Abstract:
A mask assembly adapted for use with a positive airway pressure device includes a mask frame, a cushion provided to the frame, a forehead support assembly, and a neck to connect the frame to the forehead support assembly. The neck includes at least one wall including a first edge and a second edge, wherein lower ends of the first edge and the second edge converge towards one another in an upward direction and upper ends of the first edge and second edge diverge from one another in an upward direction. The mask assembly is configured so that a relatively narrow portion of the neck overlies the bridge of the nose or is between the eyes of a user. The relatively narrow portion is a portion of the neck where a distance between the first edge and second edge is smallest.

Description:
CROSS REFERENCE TO APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 60/729,746, filed Oct. 25, 2005, which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a nasal assembly used for treatment, e.g., of Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NPPV). 
       BACKGROUND OF THE INVENTION 
       [0003]    Interfaces, such as a nasal mask assembly, for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB) typically include a soft-face contacting portion, such as a cushion, and a rigid 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 H 2 O) to be delivered to the user&#39;s or patient&#39;s or user&#39;s airways. 
         [0004]    One factor in the efficacy of therapy and compliance of patients with therapy is the comfort and fit of the patient interface. It has been necessary to design a wide variety of masks to best treat and/or suit the user&#39;s needs. While there are a large number of patient interfaces, typically each cushion has been specially designed to be used with only a single frame, headgear, etc. 
         [0005]    Puritan Bennett includes a mask commercially sold under the name of Breeze® that allows a cushion sold under the name of DreamSeal® to be retrofit to it. Further details of such mask are disclosed at the website http://www.puritanbennett.com/prod/Product.aspx?S1=SPT&amp;S2=&amp;id=233. 
       BRIEF SUMMARY OF THE INVENTION 
       [0006]    One aspect of the present invention is to provide a mask assembly including at least one main component that can be used with a variety of different styles or types of mask assemblies. 
         [0007]    In one embodiment of the invention, there is provided a system of breathing arrangements for delivering breathable gas to a patient, comprising at least first and second cushion components that are different from one another in at least one aspect, and a common frame assembly configured to support each of the first and second cushion components. 
         [0008]    In another embodiment of the invention, there is provided a mask assembly for a user comprising a frame having a main body and lateral connector portions; and a cushion component provided to the frame and defining a breathing cavity configured to accommodate at least a portion of the user&#39;s nose in use, said cushion component including a face contacting seal portion adapted to sealingly engage with at least a portion of the user&#39;s nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user&#39;s airways in use, and a main wall portion, opposite from the aperture, extending upwardly away from the frame, said main wall portion including a stiffening portion. 
         [0009]    In another embodiment of the invention, there is provided a mask assembly for a user comprising a frame having a main body and lateral connector portions; and a cushion component provided to the frame and defining a breathing cavity configured to accommodate at least a portion of the user&#39;s nose in use, said cushion component including a face contacting seal portion adapted to sealingly engage with at least a portion of the user&#39;s nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user&#39;s airways in use, and a main wall portion, opposite from the aperture, extending upwardly away from the frame, said frame being configured for positioning beneath the nose and between the user&#39;s upper lip and nose in use. 
         [0010]    In another embodiment of the invention, a mask assembly for a user comprising a frame having a main body and lateral connector portions; a cushion component provided to the frame and defining a breathing cavity configured to accommodate at least a portion of the user&#39;s nose in use, said cushion component including a face contacting seal portion adapted to sealingly engage with at least a portion of the user&#39;s nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user&#39;s airways in use, and a main wall portion, opposite from the aperture, extending upwardly away from the frame, said cushion having an upper portion and a lower portion, wherein at least the upper portion includes a nose height adjusting member. 
         [0011]    In another embodiment of the invention, there is provided a mask assembly for a user comprising a frame; a cushion component provided to the frame and defining a breathing cavity configured to accommodate at least a portion of the user&#39;s nose in use, said cushion component including a face contacting seal portion adapted to sealingly engage with at least a portion of the user&#39;s nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user&#39;s airways in use, and a main wall portion, opposite from the aperture, extending upwardly away from the frame; and a frame adjustment member to adjust the position of the cushion component relative to the frame. 
         [0012]    In another embodiment of the invention, there is provided a mask assembly for a user comprising a frame; a cushion component provided to the frame and defining a breathing cavity configured to accommodate at least a portion of the user&#39;s nose in use, said cushion component including a face contacting seal portion adapted to sealingly engage with at least a portion of the user&#39;s nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user&#39;s airways in use and a main wall portion, opposite from the aperture, extending upwardly away from the frame; and a chin strap assembly including an extension member provided to each side of the frame and a chin strap having a main chin support portion and straps coupled to the extension members. 
