Patent Publication Number: US-11638799-B2

Title: Patient interface systems

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 17/509,221, filed Oct. 25, 2021, now allowed, which is a continuation of U.S. application Ser. No. 17/330,490, filed May 26, 2021, now pending, which is a continuation of U.S. application Ser. No. 16/032,722, filed Jul. 11, 2018, now U.S. Pat. No. 11,045,619, which is a continuation of U.S. application Ser. No. 14/645,457, filed Mar. 12, 2015, now U.S. Pat. No. 10,052,448, which is a continuation of U.S. application Ser. No. 13/876,624, now U.S. Pat. No. 9,010,330, filed Mar. 28, 2013, which is the U.S. national phase of International Application No. PCT/AU2011/001258 filed 30 Sep. 2011 which designated the U.S. and claims the benefit of U.S. Provisional Applications 61/388,357, 61/443,623, 61/457,981, and 61/528,524, filed Sep. 30, 2010, Feb. 16, 2011, Jul. 27, 2011, and Aug. 29, 2011, respectively, the entire contents of each being incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present technology relates to a patient interface, or mask, system for treatment of sleep disordered breathing (SDB). 
     BACKGROUND 
     Treatment of sleep disordered breathing (SDB), such as obstructive sleep apnea (OSA), by continuous positive airway pressure (CPAP) flow generator systems involves the continuous delivery of air (or other breathable gas) pressurized above atmospheric pressure to the airways of a human via a conduit and a mask. Typically, the mask fits over or in the mouth and/or nose of the patient. Pressurized air flows to the mask and to the airways of the patient via the nose and/or mouth. Pressurized air is delivered to the mask by a conduit connected to the CPAP device and the mask. 
     The mask should be comfortable and unobtrusive so that a patient may tolerate therapy and maintain usage. Some patients may prefer a pillows or prongs type mask (as known in the art), or a nasal mask or a full face mask. Some patient&#39;s may prefer to use one or a combination of these masks interchangeably. However, this would require the purchase of a number of different mask systems, which may be expensive and/or may not be covered by insurance. 
     In addition, masks including oro-nasal masks typically include a rigid frame. Patients may not find this comfortable. The frame may also dislodge the sealing portion of the mask away from the face of the patient if it is contacted or forced by bed clothing, pillows, etc. 
     BRIEF SUMMARY 
     One aspect of the present technology relates to patent interface, or mask, systems that provide integrated nose and mouth seals that are less obtrusive than currently available systems. 
     Another aspect of the present technology relates to patient interface systems that have reduced part counts compared to currently available systems. 
     A further aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that provide a visible mouth region of the patient. 
     Still another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that do not obstruct the patient&#39;s line of sight. 
     Further aspects of the present technology relate to patient interface systems, for example oro-nasal masks, that are easier and/or more intuitive to assemble, fit, and use by patients, dealers, and clinicians, and provide improved fitting and sealing. 
     Yet another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that provide size selection from remote locations, and without assistance and/or instruction. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that are considered physiologically non-threatening and will increase patient selection of the system and adherence to therapy. 
     Further aspects of the present technology relate to patient interface systems, for example oro-nasal masks, that seal the mouth and nasal airways but have no nasal bridge touch points and/or fewer total points of contacts with the patient&#39;s face than current systems. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially planar fascia that may provide a visible mouth region of the patient. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially curved and/or smooth fascia that may provide a visible mouth region of the patient. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially curved and/or smooth fascia that may have no ridges, connector portions or other obstructions in the region of the patient&#39;s mouth, so that the fascia may provide a visible mouth region of the patient. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially smooth fascia that may have no complex shapes, connector portions or other obstructions in the region of the patient&#39;s mouth, so that the fascia may provide a visible mouth region of the patient. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises an air delivery tube connection, the air delivery tube connection positioned on the cushion. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises an air delivery tube connection, the air delivery tube connection positioned on the fascia and offset from the centre of the fascia, that may provide a visible mouth region of the patient. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that are substantially comprised of flexible components. 
     Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that are stabilised at the nose sealing portion separately to the mouth sealing portion. 
     A patient interface structure for delivery of respiratory therapy to a patient according to an example embodiment of the present technology comprises a front plate configured to conform to the shape of the patient&#39;s face; a mouth cushion defining a breathing chamber and provided to the front plate and configured to seal around the patient&#39;s mouth; and a nasal cushion configured to seal the patient&#39;s nasal airways, wherein the nasal cushion is supported by the mouth cushion, does not contact a bridge of the patient&#39;s nose in use, and extend at least partially into the breathing chamber. 
     A patient interface structure for delivery of respiratory therapy to a patient according to an example embodiment of the present technology comprises a front plate configured to conform to the shape of the patient&#39;s face; a mouth cushion defining a breathing chamber and provided to the front plate and configured to seal around the patient&#39;s mouth; and a nasal cushion configured to seal the patient&#39;s nasal airways, wherein the nasal cushion is supported by the mouth cushion, does not contact a bridge of the patient&#39;s nose in use, and is raised above the breathing chamber. 
     A patient interface system according to an example embodiment of the present technology comprises a patient interface structure according to the present technology and a patient interface structure positioning system configured to position, stabilize and secure the patient interface structure in sealing engagement with the patient&#39;s face. 
     A patient interface system according to an example embodiment of the present technology comprises a cushion adapted to sealingly engage with a patient&#39;s airways, the cushion comprising a slot adapted to receive a headgear connecting portion of a fascia. 
