Mask system

Abstract

The present application discloses a mask system. A full-face mask assembly for use in medical applications comprises: a frame and a shield detachably snap-fitted to the frame, wherein the frame comprises an upper end and a lower end, the upper end is adapted to cover the nose and the lower end is adapted to cover the patient's mouth; and a full-face cushion disposed on the frame and adapted to engage with the patient's face substantially along the nose bridge region, cheek region and lower lip region and / or chin region of the patient's face, wherein the mask assembly does not include a forehead support, and the shield comprises two reinforcing members connected to opposite sides of the shield, wherein the reinforcing members have a generally upwardly curved shape and are adapted to avoid obstructing the patient's field of vision, wherein the shield comprises an upper headband connector and a lower headband connector on each side of the shield, wherein the upper headband connector is disposed on the reinforcing member.

Description

[0001] This application is a divisional application of the patent application with application number 201810074069.7, application date February 27, 2009, and invention name “Mask system”. The patent application with application number 201810074069.7, application date February 27, 2009, and invention name “Mask system” is a divisional application of the patent application with application number 2015103415970, application date February 27, 2009, and invention name “Mask system”. The patent application with application number 2015103415970, application date February 27, 2009, and invention name “Mask system” is a divisional application of the patent application with application number 200980116004.3 (international application number PCT / AU2009 / 000241), application date February 27, 2009, and invention name “Mask system”.

[0002] Cross-references to applications

[0003] This application claims the benefit of U.S. Provisional Application No. 61 / 064,406, filed March 4, 2008, No. 61 / 071,893, filed May 23, 2008, and No. 61 / 136,617, filed September 19, 2008, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present invention relates to a mask system for treating, for example, sleep disordered breathing (SDB) using continuous positive airway pressure (CPAP) or non-invasive positive airway pressure ventilation (NIPPV). Background Art

[0005] In sleep disordered breathing (SDB) therapy, a patient interface such as a full face mask or a nasal mask used with a blower or flow generator typically includes: a soft face contact portion, such as a cushion; and a rigid or semi-rigid shell or frame. In use, the interface is supported in a sealed position by a headband to enable a positive pressure air supply (e.g., 2-30 cmH2O) to be delivered to the patient's airway.

[0006] One factor in the efficacy of treatment and patient compliance with treatment is the comfort and fit of the patient interface.

[0007] The present invention provides alternative configurations of mask systems to improve treatment efficacy and patient compliance with treatment. Summary of the invention

[0008] One aspect of the present invention relates to a mask system that is not provided with a forehead support adapted to engage the patient's forehead.

[0009] Another aspect of the present invention is directed to a mask system including a frame and a shield removably connected to the frame and adapted to be coupled to a headgear.

[0010] Another embodiment of the present invention relates to a mask system comprising: a frame defining a breathing chamber; a cushion disposed on the frame and adapted to form a seal with a patient's face; and a shield disposed on the frame. The shield and the frame are co-molded with each other. The frame is made of a relatively soft and elastic first material, and the shield is made of a second material that is more rigid than the frame. At least a portion of the frame includes a concertina section having a plurality of folds. Each fold has a side wall, and the side wall of the fold gradually becomes longer away from the patient's face.

[0011] Another aspect of the present invention relates to a cushion module, which includes a frame defining a breathing chamber and a cushion adapted to form a seal with a patient's face. The frame and the cushion are co-molded with each other. The cushion is made of a relatively soft and resilient first material, and the frame is made of a second material that is more rigid than the cushion. At least a portion of the frame includes an accordion-style portion.

[0012] Another aspect of the present invention relates to a method for constructing a liner module. The method includes: molding a first component of the liner module with a relatively soft and elastic first material; co-molding a second component of the liner module on the first component with a second material that is more rigid than the first material; and molding at least a portion of the second component to include an accordion-type portion.

[0013] Another embodiment of the present invention relates to a shield for a mask system, which includes: a retaining portion constructed as a fixed frame; a pair of upper headband connectors, each of which includes an extended arm and a narrow slot at the free end of the arm suitable for receiving a headband strap; and a pair of lower headband connectors, each of which is suitable for connecting to the headband strap, wherein the retaining portion, the upper headband connectors and the lower headband connectors are integrally formed as a one-piece structure.

[0014] Another aspect of the present invention relates to a mask system, comprising: a frame defining a breathing chamber; a cushion disposed on the frame and adapted to form a seal with a patient's face; a shield disposed on the frame and adapted to be connected to a headgear; and an elbow disposed on the frame and adapted to be connected to an air delivery tube that delivers breathable gas to the patient. The shield includes a fixing mechanism configured to establish a rigid connection between the shield and the frame.

[0015] Another embodiment of the present invention relates to a mask system, which includes a frame defining a breathing chamber and a cushion disposed on the frame. The cushion includes a body and a cushion, wherein the cushion is adapted to engage at least a portion of a patient's face. The cushion includes a base wall connected to a bottom cushion layer and a diaphragm, wherein the diaphragm extends around the periphery of the cushion and contacts the patient's face. The bottom cushion layer is located underneath the diaphragm and supports the diaphragm. The bottom cushion layer provides different support for the diaphragm in predetermined areas of the face.

[0016] Another aspect of the present invention relates to a mask assembly for use in medical applications, having a top end and a bottom end defined by its position relative to a patient's face, wherein the mask assembly is connected to a plurality of flexible straps adapted to engage the patient's head. The flexible straps engage at least two rigid extension arms integrally molded to a portion of the mask assembly, and wherein the extension arms are molded to the mask assembly proximate the top end of the mask assembly.

[0017] Another embodiment of the present invention relates to a mask assembly for use in medical applications, comprising a body connected to a cushion adapted to cover the nose and / or mouth, wherein the mask assembly is attached by a force directed substantially vertically toward the face, wherein the force is approximately constant along the length of the mask and is balanced by a portion of the cushion that engages the patient's cheek.

[0018] Another aspect of the present invention relates to a liner for use with a medical mask, comprising: an outer membrane layer adapted to sealably engage a face; and a bottom liner layer adapted to support the membrane layer. The membrane or bottom liner layer includes a surface between the two layers, the surface being adapted to allow the two layers to slide against the respective surfaces.

[0019] Another embodiment of the present invention relates to a mask system comprising: a frame defining a breathing chamber; a cushion disposed on the frame and adapted to form a seal with the patient's face; and a releasable shield adapted to engage a portion of an outer surface of the frame, wherein the shield is connected to a strap to position the mask system.

[0020] Another aspect of the present invention relates to a mask assembly for use in medical applications, comprising: an upper end and a lower end, wherein the upper end is adapted to cover a nose and the lower end is adapted to cover a patient's mouth. The mask assembly does not include a forehead support, but includes two stiffened members connected to the upper end at opposite sides of the mask assembly, wherein the stiffening members have a generally curved shape and are adapted to avoid obstructing the patient's field of view.

[0021] Another aspect of the invention relates to a cushion attached to a medical mask, wherein the cushion is flexible and includes a diaphragm attached to a peripheral edge of the cushion and adapted to seal against a patient's face, and at least one under-cushion adapted to support the diaphragm and to be positioned beneath the diaphragm to prevent the diaphragm from shrinking during use. The diaphragm is softer than the under-cushion. The height of the under-cushion in the region of the bridge of the nose or chin is between 0 mm and 30 mm when measured between the bottom and top of the under-cushion.

[0022] Another aspect of the present invention relates to a mask assembly for use in medical applications, comprising an upper end and a lower end, wherein the upper end is adapted to cover a nose and the lower end is adapted to cover a patient's mouth. The mask assembly does not include a forehead support and includes two reinforcement members connected to the upper end at opposite sides of the mask assembly, wherein the reinforcement members have a generally curved shape and are adapted to avoid obstructing the patient's field of view.

[0023] In an alternative embodiment, the mask system may include a headband connector or rigidizer configured to attach to the frame via a snap fit, mechanical interlock, friction fit, and / or a grommet configuration (eg, made of rubber).

[0024] In an alternative embodiment, the mask system may include a mask having a silicone and / or Breath-O-Prene TM Headband with strap configuration made of material.

[0025] Other aspects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, which constitute a part of this disclosure and illustrate, by way of example, the principles of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings facilitate understanding of the various embodiments of the present invention. In these drawings:

[0027] Figure 1A is a front perspective view of a mask system according to an embodiment of the present invention;

[0028] Figure 1B It is shown Figure 1A A stereoscopic view of a mask system with a headband positioned on a patient's head;

[0029] Figure 1C yes Figure 1A A cross-sectional view of a mask system;

[0030] Figure 1D yes Figure 1A Another cross-sectional view of a mask system;

[0031] Figure 1E yes Figure 1A A side view of a mask system;

[0032] Figure 2 It is shown Figure 1A A front perspective view of a frame and a cushion of a mask system;

[0033] Figure 3 yes Figure 1A An exploded perspective view of a mask system of , showing a frame, a liner, a shield and an elbow;

[0034] Figure 4 yes Figure 1A Another exploded perspective view of the mask system of , showing the frame, cushion and elbow;

[0035] Figure 5 yes Figure 1A An exploded perspective view of a mask system of , showing the shield and assembled frame / cushion;

[0036] Figure 6 It is shown Figure 1A A front perspective view of a shield of a mask system;

[0037] Figure 7 It is shown Figure 1A A front perspective view of a cushion of a mask system;

[0038] Fig. 8A It is shown Figure 7 a cross-sectional view of a portion of a liner in;

[0039] Figure 8B yes Figure 7 A cross-sectional view of the chin area and the bridge of the nose area of ​​the cushion;

[0040] Fig. 9 is a plan view of a flattened headband according to an embodiment of the present invention;

[0041] Fig.10 is a front perspective view of a mask system according to another embodiment of the present invention;

[0042] Fig.11 It is shown Fig.10 A front perspective view of a frame of a mask system;

[0043] Fig.12 It is shown Fig.10 A front view of a frame of a mask system;

[0044] Fig.13 It is shown Fig.10 A side view of a frame of a mask system;

[0045] Fig.14 It is shown Fig.10 A front perspective view of a shield of a mask system;

[0046] Fig.15 It is shown Fig.10 A front view of a shield of a mask system;

[0047] Fig.16 It is shown Fig.10 A side view of a shield of a mask system;

[0048] Fig.17 It is shown Fig.10 A rear perspective view of a shield of a mask system;

[0049] Figure 18-1 to Figure 18-2 It is shown in a sequential relationship Fig.10 A cross-sectional view of a mask system with a shield connected to a frame;

[0050] Figure 19-1 to Figure 19-4 It is shown in a sequential relationship Fig.10 A cross-sectional view of a mask system with a shield connected to a frame;

[0051] Fig. 20 is a perspective view showing an alternative arrangement for attaching the shield to the frame;

[0052] Fig.21 It is shown Fig.10 A rear perspective view of a shield of a mask system;

[0053] Fig. 22 It is shown Fig.10 A cross-sectional view of a mask system with a shield connected to a frame;

[0054] Fig.23 It is shown Fig.10 Cross-sectional view of the mask system with the shield, frame and elbow connected

[0055] Fig.24 is a cross-sectional view showing an alternative arrangement for attaching the shroud to the frame;

[0056] Fig.25 is a front perspective view of a mask system according to another embodiment of the present invention;

[0057] Fig.26 yes Fig.25 A rear perspective view of the mask system in FIG.