         [0013]    In another embodiment of the invention, there is provided a mask assembly for a user comprising a common frame; a cushion component provided to the frame and including a pair of nasal prongs or nozzles adapted to engage the user&#39;s nares in use; and a supplemental cushion component in the form of a nasal cushion or a full-face cushion, wherein the cushion component and the supplemental cushion component cooperatively seal with the user&#39;s face in use. 
         [0014]    These and other aspects of the invention will be described in or apparent from the following detailed description of embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    Preferred embodiments of the invention will be described in relation to the following figures, in which: 
           [0016]      FIG. 1  is a schematic view of a mask assembly according to an embodiment of the present invention; 
           [0017]      FIGS. 2-13  are views of a mask assembly according to another embodiment of the present invention; 
           [0018]      FIG. 14  is a perspective view of a mask assembly according to another embodiment of the present invention; 
           [0019]      FIGS. 15-16  are views of a mask assembly according to yet another embodiment of the present invention; 
           [0020]      FIGS. 17-19  are views of a portion of a mask assembly according to still another embodiment of the present invention; 
           [0021]      FIG. 20  is a perspective view of a mask assembly according to another embodiment of the present invention; 
           [0022]      FIG. 21  is a perspective view of a mask assembly according to another embodiment of the present invention; 
           [0023]      FIG. 22  is a perspective view of a mask assembly according to another embodiment of the present invention; 
           [0024]      FIG. 23  is a perspective view of a mask assembly according to another embodiment of the present invention; 
           [0025]      FIG. 24  is a perspective view of a mask assembly according to another embodiment of the present invention; 
           [0026]      FIGS. 25-26  are views of a mask assembly according to another embodiment of the present invention; and 
           [0027]      FIGS. 27-31  are views of a mask assembly according to still another embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0028]    The following description is provided in relation to several embodiments which may share common characteristics and/or features. It is understood that one or more features of any one- embodiment may be combinable with one or more features of the other embodiments which combinations form additional embodiments. 
         [0029]    1.0 First Embodiment—Common Frame with Activa™ or UltraMirage™ Cushion Component 
         [0030]      FIG. 1  illustrates an interchangeable mask system  5  according to an embodiment of the present invention. Mask system includes a common frame component  10 , one of two cushion components  15 ,  20 , one of two elbow components  25 ,  30 , and headgear  35 . The mask system is intended for use in positive pressure therapy for users with obstructive sleep apnea (OSA) or another respiratory disorder. 
         [0031]    The common frame  10  has a main body  40  defining a central opening  45 . Main body  40  includes at least two lateral arms  50 , each of which can be coupled to a headgear strap  55  of headgear. The straps may be connected to the frame using a press-fit connector  60 , as is known in the art. Common frame  10  may also include a forehead support  65  that has a bridge  70  provided with forehead pads  75  to rest against the user&#39;s forehead in use. Forehead support may be adjustably mounted to the common frame, in a manner known in the art. 
         [0032]    Common frame  10  is configured to be selectively coupled to one of cushion components  15 ,  20  and to one of elbow components  25 ,  30 . Cushion components  15 ,  20  differ in at least one respect such that one may be more optimal or preferable for use with one user, while another may be more suitable or preferably for use with another user. For example, cushion component  15  may be an Activa™ component, while cushion component  20  may be an UltraMirage™ Series II cushion component, both available from ResMed. These cushion components can be significantly different from one another, e.g., the Activa™ includes a gusset portion  80  and a cushion clip assembly (not shown) which is not incorporated in the UltraMirage™ cushion design. 
         [0033]    Common frame  10  is also configured for use with either elbow component  25 , or elbow component  30 . Elbow components differ in at least one respect, e.g., each may include gas washout vents that are configured for predetermined washout rates, noise, etc. 
         [0034]    Common frame  10  is advantageous since it works with a plurality of different cushion components, elbow components, forehead supports, etc., thereby eliminating the need to specifically make the frame for a particular peripheral component, as is the standard. 
         [0035]    2.0 Second Embodiment—Common SWIFT™ Frame with VISTA™ Cushion Component—Below the Nose 
         [0036]      FIGS. 2-13  show a mask system  90  according to another embodiment of the present invention. As shown in  FIG. 2 , mask system  90  includes a common frame  95 , a cushion component  100  and a common headgear assembly  105 . 
