the seal 114 through the orifice 128. Figure 45A-45C 1310 woven mesh and Figure 45D-45E Compared to the orifice cover 1410, the orifice 128 has a series of tethers 1510 attached to the periphery of the orifice 128 along its upper edge 234, lower edge 236, and side edges 238. 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 worn. If the user continues to insert his / her nose into the orifice 128, the tethers 1510 will block or prevent the user from pushing further into the orifice 128.

[0454] The tether 1510 extends downward into the seal 114 and attaches to the inner surface 1520 of the bottom wall of the seal. The tether 1510 is made of long, string-like silicone strands that are bonded to or integrally molded with components of the seal 114 or the seal 114 itself. The tether 1510 is evenly spaced around the periphery of the orifice 128.

[0455] like Figure 46CAs shown, when the seal 114 is not deformed (i.e., the seal 114 is not worn by the user), the tether 1510 is taut (i.e., there is tension within the tether 1510). Therefore, the tether 1510 anchors the central portion 204 of the seal 114 to the inner surface 1520 at the bottom of the seal 114, allowing 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 worn by the user, the tether 1510 is slack (i.e., there is no tension within the tether 1510). In other words, when the seal 114 is worn by the user, the seal 114 is compressed, thus reducing the distance between the orifice 128 and the inner surface 1520 at the bottom of the seal 114. Therefore, the tether 1510 is compressed and becomes slack.

[0456] Figures 46E to 46H An alternative configuration of the nose seal 114 is shown, which prevents the user's nose from being inserted into the seal 114 through the orifice 128. Figures 46A-46D Compared to the tether 1510, the seal 114 has a buffer 1610, which is attached to the inner surface 1620 at the bottom of the seal 114 and positioned immediately below the orifice 128. Figure 46F As shown, when a user attempts to insert his / her nose into orifice 128, seal 114 will compress and the user's nose will contact buffer 1610. Upon contact with buffer 1610, the user is provided with feedback so that the user is aware that he / she should not insert his / her nose into orifice 128 and will attempt to re-puttighten seal 114, thereby positioning the user's nose outside orifice 128.

[0457] The buffer includes a vertical support 1612 and a lateral crossbeam 1614. The support 1612 is positioned below the orifice 128 and attached to the inner surface 1620 at the bottom of the seal 114. The support 1612 extends vertically upward toward the orifice 128. The upper end of the support 1612 is attached to the crossbeam 1614. The crossbeam 1614 has an elongated shape that extends laterally across the width of the orifice 128.

[0458] The support column 1612 has a certain height, so that when the seal 114 is correctly worn onto the user, the crossbeam 1614 is positioned at a certain distance below the orifice 128, such as... Figure 46CAs shown. In other words, when the seal 114 is properly worn onto the user, the crossbeam 1614 does not contact the user's nose. The seal 114 may be slightly compressed due to the force required to provide an airtight seal around the user's nose. However, the support 1612 has a certain height such that the crossbeam 1614 does not contact the user's nose, despite the compression of the seal 114. The support 1612 and the crossbeam 1614 may be formed of silicone material, making them flexible and causing no pain or injury upon contact with the user's nose. The support 1612 and the crossbeam 1614 may be integrated with or integrally molded with components of the seal 114 or the seal 114 itself. Furthermore, the support 1612 may have a curved shape, so that the shape of the support 1612 provides a certain amount of flexibility, allowing the support 1612 to deform upon contact with the user's nose.

[0459] The crossbeam 1614 is shown as having a straight and elongated cylindrical shape. However, those skilled in the art will understand that the crossbeam 1614 can have one of a variety of shapes that obstruct the user's nose or other objects from descending through the orifice 128 into deeper parts of the seal 114. Furthermore, in some configurations, the seal 114 may have a strut 1612 without the crossbeam 1614 attached to the upper end of the strut 1612. Figure 46H The arrangement of supports is shown, which has support column 1612 but no crossbeam.

[0460] Figures 47A to 47GAn alternative configuration of the orifice 128 for a seal (not shown) is shown, which inhibits or prevents insertion of the user's nose into the orifice 128 by providing different positions for the user's left and right nostrils above the orifice 128. As shown, the upper edge 234 and lower edge 236 of the orifice 128 narrow at the lateral midpoint of the orifice 128 to form a narrow central portion 1710 of the orifice 128, which is positioned between the left nostril portion and the right nostril portion 1712. The widest distance between the upper edge 234 and the lower edge 236 of the orifice 128 at the narrow central region 1710 is significantly narrower than the widest distance between the upper edge 234 and the lower edge 236 at the left nostril portion and the right nostril portion 1712. Therefore, the narrow central portion 1710 defines distinct left and right nostril portions 1712, allowing the user to intuitively and clearly perceive that his / her nostrils should be positioned above the left and right nostril portions 1712, as the user will realize that the opening 128 is too narrow at the narrow central portion 1710 for insertion of his / her nose. Furthermore, if the user attempts to insert his / her nose into the opening 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 opening 128. The left and right nostril portions 1712 may be oval in shape. The opening 128 may be formed in various shapes, such as, but not limited to, a kidney shape. Figures 47A-47D ) or crescent shape ( Figure 47E The left and right nostrils 1712 may be angled toward each other, such that their uppermost edges are closer together than their lowermost edges. In some configurations, the left and right nostrils 1712 may be angled away from the narrow central region 1710. Each of the left and right nostrils 1712 may have a shape such that the width of its uppermost portion is narrower than the width of its lowermost portion. In some configurations, the narrow central region 1710 may be positioned closer to the upper edge 234 of the opening 128, such as... Figure 47A , 47C As shown in 47D. In other configurations, the narrow central region 1710 can be positioned closer to the lower edge 236 of the aperture 128, as... Figure 47B As 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 according to 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 according to the size and shape of the user's nose and nostrils. Figure 47F and 47G An opening 128 with overlapping upper edges 234 and lower edges 236 is shown. As shown, the lower edge 236 extends over the upper edge 234, thus completely separating the left and right nostril portions 1712. The separated left and right nostril portions 1712 provide clearly distinct positions for the user's left and right nostrils above the opening 128.

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

[0463] Figures 48A to 48D An alternative configuration of the nose seal 114 is shown, which provides the user with visual guidance on how the seal 114 should be properly fitted onto the nose. For example... Figure 48AAs shown, the seal 114 has a mark 1810 to visually indicate to the user where his / her nose should be positioned above the orifice 128. The mark 1810 is depicted as a circular target with a central "bullseye." The mark 1810 is positioned at a specific location on the central portion 204 of the seal 114 where the user's nose should be positioned. The mark 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-removable, washable ink, allowing the user to remove the mark 1810 once they have learned how to properly wear the seal 114. In other configurations, the mark 1810 can be a label applied using adhesive to or onto the inner surface of the seal 114 in an unused space, making the mark 1810 visible through the surface of the seal 114. Figure 48B An alternative target-type marker 1810 was demonstrated. Figure 48C A combination of markings is shown, including marking 1810A indicating the alignment of the user's nose on the seal 114 and marking 1810B indicating the position of the underside of the user's nose on the orifice 128. Figure 48D Marking 1810 shows the outline of the user's nose to indicate the alignment of the user's nose on the seal 114 and the position of the user's nose above the orifice 128.

[0464] Instead of explicit images indicating the precise location, placement, and / or alignment of the user's nose, the markings 1810 may include humorous or comical images to convey the position of the seal 114 on the user's face. Figure 48E Mark 1810 depicts a mustache-shaped feature printed on the central portion 204 of the seal 114 below an opening 128 positioned below the user's upper lip. The image of the mustache provided by mark 1810 indicates to the user where his / her upper lip should be positioned. Similarly, Figure 48F A flower-shaped mark 1810 is depicted printed on the central portion 204 of the seal 114 above an opening 128 positioned below the user's nose. In some configurations, the mark 1810 may also have a scent (e.g., floral) to further indicate how the seal 114 should be worn. In other configurations, the mark 1810 may be a label applied to the seal 114 using an adhesive. In still other configurations, the mark 1810 may be applied using temperature-sensitive ink or labeling, 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 can provide positive or negative feedback regarding the user's behavior.

[0465] Compared to the printed mark 1810, Figures 48G to 48I Markers 1910, formed as frosted silicone resin, are shown. Markers 1910 can be integrally and monolithically molded into sealant 114 to provide frosted silicone resin marks 1910 having an opaque appearance that contrasts with the translucent appearance of the remainder of sealant 114. Similar to... Figure 48D , Figure 48G A frosted silicone marker 1910 is shown, which indicates 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 A frosted silicone marker 1910 is shown, which indicates the position of a user's nostrils on orifice 128 by outlining the shape of the user's nostrils within the frosted silicone. Similar to... Figure 48A , Figure 48I A target-like marker 1910 in frosted silicone is shown, which can 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 compressible vortex 2010 is shown, which deforms to indicate that the seal 114 is correctly worn on the user. Similar to a target or "bullseye" shaped marker 1810, the vortex 2010 is positioned at a specific location on the central portion 204 of the seal 114, where the user's nose should be positioned. Figure 49C As demonstrated, when depressed, the trap 2010 deforms inward toward the inner cavity or unused space of the seal 114. Therefore, when the tip of the user's nose is positioned over the trap 2010, the trap 2010 deforms inward to provide the user with positive tactile feedback that the seal 114 is correctly positioned. The trap 2010 can also produce an audible "pop" noise as it deforms inward. When the seal 114 is removed from the user's face, the trap 2010 can be reset to extend outward (i.e., away from the interior or unused space of the seal 114), thus allowing the trap 2010 to be repositioned for the next wear. Since deformable traps are also used in consumer products (e.g., takeaway coffee lids), the trap 2010 provides an easily identifiable mechanism for indicating where the user's nose should be placed on the seal 114.