[0058] Fig. 27 is a front perspective view of a mask system according to another embodiment of the present invention;

[0059] Fig.28 is Fig. 27 An exploded view of the mask system shown in FIG.

[0060] Fig.29 is Fig.17An enlarged front perspective view of the mask system shown in;

[0061] Fig.30 is Fig. 27 A side view of the mask system shown in FIG.

[0062] Figure 31-1 is a rear view of a pad according to an embodiment of the present invention;

[0063] Figure 31-2 It is a partial section Figure 31-1 A front view of the pad shown in ;

[0064] Figure 31-3 is along Figure 31-1 A cross-sectional view taken along line 31-3-31-3 in FIG.

[0065] Figure 31-4 is along Figure 31-1 A cross-sectional view taken along line 31-4-31-4;

[0066] Figure 31-5 is along Figure 31-1 A cross-sectional view taken along line 31-5-31-5;

[0067] Figure 32-1 to Figure 32-3 A top view, a front view and a side view of an accordion-type portion according to an embodiment of the present invention are respectively shown;

[0068] Fig.33 is a side view of a mask system according to a variation of the present invention;

[0069] Fig.34 A pad including an accordion-style portion according to an embodiment of the present invention is shown;

[0070] Figure 35-1 to Figure 35-3 is a front view, a side view and a rear view of a mask system according to another embodiment of the present invention;

[0071] Fig.36 is a perspective view of a shield for a mask system according to an embodiment of the present invention;

[0072] Figure 37-1 to Figure 37-3 is a perspective view, a front view and a side view of a mask system according to another embodiment of the present invention;

[0073] Figure 38-1 to Figure 38-5 is Figures 37-1 to 37-3 A perspective view, a front view, a top view, a side view and a bottom view of the shield of the mask system shown in;

[0074] Figure 39-1 to Figure 39-6 is a perspective view, a front view, a side view, a bottom view and a top view of a mask system according to another embodiment of the present invention;

[0075] Figure 40-1 and Figure 40-2 is a perspective view and a side view of a mask system according to another embodiment of the present invention;

[0076] Figure 40-3 is Figure 40-1 and 40-2 A perspective view of a frame of a mask system shown in ;

[0077] Figure 40-4 and Figure 40-5 Shown in Figure 40-3 The fixing elements of the frame shown in ;

[0078] Figure 40-6 and Figure 40-7 Shown in Figure 40-1 and Figure 40-2 The clip-on upper headband connector of the mask system shown in ;

[0079] Figure 41-1 and Figure 41-2 is a rear and front perspective view of a mask system according to another embodiment of the present invention;

[0080] Figure 41-3 and Figure 41-4 is Figure 41-1 and Figure 41-2 An exploded view of the mask system shown in;

[0081] Figure 41-5 to Figure 41-12 is Figure 41-1 and Figure 41-2 Various views of the clip-on upper headband connector of the mask system shown in;

[0082] Figure 42-1 is a rear perspective view of a mask system according to another embodiment of the present invention;

[0083] Figure 42-2 is Figure 42-1 An exploded view of the mask system shown in;

[0084] Figure 42-3 to Figure 42-7 is Figure 42-1 Various views of the clip-on upper headband connector of the mask system shown in;

[0085] Figure 43-1 to Figure 43-4 is a perspective view, a side view, a front view and a rear view of a mask system according to another embodiment of the present invention;

[0086] Fig.44 A mask system according to another embodiment of the present invention is shown;

[0087] Fig.45 A mask system according to another embodiment of the present invention is shown. DETAILED DESCRIPTION

[0088] The following description relates to multiple embodiments or examples with common characteristics and features and is provided. It should be understood that one or more features of any one embodiment or example can be combined with one or more features of other embodiments or examples. In addition, any single feature or combination of features in any one embodiment or example can constitute additional embodiments or examples.

[0089] In this specification, the word "comprising" should be understood in its "open" sense, i.e., the sense of "including...", and is therefore not limited to its "closed" sense, i.e., the sense of "consisting only of...". The corresponding words "comprising", "including" and "comprising" also have corresponding meanings.

[0090] The term "air" is taken to include breathable gases, such as air with supplemental oxygen.

[0091] The term "shield" is used to include an element that partially or completely covers the second element in the illustrated embodiment. In an embodiment, the shield may include an element that partially covers the frame member in the illustrated embodiment or is mounted on the frame member.

[0092] The term "positive connection" is used to include connections between components in the described embodiments, wherein connectors mounted on the respective components are adapted to engage with each other, respectively.

[0093] 1. Mask system

[0094] Embodiments of the present invention are directed to a mask system that is not provided with a forehead support adapted to engage with the patient's forehead. This configuration provides a less obtrusive configuration for the mask system, thereby not significantly affecting the patient's field of vision. Although the system is designed to not require a forehead support, a forehead support may be added if desired.

[0095] As will be described in more detail below, the mask system includes: a frame; a cushion disposed on the frame and adapted to form a seal with the patient's face; a shield disposed on the frame and adapted to be connected to a headband; and an elbow disposed on the frame and adapted to be connected to an air delivery tube that delivers breathable gas to the patient. The headband can be removably connected to the shield to maintain the mask system in a desired adjustment position on the patient's face. The mask system is intended for positive pressure therapy for users with obstructive sleep apnea (OSA) or other breathing disorders.

[0096] Although the various embodiments below are described as including full-face or oral-nasal interface types, each embodiment is suitable for use with other suitable interface types. That is, the interface types are merely illustrative, and each embodiment is suitable for including other interface types, such as nasal interfaces, nasal masks, nasal prongs, etc.

[0097] 2. Stable organization

[0098] The stabilizing mechanisms (e.g., frame, shield, headband with associated headband vectors) of a mask system according to embodiments of the present invention are configured to accommodate the removal of a forehead support from a full-face interface. For example, a forehead support typically precludes rotation of the mask system in the sagittal and coronal planes, so the mask system and headband according to embodiments of the present invention are configured to assume these functions due to the absence of a forehead support.

[0099] The headband is connected to the top and bottom of the frame directly or via a shield, wherein the shield provides headband connection points for the headband, and the headband is positioned and configured to stably hold the mask system in place on the patient's face.

[0100] 2.1 Framework

[0101] like Figure 1A , Figure 1B-1E and Figure 2-5 As shown, the frame 1040 of the mask system 1010 is configured to hold the cushion 1060, the shield 1020, and the elbow 1070 in a working position relative to the patient's face. The frame 1040 is made (e.g., injection molded) of a more rigid material (e.g., polyurethane) than the cushion 1060 (e.g., made of silicone), but other materials can also perform similar functions (e.g., polycarbonate). In one embodiment, the frame has a typical wall thickness of about 1-2 mm, such as 1.5 mm.

[0102] The frame 1040 defines a breathing chamber or cavity adapted to accommodate the nose and mouth of the patient and provide air communication for the patient. One portion or lower portion of the frame 1040 includes an opening 1046 adapted to accommodate or otherwise communicate with an elbow 1070 (e.g., a swivel elbow), and another portion or upper portion of the frame 1040 includes a vent device 1076 for gas flushing. In addition, the upper portion of the frame 1040 includes an interfacing structure 1048 adapted to interface with the shield 1020 or otherwise be removably connected to the shield 1020.

[0103] Figure 27-30The mask system 10 is shown to include a frame 40 having a cushion 44 that provides a sealing portion or sealing ring adapted to form a seal with the patient's nose and / or mouth. Furthermore, the frame 40 includes an opening 46 adapted to communicate with an elbow 70.

[0104] 2.2 Shield

[0105] like Figure 1A and Figure 3-6 As shown, the shield 1020 is connected to the frame 1040 and is configured to connect the headband to the mask system. In one embodiment, the shield 1020 is made of a resilient material including but not limited to plastic or nylon (e.g., nylon 12) (e.g., injection molded). However, the shield can be made of, for example, polycarbonate, polypropylene, thermoplastic elastomer (TPE), In one embodiment, the shield has a typical wall thickness of about 1-2 mm, such as 1.3 mm.

[0106] The top end of the shield 1020 is adapted to be positioned proximate to the nasal bridge region or nose of the patient, while the bottom end is adapted to be positioned proximate to the mouth or chin of the patient. The top end includes an opening or vent receiving hole 1021 that receives a vent device 1076 protruding from the frame 1040, and the bottom end includes an opening or elbow hole 1032 that receives an elbow 1070 that opens into the frame 1040 (e.g., the shield does not provide contact with the elbow when assembled).

[0107] An upper headband connector 1024 extends from each side of the top end and a lower headband connector 1025 extends from each side of the bottom end. The headband connectors 1024, 1025 may be integrally molded to the shield or otherwise attached to the shield.

