# Patent

## Title
Mask system

## Abstract

A full face mask system for treatment of respiratory disorder with Continuous Positive Airway Pressure equipment suitable to generate a supply of gas at positive pressure to be delivered to a patient's airways, the mask system comprising a frame module; a cushion module provided to the frame module and adapted to form a seal with the patient's face; an elbow module provided to the frame module and adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and headgear removably attachable to the frame module.

## Background
CROSS-SECTION TO RELATED APPLICATIONS
This application is a continuation application of application Ser. No. 12/736,024, filed Sep. 2, 2010, which is the U.S. national phase of International Application No. PCT/AU2009/000241, filed Feb. 27, 2009, which designated the U.S. and claims the benefit of U.S. Provisional Application Nos. 61/064,406, filed Mar. 4, 2008, 61/071,893, filed May 23, 2008, and 61/136,617, filed Sep. 19, 2008, each of which is incorporated herein by reference in its entirety.


FIELD OF THE INVENTION
The present invention relates to a mask system used for treatment, e.g., of Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPY).
BACKGROUND OF THE INVENTION
Patient interfaces, such as a full-face or nasal mask systems, for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB), typically include a soft face-contacting portion, such as a cushion, and a rigid or semi-rigid shell or frame module. In use, the interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure (e.g., 2-30 cm H2O) to be delivered to the patient's airways.
One factor in the efficacy of therapy and compliance of patients with therapy is the comfort and fit of the patient interface.
The present invention provides alternative arrangements of mask systems to enhance the efficacy of therapy and compliance of patients with therapy.
SUMMARY OF THE INVENTION
One aspect of the invention relates to a mask system including a frame module and a cushion module provided to the frame module. The cushion module includes a main body defining a breathing chamber and a cushion adapted to form a seal with the patient's face. The frame module and the cushion module are co-molded with one another. The cushion module is constructed of a first, relatively soft, elastomeric material and the frame module is constructed of a second material that is more rigid than the cushion module. At least a portion of the cushion module includes a concertina section having a plurality of folds. Each of the folds has a side wall with the side walls of the folds becoming progressively longer away from the patient's face.
Another aspect of the invention relates to a cushion module including a main body defining a breathing chamber and a cushion adapted to form a seal with the patient's face. The main body and the cushion are co-molded with one another. The cushion is constructed of a first, relatively soft, elastomeric material and the main body is constructed of a second material that is more rigid than the cushion. At least a portion of the main body includes a concertina section.
Another aspect of the invention relates to a method for constructing a cushion module including molding a first part of the cushion module with a first, relatively soft, elastomeric material, co-molding a second part of the cushion module to the first part with a second material that is more rigid than the first material, and molding at least a portion of the second part to include a concertina section.
Other aspects, features, and advantages of this invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of this invention.



BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings:
FIG. 1 is a front perspective view of a mask system according to an embodiment of the present invention;
FIG. 2 is an exploded view of the mask system shown in FIG. 1;
FIG. 3 is an enlarged front perspective view of the mask system shown in FIG. 1;
FIG. 4 is a side view of the mask system shown in FIG. 1;
FIGS. 5-1 is a rear view of a cushion according to an embodiment of the present invention;
FIG. 5-2 is a front view of the cushion shown in FIG. 5-1 with a partial cut-away;
FIG. 5-3 is a cross-section view through line 5-3-5-3 in FIG. 5-1;
FIG. 5-4 is a cross-section view through line 5-4-5-4 in FIG. 5-1;
FIG. 5-5 is a cross-section view through line 5-5-5-5 in FIG. 5-1;
FIGS. 6-1 to 6-3 illustrate top, front, and side views respectively of a concertina section according to an embodiment of the present invention;
FIG. 7 is a side view of a mask system including a cushion module according to a variation of the present invention; and
FIG. 8 illustrates a cushion including a concertina section according to an embodiment of the present invention.



DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
The following description is provided in relation to several embodiments which may share common characteristics and features. It is to be understood that one or more features of any one embodiment may be combinable with one or more features of the other embodiments. In addition, any single feature or combination of features in any of the embodiments may constitute additional embodiments.
While each embodiment below is described as including a full-face interface type, each embodiment may be adapted for use with other suitable interface types. That is, the interface type is merely exemplary, and each embodiment may be adapted to include other interface types, e.g., nasal interface, etc.
In this specification, the word “comprising” is to be understood in its “open” sense, that is, in the sense of “including”, and thus not limited to its “closed” sense, that is the sense of “consisting only of”. A corresponding meaning is to be attributed to the corresponding words “comprise”, “comprised” and “comprises” where they appear.
The term “air” will be taken to include breathable gases, for example air with supplemental oxygen.
1. Mask System
FIGS. 1-4 illustrate a mask system 10 according to an embodiment of the present invention. In this embodiment, the mask system 10 includes a full-face or oro-nasal interface. The mask system 10 includes a frame module 20, a cushion module 40 provided to the frame module 20 and adapted to form a seal with the patient's face, and an elbow module 70 provided to the frame module 20 and adapted to be connected to an air delivery tube that delivers breathable gas to the patient. Headgear 90 may be removably attached to the frame module 20 to maintain the mask system 10 in a desired adjusted position on the patient's face. The mask system is intended for use in positive pressure therapy for users with obstructive sleep apnea (OSA) or another respiratory disorder.
As described below, the mask system 10 provides a modular design that allows different styles and/or sizes of the frame module 20, cushion module 40, and elbow module 70 to be interchanged or mixed and matched with one another to provide a more customized mask system for the patient. In addition, such design allows selected modules to be easily replaced, e.g., treatment requirements change, worn out or damaged, etc.
1.1 Frame Module
The frame module 20 (e.g., constructed from polycarbonate, polypropylene, thermoplastic elastomer (TPE), Pocan®, etc.) is structured to maintain the cushion module 40 and the elbow module 70 in an operative position with respect to the patient's face. In addition, the frame module 20 is structured to removably attach to the headgear 90 adapted to maintain the mask system 10 in a desired position on the patient's face.
As best shown in FIG. 2, the frame module 20 (also referred to as a skeleton frame) includes an open construction that provides an annular or part annular retaining portion 22 structured to retain the cushion module 40 and the elbow module 70. The frame module 20 also includes upper and lower headgear connectors 24, 25 on each side of the retaining portion 22.
In the illustrated embodiment, each upper headgear connector 24 includes an elongated arm 26 and a slot 27 at the free end of the arm 26 adapted to receive a respective headgear strap in use. Each arm 26 may be at least semi-rigid (i.e., rigidizer) to stabilize the mask system on the patient's face. Also, each arm 26 is suitably formed, shaped, or contoured to follow the contours of the patient's face and avoid line of sight in use. A cheek pad may be provided to the inner surface of the arm 26 to support the arm 26 on the patient's cheek in use.
Each lower headgear connector 25 includes a clip receptacle 31 adapted to be removably interlocked with a headgear clip 33 associated with a respective headgear strap. As best shown in FIG. 2, each clip 33 includes two spring arms 35 adapted to interlock with the respective clip receptacle 31 with a snap-fit and a slot 37 adapted to receive a respective headgear strap in use.
In an embodiment, the arm 26 may be removably coupled to the frame module 20, e.g., arm 26 includes clip structure adapted to removably interlock with a clip receptacle provided to the frame module 20. This arrangement allows different styles of upper and lower headgear connectors to be used with the frame module, e.g., arms for both upper and lower headgear connectors, clips for both upper and lower headgear connectors, different length arms for upper and lower headgear connectors, etc.
However, the frame module 20 may provide other suitable arrangements for attaching headgear straps of headgear. Also, the frame module 20 may include one or more additional components, e.g., forehead support.
The mask system 10 is provided without a forehead support adapted to engage the patient's forehead. This provides the mask system 10 with a less obtrusive arrangement which does not significantly affect the patient's field of view.
1.2 Cushion Module
The cushion module 40 is structured to interface with the frame module 20 and form a seal with patient's nose and mouth in use.
The cushion module 40 includes a main body 42 and a cushion 44 provided to the main body 42. In use, the main body 42 defines a breathing chamber and is adapted to interface with or otherwise attach to the frame module 20 and the cushion 44 provides a sealing portion or sealing ring adapted to form a seal with the patient's nose and/or mouth. Also, the main body 42 includes an opening 46 that is adapted to communicate with the elbow module 70.
In the illustrated embodiment, the cushion 44 is a full-face cushion adapted to engage the patient's face generally along nasal bridge, cheek, and lower lip/chin regions of the patient's face. However, other cushion interfaces are possible, e.g., nasal.
FIGS. 5-1 to 5-5 illustrate various views of a cushion (e.g., constructed of silicone) according to an embodiment of the present invention. As illustrated, the cushion 44 includes a base wall 44(1) provided to the main body 42, an undercushion layer (UCL) 44(2) extending away from the base wall 44(1), and a membrane 44(3) provided to substantially cover the UCL 44(2) and provide a sealing structure. In the illustrated embodiment, the cushion 44 is structured to sit lower on the nasal bridge to reduce mask obtrusiveness and improve “line of sight” in use.