[0467] The trap 2010 can also be used to indicate whether the seal 114 is sufficiently tight against the user. For example, the force distribution curve or threshold amount of the force required to deform the trap 2010 can be determined based on the appropriate tightness of the seal 114 against the user's nose or face. Therefore, the trap 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 interface 3110 is shown, which adjusts the angle of the nasal seal 3114 according to the user's nasal angle 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 subnasal region. Generally, the user's subnasal region is sensitive to the upward force applied by the seal. However, to suppress or prevent seal leakage, the seal must apply an upward force greater than the blow-out force to the user's nose. The blow-out force varies depending on the upward or downward angle of the user's nose. Thus, a seal that comfortably fits a user with an upward-angled nose (i.e., by applying minimal force to the user's subnasal region) may be uncomfortable for a user with a downward-angled nose because the seal will not align with the blow-out force, thus applying a greater amount of force to the user's subnasal region. Therefore, in order to reduce or minimize the amount of force applied to the subnasal region, the interface 3110 provides a seal 3114 that is rotatable according to the upward or downward angle of the user's nose in order to provide a sealing force aligned with and opposite to the user's blowing force, thereby reducing or minimizing the amount of force applied to the user's subnasal region.

[0469] exist Figure 50A In the middle, interface 3110 has a seal 3114 attached to frame 3116. Seal 3114 and frame 3116 are similar to... Figure 1-22The seal 114 and frame 116 are described, and therefore, much redundant description of similar structures will be omitted. Frame 3116 is rotatably attached to upper frame track 3122 at upper connecting portion 3152 and rotatably attached to lower frame track 3124 at lower connecting portion 3154. That is, frame 3116 rotates about upper connecting portion 3152 relative to upper frame track 3122, and frame 3116 also rotates about lower connecting portion 3154 relative to lower frame track 3124. Upper frame track 3122 and lower frame track 3124 may be formed of relatively rigid, semi-rigid, or rigid materials, such as polycarbonate. The ends of upper frame track 3122 and lower frame track 3124 are attached to the forward strap 3140 of headgear 3118. That is, the end of the upper frame track 3122 is attached to the upper headgear strap 3142, and the end of the lower frame track 3124 is attached to the lower headgear strap 3144. Thus, 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 track 3122 and the lower frame track 3124 can be attached to the upper headband strap 3142 and the lower headband strap 3144 by a connecting mechanism 3160, thus allowing the upper frame track 3122 and the lower frame track 3124 to extend or retract relative to the headband 3118, such as... Figure 50B As shown. More precisely, the extension or retraction of the upper frame track 3122 and the lower frame track 3124 changes the relative position of the upper connecting portion 3152 and the lower connecting portion 3154, which causes the seal 3114 to rotate and allows the seal 3114 to have angular adjustment within a certain range of rotation. Figure 50B The rotational position of seal 3114 is depicted by dashed lines.

[0471] For demonstration purposes, Figure 50C and 50DThis is a schematic side view of the upper frame track 3122 and the lower frame track 3124 to show the corresponding positions of the upper connecting portion 3152 and the lower connecting portion 3154 when the upper frame track 3122 and the lower frame track 3124 extend or retract from the upper headband strap 3142 and the lower headband strap 3144. As shown, length L1 is measured as the distance between the end of the upper connecting portion 3152 and the upper headband strap 3142. Similarly, length L2 is measured as the distance between the end of the lower connecting portion 3154 and the lower headband strap 3144. Therefore, extending or retracting the upper frame track 3122 or the lower frame track 3124 relative to the upper connecting portion 3152 and the lower connecting portion 3154 changes the lengths L1 and L2. To further demonstrate the function of extending or retracting the upper headband strap 3142 and the lower headband strap 3144, the front plane of the frame 3116 is represented by the front plane projection line FP defined by the upper connecting portion 3152 and the lower connecting portion 3154. Thus, the angle of the front plane projection line FP changes according to the lengths L1 and L2 of the upper frame track 3122 and the lower frame track 3124.

[0472] When comparing Figure 50C and 50D At that time, Figure 50C and 50D Between these points, the length L1 remains unchanged. However, from Figures 50C to 50D The length L2 increases. That is to say, Figure 50D The length L2 in is greater than that in Figure 50C The middle part is larger. Therefore, the lower connection portion 3154 is positioned larger than the middle part. Figure 50C The center is further away from the headgear 3118 (which causes the seal 3114 to rotate downwards), as by Figure 50D The clockwise rotation of the front plane projection line FP is depicted. Similarly, although not depicted, the extension of the upper frame track 3122 and the retraction of the lower frame track 3124 will cause the seal 3114 to rotate upward and cause the front plane projection line FP to rotate counterclockwise. The angular rotation range provided by the upper frame track 3122 and the lower frame track 3124 can depend on the amount or range of extension and retraction provided by the connecting mechanism 3160 to the upper frame track 3122 and the lower frame track 3124. Therefore, the rotation of the seal 3114 within the angular rotation range allows the seal 3114 to comfortably fit within a wide range of positive or negative nasal angles of the user's nose in order to minimize the amount of force applied to the user's subnasal region.

[0473] To demonstrate the rotatable adjustability of the seal 3114 provided by interface 3110, Figure 50E A cross-sectional view of a seal 3114 that fits into the nose of a user with a positive nasal angle is shown. Figure 50FA cross-sectional view of a seal 3114 fitted to the nose of a user with a negative nose angle is shown. The nose angle is determined based on the angle σ between the bottom plane BP of the user's nose and the horizontal reference plane H. A positive nose angle is defined as the angle σ above the horizontal reference plane H. A negative nose angle is defined as the angle σ below the horizontal reference plane H. Figure 50E-50F The blowout force vectors BOF for positive and negative nose angles are also depicted. As shown in the figure, the blowout force vector BOF for the positive nose angle is angled closer to the horizontal plane than the blowout force vector BOF for the negative nose angle. Figure 50E-50F The front plane projection line FP is also depicted, which is defined by the connecting portion 3152 and the lower connecting portion 3154 and indicates Figures 50A-50D The front plane of the frame 3116 is shown. Interface 3110 accommodates the airflow force vector BOF, which has different angles due to positive and negative nose angles, by allowing the seal 3114 to rotate according to the nose angle, such that the front plane projection line FP is perpendicular to the airflow force vector BOF. Aligning the front plane projection line FP perpendicular to the airflow force vector BOF minimizes the amount of force applied to the user's subnasal region.

[0474] like Figure 50E As shown, the seal 3114 is fitted to the negative nose angle. Figure 50F In contrast, the seal 3114, which is fitted to the nasal angle, rotates clockwise, so that the anterior plane projection line FP is perpendicular to the blowing force. Therefore, the amount of force applied to the user's subnasal region 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 a positive nose angle, the seal 3114 fitted to a negative nose angle rotates counterclockwise, so that the anterior plane projection line FP is also perpendicular to the blowing force. Therefore, the amount of force applied to the user's subnasal region to provide a seal against the user's nose is minimized. To further illustrate the difference in the rotation angle of the anterior plane projection line FP, the angle θ between the anterior 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 to the nose angle is less than Figure 50F The angle θ of the front plane projection line FP of the seal 3114 that is fitted to the negative nose angle.

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

[0476] The connection mechanism 3160 may include any connection arrangement between the headgear 3118 and the upper frame track 3122 and the lower frame track 3124, such arrangement providing extension and retraction of the upper frame track 3122 and the lower frame track 3124, thereby allowing the seal 3114 to be rotatable through a range of angular rotation. The connection mechanism 3160 may include a rigid 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 rotate through a certain angular range. Figures 51A-51B A connecting mechanism 3260 is shown, comprising a loop 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 frame rail 3122 and the lower frame rail 3124, the closed-loop cable 3220 is connected to the frame 3116 at the upper connecting portion 3152 and the lower connecting portion 3154. The upper connecting portion 3152 and the lower connecting portion 3154 may include rings or through holes positioned 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 frame rail 3222 and the lower frame rail 3224.