[0108] 2.2.1 Upper head with connector

[0109] Each upper headband connector 1024 includes an elongated arm 1026 and a slot or receiving hole 1027 at the free end of the arm 1026 adapted to receive a corresponding headband strap. In use, the arm 1026 extends around the patient's face at a generally concave angle below the patient's eyes to avoid the patient's field of vision, i.e., to guide the headband away from the patient's eyes. For example, Figure 1EAs shown, each arm 1026 can extend at an angle α of about 10-25° (e.g., 17°) relative to the horizontal line. That is, each arm 1026 is appropriately formed, shaped, or contoured to follow the contour of the patient's face and avoid the line of sight during use. In one embodiment, the shape of the arm can be generally arched and suitable for extending in a direction across the patient's cheek but avoiding the eyes or limiting the field of vision. In one embodiment, the arm can be integrally molded onto the shield of the mask system. A potential advantage of molding the arm onto the shield is that it greatly increases manufacturability, and in the event of an accidental breakage of the arm, the shield can be easily replaced instead of replacing the entire mask system. In addition, molding the arm onto the shield can also greatly increase the strength of the connection and reduce or limit the actual possibility of arm breakage.

[0110] In one embodiment, arm 1026 is at least semi-rigid (e.g., relatively rigid) to prevent the arm from moving up and down or bending relative to the patient's face. Therefore, arm 1026 can act as a hardener to effectively act as a level arrangement and produce a mechanical advantage: the force or pressure applied to the top of the mask system is readjusted to the fulcrum point near the center of balance between the top and bottom of the mask system. In one embodiment, the arm is connected to a point as high as possible relative to the mask system to additionally stabilize the structure. In one embodiment, the fulcrum or pivoting moment is located between the upper and lower connection points of the strap, and the design, angle, length and / or structure of arm 1026 can effectively adjust the fulcrum. In the illustrated embodiment, the fulcrum is shown between the vent device and the elbow of the mask system. In addition, when the mask system is located on the face, it can have a fulcrum around the area between the bottom of the patient's nose and the lip area or everywhere in this area. This feature effectively stabilizes the mask system on the patient's face without the need for an additional forehead support.

[0111] The net result of the arm 1026 being mounted at a position extending from the top of the mask system around the patient's face is that the mask system is more stable and the movement of the mask system in the x-axis 1001 (see FIG. Figure 1A ) is subjected to a net torque on the mask. Note that arm 1026 can be rigidly connected to the mask system at other appropriate locations to produce similar results.

[0112] In one embodiment, the arm 1026 can be used to stabilize the mask system by contacting the patient's face at the cheek. Cheek cushions can be provided on the inner surface of the arm to support the arm on the patient's cheek during use. Moreover, the arm 1026 can be enclosed in a soft fabric sleeve to act as additional padding for the patient's cheek. The soft fabric sleeve can be in the form of an elastic tube covering a portion of the arm 1026.

[0113] 2.2.2 Lower Headband Connector

[0114] Each lower headband connector 1025 includes a shortened arm and a clip receptacle 1031 at the free end of the arm, the clip receptacle 1031 being adapted to removably interlock with a headband clip coupled to a corresponding headband strap. The clip allows for easier positioning or donning / removal of the mask system. In one embodiment, the shortened arm and clip are also relatively rigid, thereby preventing lateral movement of the arm along the y-axis 1002 relative to the mask system during use.

[0115] Figure 27-30 An exemplary headband clip 33 adapted to removably interlock with the clip receptacle 31 is shown. Fig.28 As best shown, each clip 33 comprises two spring arms 35 adapted to interlock with a corresponding clip receptacle 31 in a snap-fit ​​manner, and a slot 37 adapted to receive a corresponding headgear strap in use.

[0116] 2.2.3 Optional Headband Connector

[0117] like Figure 27-30 As shown, the arm 26 is removably coupled to the shield, for example, the arm 26 includes a clip structure adapted to removably interlock with a clip receptacle provided on the shield. This configuration allows different types of upper and lower headband connectors to be used with the shield, such as arms for both upper and lower headband connectors, clips for both upper and lower headband connectors, arms of different lengths for upper and lower headband connectors, and the like.

[0118] However, the shield may be provided with other suitable configurations for being connected to the headband straps of the headband. Moreover, the shield may include one or more additional elements, such as a forehead support.

[0119] 2.2.4 Headband connector positioning

[0120] exist Figure 1A-6 In an embodiment of the invention, the upper and lower headband connectors 1024, 1025 provide headband connection points (i.e., the top and bottom of the frame) that are as far away from each other as possible to allow greater adjustability (e.g., allowing adjustment at the top and bottom of the mask system) and stability (e.g., the anchor points are dispersed around the mask system so it is more stable on the patient's face). Moreover, the upper headband connector is positioned as close to the top of the mask system as possible and out of the way of the patient's eyes during use.

[0121] 2.2.5 Separate shield

[0122] exist Figure 1A-6In an embodiment, the shield 1020 is formed separately (e.g., molded) and attached to the frame 1040. This configuration facilitates molding of the shield; allows the frame and shield to be made of different materials (e.g., the frame can be semi-rigid or rigid for stability, and the shield with headband stiffeners can be flexible for adjustment); allows the shield to hide the elbow retaining elements that secure the elbow to the frame around the elbow / frame opening (e.g., a visible shield is set for aesthetics); allows the frame to have no lower clip receptacle; allows the shield to be used with frames of different sizes; and allows the shield to be designed or manufactured to minimize the obtrusiveness of the mask system. A separate shield may also allow the headband, frame, cushion, and / or elbow to be replaced or washed separately.

[0123] 2.2.6 Bushing

[0124] In one embodiment, a soft fabric sleeve may also be mounted on the upper and / or lower headband connectors. For example, the sleeve may be elastic and adapted to slide over the arms of the headband connector to form a tight fit. In one embodiment, the sleeve forms an elastic tube. The sleeve may be padded to increase the comfort of the mask system during use. The sleeve may be particularly useful where the arms of the headband connector contact the patient's skin, for example to protect the patient's skin from irritation.

[0125] 2.2.7 Arms extending above the patient's ears

[0126] Figure 35-1 to Figure 35-3 and Fig.36 The shield 220 for the mask system 210 according to another embodiment of the present invention is shown. The shield 220 includes an annular fixing portion 222 configured as a fixing frame 240 and upper and lower headband connectors 224, 225 on each side of the fixing portion 222. In the illustrated embodiment, the shield 220 is integrally formed as a single piece (see, for example, FIG. 21 ). Fig.36 ).

[0127] In the illustrated embodiment, each upper headband connector 224 includes an elongated arm 226 and a slot 227 at the free end of the arm 226 adapted to receive a corresponding rear strap 298 in use. As shown, the arm 226 is appropriately contoured to extend along the cheek and above the patient's ear just in front of the patient's temple and to secure the corresponding rear strap 298 above the patient's ear in a spaced relationship with the patient's ear, for example to avoid rubbing or irritating the patient's ear during use.

[0128] Moreover, each arm 226 is configured to extend along the upper strap 292 of the headband and engage with the upper strap 292 during use. As shown, each arm 226 is secured to the upper strap 292 to increase the rigidity of the strap and stabilize the mask system on the patient's face during use. In addition, the strap 292 provides padding for the arm 226 on the patient's face during use. In one embodiment, the upper strap 292 can be secured to the arm 226 by, for example, gluing or sewing. Alternatively, the arm 226 can be enclosed by or inserted into the corresponding strap 292 so that the arm 226 is substantially invisible.

[0129] Each lower headband connector 225 includes a shortened arm 228 with a slot 229 at the free end of the arm 229 and adapted to receive, in use, a corresponding lower strap 294. As shown, the arms 228 are appropriately oriented to secure the corresponding lower strap 294 above the patient's ear in a spaced relationship with the patient's ear, e.g., to avoid the strap rubbing or irritating the patient's ear during use.

[0130] In one embodiment, each arm may be connected to the upper end of the mask system and bend below the patient's field of vision or eyes and upward away from the horizontal axis at an angle of between approximately 10 and 20 degrees.

[0131] In an alternative embodiment, if Fig.36 As shown, each lower headband connector 225 may include a clip receptacle 231 adapted to removably interlock with a headband clip (not shown) coupled to the corresponding lower strap 294. In one embodiment, the headband clip receptacle and clip may be similar to the headband clip receptacle of the Mirage Liberty by ResMed. TM Headband Clip Sockets and Clips on Masks. Exemplary clip configurations are disclosed in U.S. Patent Publication Nos. 2007 / 014452 and 2006 / 0283461, the entire contents of which are incorporated herein by reference.

[0132] 2.2.8 Shield without upper headband connector

[0133] Figure 37-1 to Figure 37-3 A mask system 310 according to another embodiment of the present invention is shown. As shown, the mask system 310 includes a shield 320, a frame 340, a cushion 344 and an elbow 370.

[0134] like Figure 38-1 to Figure 38-5 As best shown, the shield 320 includes an opening 322 configured to receive the elbow 370 and headband connectors 325 on each side thereof. In the illustrated embodiment, each headband connector 325 includes a clip receptacle 331 adapted to removably interlock with a headband clip (not shown) coupled to a corresponding lower headband strap.

[0135] The frame 340 is removably coupled to the shield 320 , such as by fingers and protrusions 345 extending from the opening 322 adapted to engage a collar of the frame 340 .

[0136] The frame 340 includes upper headband connectors 324 on each upper side thereof. Each headband connector 324 includes a clip retainer 333 adapted to removably interlock with a headband clip (not shown) coupled to a corresponding upper headband strap.

[0137] Figure 39-1 to Figure 39-6 An alternative form of the mask system 310 is shown, which is indicated by similar reference numerals. As shown, the frame 340 is not provided with an upper headband connector, and each clip receptacle 331 includes an alternative structure (e.g., a hole for a snap-fit ​​protrusion on the clip). Moreover, although Figure 37-1 to Figure 38-5 The shield 320 in the embodiment includes a support rod 329 extending forward of the corresponding auxiliary port 343, but in Figure 39-1 to Figure 39-6 The shield 320 in FIG. 3 includes a support rod 329 configured to surround a corresponding auxiliary port 343 .

[0138] 2.3 Headband

[0139] The headband can be removably connected to the headband connectors 1024, 1025 of the shield 1020 to maintain the mask system 1010 in a desired position on the patient's face, such as shown in Figure 1B .