     Other aspects, features, and advantages of this technology 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 technology. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings facilitate an understanding of the various embodiments of this technology. In such drawings, in which like reference symbols indicate like features: 
         FIGS.  1 - 6    are front isometric, front, rear, left, right, and bottom views, respectively, of an example embodiment of a patient interface system according to the present technology; 
         FIGS.  7 - 13    are front isometric, front, rear, top, bottom, right and left side views, respectively, of a fascia, or front plate, of the patient interface system of  FIGS.  1 - 6   ; 
         FIGS.  14 - 19    are front isometric, front, left side, right side, rear and bottom views, respectively, of a patient interface system according to another example embodiment of the present technology; 
         FIGS.  20 - 25    are front, rear, rear isometric, top, bottom, and left side views, respectively, of a fascia, frame or front plate, of the patient interface system of  FIGS.  14 - 19   ; 
         FIG.  26    is a front isometric view of a patient interface according to another example embodiment of the present technology and  FIGS.  27 - 33    are front isometric, front, rear, right side, left side, top, and bottom views, respectively, of a fascia, frame or front plate, of the patient interface system of  FIG.  26   ; 
         FIGS.  34 - 40    are front isometric, front, rear, left side, right side, top, and bottom views, respectively, of a patient interface system according to another example embodiment of the present technology; 
         FIGS.  41 - 47    are front isometric, front, rear, left side, right side, top, and bottom views, respectively, of the fascia, frame or front plate, including an elbow and the patient interface positioning system of the patient interface system of  FIGS.  34 - 40   ; 
         FIG.  48    is a front isometric view of the fascia, or front plate, including the elbow, and the seal (e.g. cushion) of the patient interface system of  FIGS.  34 - 30   ; 
         FIGS.  49 - 55    are front isometric, front, rear, right side, left side, top, and bottom views, respectively, of the fascia, frame or front plate, including the elbow, of the patient interface system of  FIGS.  34 - 40   ; 
         FIGS.  56 - 62    are front isometric, front, rear, rear isometric, right side, top, and bottom views, respectively, of a patient interface positioning system according to an example embodiment of the present technology; 
         FIGS.  63 - 69    are front isometric, front, rear, top, bottom, right side, and left side views, respectively, of a mouth seal, or cushion, according to an example embodiment of the present technology; 
         FIGS.  70 - 76    are front/bottom isometric, front, rear, top, bottom, side, and front/top isometric views, respectively, of a nasal seal, or cushion, according to an example embodiment of the present technology; 
         FIGS.  77 - 83    are front isometric, front, rear isometric, rear, right side, top, and bottom views, respectively, of a seal, or cushion, including the mouth and nasal seals, or cushions, of  FIGS.  63 - 69  and  70 - 76   , respectively, according to an example embodiment of the present technology; 
         FIG.  84    is a front view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  85    is a front view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  86    is a front isometric view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  87    is a rear view of a patient interface system according to another example embodiment of the present technology; 
         FIGS.  88 - 94    are views of a patient interface system according to another example embodiment of the present technology; 
         FIG.  95    is a front isometric view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  96    is a front view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  97    is a front view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  98    is a front view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  99    is a front view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  100    is a front view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  101    is a front isometric view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  102    is an exploded assembly view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  103    is a front isometric view of a patient interface system according to another example embodiment of the present technology; 
         FIG.  104    is a rear view of a mouth seal, or cushion, according to an example embodiment of the present technology; 
         FIG.  105    is a left side view of the mouth seal, or cushion, of  FIG.  104   ; 
         FIG.  106    is a schematic illustration of a fascia, or front plate, and a seal, or cushion, including an anti-asphyxia valve according to an example embodiment of the present technology; 
         FIG.  107    is a schematic illustration of a fascia, or front plate, and a seal, or cushion, including an anti-asphyxia valve according to another example embodiment of the present technology; 
         FIG.  108    is a schematic illustration of a fascia, or front plate, and a seal, or cushion, including a gusseted side wall according to an example embodiment of the present technology; 
         FIG.  109    is a schematic illustration of a strap, for example a rear strap, of a patient interface positioning system (e.g. headgear) according to an example embodiment of the present technology; 
         FIG.  110    is schematic illustration of the strap of  FIG.  109    connected to a delivery tube or conduit or hose; 
         FIG.  111    is a schematic illustration of a strap, for example a rear strap, of a patient interface positioning system (e.g. headgear) according to another example embodiment of the present technology; 
         FIG.  112    is a schematic illustration of a strap, for example a rear strap, of a patient interface positioning system (e.g. headgear) according to another example embodiment of the present technology; 
         FIG.  113    is a schematic illustration of a fascia, or front plate, including a venting arrangement according to an example embodiment of the present technology; 
         FIG.  114    is a schematic illustration of a patient interface system rotatably connectable to a patient interface positioning system according to an example embodiment of the present technology; 
         FIG.  115    is a rear view of a cushion assembly, including a mouth seal or cushion and a nasal seal or cushion; 
         FIG.  116    is a front view of the cushion assembly of  FIG.  115    including a cushion clip; 
         FIG.  117    is a cross section view of the cushion assembly and cushion clip along line  117 - 117  in  FIG.  116   ; 
         FIG.  118    is a detailed view of the connection of the cushion assembly and the cushion clip at a lower portion of the cushion assembly; 
         FIG.  119    is a detailed view of  FIG.  118   ; 
         FIG.  120    is a detailed view of the connection of the cushion assembly and the cushion clip at an upper portion of the cushion assembly; 
         FIG.  121    is a detailed view of  FIG.  120   ; 
         FIG.  122    is a top view of the cushion assembly and cushion clip; 
         FIG.  123    is a rear view of the cushion clip; 
         FIG.  124    is a front view of the cushion clip; 
         FIG.  125    is a cross section view of the cushion clip along line  125 - 125  in  FIG.  124   ; 
         FIG.  126    is a left side view of the cushion clip; 
         FIG.  127    is a detailed view of  FIG.  125   ; 
         FIG.  128    is a top view of the cushion clip; 
         FIG.  129    is a rear isometric view of a cushion assembly according to an embodiment of the present technology; 
         FIG.  130    is a rear view of the cushion assembly of  FIG.  129   ; 
         FIG.  131    is a cross section view of the cushion assembly along line  131 - 131  in  FIG.  130   ; 
         FIG.  132    is a rear isometric view of a cushion according to an embodiment of the present technology; 
         FIG.  133    is a rear view of the cushion assembly of  FIG.  132   ; 
         FIG.  134    is a cross section view of the cushion assembly along line  134 - 134  in  FIG.  133   ; 
         FIG.  135    is a front isometric view of the cushion assembly and cushion clip of  FIG.  125   ; and 
         FIG.  136    is a left side view of the cushion assembly and cushion clip of  FIG.  135   . 
