Face mask system

Abstract

This invention discloses a nasal mask system. A nasal mask defines a breathing chamber for supplying positive pressure gas into a patient's airway, including sidewalls and a liner positioned posteriorly adjacent to the sidewalls. The posterior sealing surface of the liner has a contour with a concave curvature in the top lip region to have a shape complementary to the top lip region. The contour of the posterior surface of the liner is configured to extend from the bridge of the nose region to the respective left and right nasal corner regions along the corresponding left and right sides of the nose during use, and is adapted to extend from the left side of the nose to the right side of the nose along the top lip. The liner includes a relatively thick auxiliary band formed of an elastic flexible material and extending from the sidewalls to form corresponding cantilevered sections in the top lip region, corner region, and nasal side region of the liner. The top lip region cantilever has a C-shaped cross-section. It also includes a relatively thin facial flap that curves inward and extends along the periphery of the liner to define the posterior sealing surface of the liner, the inner edge of which defines an opening through which the patient's nose portion passes during use.

Description

[0001] This application is a divisional application of patent application No. 201910270973.X, filed on May 28, 2010, entitled "Nose Mask System". Application No. 201910270973.X is a divisional application of patent application No. 201610243366.0, filed on May 28, 2010 (divisional filing date April 18, 2016), entitled "Nose Mask System". This application is a divisional application of patent application No. 201080033786.7 (international application No. PCT / AU2010 / 000657), filed on May 28, 2010, entitled "Nose Mask System".

[0002] Cross-references to related applications

[0003] This application claims U.S. Provisional Application No. 61 / 213,326, filed May 29, 2009; U.S. Provisional Application No. 61 / 222,711, filed July 2, 2009; U.S. Provisional Application No. 61 / 272,162, filed August 25, 2009; U.S. Provisional Application No. 61 / 272,250, filed September 4, 2009; and U.S. Provisional Application No. 61 / 272,250, filed November 20, 2009. The entire contents of the following applications are incorporated herein by reference: U.S. Provisional Application No. 61 / 263,175, U.S. Provisional Application No. 61 / 282,693, filed March 18, 2010; Australian Provisional Application No. 2009902524, filed June 2, 2009; and Australian Provisional Application No. 2009906101, filed December 15, 2009. The entire contents of Australian Provisional Application No. 28, 2010 (application number unknown – attorney reference C10110) are also incorporated herein by reference. Technical Field

[0004] This invention relates to nasal mask systems for therapeutic purposes, such as treating sleep apnea (SDB) by continuous positive ventilation pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV). Background Technology

[0005] In the treatment of sleep-disordered breathing (SDB), patient interfaces such as full-face masks or nasal mask systems, used in conjunction with blowers and fluid generators, typically include a soft, padded face contact area and a rigid or semi-rigid housing or frame. During use, the interface is held in a sealed position by a headband, enabling the delivery of a positive pressure (e.g., 2 cm to 30 cm H2O) air supply into the patient's airway.

[0006] One factor that influences treatment efficacy and patient adherence is comfort and the appropriateness of the patient interface.

[0007] This invention provides optional mask system configurations that can improve treatment efficacy and patient compliance. Summary of the Invention

[0008] One aspect of this technology is to provide a simple and unobstructed face mask system. Another aspect is a face mask system capable of accommodating a wide range of facial shapes, including those with high and low nasal bridges, as well as narrow and wide noses. Yet another aspect is a face mask system with a wide range of wearing options.

[0009] A face mask according to this technology can adapt to the relative effects of varying sealing forces depending on the size and shape of the wearer's face and nose. In one construction, the tension can be increased by outwardly expanding the base pad.

[0010] One aspect of this technology is a mask pad that provides an upper seal in the nasal region, roughly adjacent to the junction of bone and cartilage, for users with a certain range of larger noses, while avoiding visual impact for users with smaller noses.

[0011] Another aspect of this technology is a mask pad that includes a thicker base pad or auxiliary band for supporting a thinner diaphragm or facial flap. In one configuration, the pad has a base pad or auxiliary band that is relatively less rigid in the upper lip region than in the nasal corner region, in a direction perpendicular to the user's facial plane. In one configuration, the pad has no base pad or auxiliary band in the bridge of the nose region. In one configuration, the base pad or auxiliary band directs the sealing force toward the nasal side in the bridge of the nose region. In one configuration, the pad is constructed and configured such that when used by a user with a relatively high nasal bridge, the sides of the pad in the bridge of the nose region are pulled inward, and the force on the nasal side increases. In one configuration, when used by a user with a relatively low nasal bridge, the sides of the pad in the bridge of the nose region are flared outward. In one configuration, the base pad is constructed and configured in a curved shape. In one configuration, the base pad has a C-shaped or sickle-shaped cross-section.

[0012] In one configuration, the sealing surface of the gasket according to the present invention has a non-sticky surface. In one configuration, the sealing surface of the gasket according to the present invention has a non-polished surface. In one configuration, the sealing surface of the gasket according to the present invention has a frosted polished surface.

[0013] A liner according to this technology is suitable for forming a seal around a patient's nose, including a seal in the bridge of the nose area. The bridge of the nose area is a region of significant variation between different patients compared to other areas of the nose. Another area of ​​potential variation between different facial features is the angle of the forehead relative to the facial plane.

[0014] To accommodate a wide range of facial shapes, a series of masks in different sizes and shapes can be constructed. However, this would be very expensive. According to this technology, a pad angle adjustment device can be provided for the mask system to facilitate the rotation or orientation of the pad relative to the facial plane. In this way, a given mask system can be adapted to fit a wider range of patients.

[0015] The pad size and shape can be configured to fit a wide range of different facial shapes.

[0016] One aspect of the invention relates to a face mask system comprising: a frame adapted to connect a headband; a sealing device detachably connected to the frame; and a bend disposed on the sealing device and adapted to connect to an air delivery tube providing breathable gas to a patient. The sealing device defines a breathing chamber and is adapted to form a seal with the patient's face. The sealing device includes a structure that establishes a rigid connection with the frame and the bend.

[0017] Another aspect of the invention relates to a face mask system comprising: a frame and a sealing device disposed on the frame. The sealing device includes a silicone liner and a foam liner disposed on the silicone liner. The silicone liner defines a breathing chamber, and the foam liner is supported by the silicone liner, thus there is no communication between the foam liner and the breathing chamber. The foam liner supports the sealing device on the frame.

[0018] Another aspect of the invention relates to a face mask system comprising: a frame adapted to connect a headband; and a sealing device detachably connected to the frame. The sealing device defines a breathing chamber and is adapted to form a seal with a patient's face. The sealing device includes one or more protrusions adapted to interlock with corresponding openings on the frame and provide visual reinforcement of the established connection.

[0019] Another aspect of the invention relates to a sealing device for a mask system, comprising: a sidewall defining a breathing chamber; a base liner that bends outward from the sidewall and away from the breathing chamber; and a diaphragm that at least partially covers the base liner. The diaphragm extends from the base liner and bends inward into the breathing chamber.

[0020] Another aspect of the invention relates to a face mask system comprising: a frame; a sealing device detachably connected to the frame; a bend disposed on the sealing device and adapted to be connected to an air delivery tube providing breathable gas to a patient; and a forehead support disposed on the frame. The sealing device defines a breathing chamber and is adapted to form a seal with the patient's face. The forehead support includes an elongated arm adapted to extend from the frame and an upper headband connector adapted to connect to an upper headband strap. At least a portion of the arm may be made of metal.

[0021] Another aspect of the invention relates to a vent assembly for venting gas from a face mask, comprising at least two vent arrays and a connecting structure capable of engaging the at least two vent arrays together. Each of the at least two vent arrays includes at least one vent configured to vent gas from the face mask. The connecting structure has a first position and a second position, in which the at least two vent arrays are configured to be offset by an angle from the at least two vent arrays present in the first position.

[0022] Another aspect of the invention relates to a method of manufacturing a face mask, comprising: molding a vent structure, inserting the vent structure into a mold of a face mask component, and then molding the face mask component onto the vent structure, wherein molding the face mask component aligns with the vent structure to create an airflow channel that reduces interference with exhaust airflow during use.

[0023] Another aspect of the invention relates to a nasal mask that defines a breathing chamber for delivering a positive pressure gas supply into a patient's airway. The nasal mask includes sidewalls and a pad located posteriorly to the sidewalls. The rear sealing surface of the pad has a contour with a concave curvature in the top lip region to have a shape complementary to the user's top lip region. The contour of the rear surface of the pad is constructed and configured such that, in use, it extends along the respective left and right sides of the nose from the bridge of the nose region adjacent to the user's nasal bone and cartilage junction to the respective left and right nasal corner regions adjacent to the user's left and right nasolabial boundaries. The contour of the rear sealing surface of the pad is further adapted to extend along the user's top lip from the left side of the nose to the right side of the nose. The pad includes relatively thick auxiliary bands made of an elastic, flexible material and extending from the sidewalls to form respective cantilevered sections in the top lip region, corner region, and nasal side region of the pad. Each cantilever has a length and thickness, and the cantilever defines the rigidity of the respective lip region, corner region, and nasal side region. In a direction perpendicular to the facial plane, the corner cantilever is more rigid than the top lip cantilever. The pad further comprises a relatively thin facial flap. The facial flap curves inward and extends along the periphery of the pad to define the posterior sealing surface of the pad. The inner edge of the facial flap defines an orifice through which the patient's nose portion passes during use.

[0024] Another aspect of the invention relates to a nasal mask defining a breathing chamber for delivering a positive pressure gas supply into a patient's airway. The nasal mask includes sidewalls and a pad positioned adjacent to the sidewalls at the rear of the nasal mask. The rear sealing surface of the pad has a profile in the top lip region, the profile being concave to have a shape complementary to the user's top lip region. The profile of the rear surface of the pad is constructed and configured to extend, in use, along the respective left and right sides of the nose from the user's bridge of the nose region to the respective left and right nasal corner regions. The profile of the rear sealing surface of the pad is further adapted to extend along the user's top lip from the left side of the nose to the right side of the nose. The pad includes a relatively thick auxiliary band made of an elastic, flexible material and extending from the sidewalls to form respective cantilevered sections in the top lip region, corner region, and nasal side region of the pad. The cantilevered section in the top lip region has a C-shaped cross-section. The pad further includes a relatively thin facial flap. The facial flap is curved inward and extends along the periphery of the pad to define the rear sealing surface of the pad. The inner edge of the facial flap defines the opening through which the patient's nose portion passes during use.

[0025] Another aspect of the invention relates to a nasal mask defining a breathing chamber for delivering a positive pressure gas supply into a patient's airway. The nasal mask includes sidewalls and a pad located posteriorly to the sidewalls. The rear sealing surface of the pad has a contour with a concave curvature in the top lip region to have a shape complementary to the user's top lip region. The contour of the rear surface of the pad is constructed and configured to extend, in use, along the respective left and right sides of the nose, from the user's bridge of the nose region to the respective left and right nasal corner regions. The contour of the rear sealing surface of the pad is further adapted to extend along the user's top lip from the left side of the nose to the right side of the nose. The pad includes a relatively thin facial flap. The facial flap is curved inward and extends along the periphery of the pad to define the rear sealing surface of the pad. The inner edge of the facial flap defines an opening through which the patient's nose portion passes during use. The pad further includes relatively thick auxiliary bands made of an elastic, flexible material and extending from the sidewalls to form respective cantilevered sections in the top lip region, corner region, and nasal side region of the pad. The length of the nasal side cantilever is greater than the length of the corner cantilever, and the nasal side cantilever is constructed and configured to provide a force in a direction approximately perpendicular to the nasal side.

[0026] In one configuration, the padding and the mask body are integrally molded. Preferably, the padding and adjacent sidewalls are integrally molded. This configuration allows for more controllable and comfortable bending of the base padding.

[0027] Another aspect of the invention relates to a nasal pad for a mask system. The nasal pad includes: a sidewall defining a breathing chamber; a base pad extending from the sidewall; and a septum at least partially covering the base pad. In use, the septum is adapted to seal along the bridge of the nose, sides of the nose, corners of the nose, and upper lip of the patient's face. The base pad is disposed only along the sides of the nasal pad, corners of the nose, and upper lip region. The base pad includes a flap or extension in each side of the nasal pad region, the side of the nasal pad being wider than the other regions and adapted in use to engage and apply force to the patient's nose.

[0028] Another aspect of the invention relates to a nose pad for a face mask system. The nose pad includes a pad perimeter providing multiple regions. Specifically, each region is configured to seal along or around the nose, and each region has the characteristics of at least partially defining the sealing force, stability, force distribution, comfort, and / or wearing range provided by the pad.

[0029] Another aspect of the invention relates to a forehead support for a respiratory mask, comprising: a forehead support arm configured to extend from a frame; and a forehead support pad disposed on the arm. The forehead support pad includes an upper headband connector adapted to engage an upper headband strap and a flexible region. The upper headband connector is made of a first material, and the flexible region is made of a second material that is more flexible than the first material, thereby allowing adjustment of the distance between the forehead support pad and the patient's forehead during use.

[0030] Another aspect of the invention relates to a headband connector for a breathing mask, comprising: a frame connection portion configured to extend from a frame; and a connector disposed on the frame connection portion. The frame connection portion is made of a more rigid material to maintain the shape of the connector and transmit headband tension to the mask; and the connector is made of a more flexible material to facilitate engagement and disengagement of the headband strap from the connector.

[0031] Another aspect of the invention relates to an air vent for a breathing mask, comprising: a main path; at least one branch extending from the main path; and an array of air vents disposed at the end of each branch. Each array of air vents includes a body and at least one vent through the body. The branches are spaced apart around the main path and / or angled relative to the main path, such that each array of air vents is positioned to allow for a dispersed exhaust airflow.

[0032] Another aspect of the invention relates to a bend for a breathing mask, comprising a mask connection end adapted for connection to a mask and a tube connection end adapted for connection to an air delivery tube. The mask connection end includes a first region made of a more rigid material and a second region made of a more flexible material. The second region provides flexibility for one or more portions of the mask connection end to support engagement and disengagement of the bend from the mask and / or a seal between the bend and the mask.

[0033] Further aspects of the present invention are described in the claims.

[0034] Other aspects, features, and advantages of the invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, which are part of this disclosure and illustrate the principles of the invention by way of example. Attached Figure Description

[0035] The following figures are provided to aid in understanding various examples of the invention. In these figures:

[0036] Figure 1-1 A perspective view of a nose mask system according to an example of the present invention;

[0037] Figure 1-2 for Figure 1-1 An exploded perspective view of the nasal mask system, showing the frame, silicone liner, bend, and swivel.

[0038] Figure 1-3 To show Figure 1-1 A three-dimensional view of the liner of the nasal mask system;

[0039] Figure 1-4 for Figure 1-3 A cross-sectional view of the liner;

[0040] Figure 1-5 A perspective view of a pad according to an example of the present invention;

[0041] Figure 1-6 for Figure 1-5 Side view of the padding;

[0042] Figure 1-7 for Figure 1-5 A bottom view of the padding;

[0043] Figure 1-8 for Figure 1-5 Front view of the liner;

[0044] Figure 1-9 For along Figure 1-8 A sectional view of line 1-9--1-9;

[0045] Figure 1-10 For along Figure 1-8A sectional view of line 1-10--1-10;

[0046] Figure 1-11 For along Figure 1-8 A sectional view of line 1-11--1-11;

[0047] Figure 1-12 For along Figure 1-8 A sectional view of line 1-12--1-12;

[0048] Figure 2-1 A perspective view of a nasal mask system according to another example of the present invention;

[0049] Figure 2-2 for Figure 2-1 An exploded perspective view of the nasal mask system, showing the frame, foam padding, silicone padding, bend, and swivel.

[0050] Figure 2-3 To show Figure 2-1 A three-dimensional view of the frame of the nasal mask system;

[0051] Figure 2-4 To show Figure 2-1 A three-dimensional view of the foam padding, silicone padding, bends, and swivels of the nasal mask system.

[0052] Figure 2-5 for Figure 2-4 Cross-sectional views of foam liners, silicone liners, bends, and swivels;

[0053] Figure 2-6 for Figure 2-1 A cross-sectional view of the silicone liner of the nasal mask system.

[0054] Figure 2-7 for Figure 2-1 A cross-sectional view of the silicone and foam pads of the nasal mask system.