[0478] like Figures 51A-51B As shown, the closed-loop cable 3220 is wound around the pulley 3230. The pulley 3230 is attached to the forward strap 3240 of the headgear 3118. The pulley 3230 rotates clockwise or counterclockwise to allow the upper loop portion 3222 and the lower loop portion 3224 to increase or decrease in length, thereby causing the seal 3114 to rotate. That is, the rotation of the pulley 3230 pulls the upper connecting portion 3152 or the lower connecting portion 3154 closer to the headgear 3118. Therefore, 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, pulley 3230 may have a recessed groove around its periphery to receive closed-loop cable 3220. Additionally, a user can put on and take off seal 3114 by detaching closed-loop cable 3220 from pulley 3230. Furthermore, pulley 3230 may be adjustably attached to the front strap 3240 of headgear 3118 to allow adjustment of the slack within closed-loop cable 3220 and thus the tightness of seal 3114 against the user's face. More precisely, the position of pulley 3230 can be moved along the front strap 3240 (i.e., closer to or further away from frame 3114), thus allowing adjustment of the tightness of seal 3114 against the user's face. Alternatively, closed-loop cable 3220 of different lengths can be provided, thus allowing adjustment of the tightness of seal 3114 against the user's face.

[0480] Figure 51C-51D An alternative connection mechanism is shown, 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 lower yoke 3324 have a fixed length and can be rigid or semi-rigid in construction. Therefore, the rigidity of the upper yoke 3322 and lower yoke 3324 is sufficient to resist yielding to vertical forces, such as the vertical component of a blowout force. The upper yoke 3322 and lower yoke 3324 are rotatably attached to the pulley 3230 to allow rotation of the upper yoke 3322 and lower yoke 3324 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 precisely, the rotation of pulley 3230 can push or pull the upper yoke 3322 and the lower yoke 3324, which in turn 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, pulley 3430 may have a gear 3460 positioned on one side of pulley 3430. Gear 3460 may engage teeth 3462 attached to headgear 3118. Teeth 3462 engage the teeth of gear 3460 to suppress or prevent rotation of pulley 3430, thus maintaining the rotational orientation of seal 3114. In some configurations, pulley 3460 may have a toothed outer periphery. Pulley 3430 and teeth 3462 may be formed of plastics such as thermoplastic polyurethane (TPU).

[0482] Figure 51F A pulley 3430 with a knurled outer perimeter 3470 is shown. The texture provided by the knurled outer perimeter 3270 provides increased gripping force, allowing the user to overcome the holding force of the teeth 3462 and rotate the pulley 3430. Similarly, Figure 51G A pulley 3430 with a rod 3480 extending radially outward from the periphery of the pulley 3430 is shown. Therefore, the pulley 3430 can be rotated by rotating the rod 3480.

[0483] Figures 52A to 52C An alternative configuration of the roll seal 4114 is shown, which deforms to comfortably fit the user's nose within a wide range of upward or downward angles, thereby minimizing the amount of force applied to the user's subnasal region. Compared to mechanisms that rotate the seal upwards or downwards to align with the angle of the user's nose, the seal 4114 deforms and rolls downwards onto itself, allowing it to conform to the shape and angle of the user's nose. More specifically, the seal 4114 includes areas with varying thickness or hardness, such that when force is applied to the seal 4114, deformation of the seal 4114 can be controlled and provided in predetermined areas, thereby minimizing the amount of force applied to the user's subnasal region. When the seal 4114 is removed, the upper peripheral region 4250 returns to its undeformed shape.

[0484] The seal 4114 has an opening 4128 surrounded by an inwardly or rearwardly facing central portion 4204, which faces or contacts the lower portion of the 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 outer 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 outer periphery of the seal 4114. The upper peripheral region 4250 is connected to the inner upper edge of the lower peripheral region 4252, which is adjacent to an unused space 4206 in the seal 4114. A seal port 4172 may be formed at the central midpoint region 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 outer peripheral region 4252 (i.e., the wall thickness of the seal 4114 at the lower outer peripheral region 4252) is much greater than the thickness of the upper outer peripheral region 4250. Therefore, the lower outer peripheral region 4252 has significantly greater hardness and stiffness compared to the upper outer peripheral region 4250. In some configurations, the lower outer peripheral region 4252 may be formed of a rigid plastic material, on which the silicone portion of the seal 4114 is overmolded. Therefore, when a downward force is applied to the central portion 4204 of the seal 4114 (i.e., if the user has a nose angled downwards), the upper outer peripheral region 4250 rolls inwards and downwards onto itself and / or the lower outer peripheral region 4252, as... Figure 52CAs shown. More precisely, in response to the applied force, the central portion 4204 moves downward and / or inward into the ineffective space 4206 of the seal 4114, causing the upper outer peripheral region 4250 to collapse and roll inward into the ineffective space 4206 of the seal 4114 and downward onto itself and / or the lower outer peripheral region 4252. The rolling of the upper outer peripheral region 4250 allows the seal 4114 to move downward and / or inward to conform to the shape and angle of the bottom plane of the user's nose, thus reducing the force applied to the area under the user's nose. Furthermore, by adjusting the thickness and hardness of the upper outer peripheral region 4250, the force required to cause the rolling of the upper outer peripheral region 4250 can be controlled, thereby controlling the force applied against the user's nose. For example, by gradually changing the thickness or hardness, the rolling of the upper outer peripheral region 4250 can be resisted more or less within the range of motion.

[0486] The seal 4114 may include a reinforcing portion or thickened band 4240 positioned between the upper outer peripheral region 4250 and the central portion 4204. The band 4240 may extend along the upper outer edge of the central portion 4204 on the inner wall of the seal 4114. The band 4240 reduces the incidence of bulging and provides additional structure between the upper outer peripheral region 4250 and the central portion 4204 to suppress or prevent roll-up of the central portion 4204 and promote roll-up of the upper outer peripheral region 4250. The band 4240 may be a component 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 may also include a thickened or reinforced orifice region 4242 surrounding the orifice 4128. The reinforced orifice region 4242 may extend around or surround the orifice 4128 to suppress or prevent edge deformation of the orifice 4128 and collapse into the unused space 4206 of the seal 4114. Additionally, the reinforced orifice region 4242 may help transfer downward forces applied by the user's nose to the upper peripheral region 4250. Similar to the band 4240, the reinforced orifice region 4242 may be a component 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.

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

[0489] Although the illustrated configuration uses a region with varying thickness, other methods can be used to induce rolling of the seal 4114 to provide a region with varying hardness. For example, the material of the seal 4114 can be configured to include a relatively increased or decreased hardness through material selection or material properties. Furthermore, a composite of multiple materials can be used to provide a region with varying hardness or stiffness. Additionally, any suitable combination of techniques can be used. However, the upper peripheral region 4250 configured with a reduced thickness provides a simple way to achieve a region with decreasing but increasing hardness.

[0490] Figures 53A to 53D An alternative configuration of the roll seal 5114 is shown, which is adapted through deformation to accommodate users with a wide range of infranasal angles, the infranasal angle being a combination of the user's nose angle and upper lip angle. Similar to... Figures 52A-52C The seal 4114 has an upper peripheral region 5250 that rolls downwards to accommodate a user with a negative nasal angle. However, the seal 5114 also has a lower peripheral region 5252 that rolls upwards to accommodate a user with a protruding upper lip angle. That is, the upper peripheral region 5250 and the lower peripheral region 5252 roll downwards and upwards respectively, thus compressing the seal 4114 to fit the space between the user's nose and upper lip. When the seal 4114 is removed from the space between the user's nose and upper lip, the upper peripheral region 5250 and the lower peripheral region 5252 return to their undeformed shape.

[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 of thick silicone resin, making it substantially non-flexible. Alternatively, the rigid frame portion 5260 can be formed of a rigid plastic material, and the upper peripheral region 5250 and the lower peripheral region 5252 can be overmolded onto this rigid plastic material using a flexible material such as silicone resin. A sealing port 5172 can be formed at the central midpoint of the front region of the rigid frame portion 5260. The rigid frame portion 5260 is shown to be peripherally recessed relative to the outer sides of the upper peripheral region 5250 and the lower peripheral region 5252. However, in some configurations, it will be understood by those skilled in the art that the rigid frame portion 5260 can be flush with or protrude from the outer sides of the upper peripheral region 5250 and / or the lower peripheral region 5252.

[0492] The seal 5114, which has a rolled upper peripheral region 5250 and a lower peripheral region 5252, is adapted to users with a wide range of nose angles (i.e., a combination of nose angle and upper lip angle). Figure 53B This 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 protruding upper lip angle. The subnasal angle is measured between the subnasal region and the upper lip. Users with a positive nose angle and a shallow upper lip angle are shown as having a θ. 最大 The lower nasal angle. Users with a negative nasal angle and a protruding upper lip angle are shown as having θ. 最小 The lower nasal angle. In other words, for users with a positive nasal angle and a shallow upper lip angle, the lower nasal angle is larger compared to users with a negative nasal angle and a protruding upper lip angle.

[0493] Seal 5114 is adapted to have θ 最小 to θ 最大 Users with a lower nasal angle within the specified range. Figure 53C It is configured to cooperate with a nose-down angle θ 最大 The side view orientation of the user's seal 5114. As shown, the upper outer peripheral region 5250 and the lower outer peripheral region 5252 are not deformed, thus allowing the seal 5114 to span the nose at the lower angle θ. 最大 It then presses against the user's nose to create a seal. Figure 53D It is configured to cooperate with a nose-down angle θ 最小 The side view orientation of the user's seal 5114. In contrast, the upper outer peripheral region 5250 and the lower outer peripheral region 5252 deform and roll onto themselves, so that the seal 5114 conforms to fit the lower nose angle θ. 最小It presses against the user's nose to create a seal, while minimizing the force applied to the area under the user's nose.