[0140] like Fig. 9 As shown, the headband 1090 includes a pair of upper and lower straps 1092, 1094, wherein the upper strap 1092 is detachably connected to the corresponding upper headband connector 1024, and the lower strap 1094 is detachably connected to the corresponding lower headband connector 1025. The free end of each strap may include A hook and loop closure configured to engage the remainder of the strap to secure the strap in place. The attachment also allows the length of the strap to be adjusted. However, the upper and lower headgear straps may be secured to the shield in any other suitable manner, such as by an adjustable ladder-like locking arrangement or the like.

[0141] The upper strap 1092 is bifurcated at the top of the patient's head into a top strap 1096 and a rear strap 1098, wherein the top strap 1096 (e.g., connected to each other by a buckle) is adapted to pass across the top of the patient's head during use, and the rear strap 1098 is adapted to pass behind the patient's head during use. In one embodiment, the headband 1090 is configured to be self-supporting.

[0142] exist Fig. 9In the embodiment, the top straps 1096 are adapted to be connected to each other via buckles. Figure 27-30 As shown, the headband 90 may include upper and lower straps 92, 94, a top strap 96, and a rear strap 98, the top strap 96 being integral with one another.

[0143] The upper strap 1092 is designed to adjust the position of the mask in a similar manner to how an adjustable forehead support changes the position of a mask system, i.e., by moving the top of the mask system closer to or away from the bridge of the patient's nose.

[0144] Without the forehead support, the headband is connected to the top and bottom of the mask frame 1040 via the shield 1020, and the arms 1026 of the upper headband connector extend at an angle to avoid the eyes and ears. By doing so, the headband vectors V1 and V2 (see Figure 1A and Figure 1B ) is adjusted so that the mask system can have a tendency to be worn on the patient's face (i.e., the upper headband connector positions the upper headband vector upward from the horizontal line, and the lower headband connector positions the lower headband vector to be generally horizontal). By bifurcating the upper headband strap 1092 at the top of the patient's head (i.e., the top and rear straps 1096, 1098), the upper headband vector can be readjusted to prevent the mask system from sliding off the patient's face.

[0145] 2.3.1 Headband adjustment

[0146] Figure 35-1 to Figure 35-3 A head strap 290 is shown connected to the head strap connectors 224, 225 of the mask to hold the mask system in a desired position on the patient's face.

[0147] In the illustrated embodiment, the headband 290 includes a pair of upper or top straps 292, a pair of lower or bottom straps 294, and a pair of rear straps 298. In use, the upper straps 292 are secured to respective upper connectors or arms 226, the lower straps 294 are removably connected to respective lower connectors via slots 229 / clip arrangements 231, and the rear straps 298 are removably connected to respective upper connectors via slots 227. The upper straps 292 may include upper strap portions adapted to traverse the top of the patient's head and coupled to one another, such as via headband buckles or an adjustable ladder-like locking arrangement 299. In the illustrated embodiment, the lower straps 294 and rear straps 298 are formed as a single piece.

[0148] This headband configuration allows adjustment to occur in three locations, namely the upper strap 292 at the headband buckle 299, the lower strap 294 at the slot 229 / clip 231 connection, and the rear strap 298 at the slot 227 connection.

[0149] As shown, the free end of each strap may include a hook and loop fastener 295 (e.g., ). This hook and loop attachment also makes it easy to adjust the length of the strap.

[0150] In the illustrated embodiment, the lower strap 294 and the rear strap 298 are adapted to meet and pass behind the patient's head during use (e.g., as seen in FIG. Figure 35-3 ). As shown, the lower straps 294 meet at an angle α (e.g., similar to the bottom straps in ResMed's Mirage Liberty mask) to prevent the straps from irritating the patient's neck and / or preventing the straps from moving due to movement of the patient's neck during use.

[0151] In one embodiment, the headband can be similar to the headband used in ResMed's Mirage Liberty mask, but the top strap is modified and there is no added stiffener system. The top strap can be similar to ResMed's Swift-type headband, where the stiffeners extend along both sides.

[0152] 2.3.2 Optional headband materials

[0153] Figure 43-1 to Figure 43-4 A mask system 610 including a mask 615 and a headband 690 according to another embodiment of the present invention is illustrated. In the illustrated embodiment, the headband 690 includes a strap configuration in which some straps are made of silicone and some straps are made of Breath-O-Prene. TM However, the headband can be constructed so that the straps are made entirely of silicone or entirely of Breath-O-Prene TM Made.

[0154] As shown in the figure, the lower strap portion 692 of the headband is made of Breath-O-Prene TM The upper strap portion 694 of the headband is made of silicone and includes: side straps 694(1) which extend along the upper cheeks and above the patient's ears; top straps 694(2) which extend over the top of the patient's head; and rear straps 694(3) which extend behind the patient's head and connect to the lower strap portion 692 (see FIG. Figure 43-4 ); and a connecting portion 694(4), which extends from the corresponding side strap 694(1) in front of the patient's ear and is connected to the lower strap portion 692.

[0155] The headgear straps can be connected to the mask in any suitable manner. For example, in the illustrated embodiment, the lower strap portion 692 is connected to the mask via a headgear clip configuration, and the upper strap portion 694 is connected to the mask using an elongated buckle 695 having a buckle portion at each end thereof.

[0156] In one embodiment, the headgear straps are configured such that the force vectors applied by the headgear to the mask are substantially perpendicular to the mask and substantially parallel to each other (e.g., Figure 43-2 ). This configuration enhances the mask seal because the headgear pushes the mask directly onto the patient’s face.

[0157] 3. Seals

[0158] The seal (ie, cushion) of the mask system is constructed to accommodate removal of the forehead support from the full-face interface.

[0159] 3.1 Pad

[0160] like Figure 1A-5 to Figure 7-8A As shown, the cushion 1060 is configured to interface with the frame 1040 and form a seal with the patient's nose and mouth during use. In the illustrated embodiment, the cushion is a full-face cushion that is adapted to engage the patient's face generally along the bridge of the nose, cheeks, and lower lip / chin area of ​​the patient's face. However, other cushion interfaces are possible, such as a nasal cushion interface.

[0161] The cushion 1060 is constructed to be more compliant or flexible (eg, particularly in the bridge of the nose area) to accommodate more movement due to some loss of stability without a forehead support.

[0162] The liner 1060 is made of a soft and flexible biocompatible material, such as silicone, for example. In the illustrated embodiment, the liner 1060 comprises a double-walled structure, wherein the liner comprises a Fig. 8A A bottom pad or support wall 1062 is shown beneath the diaphragm 1064.

[0163] The diaphragm 1064 is generally softer than the undercushion 1062 and less rigid than the undercushion 1062 and provides a seal against the patient's face in use. The diaphragm can be relatively thin to allow a wider fit range and better conformity to the patient's face for the poorer mask stability of the forehead support. The undercushion is configured to generally support the diaphragm and prevent collapse of the diaphragm when the mask system is connected and tightened using the headgear.

[0164] The diaphragm 1064 is generally concave and curves inwardly toward the breathing chamber. The bottom cushion 1062 may also curve inwardly but is typically shorter, thicker and more rigid than the diaphragm.

[0165] In one embodiment, the cushion 1062 is shorter in height or absent entirely in the area of ​​the patient's nose bridge and / or chin, and the height of the cushion 1062 from top to bottom can be between about 0 mm and 30 mm. In any given cross-section, the septum is generally longer than the base cushion 1062, and the septum can be between about 1 mm and 40 mm. For example, Figure 8B A cross-section through the bridge of the nose and chin areas of the cushion is shown to illustrate the membrane 1064 without the undercushion in these areas.

[0166] In one embodiment, the bottom cushion 1062 may be provided only in selected areas of the mask system, such as where the mask system is pushed away from the patient's face. It may be preferred to avoid certain predetermined areas on the patient's face where pressure is applied by tightening the headgear. In the illustrated embodiment, the bridge of the patient's nose and chin areas do not include the bottom cushion 1062. In these areas, the bottom cushion is provided only along the lateral sides of the cushion (e.g., as seen in FIG. Figure 7 ), the lateral sides of the cushion are pressed against the cheeks to more evenly distribute the force vectors applied by the mask system during use. In one embodiment, along the cheek region, the bottom cushion can be relatively stiff because these contact points act as anchor points, even if the mask system is supported in place to provide an effective seal.

[0167] This structure that avoids the bridge of the patient's nose and chin can increase the comfort of the mask system to the patient by reducing the force or pressure applied to sensitive areas or protruding areas of the patient's face that are subject to relatively higher contact pressures. In addition, this configuration avoids the cushion from squeezing the bridge of the patient's nose when adjusting the mask system. In addition, due to the absence of the bottom cushion, the cushion of this embodiment can be significantly softer in the area of ​​the bridge of the nose and chin.

[0168] In one embodiment, the base cushion may include varying heights, stiffnesses, and / or thicknesses to create varying softness in the aforementioned predetermined areas of the face where lighter support is desired.

[0169] In the illustrated embodiment, the cushion can be configured to seal against the bridge of the patient's nose and lower eye sockets, making the cushion less obtrusive.

[0170] In one embodiment, the cushion is generally frosted except for the patient contacting surface where it is polished. In one embodiment, frosting of the cushion can reduce the constraint between the face and the diaphragm and / or between the diaphragm and the bottom cushion. Frosting allows the surfaces of the diaphragm and the bottom cushion to slide relative to each other's corresponding surfaces without the same constraint of unfrosted silicone. This feature can also prevent or limit the diaphragm from adhering to the bottom cushion element and can generally improve the overall comfort and sealing characteristics of the cushion. In addition, frosting of the cushion is also easier to manufacture and can result in a reduction in manufacturing costs. The cushion can be made of frosted silicone or other suitable materials.

[0171] 3.2 Cushion lower on nasal bridge

[0172] Figure 31-1 to Figure 31-5 Various views of a cushion 44 (e.g., made of silicone) according to an embodiment of the present invention are illustrated. As shown, the cushion 44 includes a base wall 44 (1) disposed to the frame; an under-cushion layer (UCL) 44 (2) extending away from the base wall 44 (1); and a membrane 44 (3) disposed to substantially cover the UCL 44 (2) and provide a sealing configuration. In the illustrated embodiment, the cushion 44 is configured to be located below the bridge of the nose to reduce mask obtrusiveness and improve "line of sight" during use.