Also, as best shown in FIGS. 5-3 and 5-5, the UCL 44(2) design in the nasal bridge region is structured to provide improved stability across the nasal bridge in use. As shown in FIGS. 5-1 and 5-3, the UCL is not provided in the lower lip/chin region. However, other arrangements of the UCL are possible, e.g., UCL around entire perimeter.
In an embodiment of the cushion shown in FIGS. 5-1 to 5-5, D1 may be about 15-20 mm, e.g., 18.2 mm, D2 may be about 53-59 mm, e.g., 55.8 mm, D3 may be about 88-93 mm, e.g., 90 mm, D4 may be about 78-83 mm, e.g., 81.1, D5 may be about 58-63 mm, e.g., 60 mm, D6 may be about 95-100 mm, e.g., 98.1 mm, D7 may be about 57-62 mm, e.g., 59.7 mm, D8 may be about 77-82 mm, e.g., 79 mm, D9 may be about 88-93 mm, e.g., 90.7 mm, D10 may be about 30-35 mm, e.g., 33.1 mm, D11 may be about 14-19 mm, e.g., 16.4 mm, D12 may be about 8-13 mm, e.g., 9.6 mm, D13 may be about 0.3-0.5 mm, e.g., 0.35 mm, D14 may be about 0.4-0.6 mm, e.g., 0.5 mm, and D15 may be about 0.3-0.5 mm, e.g., 0.4 mm. Although specific dimensions and ranges are indicated, it is to be understood that these dimensions and ranges are merely exemplary and other dimensions and ranges are possible depending on application. For example, the exemplary dimensions may vary by 10-20% or more or less depending on application.
The mask system 10 may be provided with a number of different cushion modules 40, e.g., each having cushions of different styles and/or sizes (e.g., depending on patient preference and/or fit). For example, the main body 42 of each cushion module may include a common or universal configuration for interfacing with the frame module 20, and the cushion 44 may include different styles and/or sizes. This provides a modular arrangement that allows the frame module 20 to be selectively (e.g., and removably) coupled to one of multiple cushion modules. For example, the different cushion modules may include different size cushions (e.g., small, medium, and large) and may include a different cushion structures.
Similarly, the cushion module 40 may be provided with different frame modules 20, e.g., each frame module having a different style and/or size (e.g., frame module with forehead support, frame module with different arrangement/style of headgear connectors, etc).
1.2.1 Co-Molding Main Body and Cushion
In an embodiment, as shown in FIGS. 1-4, the main body 42 and cushion 44 may be co-molded with one another to form a one-piece, integrated component. For example, the main body 42 may be molded of a first material adapted to interface with the frame module 20 and the cushion 44 may be co-molded onto the main body 42 of a second material adapted to interface with patient's face.
In such embodiment, the cushion 44 may be constructed of a relatively soft elastomeric material (e.g., silicone) for sealing and the main body 42 may be constructed of a more rigid material than the cushion 44 (e.g., polycarbonate, polypropylene) for interfacing with the frame.
Co-molding the main body 42 to the cushion 42 provides a chemical bond without necessarily forming a mechanical interlock. As a result, the connection includes no cracks, a gas tight seal, and clean interface. Moreover, such co-molded connection relaxes tolerances as the mold materials are sufficiently flexible to fill in any gaps at the interface between the main body 42 and the cushion 44. Also, the co-molded cushion module 40 provides a reduced part count (reduced cost) and facilitates assembly/disassembly to the frame module 20.
The frame module 20 is structured to hold and secure the cushion module 40 in an operative position with respect to the patient's face. As shown in FIG. 2, the annular retaining portion 22 includes an interfacing structure 23 along an inner edge that is adapted to interface with or otherwise removably connect to an interfacing structure 48 along the outer perimeter of the main body 42 of the cushion module 40 (e.g., see FIG. 2). In the illustrated embodiment, the interfacing structure 23 is in the form of opposed flanges 23(1) that are adapted to interlock with respective locking structures 48(1) provided on opposing sides of the main body 42. However, other suitable arrangements for attaching the cushion module 40 to the frame module 20 are possible, e.g., friction fit, snap-fit, mechanical interlock, or other suitable attachment mechanism.
For example, the cushion module 40 may be coupled to the frame module 20 in a manner that allows the cushion module 40 to be locked in different angular positions with respect to the frame module 20, e.g., pivotally mounted.
1.2.2 Co-Molding Cushion Module and Frame
In the arrangement shown in FIG. 7, the main body 42 and cushion 44 may be integrally formed in one piece, e.g., of a silicone material. That is, the cushion module 40 may have the same shape and structure as described above, but be integrally molded of the same material, e.g., silicone.
In an embodiment, the integrally formed cushion module 40 may be co-molded to the frame module 20, e.g., constructed of polycarbonate or polypropylene. For example, frame module 20 may be constructed of a relatively rigid material (e.g., polycarbonate or polypropylene) and the cushion module 40 may be co-molded onto the frame module 20 of a relatively soft elastomeric material (e.g., silicone).
1.2.3 Concertina Section
As best shown in FIGS. 4 and 7, a concertina section 50 is provided in a nasal bridge region of the cushion module 40. As illustrated, the concertina section 50 includes a bellows structure with one or more folds 52 that provide a higher degree of flexibility or increased movement to the main body 42. That is, the concertina section 50 provides a higher level of adaptability or flexibility to the nasal bridge region of the cushion module 40 which is a more sensitive region of the patient's face in use. Moreover, the concertina section 50 provides increased movement without compromising seal.
FIGS. 6-1 to 6-3 illustrate various views of a concertina section 50 (isolated from the remainder of the cushion module) with one or more folds 52 according to an embodiment of the present invention. As best shown in FIG. 6-3, the folds may have different lengths, depths, and/or contours with respect to one another to optimize the concertina effect, e.g., provide sufficient degree of movement without compromising seal. For example, as shown in FIG. 6-3, each fold 52 includes a first side wall 52(1) and a second side wall 52(2) that interconnects adjacent side walls 52(1).