[0494] The upper outer peripheral region 5250 and the lower outer peripheral region 5252 can be structurally similar to the upper outer peripheral region 4250 and to each other. Thus, the upper outer peripheral region 5250 and the lower outer peripheral region 5252 can deform similarly under similar forces. Therefore, the sealing port 5172 is balanced between the upper outer peripheral region 5250 and the lower outer peripheral region 5252. Furthermore, when the upper outer peripheral region 5250 and the lower outer peripheral region 5252 roll and reach equilibrium at a new position, they absorb continuous vertical external forces. Temporary vertical external forces caused, for example, by accidental hose pulling are absorbed by the upper outer peripheral region 5250 and the lower outer peripheral region 5252, and the upper outer peripheral region 5250 and the lower outer peripheral region 5252 will return towards or return to their equilibrium position. In some configurations, the upper outer peripheral region 5250 and the lower outer peripheral region 5252 can have different sizes, geometries and / or structures, so that the upper outer peripheral region 5250 can provide a different force distribution curve than the lower outer peripheral region 5252.

[0495] Similar to seal 4114, a reinforcing portion or thickened band 5240 extends along 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. Additionally, seal 5114 may include a thickened or reinforced orifice region 5242 surrounding orifice 5128. The band 5240 and the reinforced orifice region 5242 help transfer forces applied by the user's nose and upper lip to the upper peripheral region 5250 and lower peripheral region 5252. Figure 53E An alternative to the reinforcing strip 5240 is shown. As shown, the seal 5114 can have a spring steel strip 5340, onto which an upper outer peripheral region 5250 and a lower outer peripheral region 5252 are overmolded. The spring steel strip 5340 facilitates the rolling of the upper outer peripheral region 4250 by suppressing or preventing rolling at other areas of the seal 5114.

[0496] Figures 54A to 54G An alternative configuration of the seal 6114 with a telescopic region 6202 is shown, which allows the seal 6114 to be adjusted to accommodate a range of nose lengths. The telescopic region 6202 is a deformable region of the seal 6114 that receives and deforms to accommodate the length and shape of the user's nose, and expands outward and / or upward to reduce and decrease the amount of force exerted against the user's nose. Figures 54A-54BAs shown, the expansion region 6202 is a flexible region formed by the thin-walled portion of the seal 6114. The expansion region 6202 can have the thinnest wall thickness compared to all other portions of the seal 6114, such that deformation occurs only within the expansion region 6202. The thin wall thickness provides flexibility that allows the expansion region 6202 to change shape by deforming inward and expanding outward. The expansion region 6202 may include a central portion 6204, such that the expansion region 6202 surrounds the orifice 6128. Additionally, the expansion region 6202 may extend to include a portion of the upper outer peripheral region 6250. The seal 6114 may also include a thickened or reinforced orifice region 6242 surrounding the orifice 6128. In other words, the orifice 6128 may have a thickened or reinforced orifice region 6242 (i.e., relative to the rest of the seal 6114) formed of thickened silicone resin, thus strengthening and reinforcing the orifice 6128 to suppress or prevent the seal 6114 from collapsing around the orifice 6128. Therefore, the reinforced orifice region 6242 ensures that when the seal 6114 is fitted to the user, the expansion region 6202 of the seal 6114 deforms (completely different from the region around the orifice 6128).

[0497] Figure 54C This 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 nose and an upward angle. As shown, the longer nose extends deeper into the seal 6114 compared to the shorter nose. Therefore, the telescopic region 6202L deforms inward to receive the longer nose. Additionally, the telescopic region 6202L protrudes outward in the forward and upward directions to increase the volume within the seal 6114, thus minimizing the increase in pressure within the seal 6114. Therefore, 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 telescopic region 6202L extending upward along the user's nose improves the comfort of the seal 6114 because this amount of force is distributed over a larger area of ​​contact with the nose. In contrast, the telescopic region 6202S bulges or extends towards the user to receive the shorter nose. The shorter nose does not extend deep into the seal 6114. Thus, the telescopic region 6202S does not protrude outward in the forward and upward directions like the telescopic region 6202L.

[0498] Figure 54D A seal 6114 is shown that fits into a user's nose with a longer horizontal nose angle. Figure 54EA seal 6114 is shown that fits to a user with a longer nose and a negative nose angle. As shown, the telescopic region 6202 of the seal 6114 protrudes outward in both forward and upward directions to accommodate both nose angles. Similarly, Figure 54F A seal 6114 is shown that fits into a user's nose with a shorter, more positive nasal angle. Figure 54G A seal 6114 is shown that fits to a user with a shorter nose and a negative nose angle. As shown, the telescopic region 6202 of the seal 6114 extends upward to accommodate both nose angles. In some configurations, the thickness and stiffness along the telescopic region 6202 can vary, allowing the seal 6114 to initially expand or protrude 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 telescopic region 6202 can then expand or protrude forward to relieve pressure within the seal 6114.

[0499] The comfort of a nasal pillow seal can be improved by avoiding a nasal seal protruding into the user's nostrils. A nasal seal that does not protrude into the user's nostrils can form a seal with the user by having a lower portion that rests against the user's nose and a surface that compresses the upper lip. This allows the nasal seal to have a larger profile compared to a seal that protrudes into the patient's nostrils. The problem with large-profile nasal pillow seals is that if the seal comes into contact with another surface, such as when the user changes their position to their side, the seal may shift. Reducing the profile of the nasal seal can reduce the perceived forcefulness of the seal and can reduce the negative effects experienced when sleeping on one's side. Because a low-profile breathing interface is smaller, it is less likely to come into contact with a pillow or another surface associated with sleep that could shift the breathing interface and disrupt the seal on the patient's nose. However, a low-profile breathing interface can have a smaller surface area to form a seal with the user's skin. The breathing 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 is possible to be with Figure 1 A perspective view of another instance of the interface components used or incorporated into the system 10 or the breathing mask system 110. The mask system 110 may be similar to, at least in some respects, the interface components used or incorporated into the system 10. Figure 2-22The mask system 110 is described in the context of its differences from a previous mask system 110. Components or features of this mask system 110 that are not described in detail may be the same as or similar to corresponding components or features of a previous mask system 110, or may have another suitable arrangement. Therefore, in some instances, the same reference numerals are used to refer to the same, 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 may 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 a user. The headgear 118 may include a yoke 127 extending along the front of the patient interface 112. The yoke 127 may 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 breathing mask system 110 does not include a T-shaped piece extending upward (when worn) from the frame 116 to connect to the headgear 118 at the user's forehead. However, aspects, features, or components of the disclosed breathing mask system 110 may be used in designs incorporating the T-shaped piece if desired. The seal 114 does not rest on the bridge of the nose, thereby reducing the size and profile of the seal and making it less forceful. Additionally, by not resting on the bridge of the nose, the seal 114 is adapted to reduce any chance of pressure injury in the sensitive nasal area.

[0501] In some configurations, the breathing 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 connection to the supply conduit 12 of the CPAP system 10 or other breathing 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., a bend) or straight. In some configurations, the connector 122 can rotate relative to the mask 112 about one or more axes of rotation, such that the path of the gas delivery conduit 120 relative to the mask 112 on the user's face can be adapted to the user's sleeping posture. However, in other arrangements, the connector 122 can be integral or integral 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 to the connector 122 may include a connector 124 suitable for connecting the gas delivery conduit 120 to the supply conduit 12. In some configurations, the connector 124 may be or include a swivel connector that allows relative rotation between the gas delivery conduit 120 and the supply conduit 12.

[0502] The breathing mask system 110 preferably includes a flow-limiting outlet or deflector vent 126 for providing gas flushing from the breathing mask system 110. In some configurations, the deflector vent 126 is in the form of a series of small orifices. The deflector vent 126 may be located in the frame 116 (as shown), in the connector 122, or elsewhere on the breathing mask system 110.

[0503] In some configurations, the face mask 112 may include a seal 114, a frame 116, and a connector 122. In some configurations, the frame 116 (and the connector 122, if desired) may be more rigid than at least a portion of the seal 114 (e.g., the portion defining the user contact surface). In some configurations, the seal 114 is removably coupled to the frame 116 around a passage from the interior of the connector 122 through the frame 116. 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 may also be formed of thickened silicone or other plastic materials. Thus, the seal 114 and the frame 116 may together form a closure having a gas inlet from the CPAP system 10 and an aperture 7128 through the seal 114 to the user (see example...). Figure 58A ).

[0504] In some configurations, the headband 118 includes side arms 130 that extend outward (away from each other), backward, and upward at shallow angles, beyond the left and right ends of the seal 114, and along the left and right cheeks, specifically the user's cheekbones, to attach to the headband 118 to hold the seal 114 to the user's face. These side arms 130 may be longer than their depth or thickness and may be resiliently and flexibly attached to the frame and / or resiliently and flexibly along their length (width rather than height). In some configurations, the side arms 130 extend toward or to a location between the user's ears and eyes and / or to the user's temples or their vicinity. In some embodiments, the side arms 130 extend along the cheeks and upward toward the top of the head to form a closed-loop headband 118.

