NZ760323B2 - Mask System - Google Patents

Abstract

Disclosed is a CPAP breathing mask system with a headgear and cushion module and a seal and frame module that provide a better air-tight seal between the mask and the user’s face. The seal and frame module includes a sealing portion adapted to form a seal with a patient’s face and a frame portion adapted to form a breathing chamber. The headgear and cushion module includes a cushion region adapted to support and shape the sealing portion and a headgear region adapted to support and stabilize the mask system on the patient’s face. The headgear and cushion module includes a composite including an outer fabric layer that provides an exterior surface of the headgear and cushion module, the cushion region including a cushioning component within the composite. The sealing portion of the seal and frame module includes a first side and a second side opposite to the first side, the first side providing the sealing portion, and the second side providing a channel , wherein the channel is configured to receive the cushion region of the headgear and cushion module and to maintain the position of the cushion region on the patient’s face in use. apted to form a breathing chamber. The headgear and cushion module includes a cushion region adapted to support and shape the sealing portion and a headgear region adapted to support and stabilize the mask system on the patient’s face. The headgear and cushion module includes a composite including an outer fabric layer that provides an exterior surface of the headgear and cushion module, the cushion region including a cushioning component within the composite. The sealing portion of the seal and frame module includes a first side and a second side opposite to the first side, the first side providing the sealing portion, and the second side providing a channel , wherein the channel is configured to receive the cushion region of the headgear and cushion module and to maintain the position of the cushion region on the patient’s face in use.

Description

MASK SYSTEM CROSS-REFERENCE TO APPLICATION This application claims the benefit of US. ional Application No. 61/344,621, filed September 1, 2010, which is incorporated herein by reference in its entirety.

FIELD OF LOGY The present technology 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 (NIPPV).

BACKGROUND OF TECHNOLOGY Patient aces, such as a full-face or nasal mask systems, for use with positive airway pressure (PAP) devices in the treatment of Sleep Disordered ing (SDB), typically include a sofi face-contacting portion, such as a cushion, and a rigid or semi- rigid shell or frame. 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 H20) to be delivered to the patient's airways.

One factor in the efficacy of therapy and ance of patients with therapy is the comfort and fit of the patient interface.

The present technology provides alternative arrangements ofmask systems to enhance the efficacy of therapy and compliance of ts with therapy.

SUMMARY OF TECHNOLOGY One aspect of the sed technology relates to a mask system that is easy to fit, provides a low part count, provides low manufacturing cost, and/or provides high quality mance, e.g., seal.

Another aspect of the disclosed technology s to a mask system including a headgear and cushion module and a seal and flame module provided to the headgear and n module. The seal and frame module includes a sealing portion adapted to form a seal with the patient’s face and a frame portion adapted to form a breathing chamber. The headgear and cushion module includes a cushion region adapted to support and shape the sealing portion and a headgear region d to support and stabilize the mask system on the patient’s face.

Another aspect of the disclosed technology relates to a mask system including a cushion and headgear module including a one piece construction having an outer fabric layer and an inner cushioning layer within the fabric layer. The cushion and headgear module includes a n region adapted to define a breathing chamber and form a seal with the patient’s face and a headgear region including straps adapted to maintain the cushion region in position on the patient’s face in use.