[0055] Figure 2-8 for Figure 2-1 Side view of the silicone and foam pads of the nasal mask system;

[0056] Figures 3-1 to 3-79 This is a schematic diagram of an optional example of a headband strap configuration and a headband connection configuration according to the present invention;

[0057] Figures 4-1 to 4-4 A schematic diagram of an optional example of a bend and gasket connection configuration according to the present invention;

[0058] Figures 4-5 to 4-9 A schematic diagram of a swivel and bend connection configuration according to an optional example of the present invention;

[0059] Figure 5-1 and Figure 5-2 This is an isometric view of an optional embodiment of the present invention;

[0060] Figure 5-3 This is a front view of an optional embodiment of the present invention;

[0061] Figure 5-4 This is a rear view of an optional embodiment of the present invention;

[0062] Figure 5-5 This is an optional embodiment of the invention in use;

[0063] Figure 5-6 This is a side view of an optional embodiment of the present invention;

[0064] Figures 6-1 to 6-12(b) This is a schematic diagram of a headband connection configuration according to an optional example of the present invention;

[0065] Figures 7-1 to 7-3 Views of a face mask system according to an embodiment of the present invention are shown;

[0066] Figures 8-1 to 8-3 Views of the lower headband connector of a frame according to an embodiment of the present invention are shown;

[0067] Figure 8-4 and Figure 8-5 A lower headband connector according to an optional embodiment is shown;

[0068] Figure 9-1 An elongated arm of a forehead support portion according to an embodiment of the present invention is shown;

[0069] Figure 9-2 and Figure 9-3 A mask system with a slender arm for forehead support is shown according to another embodiment of the invention;

[0070] Figure 9-4 A mask system with a slender arm for forehead support is shown according to another embodiment of the invention;

[0071] Figures 10-1 to 10-5 Views of a forehead support portion according to an embodiment of the present invention are shown;

[0072] Figure 10-6 A forehead support portion according to another embodiment of the present invention is shown;

[0073] Figure 11-1 A liner according to an embodiment of the present invention is shown;

[0074] Figures 11-2 to 11-9 Views of a liner according to another embodiment of the invention are shown;

[0075] Figures 12-1 to 12-3 Views of a bent pipe according to an embodiment of the present invention are shown;

[0076] Figures 12-4 to 12-8 Views of a bent pipe according to another embodiment of the present invention are shown;

[0077] Figure 12-9 This is an end view of a bent pipe according to an embodiment of the present invention;

[0078] Figure 13-1 A swivel / ventilation ring according to an embodiment of the present invention is shown;

[0079] Figure 13-2 A swivel / ventilation ring according to another embodiment of the present invention is shown;

[0080] Figure 14-1 and Figure 14-2 A headband according to an embodiment of the present invention is shown;

[0081] Figures 15-1 to 15-3 Views of the frame and padding joining according to an embodiment of the present invention are shown;

[0082] Figure 16-1 and Figure 16-2 A face mask system according to an embodiment of the present invention is shown;

[0083] Figure 17-1 and Figure 17-2 A face mask system according to an embodiment of the present invention is shown;

[0084] Figure 18-1 and Figure 18-2 A headband path according to an embodiment of the present invention is shown;

[0085] Figure 19-1 and Figure 19-2 A headband path according to an embodiment of the present invention is shown;

[0086] Figures 20-1(a), 20-1(b), and 20-1(c) are sequential top views of a bendable or flexible forehead support according to an embodiment of the present invention;

[0087] Figures 20-2(a), 20-2(b), and 20-2(c) are sequential perspective views of a bendable or flexible forehead support according to an embodiment of the present invention;

[0088] Figures 21(a), 21(b), 21(c), 21(d), 21(e), 21(f), and 21(g) are views of a forehead support portion including a flexible region according to an embodiment of the present invention;

[0089] Figures 22(a), 22(b), 22(c), 22(d), 22(e), 22(f), 22(g), and 22(h) are views of a forehead support portion including a flexible region according to an embodiment of the present invention;

[0090] Figures 23(a), 23(b), 23(c), 23(d), and 23(e) are views of a forehead support portion including a flexible region according to an embodiment of the present invention;

[0091] Figures 24(a) and 24(b) show a forehead support according to an embodiment of the present invention, wherein each side of the crossbar includes a resilient spring arm;

[0092] Figure 25 and Figure 26 A forehead support portion comprising a forehead pad made of soft foam material is shown according to an embodiment of the present invention;

[0093] Figures 27 to 32 Views of the frame of a face mask system according to an embodiment of the present invention are shown;

[0094] Figures 33 to 39 Views of the padding of a face mask system according to an embodiment of the present invention are shown;

[0095] Figures 40 to 45 An embodiment of the present invention is shown. Figures 33 to 39 padding and Figures 27 to 32 The frames are assembled into each other's views;

[0096] Figures 46 to 54 Views of the bends and swivels of a mask system according to an embodiment of the present invention are shown;

[0097] Figure 55 A top view of a vent assembly according to another embodiment of the present invention is shown;

[0098] Figure 56 For along Figure 55 Sectional view of line 56-56;

[0099] Figure 57 for Figure 55 A side view of the vent assembly shown;

[0100] Figure 58 An embodiment of the present invention is shown with the following configuration: Figure 55 The mask liner of the vent assembly;

[0101] Figure 59 For along Figure 58Sectional view of line 59-59;

[0102] Figure 60 and Figure 61 A bend with a vent is shown according to another embodiment of the invention;

[0103] Figure 62 and Figure 63 A gasket with a vent is shown according to another embodiment of the invention;

[0104] Figure 64 and Figure 65 for Figures 55 to 59 Optional view of the vent assembly;

[0105] Figures 66 to 69 An optional view of a forehead support arm and a forehead support pad according to an embodiment of the present invention is shown;

[0106] Figure 70 An optional view of the lower headband connector according to an embodiment of the present invention is shown;

[0107] Figure 71 This is a front perspective view of a pad according to an embodiment of the present invention;

[0108] Figure 72 for Figure 71 Rear-view perspective of the padding;

[0109] Figure 73 for Figure 71 Front view of the liner;

[0110] Figure 74 for Figure 71 Rear view of the liner;

[0111] Figure 75 for Figure 71 A top view of the padding;

[0112] Figure 76 for Figure 71 A bottom view of the padding;

[0113] Figure 77 for Figure 71 Side view of the padding;

[0114] Figure 78 To show the cutting line Figure 71 Front view of the liner;

[0115] Figure 79 For along Figure 78 Sectional view of line 79-79;

[0116] Figure 80 For along Figure 78A sectional view with lines 80-80;

[0117] Figure 81 For along Figure 78 Sectional view of line 81-81;

[0118] Figure 82 For along Figure 78 Sectional view of line 82-82;

[0119] Figure 83 In order to be in Figure 71 Enlarged cross-sectional view of the flap of the base liner in the nasal region of the liner;

[0120] Figure 84 To show Figure 71 A schematic diagram showing the localized thickening of the bottom pad of the liner;

[0121] Figure 85 In order to be in Figure 71 An enlarged cross-sectional view of the underlayment in the nose corner area of ​​the liner;

[0122] Figure 86 A schematic diagram illustrating the sealing force of the liner as viewed from the side of the patient's nose, according to an embodiment of the present invention;

[0123] Figure 87 A schematic diagram illustrating the sealing force of the liner as viewed from the front of a patient's nose, according to an embodiment of the present invention;

[0124] Figure 87 -1(a) and Figure 87 -1(b) is along Figure 87 The sectional view of line 87-1—87-1 shows the deformation of the underlay for low and high nose bridges;

[0125] Figure 87-2 A schematic diagram illustrating the liner sealing force as seen from the top of the patient's nose according to an embodiment of the present invention is provided to better illustrate the position of the base liner where the liner septum is lowered.

[0126] Figures 88 to 93 Views of a frame according to an embodiment of the present invention;

[0127] Figure 94 This is a front view of a frame and padding according to an embodiment of the present invention, with section lines also shown;

[0128] Figure 95 For along Figure 94 A sectional view with line 95-95;

[0129] Figure 96 For along Figure 94 A sectional view along line 96-96;

[0130] Figure 97 For along Figure 94 A sectional view along line 97-97;

[0131] Figure 98 For along Figure 94 A sectional view along line 98-98;

[0132] Figures 99 to 105 Here are various views of a face mask system according to an embodiment of the present invention;

[0133] Figure 106 and Figure 107 An embodiment of the present invention is shown. Figures 99 to 105 A mask system in use where the headband is positioned on the patient's face;

[0134] Figure 108 This is an assembly view of a bent pipe according to an embodiment of the present invention;

[0135] Figure 109 for Figure 108 A cross-sectional view of the bent pipe;

[0136] Figure 110 for Figure 108 Side view of the bend in the pipe;

[0137] Figure 111 For along Figure 110 A sectional view of line 111-111;

[0138] Figure 112 For along Figure 110 A sectional view along line 112-112;

[0139] Figure 113 A side view of a bent pipe according to an embodiment of the present invention;

[0140] Figure 114 For along Figure 113 A sectional view of line 114-114;

[0141] Figure 115 For along Figure 113 A sectional view along line 115-115;

[0142] Figure 116-1 , Figure 116-2 and Figure 116-3 A sealing of the liner in the bridge of the nose region is shown according to an embodiment of the present invention;

[0143] Figures 117 to 120 The bending portion or bending area of ​​the base liner according to different embodiments of this technology is shown;

[0144] Figure 119A cross-section of a base liner or auxiliary band suitable for use along the nasal side, providing a seal to the facial plane (upward arrow) and the nasal side (leftward arrow). Detailed Implementation

[0145] The following description focuses on several examples that can share common characteristics and features. It should be understood that one or more features of any example can be combined with one or more features of other examples. Furthermore, any feature or combination of features in any example can constitute another example.

[0146] In this instruction manual, the word "including" will be understood as "open," that is, as meaning "including...included," and therefore cannot be limited to its "closed" meaning, i.e., "consisting only of...". The corresponding words "including," "being included," and "including" also have corresponding meanings.

[0147] The term "air" should be understood to include breathable gases, such as air containing supplemental oxygen.

[0148] 1. Nasal mask system

[0149] The examples of this invention primarily describe a nasal mask system with the following advantages: easy and quick to wear (e.g., requiring little or no adjustment), reduced strap tension, suitable for mass production, attractive to consumers, comfortable and airtight, reliable quality, unobstructed view, and / or suitable for most people.

[0150] As described in more detail below, the nasal mask system includes: a frame; a sealing device (such as a pad) disposed on the frame and adapted to form a seal with the patient's nose; and a bend, for example disposed on the sealing device, adapted to connect to an air delivery tube providing breathable gas to the patient. A swivel may optionally be provided to connect the bend and the sealing device. A headband may be detachably attached to the frame to hold the nasal mask system in a desired, adjusted position on the patient's face. The nasal mask system is designed to provide positive pressure therapy to users suffering from obstructive sleep apnea (OSA) or other breathing disorders.

[0151] Although each example below is described as including a nose interface type, the solutions of this invention can be used in conjunction with other suitable interface types such as full-face interfaces, nose forks, etc.

[0152] 2. Framework

[0153] like Figure 1-1 , Figure 1-2 and Figures 2-1 to 2-3As shown, the frame 20 (also referred to as the exoskeleton or skeleton) is configured to hold, fix, and / or support the sealing device 40 (and the bend 70) in a working position relative to the patient's face. Furthermore, the frame 20 is configured to connect the headband and the nasal mask system.

[0154] As shown in the figure, the main body 22 of frame 20 (see reference) Figure 1-2 , Figure 2-2 and Figure 2-3 The frame 20 includes: an open structure with a central opening 24 that allows the sealing device 40 to communicate with or accommodate the bend 70; and sidewalls 26 configured to retain or engage the sealing device 40. In use, the frame 20 of this example is not in the air passage; that is, as described below, the sealing device 40 defines a breathing chamber and is directly connected to the bend 70. The frame 20 can be semi-rigid or at least somewhat flexible. The frame 20 can be made of a single material, a combination of multiple materials, or a combination of the same materials with varying hardness. The material of the frame 20 can be polycarbonate, polypropylene, nylon, clear nylon, thermoplastic elastomer (TPE), silicone, or any other suitable material.

[0155] A forehead support 30 extends from the top of the main body 22. The forehead support 30 can be fixed (i.e., not adjustable), adjustable (e.g., the height or length of the slender arm can be extended, or the angle of the forehead support can be changed), or interchangeable (e.g., providing forehead supports of various sizes for patients of different sizes, or the slender arm can be replaced with arms of various lengths). The forehead support 30 includes an slender arm 32 and an upper headband connector 34, the upper headband connector 34 having a slot or receiving hole 35 at the free end of the arm adapted to receive a corresponding headband strap in use, thus using the headband strap lining without the need for a separate pad. In one example, the headband connector can be, for example, adjustable relative to the arm 32 (e.g., tilted or angled toward the patient's forehead). Lower headband connectors 36 are disposed on corresponding sides of the main body 22. Each lower headband connector 36 includes an elongated arm 38 and a slot or receiving hole 39 located at the free end of the arm, the slot or receiving hole 39 being adapted to receive a corresponding headband strap during use. The elongated arm 38 can be bent or selectively deformed to allow the arm to bend toward or away from the patient's face during use, thereby pulling the headband onto the patient's face, for example, allowing for side-lying. In one example, if the pressure of the user's hand can cause the elongated arm 38 to bend or deform, the elongated arm can be suitably extended to maintain the deformed shape. This feature of the elongated arm 38 can increase the comfort, wearability, and / or sealing effect of the embodiment. The forehead support and headband connectors can provide an unobstructed configuration, i.e., extending outside the patient's line of sight. When wearing the mask of this embodiment, the generally thin and elongated configuration of the elongated arm 38 can at least partially prevent or limit obstruction of the patient's line of sight. In one example, the elongated arm 38 may be made of wire or a metal alloy. However, those skilled in the art can conceive of using other materials, including but not limited to polymeric materials.

[0156] In one example, arms 32, 38 may be suitably shaped, defined, or contoured to conform to the patient's facial contours while avoiding obstruction of the patient's line of sight or impediment to their vision. Additionally, arms 32, 38 may include some inherent flexibility to allow for adjustment within a range. The elongated arms 32, 38 may be made of materials that are not typically extensible, such as aluminum, stainless steel, polycarbonate, polypropylene, TPE, or any other suitable material. Alternatively, the elongated arms 32, 38 may be part of a continuation of frame 20 and therefore made of the same material, or the elongated arms 32, 38 may be made of the same material as frame 20 but not a monolithic structure (i.e., the elongated arms 32, 38 may be attached to frame 20). However, the elongated arms 32, 38 may be made of a different material than frame 20 and may be secured to frame 20 using optional mounting or securing methods such as adhesive. The upper headband connector 34 may be made of the same material as the elongated arms 32. Alternatively, the upper headband connector 34 may be made of a more flexible material than the elongated arm 32, such as Hytrel™, silicone, nylon, or any other suitable material. The lower headband connector 36 may be part of a continuation of the frame 20 and therefore made of the same material, or the lower headband connector 36 may be made of the same material as the frame 20 but not a monolithic structure (i.e., the elongated arm 38 may be attached to the frame 20). Alternatively, the lower headband connector 36 may be made of a more flexible material than the frame 20, such as Hytrel™, silicone, nylon, or any other suitable material.

[0157] The forehead support and headband connector can be integrally molded or attached to the body of the frame 20. The frame 20 is made of a material that is more rigid than the sealing device 40 (e.g., made of silicone, foam). For example, the frame can be made of plastic (e.g., polycarbonate) and / or metal (e.g., a relatively thin metal material).

[0158] In one example, the arms 32 and / or 38 may be relatively thin or micro-thin (e.g., 1-3 mm). In one example, the forehead support 30 and the headband connector 36 may be made of a material different from that of the frame body 22 (a metallic material). In this example, the forehead support 30 and the headband connector 36 may be connected to the frame body 22. Relatively thin or micro-thin walls 32 and / or 38 can reduce the overall visual impact of the mask or embodiment.

[0159] In one example, the upper headband connector 34 provides a flat area for attaching the headband strap. In one example of this embodiment, the strap is attached to the upper headband connector 34 through two holes 35 arranged on opposite sides of the upper headband connector 34, and the strap is adapted to pass through the holes and direct force toward the patient's face, thereby effectively tightening the upper headband connector 34 toward the patient's forehead.

[0160] 2.1 Optional Framework

[0161] Figures 5-1 to 5-6 An alternative embodiment of the frame 420 is shown, which is configured to hold or support the sealing device 440 (and the bend 70) in a working position relative to the patient's face.

[0162] Frame 420 can be configured to connect a headband and a nose mask system. Frame 420 can be made of polycarbonate, polypropylene, nylon, or any other suitable material. A swivel 90 can be used to connect the sealing device 440 and the bend 70. The swivel 90 can be any suitable polymer, such as polycarbonate and polypropylene. The bend 70 can be small in size and unobstructed. The bend may include a venting device 75 containing multiple holes or cavities for ventilation. The bend 70 can be made of polycarbonate, polypropylene, or any other suitable material.

[0163] A forehead support 430 extends from the top of the body 422 of the frame 420. The forehead support 430 can be fixed (i.e., not adjustable), adjustable (e.g., the height or length of the slender arm can be extended, or the angle of the forehead support can be changed), or interchangeable (e.g., providing forehead supports of various sizes for patients of different sizes, or the slender arm can be replaced with arms of various lengths). The forehead support 430 includes an slender arm 432 and an upper headband connector 434, which has a slot or receiving hole 435 at the free end of the arm 432 adapted to receive a corresponding headband strap during use, thus using the headband strap lining without the need for a separate pad. In one example, the headband connector 434 can be adjustable relative to the arm 432 (e.g., tilted or angled toward the patient's forehead).

[0164] The upper headband connector or forehead support pad 434 can be made of silicone, nylon, polypropylene, TPE, polycarbonate, or any other suitable material. The slender arm 432 can be made of malleable metal. The frame 420 can be the connection point between the slender arm 432 and the sealing device 440.

[0165] The lower headband connector 436 is disposed on a corresponding side of the body 422 of the frame 420. The lower headband connector 436 may be hook-shaped. The lower headband connector 436 may also be integrally formed with the body 422 of the frame 420, or they may be formed separately from the body and then connected together by means such as adhesive or any mechanical fastening.

[0166] Each lower headband connector 436 may include a gap 439 between the upper end of the connector 436 and the body 422 of the frame to allow the headband strap to be inserted therebetween. It should be understood that the headband connector 436 may also be connected to both the lower and upper ends of the body 422 of the frame 420. The connector 436 may be bent or selectively deformed to allow the connector 436 to bend toward or away from the patient's face during use, thereby pulling the headband onto the patient's face, for example, allowing for lateral recumbency. This can increase the comfort, wearability, and / or seal of the nasal mask system. The forehead support 430 and the headband connectors 434, 436 can provide an unobstructed configuration, i.e., extending outside the patient's line of sight. The lower headband connector 436, positioned at the lower corner of the body 422 of the frame 420, can at least partially prevent or limit obstruction of the patient's line of sight when wearing the nasal mask system.

[0167] 2.2 Optional Framework

[0168] The following examples illustrate alternative embodiments of the mask system's frame, arms, and forehead support.

[0169] 2.2.1 Framework

[0170] Figures 7-1 to 7-3 A nose mask system is shown, including a frame 520, a sealing device or pad 540, an elongated arm 532 and a forehead support 530, a bend 570 and a ring 590 for connecting the bend and the pad.

[0171] like Figures 8-1 to 8-3 The best illustration shows that each lower headband connector 536 disposed on the frame can be generally S-shaped. Each lower headband connector includes a top 536 (1), a middle 536 (2), a lower 536 (3), and a connecting portion 536 (4) for connecting the connector and the frame. The top 536 (1) may have a guide adapted to guide the headband strap into place. The middle 536 (2) is adapted to abut or be adjacent to the frame so that the strap is held within the connector once engaged. The lower 536 (3) is adapted to receive the strap once it is pushed through the middle. The connecting portion 536 (4) allows the connector to hinge outward or away from the frame so that the headband strap can pass between the middle of the connector and the frame.

[0172] Connector 536 is located near the frame to facilitate sliding of the headband along the side of the frame. The self-closing connector has the advantage of being easy to use while still serving as a headband retaining component.

[0173] In one embodiment, one or more portions of the connector may be made of TPE material.

[0174] Figure 8-4 and Figure 8-5Optional lower headband connectors are shown, such as hook connector 536-1 and connector 536-2 having a free end adapted to engage a connector base 520-1 on a coupling frame. Figure 8-5 As shown, the free end of the hook connector 536-1 includes a retaining hook for helping to hold the headband strap in place. Figure 8-4 As shown, connector 536-2 can be biased to engage with base 520-1 to help retain headband straps.