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

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

[0507] Preferably, the seal 114 and frame 116 include an alignment or keying arrangement such that the seal 114 and 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 configured to receive a key or protrusion (not shown) of the seal 114. The recess 7180 and the protrusion may 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 may also be reversed. Furthermore, other suitable arrangements may be used, such as a non-circular shape for the connector 7172 and the gas inlet orifice 7175. In some embodiments, the gas inlet orifice 7175 may have a generally D-shaped form, wherein the bottom portion of the gas inlet orifice 7175 is flattened or closer to the central point of the gas inlet orifice 7175 than the other portions of the gas inlet orifice 7175. Frame 116 may include a D-shaped seal connector 7172 that mates with a D-shaped gas inlet port 7175 to ensure proper alignment of seal 114 relative to frame 116 and to prevent rotation of the seal relative to the frame. The D-shaped or non-circular gas inlet port 7175 may also reduce the overall height of the breathing mask system 110, making the breathing mask system 110 less restrictive and more desirable.

[0508] exist Figure 58A In one embodiment, the gas inlet 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 7175a is between 28 and 34 mm. Figure 58B In one embodiment, the gas inlet orifice 7175b is generally circular in shape and has a diameter of approximately 26.5 mm, but the lower edge of the gas inlet orifice 7175b includes a truncated portion 7177 with a slightly reduced diameter. Figure 59B This truncated portion 7177 can provide the sealing connector discussed below. Figure 72 and 73 The truncated portion 7177 is a visual indication of the orientation of the gas inlet orifice 7175. It can be located at any one or both 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 one embodiment, the gas inlet orifice 7175c is generally circular in shape and has 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 and 32 mm.

[0509] The seal 114 has a hollow interior that is filled with air under positive pressure and is configured to seal below the user's nose, along a portion extending laterally to the nose along the face, 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 within the hollow interior of the seal 114 and adjacent to the rear wall 7202 of the seal 114. Figures 66A-66C Communication is established between the seal 114 and the front wall 7212 of the seal 114. A gas inlet 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 nose orifice 7128. In some configurations, the seal 114 may include a nose orifice 7128 defined within a superstructure, such as a nose pillow, fork, or the like. In some configurations, the nose orifice 7128 may be defined by a nose cushion or insert that may be overmolded or otherwise fixed to the base structure of the seal 114. Examples of suitable arrangements of the seal 114 are disclosed in the applicant's publication WO 2014 / 077708, the entire contents of which are incorporated herein by reference.

[0510] As discussed in detail below, seal 114 can be designed to have a low profile and maintain good sealing properties under positive pressures up to and including 18-20 mm H2O. The profile of seal 114 may be characterized by extending beyond the user's nose. In general, Figure 58C The seal 114 in the middle and Figure 58A The seal 114 in the middle has a lower profile compared to the other two. Figure 58B The profile of seal 114 is between Figure 58A and 58C The outline of the seal is in the middle.

[0511] Figures 59A-59C It shows Figures 58A-58C The front view of seal 114 is shown. Seal 114 may have a total height 7140 and a total width 7142, as shown. Figures 59A-59C As shown. Figure 60A-60C It shows Figures 59A-59C Left view of seal 114. Seal 114 may have a total depth of 7144, such as... Figure 60A-60CAs shown. In some embodiments, the profile of the seal 7144 can be reduced by decreasing one or more of the total height 7140, total width 7142, and / or total depth 7144 of the seal 114. While specific dimensions are discussed herein, the proportions of specific dimensions relative to each other are also considered to be within the scope of this disclosure. For example, disclosures of height and depth include disclosures of the height-to-depth ratio.

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

[0514] exist Figure 59C and 60C In the illustrated embodiment, the total height 7140c is 35.6 mm, the total width 7142c is 59.0 mm, and the total depth 7144c is 43.2 mm. In some configurations, the total height 7140c is between 30-40 mm, between 33-37 mm, or approximately 35 mm. In some configurations, the total width 7142c of the seal 114c is between 54-64 mm, between 57-61 mm, or approximately 59 mm. In some embodiments, the total 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 accommodate 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 accommodate nasal structures of different races (e.g., Caucasian, Asian, African American). The range of the total height 7140, width 7142, and depth 7144 described above can represent... Figures 59A-59C The medium size is shown in the different embodiments. For Figure 59C In the embodiment shown, the total width 7142c can range from approximately 45mm for a small size to approximately 80mm for a large size. Figure 59C The larger version in the embodiments can have the same Figure 59C The medium-sized ones shown are similar in height (7140c) and depth (7144c). In some variations, Figure 59C The larger and smaller versions of the embodiments in the example Figure 59C The medium size shown has a greater height of 7140c and / or a greater depth of 7144c compared to the standard size. Figure 59C The smaller number in the embodiment can be compared with Figure 59C The medium size shown has a similar width of 7142c. In some variations, it is... Figure 59C Compared to the medium size shown, the small size has a smaller width of 7142c, a height of 140c, and / or a depth of 7144c. Figure 59C The width of the embodiment can be between 70-80 mm, between 73-77 mm, or about 75 mm 7142c. Figure 59C The width of the embodiment can have the same as Figure 59C The medium-sized ones shown are similar to those with a larger height of 7140c and / or a depth of 7144c.

[0516] refer to Figure 60A-60C When the bottom wall of the seal 114 is horizontal, the highest point 7182 of the gas inlet 7175 can be positioned distal to the lowest point 7184 of the gas inlet 7175. As shown in the figure, a line passing through the highest point 7182 and the lowest point 7184 of the gas inlet 7175 can form an angle 7186 with a vertical line passing through the lowest point 7184. This angle 7186 can be referred to as the gas inlet angle 7186. Figure 60A In this embodiment, 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 this embodiment, 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 away from the lowest point 7184c.

[0517] In some configurations, the gas inlet angle 7186 can range from 5° to 30°, from 7° to 20°, or from 8° to 16°. In some variations, the gas inlet 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 rigidity of the seal 114. The volume within the hollow interior of the seal 114 can also be referred to as ineffective space. Reducing ineffective space can improve the flushing of exhaled air and carbon dioxide. The gas inlet angle 7186 can be selected to tilt the gas inlet port 7175 (and the gas delivery conduit protruding from the gas inlet port) toward the horizontal axis. Angles the gas delivery conduit protruding from the mask 112 toward the horizontal axis, allowing the gas delivery conduit 120 to be connected to the supply conduit 12 without using a bend connector. Angles the gas delivery conduit 120 toward the horizontal axis, reducing hose pull.

[0518] In addition to reducing the overall height 7140, width 7142, and depth 7144 of the seal 114, the profile of the seal 114 can also be reduced by changing the shape of the seal 114. Figures 61A-61C It shows Figures 58A-58C Rear view of seal 114 shown. (Reference) Figures 61A-61C ,and Figure 61A and 61B Compared to the rear surfaces 7202a and 7202b of the embodiments, Figure 61C The rear wall 7202c of the embodiment has a more triangular shape. For example... Figures 61A-61C As shown, the rearward protrusion of the rear wall 7202 can define a circumferential periphery surrounding the nasal opening 7128. This periphery can be referred to as the rear periphery. Figure 61C The seal 114 shown has the same Figure 61A The rear perimeter of the seal shown is smaller than that of the other seal. In some variations, the profile of seal 114 can be reduced by decreasing the rear perimeter of seal 114.

[0519] The nose opening 7128 of the seal 114 is disposed in the central portion of the rear wall 7202. The central portion of the rear wall 7202 is distal to the lateral portion of the rear wall 7202, thereby forming a nose recess 7214. In use, the nose recess 7214 receives the tip of the user's nose. The seal 114 has a bottom wall 7216 extending proximally upward to meet the rear wall 7202. Figure 61B and 61CIn one embodiment, 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 poorly 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 As shown. A well-defined shelf 7218 allows for a reduction in the volume of the hollow interior of the seal 114, thereby reducing the profile of the seal 114. The shelf 7218 also improves the stability of the seal 114, thereby allowing for a reduction in the size of the seal 114 while maintaining good performance of the seal 114 (e.g., sealing).

[0520] Figures 62A-62C It shows Figures 58A-58C A top view of the seal 114 shown. (Reference) Figures 62A-62C , Figure 62C The rear wall 7202c of the embodiment is compared to Figure 62A and 62B In the embodiment, the rear surfaces 7202a and 7202b extend further distally. When the seal 114 is viewed from the top, Figure 62C The orifice 7128c of the seal 114c shown is closer to the farthest side point 7230c of the seal 114c than to the nearest side point 7232c of the seal 114c. Figure 62A In the embodiment, the orifice 7128a is closer to the nearest side point 7232a of the seal 114a than to the farthest side point 7230a of the seal 114a. Figure 62A In the illustrated embodiment, with Figure 62B and 62C Compared to the front surfaces 7212b and 7212c of the seals 114b and 114c shown, the front wall 7212a opens more widely as it extends rearward. As the front surfaces 7212b and 7212c extend rearward, they maintain a parabolic shape and, in some configurations, can bend continuously in one direction without an inflection point. In contrast, the front wall 7212a of seal 114a has an inflection point 7201, such as... Figure 62A As indicated. In some configurations, the nearest point of the rear surface 7202c is located halfway down the seal 114c in the distal direction, or less than halfway down the distance from the farthest point 7230c to the nearest point 7232a in the longitudinal direction of the seal 114c. In some configurations, the nearest point of the rear surface 7202c is located at approximately 30-50% or approximately 40% of the distance from the farthest point 7230c to the nearest point 7232a.