Other aspects, features, and advantages of this technology will become apparent from the following detailed ption when taken in ction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of this technology.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings facilitate an understanding of the s examples of this technology. In such drawings: Fig. 1 is a perspective view of a mask system according to an example of the present technology, the mask system in position on a patient’s head; Fig. 2 is a perspective view of a headgear and cushion module of the mask system shown in Fig. l; Fig. 3 is a side perspective view of a headgear and n module of the mask system shown in Fig. 1; Fig. 4 is a sectional view of a n region of a headgear and cushion module ofthe mask system shown in Fig. l; Fig. 5 is perspective view of a seal and frame module of the mask system shown in Fig. 1; Fig. 6 is a cross-sectional view of a seal and frame module of the mask system shown in Fig. l; Fig. 7 is ctive view of a seal and frame module of the mask system shown in Fig. 1 provided with an elbow; Fig. 8 is another perspective view of a headgear and cushion module of the mask system shown in Fig. l; Fig. 9 is a plan-type view of a headgear and cushion module of the mask system shown in Fig. 1; Fig. 10 is a schematic view showing a cturing process for making a headgear and n module according to an example of the present technology; Fig. 1 l is a perspective view of a mask system according to another example ofthe present technology, the mask system in position on a patient’s head; Fig. 12 is a cross-sectional view of the mask system shown in Fig. 11; Fig. 13 is a perspective view of a mask system according to another example of the present technology, the mask system in position on a patient’s head; Fig. 14 is a perspective view of a mask system according to another example of the t technology, the mask system in position on a patient’s head; Fig. 15 is a plan-type view of a ar and cushion module of the mask system shown in Fig. 14; Figs. 16 to 18 are cross-sectional views of a mask system according to another example ofthe present technology; and Fig. 19 is a cross-sectional view of a seal and frame module of a mask system according to another example ofthe present technology.

DETAILED DESCRIPTION OF ILLUSTRATED EXAMPLES The following description is provided in relation to l examples (most of which are illustrated, some of which may not) which may share common characteristics and features. It is to be understood that one or more features ofany one example may be combinable with one or more features of the other examples. In-addition, any single feature or combination of features in any example or examples may tute patentable subject matter.

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 .

Mask System In the illustrated example, the ace mask system 10 includes a headgear , [0031] and cushion module 20 and a seal and flame module 50 provided to the headgear and cushion module. An elbow 90 may be provided to the seal and frame module 50 and adapted to be connected to an air delivery tube that rs breathable gas to the t. The mask system is intended for use in positive pressure therapy for users with Obstructive Sleep Apnea (OSA) or another respiratory disorder.

Exemplary advantages of the mask system 10 include a relatively low cost and a robust seal. For example, the vely low cost may be provided by combining elements that would normally be multiple parts, e.g., headgear and cushion, and automated manufacturing. The robust seal may be provided by little to no air pressure to assist seal and/or comfort ofthe seal.

While each example below is described as including a ace interface type, aspects of the present technology may be adapted for use with other suitable interface types, e.g., nasal interface, nasal prongs, etc. 1. Headgear and n Module The headgear and cushion module 20 includes a composite including an outer fabric or textile layer that provides an exterior surface of the module and an inner conformable, cushioning, and flexible layer or filler encapsulated or contained within the fabric layer. In an example, the fabric and filler (e.g., including cushioning and ural components) may include a single piece construction (e.g., made by laminating, heat ng, welding, sewing, etc. components together). The one piece or integral construction of the headgear and n module provides fewer components which may be more consumer friendly. As described in greater detail below, the headgear and cushion module 20 includes a cushion region 30 and a headgear region 40.

In an example, the composite may be formed ofa foam and a fabric, with the foam being completely encapsulated or contained within the fabric. The foam may be laminated to, insert molded on, ssed, or otherwise attached to the fabric.

Alternatively, the foam may not be ed to the fabric but rather may be adjacent to it, e.g., foam inserted into a fabric sock.

The fabric may be coated or otherwise sealed to create an air impermeable seal. The fabric may be coated with a laminate, e.g., a silicone, ethane or other polymer sheet. atively, the fabric may be spray coated with a polymer.

In an alternative example, the foam may be replaced by an alternative material, e.g., a spacer fabric. Preferably, the filler (i.e., foam, spacer fabric) may be conformable and flexible. 1.1 Cushion Region Cushioning Component The cushion region 30 includes a cushioning component 31 within the fabric layer 25 (see Fig. 4). The cushioning component may be a conformable, flexible region that provides comfort for the t. The cushioning component may also t and shape the sealing membrane 52 ofthe seal and frame module 50 (described below) when positioned on the t’s face in use. Preferably, the cushioning ent is c or resilient such that it applies a reactive force when in use on the patient’s face. Alternatively, the cushioning component may be visco-elastic.