[0175] Figure 16-1 and Figure 16-2 Another embodiment of the frame 520-1 for supporting the padding and headband is shown (e.g., an open frame configuration having a lower crossbar 5536 for the lower headband strap and a forehead support bar with an opening 5537 for the upper headband strap). Figure 17-1 and Figure 17-2 Another embodiment of the frame 520-2 for supporting the padding and headband is shown (e.g., the headband clip 5540 includes an opening 5440(1) adapted to engage a receptacle 5541 on the frame). The frame 520-2 also includes as described above. Figure 16-1 and Figure 16-2 The frame 520-2 includes a forehead support bar with an opening for the upper headband strap. Additionally, the frame 520-2 includes an upwardly extending padding support bar 521 adapted to support and / or retain the padding.

[0176] In an alternative embodiment, the frame may include a clip receptacle adapted to disengage from a corresponding headband clip associated with the same lower headband strap.

[0177] 2.2.2 Slender Arm

[0178] The frame supports the slender arms that bear the forehead support (such as those made of metal or malleable metal).

[0179] In one embodiment, such as Figures 7-1 to 7-3 As shown, metal arm 532 can be an extruded packaged part. (As...) Figure 9-1 As shown, the front portion of the metal m of arm 532 can be wider so that the plastic package p does not obscure the metal. This packaging configuration provides a soft tactile feature to soften and protect the metal.

[0180] In another embodiment, such as Figure 9-2 and Figure 9-3 As shown, the metal arm can be an exposed extruded part (such as a polished extruded aluminum part). This configuration highlights the metallic features and provides a streamlined, unobstructed design.

[0181] Figure 9-4An arm 532 made of glass-filled nylon encapsulated with a polymer coating (such as silicone or TPE) is shown. The encapsulated metal design can be replaced with reinforced plastic to provide the strength of a metal-based arm and enable a thinner, unobstructed design. Furthermore, this configuration allows for increased color and texture detail.

[0182] 2.2.3 Forehead support

[0183] The forehead support is provided by arm 532. (As shown) Figures 10-1 to 10-5 As shown, the forehead support 530 may have a flexible region 531 built therein, allowing it to elastically deform from a natural V-shaped position or shape to a more linear position or shape. The flexible region may be a thin portion of material (i.e., the same material as the rest of the forehead support, only thinner to allow for bending), a softer and less rigid material, or a combination of a softer material and a portion thinner than the rest of the forehead support 530.

[0184] The flexible area can be a co-molded portion of a flexible material, such as thermoplastic elastomer (which may also be colored), silicone, or any other flexible material. The remainder of the forehead support can be made of a less flexible material, such as nylon, polycarbonate, or polypropylene. Co-molding can be achieved through a chemical and / or mechanical bond between the two materials. Individually formed / assembled flexible areas reduce the risk of breakage and can be assembled off-site with the headband. The forehead support may include a frosted surface.

[0185] In one embodiment, the forehead support 530 can first be molded into a flat shape. Then, when the forehead support 530 is positioned for use or in a flexural configuration, a flexible region 531 is molded on the forehead support 530. This allows the forehead support to be preloaded or to be biased or resilient.

[0186] The flexible area provides an automatically adjusting flex feature, which adjusts via headband tension, allowing for greater biasing of the pad to aid wear. Preferably, the forehead support can flex to tilt or rotate the upper portion of the mask pad inward or outward toward the patient's nasal area. In one configuration, when the headband straps are tightened, the forehead support can open outward or flatten relative to the patient's forehead. This tilts or rotates the mask pad with the lower portion of the mask pad as a hinge point. Thus, in a direction generally perpendicular to the patient's facial plane, the upper portion of the mask pad can tilt or rotate inward toward the patient's nasal area. This is particularly useful for patients with a higher nasal bridge than others, as it promotes a seal between the nasal area of ​​the mask pad and their nose.

[0187] Alternatively, the forehead support can be made of a thickened, compliant material, such as foam, that can be compressed to achieve a similar effect.

[0188] like Figure 10-2 As shown, when there is no load (i.e., in a natural state), the position of the forehead support can be at an angle α, which can be from 5° to 90°, for example, 15°.

[0189] When in use, the forehead support allows for movement in the front-to-back direction (e.g., Figure 10-2 and Figure 10-4 (As indicated by the middle arrow) Adjustment is approximately 0mm to 30mm. In one exemplary embodiment, the forehead support may allow adjustment in the front-to-back direction of approximately 5mm to 20mm (e.g., approximately 10mm to 20mm, approximately 10mm to 15mm). This can provide a wider range of patient fit, as the forehead support can accommodate a large number of different anthropometric dimensions, particularly in the nasal bridge area.

[0190] The headband can pass through the loop hole 535 (see, for example, see...) Figure 10-1 and Figure 10-3 ) Connected to the forehead support, or extended through slot 535-1 into the loop-through arrangement in hole 535 (see) Figure 10-6 ) to make a link.

[0191] 2.3 Optional Embodiments of Forehead Support

[0192] Figures 20-1(a) to 26 An alternative embodiment of the forehead support is shown.

[0193] One advantage of forehead support is that it provides a reasonable amount of adjustment without requiring many additional components. In a preferred example, the forehead support is molded entirely as a single unit. Furthermore, tightening the headband strap towards the back of the patient's head in the forehead area results in a direct movement of the pads towards the bridge of the nose, potentially reducing and eliminating gaps in that area.

[0194] According to one example of this technology, a mask system is provided, which includes a nose pad and a frame. The frame includes a forehead support with a T-shaped bar. The T-shaped bar includes a main shaft and a crossbar. In one configuration, the crossbar includes a left side portion and a right side portion.

[0195] A face mask system according to one embodiment of the present technology includes a headband. In one configuration, the headband includes a left forehead strap and a right forehead strap. The left and right forehead straps are constructed and configured to engage with corresponding left and right portions of a crossbar at a position distal to the apex during use.

[0196] In one configuration, the left and right sides are configured at an angle of less than approximately 180 degrees to each other. In this configuration, the crossbar can be V-shaped when viewed from a top view. The apex is defined between the left and right sides. In another configuration, the left and right sides are constructed and configured to bend or flex about the apex. In one configuration, bending or flexing the distal ends of the sides by pulling them causes an increase in the included angle between them, resulting in displacement of the contact portion between the crossbar and the main shaft closer to the forehead and rotation of the padding.

[0197] In one alternative configuration, the left and right sides of the crossbar can be U-shaped. In this U-shaped configuration, the crossbar has the same function as the V-shaped configuration described above.

[0198] For example, Figures 20-1(a) to 20-1(c) and Figures 20-2(a) to 20-2(c) Sequential views of a generally U-shaped crossbar 1034 are shown, configured to bend or flex about its apex when the headband tension of the headband strap 1080 is applied to the corresponding side of the crossbar. As shown, the forehead support begins at an extension in front of the patient's forehead. When the patient tightens the headband (i.e., pulls the headband strap outward from the crossbar as indicated by the arrow), the sides of the crossbar open or flex outward, and the crossbar moves to a generally flat position on the patient's forehead, thereby causing the padding to be biased inward toward the patient's face. The slot 1035 in the crossbar of the corresponding headband strap can be located at a relatively distant position outward from the apex (e.g., distance d shown in Figure 20-2(c)) to enhance the vector (e.g., requiring only a small force to effectively pull the forehead support toward the patient's head).

[0199] Bending or deflection can be achieved by molding crossbars using materials with a thinner mid-section. This results in greater flexibility in the mid-section of the crossbar compared to its ends. Alternatively, the crossbar can be formed by co-molding a more rigid material (such as nylon) with a more flexible material (such as thermoplastic elastomer).

[0200] For example, such as Figures 20-1(a) to 20-1(c) and Figures 20-2(a) to 20-2(c) As shown, the crossbar may include a middle portion 1034(1) made of a more flexible material (such as flexible TPE or silicone) and an end or side portion 1034(2) made of a more rigid material (such as transparent nylon).

[0201] Figures 21(a) to 23(e) An optional construction of the forehead support and its crossbar is shown. For example, Figures 21(a) to 21(g) A forehead support is shown, comprising a flexible region 1036 positioned between a more rigid region, namely the middle portion 1034(1) of the crossbar, and a corresponding side portion 1034(2). The flexible region 1036 is made of a more flexible material (such as... The flexible region is made of a more rigid material (such as nylon), while the middle part 1034(1) and the side part 1034(2) are made of a more rigid material (such as nylon). As shown, the flexible region can be embedded into the more rigid region. Moreover, the flexible region can be interlocked with the more rigid region by retaining components such as tenons. Figures 22(a) to 22(h) and Figures 23(a) to 23(e) An alternative configuration is shown in which the flexible region 1036 is interlocked or connected with the more rigid regions 1034(1), 1034(2). Figures 23(a) to 23(e) In the middle, the flexible area includes the side of the crossbar.

[0202] The forehead support and headband are constructed and configured to move the main axis and rotate the padding by tensioning the left and / or right forehead straps. This allows for adjustment of the mask fit to different face shapes. For example, pulling the straps can rotate the padding towards the face, reducing gaps in the bridge of the nose area.

[0203] Figures 24(a) and 24(b) illustrate a forehead support in which each side of the crossbar includes a resilient spring arm 1037. As shown, a headband strap 1080 is adapted to form a loop around the spring arm, thereby enabling the headband strap to engage the patient's forehead with the spring arm located between the crossbar and the headband strap. In use, the tension of the headband can cause the spring arm to bend or flex, and displace the contact portion of the forehead support closer to the patient's forehead.

[0204] Figure 25 and Figure 26 A forehead support is shown, comprising a forehead pad 1090 made of an compliant material such as foam or gel. Figure 25 As shown, the forehead pad 1090 can be connected to the crossbar 1034 via, for example, a snap-fit ​​connection. The forehead pad 1090 includes snap fingers 1091 adapted to engage with corresponding openings 1038 in the crossbar via a snap-fit ​​connection. Opposite sides of the crossbar each include end opening slots adapted to engage with headband straps. Figure 26 As shown, the headband 1080 can pass through the crossbar 1034 and its forehead pad 1090, so that the headband can engage the patient's forehead with the forehead pad located between the crossbar and the headband.

[0205] 2.4 Another Optional Framework Implementation

[0206] The frame can be installed on the system to stabilize the pad in place and anchor the head strap to keep the pad in position. The frame can further add structure or support to the pad.

[0207] Figures 27 to 32 The optional frame 2020 shown consists of a main body 2100, a forehead support arm 2400, and a forehead support pad 2530.

[0208] The main body 2100 can be configured to capture or engage the liner and the lower headband strap. The upper region 2700 engages the top or apex region of the mask liner. The upper region 2700 can be positioned above or on top of the main body 2100 on the non-patient side of the mask frame 2020. By adding rigidity or support to this region of the liner, the upper region 2700 can also provide stability to the front or bend joint of the liner. The lower region 2800 can be positioned generally below the upper region. The lower region 2800 can engage with or otherwise dock with the bottom region of the mask liner.

[0209] Rear connector or joint 2650 (see Figure 29 and Figure 32 The rear connector 2650 can be configured to accommodate a tongue or locking element on the mask liner. The rear engagement 2650 can also assist in the positioning of the mask liner within the mask frame 2020. The rear engagement 2650 can be an incision or notch. The rear connector 2650 can be positioned on the patient side of the frame 2020.

[0210] The lower headband connector 2520 can be configured to receive a headband loop. The lower headband connector 2520 can be generally hook-shaped or C-shaped to receive and hold the headband strap in place. The lower headband connector 2520 can be connected to or formed together with the body 2100 via a connecting portion 2525. The connecting portion 2525 can have some degree of flexibility or hinged rotational capability, thereby providing some degrees of freedom for the movement of the lower headband connector 2520.

[0211] The lower headband connector 2520 can be formed of a flexible material, including but not limited to silicone, TPE, or any other suitable material. The lower headband connector can be formed of a combination of materials, such as a relatively rigid material for maintaining shape and transmitting headband tension to the face mask, and a more flexible material for making engagement and disengagement of the headband easier. This can include a combination of materials such as nylon and silicone. The flexible material can also include adhesiveness and friction to prevent the headband from slipping within the connector. This can include, but is not limited to, silicone. Preferably, the force required to assemble the headband with the lower headband connector is less than the force required to remove the headband from the lower headband connector. Preferably, the disassembly force is less than 15 N. Most preferably, the disassembly force is less than 10 N.

[0212] Figure 70An alternative view of the lower headband connector 2520 is shown. As shown, the generally hook-shaped or C-shaped lower headband connector 2520 (made of a more flexible material such as silicone) is overmolded or co-molded with the body connection portion 2525 of the body 2100 (e.g., made of a more rigid material such as nylon). Preferably, the flexible material may be silicone. Preferably, the flexible material may have a Shore A hardness of approximately 20 to 80. Most preferably, the flexible material may have a Shore A hardness of approximately 40 to 60. Most preferably, the flexible material may have a Shore A hardness of approximately 60. The connection portion 2525 includes a connection portion 2526 for assisting in molding the connector 2520 to the connection portion 2525. The connection portion 2526 includes a retaining slot 2526(1) for assisting in interlocking or mechanically locking the overmolded flexible connector 2520 to the more rigid connection portion 2525. Furthermore, the connecting portion 2526 extends substantially to the apex or top of the connector 2520 to enhance the headband connection at the connector; that is, the rigider material of the connecting portion maintains the shape of the connector to prevent the headband from slipping off the connector and to transfer the headband tension to the face mask. The flexible connector 2520 also makes it easier to remove the strap from the connector and attach the strap to the connector; for example, the connector can deform to facilitate the removal and attachment of the strap.

[0213] like Figure 89 As shown, the lower headband connector may provide internal surfaces 2521(1) and 2521(2) at an angle α1 to each other to help retain the headband strap and prevent accidental detachment of the headband strap. Preferably, α1 may be less than 180°. Preferably, α1 may be approximately 110° to 160°. Most preferably, α1 may be approximately 120° to 150°. Furthermore, the spacing between the connector and the body of the frame also contributes to strap retention. Preferably, the spacing between the connector and the body may vary with the length of the connector. Preferably, the widest gap between the connector and the body may be less than 15 mm to help retain the strap. Most preferably, the widest gap between the connector and the body may be less than 10 mm to help retain the strap.

[0214] like Figures 41 to 44 As shown, the side-engaging tongue 2600 can be positioned on the transverse flange of the body 2100 and on the patient side of the mask frame for connecting and supporting the mask liner. In one embodiment, the tongue is positioned at the end of the lower liner in the area adjacent to the bridge of the nose. The tongue can form an interference fit with a portion of the liner. The tongue can be thinner than the rest of the frame or surrounding portions. Additionally, the tongue can also support the liner in a manner that allows for a sealing engagement with the patient's nasal or cheek area. The tongue 2600 provides structural support for the flexible liner, so that during use the liner does not collapse away from the patient's face (e.g., leak air) and compromise the seal. Figure 43As shown, the tongue 2600 can extend rearward from the arm 2400.

[0215] The forehead support arm 2400 extends from the body 2100 to the forehead pad 2530. Preferably, the forehead support arm 2400 is thin (e.g., 1 mm to 5 mm, less than 10 mm, or about 1 mm to 5 mm) to avoid obstructing the patient's vision and is structurally stable or relatively non-extendable to support the mask in place.

[0216] The forehead support pad 2530 may include an upper headband connector 2535 for engaging with an upper headband strap. The forehead support pad may further include a flexible region 2540 for adjusting the distance between the forehead support pad and the patient's forehead during use. By tightening or adjusting the upper headband strap within a normal tension range that will not cause discomfort, the flexible region 2540 can flatten to pull the forehead support pad closer to the patient's forehead. This then sequentially tilts the body inward toward the patient's nasal bridge, thereby pushing the mask pad in use further onto the patient's nasal bridge. In one embodiment, the force used to flatten the flexible region may be in the range of approximately 1N to 8N. Preferably, the force used to flatten the flexible region may be in the range of approximately 2N to 6N. Most preferably, the force used to flatten the flexible region may be in the range of approximately 2N to 4N.

[0217] Figures 66 to 69 An alternative view of the forehead support arm 2400 and the forehead support pad 2530 is shown. As shown, the forehead support pad 2530 includes an upper headband connector 2535 (e.g., made of a more rigid material such as nylon) and a flexible region 2540 (made of a more flexible material such as silicone). The flexible region is overmolded with the upper headband connector 2535 and the support arm 2400 (e.g., made of a more rigid material such as nylon), thereby enabling the headband connector to interconnect with the support arm and providing flexibility to the forehead support to adjust the distance between the forehead support and the patient's forehead during use.

[0218] Each upper headband connector 2535 includes an annular hole 2536 for connecting the headband and the connector 2538, which assists in molding the flexible area onto the headband connector. As shown, a slot 2536-1 extends into the hole 2536 to provide an open-loop configuration. The support arm includes a connector 2402 for assisting in molding the flexible area onto the support arm. Each of the connectors 2538, 2402 includes a corresponding retaining slot 2538(1), 2402(2) for assisting in interlocking or mechanically locking the overmolded silicone flexible area 2540 with the nylon headband connector 2535 and the support arm 2400. Furthermore, as Figure 67As shown, on each side of the nylon support arm 2400, the silicone flexible region 2540 has sufficient thickness (e.g., more than 0.5 mm per side, such as 0.8 mm per side) to enhance the interlocking. In one embodiment, the flexible region may be thicker in the middle portion around the arm 2400 and gradually taper toward the connector 2535.

[0219] like Figure 66 and Figure 68 As shown, the headband connector 2535 and support arm 2400 may include components for assisting in molding with the silicone flexible area 2540 and preventing flash and frame damage. For example, the support arm 2400 may include a lip 2404 for assisting in molding the silicone flexible area onto the nylon arm. Furthermore, each headband connector 2535 may include a rounded wall 2539 (e.g., with a height of approximately 0.2 mm to 0.6 mm, or 0.4 mm) to assist in molding the silicone flexible area onto the nylon headband connector. In one embodiment, the wall 2539 may be a pressure strip extruded in a mold.

[0220] In a preferred embodiment, the headband connector 2535 and the arm 2400 are formed separately from each other (e.g., three separate parts) and then connected together via the flexible region 2540. In an alternative embodiment, as Figure 69 As shown, the headband connector 2535 can be connected to the arm 2400 via the runner 2555 (e.g., the headband connector is formed integrally with the arm) and then overmolded together with the flexible area.