In the illustrated embodiment, the first side walls 52(1) and/or the second side walls 52(2) may become progressively longer away from the patient's face. For example, the first side wall 52(1) and/or the second side wall 52(2) adjacent patient's face, or the combination of side walls 52(1) and 52(2), may have a length that is longer than and in some cases significantly longer than the adjacent side wall 52(1) and/or 52(2) (e.g., one side wall at least 25% greater than and up to 5× as long as the other side wall, e.g., 1×, 2×, 3×, or 4×).
The folds may be constructed and arranged to provide a predetermined order of movement or folding, e.g., folds structured to fold in a sequential or progressive manner wherein one fold collapses before an adjacent fold collapses. For example, upon application of force, the folds closest to the patient's face may fold or collapse before the folds furthest from the patient's face. Also, the folds may be constructed and arranged to provide various degrees of fold or collapse, e.g., folds may fold or collapse more than others.
In an embodiment of the concertina section shown in FIGS. 6-1 to 6-3, D1 may be about 50-60 mm, e.g., 55.7 mm, D2 may be about 5-15 mm, e.g., 9.7 mm, and D3 may be about 0.3-0.5 mm, e.g., 0.4 mm. Although specific dimensions and ranges are indicated, it is to be understood that these dimensions and ranges are merely exemplary and other dimensions and ranges are possible depending on application. For example, the exemplary dimensions may vary by 10-20% or more or less depending on application.
It should be appreciated that a concertina section 50 may be provided in other regions of the cushion module 40, e.g., depending on patient comfort. For example, the concertina section 50 may be provided around the entire perimeter of the cushion module 40 or may be provided in selected regions of the cushion module 40.
Also, the flexibility of the concertina section 50 may be varied and may be varied in different regions of the cushion module 40, e.g., depending on patient comfort. For example, the cushion module 40 may include a concertina section in the nasal bridge region with a relatively high degree of flexibility and a concertina section in the lower lip/chin region with a relatively low degree of flexibility. The flexibility of the concertina section 50 may be varied by varying the number of folds 52 (e.g., 1-5 folds), the wall lengths, the wall thickness of the folds 52, the depth of the folds 52, etc.
As noted above, the cushion module may be co-molded of two parts with different materials/rigidities or may be integrally formed of the same material. In both embodiments, the concertina section may be provided in the main body and/or the cushion.
In FIGS. 1-4, the cushion module 40 is co-molded of two parts (i.e., main body 42 and cushion 44) with the concertina section 50 provided in the main body 42. The main body 42 and cushion 44 include different rigidities in order to optimize the function of each part. For example, one part (i.e., cushion 44) may be constructed of a relatively soft, supple material to optimize the sealing effect and the other part (i.e., main body 42) may be constructed of a more rigid material to provide adequate support for the cushion while at the same time allowing a sufficient degree of movement to optimize the concertina effect. While the main body is more rigid than the cushion, the main body may be constructed of a flexible material to allow the concertina effect.
In FIG. 7, the main body 42 and cushion 44 are integrally formed in one piece with the concertina section 50 provided in the main body 42. The material properties and/or dimensions may be selectively modified to optimize sealing and concertina effects.
For both embodiments of FIGS. 1-4 and 7, it should be appreciated that the concertina section may be alternatively provided in the cushion 44 or in both the main body 42 and cushion 44. For example, FIG. 8 illustrates a concertina section 50 integrally formed with the cushion 44 in the nasal bridge region.
1.3 Elbow Module
The elbow module 70 includes an elbow 74, a vent arrangement 76 provided to the elbow 74 for gas washout, and an anti-asphyxia valve (AAV) 85 provided to the elbow 74.
In an embodiment, the mask system may be provided with a number of different elbow modules 70, e.g., each having a vent arrangement, AAV (in the case of an oro-nasal mask), and/or elbow of different styles and/or sizes. In the illustrated embodiment, the vent arrangement 76 and AAV 85 are structured to be removably attachable to the elbow 74. This provides a modular arrangement that allows the elbow module 70 to be selectively and removably coupled to one of multiple vent arrangements 76 and/or AAVs 85. This also allows the vent arrangement and AAV to be easily replaced, e.g., if damaged.
1.3.1 Elbow
The elbow 74 (e.g., constructed of a relatively hard material such as polycarbonate or polypropylene) includes a first end portion 74(1) and a second end portion 74(2). The first end portion 74(1) provides an interfacing structure 75 structured to interface or otherwise attach to the frame module 20. The second end portion 74(2) is provided to a swivel joint 80 adapted to be connected to an air delivery tube.
As illustrated, the first end portion 74(1) of the elbow 74 provides a relatively large diameter which allows the potential for cleaner/smoother lines thereby contributing to the overall mask aesthetic and reduced obtrusiveness. In addition, the relatively large diameter elbow offers the potential for the patient's nose to protrude into the elbow cavity thereby permitting the mask to be brought closer to the patient's face (i.e., reduced obtrusiveness).
In the illustrated embodiment, the swivel joint 80 is provided to a short tube 82 (e.g., extendable and retractable tube) that interconnects the elbow with the air delivery tube. In an embodiment, the swivel joint 80 may be integrally formed in one piece with the short tube 82.
1.3.2 Vent Arrangement
In the illustrated embodiment, the vent arrangement 76 is in the form of a vent insert that is adapted to be removably supported within an outlet opening in the elbow 74. In an embodiment, the vent arrangement 76 includes a base adapted to be supported within the outlet opening, one or more grill components or media (e.g., filter, membrane, or other porous material) provided to the base and structured to diffuse vent flow, and a cover to maintain the grill components/media within the base. Only the cover 77 of the vent arrangement 76 is visible in FIGS. 1-4.
Exemplary embodiments of such a vent arrangement are disclosed in U.S. Provisional Patent Application No. 60/957,766, filed Aug. 24, 2007, which is incorporated herein by reference in its entirety.
However, it should be appreciated that the vent arrangement may include other suitable arrangements, e.g., vent insert with one or more vent holes.