Preferably, the cushioning component may include at least one layer or filler within the fabric layer. Preferably, at least one layer is a foam. The foam may be a ne foam (e.g., biocompatible so suitable for use in the air path) or a polyurethane foam. Other materials that may be used include spacer fabric, gel, TPE or silicone. In a preferred example, there are two or more layers offoam forming the cushioning component, e.g., a first sofier layer of foam 32(1) and second harder layer offoam 32(2) as shown in Fig. 4. The foams may differ in their chemical composition, densities, hardness, shape, visco-elasticity, elasticity, cell structure or any other property of the foam. In a preferred example, a first layer may be constructed from a foam with a hardness ILD @ 40% of less than 100N, e.g., 25-80N.

WO 27792 2011/001129 A second layer may be constructed from a foam with a hardness ILD @ 40% of less than 100N, e.g., 25-80N. The layers of foam may be joined together by glue or may be co-molded.

Alternatively, the cushioning component may be an arrangement of one or more springs. Alternatively, the cushioning component may be a bladder or space filled with air or other flowable material, such as gel, oil, water. Alternatively, the cushioning component may be a r filled with beads or beans.

The cushioning component may be generally triangular, oidal, oval, circular, trilobular, or any other shape such that when positioned on the face ofthe patient, it passes the nasal bridge region, cheek regions and either the chin or upper lip regions. The cushioning component may have a constant cross section or have a variable cross section.

Structural Component As shown in Fig. 4, the cushion region 30 may also e a structural component 35 that provides support to the cushioning component 31 so that the cushion can be positioned so as to engage with the patient’s face. The structural component (also referred to as a stiff element, rigid element, or rigidizer) may provide structural support to help prevent the cushion fiorn flexing or bending out of contact with the patient’s face. The structural component may be made from a silicone (preferably low ter silicone so that the mask is flexible, for example 10-30 Shore A), TPE, polypropylene, polycarbonate, polyurethane. Alternatively, the structural component may be formed of a e or foam that has been thermoforrned or embossed to create a dense or stiffer section of textile or foam.

The structural component may ce the position of the cushion component. For e, the structural component may be curved, for example to the contours of a person’s face, so that when in contact with the cushion component, the cushion is also curved. Furthermore, the structural ent may be adjustable so that the patient can influence the position of the cushion component by altering the shape of the structural component. For example, the structural component may be a malleable wire.

The structural component may extend around the n component.

Alternatively the ural component may only be in one or more regions of the cushion component; for example, there may be a structural component at the nasal bridge region of the cushion to support the seal as this area is prone to leak. Ifthe structural component is adjustable, it may be adjustable in one or more regions of the structural component. For e, the ural component may be adjustable at the nasal bridge region so the patient can compress the cushion into position around their nose.

The structural component may be removably or fixedly connected to the cushion component by chemical (for example, glue, ding, overmolding) or mechanical means (for example, clip, interference fit, tongue and groove, hook and loop, magnetic).

However, it should be iated that the structural component may be optional, and it may be possible to utilize higher y foam, embossing, 3D , spacer fabrics, etc. to provide stiffness to the cushioning ent.

The structural component may have varying hardness or stiffness zones that may create regions having more t of the cushion component, and other regions having less support for the cushion ent. For example, the structural component may have a lower stiffness at the nose bridge to accommodate varying nose bridge sizes, and may have a higher stiffness at the comers of the nose or chin region to ensure stability and anchoring of the cushion component at the honey regions of the face.

In an example, the structural component may be thermoformed within the fabric layer to assist in shaping the seal portion of the seal and frame module 50. The structural component may be an additional ent, e.g. malleable wire or plastic strip, or may be a region of the foam having a stiffer or more rigid property than surrounding regions ofthe foam, i.e., the foam may be selectively stiffened in one more regions. Selective stiffening of the foam may be achieved by using ent types of foams for different regions ofthe cushion, or by treating the foam in ent regions to alter the properties of the foam, e.g., compress or heat press, cut holes in the foam.