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

[0522] Continue to refer to Figures 63A-63C The profile of the seal 114 can be lowered 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 embodiments, with Figure 63A and 63B Compared to the lateral portions of the embodiments of seals 114a and 114b shown, the lateral portion of seal 114c further inserts into the space between the user's cheek and nose. Additionally, or in an alternative, the lower portions of seals 114b and 114c are positioned closer to the user's face (e.g., upper lip) during use compared to the lower portion of seal 114a (where the lower portion of seal 114c is closer than the lower portion of seal 114b). This arrangement can provide an advantageous orientation or angle for the gas delivery tube or conduit and / or the frame or headgear. The orientation of the gas inlet 7175 can be characterized by angle 7240, also referred to as the usage angle 7240. The usage angle 7240 is the angle between a horizontal axis and a line orthogonal to a line extending between the highest point 7182 and the lowest point 7184 of the gas inlet 7175 when the nasal orifice 7128 is guided toward the user's nasal passage. Figure 63A In the embodiment of seal 114a, the angle 7240a is approximately 30.0°. In examples such as... Figure 63B and 63C In other arrangements, such as embodiments, angles 7240b and 7240c are used that are greater than about 35° or greater than about 40°. Figure 63B In this embodiment, angle 7240b is approximately 43.7°. Figure 63C In the embodiments described, the angle 7240c is approximately 45.6°. Due to the diversity of nasal shapes within human populations, the angle 7240 can vary significantly for a given seal. For example, the angle 7240 can vary from approximately 0° to approximately 70°. However, a relatively large angle 7240 may be advantageous to reduce the negative effects of hose pulling. In some variations, the angle 7240 can range from approximately 70° to approximately 90°.

[0523] Seal 114 may have an effective taper, which is defined as the depth 7144 of seal 114 when viewed from the side. Figure 60A-60C The ratio of the projected area of ​​the front wall 7212 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 be a line extending between the highest point 7182 and the lowest point 7184 of the gas inlet orifice 7175. Figure 63A In this embodiment, the effective taper has a value of approximately 0.37. Figure 63C In some embodiments, the effective taper has a value of approximately 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 The seal 114 may have a variable wall thickness. The thickened wall portion may be designed to provide a support structure that helps the seal 114 maintain contact with the user's skin during use. In some variations, the thickened wall portion helps the seal 114 resist deformation during use. The thickened wall portion may allow less material to be used to make the seal 114, thereby reducing the profile of the seal 114. The thickened wall portion may extend into the hollow interior of the seal. For example, the thickened wall portion may extend proximally from the front wall 7212 and / or distally from the rear wall 7202.

[0525] The seal 114 may include regions with varying thicknesses. For example, each lateral portion of the seal 114 may have a top region 7302, a rear region 7304, a front region 7306, and a central region 7308. Only one lateral portion has... Figure 11 The area is marked. The area on the other side may be a mirror image of the shown side. The rear area 7304 may have a greater thickness compared to the thickness of all other areas. The top area 7302 and / or the central area 7308 may have a smaller thickness compared to the thickness of all other areas. In the shown embodiment, the top area 7302 and the central area 7308 have a thickness of approximately 0.3 mm, the front area 7306 has a thickness of approximately 2.6 mm, and the rear area 7304 has a thickness of approximately 3.9 mm.

[0526] Figure 65A and 65B It shows Figure 58C The thickened wall portion or area of ​​the embodiment of the seal 114c shown. Figure 65A and 65B The area shown can be compared with Figure 64 The areas shown are the same or similar. The thickened wall portion extends into the hollow interior of seal 114c. Figure 65AFor clarity, the profile of seal 114c is shown. The top region 7302c and 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 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 nearest side 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 of the seal 114a shown, Figure 58C The thickness of the thickened wall portion in the illustrated seal 114c has been reduced. Reducing the thickness of the wall portion helps to reduce the weight and / or rigidity of the seal 114. The thickness of the thickened wall portion can be increased to increase rigidity and friction between the seal 114 and the frame 116. In some variations, the thickness of the thickened wall portion is increased to increase the vertical stability of the seal 114.

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

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

[0531] Continue to refer to Figures 67A-67C The rear wall 7202 may have a thickened portion 7330 surrounding the nose opening 7128. The thickened portion 7330 may extend distally from the distally facing surface of the rear wall 7202 and may have a maximum thickness 7332. The thickened portion 7330 may be adapted to prevent edge deformation (e.g., "blow-out") of the opening 7128 when the seal 114 is under pressure during use. Deformation of the opening 7128 can reduce the effectiveness of the seal 114 and increase user discomfort. The thickened portion 7330 can improve the effectiveness of the seal 114.

[0532] Figure 67A The seal 114a has an elliptical, gasket-like thickened portion 7330a. The thickened portion 7330a has a maximum thickness of approximately 1.5 mm 7332a. As the thickened portion 7330a extends away from the nose opening 7128, the thickened portion gradually tapers. Figure 67B The seal 114b in the middle has a similar Figure 67A The thickened portion 7330a of the seal 114a shown is similar to the thickened portion 7330b.

[0533] refer to Figure 68The seal 114b may include a thickened ridge 7340 extending distally about 1.0 mm from the distally facing surface of the rear wall 7202b. The ridge 7340 may be positioned at the interface between the thickened portion 7330b and the top region 7302b of the seal 114b. In some variations, the ridge 7340 reinforces the seal 114b to prevent it from wrinkling as air pressure increases within its hollow interior. In some embodiments, the thickened portion 7330 may contribute to some distortion of the seal when it bulges. The ridge 7340 may allow the seal 114b to bulge smoothly. In some embodiments, the seal 114b with the thickened portion 7330 may bulge smoothly without the ridge 7340. In some variations, the seal 114c, which has a thickened portion 7330c that closely matches the nose opening 7128, can bulge smoothly without the seal 114c having a raised ridge 7340.

[0534] Figure 69 Showing more details Figure 68 The thickened portion 7330b of the seal 114b. The thickened portion 7330b extends a maximum distance 7334b of approximately 7.9 mm from the edge of the nose opening 7128. The thickened portion extends a maximum thickness 7332b of approximately 1.5 mm from the distal surface of the rear wall 7202.

[0535] Figure 70 It shows Figure 67C A detailed front view of the thickened portion 7330c of the seal 114c shown. The thickened portion 7330c is... Figure 67A and 67B The thickened portions 7330a and 7330b shown fit more closely to the periphery of the nose 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 does not directly contact 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 for a reduction in the area of ​​the nasal orifice 7128 without the user perceiving a restriction on flow through the orifice 7128. Reference Figures 71A-71CThe area of ​​the nasal opening 7128 can be evaluated by comparing the area of ​​the rearward protrusion of the nasal opening 7128. The rearward protrusion of the nasal opening 7128 may have a minimum height 7342, a maximum height 7344, and a total width 7346. Figure 71A The seal 144a has a minimum height 7342a of about 4.0 mm, a maximum height 7344a of about 12.0 mm, and a total width 7346a of about 18.8 mm. Figure 71B The seal 144b has a minimum height 7342b of about 4.0 mm, a maximum height 7344b of about 11.0 mm, and a total width 7346b of about 17.1 mm. Figure 71C The seal 144c has a minimum height 7342c of approximately 4.5 mm, a maximum height 7344c of approximately 11.0 mm, and a total width 7346c of approximately 16.9 mm. In some variations, each of these minimum height 7342, maximum height 7344, and total width 7346 may be increased or decreased by at least 20%.

[0537] Compare Figures 71A-71C Another way to reduce the size of the nose opening 7128 of the seal 114 shown is by comparison. Figure 71A The aperture 7128a shown is... Figure 71C The surface area variation between the orifices 7128c is shown. The surface area of ​​orifice 7128 can be measured along the curved surface of the nose recess 7214 to obtain a more accurate measurement result compared to that obtained from the 2D rearward protrusion data discussed above. For the seal 114a in 71A, the surface area of ​​orifice 7128a along the curved surface of nose recess 7214a is approximately 161 mm. 2 For seal 114c in 71C, the surface area of ​​the orifice 7128c along the curved surface of the nose recess 7214c is approximately 141 mm. 2 In some configurations, the surface area of ​​orifice 7128 is less than or equal to approximately 160 mm². 2 Less than or equal to approximately 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 permanently integrated with the seal 114 (e.g., the seal 114 is overmolded over the connector 7222 portion of the frame 116). In some embodiments, the connector 7222 includes a clamping portion that allows connection to another frame 116 or to a 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 flange 7224 and the rear flange 7226. The connector 7222 may be configured to capture a portion of the seal 114 between the front flange 7224 and the rear flange 7226. In some embodiments, connector 7222 is overmolded onto seal 114. In some embodiments, seal 114 is overmolded onto connector 7222. In some configurations, front flange 7224 can be connected to rear flange 7226 via a snap-fit ​​arrangement, which can be a permanent or removable connection.