[0173] Moreover, as in Figure 31-3 to Figure 31-5 As best shown in FIG. 1 , the UCL44(2) design in the nasal bridge region is configured to provide improved stability across the nasal bridge during use. Figure 31-1 and Figure 31-3 As shown, no UCL is provided in the lower lip / chin area. However, other UCL configurations are possible, such as a UCL around the entire circumference.

[0174] exist Figure 31-3 to Figure 31-5 In the embodiment of the pad shown in FIG. 1 , D1 may be approximately 15-20 mm, such as 18.2 mm, D2 may be approximately 53-59 mm, such as 55.8 mm, D3 may be approximately 88-93 mm, such as 90 mm, D4 may be approximately 78-83 mm, such as 81.1, D5 may be approximately 58-63 mm, such as 60 mm, D6 may be approximately 95-100 mm, such as 98.1 mm, D7 may be approximately 57-62 mm, such as 59.7 mm, and D8 may be approximately 77-8 2mm, for example 79mm, D9 can be about 88-93mm, for example 90.7mm, D10 can be about 30-35mm, for example 33.1mm, D11 can be about 14-19mm, for example 16.4mm, D12 can be about 8-13mm, for example 9.6mm, D13 can be about 0.3-0.5mm, for example 0.35mm, D14 can be about 0.4-0.6mm, for example 0.5mm, and D15 can be about 0.3-0.5mm, for example 0.4mm. Although specific sizes and ranges are marked, it should be understood that these sizes and ranges are merely exemplary, and other sizes and ranges are also possible depending on the application. For example, depending on the application, the exemplary sizes can vary by 10-20% or more or less.

[0175] 3.3 Cushion higher on nasal bridge

[0176] Figure 35-1 to Figure 35-2 A full face cushion 244 is illustrated that is adapted to engage the patient's face generally along the bridge of the nose, cheeks, and lower lip / chin area of ​​the patient's face. In this embodiment, cushion 244 is configured such that it is located above the bridge of the nose (e.g., relative to cushion 44 described above) for sealing and comfort. Cushion 244 is also more optimal with respect to anthropometrics, i.e., the cushion will fit more people.

[0177] In one embodiment, the cushion 244 may include an accordion-style portion as described below (eg, in the nose bridge region) to increase the flexibility of the cushion during use.

[0178] 3.4 Accordion Section

[0179] As in Fig.30 and Fig.33 As best shown in the Figures, an accordion portion 50 can be disposed in the bridge of the nose region of the cushion and / or frame. As shown, the accordion portion 50 includes a bellows structure having one or more folds 52 that provide a higher degree of flexibility or increased movement. That is, the accordion portion 50 provides a higher level of adaptability or flexibility to the bridge of the nose region of the cushion / frame, which is a more sensitive area of ​​the patient's face during use. Moreover, the accordion portion 50 provides increased movement without compromising sealing.

[0180] Figure 32-1 to Figure 32-3 Various views of an accordion-style portion 50 (isolated from the rest of the cushion / frame) having one or more folds 52 are illustrated in accordance with an embodiment of the present invention. Figure 32-3 As best shown, the folds may have different lengths, depths and / or profiles relative to each other to optimize a concertina effect, such as providing a sufficient degree of movement without compromising sealing. Figure 32-3 As shown, each fold 52 includes a first side wall 52(1) and a second side wall 52(2) interconnecting adjacent side walls 52(1).

[0181] In the illustrated embodiment, the first side wall 52(1) and / or the second side wall 52(2) can be gradually longer away from the patient's face. For example, the first side wall 52(1) and / or the second side wall 52(2), or the combination of the side walls 52(1) and 52(2) adjacent to the patient's face can have a length that is longer and in some cases significantly longer than the adjacent side walls 52(1) and / or 52(2) (e.g., one side wall is at least 25% longer than the other side wall, up to 5 times longer than the other side wall, such as 1, 2, 3, or 4 times longer).

[0182] The folds can be constructed and configured to provide a predetermined sequence of movement or creasing, such as a fold being constructed to crimp in a sequential or progressive manner, with one fold crimping before an adjacent fold crimping. For example, when a force is applied, the fold closest to the patient's face can crimp or wrinkle before the fold farthest from the patient's face. Moreover, the folds can also be constructed and configured to provide different degrees of crimping or wrinkling, such as a fold can fold or wrinkle more than another.

[0183] exist Figure 32-1 to Figure 32-3 In the embodiment of the accordion-style portion shown, D1 can be about 50-60 mm, such as 55.7 mm, D2 can be about 5-15 mm, such as 9.7 mm, and D3 can be about 0.3-0.5 mm, such as 0.4 mm. Although specific sizes and ranges are indicated, it should be understood that these sizes and ranges are merely exemplary, and other sizes and ranges are possible depending on the application. For example, the exemplary sizes can vary by 10-20% or more or less depending on the application.

[0184] It should be understood that, for example, depending on patient comfort, the accordion portion 50 can be disposed in other areas of the cushion and / or frame. For example, the accordion portion 50 can be disposed around the entire periphery of the cushion and / or frame, or can be disposed in selected areas of the cushion and / or frame.

[0185] Moreover, the flexibility of the accordion portion 50 can vary, e.g., depending on patient comfort, and can vary in different areas of the cushion and / or frame. For example, the cushion and / or frame can include an accordion portion with a relatively high degree of flexibility in the nose bridge area and an accordion portion with a relatively low degree of flexibility in the lower lip / chin area. The flexibility of the accordion portion 50 can be varied by varying the number of folds 52 (e.g., 1-5 folds), the wall length of the folds 52, the wall thickness, the depth of the folds 52, etc.

[0186] As noted above, the pad and frame may be co-moulded from two parts having different materials / rigidities, or integrally formed from the same material. In both embodiments, accordion-style sections may be provided in the frame and / or the pad.

[0187] exist Figure 27-30In the embodiment of the present invention, the cushion 44 and the frame 40 are co-molded from two parts, and the accordion-like portion 50 is disposed in the frame 40. The frame 40 and the cushion 44 have different stiffnesses to optimize the function of each part. For example, one part (i.e., the cushion 44) can be made of a relatively soft and compliant material to optimize the sealing effect, while the other part (i.e., the frame 40) can be made of a more rigid material to provide sufficient support for the cushion while allowing a sufficient degree of movement to optimize the accordion-like effect. Although the frame is more rigid than the cushion, the frame can also be made of a flexible material to allow for the accordion-like effect.

[0188] exist Fig.33 In the embodiment, the frame 40 and the gasket 44 are integrally formed as a single piece, and the accordion-like portion 50 is disposed in the frame 40. The material properties and / or dimensions may be selectively modified to optimize the seal and the accordion-like effect.

[0189] for Figure 27-30 and Fig.33 In the embodiment of FIG. 4 , it should be understood that, alternatively, the accordion-type portion may be provided in the pad 44 or in both the frame 40 and the pad 44. For example, Fig.34 The accordion-style portion 50 is shown as being integrally formed with the cushion 44 in the nose bridge area.

[0190] 4. Cubital Tunnel

[0191] like Figure 3 As shown, elbow 1070 (e.g., made of a relatively rigid material such as polycarbonate or polypropylene) includes a first end 1074(1) and a second end 1074(2). First end 1074(1) provides a docking structure configured to dock with frame 1040 or otherwise connect to frame 1040. Second end 1074(2) is adapted to connect to an air delivery tube.

[0192] 4.1 Connection between elbow and frame

[0193] The frame 1040 is configured to hold the elbow 1070 in a working position relative to the patient's face. That is, the frame acts as a bracket or support surface for the elbow. The frame and elbow can be connected with a friction fit, a snap fit, a mechanical interlock, or other suitable connection mechanism. However, other suitable configurations for connecting the elbow to the frame are also possible.

[0194] In the illustrated embodiment, the elbow 1070 includes a series of tangs 1075 adapted to releasably engage, such as by a snap fit, within the opening 1032 of the frame 1040. The tangs 1075 hold the elbow in place (e.g., preferably a relatively airtight connection) and allow the elbow to rotate or swivel relative to the frame.

[0195] That is, the elbow is rotatably connected to the frame so that the elbow can be rotated relative to the frame during use, for example 360°. This configuration allows the elbow to assume different orientations during use, for example depending on patient preference. For example, the elbow can assume a first orientation so that the elbow extends generally downward from the mask so as to guide the air delivery tube under the patient's head during use. Alternatively, the elbow can be rotated and assume a second orientation so that the elbow extends generally upward from the mask so as to guide the air delivery tube above the patient's head during use. In one embodiment, the frame and the elbow can be made of different materials to prevent or at least reduce sliding noise between the components during use.

[0196] The second end of the elbow may be disposed on a swivel joint adapted to be connected to the air delivery tube. Figure 27-30 The figure shows a swivel joint 80 disposed at the second end 74 (2) of the elbow 70. In the illustrated embodiment, the swivel joint 80 is disposed to a short tube 82 (e.g., an extendable and retractable tube) that interconnects the elbow with the air delivery tube. In one embodiment, the swivel joint 80 can be integrally formed as a single piece with the short tube 82.

[0197] 4.2AAV

[0198] The elbow 1070 includes a slot 1081 for receiving an anti-asphyxia valve (AAV); a port 1079 that is selectively closed by a flap portion of the AAV (depending on the presence of compressed gas); and structure for connecting to the AAV, such as with a snap fit.

[0199] Figure 27-30 An exemplary AAV 85 is illustrated that includes a flap portion 86 that selectively closes the port 79 in the elbow 70. In this embodiment, a clip portion 88 for attaching the AAV 85 to the elbow 70 is disposed on the flap portion 86. In the illustrated embodiment, the flap portion 86 and the clip portion 88 are co-molded with each other to form a one-piece, unitary component. However, the flap portion 86 and the clip portion 88 may be secured to each other in other suitable ways, such as mechanical interlocking.

[0200] In one embodiment, the flap portion 86 may be made of a relatively soft, resilient material (eg, silicone), while the clip portion 88 may be made of a more rigid material (eg, rigid plastic) to interface with the elbow 70 .