Also, the elbow may provide an alternative venting arrangement to the vent insert. For example, as indicated in dashed lines in FIG. 4, the first end portion 74(1) of the elbow 74 (e.g., along the interfacing structure 75) may include one or more vent holes 276 for gas washout. The one or more holes 276 may be provided to a soft part (e.g., silicone seal as described below) and/or a hard part (e.g., polycarbonate, polypropylene) of the elbow. The holes 276 may extend around the entire perimeter of the first end portion 74(1) or may extend along one or more portions of the first end portion 74(1). It is noted that providing vent holes along the entire perimeter of the elbow may help to disperse the vent flow in use. However, other suitable hole arrangements, hole numbers, and/or hole shapes along the first end portion 74(1) and/or other portions of the elbow are possible.
1.3.3 AAV
The elbow 74 includes a slot to receive the AAV 85, a port 79 that is selectively closed by a flap portion 86 of the AAV 85 (depending on the presence of pressurized gas), and structure for attaching the AAV 85, e.g., with a snap-fit.
The AAV 85 includes a flap portion 86 and a clip portion 88 provided to the flap portion 86 for attaching the AAV 85 to the elbow 74. In the illustrated embodiment, the flap portion 86 and the clip portion 88 are co-molded with one another to form a one-piece, integrated component. However, the flap portion 86 and clip portion 88 may be secured to one another in other suitable manners, e.g., mechanical interlock.
In an embodiment, the flap portion 86 may be constructed of a relatively soft elastomeric material (e.g., silicone) and the clip portion 88 may be constructed of a more rigid material (e.g., rigid plastic) for interfacing with the elbow 74.
The clip portion 88 of the AAV 85 includes structure for removably interlocking with the elbow 74, e.g., with a snap-fit. For example, the clip portion 88 may include tabs structured to interlock with respective recesses/protrusions provided to the elbow 74.
Alternative embodiments of the AAV are disclosed in PCT Application No. PCT/AU2006/000031, which is incorporated herein by reference in its entirety.
1.3.4 Elbow Module Attachment to Frame Module
The frame module 20 is structured to maintain the elbow module 70 in an operative position with respect to the patient's face. That is, the frame module 20 acts as a carrier and bearing surface for the elbow module 70. The frame module 20 and elbow module 70 may connect with a friction fit, snap-fit, mechanical interlock, or other suitable attachment mechanism. However, other suitable arrangements for attaching the elbow module to the frame module are possible.
In the illustrated embodiment, the elbow module 70 may be rotatably attached to the frame module 20 so that the elbow module 70 may be rotated relative to the frame module 20 in use, e.g., 360° rotation. This arrangement allows the elbow module 70 to assume different orientations in use, e.g., depending on patient preference. For example, the elbow module 70 may assume a first orientation so that the elbow extends generally downwardly from the mask to direct the air delivery tube under the patient's head in use. Alternatively, the elbow module 70 may be rotated and assume a second orientation so that the elbow extends upwardly from the mask to direct the air delivery tube over the patient's head in use. In an embodiment, the frame module 20 and elbow module 70 may be constructed of dissimilar materials to prevent or at least reduce squeak between the components in use.
1.4 Interface Seal
In an embodiment, a seal may be provided at the interface between the elbow module 70 and the frame module 20, at the interface between the cushion module 40 and the frame module 20, and/or at the interface between the elbow module 70 and the frame module 20. For example, a seal (e.g., elastomeric, ring-shaped seal) may be formed separately from the modules and attached at the interface (e.g., sandwiched between modules, adhesive, etc.). Alternatively, a seal may be co-molded with one or more of the modules. In an embodiment, a silicone lip seal may be provided to the cushion module to seal against the elbow module, thereby reducing leak.
In another embodiment, the interfacing structure 75 of the elbow module 70 may be constructed of a relatively soft, sealing material (e.g., silicone, which may be co-molded to the harder material of the elbow) that is structured to provide a seal at the interface between the elbow module 70 and the frame module 20. Also, the relatively soft interfacing structure 75 (e.g., silicone) provides a “soft” attachment to the relatively hard frame 20 (e.g., polycarbonate, polypropylene) which may allow an interference type fit. As noted above, one or more vent holes may be provided to the softer interfacing structure and/or the harder elbow.
1.5 Headgear
Headgear 90 may be removably attached to the headgear connectors 24, 25 of the frame module 20 to maintain the mask system in a desired position on the patient's face.
In the illustrated embodiment, the headgear 90 includes a pair of upper and lower straps 92, 94 with the upper straps 92 removably attached to respective upper headgear connectors 24 and the lower straps 94 removably attached to respective lower headgear connectors 25. The free end of each strap may include a Velcro® tab structured to engage the remainder of the strap to secure the strap in place. Such Velcro® attachment also allows adjustment of the length of the straps. However, the upper and lower headgear straps 92, 94 may be secured to the frame module 20 in any other suitable manners, e.g., adjustable ladder-lock arrangement, etc.
The headgear 90 also includes an upper strap 96 adapted to pass over the top of the patient's head in use and a rear strap 98 adapted to pass behind the patient's head in use.
The headgear 90 is structured to be self-supporting.
While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Also, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to realize yet other embodiments. Further, each independent feature or component of any given assembly may constitute an additional embodiment. Furthermore, each individual component of any given assembly, one or more portions of an individual component of any given assembly, and various combinations of components from one or more embodiments may include one or more ornamental design features. In addition, while the invention has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in non-medical applications.