The structural component may extend outside of the outer fabric layer to enable connection of the structural component to external components. For example, as ‘ shown in Fig. 13, a mask having a cushion region 330 and a sealed region 350 (e.g., a sealed textile portion or polymer portion) may include a structural component 335 that may extend outside of an outer fabric layer 325 to form a headgear connection region adapted to receive a headgear strap 340.

Alternatively, the structural component may extend outside of the outer fabric to form a tube tion portion adapted to receive an air delivery tube. Such an 2011/001129 arrangement may be ble ifthe cushion and headgear component are air holding and/or deliver breathable gas to the patient. 1.2 Headgear Region The headgear region 40 is used to support and stabilize the headgear and cushion module 30 on the face ofthe user. The headgear region preferably is positioned along the cheeks and under the ears of the patient extending to the back of the patient’s neck in use, e.g., see Fig. 1. Alternative configurations are possible, e.g., over the ear, over the crown, etc.

The headgear region includes headgear straps 44 that extend from either side ofthe cushion region 30 so as to wrap the headgear and cushion module around the head of the wearer. The headgear straps preferably connect to one another by hook and loop material 45 (e.g., see Figs. 2, 8, and 9). Alternatively, the headgear straps may connect to each other by any other reasonable means, for example clips or buckles.

There may be at least two headgear straps. Preferably, there are four headgear straps, i.e., two upper ar straps 42 on either side of the nose bridge region that removably attach to the lower headgear straps, and two lower headgear straps 44 that extend lly from the cheek region to the back of the patient’ neck.

The upper headgear straps 42 may be thin so as to reduce visual obtrusiveness of the mask. For example, the upper headgear straps may be 1-10 mm wide. The upper headgear straps allow adjustment ofthe position of mask at the nasal bridge region.

The lower ar straps 44 may be tapered at the cheek region to reduce visual iveness of the mask, e.g., see Fig. 1. For example, the cheek region of the lower headgear straps may be at least 2 mm thinner than the rest of the lower headgear straps.

In the illustrated example as shown in Fig. l, the headgear straps 44 are d to extend under the patient’s ear in use. ative arrangements are possible, e.g., strap extending from the nose bridge region of the mask/apex, between the t’s eyes, and over the patient’s head. This alternative strap arrangement may assist with seal at the nose bridge region. In another example, four straps may be provided and arranged to extend above and below the patient’s ears on both sides of the patient’s head in use. Such an arrangement is shown in Figs. 14 and 15, with upper straps 410 extending over the patient’s ears, and lower straps 420 extending under the patient’s ears. Upper straps 410 and lower straps 420 may attach to cushion region 430, with upper straps ecting to lower straps 420 and lower straps 420 connectable to each other with, for example, hook and loop material 460. It should be appreciated that other headgear strap arrangements are also possible.

In an alternative e, one or more headgear straps may be formed with an air delivery tube within the fabric. For example, an air ry tube may be contained with the fabric and communicated with the seal and frame module to deliver breathable gas to the seal and frame module. 1.3 Overall Construction Fabric Component The fabric may be a soft, flexible textile and may be elastic or non-elastic.

Preferably, the textile may not irritate the skin. Preferably, the textile may allow the skin to breathe and/or may allow for moisture and heat to travel from the skin. For example, the textile may be moisture wicking. The textile may provide ning through the thickness, pile, knit, weave or fleece structure.

In an example, the fabric may be a woven, non-woven, spacer fabric, knit, polymeric weave or other suitable textile.

The fabric may be laminated or otherwise sealed so as to be air holding either completely or in part. The fabric may be selectively sealed or the entire fabric may be sealed.

Laminating Fig. 10 illustrates a laminating process for forming the headgear and cushion module 20 according to an example of the present logy. A first fabric layer F1 is positioned for the laminating process. Preferably, this first fabric layer may have a layer of foam ted across its length for comfort. A layer of adhesive may then be positioned over the first fabric layer. A second layer L2 is positioned over the adhesive. This second layer may be a cushioning component or a ural component. Multiple layers of cushioning and/or structural components may be positioned above this second layer. These additional layers may be rested or adhered on top of the previous layer. Preferably, a second layer is a cushioning component including a foam (e.g., Nylon/Spandex and Polyurethane foam). Preferably, a third layer L3 is cushioning component including a foam. Preferably, a fourth layer L4 is structural component (e.g., rigidizer constructed of, e.g., silicone, polypropylene, ess steel).