[0201] The clip portion 88 of the AAV 85 includes a configuration that removably interlocks with the elbow 70, such as by a snap fit. For example, the clip portion 88 may include a tab that is configured to interlock with a corresponding groove / protrusion provided on the elbow.

[0202] Figure 35-1 and Figure 35-2 An elbow 270 is shown including a port 279 that is selectively closed (depending on the presence of compressed gas) by a baffle portion 286 of an AAV 285. Also, Figure 37-1 to Figure 37-3 An elbow 370 is shown including a port 379 and a slot 381 for securing the AAV.

[0203] Alternative embodiments of AAVs are disclosed in PCT Application No. PCT / AU2006 / 000031, which is incorporated herein by reference in its entirety.

[0204] 4.3 Large diameter end

[0205] like Figure 27-30 As shown, the first end 74(1) of the elbow 70 can provide a relatively large diameter, which allows for the possibility of cleaner / smoother lines, thereby contributing to the overall mask aesthetics and reduced obtrusiveness. In addition, the relatively large diameter elbow provides the patient's nose with the possibility of protruding into the elbow cavity, thereby allowing the mask to be closer to the patient's face (i.e., reduced obtrusiveness), resulting in less torque due to the mask's center of gravity being closer to the patient's face, and / or improving line of sight.

[0206] 5. Modular design

[0207] The mask system provides a modular design, which allows different types and / or sizes of frames (also referred to as frame modules), shields (also referred to as shield modules), cushions (also referred to as cushion modules) and / or elbows (also referred to as elbow modules) to be interchanged or mixed and matched with each other, thereby providing a more customized mask system for the patient. In addition, this design allows for easy replacement of selected modules, such as when treatment needs change, breakage or damage.

[0208] In one embodiment, the mask system can be provided with a number of different cushions, for example, each having a different type and / or size of cushion (e.g., depending on patient preference and / or fit). For example, the non-face contacting side of each cushion can include a common or universal structure for docking with the frame, while the face contacting side of the cushion can include different types and / or sizes. This provides a modular configuration that allows the frame to be selectively (e.g., and removably) coupled to one of the plurality of cushions. For example, the different cushions can include cushions of different sizes (e.g., small, medium, and large), and can include different cushion configurations.

[0209] In one embodiment, the mask system can be provided with different shields, for example, each shield has a different type and / or size (e.g., shields with different configurations / types of headband connectors; shields with forehead supports, different headband vectors, etc.).

[0210] In one embodiment, the mask system can be provided with different frames, for example, each frame having a different type and / or size (eg, a frame with different vent arrangements; small, medium and large frames, etc.).

[0211] In one embodiment, the mask system may be provided with a number of different elbows, for example each having a vent device, an AAV (in the case of an oronasal mask), and / or elbows of different types and / or sizes. Figure 27-30 In the illustrated embodiment, the vent device 76 and AAV 85 are configured to be removably connected to the elbow 70. This provides a modular configuration that allows the elbow to be selectively and removably coupled to one of a plurality of vent devices and / or AAVs. This also allows the vent device and AAV to be easily replaced, for example if damaged.

[0212] 5.1 Connection of shield to frame

[0213] The shield is mounted on the outer surface of the frame, such as preferably by a close and conforming fit on the frame.

[0214] 5.1.1 Upper fixing mechanism

[0215] exist Figure 1A-5 In the illustrated embodiment, the shield 1020 is connected to the frame 1040 via an upper securing mechanism or docking structure 1048 located at the top end of the frame and shield.

[0216] like Figures 2 to 5 As shown, the upper securing mechanism 1048 is in the form of two tapered locks configured to secure the shield 1020 to the frame 1040 and prevent inadvertent removal, particularly due to headband forces. In this embodiment, the opposing sides of the frame each include a concave slot 1055 adapted to receive a corresponding tang protrusion (which tapers along its length) on the underside of the shield 1020. The tapered protrusions engage within the corresponding concave slots, for example with a friction fit.

[0217] Figure 10 to Figure 19-4 Another embodiment of a mask system is shown that more clearly illustrates an embodiment of a tapered lock. Figures 10 to 17 Various views of the frame 1140, shield 1120, and elbow 1170 of the mask system 1110 are shown.

[0218] As in Figures 11 to 13 As best shown, opposite sides of the top end of the frame 1140 each include a platform 1154 that provides a first concave slot 1151 (1). In addition, the space between the outer surface of the frame 1140 and the platform 1154 defines a second concave slot 1151 (2). Fig.17As best shown in FIG. 1 , opposite sides of the top end of the shield 1120 each include a tang protrusion 1156 on the inner side of the shield 1120. The tang protrusion 1156 includes a first tang 1156(1) and a second tang 1156(2) extending generally transverse to the first tang 1156(1). Figure 18-1 and Figure 18-2 As shown, each tang may taper along its length, ie become thinner towards its free end.

[0219] Figure 18-1 and Figure 18-2 and Figure 19-1 to Figure 19-4 The shield 1120 is illustrated as being connected to the frame 1140 in a sequential relationship. As shown, the tangs 1156(1), 1156(2) of each tang protrusion 1156 are configured to engage the corresponding slots 1155(1), 1155(2), such as by a friction fit. Figures 19-1 to 19-4 As best shown in FIG. 1 , each slot 1155 ( 2 ) includes a lead-in or guide 1157 that is curved along its length (i.e., extends in both the vertical and horizontal directions) to guide the tang 1156 ( 2 ) into the slot 1155 ( 2 ) and assist in assembly. Figure 18-2 and Figure 19-4 The tangs 1156(1), 1156(2) are shown fully inserted into the corresponding slots 1155(1), 1155(2).

[0220] In an alternative embodiment, if Fig. 20 As shown, the upper fixing mechanism may include a clip-type configuration. As shown, opposite sides of the top of the frame 1240 are provided with shoulders 1255 (1) and tapered protrusions 1255 (2). Opposite sides of the top of the shield 1220 include first tangs 1256 (1) and second tangs 1256 (2) on the inner side of the shield 1220. In use, each first tang 1256 (1) engages with a corresponding shoulder 1255 (1), and the second tang 1256 (2) engages with the tapered protrusion 1255 (2) or is clipped onto the tapered protrusion 1255 (2), such as by a snap fit.

[0221] 5.1.2 Lower fixing mechanism

[0222] In one embodiment, the shield can also be connected to the frame by a lower fixing mechanism located on the bottom ends of the frame and the shield. For example, the fixing mechanism can be disposed on an opening of the shield that is configured to interlock with an opening of the frame or otherwise engage with an opening of the frame.

[0223] For example, Fig.14 , 15, 17 and 21, the opening 1132 of the shield 1120 may include a structure adapted to snap-fit ​​with a collar 1149 surrounding the frame opening 1146. As shown, the shield 1120 includes snap fingers 1145(1) (e.g., three snap fingers) and clamping protrusions 1145(2) (e.g., three clamping protrusions) extending from the opening 1132. Optionally, the snap fingers and clamping protrusions are spaced around the opening.

[0224] In use, the snap fingers 1145(1) are resiliently deflected (e.g., 0.5 mm deflection) and engage corresponding partial annular protrusions 1149(1) provided on the collar 1149 (e.g., see Fig. 22 and Fig.23 ), thereby providing initial retention of the shield 1120 (e.g., to allow stress) to the frame 1140, for example, to facilitate assembly and disassembly. In addition, as the snap fingers 1145 (1) engage with the corresponding protrusions 1149 (1), the clamping protrusions 1145 (2) are received in corresponding grooves 1149 (2) provided on one end of the collar 1149 (e.g., see Fig. 22 and Fig.23 ). When the elbow 1170 is engaged with the frame 1140 (see Fig.23 ), the annular protrusion 1171 on the elbow 1170 is located on an opposite side of the clamping protrusion 1145 (2), so that the clamping protrusion 1145 (2) is clamped between the collar 1149 and the elbow 1170. Therefore, in use, the clamping protrusion secures the shield to the frame using the elbow retention force. The elbow 1170 has a distal shoulder 1173 adapted to extend below the edge of the frame 1140 to secure the elbow to the frame. The snap finger 1145 (1) allows the shield to be connected to the frame independently of the elbow.

[0225] In an alternative embodiment, if Fig.24 As shown, the lower portion of the shield can be configured to clip onto a single point below the collar. As shown, the lower end of the shield 1320 includes a snap-fit ​​finger 1345 that engages or clips onto a protrusion 1349 (1) spaced from the collar 1349 below the collar 1349 of the frame 1340, such as by snap fit. In this embodiment, the protrusion 1349 extends from a cover that seals the auxiliary port. This configuration can facilitate molding the collar onto the frame, for example, the uniform thickness of the collar prevents molding deformation, and further, removing the protrusion 1149 (1) / groove 1449 (2) from the collar can reduce the risk of leakage.

[0226] 5.1.3 Finger grip

[0227] In one embodiment, the outer surface of the frame 1040 may include a finger grip or recessed portion 1097 positioned to be exposed below the shield 1020. The finger grip is adapted to allow the patient to improve the ability to grip the frame and / or shield, which is particularly useful when separating the shield from the frame.

[0228] 5.1.4 Optional docking structure

[0229] In an alternative embodiment, if Figure 27-30 As shown, the shield 20 includes an open structure that provides an annular or partially annular fixing portion 22 configured to fix the frame 40 and the elbow 70. As shown, the annular fixing portion 22 includes a docking structure 23 along the inner edge, and the docking structure 23 is suitable for docking with a docking structure 48 along the outer periphery of the frame 40 or vice versa, which can be detachably connected to the docking structure 48 (e.g., see Fig.28 In the illustrated embodiment, the docking structure 23 is in the form of opposed flanges 23(1) adapted to interlock with corresponding locking structures 48(1) disposed on opposite sides of the frame 40. However, other suitable configurations for connecting the frame 40 to the shield 20 are also possible, such as friction fits, snap fits, mechanical interlocks, or other suitable connection mechanisms.

[0230] For example, the frame 40 may be coupled to the shroud 20 in a manner that allows the frame 40 to be locked in different angular positions relative to the shroud 20, such as being pivotally mounted.

[0231] 5.1.5 Optional upper headband connector

[0232] Figure 40-1 to Figure 40-7 A frame and clip-on headband connector or stiffener according to another embodiment of the present invention is illustrated.