## Claims

1. A full face mask system for treatment of respiratory disorder with Continuous Positive Airway Pressure equipment suitable to generate a supply of gas at positive pressure to be delivered to a patient's airways, the mask system comprising:
a frame module;
a cushion module provided to the frame module and adapted to form a seal with the patient's nose and mouth;
an elbow module provided to the frame module and adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and
headgear removably attachable to the frame module, wherein:
the frame module is structured to assist in maintaining the cushion module and the elbow module in an operative position with respect to the patient's face,
the frame module includes an open construction, said frame module being structured to retain the elbow module,
the frame module includes two headgear connectors to connect with the headgear, the two headgear connectors each including a slot at a free end of the connector adapted to receive a respective headgear strap of the headgear,
each said headgear connector is removably coupled to the frame module, each said headgear connector including a clip structure adapted to removably engage with a corresponding portion of the frame module,
the cushion module is structured to interface with the frame module,
the cushion module includes a main body of relatively harder material and a cushion of relatively softer material provided to the main body, the main body defining a breathing chamber and being adapted to interface with the frame module,
the cushion provides a sealing portion adapted to form the seal with the patient's nose and mouth,
wherein a portion of the main body is exposed and remains uncovered by the frame module when the frame module and the main body are engaged,
the main body includes an entry opening for the introduction of the supply of gas into the breathing chamber, the opening being adapted to fluidly communicate with the elbow module,
the cushion is a full-face cushion adapted to engage the patient's face generally along nasal bridge, cheek, and chin regions of the patient's face,
the cushion includes a base wall provided to the main body, an undercushion layer extending away from the base wall, and a membrane provided to substantially cover the undercushion layer,
the undercushion layer is provided in a nasal bridge region of the cushion,
the undercushion layer is not provided in at least a part of a chin region of the cushion,
the frame module is structured to hold the cushion module in an operative position with respect to the patient's face,
the elbow module includes an elbow, a vent arrangement provided to the elbow for gas washout, and an anti-asphyxia valve provided to the elbow,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube,
the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having one or more vent holes,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve, the structure being positioned between the swivel joint and the vent arrangement,
the frame module is structured to maintain the elbow module in an operative position with respect to the patient's face, and
the elbow module is rotatably attached to the frame module so that the elbow module is permitted to be rotated 360 degrees relative to the frame module.

2. The mask system according to claim 1, wherein the frame module includes a forehead support.

3. The mask system according to claim 2, further comprising two additional headgear connectors.

4. The mask system according to claim 3, further comprising a concertina section that is provided in a nasal bridge region of the cushion, the concertina section including one or more folds that provide a degree of flexibility or movement relative to the main body without compromising the seal.

5. The mask system according to claim 4, wherein the concertina section is provided around the entire perimeter of the cushion.

6. The mask system according to claim 5, wherein flexibility of the concertina section is varied in different regions of the cushion.