[0221] In an alternative embodiment, headband connector 2535 may include a silicone connector, such as the lower headband connector 2520 described above.

[0222] Figures 88 to 93 Views of the frame 2020, its forehead support arm 2400, upper headband connector 2535, flexible region 2540, and lower headband connector 2520 are shown. In one embodiment, as Figure 91 As shown, the angle between the individual connectors 2535 can be approximately 100° to 170°, such as 125° to 145°. Figures 94 to 98 It has been shown that it has been associated with Figures 71 to 87 The 6540 padding is joined Figures 88 to 93 The framework for 2020.

[0223] 3. Sealing device

[0224] The sealing device 40 is configured to mate with the frame 20 and form a seal with the patient's nose during use. In this example, the sealing device 40 provides a nasal interface adapted to engage with the patient's face generally along the bridge of the nose, cheek, and upper lip region. However, other interfaces, such as a full-face interface, may also be used. The sealing device provides a compliant means adapted to seal relatively quickly during use and maintain the seal. In one example, the sealing device may be configured as an air pressure seal or a non-air pressure seal.

[0225] 3.1 Silicone Gasket

[0226] exist Figures 1-1 to 1-4 In the example, the sealing device 40 includes a liner 42 typically made of a flexible material, including but not limited to silicone, TPE, gel, or other materials. The liner may be molded from a material with a Type A hardness of approximately 35 to 45, for example, approximately 37 to approximately 42, preferably approximately 40. The liner 42 defines a breathing chamber or cavity suitable for accommodating a patient's nose and providing air exchange for the patient.

[0227] The face-contact side of the liner 42 includes a double-walled construction, wherein the liner includes a base liner 44 and a diaphragm 46 that at least partially covers the base liner (see, for example, see...). Figure 1-4 The diaphragm is typically softer and less rigid than the base liner, and provides a seal that conforms to the patient's face during use. The base liner is configured to substantially support the diaphragm and prevent it from collapsing when the headband is attached and tightened to the nasal mask system. In one example, the base liner may be placed only in selected areas of the mask system, such as along the cheek area, or no base liner may be placed at all. Furthermore, the liner may be frosted (e.g., to improve wearability and comfort) and / or dyed.

[0228] Figure 1-4 A cross-section of the cheek region on the face-contact side of the liner 42 is shown. As illustrated, the liner comprises a sickle-shaped or question mark-shaped construction having a base 60 and an upper portion 62 radially offset outward from the base 60, for example, to reduce size and visual volume, minimize dead zones within the respiratory chamber, and / or increase the flexibility of the base liner and diaphragm during use. This cross-section may be positioned around the entire perimeter of the liner or only in selected areas of the liner. In one example, the question mark-shaped cross-section in the upper lip region may include a smaller curvature, for example, to prevent the liner from drooping over the patient's mouth and to prevent nasal obstruction.

[0229] In one example, for instance, the gap or spacing 45 between the diaphragm 46 and the base liner 44 can be adjusted (see, for example, see...). Figure 1-4To reduce wrinkles and leaks. For example, the gap can be relatively small so that the diaphragm closely conforms to the geometry of the underliner. In one example, the underliner can be molded with a larger gap; however, the diaphragm is preloaded to hinge closer to the underliner after molding. In another example, bellows 64 (as...) Figure 1-4 (As shown by the dashed line) can be set or molded together with the diaphragm to bias the diaphragm closer to the base liner.

[0230] The non-face contact side or frame side of the pad 42 includes one or more mating structures adapted to mat or detachably connect to the frame 20. In the illustrated example, the pad 42 includes, for example, one or more elongated and spaced-apart protrusions 50 along its sides and bottom, said protrusions 50 adapted to engage or interlock with corresponding openings 27 along the sidewall 26 of the frame 20. Figure 1-1 and Figure 2-1 As shown, this configuration provides positive reinforcement for an established connection because the user can visually see the connection and, optionally, may produce a click sound upon proper connection. Furthermore, the gasket 42 includes a notch or groove 52 arranged along its top, adapted to engage or interlock with a bead or catch on the inner side of the frame sidewall 26 (not shown) to aid alignment or even prevent displacement. However, it should be understood that the gasket can be connected or interlocked with the frame in other suitable ways.

[0231] For example, U.S. Patent No. 7,000,614 discloses a possible configuration for connecting the pad 42 to the frame 20, the entire contents of which are incorporated herein by reference.

[0232] The non-face contact side of the pad 42 also includes an opening 55 adapted to receive or otherwise communicate with the bend 70 as described below.

[0233] Figures 1-5 to 1-12 A liner roughly similar to the liner 42 described above is shown and labeled with the same reference numerals. The difference is that... Figures 1-5 to 1-12 The liner does not include notches or grooves arranged along the top.

[0234] As shown in the figure, the face-contact side of the liner (i.e., including the diaphragm 46 and the base liner 44) can be co-molded or formed separately and connected to the non-face-contact side of the liner (i.e., defining the opening 55 and the breathing chamber). Preferably, the face-contact side and the non-face-contact side of the liner are formed as a single component. Preferably, this single component can be made of a flexible sealing material that has relative biocompatibility when in contact with the patient's skin, including but not limited to silicone resins.

[0235] Figures 1-9 to 1-12 The cross-sections of the cut-out gasket are shown. (Example) Figure 1-9As shown, the liner may not include a base liner in the bridge of the nose area. Furthermore, as... Figure 1-9 As shown, the curvature and / or length of the septum and base pad in the upper lip region can be selected based on factors such as wearing range, comfort, and prevention of nasal obstruction. Conversely, compared to the upper lip region, the curvature of the septum in the bridge of the nose region can be more gentle and / or the length can be greater, for example, to increase seal stability and wearing range. This is because the pad must accommodate various bridge of the nose heights, including high and flat bridges, thus requiring a longer septum in the bridge of the nose region. There is no base pad in the bridge of the nose region to allow for greater flexibility and apply less force to the sensitive area, i.e., the bridge of the nose. Patients have less variation in anthropometric dimensions in the top lip region, therefore the length of the septum is shorter than in the bridge of the nose region. The base pad is placed in the top lip region to assist in stabilizing the pad in the proper position on the patient's face.

[0236] Figure 1-11 and Figure 1-12 The cross-sectional structure of the cheek area on the face contact side of the liner is clearly shown in a sickle or question mark shape, while... Figure 1-9 and Figure 1-10 The upper lip area, which generally lacks this construction, is shown. The cheek area requires a sickle shape to provide greater flexibility to the pads, accommodating variations in the anthropometric dimensions of the patient's face. For example, some patients may have generally flat faces, thus requiring the pads to be able to flex from their basic curved contour to a flatter contour. The cheek area will need to flex inward or downward. Alternatively, for patients with thin or narrow-fronted-wide-backed cheeks, they do not require the same amount of pad flexion. In both options, the patient should experience approximately the same level of comfort and pressure from the pads on the face. The increased flexibility of the sickle shape allows the pads to deflect within a certain range while applying approximately the same force feedback to the patient's face.

[0237] In addition, the lip seal 57 can be provided inward from the opening 55 so that it can fit against the bend to form a seal during use.

[0238] 3.2 Foam pads with silicone diaphragms

[0239] In an optional example, such as Figure 2-1 , Figure 2-2 and Figures 2-4 to 2-8 As shown, the sealing device 40 may include a foam liner 241 and a silicone liner or diaphragm 242.

[0240] The silicone liner 242 defines a breathing chamber and is adapted to support or otherwise retain the foam liner 241. (Example) Figure 2-6As best illustrated, the face-contact side of the silicone pad 242 provides a double-walled construction, including a base pad 244 and a diaphragm 246. The non-face-contact side of the silicone pad 242 includes an opening 255 adapted to receive or otherwise communicate with the bend 70.

[0241] The base liner 244 and adjacent sidewalls 247 extending from the base liner 244 are configured to retain the foam liner 241. The base liner 244 bends outward from the sidewalls 247 and away from the breathing cavity to provide a groove 248 opposite to the diaphragm 246 that bends inward into the breathing cavity. As shown, at least the patient side of the foam liner 241 is inserted into the groove 248 defined by the base liner 244 (e.g., see...). Figure 2-2 and Figure 2-6 The inner surface of the foam pad 241 is supported by the sidewall 247. The foam pad 241 can be held in place by interference and / or frictional engagement with the silicone pad 242. The foam pad 241 is positioned below the diaphragm 246 and inside the bottom pad 244, but not in the air passage or breathing chamber. In use, the foam pad 241 can absorb forces, for example, applied to the bottom pad 244 along the cheek area of ​​the silicone diaphragm.

[0242] The non-patient side of the foam pad 241 supports the foam pad 241, and thus the silicone pad 242, against the frame 20. As shown, the foam pad 241 includes one or more mating structures adapted to mat or detachably attach to the frame. In the illustrated example, the foam pad 241 includes, for example, one or more spaced-apart elongated protrusions 250 along its side, adapted to engage or interlock with corresponding openings 27 arranged along the sidewall of the frame 20. However, it should be understood that the foam pad can be connected or interlocked to the frame in other suitable ways, or the frame can be connected to the silicone pad in a manner that engages with the foam pad.

[0243] In one example, the outer lip 249 of the silicone pad 242 (see, for example, see...) Figure 2-5 (i.e., the junction between the diaphragm and the base liner) can be configured to engage with the outer edge of the frame 20 so that the silicone liner 242 and the frame 20 encapsulate the foam liner 241.

[0244] In one example, such as in the bridge of the nose area of ​​the silicone liner, an accordion or corrugated configuration can be provided to offer greater flexibility or increase the range of motion during use without affecting the seal. For example, the silicone liner may include an accordion-style section, as described in PCT application No. PCT / AU2009 / 000241, filed February 27, 2009, the entire contents of which are incorporated herein by reference.

[0245] In one example, corrugations may be provided in the upper lip region of the septum and / or base liner of the silicone liner, for example, to prevent nasal blockage.

[0246] Foam pad 241 may comprise skinned or non-skinned foam. Foam pad 241 may be open-cell foam, closed-cell foam, or a combination of both. Foam pad 241 may be punched, molded, or die-cut. Foam pad 241 may be made of polyurethane foam, silicone foam, or any other suitable material. Foam pad 241 may be made of the same material or a combination of materials, such as two foams with different properties. For example, protrusion 250 may be made of a denser or stiffer foam than the rest of foam pad 241.

[0247] The liner 242 may also be made of materials other than silicone. For example, the liner 242 may be made of TPE, gel filler, or any suitable material.

[0248] 3.3 Single-size universal gasket

[0249] According to one embodiment of the invention, the pad can be constructed to fit a wide range of patient faces in a single size, i.e., it can accommodate a large number of anthropometric dimensions.

[0250] The base liner may include an elongated slit or may be made of multiple individual narrow sections or fingers, which may be configured such that the force applied by the user when wearing the mask causes the fingers to spread outwards. The fingers are configured to spread outwards, thereby compressing or supporting the diaphragm over a large area of ​​the patient's face. Furthermore, the fingers may be configured to bend, flex, and move into gaps and folds in the patient's face (e.g., wrinkles on the patient's skin or wrinkles on the nasal side when the nostrils are open), thereby supporting a seal in areas that are typically difficult to seal.

[0251] Figures 71-87 A pad 6540 according to an embodiment of the invention is shown. As detailed below, the pad 6540 provides a nasal inlet adapted to generally lie along the bridge of the nose region NB, the lateral nasal region SN (including the upper and lower sides of the nose), the nasolabial fold or nasal corner region CN, and the upper or crown lip region UL (e.g., see...). Figure 74 , Figures 78 to 82 and Figures 94 to 98 (Joint the patient's face)

[0252] The face-contact side of the pad 6540 includes a double-walled construction, wherein the pad includes a base pad 6544 and a diaphragm 6546 that at least partially covers the base pad 6544. In the illustrated embodiment, the base pad is not disposed in the bridge of the nose region NB, see, for example, [reference needed]. Figure 79 and Figure 95 For example, such as Figure 79 As shown, the free end of the diaphragm 6546 may include a sealing strip 6546(1). Including the sealing strip allows the orifice defined by the diaphragm to be molded into the gasket, thus forming the orifice without additional cutting. In the illustrated embodiment, the diaphragm is relatively thin, for example, from about 0.2 mm to about 0.35 mm.

[0253] The padding may include one or more sickle-shaped areas, for example, see Figures 79 to 82 The upper lip, sides of the nose, and corners of the nose. When in use, the sickle shape of the pad provides a hinged turning or flexural portion 6567 (see, for example, see...). Figure 98 This design facilitates control of gasket deformation during use. Furthermore, this sickle shape allows one or more portions of the gasket to hang over the frame 2020 (see, for example, see...). Figures 95 to 98 This allows the frame to support one or more portions of the padding that deform during use. In one configuration, this arrangement provides a less rigid bottom padding to reduce the likelihood of the padding bottoming out over the range of displacement during use, thus making the padding more comfortable.

[0254] Figure 117 A curved portion or curved area BP of a bottom pad or auxiliary strip 6544 according to an embodiment of the present invention is shown. Figure 118 , Figure 119 and Figure 120 The curved section BP of the base liner is shown in other configurations. Different cross-sections can be used in different areas.

[0255] Preferably, Figure 117 The configuration shown is for the top lip region of the underlay or auxiliary strip. This configuration can be described as a double cantilever depending on the relative thickness of the different sections. Increasing the thickness increases rigidity. The shape of the cross-section can be configured to extend laterally or radially outward along the adjacent sidewalls, or in a manner such as... Figure 118 Another configuration shown is more aligned with the adjacent sidewalls and has a similar radially outward extension by configuring the adjacent sidewalls to fold inward or bend.

[0256] Preferably, Figure 119 The cross-section shown is suitable for use along the nasal side. This configuration allows for the application of increased lateral force to seal areas of the face that are difficult to seal. This configuration can be described as a three-cantilever structure that depends on the relative stiffness of the different sections.

[0257] Figure 120 An optional configuration is shown, which can be described as a single cantilever.

[0258] The non-face contact side or frame side of the pad 6540 includes an elongated protrusion or locking tongue 6550 arranged along its side for engaging or interlocking the frame 2020 to secure the pad in place, see, for example, [link to relevant documentation]. Figure 97 and Figure 98 The gasket 6540 also includes a raised retaining tongue arranged along its underside for mating or engaging the frame (see, for example, see...). Figure 97 and Figure 98 ); and a raised top tongue 6554 located at the apex of the pad for mating or joining the frame. Figure 95 A tongue 6554, which engages with the frame 2020, is shown to help hold the gasket on the frame. Additionally, the raised top tongue 6554 can also assist in the mechanical demolding of the gasket from the mold. However, it should be understood that the gasket can be connected, interlocked, and / or aligned with the frame in other suitable ways.

[0259] The non-face contact side of the pad also includes an opening 6555, adapted to receive or otherwise communicate with a bend in the tube. As shown, this opening can be fitted with a vent device, such as... Figure 13-1 and Figure 13-2 As shown. However, it should be understood that the gasket can have an optional vent configuration, such as... Figures 55 to 59 As shown.

[0260] bridge of the nose area

[0261] like Figure 79 The best illustration shows that the length or depth d1 of the nasal bridge region septum 6546 is in the range of approximately 10 mm to 30 mm, for example, 15 mm to 25 mm, 19 mm to 20 mm, or 19.58 mm. As shown, the depth d1 extends from near the starting position of the septum (i.e., the position where the thin seal can flex / hinge from the connection 6547) to the tangent of the patient contact area. The depth d1 of the nasal bridge region septum is relatively greater than the septum depth of similar products in the art and has been optimized to accommodate variations in anthropometric dimensions. For example, a relatively high nasal bridge can extend further into the septum, while a relatively low nasal bridge can be attached to the septum, with little or no flexion of the septum.

[0262] When viewed from above, the geometry or curvature of the nasal bridge septum 6546 is also configured to fit a wide range of patient faces. For example... Figure 75 The best illustration (showing the fan-shaped or curvature of the bridge of the nose and the protrusion 6549 of the nasal side region) shows that the depth d2 in the bridge of the nose is in the range of about 10 mm to 15 mm, for example 11 mm to 12 mm, such as 11.52 mm, and the width d3 in the bridge of the nose is in the range of about 10 mm to 20 mm, for example 15 mm to 16 mm, such as 15.35 mm.

[0263] Depth d2 is sufficient to accommodate the flattest nose, so that the edge of the septum will be located on the bridge of the nose, and the protrusion 6549 will be located on the corresponding nasal side. Higher bridges of the nose will be anchored on the nasal side at the protrusion, and the septum in the bridge of the nose region will flex to allow the bridge of the nose to move into the septum in the bridge of the nose region and stop somewhere within region z.

[0264] A width d3 is sufficient to accommodate a wide nasal bridge. The protrusion 6549 will be anchored at the side of the nose, and then the septum will flex or stretch to conform to the nasal bridge. Choose a width d3 that fits the widest nose so that the protrusion is always positioned on the harder bone tissue below the eye socket, thereby anchoring, stabilizing, and positioning the pad in the desired location.

[0265] In use, in a preferred configuration, since the base pad does not substantially support the septum or sealing flap in the nasal bridge region, the septum tensions at the highest point of the nasal bridge when the nose is moved to the sealing position. Moreover, preferably, the septum "contracts" on the nasal side in the region adjacent to the highest point of the nasal bridge. The lateral force on the nasal side can be configured to vary with the height of the nasal bridge. A deeper nasal bridge further pushes the septum forward, thereby increasing the tension in that area and pulling the side of the pad flexed or cantilevered inward, increasing the lateral force and improving the nasal side seal. For faces with relatively low nasal bridges and high cheekbones, the pad region adjacent to the nasal bridge can be flared outward, thereby increasing the tension in the septum and thus increasing the seal on the relatively low nasal bridge. In a preferred configuration of the invention, the auxiliary band or base pad is able to flex more freely inward and outward in the region adjacent to the nasal bridge compared to prior art pads. See also Figures 116-1 to 116-3 .

[0266] Nasal side

[0267] Specifically, due to the curvature of the face transitioning from the nose to the cheeks, the nasal-side underlay 6544 has been constructed to anchor, position, and stabilize the septum. This curvature varies from patient to patient. The underlay positions the septum and maintains its contour shape to prevent wrinkling.