[0233] The frame 442 includes an opening 449 adapted to engage a frame shroud and / or elbow. Surrounding and below the opening 449 is a U-shaped slot 402 for gas flushing and auxiliary ports 443 on each side thereof.

[0234] In this embodiment, each upper side of the frame 442 includes a fixing element 433 , and the upper middle portion of the frame 442 includes a fixing slot 435 that is constructed and configured to fix the upper headband connector or stiffener 424 .

[0235] like Figure 40-6 and Figure 40-7 As best shown, the upper headband connector 424 includes a pair of elongated arms or stiffeners 426 connected by a pair of cable elements 428. Each stiffener 426 includes a slot 427 at a free end thereof adapted to receive a respective headband strap in use.

[0236] In use, the upper headband connector 424 is adapted to be clipped onto the frame 442 (see, for example, Figure 40-1 and Figure 40-2 Specifically, the middle portion of the cable element 428 is received in the corresponding groove 435 of the frame 442, and the end of the cable element 428 extends through the corresponding fixing element 433, wherein the hardening member 426 provides a shoulder that interlocks with the corresponding fixing element 433. Figure 40-4 and Figure 40-5 The upper portion of the fixing element 433 is shown to illustrate the groove 433 (1) adapted to receive a corresponding cable. As shown, one end of the groove 433 (1) includes a tapered sidewall 433 (2) and decreases toward the rear side 433 (3) to position the stiffener 426 in interlocking engagement with the fixing element 433.

[0237] Figure 41-1 to Figure 41-12 An upper portion of a frame and a clip-on upper headband connector or stiffener are illustrated according to another embodiment of the present invention.

[0238] As shown, the upper portion of the frame 542 includes fixing elements 533 on each side thereof and fixing grooves 535 along the middle thereof, and the fixing elements 533 and fixing grooves 535 are constructed and configured to fix the upper headband connector or stiffener 524.

[0239] like Figure 41-5 and Figure 41-12 As best shown, the upper headband connector 524 includes a pair of elongated arms or stiffeners 526 joined by a connecting portion 528. Each stiffener 526 includes a slot 427 at its free end adapted to receive a corresponding headband strap in use. In addition, the upper headband connector 524 includes a clip formation 525 on each side of the connecting portion 528.

[0240] In use, the upper headband connector 524 is adapted to be clipped onto the frame 542 (see, for example, Figure 41-1 and Figure 41-2 ). Specifically, the connecting portion 528 is received in the slot 535 of the frame 542, and the clip structure 525 is releasably interlocked with the corresponding fixing element 533. Figure 41-3 and Figure 41-4 As best shown, each securing element 533 provides a crossbar and each clip formation 525 provides a V-shaped structure adapted to resiliently deflect through the crossbar and provide a shoulder that releasably interlocks with the crossbar.

[0241] Figure 42-1 to Figure 42-7An alternative embodiment of an upper headband connector engagement frame is illustrated. As shown, each fixing portion 533 provides an open-ended crossbar and each clip structure 525 provides an extension arm. In this embodiment, the crossbar is configured to be resiliently deflected to allow the clip structure 525 to extend through the crossbar and releasably engage the crossbar, such as by a friction fit. In addition, Figure 42-1 to Figure 42-7 The upper headband connector 524 in the embodiment includes a C-clip structure 529 adapted to interlock with a protrusion 549 disposed on the frame 542 (see Figure 42-1 and Figure 42-2 ).

[0242] 5.1.6 Grommet connection

[0243] Fig.44 and Fig.45 An alternative face shield configuration is illustrated in which the shield is attached to the frame via grommets.

[0244] For example, Fig.44 As shown, the frame 740 includes a grommet 745 (e.g., made of rubber), and the shield 720 includes an opening 725 adapted to receive the grommet 745 to secure the shield 720 to the frame 740. As shown, the shield 720 includes an upper elongated arm 724 and a lower elongated arm 726, each arm having a slot 727 at its free end adapted to receive a corresponding headgear strap in use.

[0245] Fig.45 An alternative shield 820 is illustrated that includes a single arm having a slot 827 at each end thereof adapted to receive a corresponding headgear strap in use. In addition, the shield 820 is provided with an inner elongated slot 825 adapted to receive the grommet 745 of the frame 740. In contrast to the shield 720 that provides a single fixed position, the elongated slot 825 allows the grommet 745 to be secured at one of a plurality of positions along the length of the elongated slot 825. In an embodiment, the shield 820 may be slidable relative to the grommet 745 to allow an unlimited number of positions relative to the frame 740.

[0246] In each embodiment, a grommet 745 (e.g., made of rubber) secures the shield in place, but the inherent flexibility of the grommet 745 provides a flexible connection to separate the shield from the frame and allow a range of movement between the two elements, such as a ball joint or a universal joint. This configuration helps to mount and seal the mask to the patient's face. That is, the flexible connection allows the mask to be selectively adjusted and / or self-fitting relative to the patient's face.

[0247] 5.2 Connection between gasket and frame

[0248] exist Figure 1A-8A1040, the non-face contacting side of the pad 1060 is connected to the frame 1040 in a tongue and groove relationship. The tongue 1066 (see Figure 1C , Figure 1D and Fig. 8A ) is inserted into the groove 1041 (see Figure 1C and Figure 1D ). The tongue and groove relationship may also include an undercut bead 1042 (see Figure 1C and Figure 1D ) interlocking liner locking lip or sealing lip 1068 (see Figure 1C , Figure 1D and Fig. 8A ), thereby firmly securing the liner to the frame.

[0249] In the illustrated embodiment, the cushion 1060 also includes one or more positioning features disposed about its periphery to assist in properly aligning the cushion with the frame 1040. Figure 7 As shown, the gasket 1060 includes notches and / or protrusions (eg, two notches 1067 and one protrusion 1069) adapted to engage complementary features in the frame, such as in an interlocking relationship.

[0250] 5.2.1 Co-molded frame and gasket

[0251] In one embodiment, if Figure 27-30 As shown, the frame 40 and the cushion 44 can be co-molded with each other to form a one-piece integral element. For example, the frame 40 can be molded from a first material suitable for docking the shield 20, and the cushion 44 can be co-molded to the frame 40 from a second material suitable for docking the patient's face.

[0252] In such an embodiment, the gasket 44 may be made of a relatively soft, resilient material (eg, silicone) for sealing, while the frame 40 may be made of a more rigid material (eg, polycarbonate, polypropylene) than the gasket 44 of the docking frame.

[0253] Co-molding the frame 40 to the gasket 44 provides a chemical bond without the need to form a mechanical interlock. As a result, the connection does not include cracks, but rather includes a hermetic seal and a clean interface. Moreover, since the molding material is flexible enough to fill any gaps at the interface between the frame 40 and the gasket 44, this co-molded connection relaxes tolerances. Moreover, the co-molded frame / gasket provides a reduced total number of parts (reduced cost) and facilitates assembly / disassembly with the shield 20.

[0254] In an alternative embodiment, if Fig.33As shown, the frame 40 and the cushion 44 may be integrally formed as a single piece, for example, from a silicone material. That is, the frame 40 may have the same shape and configuration as described above, but is integrally molded from the same material, for example, silicone.

[0255] In one embodiment, the integrally formed frame 40 / cushion 44 can be co-molded onto the shield 20, which is made of, for example, polycarbonate or polypropylene. For example, the shield 20 can be made of a relatively rigid material (such as polycarbonate or polypropylene), and the frame 40 / cushion 44 can be co-molded onto the shield 20, which is made of a relatively soft and flexible material (such as silicone).

[0256] 5.3 Vent device

[0257] exist Figure 1A , Figure 1B , Figure 1C , Figure 1D and Figure 2-5 In , a vent device 1076 is disposed on a frame and includes a plurality of holes 1077 (e.g., 5-100 holes, such as 20-50 holes, or about 35 holes) positioned at an angle (e.g., 45°) on the outer surface of the frame to ensure that exhaled air is directed away from the patient, preferably away from their bed partner while the patient is sleeping. Figure 1C and Figure 1D As shown in , each hole 1077 may include a profile or taper along its length. However, it should be understood that the vent device may include other suitable configurations, such as a different number of holes, hole configurations, positioning on the frame, the vent providing a portion of an interlocking structure with the shield, etc.

[0258] Figure 35-1 A vent device 276 for gas flushing is illustrated disposed on the frame 240. In the illustrated embodiment, the vent device 276 is in the form of a vent insert (e.g., a resilient vent insert) adapted to be removably supported within an exhaust port in the frame 240. The vent insert may be similar to the vent inserts described in U.S. Patents 6,561,190, 6,561,191, and 7,207,335, the entireties of which are incorporated herein by reference. However, it should be understood that the vent device may have other suitable forms (e.g., vent holes in the body, etc.).

[0259] Figure 37-3 , Figure 39-2 and Figure 39-4A frame 340 is illustrated that includes a u-shaped slot 302 that receives a u-shaped plug vent 305 for gas flushing. As shown, the plug vent 305 surrounds and under the opening of the frame 340 for the elbow 370. The plug vent 305 includes a plurality of channels or slots 307 on each side thereof. In use, the slotted plug vent 305 forms a seal with the slot 320 so that exhaled air can be exhausted between the slot wall and the slot 307 on the plug vent 305. In one embodiment, a port cap 347 can be incorporated or incorporated into the plug vent 305 (e.g., integrally formed as a single piece). U.S. Patent Application No. 12 / 230,120, filed on August 22, 2008, provides detailed details of such a plug vent device, which is incorporated herein by reference in its entirety. Figure 39-2 to Figure 39-6 The frame 340 is shown with the slotted plug vent 305 removed to more clearly show the u-shaped slots 302 and auxiliary ports 343 on each side thereof.

[0260] Furthermore, it should be understood that the vent device may be provided on the elbow. Figure 27-30 As shown, the vent device 76 is in the form of a vent insert adapted to be removably supported within the exhaust port in the elbow 70. In one embodiment, the vent device 76 includes: a base adapted to be supported within the exhaust port; one or more grid elements or media (e.g., filters, membranes, or other porous materials) disposed on the base and configured to diffuse the vent flow; and a cover that retains the grid elements / media within the base. Figure 27-30 Only the cover 77 of the vent arrangement 76 is visible.