7. The mask system according to claim 6, wherein the concertina section in the nasal bridge region has a relatively high degree of flexibility and the concertina section in a chin region of the cushion has a relatively low degree of flexibility.

8. The mask system according to claim 7, wherein the flexibility of the concertina section is varied by varying a wall length and a depth of the one or more folds.

9. The mask system according to claim 1, wherein the mask system is provided with a number of different sized cushion modules, the main body of each cushion module including a common configuration for interfacing with the frame module, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of the number of cushion modules and that allows the cushion modules to be selectively and removably coupled to each of a plurality of differently sized frame modules.

10. The mask system according to claim 9, wherein the different cushion modules include different size cushions, including small, medium, and large.

11. The mask system according to claim 10, wherein the main body and cushion are co-molded with one another to form an integrated co-molded component, the relatively harder material of the main body comprising first molded material adapted to interface with the frame module, and the relatively softer material of the cushion comprises a second molded material adapted to interface with patient's face.

12. The mask system according to claim 11, wherein the integrated co-molded component comprises a chemical bond between the first and second molded materials.

13. The mask system according to claim 12, wherein the integrated co-molded component does not include a mechanical interlock.

14. The mask system according to claim 1, further comprising a mechanical interlock to mechanically interlock the elbow module and the frame module to form a combined elbow and frame module, and a snap-fit attachment mechanism that releasably snap-fits the combined elbow and frame module with the main body of the cushion module.

15. A full face mask system for treatment of a respiratory disorder with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV) equipment suitable to generate a supply of gas at positive pressure to be delivered to a patient's airways, the mask system comprising:
a frame module;
a cushion module provided to the frame module and adapted to form a seal with the patient's nose and mouth;
an elbow module provided to the frame module and adapted to be connected to an air delivery tube to deliver breathable gas to the patient;
headgear removably attachable to the frame module, and
four headgear connectors to connect with the headgear, two of the headgear connectors including an arm and a slot at a free end of the arm adapted to receive a respective headgear strap of the headgear, each arm being at least semi-rigid to stabilize the mask system on the patient's face, each arm is removably coupled to the frame module, each said arm including clip structure adapted to removably engage with a corresponding portion of the frame module, wherein:
the frame module is structured to maintain the cushion module and the elbow module in an operative position with respect to the patient's face,
the frame module includes an engaging portion structured to engage the cushion module,
the cushion module is structured to interface with the frame module,
the cushion module includes a main body of polycarbonate material and a cushion of silicone material provided to the main body, the main body defining a breathing chamber and being adapted to interface with the frame module, wherein a portion of an exterior surface of the main body remains exposed when the main body and the frame module are engaged,
the cushion provides a sealing portion adapted to form the seal with the patient's nose and mouth,
the main body includes an entry opening for the introduction of the supply of gas into the breathing chamber, the opening being adapted to communicate with the elbow module,
the cushion is a full-face cushion adapted to engage the patient's face generally along nasal bridge, cheek, and chin regions of the patient's face,
the cushion includes a base wall provided to the main body, an undercushion layer extending away from the base wall, and a membrane provided to substantially cover the undercushion layer,
the undercushion layer is provided in a nasal bridge region of the cushion,
the undercushion layer is not provided in at least a part of a chin region of the cushion,
the frame module is shaped and structured to hold the cushion module in an operative position with respect to the patient's face, the frame module including an interfacing structure along an inner edge that is adapted to interface with a portion of the main body of the cushion module,
the elbow module includes an elbow, a vent arrangement provided to the elbow for gas washout, and an anti-asphyxia valve provided to the elbow,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion having a swivel joint adapted to be connected to the air delivery tube,
the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having one or more vent holes,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve, the structure being positioned between the swivel joint and the vent arrangement,
the frame module is structured to maintain the elbow module in an operative position with respect to the patient's face,
the elbow module is rotatably attached to the frame module so that the elbow module is rotatable 360 degrees relative to the frame module and the cushion module,
the headgear is removably attachable to the headgear connectors to maintain the mask system in a desired position on the patient's face,
the headgear includes a pair of upper and lower straps and a rear strap adapted to pass behind the patient's head, the upper straps being removably attached to respective upper headgear connectors and the lower straps being removably attached to respective lower headgear connectors, a free end of each strap including a hook and loop tab structured to adjustably engage the remainder of the strap to secure the strap in place.

16. The mask system according to claim 15, wherein the frame module includes a forehead support.

17. The mask system according to claim 16, further comprising a concertina section provided in the nasal bridge region of the cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement.

18. The mask system according to claim 17, wherein the concertina section is provided around the entire perimeter of the cushion of the cushion module.

19. The mask system according to claim 18, wherein flexibility of the concertina section is varied in different regions of the cushion of the cushion module.

20. The mask system according to claim 19, wherein the concertina section in the nasal bridge region has a different degree of flexibility compared to the concertina section in the chin region.