[0268] The underlay 6544 has a flap or extension 6545 wider than other areas of the underlay, such as the nasal corner area or the pars labial area. This configuration ensures that a very narrow nose contacts the septum in the area supported by the underlay and ensures a smooth transition of the septum from the nose to the cheek. A wider nose will contact a larger area of ​​the septum, thus a larger portion of the underlay will support the septum.

[0269] Figure 74Exemplary dimensions are shown to indicate the approximate location of the flap 6545 of the base liner. In one embodiment, d4 is approximately 5 mm to 15 mm, such as 9 mm to 10 mm, such as 9.26 mm; d5 is approximately 10 mm to 15 mm, such as 12 mm to 13 mm, such as 12.80 mm; d6 is approximately 20 mm to 25 mm, such as 22 mm to 23 mm, such as 22.10 mm; and d7 (e.g., the distance from the bottom of the flap to the top lip region) is approximately 10 mm to 20 mm, such as 15 mm to 16 mm, such as 15.58 mm. Figure 75 An exemplary distance d8 from the top of flap 6546 to the approximate contact point of the pad in the parietal lip region is also shown. Typically, the pad is located in approximately the same position on the patient's parietal lip, but the position of the pad on the bridge of the nose may vary. Accordingly, the distance between the flap and the parietal lip region is large enough to be located nasally.

[0270] Figure 83 This is a cross-sectional view of the widest portion of the flap 6545 of the base liner 6544. As shown, the flap has a relatively large radius to allow the base liner to roll or flex easily inward, thereby avoiding undue pressure on the nasal side (e.g., pressure that could obstruct the nostrils or cause a pinching sensation). In one embodiment, the radius r1 of the outer surface is approximately 12 mm to 20 mm, for example, 16 mm; and the radius r2 of the inner surface is approximately 8 mm to 16 mm, for example, 12 mm. Furthermore, the thickness t1 of the free end of the flap is approximately 0.5 mm to 1.5 mm, for example, 0.9 mm, to facilitate flexion; and the thickness t2 from the free end of the flap inward is approximately 1.0 mm to 1.5 mm, for example, 1.2 mm, to promote hinged rotation of the base liner rather than collapse.

[0271] The length of flap 6545 is the distance from the tip of the flap to its connection with the frame or the front of the padding. The length of the flap is approximately 10 mm to 30 mm. Preferably, the length of the flap is approximately 15 mm to 25 mm. Most preferably, the length of the flap is approximately 18 mm to 23 mm. Most preferably, the length of the flap is approximately 20 mm.

[0272] nose wrinkles or corners

[0273] The liner located in the folds or corners of the nose has been constructed to stabilize or anchor the mask in this area. Furthermore, sealing the folds or corners of the nose is difficult due to the complex geometry of this area of ​​the face, where the nostrils are open, and the roof of the mouth and cheek areas converge at skin depressions and / or folds. The liner in this area is more rigid to support the septum, thus positioning the septum close to or conforming to this complex geometry. Figure 84As shown (illustrating half of the base liner), the base liner in the nose corner region includes a locally thickened portion to increase its rigidity. In one embodiment, the local thickness t3 can be approximately 1 mm to 2 mm, for example, 1.4 mm. Furthermore, Figure 81 and Figure 82 The underlay in the nose corner region CN is shown, along with its relatively thick thickness and relatively small radius.

[0274] Figure 85 This is a cross-sectional view of the nose corner region of the substrate 6544. In one embodiment, the radius r3 of the outer surface is approximately 5 mm to 15 mm, for example, 8 mm; the radius r4 of the inner surface is approximately 2 mm to 8 mm, for example, 4.85 mm. Furthermore, the thickness t4 of the substrate tip is approximately 0.5 mm to 1.5 mm, for example, 0.85 mm; and the thickness t5 of the substrate peak is approximately 1 mm to 2 mm, for example, 1.4 mm. The relatively large thickness t5 of the peak stabilizes the diaphragm and allows for hinged rotation about this location, rather than hinged rotation about the base b of the substrate.

[0275] upper lip or vertex lip area

[0276] like Figure 79 and Figure 95 The best illustration shows that the underlay in the upper lip or crown lip region UL has been constructed to accommodate sensitive oral gingival tissue. Therefore, the thickness of the underlay in this region is approximately 0.5 mm to 1.0 mm, for example, 0.7 mm. The thickness of the underlay in the crown lip region can be the thinnest relative to other regions of the underlay. The radius of the underlay in the crown lip region is relatively large so that the underlay adheres to the crown lip region rather than being anchored there. In one embodiment, the radius of the crown lip region may not be constant; for example, the radius r5 at its center is approximately 65 mm to 75 mm, such as 72.71 mm, and the radius r6 towards the nasal corner region is approximately 30 mm to 40 mm, such as 36.85 mm.

[0277] The mask according to this technology can adapt the sealing force according to the size and shape of the wearer's face and nose. For example, in the top lip area, the sealing force can be the result of the combined effect of the compressive force of the base pad or auxiliary band and the tension force of the septum or facial flap. A wider nose can cause the corners of the pad to flare outward and increase the tension applied to the face to achieve a seal. This configuration can be adapted to flatter facial shapes in this area.

[0278] Relationship between diaphragm and backing

[0279] In the illustrated example, the distance between the septum and the underliner can vary in different areas of the liner; that is, the gap between the septum and the underliner can vary in different areas of the liner. In areas with greater variability in facial anatomy (e.g., the top and sides of the nose), a larger gap can be provided to allow additional area for septal deflection. Furthermore, in some areas, such as the top lip region where the septum tends to stretch or exert tension on the top lip, a smaller gap can be provided to allow less deflection, thus providing more support for the septum. Figure 76 and Figure 79 Exemplary distances for the gaps between the liner and the underliner are shown in different areas of the liner. In one embodiment, distance d9 is approximately 5.8 mm to 6.0 mm, for example, 5.89 mm; d10 is approximately 4.8 mm to 5.0 mm, for example, 4.93 mm; d11 is approximately 4.2 mm to 4.4 mm, for example, 4.29 mm; d12 is approximately 4.0 mm to 4.2 mm, for example, 4.06 mm; d13 is approximately 3.2 mm to 3.4 mm, for example, 3.3 mm; d14 is approximately 3.4 mm to 3.6 mm, for example, 3.49 mm; d15 is approximately 3.7 mm to 3.9 mm, for example, 3.76 mm; and d16 is approximately 3.7 mm to 3.9 mm, for example, 3.76 mm.

[0280] Sealing force

[0281] Figure 86 and Figure 87 This is a schematic diagram illustrating the exemplary sealing force of a liner in use, viewed from the side and front of a patient's nose.

[0282] like Figure 86 As shown, the liner in the bridge of the nose area is not sealed along the sellion or the sloping part of the nose indicated by A, but rather along the lower part of the bridge of the nose indicated by B. Because the liner is sealed along the lower part of the nose area, the base liner has a relatively large incision in the bridge of the nose area (see, for example, see...). Figure 74 (Incision 6557). That is to say, the lower part of the nose is wider, so the width of the incision is wide enough to accommodate a wide range of patients.

[0283] The septum in the nasal bridge region includes a stretching function to apply force to the patient's nasal bridge; that is, the stretching or elasticity of the septum is used to apply force to the nasal bridge, rather than to the base liner as in other areas of the liner. For example, the liner is pushed up against the patient's face until there is no gap or gap between the septum and the base liner. Because there is no base liner in the nasal bridge region, the septum stretches when the liner is pushed up against the patient's face, meaning the septum spans... Figure 75 The protrusion 6549 shown extends. The extended or inflated diaphragm provides a taut, trampoline-like diaphragm section to apply force to the bridge of the nose.

[0284] For example, Figure 116-1 , Figure 116-2 and Figure 116-3 This illustrates the seal achieved through stretching and tensioning in the NB area of ​​the nose bridge. Figure 116-1 The padding before contact with the patient's nose is shown. As shown, the septum or facial flap 6546 is separated from the base padding or auxiliary band 6544. Figure 116-2 The nose is shown in contact with diaphragm 6546, thereby causing the diaphragm to engage with the underlay, so that the diaphragm in a tensioned state (shown as a point load in the figure) crosses the gap defined by the underlay in the bridge of the nose region. Figure 116-3 As shown, as the nose is pushed further into the padding, the bottom padding acts as a cantilever spring and begins to bend (as shown in the figure as a point load).

[0285] The diaphragm surface can be sanded or polished to create friction and enhance the sealing effect. Polishing the mold surface can produce a more tacky or adhesive feel and increase friction. By increasing the roughness of the mold surface, a sanded sealing surface can be provided. In some areas, a sanded surface may be preferred.

[0286] like Figure 87 and Figure 87-2 As shown, the curved flap 6545 with a base liner is configured to provide a seal over the nasal vent indicated by C on the nasal side. The curved flap is advanced and / or rolled to the nasal side and around the nose (excluding the bridge of the nose area). There is no base liner from the top of the flap to its apex. The gap G between the flaps is sized to suit the user with the smallest nose, i.e., the gap is narrow enough to ensure that the flap has a wide range of nasal contact with the patient. In one embodiment, the gap G is approximately 10 mm to 30 mm, for example 15 mm to 25 mm, such as 18.5 mm.

[0287] As a result of the preferred relatively large radius flap 6545, each flap defines a curved portion suitable for a low-bridged nose type, which is sufficiently spaced from the rigid portion of the lateral wall. In use, each flap bends or curls without the low bridge of the nose touching the rigid portion of the lateral wall. Figure 87 -1(a) shows an exemplary deformation of the flap suitable for a low nasal bridge. Figure 87 -1(b) illustrates an exemplary deformation of a flap suitable for a high nasal bridge. This configuration is quite different from the liner known in the prior art, which has a smaller radius, allowing a wider / lower nose to meet a harder area of ​​the sidewall.

[0288] like Figure 87As shown, the thickened base liner in the nasal corner area provides a seal at the nasal crease indicated by D on the patient's facial plane. This area of ​​the face is less sensitive and can withstand greater force to stabilize the mask on the patient's face. For nasal liners, sealing at the nasal crease is crucial, whereas this area is omitted with full-face liners. Therefore, the base liner is relatively firm in the nasal corner or crease area to fill the crease and force the liner into the patient's facial plane for sealing and stability. Furthermore, the liner in the crease area includes a sickle shape (e.g., see...). Figure 82 ), to provide controllable deformation during use.

[0289] Used on the patient's upper lip ( Figure 86 The underlay in the lip area (shown in E) that provides a seal is relatively soft to increase comfort.

[0290] The shape, size, curvature, and / or thickness of the underlay can be varied to alter the force in different areas of the face.

[0291] 3.4 Optional sealing devices

[0292] Figures 5-1 to 5-6 An alternative embodiment of the sealing device 440 is shown. The sealing device 440 may include one or more protrusions 450 configured to be received in an opening in the body 422 of the frame 420 in a manner similar to that described above. The sealing device 440 may also include the gasket described above. For example, the sealing device 440 may include the bottom gasket and diaphragm described above, or a foam gasket and a silicone gasket.

[0293] The liner may have a double-walled seal, and the base liner in the bridge of the nose area may be cut off or removed. The base liner on the upper cheek or nasal side may be raised to stabilize the liner on the patient's face. The liner may have a polished outer surface and a rough inner surface. The liner may be made of silicone or any suitable material.

[0294] 3.5 Optional padding

[0295] exist Figure 11-1 In the middle, each side of the pad 540 includes a protrusion 550, which provides a retaining member adapted to interlock with the frame in the manner described above. The top of the frame includes a platform 541 for marking and pad retention, and each side of the frame includes a cup-shaped portion 543 for auxiliary retention and aesthetic integration with the platform located at the top of the frame.

[0296] Figures 11-2 to 11-9 Views of a liner 540-1 according to another embodiment are shown. Figure 11-8 and Figure 11-9As best illustrated, the face contact portion of the pad (e.g., diaphragm 546, bottom pad 544, and sidewall 542) is provided with a sickle-shaped or question mark-shaped construction to enhance comfort and flexibility.

[0297] like Figures 11-6 to 11-9 As best illustrated, gasket 540-1 includes an impact-absorbing portion 545 located in front of the gasket, i.e., the portion between the seal and the bend. The impact-absorbing portion is a thinned area, for example, with a thickness of 1 mm, while the rest of the gasket has a thickness of 2 mm to 3 mm.

[0298] Figures 15-1 to 15-3 The following are views of the pad 540-1 already engaged with the frame. Similar to the configuration described above, the pad includes a protrusion 550 adapted to engage or interlock with a corresponding opening arranged along the side wall of the frame 520.

[0299] In one embodiment, the underliner located in the top lip area can be removed to prevent discomfort caused by pressure on the patient's top lip when using the liner.

[0300] In one embodiment, the patient side of the liner may include a frosted surface, while the non-patient side of the liner may include a polished surface.

[0301] 3.6 Another optional pad

[0302] Figures 33 to 39 An embodiment of the pad 2010 is shown. The pad 2010 can be designed to fit a wide range of patients in a single size. To achieve this, the various areas of the pad 2010 can be customized to comfortably fit larger and smaller noses by flexion and adjustment.

[0303] In use, the diaphragm 2040 contacts and seals against the patient's face. The nasal bridge region 2041 is configured to be adjacent to the bridge of the nose or the top of the patient's nose during use. The nasal bridge region 2041 is elastically deformable, thus allowing it to stretch across the patient's nose during use. During use, the raised side 2042 can engage and compress the patient's nasal side near the eyes. This compression force allows the pad to be stably engaged with the patient's nasal side. For wider noses, the compression force can also allow the nasal bridge region 2041 to stretch across the patient's nasal bridge. Alternatively, the nasal bridge region 2041 can be attached to or adjacent to the patient's nose without stretching. Furthermore, the nasal bridge region 2041 can be deeper or longer so that patients with high nasal bridges can position their noses on the diaphragm and flex the nasal bridge region 2041 of the diaphragm on a longer nasal bridge during use.

[0304] The lateral flap 2043 extends longer or further into the mask liner, allowing the liner to seal a relatively flat or shallow nose when in use. The lateral flap 2043 can be flexible so that it can bend into the liner when the patient has a high nasal bridge.

[0305] The apex 2046 on the septum can be a raised portion or area that is higher than other areas of the septum. This ensures that the pad is secured at the corner of the user's nose near the nostrils or where the nostrils are open during use.

[0306] The upper lip region 2044 is located below the septum and, in use, it can engage or adhere to the user's upper lip. The curvature can be swept to conform to the various geometries of the patient's upper lip.

[0307] The flexible portion 2045 can be positioned near the connection of the bend or the swivel on the gasket 2040. The flexible portion 2045 can be an area made of a thinner or more flexible material to allow the tube to separate from the gasket.

[0308] Locking tongue 2601 may be located on at least a portion of the front area of ​​the pad. Locking tongue 2601 may have a raised profile or peak for securing the pad in place when assembled with the frame.

[0309] The retaining tongue 2661 may also be positioned on at least a portion of the front area of ​​the pad. The retaining tongue 2661 may also be higher than other portions of the pad to butt or otherwise engage the frame.

[0310] The top tongue 2651 may be a protrusion positioned at the apex of the gasket. The positioning of the top tongue 2651 should take into account factors such as facilitating mechanical demolding of the gasket and engagement with the frame.

[0311] A vent ring or swivel 2090 may be positioned at an opening in the liner to receive a bend or to supply breathable gas. The vent ring 2090 may be molded together with the liner 2010 or otherwise permanently attached to the liner 2010. The vent ring 2090 may have a plurality of vents arranged around at least a portion of its perimeter to allow gas to escape from the mask system.

[0312] Figures 40 to 45 The above-mentioned pad 2100 and frame 2020 are shown assembled together according to an embodiment of the present invention.

[0313] 4. Pipe bend

[0314] The bend 70 includes a first end 72 and a second end 74, see, for example, see Figure 1-2 , Figure 2-2 and Figure 2-5 The first end 72 is provided with a mating structure configured to connect to or otherwise join with the sealing device 40. The second end 74 is adapted to connect to an air delivery pipe. The first part is at an angle of approximately 135° relative to the second part. However, the first and second parts of the bend can be at other suitable angles relative to each other, such as 0°, 90°, 120°, etc.

[0315] In one embodiment, the bend may be similar to the bend disclosed in PCT application No. PCT / AU2008 / 001557, filed on October 22, 2008, the entire contents of which are incorporated herein by reference.

[0316] 4.1 Bend connection of sealing device

[0317] The sealing device 40 is configured to hold the bend 70 in a working position relative to the patient's face. That is, the sealing device acts as a carrier and support surface for the bend 70. The sealing device and the bend can be connected by friction fit, snap-fit ​​fit, mechanical interlock, or other suitable connection mechanisms. However, other suitable configurations can be used to connect the bend to the sealing device.

[0318] In the illustrated example, the swivel 90 is configured to connect the bend 70 and the sealing device 40. The swivel 90 is an optional component, and it should be understood that the bend 70 can be directly connected to the sealing device without using the swivel.

[0319] like Figure 2-5 In the best illustration, the swivel ring 90 includes an annular groove 92 along its outer circumference, adapted to interlock defining the opening 255 of the silicone pad 242 (or Figures 1-1 to 1-4 The swivel 90 has an annular flange 256 (opening 55 in the gasket 42). The inner circumference of the swivel 90 provides a relatively smooth annular surface 94 suitable for engaging the outer surface of the first end 72 of the bend 70. The free end of the first end 72 provides an annular sealing strip 73 for engaging the inner shoulder of the swivel 90, for example, in a snap-fit ​​manner. This connection holds the bend in place (e.g., preferably a relatively airtight connection) and allows the bend to rotate or tumble relative to the sealing device.

[0320] The swivel is made of a material that is more rigid than the sealing device (e.g., plastic, silicone, foam). This device facilitates the connection of bends, such as connecting a rigid bend to a rigid swivel, rather than connecting a rigid bend to a flexible sealing device. In one example, the swivel may be co-molded, mechanically overmolded, and / or chemically bonded together with a sealing diaphragm or gasket, for example, to reduce the number of parts. Alternatively, the swivel may be configured as a separate part, for example, allowing for disassembly.