A final layer of adhesive may be applied on top ofthe final layer. A second fabric layer F2 is then positioned on top of the adhesive. This second fabric layer may also have a foam layer FL laminated across its length (e.g., Nylon/Spandex and Polyurethane foam).

Heat and pressure (e.g., 190°C for 80 seconds) or an ultrasonic ode are then d by a laminating tool so that the components adhere to one another. As illustrated, the tool es an upper part 3 and a lower part 5, e.g., each part cast or machined of aluminum. The tool may be shaped to produce a curved component, for example the cushion component could be shaped to mimic the general curvature of the face.

The adhesive may be a TPU ve. It may be in a spray, powder or strip form. It may be possible to have a foam and fabric ation where no adhesive is required, as the foam or fabric (e.g., polypropylene fabric) may melt onto the fabric or foam when heat is applied thereby fusing the foam to the fabric.

In an alternative example, flame lamination may be used to form the headgear and cushion module.

In another alternative example, fabric may be placed in a die and a stiffening material (e.g., a polymer) may be injection molded onto the fabric. The fabric may then be formed with the foam, e.g., the foam may be glued onto the injection molded polymer, the foam may be foamed onto the injection molded polymer, or the foam may be flame laminated onto the injection molded polymer.

Cutting The shape ofthe headgear and cushion module may be cut before or after the laminating process. Preferably, the module will be cut by ultrasonic die cutting. onic die cutting allows the edges of the fabric to be substantially rounded so there is less chance of facial g and es a more appealing look and feel. Alternatively, the module could be cut using laser cutters or die cutters. In r alternative, the fabric may be cut first, and then the foam may be foamed or otherwise provided onto the .

Preferably, if the fabric has an edge from stitching, die cutting, etc., this edge may be positioned away from the patient’s face, e.g., to avoid facial marking. 1.4 Shape on The shape ofthe mask system may be influenced or controlled by selectively weakened areas or areas that may be prone to bending or flexing. For example, the headgear straps may be selectively welded through their width to create a hinge point for the headgear straps to bend about. A weld may be positioned, for example, between the cushion region and the strap to encourage the strap to bend about the weld and thereby fold inwards towards the t’s cheeks.

In an example, the headgear and cushion module may be formed with little to no pre-detemrined shape, i.e., the headgear and cushion module may be ntially planar.

In use, the wrapping or positioning of the headgear straps may cause the cushion region to move into engagement with the patient’s face, thereby shaping or bending the cushion region to match that particular patient’s face shape. This is unlike typical mask systems having a rigid frame or predetermined shape of cushion that may fit a limited population due to its specified shape. 1.5 Venting In an example, the elbow 90 may include one or more vent holes 91 (e.g., see Figs. 6 and 7) to permit the exhaust of gases from the mask system.

In an alternative e, venting may be achieved through the /foam composite material of the headgear and cushion module. For example, one'or more vent holes may be cut (e.g., die cut, laser cut) or otherwise provided though the cushion region.

Alternatively, the composite may be selectively coated (e.g., with a laminate) to create air permeable s in the cushion region, e.g., one or more selected regions coated to create air impermeable regions for sealing and one or more s uncoated to create airpermeable regions for venting. 2. Seal and Frame Module The seal and flame module 50 (shown in, for e, Figs. 5 and 6) includes a seal n 51(also called the sealing membrane hereafter) and a frame portion 54. One side of the sealing membrane 51 provides a channel 52 for engaging the n region of the headgear and cushion module within it. The channel 52 receives the cushion region and maintains it in position. The te side of the sealing membrane provides a sealing surface 53 adapted to engage the patient’s face in use and provide seal. The cushion region provides a reactive force to maintain the sealing surface of the sealing membrane in sealing engagement with the face of the patient. The channel is also a means of attaching the frame portion to the headgear and cushion module.