[0539] When connector 7222 is assembled onto seal 114, rear flange 7226 is positioned within seal 114, and hub portion 7228 extends through gas inlet orifice 7175 of seal 114. Front flange 7224 of connector 7222 is positioned on the outside of seal 114. Seal 114 may include an annular edge surrounding gas inlet orifice 7175 and configured to be captured by front flange 7224 and rear flange 7226 of connector 7222.

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

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

[0542] Figure 74 Another embodiment of seal 114d is shown, which is similar to seals 114, 144a, 114b, and 114c, except as described below differently. Features of seal 114d may be combined with or included in seal 114 or any other embodiment discussed herein. The illustrated embodiment has a connector 7222d attached to seal 114d. Connector 7222d is similar to connector 7222, except as described below differently. As discussed, connector 7222d has side arms 7252d that extend laterally proximal to the 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 is blue in color and 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 for the user. In some embodiments, coloring is intended to be used as an indication of the component within 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 connector 7222e attached to seal 114e is shown. Seal 114e is similar to seal 114 or any other embodiment discussed herein, except as described differently below. Connector 7222e is similar to connector 7222 or any other embodiment discussed herein, except as described differently below. Features of seal 114e and connector 7222e may be combined with or included therein with 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 may laterally and / or distally project beyond the front wall 7212e of seal 114e. In some embodiments, at least a portion of the front wall 7212e of seal 114e may laterally and / or distally project beyond the front wall 7254e of connector 7222e.

[0544] As discussed above, seals 114 can be made in different sizes to allow at least one of seals 114 to fit a wider variety of nose structures. For example, seals 114 can be made in four different sizes: small, medium, large, and wide. The four sizes of seals 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 seals 114 to be feasible for most or most of the population. Seals 114 can be made in more than four different sizes (e.g., extra-large, medium-wide, extra-small).

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

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

[0547] like Figure 76A As shown, the seal 114e may be symmetrical with respect to the vertical axis 7256. The vertical axis 7256 passes through the centerline of the seal 114e and is aligned with a longitudinally bisecting plane extending from the front of the seal to the rear of the seal 114e. As discussed above, the front wall 7212e of the seal 114e may have a recessed portion 7258e. The recessed portion 7258e may be configured to receive a portion of the connector 7222e. For example, the recessed portion 7258e may receive the front flange 7224 of the connector 7222. Reference Figures 76A-76B Seal 114e can have the same characteristics as the above-mentioned seals. Figures 59A-59C The seals 114a-114c shown describe similar total height 7140e, total width 7142e, and total depth 7144e. Table 1 below shows examples of approximate dimensions of the total height 7140, total width 7142, and total depth 7144 for 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 may be ±10% of the dimensions listed in Table 1. This disclosure includes ratios that can be derived from the dimensions disclosed herein. For example, this disclosure includes not only the disclosed total width of the small and large seals, but also the ratio of the width of the small seal to the width of the large seal, and any other ratios that can be derived from the dimensions disclosed herein.

[0548] Table 1. Approximate dimensions of small, medium, large, and wide-size seals.

[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 size 38.0 72.0 43.9

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

[0551] Figure 77 It shows Figure 76A The perspective view of the center seal 114e shown. Figure 78 A perspective view of an embodiment of the wide-code seal 114f is shown. Figure 77 and 78As shown, the recessed portion 7258e of the middle code seal 114e is more blunt compared to the recessed portion 7258f of the wide code seal. For example, in the illustrated embodiment, the recessed portions 7258e and 7258f of the middle code seal 114e and the wide code seal 114f can be described as having a height dimension measured parallel to the vertical axis 7256. Compared to the height dimension of the middle code seal 114e, the height dimension of the wide code seal 114f decreases more slowly towards the lateral surfaces 7260e and 7260f of the recessed portions 7258e and 7258f.

[0552] Figures 79A-79B yes Figure 77 The left and right views of the center seal 114e are shown. (Reference) 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 inlet orifice 7175e when the vertical axis 7256 and the bottom wall 7216e are aligned to be approximately horizontal (as described above regarding...). Figure 60A-60C (As described). Because the bottom wall 7216e is curved, the entire bottom wall 7216e is not horizontally aligned, nor is the entire front portion of the bottom wall 7216e. In the illustrated embodiment, the gas inlet angle 186e is 14.0°. In some embodiments, the gas inlet angle 7186e can be an angle other than 14.0°. The distal displacement 7261e of the front wall can be defined as the distance between the farthest point of the seal 114e (corresponding to the highest point 7182e in the illustrated arrangement) and the vertical axis 7256. In the illustrated embodiment, the distal displacement 7261e of the front wall is 7.9 mm. In some embodiments, the distal displacement 7261e of the front wall can be a value other than 7.9 mm. Orienting the gas inlet orifice 7175 downward helps resist hose drag during use of the seal 114. For example, aligning the gas inlet orifice 7175 downward can reduce drag from the gas delivery conduit 120 attached to the seal 114.

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

[0554] Table 2 shows a comparison of the approximate vertical distance 7262 for seals 114 of different sizes (e.g., small, medium, large, wide). In some embodiments, the variation in one or more of the dimensions of seals 114 can be ±10% of the dimensions listed in Table 2. As discussed above, this disclosure includes ratios that can be derived from the dimensions disclosed herein. As shown in Table 1 above, due to the anthropometric dataset applied, a medium-sized seal 114 may have a slightly smaller vertical distance 7262 compared to a small-sized seal 114.

[0555] Table 2. Approximate front wall displacement for small, medium, large, and wide-size seals.

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

[0557] Figure 80 A side view of the seal 114e, positioned on the user's face during use, is depicted. (As described above regarding...) Figures 63A-63C As described, the orientation of the gas inlet port 7175e can be characterized by the use angle 7240e. The use angle 7240e characterizes the angle at which the seal 114 sits on the user's nose relative to the lateral plane of the user's head. In the illustrated embodiment, the use angle 7240e is approximately 45°. In other embodiments, the gas inlet port 7175e may be in a different orientation. In some variations, the orientation of the gas inlet port 7175e may depend on the size and physical characteristics of the user's nose.

[0558] Figure 81 It shows Figure 76A The front view of the seal 114e shown. Figure 81 The orientation of the front view shown is different Figure 76A The front view of seal 114e shown is because Figure 81 The view shown is aligned with a plane perpendicular to the axial direction of the gas inlet orifice 7175e. As discussed in detail below, the seal 114e may include a connector engagement structure or connector retention structure 7262e surrounding the gas inlet orifice 7175e. Other embodiments of the seal 114 disclosed herein may also include a connector retention structure 7262 similar to the connector retention structure 7262e described below. The connector retention structure 7262e defines the gas inlet orifice 7175e and provides a way to allow the connector 7222 (in) Figure 72 (As shown in the figure) the structure connected to the body of the seal 114.

[0559] The gas inlet 7175e may include a truncated portion 7177e, as per [reference to...] Figure 59B and 59CAs described. The 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 may be positioned on the top edge of the connector retaining structure 7262e, on any one or two of the lateral edges of the connector retaining structure 7262e, or any combination thereof.

[0560] Because the connector retains the truncated portion 7177e of structure 7262e, the gas inlet port 7175e can have a vertical dimension 7264e that differs from the lateral dimension 7266e of the gas inlet port 7175e. For example, in Figure 81 In this embodiment, the truncated portion 7177e is positioned on the bottom edge of the connector retaining structure 7262e, such that the vertical dimension 7264e of the gas inlet 7175e is smaller than the lateral dimension 7266e of the gas inlet 7175e. In the illustrated embodiment, the gas inlet 7175e has a vertical dimension 7264e of 26.5 mm and a lateral dimension 7266e of 31.17 mm. However, these dimensions are illustrative only 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 areas with different thicknesses, as described above. Figure 64 As described. Figure 82A An isometric view of seal 114e is shown. Figure 82B As shown, seal 114e may have a top region 7268e, a core region 7270e, and an intermediate region 7272e disposed between the top region 7268e and the core region 7270e. The top region 7268e of seal 114e may have a thickness of approximately 0.3 mm. In the illustrated embodiment, the thickness of the top region 7268e is different from that of other embodiments of seal 114 (e.g., Figure 64 The thickness of the seal 114e is reduced compared to that of the previous seal 114e. 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 114e on the user's face when the seal 114e is in use.

[0562] Continue to refer to Figure 82BThe thickness of the intermediate region 7272e can be non-constant. In some embodiments, the thickness of the intermediate region 7272e can increase non-linearly as the seal 114e traverses laterally along the intermediate 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. In the illustrated embodiment, the thickness of the intermediate 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 intermediate region 7272e can simply vary between approximately 0.3 mm and approximately 3.8 mm at different locations along the contour of the intermediate 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 orthogonal to the surface of seal 114e. In some embodiments, the variation of one or more of the thicknesses described above may be ±10% of these stated values.