[0321] Furthermore, the area around the opening 55 / 255 may include some flexibility to allow the bend to separate from the rest of the mask system, for example, to reduce tube drag. For example, the separation mechanism between the pad 55 and the bend 70 may include a flexible balancing ring or diaphragm on the pad 42 in the area of ​​the opening 55. A similar separation mechanism is disclosed in U.S. Patent Application No. 12 / 379,940, filed March 4, 2009, the entire contents of which are incorporated herein by reference. The thickness of the balancing ring area may be one-third of the pad thickness adjacent to the balancing ring area. Preferably, the thickness of the balancing ring may be less than one-third of the pad thickness adjacent to the balancing ring area. Most preferably, the thickness of the balancing ring is less than half the pad thickness adjacent to the balancing ring area. Figure 79 , Figure 96 and Figure 98 Another exemplary balancing ring region 6565 is shown in front of the gasket 6540 located between the seal and the bend opening. As shown, the balancing ring region includes a thicker region and a thinner region, with the thinner region facing the bend opening.

[0322] The sealing mechanism between the gasket and the bend can be similar to the sealing mechanism disclosed in U.S. Patent Publication No. US 2006 / 0201514, the entire contents of which are incorporated herein by reference.

[0323] Figures 4-1 to 4-4 An optional configuration for connecting the bend 70 and the gasket 42 is shown. Figure 4-1 In the middle, the gasket 42 includes an interference lip seal 57 extending inward from the opening 55, adapted to fit the end seal of the bend 70 in use. Figure 4-2 It shows Figure 4-1 Optional sealing configuration of the lip seal 57. As shown, the lip seal 57(1) can conform to the end seal of the bend 70, for example, with Figure 4-1 The configuration is similar. Alternatively, the lip seal 57(2) can be configured as a perimeter seal around the bend 70. Figure 4-3 A bend 70 is shown connected to a gasket 42 via a swivel 90 as described above. In this embodiment, the gasket provides an inwardly extending interference lip seal 57 adapted to fit and seal the end of the bend 70 in use. Figure 4-4 One configuration is shown in which the swivel 90 provides an inwardly extending lip seal 91 adapted to maintain a circumferential seal around the bend 70 during use.

[0324] In the example, the rotor can be positioned at the second end of the bend and is adapted to connect an air delivery pipe. Figure 4-5 An example of a 95-degree rotation is shown. Figures 4-6 to 4-9 An optional configuration is shown where a seal is formed between bend 70 and rotor 95. (As shown) Figure 4-6As shown, the lip seal 96 can be provided (e.g., co-molded) on the inner surface of the rotating body 95 for sealing the bend. Figure 4-7 As shown, the rotating body 95 may include flanges 97(1) and 97(2) adapted to suspend corresponding ends of the bend 70. In this embodiment, the bend 70 defines a groove 71 for receiving and holding the ends of the rotating body 85. Figure 4-8 In the rotating body 95, the end includes a resilient clip 98 adapted to clamp onto the flange 73 of the bend 70. Furthermore, a lip seal 96 may be provided on the inner surface of the rotating body 95 for sealing the bend 70. The lip seal 96 may be configured to engage with the bend 70 under bias during use. Figure 4-9 A rotating body 95 is shown, wherein an inner lip seal 96 is formed separately from the rotating body 95 and is connected to the rotating body 95 by means of, for example, rotational welding or adhesive bonding.

[0325] 4.2 Ventilation port configuration

[0326] like Figure 1-1 and Figure 1-2 As shown, the bend 70 includes a vent configuration for gas washing. The vent configuration 75 includes multiple holes (e.g., 5 to 100 holes, 20 to 50 holes, or approximately 45 holes). Figure 2-5 As shown, each hole may include a profile or a tapered shape along its length. However, it should be understood that the vent configuration may include other suitable configurations, such as different numbers of holes, hole configurations, vent plugs with one or more vents, etc.

[0327] For example, the vent could also be a diffuse vent disclosed in U.S. Patent Publication No. US 2009 / 0050156, the entire contents of which are incorporated herein by reference.

[0328] 4.3 Optional bends

[0329] Figures 12-1 to 12-3 Views of an embodiment of a ventless bend are shown. Figures 12-4 to 12-8 Views of another embodiment of the ventless bend are shown. Each bend 570 includes a liner connection end 570(1) adapted for connection to a liner, and a tube connection end 570(2) adapted for connection to an air delivery tube. Figures 12-4 to 12-8 In the middle, the side of the bend is provided with a "button" or flexible finger 573 for the user to grab and quickly separate the bend from the liner.

[0330] like Figures 12-4 to 12-8The best illustration shows that the bend includes a flexible region 571 (made of TPE or a flexible polymer with a soft touch) that can be co-molded with a more rigid region (made of a polymer such as polypropylene or polycarbonate). When the patient squeezes or presses these regions, the flexible regions allow portions of the bend to flex inward, thereby disengaging the padding connection end from the mask.

[0331] This configuration also offers the following advantages: sealed bends, added soft-touch features, coloring of components to make them more appealing, and ease of assembly.

[0332] like Figure 12-9 As shown, a stop 575(1) can be provided inside the bend to prevent the flexible area from blocking the air passage during use. A support beam 575(2) can also be provided inside the bend to provide strength to the toroidal surface of the bend and to hold the stop in place.

[0333] In one embodiment, the TPE portion may be molded onto the gasketed connection end of the bend to provide a better seal and facilitate rotation when the bend is connected to the gasket.

[0334] The use of the vent ring, as described below, allows the bend to be without a vent.

[0335] In one embodiment, the bend may include a frosted surface.

[0336] 4.4 Rotary ring / vent ring

[0337] The swivel / vent ring is configured to provide an interface between the gasket and the bend, allowing the bend to connect to the gasket. For example... Figure 13-1 As shown, ring 590 provides an interface 591 for gasket connection, an interface 593 for bend connection, and vent holes 595 arranged along the periphery of the ring for diffused ventilation. In one embodiment, the ring may be co-molded with the gasket (by chemical or mechanical holding forces).

[0338] The ring allows for easy adjustment of airflow (i.e., vents can be added or removed), improved carbon dioxide flushing, control of humidity requirements, enhanced diffusion capacity, unobstructed flow, simplified bend manufacturing (because there are no vents in the bend), and / or contributes to the aesthetic freedom of the bend.

[0339] In one embodiment, the lip seal may be provided (e.g., co-molded) with the ring. For example, as Figure 13-2As shown, the ring can be molded together with the groove 596 between the vents 595 located on the patient side. The vent ring is then placed in a mold for manufacturing the liner. As material for manufacturing the liner is injected into the mold, some of the liner material will flow through the groove between the vents to form a lip seal 597. The lip seal 597 can provide a more effective seal between the liner 540 and the bend 570. Molding the lip seal in the vent ring helps reduce the number of parts that require patient manipulation.

[0340] In one embodiment, the ring may be a ventless structure (i.e., without vent holes) for use with a ventless face mask embodiment or a ventless bend.

[0341] 4.5 Optional pipe bending and rotation

[0342] Figures 46 to 50 An embodiment of the bend 3000 and the swivel 3500 is shown.

[0343] The bend 3000 includes a first portion 3010 adapted for connection to a face mask (e.g., the ventilation ring 2090 of the aforementioned pad 2010) and a second portion 3020 adapted for connection to an air delivery tube and disposed on a rotating body 3500. In one embodiment, the rotating body (e.g., made of nylon) may be overmolded onto the bend (e.g., made of polypropylene), for example, the second portion of the bend may include a stepped shoulder 3030 for rotational overmolding and machining cut. However, the rotating body may be connected to the bend by other suitable means, such as a snap-fit ​​connection. An annular ring 3600 is disposed on the rotating body, providing a retaining element for connection to the air delivery tube.

[0344] The first part includes a flexible, quick-release mechanism for connecting the bend to the face mask, such as a vent ring 2090 of the pad 2010. The mechanism includes buttons 3100 located on one or both sides of the first part and a groove 3200 surrounding each button, allowing the button to flex relative to the first part. The buttons are raised structures that are easy to use and allow for pinch travel. The outline shape of the buttons can vary, for example, depending on function and manufacturing. Furthermore, each button includes a tongue or stop hook 3040 adapted to engage the vent ring 2090 via, for example, a snap-fit ​​mechanism, thereby enabling the bend to be detachably secured to the pad 2010.

[0345] Furthermore, at least a portion of the button is made of a soft tactile material (such as TPE), for example, to facilitate use. Figure 49 , Figure 53 and Figure 54 As best illustrated, channels 3070 are positioned between the buttons to allow flow of TPE or soft-touch materials. Additionally, internal retainers 3300 are provided to prevent the buttons from being excessively compressed into the curved cavity and potentially breaking.

[0346] As shown in the figure, the upper and lower tongues 3050 are provided on the first part to connect with the vent ring 2090 and prevent the bend from being pushed too much into the vent ring.

[0347] Figures 108 to 112 An optional view of the bend is shown. Figure 108 The diagram shows a swivel 3500 overmolded onto a bend 3000, and subsequently a button 3100 overmolded onto the bend. As shown, the bend includes: a retaining stop hook 3040; a support surface 3041 for facilitating rotation relative to a gasket; a sealing edge 3043 for sealing with the gasket; and insertion limiters 3045 (located at the top, bottom, and sides of the first portion of the bend) for providing a limit for the connection of the gasket. Figure 109 An internal stop 3300 is shown to prevent the corresponding button from being excessively pressed. (See diagram.) Figure 110 and Figure 111 As shown, button 3100 may include a wall step 3101 (e.g., 0.85 mm or greater) arranged along its perimeter for suspending the bend. This wall step provides a flat and uniform portion for button movement during use. In an alternative embodiment, as... Figure 113 and Figure 114 As shown, the wall steps can be very thin (e.g., 0.35 mm). For example... Figure 112 As shown, the button may include a generally thin (e.g., approximately 0.4 mm thick) concave portion 3103 arranged along its perimeter to assist in button depressurization. The portion 3103 may be made of an elastomer such as TPE or silicone. The portion 3103 may seal the button to a bent tube body to seal the air passage through the bent tube. In one embodiment, the downward force F may be less than approximately 10 N. In one embodiment, as... Figure 115 As shown, the concave portion 3103 can be relatively thick (e.g., approximately 1.3 mm), thereby increasing the downward pressure. It should be understood that the thickness of the concave portion can be used to adjust the pressure.

[0348] As described above, ventilation of the mask is achieved by the ventilation ring 2090. This configuration has several advantages, such as easy airflow tuning, improved carbon dioxide washout, control of humidity requirements, improved diffusion capacity, unobstructed view, simplified tube manufacturing, and / or facilitates aesthetically pleasing tube design.

[0349] 5. Optional vent assembly

[0350] Figures 55 to 59 An optional vent 4000 is shown, which can be molded into or molded together with another part of the mask assembly. One embodiment of the invention relates to an assembly of interconnected vent structures, said interconnected vent structures being joined together in a first position by elements or structures capable of deforming to move the vent structures to a second position.

[0351] One embodiment of the invention relates to a vent 4000 molded into the pad 4500; however, the vent 4000 may be molded into any other component of the mask assembly in the air passage, such as a tube, bend, or frame.

[0352] The vent 4000 may include a first structure for interconnecting the vent array, wherein if the shape of the first structure changes, the configuration or position of the vent array will also change.

[0353] Figure 55 An embodiment of the vent 4000 is shown. A first structure may include a main path 4100 and / or at least one branch path 4150. The main path 4100 may support the vent branch path array 4200. The main path 4100 may be located centrally within the branch paths 4150. The main path 4100 may be positioned and / or hold the branch paths 4150 according to a defined spacing or array. The main path 4100 may also be configured to assist the alignment of the vent 4000 relative to the pad 4500 or other mask system elements (e.g., bends, frames, etc.).

[0354] Figure 55 The illustrated embodiment of trunk line 4100 has an annular or circular structure. It should be understood that trunk line 4100 can have alternative configurations, such as rectangular, triangular, or any other shape that satisfies the desired result of positioning and aligning vents 4000 in the mask system and spacing out branches 4150.

[0355] The main channel 4100 may have an aperture 4600. The aperture 4600 may be constructed and configured to accommodate part of a mask system. For example, as... Figure 58 and Figure 59 The best illustration shows that hole 4600 is located in the bend that houses the mask system.

[0356] Branch lines 4150 can connect main lines 4100 to vent array 4200. Branch lines 4150 can be evenly spaced around main lines 4100 or can have an optional configuration. The spacing of branch lines 4150 can be configured such that vent array 4200 is positioned such that the airflow discharged from each vent array is dispersed.

[0357] In another embodiment, branch 4150 can be selectively deformed. Branch 4150 can be formed into a first position by molding, cutting, or any other forming method. Then, branch 4150 can be deformed into a second position by heating, cooling, applying pressure, or other methods. In one embodiment, branch 4150 can be deformed by placing vent 4000 into a mold of the mask component, closing the mold to force the branch to bend or otherwise deform by the mold shape, and then injecting or otherwise adding a second material to the mold, allowing the second material to be fixed or stabilized around vent 4000, thereby holding branch 4150 in its deformed position.

[0358] In one embodiment, the second or modified position of the branch can be at an angle of 0° to 120° relative to the first position. In one embodiment, the second or modified position of the branch can be at an angle of 30° to 90° relative to the first position. In one embodiment, the second or modified position of the branch can be at an angle of 40° to 60° relative to the first position. In one embodiment, the second or modified position of the branch can be at an angle of 45° relative to the first position.

[0359] In another embodiment, the trunk line 4100 can be selectively deformed. The trunk line 4100 can be formed into a first position by molding, cutting, or any other forming method. Then, the trunk line 4100 can be deformed into a second position by heating, cooling, applying pressure, or other methods. In one embodiment, the trunk line 4100 can be deformed by placing the vent 4000 into a mold of the mask component, closing the mold to force the trunk line to bend or otherwise deform, and then injecting or otherwise adding a second material to the mold, allowing the second material to be fixed or stabilized around the vent 4000, thereby holding the trunk line 4100 in its deformed position.

[0360] In one embodiment, the second or modified position of the branch can be 0° to 120° relative to the first position. In one embodiment, the second or modified position of the branch can be 30° to 90° relative to the first position. In one embodiment, the second or modified position of the branch can be 40° to 60° relative to the first position. In one embodiment, the second or modified position of the branch can be 45° relative to the first position.

[0361] like Figures 55 to 57 The best illustration shows that a branch can be connected to at least one vent array 4200. The vent array 4200 may include a body 4240 and at least one vent 4250.

[0362] like Figure 56 and Figure 57As best illustrated, the body 4240 can be generally rectangular or any other shape that accommodates at least one vent 4250. The body 4240 may also include a flange or protrusion 4230, which, when formed with a mask component such as a liner 4500, can assist in mechanically engaging or locking the vent 4000 in place.

[0363] In one embodiment, each body 4240 has at least one vent 4250. In the illustrated embodiment, as shown... Figure 55 As shown, each body 4240 is provided with four vents 4250. However, any number of vents is possible, such as 1, 5, 10, 11 or more vents.

[0364] In one embodiment, the vents 4250 may gradually decrease in size, meaning their inlet diameter is larger than their outlet diameter. In one embodiment, their outlet diameter is approximately 0.1 mm to 2 mm. In one embodiment, the outlet diameter is approximately 0.3 mm to 0.8 mm. In one embodiment, the outlet diameter is approximately 0.7 mm. In one embodiment, the vents have an aspect ratio of approximately 1:3.

[0365] Figure 58 and Figure 59 A vent 4000 is shown configured in the gasket 4500. A vent array 4200 is distributed around the hole 4600. Figure 59 The longitudinal axis 4155 of the branch 4150, arranged at an angle α to the axis 4610 of the orifice 4600, is shown. Therefore, the vents 4250 on the body 4240 are configured such that the exhaust airflow from the vents 4250 forms an angle α with respect to the orifice 4600, thereby diffusing or dispersing the airflow from each vent. This disperses the airflow channels, thereby reducing airflow jetting onto the person in bed or the sheets. This configuration also reduces ventilation noise.

[0366] In an alternative embodiment, a similar vent 4000 can be configured in a bend, whereby the vent 4000 is formed in a first position and then placed into a mold of the bend. In the mold of the bend, the branch and vent array are deformed approximately 90° relative to the first position, thereby positioning it on a portion of the bend's perimeter. Material for the bend component is then injected into the mold and shaped, thereby holding the vent 4000 in the desired position.

[0367] The vent 4000 may be made of flexible and / or stretchable materials. The vent 4000 may be made of nylon, polypropylene, thermoplastic elastomer, silicone, polycarbonate, polyurethane, or any other moldable and selectively deformable polymer.

[0368] The mask component in which the vent is formed can be made of a material with a melting point lower than that of the vent material. This way, the vent will not melt when the vent is inserted into the mold of the mask component and a second material of the mask component is injected into or otherwise inserted into the mold.

[0369] Figure 64 and Figure 65 An alternative view of vents 4000 arranged in the gasket 4500 is shown. As shown, the vent configuration allows multiple vents 4250 to be molded on the release line of the plastic gasket ring and then bent during the overmolding process to create a scattered and inconspicuous array of vents around the bend 3000. This array is encapsulated and suspended within the silicone material of the gasket 4500.

[0370] Figures 99 to 105 Views of a nose mask system 6600 according to an embodiment of the present invention are shown, including a frame 6620 (e.g., Figures 88 to 93 As shown), pad 6640 (e.g., Figures 71 to 87 As shown, it contains Figures 55 to 59 and Figures 64 to 65 (vent) and bend 6670 (e.g., Figures 46 to 50 (As shown). Figure 106 and Figure 107 A mask system 6600 is shown in which a headband 6680 is secured to a patient's head during use. For example, the headband includes an upper strap 6682 located above the ears and a lower strap 6684 passing below the ears. In one embodiment, the mask system may be used with the headband described in U.S. Patent No. 7,509,958 and PCT Application No. PCT / AU2009 / 001605, the entire contents of which are incorporated herein by reference.

[0371] Optional vent

[0372] Figure 60 and Figure 61 A bend 6000 with a vent 6050 according to another embodiment of the invention is shown. In the illustrated embodiment, the vent 6050 includes a vent plate 6052 in which one or more vent holes 6054 are formed. The vent plate also includes a weakened or flexible region 6056 (i.e., a hinge). A pivot 6070 may be provided on the bend for connection to an air delivery pipe. Each vent hole may include a profile or a tapered shape along its length. However, it should be understood that the vents may include other suitable configurations, such as different numbers of holes, hole configurations, etc.