[0261] Illustrative embodiments of such vent devices are provided in US Patent Application No. 12 / 230,120, filed August 22, 2008, which is incorporated herein by reference in its entirety.

[0262] However, it will be appreciated that the vent arrangement may include other suitable configurations, such as a vent insert having one or more vent holes.

[0263] Furthermore, the elbow may also provide an optional vent arrangement with a vent insert. Fig.30As shown by the dashed lines in , the first end 74(1) of the elbow 70 (e.g., along the docking structure 75) may include one or more vent holes 276 for gas flushing. One or more holes 276 may be provided in the soft portion (e.g., silicone seal as described below) and / or the hard portion (e.g., polycarbonate, polypropylene) of the elbow. The holes 276 may extend around the entire periphery of the first end 74(1) or may extend along one or more portions of the first end 74(1). It should be noted that providing vent holes along the entire periphery of the elbow may assist in dispersing the ventilation flow during use. However, other suitable hole configurations, numbers of holes, and / or hole shapes along the first end 74(1) and / or other portions of the elbow are also possible.

[0264] 5.4 Ports

[0265] exist Figure 1A-5 In the embodiment, the bottom of the frame 1040 includes two ports 1043, which are positioned so that in use oxygen or other breathable gas can be delivered to the patient's nostrils or a pressure monitoring device can be connected. Ports 1043 can also be used to connect additional medical devices such as pressure or flow sensors. The ports can be selectively closed or sealed by port caps.

[0266] In an alternative embodiment, if Fig.25 and Fig.26 As shown, for example, frame 1040 may include side ports 1043 . 1 in addition to or in lieu of ports 1043 .

[0267] Figure 35-1 and Figure 35-2 A frame 240 is shown including auxiliary ports or receptacles 243 on an upper portion of the frame, such as for supplemental oxygen, measurement equipment, and the like.

[0268] exist Figure 37-1 to Figure 37-3 and Figure 39-1 to Figure 39-6 In the embodiment, the frame 340 includes auxiliary ports or receptacles 343 on each side thereof, for example, for supplemental oxygen, measurement equipment, etc. Port caps 347 are provided to seal the respective ports 343.

[0269] 6. Joint surface seals

[0270] In one embodiment, a seal may be provided at the interface between the elbow and the shroud, at the interface between the frame and the shroud, and / or at the interface between the elbow and the frame. For example, a seal (e.g., a resilient annular seal) may be formed independently of the modules and connected at the interface (e.g., sandwiched between the modules, adhered, etc.). Alternatively, the seal may be co-molded with one or more modules. In one embodiment, a silicone lip seal may be provided on the frame to seal against the elbow, thereby reducing leakage.

[0271] In another embodiment, Figure 27-30 As shown, the docking structure 75 of the elbow 70 can be made of a relatively soft sealing material (e.g., silicone, which can be co-molded onto the harder material of the elbow) that is configured to provide a seal at the interface between the elbow 70 and the shield 20. Moreover, the relatively soft docking structure 75 (e.g., silicone) provides a "soft" connection to the relatively hard shield 20 (e.g., polycarbonate, polypropylene), which can allow an interference-type fit. As noted above, one or more vent holes can be provided on the softer docking structure and / or the harder elbow.

[0272] Although the present invention has been described in conjunction with what are currently considered to be the most practical and most preferred embodiments, it should be understood that the present invention is not limited to the disclosed embodiments. On the contrary, the present invention is intended to cover various modifications and equivalent arrangements included in the spirit and scope of the present invention. Moreover, the above-mentioned different embodiments may also be implemented in combination with other embodiments, for example, the technical solution of one embodiment may be combined with the technical solution of another embodiment to implement yet another embodiment. In addition, each independent feature or element of any given component may constitute another embodiment. Furthermore, each individual element in any given component in one or more embodiments, one or more parts of each individual element in any given component, and various combinations of elements may include one or more decorative design features. In addition, although the present invention has particular applications to patients with OSA, it should be understood that patients with other diseases (e.g., congestive heart failure, diabetes, morbid obesity, stroke, and laparoscopic surgery, etc.) may benefit from the above technology. In addition, the above technology is applicable to patients and similar non-patients in non-medical applications.

Claims

1. A mask system, comprising: Liner module, comprising: a cushion comprised of a flexible material that, in use, forms a seal with the patient's face, wherein the cushion is configured to engage along a nasal bridge region of the patient's face in use, the cushion comprising an accordion-like portion disposed in the nasal bridge region, the accordion-like portion comprising one or more folds that provide a degree of flexibility or mobility to the cushion; and a frame connected to the cushion and forming a breathing chamber, the frame being constructed of a stiffer material than the cushion and including a circular frame opening configured to allow breathable gas to flow into the breathing chamber in use; a shield module, the shield module being composed of a harder material than the cushion and including a closed-shaped circular opening, the shield module including a forehead support, and the shield module including a headband connector, wherein the shield module includes a protrusion on an inner side facing the breathing chamber, the protrusion being configured to engage with a slot on the frame; a headband for holding the cushion module in a sealed position so as to enable positive pressure air to be delivered to the patient's airway, the headband comprising a pair of upper straps adapted to contact the patient's face above the patient's ears, a pair of lower straps adapted to contact the patient's face below the patient's ears, the pair of upper straps and the pair of lower straps being removably connected to the headband connector; and An elbow module, the elbow module being composed of a material harder than the liner, the elbow module comprising: a first end rotatably attached directly to the circular opening of the shroud module to allow 360° relative rotation between the elbow module and the shroud module, and, A second end is adapted for connection to an air delivery tube to deliver breathable gas to a patient.

2. The mask system according to claim 1, wherein: The cushion is a full face cushion adapted to engage the patient's face along the bridge of the nose, cheek and lower lip areas of the patient's face, and wherein the port of the elbow module is selectively closed by a flapper portion of an anti-asphyxia valve depending on whether pressurized gas is present.

3. The mask system according to claim 2, wherein: The elbow module includes a slot for receiving the flapper portion of the anti-asphyxia valve.

4. The mask system according to claim 2, wherein: The shroud module includes a receiving hole above the circular opening for alignment with the vent of the frame.

5. The mask system according to claim 1, wherein: The cushion is a nasal cushion.

6. The mask system according to claim 5, wherein: The elbow module also includes a ventilator.

7. The mask system according to any one of claims 5 to 6, wherein: The protrusion includes a first tang and a second tang oriented transversely to the first tang.

8. A mask system according to any one of claims 1 to 6, wherein: Each upper strap of the pair of upper straps includes a hook and loop material, and each lower strap of the pair of lower straps includes a hook and loop material.

9. The mask system according to any one of claims 1 to 6, wherein: The headband connector includes a lower headband connector extending from a lower end of the shield module, and the pair of lower straps are adapted to be connected to the lower headband connector.

10. The mask system according to claim 9, wherein: Each lower strap of the pair of lower straps includes a clip adapted to couple with the lower headband connector of the shield module.

11. The mask system according to any one of claims 1 to 6, wherein: The frame and the cushion are co-molded with each other.

12. The mask system according to any one of claims 1 to 6, wherein: The headband connector is molded to the shroud module.

13. The mask system according to any one of claims 1 to 6, wherein: The first end of the elbow module has a distal shoulder adapted to extend at an edge of the frame to retain the elbow module to the frame.

14. The mask system according to any one of claims 1 to 6, wherein: The frame further includes a male collar protruding from a surface of the frame and surrounding the circular frame opening, the first end of the elbow module being releasably and rotatably engaged to the male collar using a snap fit.

15. A mask system according to any one of claims 1 to 6, wherein: The headgear also includes a pair of rear straps adapted to pass behind the patient's head.

16. A mask system according to any one of claims 1 to 6, wherein: The shield is mounted on the outer surface of the frame with a close, snug fit.

17. A mask system according to any one of claims 1 to 6, wherein: The first end of the elbow module passes through the circular opening of the shroud module, the first end passes through the circular frame opening and is releasably and rotatably engaged to the frame with a snap fit.

18. The mask system of claim 1, wherein The cushion is a nasal cushion, the frame and the nasal cushion are co-molded with each other, the frame further comprising a raised collar protruding from a surface of the frame and surrounding the circular frame opening; The elbow module also includes a ventilation device; a lower headband connector extending from a lower end of the shield module, and the lower headband connector being molded to the shield module; The pair of upper straps include hook and loop material and the pair of lower straps include hook and loop material adapted to connect to the lower headband connector; and The headgear also includes a pair of rear straps adapted to pass behind the patient's head.

19. The mask system of claim 1, wherein The cushion is a full-face cushion adapted to engage the patient's face along the bridge of the nose, cheeks and lower lip regions of the patient's face, the frame and the full-face cushion being co-molded with one another, the frame further comprising a raised collar protruding from a surface of the frame and surrounding the circular frame opening; The port of the elbow module is selectively closed by a flapper portion of an anti-asphyxia valve depending on whether pressurized gas is present, the elbow module including a slot for receiving the flapper portion of the anti-asphyxia valve; The shield module includes a receiving hole above the circular opening for alignment with the vent of the frame; a lower headband connector extending from a lower end of the shield module, and the lower headband connector being molded to the shield module; The pair of upper straps include hook and loop material and the pair of lower straps include hook and loop material adapted to connect to the lower headband connector; and The headgear also includes a pair of rear straps adapted to pass behind the patient's head.

20. A mask system according to claim 18 or claim 19, wherein: The first end of the elbow module is releasably and rotatably engaged to the collar with a snap fit, the first end of the elbow module having a distal shoulder adapted to extend at an edge of the frame to retain the elbow module to the frame.

21. A mask system according to claim 18 or claim 19, wherein: Each lower strap of the pair of lower straps includes a clip adapted to couple with the lower headband connector of the shield module.

22. A device for treating sleep-disordered breathing, the device comprising: A mask system according to claim 1, 18 or 19; an air delivery tube connected to said second end; as well as A flow generator is used to deliver pressurized breathable gas to a patient wearing the mask through the air delivery tube, the flow generator being adapted to deliver pressurized breathable gas at 2-30 cm H2O above atmospheric pressure to the patient's airway.

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