     
    
    
     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. 
     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. It is also acknowledged that the blowers described herein may be designed to pump fluids other than air. 
     Patient Interface Systems 
     Referring to  FIGS.  1 - 13  and  56 - 62   , a patient interface system or mask system  10  in accordance with an example embodiment of the present technology comprises a patient interface structure or mask structure  20  that is positioned, stabilized and secured on a patient&#39;s head in sealing engagement with the patient&#39;s mouth and nasal airways by a patient interface positioning system  30 , e.g. a headgear. The patient interface structure  20  comprises a fascia or lens or front plate or frame  21  having a mouth seal, or cushion  23  that is connected to the front plate  21 . The front plate  21  includes patient interface positioning system connectors  22  (e.g. headgear connectors) to connect the patient interface positioning system (e.g. headgear)  30  to the patient interface structure (e.g. mask)  20 . The patient interface structure further comprises a nasal seal, or cushion  24  connected to the mouth seal, or cushion  23  to seal the patient&#39;s nasal airways. A vent  25  may be provided in the front plate  21  to vent exhaled gases in a breathing chamber defined by the front plate  21 , the mouth cushion  23  and the nasal cushion  24 . The vents may be provided in the front plate  21  proximate the nares and/or mouth of the patient to improve CO.sub.2 washout. The array of vent holes  25  may be laser cut, molded or otherwise formed in an upper region of front plate  21 . 
     Patient Interface Positioning System 
     The patient interface positioning system  30  comprises a crown strap  31  adapted to cup or encircle the crown of the patient&#39;s head. Top, or upper side straps  32  extend from the crown strap  31  and connect to the front plate  21  through slots  27 . The ends  33  of the top side straps  32  may be looped through the slots  27  and connect to the top side straps  32  by, for example, hook and loop material. It should also be appreciated that other connections, for example buckles, may be used to secure the ends  33  of the top side straps  32 . The top side straps  32  may be thickened or widened at the region where they connect to the crown strap  31  to allow ends  33  a larger space to connect to and also a range of angles to position ends  33  relative to slots  27 , thereby improving the fit range of the headgear  30 . Such an arrangement may also improve comfort and/or to assist in stabilizing and positioning the top side straps  32  on the patient&#39;s cheek bone regions. 
     The crown strap  31  may further comprise a loop  40  through which a right bottom, or lower side strap  35  may pass and connect to a left bottom, or lower side strap  34 . It should also be appreciated that the loop may be formed in the lower strap(s)  34  and/or  35 , for example as shown in U.S. Applications 61/443,623 and 61/457,981, each of which is incorporated by reference herein in its entirety. It should further be appreciated that other headgear may be used with the patient interface system, for example as disclosed in U.S. Patent Application Publication 2008/0110466 A1, the entire contents of which are incorporated herein by reference. The bottom right side strap  35  may comprise a first end  38  in the form of a loop or slot and a first end  36  of the bottom left side strap  34  may connect to the first end  38  by passing through the loop or slot and connecting through hook and loop material or buckles or other connectors. The second end  37  of the bottom left side strap  34  and the second end  39  of the bottom right side strap  35  may be connected to the front plate  21  through slots  26  in the connectors  22 . 
     Headgear  30  may be formed from a composite e.g. fabric and foam, which may be flame laminated and may be ultrasonically die cut or welded along its edge to create a rounded, more comfortable edge. 
     Front Plate/Fascia/Lens 
     The front plate  21  is configured to conform to or accommodate the shape of the patient&#39;s face. The front plate  21  may be flexible to allow the front plate to follow the shape of the patient&#39;s face. The front plate  21  may be formed of, for example, a flexible polymer that is able to bend and conform around the patient&#39;s mouth once the front plate  21  is connected to the patient interface positioning system  30  and fitted to the patient. The front plate  21  may also be malleable to allow the front plate to conform to the shape of the patient&#39;s face. A rib(s)  28  may be provided to the front plate  21 . The ribs  28  may be provided along the top and bottom of the front plate  21  and aid in alignment and engagement with the cushion  23 , as well as providing strength to the fascia. 
     Front plate  21  may be substantially planar, curved and/or smooth. Masks known in the art tend to include complex shapes and/or structures on the frame, and these complex shapes and/or structures make it difficult to see the patient&#39;s mouth clearly and to clean the frame. For example, these complex shapes and/or structures may include elbows, elbow connectors, ports, ridges, contours, headgear connectors, etc. Front plate  21  is adapted to be substantially smooth and without complex shapes or structures i.e. having a substantially planar surface in the region of the patient&#39;s mouth, to act as a window to permit clear visibility to the patient&#39;s mouth. 
     As shown on  FIGS.  14  and  15   , the patient interface structure  20  may be generally rectangularly or trapezoidally shaped and comprise the front panel  21  that wraps across the face of the patient  1 , and the cushion  23 ,  24  attached to the front plate  21 . The cushion  23  may comprise the integrated mouth seal or cushion  23  and the nasal seal or cushion  24 . The front plate  21  may be generally convex when viewed from the non-patient contacting side, curved or rounded shaped and adapted to follow the contour of the patient&#39;s face. The bottom side strap connector slots  26  and the top side strap connector slots  27  of the connectors  22  on either side of the front plate  21  may receive the headgear straps  32 ,  34 ,  35  and the tension or force from the headgear straps  32 ,  34 ,  35  may bend or flex the front plate  21  to conform to the shape of the patient&#39;s face. The top side strap connector slots  27  are directed generally upwards and are adapted to aid sealing of the nasal cushion  24  and direct the headgear away from the patient&#39;s eyes  4 , and the bottom side strap connector slots  26  are adapted to aid sealing of the mouth cushion  23  and direct the headgear straps  34 ,  35  under the ears  2  of the patient  1 . 