         [0037]    Common frame is similar to ResMed&#39;s SWIFT™ frame, described in more detail in relation to U.S. patent application Ser. No. 10/781,929, filed Feb. 20, 2004, incorporated herein by reference in its entirety. As shown in  FIG. 3 , common frame includes a main body  110  including two lateral connectors  115 . Each lateral connector  115  is provided with a seal portion  120  ( FIG. 4 ). Each seal portion  120  has a channel  125  structured to receive and support a ring shaped portion  130  of a yoke  135  of the headgear assembly  105 . Each seal portion  120  also includes an aperture  140  to receive either an elbow  145  or a plug  150 . In an alternative, each seal portion  120  may receive an elbow  145 , i.e., receive two sources of gas (without the plug). 
         [0038]      FIG. 3  is an exploded view of cushion component  100 , frame  95  and a clip element  175 , together defining a cushion sub-assembly  155 .  FIG. 4  shows the cushion sub-assembly  155  in the assembled condition, along with yoke  135 , seal portion  120  and elbow  145 .  FIG. 5  is a cross sectional view of the assembly.  FIGS. 6-10  are additional views of the cushion assembly as assembled with lateral headgear straps and associated yokes. 
         [0039]    Cushion component  100  includes lateral sides  160  configured to engage with corresponding channels  165  formed in the frame  95 . Cushion component  100  includes an aperture  196  (schematically illustrated) to receive the user&#39;s nose. End portions  170  of cushion component  100  are wrapped around frame  95 , and clip element  175  is attached to the sub-assembly of the cushion component and the frame, by sliding the clip element over the combined cushion component and frame.  FIGS. 4 and 13  are a cross-sectional view showing the sandwich-like connection between the lateral sides of the cushion  170 , the frame  95  and the clip element  175 . 
         [0040]      FIG. 11  is a top view of the mask assembly in use on a user&#39;s head, while  FIG. 12  is a front view. As seen, common frame  95  is positioned just below and partially under the user&#39;s nose, and above the upper lip of the user. This positioning of the frame to cushion interface closer to the centroid of the mask assembly, which helps keep a low profile (non-obstructive) and reduces moments imposed on the mask assembly tending to pull the mask assembly away from the user&#39;s face. 
         [0041]    In the embodiment described above, the cushion component  100  is bisected (see  FIGS. 4 and 13 ) along the longitudinal axis of the frame to create later sides that wrap around the frame for insertion of the channel. In another embodiment, the cushion is not necessarily bisected. Instead, the apertures in the lateral sides of the cushion are simply stretched over the connectors of the frame until a protruding portion of the cushion engages the respective channels of the frame. 
         [0042]    Further, cushion component  100  has an upper portion  200  that is configured to contact the transition between the bony and cartilage portions of the user&#39;s nose. Generally, with regard to its footprint, the cushion component is similar to ResMed&#39;s VISTA™ cushion, as described in U.S. patent application Ser. No. 11/124,251, filed May 9, 2005, incorporated herein by reference. 
         [0043]    Cushion component  100  has a thickened portion  205  that acts as a pseudo or “soft” frame to provide support for the rest of the membrane of the cushion. Effectively, the thickened portion  205  of the cushion enlarges the “frame” area of the common Swift™ frame. In this example, the thickened portion  205  has the shape of a semi-circle or trapezoid. See, e.g.,  FIGS. 2 and 12 . 
         [0044]    Common headgear assembly  105  is similar to the headgear assembly described in relation to ResMed&#39;s U.S. patent application Ser. No. 10/781,929. However, common headgear  105  has some differences. For example, as shown in  FIG. 13 , the vectors of the headgear straps  210  are changed. 
         [0045]    In  FIGS. 6-13 , the elbow  145  is omitted for clarity, although the plug  150  is illustrated. As shown in  FIGS. 3 ,  7 - 8 , and  11 , the mask assembly includes a gas washout vent  215 . The vent  215  could be on the frame and/or the cushion component. As shown in  FIG. 8 , the yoke  130  includes an alignment indicator  220  that aligns with one of a corresponding array of indicators  225  on the cushion/frame subassembly. The cushion/frame subassembly is rotatable relative to the headgear to ensure proper fit. 
         [0046]    3.0 Third Embodiment—Common Swift™ Frame with Mirage™ Cushion Component 
         [0047]      FIG. 14  illustrates a mask assembly  230  include a common frame  235 , a headgear assembly  240  and a cushion component  245 . This embodiment is similar to the prior embodiment, especially as the common frame is the same as described above in relation to  FIGS. 2-13 . The main difference is that the cushion component  245  takes the form of a nasal mask, e.g., ResMed&#39;s Mirage™ type cushion, as described in U.S. Pat. No. 6,112,746, incorporated herein by reference in its entirety. In this embodiment, the cushion component  245  is configured to form a breathing cavity that surrounds the nose of the user. The cushion component includes an upper apex portion  250  that makes contact with the bridge of the user&#39;s nose, between the eyes. 