The seal and flame module is made from silicone. Preferably, the silicone may have a polished surface so that it is sticky and may therefore maintain its position on the user’s face. Preferably, the seal and frame module is a single component, molded as one part or multiple parts co-molded together. The module may be a single hardness, for example 10- 90 Shore A. The module may be comprised of sections of ent hardness. Preferably, the sealing n or channel may be softer than the frame portion. Preferably, the elbow connection ring 95 provided to the frame n 54 (for ting the elbow 90) may be harder than the flame portion 54.

The flame portion 54 is shaped such as to create a breathing chamber or space between the mask and the patient’s nose. The frame portion is also shaped so as to receive the elbow or other connection to an air delivery tube. As shown in Fig. 5, frame portion is adapted to receive an elbow or air delivery connector at receptacle 55, perpendicular and medial to the front of the frame portion. Fig. 14 shows an alternative arrangement, where the flame portion or sealed portion is adapted to receive an elbow or air delivery tor at receptacle 455 on a lateral n of the flont of the frame n. The flame portion may be reinforced with thicker regions or with materials of higher hardness so as to maintain it’s in use position. The frame portion may e a malleable wire or other such adjustrnent feature so that the patient can form the flame to comfortably fit on to their face in use.

In an alternative arrangement as shown in Fig. 19, cushion portion 630 may include an outer fabric portion 625, and inner conformable portion 632 and a clip portion 637.

Seal portion 650 may include a patient ting portion 652 and a clip receiving portion 657. Clip receiving portion 657 may be adapted to receive clip portion 637 to secure cushion portion 630 in engagement with sea] n 650. Cushion portion 630 may be positioned to support patient ting portion 652. 3. Alternative Examples In an alternative example, the mask system may not include the seal and frame module 50 as described above. Rather, the aperture d by the ar and cushion module 30 may be sealed or otherwise closed, e.g., by an additional piece of textile or extension ofthe fabric or composite of the cushion region.

For example, Fig. 11 shows a mask system 210 with a one piece construction including a composite having an outer fabric layer and an inner cushioning layer within the fabric layer. As illustrated, the mask system 210 includes a cushion region 230 adapted to define a breathing chamber and form a seal with the patient’s face and a headgear region 240 (with upper and lower straps 242, 244 as described above). A tube connector (e.g., connection ring 295) may be provided to the cushion region 230 for connecting an elbow or air delivery tubing.

Fig. 12 shows a cross section of Fig. 11 in use. Outer fabric layer 231 and an inner cushioning layer 232 forming the cushioning region 230 are positioned about or around the patient’s airways. Central n 250 nt the t’s airways and defining the breathing chamber may be laminated or otherwise sealed. Connection ring 295 is positioned to receive an air delivery tube and r breathable gas to the sealed chamber.

In a further alternative example, the seal portion, cushion portion and chamber portion may be formed of separate components that are connected er. As shown in Figs. 16-18, seal portion 551 is adapted to contact the patient’s face and form a seal with the patient’s airways. Seal portion 551 may be formed of a silicone, TPE, TPU or other conformable polymer, or composite material including laminated textiles. Cushion portion 530 may be positioned nt to and supporting of seal portion 551. Cushion n 530 may be formed ofa composite for example a foam inner layer and fabric outer layer. Seal portion 551 may be adhered, fused or otherwise bonded to cushion n 530.

Alternatively, seal portion 551 may be removably attachable to cushion portion 530.

Chamber portion 550 may be adapted to receive an air delivery connector via connector n 595. Chamber portion 550 may also form the r through which air is delivered to the patient. Chamber portion 550 may be constructed of a polymer such as nylon, polycarbonate, polyurethane, etc. Chamber portion 550 may be welded, glued, formed or otherwise attached to cushion n 530.