     The fascia or lens or front plate  21  is positioned in front of the patient&#39;s mouth, and is adapted to provide support to the other components of the patient interface system  10  and aid in positioning these other components, for example the front plate has headgear connectors  22  and a cushion connection portion adapted to receive the patient interface positioning system  30  and a cushion  23  and position these components relative to one another. The front plate  21  also provides some structure to the patient interface system  10  due to the comparatively greater rigidity of the front plate  21  when compared to the cushion  23 . 
     The front plate  21  may take the form of a lens made from a clear material such as nylon, polycarbonate or nearly clear material such as polypropylene. The lens may be shaded, selectively shaded (e.g. gradient, patterned, random assortment of shapes), printed on or otherwise coloured. The lens may also have colour changing properties e.g. it may be clear when the light is on, and may be opaque when the light it off. The lens may also be customizable. The lens may be provided with a skin or adhesive layer that may customize or otherwise alter the lens. The lens may be surface treated e.g. frosted. The lens may be die cut, drape formed, vacuum formed, molded, cast, ultrasonically cut or formed in any other method to create the desired shape. The lens may also be formed with vent holes. The vent holes may be molded in, laser cut or otherwise formed with the lens. The lens may be flexible or capable of being shaped to fit the patient&#39;s face. 
     Cushion/Seal 
     Referring to  FIGS.  63 - 83   , the cushion or seal of the patient interface system may comprise two components the mouth cushion or seal  23  and the nasal cushion or seal  24 . The cushions  23 ,  24  may be molded together or otherwise permanently attached (e.g. glue, weld). The mouth cushion  23  provides the mouth sealing portion and also the support for the nasal cushion  24 . The mouth cushion  23  also connects to the front plate  21 . The nasal cushion  24  is a nares sealing portion that may be molded from the same or alternative material to mouth cushion  23 . Separating the cushion into two components allows use of a lower durometer (i.e. lower hardness) material for the nasal seal or cushion  24 , and the tooling required to mold the nasal seal or cushion  24  with the mouth seal or cushion  24  is difficult, so molding them in two steps rather than one facilitates manufacturing. 
     The cushions  23 ,  24  may be made from a single material such as silicone, TPE, TPU. However, combinations of materials and/or hardnesses of materials may be used. For example, the mouth seal or cushion  23  may have a TPE or silicone body, with a seal portion or flap adapted to interface with the patient. The nasal seal  24  may comprise a seal portion formed of an alternative material, for example a lower hardness silicone, TPU, fabric, etc. 
     Referring to  FIGS.  63 - 69   , the mouth cushion  23  comprises a groove or channel  231  around a front portion  238  that is adapted to receive the front plate  21 . The channel  231  may have a flap (or sealing wall)  232  around the inner side of the channel that is adapted to seal against the face of the patient around the patient&#39;s mouth. The flap  232  may comprise a single wall seal, although it should be appreciated that the flap  232  may comprise more than one wall, for example two or three walls. The mouth cushion  23  may be constructed from a deformable material such as TPE, TPU, silicone, foam (skinned or unskinned), or gel. 
     It should be appreciated that the mouth cushion  23  may be insert, over, or co-moulded to the front plate  21 . It should be further appreciated that a cushion clip may be provided to the cushion to clip to the front plate  21 . The clip may be insert, over, or co-moulded into the cushion  23  as one part. The cushion clip may add stiffness and rigidity to the cushion  23  where required, provide patient interaction points, and allow for a locating and attaching method of the cushion  23  to the front plate  21 , e.g. the cushion clip may snap onto the front plate  21 . The cushion clip may simplify the process of attaching the cushion  23  to the front plate  21  by reducing stretching and warping of the cushion  23  during assembly. 
     Slots  234  are provided in side walls  233  of the cushion  23  and are adapted to receive the connectors  22  of the front plate  21 . Slots  234  may be generally rectangular, however any other shape may be possible, such that slots  234  may be complimentary to the shape of connectors  22 . Connectors  22  may sealingly engage with side walls  233 , for example side walls  233  may comprise a lip seal or other arrangement adapted to seal against connectors  22 . 
     The upper portion  237  of the mouth seal or cushion  23  has a greater depth when compared with the lower portion  239  of the mouth seal or cushion  23 , i.e. the distance of the seal portion to the clip portion of the upper portion may be longer than the distance from the seal portion to the clip portion of the lower portion, to tilt the cushion  23  when in use to reduce the profile of the mask  20  when in use. The upper portion  237  of the mouth seal or cushion  23  may also have a greater depth than the lower portion  239  to accommodate nasal seal or cushion  24  and patients with long noses. 
     Flaps  252  are provided on nares support portions  235  to assist in positioning and stabilizing the nasal seal or cushion  24  to engage with the sides of the patient&#39;s nose or the patient&#39;s top lip. Raised portions  253  on the nares support portion  235  aid in positioning the nasal seal  24  against the flares of the patient&#39;s nostrils. Indents or apertures  254  are formed in the nasal support portions  235  and are adapted to receive lugs  241  on nasal seal or cushion  24  to aid in alignment. 
     A channel  251  may be provided around the nares support portions  235  to form a flexible region (e.g. could be localized thinning of material) adapted to permit movement of the nasal seal or cushion  24  to accommodate varying anthropometrics. 