         [0048]    The cushion component  250  may include a thickened section  255  in order to help prevent flopping of the cushion away from the user&#39;s face. The thickened section  255  may include a cutout  260  in each corner to reduce force on the nasal bridge region. 
         [0049]    4.0 Fourth Embodiment—Common Swift™ Frame with Vista™ Cushion Component—Over the nose 
         [0050]      FIGS. 15-16  show a mask assembly  275  according to another embodiment of the present invention. Mask assembly  275  includes a common frame  280 , a headgear assembly  285 , and a cushion component  290  like that described in relation to  FIGS. 2-13  above. One difference in the present embodiment is the positioning of the common frame  280  relative to the user&#39;s face/nose. Specifically, the common frame  280  is positioned above the lower portion of the user&#39;s nose, such that the tip of the nose extends below the clip element  295 . Further, as shown in  FIG. 16 , the vectors formed by the headgear straps  300  are slightly different than as shown in described in relation to  FIG. 13 . As a result of the positioning of the frame/cushion interface to more centrally locate the frame relative to the cushion, and/or because the vectors from the headgear straps act closer to the centroid of the mask on the face, this design may not necessarily include a thickened portion of the cushion. 
         [0051]    5.0 Fifth Embodiment—Vista/Swift Prongs Combination 
         [0052]      FIGS. 17-19  show a portion of another mask assembly  305  according to an embodiment of the present invention.  FIG. 17  shows a common Swift™ frame and cushion assembly  310  in isolation, including prong elements  315  for engagement with the user&#39;s nares.  FIG. 18  shows a supplemental Vista™ style cushion  320  adapted for use with the Swift™ cushion/frame assembly  310 . The mask assembly is supported on the user&#39;s head using a headgear assembly as described above. 
         [0053]    The supplemental cushion  320  includes at least one hole  325  provided on its lateral side for insertion over the frame/cushion assembly  310 . Supplemental cushion  320  also includes a centrally located hole  330  that aligns with the gas washout vents  335  of the frame/cushion assembly  310 .  FIG. 19  shows the frame/cushion assembly  310  and the supplemental cushion  320  in assembled form. To assemble the supplemental cushion over the frame, each hole  325  of the supplemental cushion  320  is stretched over the connector of the frame, and the resiliency of the material of the supplemental cushion allows it to engage with the channels of the frame and/or to simply seal with an exposed surface of the frame cushion assembly. In this position, the prongs  315  seal with the nares, while the supplemental cushion includes a face contacting portion that seals with the user&#39; face. 
         [0054]    6.0 Additional Embodiments 
         [0055]    As can be determined from the description above in relation to the embodiments of  FIGS. 2-13  and the embodiment of  FIGS. 15-16 , one aspect of the invention is directed to the combination of a Swift™ frame with a Vista component. As can be appreciated, the combination of these dissimilar mask systems required a number of adjustments, as can be derived from the above description and the drawings. 
         [0056]    6.1 Locked Elbow 
         [0057]    Furthermore, there are additional factors that may be considered when combining the various mask systems. For example, the force due to air pressure against the cushion may cause moments about the elbow. If these moments are not counteracted, the result may be the cushion rotating and losing seal. The elbow should be stiff enough to prevent rotation under pressure. A locking or ratcheting mechanism may be implemented to lock the rotation on the elbow when the desired angle is found. Locking may be achieved using an interference fit, and/or locking components, such as detents or a pin/groove arrangement. Generally, an approximation of the desired effect can be achieved by simply fixing the elbow in place relative to the frame. Otherwise, simply inhibiting rotation, e.g., by strapping the elbow to the adjacent headgear, can be effective as well. 
         [0058]    6.2 Stiffening Member For Cushion Component 
         [0059]    When the cushion is under pressure, moments about the cushion to frame interface are created. The force vector points which cause the moments may be shifted by introducing a non-flexible or stiffening member to the cushion. That is to say, in addition to having a moment about the elbow, there is also a moment about the interface of the stiff section of the cushion and the flexible part of the cushion. 