While the technology has been described in connection with several examples, it is to be understood that the technology is not to be limited to the disclosed examples, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope ofthe technology. Also, the various examples described above may be implemented in conjunction with other examples, e.g., one or more aspects of one example may be combined with one or more aspects of another example to realize yet other examples. Further, each independent feature or ent of any given assembly may constitute an additional example. In addition, while the logy 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, n'c 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 (23)

WHAT WE CLAIM IS:

1. A mask system, comprising: a headgear and cushion module; and a seal and frame module provided to the headgear and cushion module, the seal and frame module including a sealing n adapted to form a seal with a patient’s face and a frame portion adapted to form a breathing chamber; wherein the headgear and cushion module es a cushion region adapted to support and shape the sealing portion and a headgear region adapted to support and stabilize the mask system on the patient’s face; the mask system being terised in that the ar and cushion module includes a composite including an outer fabric layer that provides an exterior e of the headgear and cushion module, the cushion region including a cushioning component within the composite; and in that the sealing portion of the seal and frame module includes a first side and a second side opposite to the first side, the first side providing the sealing portion, and the second side providing a channel , wherein the channel is configured to receive the cushion region of the headgear and cushion module and to maintain the position of the cushion region on the patient’s face in use.

2. A mask system according to claim 1, wherein the ar and cushion module has a single piece construction.

3. A mask system according to claim 1 or 2, wherein the headgear and cushion module has ntially rounded edges.

4. A mask system according to claim 3, wherein the substantially rounded edges are formed using an ultrasonic die cutting process.

5. A mask system according to any one of claims 1 to 4, wherein the headgear region comprises a first lower headgear strap and a second lower headgear strap.

6. A mask system according to claim 5, wherein the first lower headgear strap is configured to in use extend from a first cheek region of the patient to the back of the patient’s neck and the second lower headgear strap extends from a second cheek region of the patient to the back of the patient’s neck.

7. A mask system according to any one of claims 1 to 6, wherein the headgear region comprises a first upper headgear strap and a second upper headgear strap.

8. A mask system according to claim 7 when dependent on either one of claims 5 or 6, wherein the first upper headgear strap is ured to in use extend from a first region of the patient’s face to the first lower ar strap, and the second upper headgear strap is configured to in use extend from a second region of the patient’s face to the second lower headgear strap.

9. A mask system according to claim 8, wherein the first region is adjacent a first side of the patient’s nasal bridge region.

10. A mask system according to claim 8 or 9, wherein the second region is adjacent a second side of the patient’s nasal bridge region.

11. A mask system according to any one of claims 7 to 10, wherein the first upper headgear strap is releasably attached to the first lower ar strap and the second upper headgear strap is ably attached to the second lower headgear strap.

12. A mask system according to any one of claims 1 to 11, wherein the cushion region includes at least one layer of foam.

13. A mask system according to claim 12, wherein the at least one layer of foam comprises a first relatively soft layer of foam and a second relatively harder layer of foam.

14. A mask system according to any one of claims 1 to 13, wherein the seal and frame module has a single piece construction.

15. A mask system according to any one of claims 1 to 14, wherein the seal and frame module is constructed of silicone.

16. A mask system according to any one of claims 1 to 15, wherein the frame portion is structured to receive an elbow.

17. A mask system according to any one of claims 1 to 16, wherein the n region includes one or more vent holes for gas washout.

18. A mask system according to any one of claims 1 to 17, wherein the cushion region is coated with an air permeable material to provide at least one region for gas washout.

19. A mask system according to any one of claims 1 to 18, wherein the cushion region is resilient, elastic or visco-elastic.

20. A mask system ing to any one of claims 1 to 19, wherein the cushion region comprises a structural component that es support to the ning component.

21. A mask system according to claim 20, wherein the structural component comprises silicone, TPE, polypropylene, polycarbonate or polyurethane.

22. A mask system ing to claim 20, wherein the structural component comprises a textile or foam that has been thermoformed or embossed.

23. A mask system according to any one of claims 20 to 22, wherein the structural component is provided in a nasal-bridge region of the cushion.