     The side walls  233  of the mouth seal or cushion  23  may have a “question mark” cross section, i.e. the mouth seal portion does not have a straight wall section but rather has a gusseted side wall that acts as a built-in spring so that the mouth seal portion can flex to fit varying patient anthropometrics. Such a side wall cross section is disclosed in, for example, U.S. Patent Application Publication 2008/0110464 A1, the entire contents of which are incorporated herein by reference. 
     The front portion  238 , the side walls  233  and the flap  232  of the mouth cushion  23  may have different hardnesses. For example, the front portion  238  may have a Shore A durometer of about 30-50, for example about 40. The side walls  233  and/or the flap  232  may have a Shore A durometer of 5-10, for example about 7. 
     Referring to  FIGS.  104  and  105   , the cushion or seal may be formed of a foam, gel, or low durometer material to seal with the patient. Two gusset or spring portions  288 ,  289  may be formed behind the seal portion to aid in adjustment of the positioned of the seal portion. The corner  287  of the nose region may be raised to ensure the seal abuts the patient&#39;s face and seals in this region. 
     Referring to  FIG.  108   , a gusset type arrangement may be provided to permit flexibility of the cushion and aid sealing under air pressure, with the flap  232  turning outwards. This arrangement may increase the fit range. 
     Referring to  FIGS.  70 - 76   , the nasal seal or cushion  24  may comprise lugs  241  adapted to be received in indents  254  of the nare support portions  235  of the mouth seal or cushion  23 . The nasal seal or cushion  24  may have a geometry the same as or similar to that disclosed in, for example, WO 2010/139014 A1, the entire contents of which are incorporated herein by reference. The nare support portions  235  and the cradle wall  236  form a trampoline type join with the nasal seal or cushion  24 . The nasal seal or cushion  24  may have a Shore A durometer of about 30-50, for example about 40. The nasal seal or cushion  24  may have a Shore A durometer of about 5-10, for example about 7. 
     Referring to  FIGS.  77 - 83   , in the assembled condition, the flaps  252  of the nares support portions  235  of the mouth seal or cushion  23  attach to the respective sides of the nasal seal or cushion  24 . A central portion  242  of the nasal seal or cushion  24  is left unsupported by the nares support portions  235  to allow the flexibility of the central portion  242  accommodate varying shaped lip regions of patients. As shown in  FIG.  78   , the upper portion  237  of the mouth seal or cushion  23  is generally in line with or vertically aligned to the nasal seal or cushion  24  so the patient&#39;s nose is likely to rest inside the cushion. The nasal seal or cushion  24  is positioned to reside within the mouth cushion  23  which reduces visual bulk and streamlines the outer edge of the mask. As shown in  FIG.  79   , the slots  234  for the connectors  22  of the front plate  21  are positioned below the nasal seal  24  so as to direct the headgear straps  34 ,  35  along or below the patient&#39;s cheeks. It should be appreciated that the patient interface system may comprise a number of nasal seals or cushions  24 . For example, a single mouth cushion  23  may be provided to fit a large percentage of the patient population and two or more nasal seals or cushions  24  may be provided to provide a more custom fit for individual patients nose sizes. 
     Referring to  FIG.  96   , it should be appreciated that a nasal seal or cushion comprising nasal pillows may be provided to the mouth cushion. It should be appreciated that a plurality of nasal seals or cushions having different size nasal pillows may be provided to the patient interface system. 
     Referring to  FIG.  97   , the tube connector may comprise an elbow  269  that is rotatably connected to the front plate  21 . Elbow  269  may be lockable in the two positions as show, i.e. left and right horizontal orientations. 
     Referring to  FIG.  98   , the patient interface structure  20  may include an anti-asphyxia valve  360  provided in the front plate  21 . 
     Referring to  FIG.  99   , the front plate  21  may include a receptacle  270  configured to receive a clip  271  provided on a strap  35  of the patient interface positioning system. As shown in  FIG.  100   , the front plate  21  may include receptacles  270  on opposing sides, each configured to receive a clip  271  attached to a strap  34 ,  35 . The clips and receptacles may also be magnetic. 
     Cushion/Seal—Cushion Clip 
     Referring to  FIGS.  115 - 128 ,  135  and  136   , a seal or cushion assembly includes a mouth seal or cushion  23  and a nasal seal or cushion  24 . The cushion assembly may be similar to that disclosed with respect to  FIGS.  63 - 83    except as otherwise described herein. The cushion assembly may comprise a cushion clip  400  attached to the cushion assembly and configured to attach the cushion assembly to a fascia or front plate or lens as described herein. The cushion clip  400  may comprise detents  402  on opposite sides to retain the cushion assembly on the fascia. As shown in, for example,  FIG.  128   , the cushion clip  400  may have a curved portion  401  that curves away from the cushion assembly to allow the nasal seal  24  to have a greater depth than a top surface of the mouth cushion  23 . This may allow the nasal seal  24  to accommodate long noses. As shown in  FIG.  116   , the central portion  242  of the mouth cushion  23  may dip or curve downwards towards the patient&#39;s lip to avoid contacting the patient&#39;s septum. As shown on  FIG.  115   , nasal seal  24  may comprise raised upper corner regions, these raised upper corner regions adapted to engage a patient&#39;s nostrils or nasal flares, thereby reducing the force on the patient&#39;s nose tip. 
     Referring to  FIG.  115   , the height of the aperture in the mouth cushion may be about 25-35 mm. Preferably, the height of the aperture on the mouth cushion may be about 25-30 mm. The height is measured from the lowest portion of the opening at the chin region to the dip or curve of the opening at the top lip region. The height of the aperture may increase towards the cheek or left and ride side regions. 
     Referring to  FIG.  122   , the height of the aperture in the nose cushion may be about 5-15 mm. Preferably, the height of the aperture in the nose cushion may be about 7-12 mm. The height of the aperture in the nose cushion may be less in the central region of the aperture compared to the height of the aperture at the side regions. That is, the nose cushion aperture may have a dip or curved portion at the central region. Such an arrangement may aid in alignment of the cushion, avoid placing excess pressure on the patient&#39;s septum and/or ensure that the lower portion of the nasal cushion is not under tension and therefore may not exert pressure on the patient&#39;s top lip. 