21. The mask system according to claim 20, wherein the flexibility of the concertina section is varied by varying a wall length and/or a depth of the one or more folds.

22. The mask system according to claim 15, wherein the main body includes a universal configuration adapted to interface with the frame module, the main body being adapted to connect with a plurality of cushions of different sizes, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of a plurality of differently sized cushion modules.

23. The mask system according to claim 22, wherein the differently sized cushion modules include different size cushions, including small, medium, and large.

24. The mask system according to claim 23, wherein the main body and cushion are co-molded with one another to form an integrated co-molded component, the polycarbonate material of the main body comprising a first molded material adapted to interface with the frame module, and the silicone material of the cushion comprises a second molded material adapted to interface with patient's face.

25. The mask system according to claim 24, wherein said integrated co-molded component comprises a chemical bond.

26. The mask system according to claim 25, wherein the integrated co-molded component does not include a mechanical interlock.

27. The mask system according to claim 15, wherein the elbow module and the frame module are mechanically interlocked via a mechanical interlock to form a combined elbow and frame module, the combined elbow and frame module including a snap-fit attachment mechanism that releasable snap-fits with the main body of the cushion module.

28. An oro-nasal mask system for treatment of respiratory disorder with Continuous Positive Airway Pressure equipment suitable to generate a supply of gas at positive pressure to be delivered to a patient's airways, the mask system comprising:
a frame module;
a cushion module having (i) a cushion adapted to form a seal with the patient's nose and mouth and (ii) a main hub body;
an elbow module adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and
headgear removably attachable to the frame module, wherein:
the frame module includes two headgear connectors to connect with the headgear, each of the two headgear connectors including a slot at a free end of the connector adapted to receive a respective headgear strap of the headgear,
each said headgear connector is removably coupled to the frame module, each said headgear connector including a clip structure adapted to removably engage with a corresponding portion of the frame module,
the main hub body comprises a relatively harder material and the cushion comprises relatively softer material provided to the main hub body,
the cushion is an oro-nasal cushion adapted to engage the patient's face generally along nasal bridge, cheek, and chin regions of the patient's face,
the cushion includes a base wall provided to the main hub body, an undercushion layer extending away from the base wall, and a membrane provided to substantially cover the undercushion layer,
the undercushion layer is provided in a nasal bridge region of the cushion,
the elbow module includes an elbow, a vent arrangement provided to the elbow for gas washout, and an anti-asphyxia valve provided to the elbow,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube,
the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having one or more vent holes,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve, the structure being positioned between the swivel joint and the vent arrangement,
the elbow module is rotatably attached to the frame module with a mechanical interlock so that the elbow module is permitted to be rotated 360 degrees relative to the frame module,
the elbow module and the frame module comprise a combined elbow and frame module that is releasably snap-fitted to the cushion module with a snap-fit attachment mechanism.

29. An oro-nasal mask system for treatment of a respiratory disorder with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV) equipment suitable to generate a supply of gas at positive pressure to be delivered to a patient's airways, the mask system comprising:
a frame module;
a cushion module engaged with the frame module;
an elbow module rotatably attached to the frame module with a mechanical interlock and adapted to be connected to an air delivery tube to deliver breathable gas to the patient;
headgear removably attachable to the frame module, and
four headgear connectors to connect with the headgear, two of the headgear connectors including an arm and a slot at a free end of the arm adapted to receive a respective headgear strap of the headgear, each arm being at least semi-rigid to stabilize the mask system on the patient's face, each arm is removably coupled to the frame module, each said arm including clip structure adapted to removably engage with a corresponding portion of the frame module, wherein:
the cushion module includes a main hub body and a cushion provided to the main hub body,
the cushion is an oro-nasal cushion adapted to seal generally along nasal bridge, cheek, and chin regions of the patient's face,
the elbow module includes an elbow, a vent arrangement provided to the elbow for gas washout, and an anti-asphyxia valve provided to the elbow,
the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module with the mechanical interlock, the second end portion having a swivel joint adapted to be connected to the air delivery tube,
the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having one or more vent holes,
the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve, the structure being positioned between the swivel joint and the vent arrangement,
the elbow module is rotatably attached to the frame module so that the elbow module is rotatable 360 degrees relative to the frame module and the cushion module,
the headgear is removably attachable to the headgear connectors to maintain the mask system in a desired position on the patient's face,
the headgear includes a pair of upper and lower straps and a rear strap adapted to pass behind the patient's head, the upper straps being removably attached to respective upper headgear connectors and the lower straps being removably attached to respective lower headgear connectors, a free end of each strap including a hook and loop tab structured to adjustably engage the remainder of the strap to secure the strap in place,
the elbow module and the frame module comprise a combined elbow and frame module due to being mechanically interconnected by the mechanical interlock, and
a snap-fit attachment mechanism releasably snap-fits the combined elbow and frame module with the cushion module.

30. The mask system according to claim 29, wherein the mechanical interlock is separate from the snap-fit attachment mechanism.