[0373] In one embodiment, the vent plate 6052 may be molded together with the vent hole 6054 and the hinge portion 6056. The vent plate can then be placed into the mold of the bend 6000. When the mold of the bend is closed, the hinge portion of the vent plate allows the vent plate to move from a first position (e.g., ...). Figure 60 As shown, the vent plate, which is in a generally upright position in the bending die, is bent to a second position in use (e.g., Figure 61 As shown, the vent plate is bent to engage with the bend. After the mold for the bend is closed, the material for the bend is injected into the mold, and the vent plate is held in its second-use position by the molded bend. Additionally, additional components can be molded onto the bend (e.g., Figure 61 The shown is the bend button 6060.

[0374] Figure 62 and Figure 63 A vent 6150 according to another embodiment of the invention is shown. In this embodiment, the vent 6150 is in the form of a vent insert molded (e.g., overmolded) together with a liner 6140. The vent insert is positioned at the top along the liner above an opening suitable for receiving a bend. As shown, the vent insert includes a plurality of vent holes 6152 oriented to guide exhaust air away from the patient's face during use. Furthermore, the vent holes can be configured to disperse the exhaust airflow. It should be understood that the vent can include other suitable configurations, such as vent holes of a specific shape, different numbers of holes, hole configurations, etc.

[0375] 6. Headband

[0376] The headband can be detachably connected to the headband connectors 34, 36 of the frame 20 to maintain the nasal mask system in the desired position on the patient's face. In the illustrated example, the frame provides four-point connections for a pair of upper headband straps and a pair of lower headband straps. However, the frame can be provided with other configurations, such as two-point or three-point connections. Hardening or reinforcing materials can be provided for one or more straps.

[0377] The headband can be made of elastic or flexible materials, such as woven or non-woven fibers, TPE, polypropylene, nylon, or any other suitable material. The headband can also be reinforced with stiffening components that increase stability.

[0378] In one example, the nose mask system can be used in conjunction with the headband described in Australian provisional patent applications filed on December 10, 2008 (AU2008906390) and January 29, 2009 (AU 2009900327), the entire contents of which are incorporated herein by reference. In one example, the connection / adjustment of such a headband can be provided by buckles or hook and loop materials. For example, the headband straps can be made of nylon elastic material, and the strap adjustment can be provided by buckles without any hook and loop materials.

[0379] However, the nose mask system can be used in conjunction with an optional headband configuration. For example, Figures 3-1 to 3-79 The following are examples of headband strap configurations and headband connection configurations according to an alternative embodiment of the invention.

[0380] Figures 3-1 to 3-4 Optional configurations for adjusting the headband strap size are shown. Figure 3-1 A headband with a two-piece top strap adjustment device is shown. Each side of the top straps 5001(1) and 5001(2) can be adjusted via a step lock or buckle connected to the face mask, or via Velcro. TM Adjustments can be made using an adjustment device or any other suitable means. This configuration provides a central adjustment mechanism for even tension and a wider fit. Furthermore, the rear of the headband strap can be narrowed or widened by sliding the rear strap 5003 (shown generally vertically, but at other angles) on the lower headband strap 5004. Figure 3-2 A headband with a single top strap 5001 and a single lower strap 5004 is shown. Preferably, the top and lower straps are made of elastic or other suitable stretchable materials to provide a wide range of fit. This configuration also allows the mask system to require minimal or no adjustment and eliminates the need for buckles or additional parts. Figure 3-3 A headband with an adjustable top strap is shown, the top strap having sides 5001(1), 5001(2), wherein a buckle 5002 is provided on one side of the top strap, thereby allowing adjustment of the length of the top strap independently of the face mask (i.e., the forehead support). This configuration provides advantages such as single-point adjustment and a slim profile. Figure 3-4A headband with an integral top strap 5001 is shown, which includes an adjustment device and an optional buckle 5002. The buckle can be hinged at one end (e.g., hinged end 5002(1)), such that when the buckle is perpendicular to the headband strap, the buckle teeth 5002(2) disengage from the strap 5001, thus allowing the strap to pass through the buckle and adjust its length in use. When the buckle 5002 is parallel to the headband strap, the buckle teeth 5002(2) engage with the strap 5001 and prevent it from slipping past the buckle, thereby locking or securing the length of the top strap. This configuration offers advantages such as single-point adjustment and a simple fastening mechanism.

[0381] Figures 3-5 to 3-7(b) Optional configurations for sizing the bottom or lower headband straps are shown. Figure 3-5 An overlapping lower strap 5004 is shown, such that at its end, the overlapping end 5004(1) will slide into contact with the lower headband connector. The lower strap end can pass through an adjusting buckle 5005, thus the overlap length of the lower strap can be adjusted by sliding the buckle along the length of the lower headband strap, thereby adjusting its length in use. This configuration advantageously provides a simple adjustment mechanism and eliminates the need for traditional adjustment devices such as hooks and loops. Figure 3-6 An overlapping lower band 5004 is shown, such that at its end, the overlapping end will slide into engagement with a lower headband connector. The lower band end can be connected along the length of the lower band material using hook and loop connectors (e.g., the lower band headband material is loop material, while the portion 5004(2) at the lower band end is hook material). This configuration advantageously provides a simple hook and loop connector and a slender profile. Figures 3-7(a) and 3-7(b) show an adjustment device that can be used at any position on the headband, but preferably on the top or lower headband band. The adjustment device may include a push-through mushroom-shaped connector 5010 located on a portion of the headband, which can engage with a selected hole 5012 located on another portion of the headband, thereby preventing sliding adjustment of the headband portion. Advantageously, this configuration still allows the individual headband portions to rotate relative to each other. Furthermore, this configuration can provide positive feedback (e.g., a click) when the adjustment device is locked in place, so that the patient can know that their headband has been adjusted. One or more holes and / or one or more mushroom-shaped connectors may be provided on the headband. The adjustment device may be made of a flexible and sufficiently rigid material, such as TPE, silicone, polycarbonate, or any other suitable material, to allow the configuration to maintain its connection during use.

[0382] Figures 3-8 to 3-13(b) The optional fixed or adjustable headband configuration is shown. Figure 3-8A headband strap size adjustment device is shown, wherein a material ring 5014 containing a hole 5014(1) is provided to allow sliding engagement with a headband strap 5004 (e.g., a lower strap). The headband strap may be provided with one or more mushroom-shaped connectors 5016 for mating or engaging with the holes 5014(1) provided in the ring material. Preferably, size indicators (e.g., S, M, L or 1, 2, 3, 4, 5, etc.) may be provided on or near the mushroom-shaped connectors to indicate the size to which the headband has been adjusted. The advantage of this configuration is that it provides a simple, known adjustment mechanism and the ability to know the size to which the headband has been adjusted. Figure 3-9 A rear bandage size adjustment device (which can be used in conjunction with a top bandage, rear bandage, or any other headband bandage) is shown, wherein the rear bandage 5006 may be provided with size indication markings 5007 (e.g., S, M, L, XL, etc.). The manufacturer, patient, or other suitable person can select which size the headband bandage is adjusted to, aligning the adjustment markings (e.g., by folding or cutting the bandage to align the markings), thereby positioning the headband to match the selected size, and then permanently securing the headband bandage in this position using stapling, ultrasonic welding, or other suitable techniques. This configuration requires no adjustment after permanent fixation and is a thin connection. Figure 3-10 A central rear strap 5008 made of an elastic or other suitable flexible material is shown, wherein the adjustable arm is similar to the adjustable arm shown in Figures 3-7(a) and 3-7(b), namely the mushroom-shaped connector 5010 and hole 5012 configuration. Figure 3-11 A headband with two top strap adjustment positions is shown, namely a hook and loop connector 5015 and a mushroom-shaped connector and hole configuration 5016 (e.g., as shown in Figures 3-7(a) and 3-7(b)). This configuration allows for greater adjustability and can thus accommodate a variety of patient head sizes. Figure 3-12A headband connector is shown in which a first headband strap 5004 (such as a lower strap) can be slidably engaged with a second headband strap 5003 (such as a rear strap). The second headband strap 5003 may be provided with an annular or additional material layer 5003 (1) which is connected to the second headband strap by ultrasonic welding, stapling, or other means. The first headband strap is positioned in a gap or groove between the second headband strap and the additional material layer. The ultrasonic welding, stapling, or other connection means may include raised or protruding portions to provide greater friction in the groove between the second headband strap and the additional material layer to prevent the first headband strap from excessively sliding through the groove. The additional material layer may be the same as the headband material or may be made of a more durable component, such as TPE or silicone. Figures 3-13(a) and 3-13(b) show a sliding clip adjustment device in which a headband strap 5018 passes through and wraps around a buckle 5020, and can be adjusted by engaging or disengaging an internal spring by pressing a button 5020(1) on the buckle. The end of the headband strap may be provided with a hole 5018(1) for connection to a frame or forehead support. This hole may be reinforced (e.g., by lamination, stapling, or other reinforcement methods), thereby preventing the hole from expanding and preventing the sliding buckle from slipping off the headband material.

[0383] Figures 3-14(a) to 3-14(h) An optional configuration for adjusting the headband strap size is shown. In one embodiment, the strap can be ultrasonically welded, may include ultrasonically cut holes, or be ultrasonically modified.

[0384] Figure 3-15 It shows something similar to Figure 3-8 The configuration is the same, but the mushroom-shaped connector 5016 used for the mating hole 5014 (i.e., roughly square) has a different shape.

[0385] Figures 3-16(a) and 3-16(b) show Figure 3-8 and Figure 3-15 An optional configuration is available, which uses similar size adjustment indicators, but with different headband paths. A first end 5021(1) of the first headband passes through a first side of the second headband 5022 to form a loop. A second end 5021(2) of the first headband passes through a second side of the second headband 5022 to form a loop. Size indicators may be present on either the first or second end of the first headband. The second headband may have a hole 5023 or other device for displaying the size indicators on the first headband.

[0386] Figures 3-17 to 3-24 The optional configuration of the headband connecting to the frame or forehead support is shown. Figure 3-17A bottom strap 5024 is shown, which can wrap around an arm or hole 5025 in the frame and then be reattached to the bottom strap using buttons or hooks and loops. This configuration offers a simple and intuitive connection (multiple connectors should be provided if multiple adjustment positions are desired), a slim design, and ease of manufacture. Figure 3-18 A bottom strap 5024 is shown, which has hook-shaped fasteners 5025 (e.g., made of plastic or other suitable materials) welded, sewn, or laminated to one or both ends of the bottom strap material. The hooks can engage with inserts 5026, slots, or holes on the frame. This connection device offers simpler connection points, a slender structure, and ease of manufacture. Figure 3-19 A headband strap 5024 is shown, with a set of fingers 5027 positioned at the end of the strap, connected by welding, sewing, or other means. The frame may also have similar fingers 5028, thereby preventing or minimizing lateral movement of the headband strap away from or towards the frame and the resulting slippage when the fingers on the headband strap interlock or cover the fingers on the frame. This is in contrast to typical headband clips (e.g., those used in ResMed Mirage Quattro). TM Compared to detaching the headband clip, detaching the fingers along the finger direction is relatively simple. Figures 3-20(a) and 3-20(b) show a headband strap 5024 with a T-shaped bar 5029 at its end. The T-shaped bar can be made of a flexible material such as TPE, silicone, polycarbonate, or any other suitable material. The T-shaped bar can be connected by forming a loop by passing the headband strap through a hole provided in the T-shaped connecting bar. Alternatively, the T-shaped bar can be connected by welding, sewing, ultrasonic welding, or any other suitable method. The T-shaped bar can form a loop via or around a snap hook or stop hook 5030 provided on the frame. Figure 3-21 A headband strap with a push-fit connector 5031 attached to its end is shown. The push-fit connector can be made of a typically flexible material such as silicone or TPE. The push-fit connector can be attached to the headband strap in a manner similar to the T-shaped rods shown in Figures 3-20(a) and 3-20(b). The push-fit connector can be a bulbous rod that engages with holes or slots 5032 on the frame. Multiple holes or slots can be provided on the frame. Figure 3-22 A headband strap 5024 is shown, which forms a loop at its end and is reattached to itself along its length by stitching or other means. The loop portion can slidably engage around a socket 5033 in the frame. Hook-like material can be provided in the loop portion of the headband strap for adjustment and then securing the headband strap. The headband material needs to be made of loop-like material to engage the hook-like material. Figure 3-23A headband strap 5024 is shown, forming a loop via a notch or barb 5034 on the frame. The headband strap can be adjusted by a sliding spring clip 5035, engaging and disengaging the headband strap by means of a spring mechanism within the clip. Figure 3-24 A headband connector hook 5036 with a slotted insertion port is shown to allow the headband strap to be inserted.

[0387] Figures 3-25(a) to 3-30 Optional configurations for the headband connection to the frame are shown. Figures 3-25(a) and 3-25(b) show a headband strap with an "R"-shaped clip 5037 attached to its end. The "R"-shaped clip can be supported on a spring or biased to preferably hold it in its locked position. A ring 5038 can be provided on the frame (e.g., the lower headband connector shown in Figures 3-25(a) and 3-25(b)) for engaging the "R"-shaped clip. Figures 3-26(a) and 3-26(b) show a headband strap with a slot or cylinder 5039 at its end, the slot or cylinder 5039 being slotted above the frame extension or finger 5040. Figure 3-27 An open-ended headband strap insertion port 5041 is shown, which can be disposed on the frame so that the headband loop can be wound vertically or wrapped around, but the cutout is disposed at the front of the insertion port. Figure 3-28 A roughly "U"-shaped headband connector 5042 is shown, positioned on the frame. This configuration is better suited for vertical insertion of the headband loop 5043 (as shown). After inserting the headband loop into the connector, the loop can pass from one side of the "U"-shaped connector to the other. Because the loop is anchored within the "U"-shaped structure, accidental detachment from the connector is prevented. Figure 3-29 Material 5044, which is directly attached to the frame, is shown for use with opposing hooks and loops in the connector strap. Figure 3-30 A magnetic connector is shown, wherein magnet 5045 is disposed on the frame and magnet 5046 is disposed on the headband strap. Figures 3-31(a), 3-31(b) and Figure 3-32 The optional configuration of the headband strap connection position on the frame is shown. Figure 3-3 l(a) and Figure 3-3 l(b) shows a headband connection socket or slot 5047 located on the perimeter of the frame, a configuration that reduces the visual volume of the mask. Figure 3-32 A headband mounting socket 5048 located on the frame is shown, adapted to receive a headband clip 5049 associated with a headband strap, the socket being similar to the contents of U.S. Patent No. 6,374,826, the entire contents of which are incorporated herein by reference.

[0388] Figure 3-33 and Figure 3-37Optional configurations for attaching the padding to the frame or attaching the lower headband strap to the frame are shown. Figure 3-33 A headband connecting loop 5050(1) located at the end of the headband connecting arm 5050(2) is shown. This configuration allows the headband connection to be moved away from the frame, resulting in a more streamlined appearance. Figure 3-34 A frame 5051 is shown, positioned along or within a groove in the padding 5052, i.e., it is connected to the padding via a butt joint or a snap-fit ​​connection. The frame may have a headband connecting arm 5053 with a generally vertical post at its end for circumferential connection with the headband strap. Preferably, the frame is made of a material that is more rigid than the padding. Figure 3-35 The lower headband connector 5054 is shown, positioned below or beneath the hole at the bend in the tube connection to fasten or otherwise engage with the padding 5055. Figures 3-36(a) and 3-36(b) show the lower headband connector assembly 5056 with a fastening engagement; it is Figure 3-21 The variant shown. Figure 3-37 A bent sealing ring 5057 is shown that engages with the headband connecting arm 5058, and hooks or otherwise mats with the frame 5059 and / or the gasket 5060.

[0389] Figures 3-38 to 3-49(b) An optional configuration is shown, in which the headband is connected to the forehead support or the forehead support arm is connected to the forehead support pad. Figure 3-38 A male buckle 5061 (push-release buckle) is shown that can engage with a female buckle 5062 mounted on a forehead support arm. The headband can be wrapped around or otherwise attached to the male buckle. Optionally, the positions of the male and female buckles can be reversed. The buckles can be made of a suitable rigid material for the buckle engagement, such as polycarbonate, polypropylene, nylon, etc. Figure 3-39 A forehead support pad 5063 with a slot or female connector 5063(1) is shown, which can engage or dock with a rod or male connector 5064(1) connected to a forehead support arm 5064. This configuration allows for some horizontal rotation according to the patient's preference or needs. Permanent or detachable retaining components for male and female component connection may also be present. Figure 3-40 It shows including Figure 3-38 The optional buckle configurations of the male buckle 5061 and female buckle 5062 are shown. Figure 3-41 It shows Figure 3-39 The optional configurations of the male connector 5064(1) and the female connector 5063(1) shown are illustrated. Figure 3-42 It shows Figure 3-39 Another optional configuration of the male connector 5064(1) and female connector 5063(1) shown. Figure 3-43A forehead support pad 5065 for connecting to the upper headband strap is shown. The forehead support pad may have a slot or cavity 5065(1) for receiving a T-shaped forehead support arm 5066. This configuration allows the forehead support arm to rotate vertically, thus enabling more flexible adjustment of the mask during use. Figures 3-44(a) and 3-44(b) show a forehead support pad 5067 with a slot 5067(1) for receiving a sliding engagement with a forehead support arm 5068. The forehead support arm can slide vertically into the slot and may be provided with a retaining tongue to prevent accidental disengagement. The forehead support arm may have a generally T-shaped cross-section to prevent horizontal rotation of the forehead support arm when connected to the forehead support pad. The T-shaped cross-section also enhances the forehead support arm. Figure 3-45 A forehead support pad 5069 is shown having a keyhole-shaped hole 5069(1) that can accommodate a forehead support arm 5070. The forehead support arm may have a generally circular disk 5070(1) attached to its end for communicating with the hole in the forehead support pad. This configuration allows the forehead support arm to rotate horizontally during use. Figure 3-46(a) and 3-46(b) A forehead support pad 5071 is shown that may have a generally C-shaped recess 5071(1) for receiving a spherical body 5072(1) connected to the end of a forehead support arm 5072. Figure 3-47 A two-piece forehead support pad is shown, comprising a first piece 5073(1) and a second piece 5073(2) that can fasten around a generally cylindrical forehead support arm 5074. Figures 3-48(a) and 3-48(b) show a two-piece forehead support pad comprising: a first side portion 5075(1) that slidably engages a generally cylindrical forehead support arm 5076; and a second side portion 5075(2) that receives the end of the forehead support arm and the first side portion. Figures 3-49(a) and 3-49(b) show a forehead support pad 5077 that may have a two-piece structure, wherein each forehead support pad is permanently or removably connected to an upper headband strap. The forehead support pad 5077 may also have a hole 5077(1) for receiving a spherical body 5078(1) connected to the end of the forehead support arm 5078 for rotational engagement with the forehead support arm. Alternatively, the ball / hole configuration can be reversed as shown in the relevant sectional view.