     Referring to  FIG.  115   , the width of the aperture in the mouth cushion may be about 60-70 mm. Preferably the width of the aperture in the mouth cushion may be about 63-68 mm. Such a width may accommodate varying mouth widths of patient&#39;s. 
     Referring to  FIG.  122   , the total width of the nose and mouth cushion may be about 90-105 mm. Preferably, the total width of the nose and mouth cushion may be about 95-100 mm. Such a width may accommodate varying patient anthropometrics. 
     Referring to  FIG.  115   , the total height of the nose and mouth cushion may be about 60-75 mm. Preferably, the total height of the nose and mouth cushion may be about 65-75 mm. Such a height may accommodate varying patient anthropometrics. 
     The patient contacting portion of the nose and/or mouth cushions may be about 0.3-1.5 mm thick. Preferably, patient contacting portion of the nose and/or mouth cushions may be about 0.3-0.7 mm thick. Such a thickness may ensure conformability of the cushion and comfort for the patient. 
     Referring to  FIG.  116   , the height of the clip may be about 40-55 mm. Preferably, the height of the clip may be about 45-55 mm. The height of the clip may be greater than the height of the mouth cushion aperture. Such an arrangement may be simpler to engage the clip with a fascia (for example) and may increase the structural integrity of the cushion. 
     Referring to  FIG.  116   , the width of the clip may be about 70-85 mm. Preferably, the width of the clip may be about 75-80 mm. The width of the clip may be greater than the width of the mouth cushion aperture. Such an arrangement may be simpler to engage the clip with a fascia (for example) and may increase the structural integrity of the cushion. 
     As shown in, for example,  FIG.  124   , the cushion clip may be generally trapezoidal, with the top portion being wider than the lower portion. Such an arrangement may mean that the overall shape of the mask is shaped to match the general shape of a humans face i.e. taper from a greater width at the top lip region to a lower width at the chin region. The top portion may be, for example, about 75-85 mm wide. The lower portion may be, for example, about 65-75 mm wide. 
     As shown in, for example,  FIGS.  117 - 121   , the cushion may be integrally formed in one piece. The mouth cushion  23  may have a single sealing wall  232  and the nasal cushion  24  may have a dual wall construction comprising a sealing wall  243  and a supporting wall  244 . It should be appreciated that the mouth cushion  23  and the nasal cushion  24  may each include a single wall, or each may include multiple walls. The sealing walls  232  and  243  of the mouth cushion  23  and the nasal cushion  24  may curve inwards toward a breathing chamber or cavity formed by the cushions. As shown in  FIG.  117   , only a portion of the supporting wall  244  of the nasal cushion  24  may be present, for example, at the tip of the nose region and not at the top of the lip region. Referring to  FIG.  122   , a parting line  245  of the mould used to form the cushion assembly may be provided so as to be above the patient contacting areas of the cushion assembly. 
     Referring to  FIG.  136   , the cushion assembly and the cushion clip  400  may be formed integrally in one piece. The cushion assembly may be insert, over, or co-moulded into the cushion  23  as one part. Alternatively, the cushion assembly and the cushion clip  400  may be chemically or mechanically bonded together. The cushion assembly and cushion clip  400  may also be repeatably attachable and detachable from one another. For example, the cushion clip  400  may include a flange configured to be received in a channel in the cushion assembly. 
     As shown in  FIGS.  117 - 121 ,  126  and  127   , the cushion clip  400  may include a flange or rib  403  to increase the surface area of the cushion clip  400  to enhance the bond between the cushion clip  400  and the cushion assembly. The cushion assembly, for example the mouth cushion  23 , may include a thickened region  310  to provide support for the sealing wall  232  and to improve the bond to the cushion clip  400 . Rib  403  may have a varying height around the perimeter of the cushion clip  400 . This varying height may support the cushion more in some regions (i.e. the regions with a greater rib height such as sensitive regions of the face such as the top lip) compared to support in other regions (i.e. regions with a lower rib height such as less sensitive regions of the face such as the cheeks). 
     Cushion Assembly—Continuous Sealing Surface 
     Referring to  FIGS.  129 - 131   , a cushion assembly including a mouth cushion  23  and a nasal cushion  24  may comprise a continuous sealing surface  246 . As show in  FIG.  131   , the sealing surface  246  is continuous with the mouth cushion sealing wall  232  and the nasal cushion sealing wall  243 . The curvature of the sealing surface  246  may be constant or approximately constant. Such an arrangement may be comfortable for the patient as there are no ridges or undulations that may mark or otherwise irritate the patient&#39;s skin. In this arrangement, the definition between the nose and mouth seal portions is not distinct, such that the seal is continuous. 
     Cushion Assembly—Separate Sealing Surfaces 
     Referring to  FIGS.  132 - 134   , a cushion assembly including a mouth cushion  23  and a nasal cushion  24  includes separate sealing surfaces  247 ,  248 . A channel  249  is provided to separate the nasal sealing surface  247  from the mouth sealing surface  248 . Such an arrangement may be preferable as the nose and mouth seal portions are visually distinct which may assist the patient with aligning the device. 
     Patient Interface Systems—Tube Connection—Behind Connector 
     Referring to  FIGS.  14 - 25   , a patient interface system  10  according to an example embodiment of the present technology includes a delivery hose, or tube, or conduit  11  that is connected to the front panel  21  by a connector  12 , e.g. a swivel connector. The tube  11  may be as disclosed in, for example, U.S. Patent Application Publication 2009/0078259 A1, the entire contents of which are incorporated herein by reference. The front panel includes an air inlet or elbow  29  that may be integrally formed with the front plate  21 . It should be appreciated that the elbow  29  may be formed separately from the front plate  21  and attached or connected to the front plate  21  or the cushion  23 , for example by adhesive or mechanical fasteners. The elbow  29  is positioned behind or adjacent to the connector  22  of the front plate  21  on the left side, although it should be appreciated that the elbow  29  may be provided on the right side of the front plate  21 . The shape of the elbow  29  is curved to avoid obscuring the headgear connector  22 . However other configurations would be possible if the headgear connector  22  was located in an alternative position. 