[0563] Figure 83 A left-side view of a cross-section of the lateral portion of seal 114e is shown. Figure 83 In the image, the front portion of seal 114e is shown in light shading to indicate the position of the selected section relative to the remaining portion of seal 114e. Figure 83 The inner surface 7274e of the front wall 7212e of the seal 114e is shown. The inner surface 7274e faces the hollow interior space of the seal 7114e. The varying 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 in use, as discussed below. The thinner regions of the seal 114e allow the seal 114e to deform when a better fit to the user's nose is required. The thicker regions of the seal 114e provide and transmit reinforcing forces that keep the seal 114e from being blown open when the seal 114e is under pressure during use.

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

[0565] Figure 85A front view of the inner surface of the rear wall of seal 114e is shown. In the illustrated embodiment, the thickened portion 7330e closely conforms to the contour line of the nose orifice 7128e at its lateral edge and extends further away from the nose orifice 7128e at its central portion. As discussed above, the thickened portion 7330e helps prevent seal 114e from being blown open when it is under pressure during use.

[0566] review Figure 84 The thickened portion 7330e in the illustrated embodiment has a maximum thickness of 1.8 mm and is located on the central axis of the seal 114e, immediately adjacent to the nose 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 maximum thickness of the adjacent portion of the rear wall 7202e can be 1.8:0.3 or 6:1.

[0567] Continue to refer to 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 with relatively high thickness adjacent to the connector retaining structure 7262e. As discussed below, at least a portion of the central portion 7284e may be characterized by a region with relatively low thickness. The region of the central portion 7284e characterized by a region with relatively low thickness is referred to herein as the subnasal window 7285e (in...). Figure 87 (As shown in the diagram). The rear portion 7282e is characterized by a region having a relatively high thickness relative to the central portion 7284e. In the illustrated embodiment, the rear portion 7282e forms a significant difference between the bottom wall 7216e and the rear wall 7202e. In the illustrated embodiment, the front portion 7280e has a thickness of 2.7 mm, the central portion 7284e has a thickness of 0.3 mm, and the rear portion 7282e has a thickness of 2.7 mm, wherein the thickness is measured along a direction orthogonal to the outer surface of the bottom wall 7216e. In some embodiments, the variation of one or more of the aforementioned thicknesses can be ±10% of these stated values.

[0568] The infranasal window 7285e of the central part 7284e (in) Figure 87(As shown in the diagram) can be described as a recessed surface on the inner surface of the bottom wall 7216e. In some embodiments, the central portion 7284e may include a band with a reduced thickness along a portion of the surface of the bottom wall 7216e facing the hollow interior of the seal 114e. In the illustrated embodiment, the central portion 7284e is recessed by 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 may be recessed by a constant dimension relative to the front portion 7280e and the rear portion 7282e.

[0569] Reducing the thickness of the central portion 7284e improves the comfort of the seal 114e over extended use. A problem some nasal seal designs, or that some users may experience, is subnasal discomfort after prolonged use. It has been found that reducing the thickness of the central portion 7284e of the bottom wall 7216e improves the comfort of the seal 114. As mentioned, reducing the thickness of the central portion 7284e creates a subnasal window 7285e between the thickened front portion 7280e and the rear portion 7282e of the bottom wall 7216e. The subnasal window 7285e allows for reinforced 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 the rear portion 7282e of the bottom wall 7216e increases the structural integrity of the seal 114e and allows for a near-airtight seal 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 the area under the nose.

[0570] In some variations, the degree of concavity in the central portion 7284e can vary. For example, the central portion 7284e may be concave to the greatest extent at the central axis (in... Figure 84 (As shown in the cross-section) and with a minimum amount of recess at the lateral end of the central portion 7284e. In some embodiments, the central portion 7284e may include a combination of adjacent regions with increasing or decreasing thickness, thereby forming multiple regions recessed to different degrees relative to the front portion 7280e and the rear portion 7282e. The boundaries between these adjacent regions may resemble a step function (e.g., a sudden change in thickness). The boundaries between these adjacent regions may be smooth curves that transition from one recess level to another in a continuous manner. In some embodiments, the central portion 7284e may have undulating thickness as it extends laterally away from the central axis. For example, the central portion 7284e may include multiple raised ridges extending laterally away from each other parallel to each other.

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

[0572] Figure 87 It shows Figure 76A The image shows a top view of a cross-section of the seal 114e. This top view is taken along a plane perpendicular to the longitudinal dividing plane. Therefore, the surface of the bottom wall 7216e facing the hollow interior of the seal 114e is... Figure 87 The center is visible. As shown, the subnasal window 7285e may have a first width 7290e, which is a measurement of the length of the subnasal window 7285e intersecting with the proximal axis 7292, which extends along the centerline of the seal 114e from the front wall 7212e to the rear wall 7202e. Figure 87 As shown, reference line 7296e can be defined as orthogonal to the proximal axis 7292 and passing through the last lateral point of the subnasal window 7285e located on the proximal axis 7292. The subnasal window 7285e can have a second width 7294e, which is a measurement of the width of the subnasal window 7285e at its most lateral point on reference line 7296e, wherein the second width 7294e is aligned to span the subnasal window 7285e by the shortest possible distance, such as... 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 the medium-sized 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 may be the maximum width of the subnasal window 7285e. As discussed, the second width 7294e may be measured at a point where the subnasal window 7285e is laterally displaced from the proximal axis 7292. In some embodiments, the subnasal window 7285e may maintain approximately the same width as it extends laterally away from the proximal axis 7292.

[0574] Figure 88 A bottom view of an embodiment of seal 114h is shown, which is similar to seal 114 or any other embodiment discussed herein, except as described differently below. The illustrated embodiment is wide-code seal 114h. Figure 88 In the seal 114h shown, the subnasal window 7285h spans the bottom wall 7216h of the seal 114h. This is compared to the subnasal window 7285, which only partially spans the length of the bottom wall 7216 (e.g., Figure 87 As shown in the diagram (subnasal window 7285e), extending the subnasal window 7285h across the entire length of the bottom wall 7216h can be beneficial, because a subnasal window 7285h with a longer lateral profile allows for a longer length of the seal 114h to be compressed during use. Therefore, this can help to further reduce potential subnasal discomfort.

[0575] Figure 89 A top view of a cross-section of an embodiment of the wide-code seal 114i is shown. This top view is taken along a plane perpendicular to the longitudinal dividing plane. Therefore, the surface of the bottom wall 7216i facing the hollow interior of the seal 114i is... Figure 89 It is visible in the middle. Figure 89 The first width 7290i of the seal 114i shown is greater than Figure 87 The seal 114e shown has a first width 7290e. In the illustrated embodiment, the first width 7290e can be approximately 6.9 mm. Figure 89As shown, the subnose window 7285i spans the length of the bottom wall 7216i. Except as described differently below, the seal 114i is similar to seal 114e or any other embodiment discussed herein. Features of seal 114i may be combined with or included therein with seal 114e or any other embodiment discussed herein. Therefore, the subnose window 7285i may have similar absolute dimensions and / or proportions and / or configurations as described with respect to subnose window 7285e or any other embodiment discussed herein.

[0576] Figure 90 A rear perspective view of an embodiment of the center seal 114j is shown. Figure 90 The subnasal window 7285j shown is... Figure 89 The similarity of the illustrated subnasal window 7285h is 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 region located between the front wall 7212j and the rear wall 7202j of the seal 114j. Therefore, the subnasal window 7285j can be said to extend laterally beyond the bottom wall 7216j, which is strictly speaking the seal 114j.

[0577] Figure 91 A top view of a cross-section of an embodiment of seal 114k is shown. This top view is taken along a plane substantially perpendicular to the longitudinal bisecting plane. Therefore, the surface of the bottom wall 7216k facing the hollow interior of seal 114i is... Figure 91The central portion 7284k is visible. In the illustrated embodiment, the central portion 7284k includes three subnasal windows 7285k characterized by a reduced wall thickness of the bottom wall 7216k of the seal 114k. In the illustrated embodiment, these three subnasal windows 7285k are separated by two struts 7287k characterized by regions 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 regions with reduced thickness) can compress, thereby reducing the pressure imposed on the user's upper lip. The struts 7287k (i.e., the thickened portions) can improve the ability of the seal 114k to maintain its shape when deformed around the user's nose in a distal to proximal direction. In the illustrated embodiment, the struts 7287k have the same wall thickness as the adjacent front portion 7280k and rear portion 7282k. In some embodiments, the strut 7287k may have a wall thickness different from that of the adjacent front portion 7280k and rear portion 7282k. For example, the strut 7287k may have a wall thickness greater than or less than that of the adjacent front portion 7280k and rear portion 7282k. In some embodiments, the wall thickness of the subnasal window 7285k may vary across the subnasal window 7285k. For example, the wall thickness of the subnasal window 7285k may gradually increase along the length of the subnasal window 7285k, such that the region of the subnasal window 7285k adjacent to the strut 7287k has the same wall thickness as the strut 7287k. Therefore, as Figure 91 As shown in the embodiments, the transition in wall thickness between the subnasal window 7285k and the strut 7287k can be gradual rather than step-like along the length of the bottom wall 7216k. The illustrated embodiment has three subnasal windows 7285k. However, some embodiments may have four or more subnasal windows 7285k. Addi...

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