[0390] Figures 3-50(a) to 3-69(b) An optional configuration for attaching the headband to the forehead support without a buckle is shown. Figures 3-50(a) and 3-50(b) show an upper headband strap 5079 that can pass through a hole in the forehead support 5080. Furthermore, the hole may have a lip or engaging tongue 5080(1) on the outside of the forehead support or on the non-patient contact side to hold the upper headband strap in place. Figure 3-51An upper headband strap 5079 is shown, which can pass through a forehead support 5080 having an engaging tongue or hook 5080(1) to anchor the upper headband strap within the forehead support. The forehead support may have holes for holding the upper headband strap. Figures 3-52(a) to 3-52(c) A flexible forehead support 5081 is shown, which can be flexed vertically away from the patient's forehead to allow for a wider fit. Figures 3-53(a) and 3-53(b) show an upper headband strap 5082 that passes through the forehead support 5083 having two engaging arms 5083(1), 5083(2) for wrapping around and holding the upper headband strap in position. Viewed from the side, the two arms can be generally C-shaped. Figure 3-54 An upper headband strap 5084 is shown that can pass through a generally Y-shaped forehead support portion 5085. A slot or gap for disengaging the headband strap may be provided at the top of the forehead support portion. Figure 3-55 An upper headband strap 5086 is shown, which may be provided with a recess or gap 5086(1) so that a forehead support 5087 can be inserted into the recess of the upper headband strap. Figure 3-56 An upper headband strap 5088 is shown, which may have a ring-shaped material 5088(1) on the external or non-patient contact side. A forehead support 5089 may have a hook-shaped material working surface 5089(1) that can abut against the upper headband strap, thereby engaging the forehead support with the upper headband strap. Figure 3-57 An upper headband strap 5090, which may have a socket 5090(1) in the structure, is shown. The socket may be a fabric or a gap in an insert reinforcement such as a small tube. The forehead support 5091 may be generally cylindrical and may be pushed into or slid into the socket to engage the forehead support with the upper headband strap. Figures 3-58(a) and 3-58(b) show a forehead support 5092 with a hinged region 5092(1) which may be encapsulated on the upper headband strap 5093, clamping the upper headband strap and holding it in a clamp. Figure 3-59 A forehead support portion 5094 is shown that can be ultrasonically welded to the upper headband strap 5095. The forehead support portion can also be permanently attached to the upper headband strap by other suitable means such as adhesive. Figure 3-60 A two-piece upper headband strap 5096 in the style of a baseball cap is shown, which can pass through the forehead support 5097. Figure 3-61 An upper headband strap 5098 with a button or pusher 5098(1) is shown, the pusher 5098(1) being used to engage a slot or receiving portion 5099(1) on a forehead support portion 5099. Figure 3-62An upper headband strap 5101 with a cylindrical portion 5101(1) is shown. The cylindrical portion 5101(1) can engage a forehead support portion 5102 in the shape of a bracket or hook so that the forehead support portion is anchored to the cylindrical portion of the upper headband strap. Figure 3-63 An upper headband strap 5103 with a cylindrical portion 5103(1) is shown, which can engage a Y-shaped forehead support portion 5104. The Y-shaped forehead support portion can surround the cylindrical portion of the upper headband strap and may include pins adapted to engage within a corresponding opening in the cylindrical portion. Figure 3-64 The upper headband strap 5105, with the end regions of each end folded into a T-shape, is shown. This T-shaped fold 5105(1) can slide into a buckle or receiving portion 5106(1) connected to the forehead support portion 5106. Figure 3-65 An upper headband strap 5107 with a two-piece sliding adjustment guide is shown, the guide may have a hole 5107(1) for receiving a protrusion 5108(1) on a forehead support 5108. Figures 3-66(a) and 3-66(b) show an upper headband strap 5109 that can be slidably engaged or otherwise engaged with a guide 5110(1) formed on the top of a forehead support 5110. Alternatively, the forehead support 5111 may be slidably engaged or otherwise engaged with a receiving guide located at the end of the headband 5112. Figure 3-67 A forehead support 5113 connected to an upper headband strap 5114 is shown, wherein the arm of the forehead support includes portions for fastening or otherwise connecting to a frame 5115. Figure 3-68 A forehead support 5116 is shown with a loop sewn into the end of the upper headband strap 5117, and then the forehead support is fastened or otherwise attached to the frame 5118. Figures 3-69(a) and 3-69(b) show a forehead support with a detachable arm 5119. In one embodiment, the arm can be attached by an elastic strap 5120.

[0391] Figures 3-70(a) to 3-76 An optional configuration for connecting the upper headband connector to the headband strap is shown. Preferably, the buckle (such as...) Figures 3-70(a) to 3-76(As shown) is adapted to form a stepped locking clip. In these examples, the headband is braided through the first and second holes in the buckle. These two holes are adapted to be parallel to each other and generally aligned with the direction of the bandage to be accommodated. Braiding the bandage through these holes allows the bandage to be secured or locked in place, thereby preventing or limiting slippage. The bandage may also include a contoured or corrugated surface for better engagement with the buckle. Furthermore, Figures 3-70(a) and 3-70(b) show an example of buckle 5130 in which the series of parallel holes (also known as a stepped lock) includes a set of teeth or corrugations 5131 located on the extended end of the buckle. In one example, the extended end is bent away from the horizontal plane to allow or facilitate the patient's fingers to enter while the bandage is secured, which is necessary for disengaging the buckle. Figures 3-71(a) and 3-71(b) show another example of buckle 5132 in which the length of the buckle has been constructed in a curved or bow shape (viewed from the side). This construction also improves the user's ability to disengage or engage the bandage as needed. Figure 3-72 Another example of a buckle 5133 that can be used in conjunction with any of the examples described above is shown. This example buckle includes another set of teeth or engaging devices 5134 positioned to make frictional contact with the strap during use. These second set of teeth are generally aligned with the general engagement direction of the strap. This second set of teeth is typically adapted to prevent or limit slippage of the strap after engagement. Figure 3-73 Another buckle 5135 is shown, in which a series of holes (see Figures 3-70(a), 3-70(b), 3-71(a), 3-71(b), and 3-72) converge to form a single hole 5136. This single hole is adapted to receive a strap and allow the strap to be braided around the buckle to prevent or limit slippage. Furthermore, an opening or notch is present on the upper surface of the hole to allow easier passage or braiding of the strap. Figures 3-74(a) and 3-74(b) show another example of a buckle 5137, in which the buckle is ultrasonically welded to one end of a headband strap 5138. The other end of the strap or another strap can be passed through or braided through the hole in the buckle. It should be noted that other methods of securing the buckle to one end of the strap can achieve the same or similar results, including friction locking, adhesive, or other suitable types of welding. Figures 3-75(a) and 3-75(b) show another buckle 5139, in which the buckle portion 5139(1) located between the two holes is slightly raised. This feature of the buckle being raised in the center can further prevent or limit slippage by increasing the friction applied to the strap 5140 during use. Figure 3-76Another buckle 5141 is shown, wherein the buckle is connected to one end of a first strap 5142(1) through two holes in a first set. The first strap is braided through the first set of holes and loops back around itself. The first strap can then be secured to itself by stapling. The buckle also includes two holes in a second set located at opposite ends, which can be used to engage a second strap 5142(2). In one example, the second set of holes is adapted to removably secure the second strap, wherein the first set of holes is relatively more permanent and substantially prevents the first strap from coming loose.

[0392] Figure 3-77 A headband is shown, comprising a rear strap loop 5143(1), an upper strap 5143(2) extending from the top of the rear strap loop, and a lower strap loop 5143(3) encircling the face mask and the bottom of the rear strap loop. The length of the lower strap loop can be adjusted by a spring-loaded clip 5144. Figure 3-78 An adjustment device is shown, including a mushroom-shaped connector 5145 disposed on a face mask, the connector 5145 being adapted to engage a hole 5146 (1) disposed on a headband clip 5146 of a headband strap. Figure 3-79 An adjustment device including a stepped locking buckle 5147 disposed on the face mask is shown, the stepped locking buckle 5147 allowing the headband strap 5148 to pass through it to form a loop.

[0393] Figures 6-1 to 6-12(b) An optional example of a headband connection configuration (e.g., a buckle clip design) according to the invention is shown. Figure 6-1 An extendable clip 5150 with a narrow configuration is shown, which includes a clip arm 5150(1) adapted to be released by being pushed along the side. The neck of the clip may be flexible. Figure 6-2 An extendable clip 5151 is shown, which includes a clip arm 5151(1) adapted to be pushed downward from the top to release. The neck of the clip may be flexible. The clip provides a relatively flat and thin design. Figure 6-3 A continuous clip 5152 with a flexible neck is shown. The clip includes a clip arm 5152(1) adapted to be pushed along the side to release. The clip does not include a gap for insertion into the clip socket. Figure 6-4 A clip 5153 is shown having a hook-shaped connector 5153(1) adapted to engage a rod-shaped socket on a frame. Figure 6-5 A clamp 5154 is shown with a flexible neck spherical or inclined guide 5154(1) and a clamp arm 5154(2), the clamp arm 5154(2) being adapted to be pushed along the side to release. Figure 6-6 A T-shaped bar clip 5155 is shown, suitable for engaging the hook-shaped socket 5156. The neck of the clip may be flexible. Figure 6-7A ball-and-socket mating configuration is shown, wherein a ball 5157(1) located at the end of an outstretched clip 5157 is adapted to engage a C-cup socket 5158 disposed on a frame, for example, by a snap-fit. In one embodiment, the socket (e.g., plastic) may be made of a material that is harder than that of a ball-and-socket mating configuration (e.g., silicone). Figure 6-8 A loop over arrangement is shown, wherein an opening 5159(1) at the end of an extended clip 5159 is adapted to engage a rod-shaped socket 5160 having an enlarged head 5160(1). Figure 6-9 The above is shown Figure 6-2 Further details and optional configurations of the clip 5151 shown are provided, for example, a socket 5161 on the frame for receiving the clip. Figures 6-10(a) and 6-10(b) show a configuration in which the frame includes a separation mechanism 5162, and an extendable clip 5163 having a spherical body for retention and a stop 5163(1). The tension of the strap can be used to release it. Figure 6-11 The above is shown Figure 6-3 Further details and optional configurations of the clip 5152 shown. Figures 6-12(a) and 6-12(b) show one configuration in which the frame includes a flexible socket 5164 and the extendable clip 5165 includes a push-button release portion 5165(1).

[0394] 6.1 Optional headband

[0395] like Figure 14-1 and Figure 14-2 As shown, the headband 580 may include two timbre combinations (e.g., blue and gray) to help identify the correct orientation of the headband when wearing the mask (e.g., the two timbres can visually indicate when the headband is correctly aligned and where the hooks and loops are positioned). For example, the inside of the headband may be configured with gray or a light color so that when the headband straps pass through the mask and fold back to secure themselves, the gray faces outward so that it is not particularly noticeable to the face.

[0396] The headband configuration looks easy to use (inherently stable structure, two-tone arrangement indication), looks comfortable (no visible hard parts, soft fiber finish, "soft" gray), doesn't look particularly eye-catching (soft neutral gray, gray corresponds to the metal and silicone colors in the system), provides a high-quality look and added feel (two tones, premium heat transfer logo, new manufacturing method), and looks quite unique (unlike traditional respirator styles, high-quality edge treatment, gray helps to highlight the logo).

[0397] Figures 18-1 to 18-2 and Figures 19-1 to 19-2The diagram shows optional configurations of the headband straps as they pass over the patient's head during use, such as the upper side strap 5560 passing above the ears and the lower side strap 5570 passing below the ears.

[0398] Although the invention has been described in conjunction with what is now considered the most practical and preferred embodiments, it should be understood that the invention is not limited to the disclosed embodiments, but rather, the invention is intended to encompass various modifications and equivalents included within the spirit and scope of the invention. Furthermore, the various embodiments described above can be implemented in combination with other embodiments; for example, a solution of one embodiment can be combined with a solution of another embodiment to form other embodiments. Further, any individual features or components of any given component can constitute other embodiments. Additionally, although the invention has specific applications for patients with OSA, it should be understood that patients with other conditions (e.g., congestive heart failure, diabetes, morbid obesity, stroke, and obesity treatment surgery, etc.) can also benefit from the above teachings. Moreover, the above teachings are equally applicable to both patients and non-patients in non-medical applications.

Claims

1. A mask system for treating sleep apnea by delivering positive pressure air, comprising: Includes headbands with paired upper straps; A sealing device configured to form a seal with a patient's face during use, the sealing device including a silicone pad configured to sealably engage the patient's face during use; and A frame configured to engage with the sealing device to support the sealing device in a working position relative to the patient's face during use, the frame comprising polycarbonate and being more rigid than the silicone of the liner, the frame comprising: A body configured to engage with the sealing device; A forehead support arm extending from the main body; and A forehead support pad, provided to the forehead support arm and configured to support the frame on the patient's forehead during use, the forehead support pad including a pair of upper headband connectors for removably engaging with the pair of upper side straps. The forehead support pad includes a first region and a second region directly connected to the first region. Compared to the first region, the second region has increased flexibility and includes a flexible portion configured to open outward in use in response to headband tension from the paired upper straps against the elasticity of the flexible portion. The first region includes the pair of upper headband connectors, each upper headband connector including a pair of receiving holes formed in the forehead support pad to receive the pair of upper side straps.

2. The mask system according to claim 1, wherein, In use, when the flexible portion opens outward in response to the tension of the headband, the flexible portion is configured to adjust the distance between the forehead support pad and the patient's forehead.

3. The mask system according to claim 2, wherein, In use, when the upper strap is tightened, the flexible portion is configured to open outward to pull the forehead support pad closer to the patient's forehead.

4. The mask system according to claim 3, wherein, As the forehead support pad is pulled toward the patient's forehead, the upper portion of the pad is configured to tilt inward toward the patient's face to aid in fit, thereby pulling the pad further toward the patient's nasal bridge area to automatically adjust to accommodate different patient nasal bridge shapes.

5. The mask system according to claim 4, wherein, The lower portion of the pad is configured to serve as a hinge point when the upper portion of the pad is tilted inward toward the patient's face.

6. The face mask system according to claim 1, wherein, When the upper strap is tightened during use, the forehead support pad is configured to be offset away from the patient's forehead by the elasticity of the flexible portion.

7. The face mask system of claim 1, wherein the forehead support pad is molded in a manner that provides elastic properties.

8. The mask system of claim 1, wherein the flexible portion has a V-shape, wherein the first side and the second side are arranged at an angle of less than 180° relative to each other.

9. The mask system of claim 8, wherein the first side and the second side are connected at the apex of the flexible portion, wherein when headband tension is applied from the paired upper straps, the first side and the second side open, resulting in an increase in the angle between the first side and the second side.

10. The mask system of claim 9, wherein the flexible bending portion is configured to pull the forehead support pad closer to the patient's forehead as the angle between the first side and the second side increases.

11. The face mask system according to any one of claims 1 to 10, wherein the second region of the forehead support pad is made of a thermoplastic elastomer.

12. The mask system according to any one of claims 1 to 10, wherein the forehead support arm is fixed relative to the body of the frame.

13. The mask system according to any one of claims 1 to 10, wherein the forehead support arm is integrally formed with the body of the frame.

14. The face mask system according to any one of claims 1 to 10, wherein the second region of the forehead support pad comprises silicone resin.

15. The mask system according to any one of claims 1 to 10, wherein the frame further comprises a pair of lower headband connectors integrally formed with the body of the frame, the headband further comprising a pair of lower side straps detachably connected to the pair of lower headband connectors.

16. The mask system according to any one of claims 1 to 10, wherein the pad is configured to seal against the bridge of the nose area of ​​the patient's face during use.

17. The face mask system according to claim 16, wherein, The padding is a full-face padding.

18. The face mask system according to any one of claims 1 to 10, wherein, The padding includes: a face contact side, the face contact side including a diaphragm configured to sealably engage the patient's face in use; and a non-face contact side, the non-face contact side including a docking structure configured to be removably connected to the frame.

19. The mask system according to any one of claims 1 to 10, further comprising a bend having a first end and a second end, the second end being configured to be connected to an air delivery pipe.

20. The face mask system of claim 19, wherein, The pad includes a face contact side, which includes an opening configured to be in fluid communication with the bend to receive a supply of breathable gas.

21. The mask system according to any one of claims 1 to 10, wherein the frame includes a vent, the vent including a plurality of holes for gas flushing.

22. The face mask system according to any one of claims 1 to 10, wherein the frame further comprises a pair of lower headband connectors integrally formed with the body of the frame, wherein the headbands are configured for four-point removable connection with the lower headband connectors and the upper headband connectors.

23. The mask system according to any one of claims 1 to 10, wherein the upper strap passes through the paired receiving holes of the upper headband connector such that the upper strap is positioned between the forehead support pad and the patient's face, and in use, the upper strap directly contacts the patient's forehead.

24. The face mask system according to claim 1, wherein, In use, when the flexible portion expands outward in response to headband tension, the flexible portion is configured to adjust the distance between the forehead support pad and the patient's forehead. In use, when the upper strap is tightened, the flexible portion is configured to open outwards to pull the forehead support pad closer to the patient's forehead. Specifically, when the forehead support pad is pulled closer to the patient's forehead, the upper portion of the pad is configured to tilt inward toward the patient's face to aid in fit, thereby further pulling the pad onto the patient's nasal bridge area to automatically adjust to accommodate different nasal bridge shapes. The lower portion of the pad is configured to serve as a hinge point when the upper portion of the pad is tilted inward toward the patient's face. The forehead support pad is molded in a manner that provides elastic properties. The flexible portion has a V-shape, wherein the first side and the second side are arranged at an angle of less than 180° relative to each other. The first and second side portions connect at the apex of the flexible portion, wherein when headband tension is applied from the paired upper straps, the first and second side portions open, resulting in an increase in the angle between the first and second side portions. Wherein, as the angle between the first side and the second side increases, the flexible portion is configured to pull the forehead support pad closer to the patient's forehead. The forehead support arm is fixed relative to the main body of the frame. The second region of the forehead support pad comprises silicone resin. The frame also includes a pair of lower headband connectors integrally formed with the main body of the frame, the headbands further including a pair of lower side straps detachably connected to the lower headband connectors, and The padding mentioned therein is a full-face padding.

Images