     The tube connection portion of the elbow  29  is adapted to receive the tube  11  in a longitudinal (e.g. vertical) direction, however other orientations are possible. The elbow  29  is not visible from the front as it is hidden behind the headgear connector  22  of the front plate  21 . This arrangement is advantageous as it is reduces the part count (i.e. no separate elbow is required) and the design may be more visually appealing. The tube  11  is connected at the side of the patient interface or mask system  10  so as to permit clear view to the patient&#39;s mouth. Because the tube connection is positioned behind the headgear connector  22  at the front plate  21 , the tube  11  is less obtrusive. The eyes  4  of the patient  1  are unobstructed and in the case of the front plate  21  being in the form of a lens, for example a clear polymer (e.g. polycarbonate), the patient&#39;s mouth would also be visible. 
     The elbow  29  may comprise a lip or protruding edge  41 , in the form of for example a chamfer, adapted to receive a slot or aperture of the cushion. The cushion  23  may comprise a slot that may be positioned to abut or align with the chamfer to aid alignment, and also ensure an air tight seal between the cushion  23  and the front plate  21  is achieved. 
     The patient interface structure  20  sits under the patient&#39;s nose  3  and the nasal cushion  24  seals around or in the nares. The mouth cushion  23  sits in the crease of the patient&#39;s chin  5 . The crown strap  31  of the headgear  30  is positioned over the top of the patient&#39;s crown and generally in line with the patient&#39;s ears  2 , although it should be appreciated that the positioning of the crown strap  31  may vary between patients. 
     Although the front plate  21  shown in  FIGS.  20 - 25    includes only the bottom side strap connector slots  26 , it should be appreciated that the embodiment shown in  FIGS.  20 - 25    may also comprise top sides strap connector slots  27 . It should also be appreciated that the front plate  21  may be provided with a vent, or alternatively another component, such as the tube  11 , the connector  12 , or the elbow  29  may have a vent. 
     Referring to  FIG.  101   , a tube connector  272  may be positioned either on the front plate  21  or molded with the cushion  23 . The tube connector  272  may receive an intermediate portion or portion  274  of a tube  273  that may interface with the tube connector  272  by an interference fit. The interference fit may be achieved by pinching or otherwise misshaping the intermediate portion or portion  274  of the tube  273  and placing it within the tube connector  272 . When the pinch or other force is released, the intermediate portion or portion  274  of the tube  273  may resiliently flex back to its original shape and interface with an inner surface of the tube connector  272 . In an alternative arrangement, tube  273  that may interface with the tube connector  272  by an interference fit such as an isometric taper or a quarter turn lock. 
     Patient Interface Systems—Tube Connection—Front Surface 
     Referring to  FIGS.  26 - 33   , a patient interface system  10  according to another example embodiment of the present technology comprises a patient interface structure  20  comprising a front plate  21 , a mouth cushion  23  provided to the front plate  21 , and a nasal cushion  24  provided to the mouth cushion  23 . The front plate  21  comprises a tube connector  42  on a front surface that is configured to receive a tube in a horizontal direction. 
     A tube may connect directly to the tube connector  42  or may have an intermediate structure such as an elbow or swivel between the tube and the tube connector  42 , possibly shaped to avoid the tube obscuring the headgear connector  22 . The tube connector  42  may have vent holes  25  molded or otherwise formed in it. The tube connector  42  may also have a lip or protruding edge  43 , which may aid in sealing the tube connector  42  to the tube or intermediate structure. The tube connector  42  may have an anti-asphyxia valve (AAV) in form of a flap built in (described in more detail below) that may occlude or block some of the vent holes  25  when air is delivered from the tube and through the tube connector  42 . When air pressure is not supplied, the AAV may flip away from the vent holes to permit the patient to breath in sufficient atmospheric air. 
     The rear face of the front plate  21  may have an aperture  44  adapted to permit the flow of air from the tube connector into the mask. The vents  25  may have a thicker cross section than the rest of the tube connector  42  (e.g. they are on a raised rectangular portion) to improve manufacturability. This may also be to increase the length of the vent holes  25  as longer vent holes are typically quieter than comparatively shorter vent holes. The tube connector  42  may follow the same general curvature of the front plate to reduce the visual bulk (i.e. more streamlined look) of the mask and aid in tube management. 
     Patient Interface Systems—Tube Connection—Elbow 
     Referring to  FIGS.  34 - 55   , a patient interface system  10  according to another example embodiment of the present technology may comprise an elbow  45  connected substantially perpendicular to the front plate  21 . The elbow  45  may be a swivel elbow or may be a ball joint elbow. The elbow  45  may be removably attachable or molded with the front plate  21 . 
     Patient Interface Systems—Vents 
     Referring to  FIG.  84   , a patient interface system  10  may comprise a front plate  21  having a vent  25  comprising a plurality of vent holes provided around a perimeter of the front plate  21 . The perimeter arrangement aids diffusivity of the exhaust gases and reduces the visibility of the vent  25 . 
     Referring to  FIG.  85   , a patient interface system  10  may comprise a front plate  21  having a vent  25  that comprises micro-perforated holes over the front surface of the front plate  21 . 
     Referring to  FIG.  113   , a tortuous vent path through front plate  21  may be provided for reducing noise. The tortuous path will slow down the exhaled gases  296  as it moves through the tortuous path, thereby having a lower sound power. The mouth seal may have an interface seal  293  and a flap or castellation  294  that obstructs the vent holes  25 , with the exhaled gases  296  moving through the vented pathway  295  of a raised portion  292  of the front plate  21  rather than directly out of the vent holes  25  to increase the length of the path for exhaled gases to get out of the mask. 
     Patient Interface Systems—Tube Cuff 
     Referring to  FIG.  86   , a patient interface system  10  may include a mouth cushion  23  having a tube cuff  255  attached to, for example, the side wall  233  of the cushion  23 . The tube cuff  255  may be moulded onto the side wall  233  and may have a hardness greater than that of the side wall  233 . 
     Referring to  FIG.  95   , a tube cuff  268  may be moulded onto the cushion  23  that is configured to be connected to a connector  12 , e.g. a swivel connector, that is configured to be connected to a tube  11 , for example a tube as disclosed in U.S. Patent Application Publication 2009/0078259 A1, the entire contents of which are incorporated herein by reference. It should be appreciated that the tube cuff  268  may be connected to the cushion by, for example, adhesive or mechanical connectors. 
     Referring to  FIG.  103   , a gap  286  between a tube connector  283  and a cuff  284  (having less width when compared to the tube connector for example) may be adapted to receive a headgear strap that extends in a substantially vertical direction. The cuff  284  may include a link or slot  285  to receive a headgear strap that extends in a substantially horizontal direction. The cuff  284  may be soft or relatively flexible. The cuff  284  may be glued on or otherwise attached to the tube connector  283 . The cuff  284  may be formed with the tube connector  283 . 
     Patient Interface Systems—Anti-Asphyxia Valves (AAV) 
     Referring to  FIG.  87   , a patient interface system  10  may comprise a front plate or lens  21  having a hole  256 . An anti-asphyxia valve in the form of a flap  257  formed in the mouth seal or cushion  23  is forced against the front plate  21  and covers the hole  256  when a flow of pressurized gas is delivered through a tube or hose or conduit  258 . In the absence of the flow, the flap  257  is released from contact with the front plate  21  and uncovers the hole  256 , allowing the patient to breathe ambient air through the hole  256  in the front plate  21 . 
     Referring to  FIGS.  88 - 95   , a patient interface system  10  may comprise a front plate  21  having a tube connector  42  configured for connection with a tube or hose or conduit  259 . The tube connector  42  comprises an aperture or window  264  that may be closed by an anti-asphyxia valve  260 . The anti-asphyxia valve  260  comprises a flap  261  that is configured to open and close the aperture  264 . The flap  261  may comprise a vent  25  for venting exhalation gases when the flap  261  closes the aperture  264 . The anti-asphyxia valve further includes a tab  262  that secures the anti-asphyxia valve  260  in the tube connector  42  through a slot  265  in the tube connector  42 . The flap  261  is pivotably connected to the tab  262  by a hinge  263 , e.g. a living hinge. As shown in  FIG.  94   , in the absence of a flow of gas in the tube connector  42 , the flap  261  extends across the tube connector, and the patient may breathe through the aperture  264 . When gas flow  266  is delivered to the tube connector  42 , the pressure of the gas flow  266  pivots the flap  261  in the direction shown by arrow  267  to close the aperture  264 . Exhalation gases may be vented through the vent  25 . Referring to  FIG.  92   , the flap  261  may include elongated vent holes  25  to reduce venting noise and increase diffusivity of the vent flow. 
     Referring to  FIGS.  106  and  107   , the cushion may have a flap or thin portion  290  around its perimeter that interfaces or otherwise abuts the front plate  21 . The flap  290  may be pressure activated i.e. when air is delivered under pressure into the mask, the flap  290  may be forced to abut the front plate  21  causing an air tight seal. If air is no longer delivered to the mask, the flap  290  may relax and permit air from atmosphere into the mask via a gap  291  created between the flap  290  and the front plate  21 . 
     Patient Interface Systems—Materials 
     Referring to  FIG.  102   , a patient interface system  10  may comprise a polyester front plate or window  279  having a TPE “macro” seal  280  and a low durometer nasal seal  281  comprising pillows, or a seal as disclosed in WO 2010/139014 A1, the entire contents of which are incorporated herein by reference. A foam “micro” seal  275  may be attached to the seal  280 . A TPE or TPU headgear  276  may be provided to position the patient interface system on the patient&#39;s head. Elastic webbing or ultrasonic die cut spacer fabric  277  may be provided. A tube connect  278  may be connected to a textile sock  282 . 
     Patient Interface Systems—Headgear Strap and Tube Attachment 
     Referring to  FIGS.  109 - 112   , a headgear strap, e.g. a lower headgear strap that is positioned under the patient&#39;s ears and loops through a slot in the crown strap, may be connected to an air delivery tube  298 . The air delivery tube  298  may connect to an end of the headgear strap  297 , with gases being delivered through the headgear clip  299 . The clips  299 ,  300  may interface with the front plate. As shown in  FIGS.  111  and  112   , the headgear strap  301  may be configured to deliver gases through an air delivery tube  302  and the clips  303 ,  304  may be formed in such a way that the strap  301  can be oriented either left ( FIG.  111   ) to right or right to left ( FIG.  112   ). 
     Patient Interface Structure—Patient Interface Positioning System Connection 
     Referring to  FIG.  114   , the front plate  21  may include a plurality of attachment locations  305  for the patient interface positioning system, e.g. headgear, and/or a rotatable attachment location  306  that provides adjustment of the angle between the patient interface structure, e.g. mask, and the patient interface positioning system, e.g. headgear. The attachment locations may be in the form of rings  307 . 
     Patient Interface Structure—Fascia 
     The fascia, frame or lens portion may comprise a fixed elbow connection, the elbow connection directed horizontally. Such an arrangement can be seen in, for example,  FIG.  99   . The fascia be structured and arranged to be flipped or rotated, such that the direction of the elbow may be changed from pointing to the left, for example, to pointing to the right. This means that the fascia may be symmetrical. 
     While the technology 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.