         [0060]    6.2.1 Stiffening Ribs 
         [0061]    The mask assembly  340  in  FIG. 20  includes a cushion component  345  that is similar in general shape to the Vista™ cushion in terms of its intended sealing footprint relative to the user&#39;s face, but it includes a plurality of ribs  350  that extend from the clip element  355  to the top of the cushion, to stop or help prevent the cushion from flexing about the elbow (or flopping off the face). The stiffening member (ribs in this example) will move this vector away from the elbow, and prevent the cushion from flopping off the face. The stiffening member should extend as close to the skin as possible without compromising comfort. The common frame is similar to that described above and may be, e.g., a Swift™ frame. 
         [0062]    The mask assembly  360  in  FIG. 21  includes a rib  365  along the perimeter of the cushion to help support and/or push the cushion onto the user&#39;s face. The rib  365  may be comolded with the cushion. The cushion forms a breathing cavity which receives the nose of the user, and the upper apex of the cushion extends across the bridge of the user, between the eyes. In this example, the cushion can be ResMed&#39;s Mirage™ cushion, adapted for assembly to common frame. Common frame is similar to that described above and maybe, e.g., a Swift™ frame. However, the clip element  370  of the cushion assembly is slightly rotated such that it is positioned to face downwardly. 
         [0063]    6.2.2 Thickened Cushion Portion 
         [0064]    The stiffening member may take the form of one or more thickened elements, e.g., by thickening the cushion which will result in it being stiffer in sections. See, e.g., the relatively thickened portion of cushion component in  FIG. 13 . Ribs could be made in the cushions, extending from the frame to the highest point of the cushion. A pseudo frame could be implemented where a large portion of the cushion is thick silicone, only the areas in contact, or requiring flex (as in a “bubble” cushion or single walled membrane) will be thin. 
         [0065]    6.3 Nose Tip Cushion Component 
         [0066]      FIG. 22  shows a mask assembly  380  according to another embodiment of the invention having a headgear assembly  385  and a common Swift™ frame  390  as described above, as well as cushion component  395  in the form of a nose tip cushion. The cushion includes a membrane that extends up the side of the nose. The membrane could extend just over the tip of the nose. The cushion could incorporate a bubble style seal over the tip of the nose. The mask assembly includes one or more vent openings  400  provided in the frame/cushion component. 
         [0067]    6.4 Full-Face Cushion 
         [0068]      FIG. 23  shows a mask assembly  405  according to yet another embodiment of the present invention having a headgear assembly  410  and common Swift™ frame  415  as described above, as well as a cushion component  420  in the form of a full-face cushion, such as that available from ResMed under the name UltraMirage™ full-face cushion and described in U.S. Pat. No. 6,513,526, incorporated herein by reference in its entirety. The cushion component  420  would be adapted for use with a Swift™ type frame, as described above. 
         [0069]    The cushion  420  may include a rib  425  that extends from the bottom to the top of the cushion. Furthermore, the frame  415  is positioned on the upper ½ to upper ⅓ of the cushion to support the cushion. The frame to cushion interface is positioned below the nose, although it may be above the nose. The cushion may include one or more gas washout vents  430 . 
         [0070]    7.0 Adjustable Positioning of the Cushion 
         [0071]    7.1 Adjustable Nose Height 
         [0072]      FIG. 24  shows a mask assembly  440  according to yet another embodiment of the present invention including a common Swift™ frame  445 , a headgear assembly  450 , and a Vista™-like cushion  455  supported by the frame. 
         [0073]    The upper part  460  of the cushion may include a thin membrane (the lower cushion may be like a double wall Vista™ cushion). This has the advantage of reduced weight and subjectively feels light to wear. It may also allow deflection around contours of nose as it will be more flexible than a conventional thick cushion. This will help with fit and the range of patients suited to each size. 
         [0074]    In an alternative, the upper part  460  of the cushion shown in  FIG. 24  includes a bellows type arrangement around the cushion which may be inflated to help pressure and fit, like the ResMed Activa™ mask, described in U.S. Pat. No. 4,772,760 and U.S. application Ser. No. 10/655,622, filed Sep. 5, 2003, each incorporated herein by reference in its entirety. In the alternative, the cushion may include a stiff drinking straw-like structure, e.g., plastic corrugations that maintain shape in a variety of positions. The straw-like structure would click or fold into different positions to allow more or less nose height. 
         [0075]    The lower part of the cushion  465  may include a gusset portion, a double gusset, or a solid silicon structure. 
         [0076]    7.2 Adjustable Cushion Height 
         [0077]    As described above, the position of the centroid of the cushion to frame interface (frame clip location) may be changed, depending on application. The closer the headgear vectors act to the centroid of the cushion the more stable the cushion will be on the face of the patient; this can reduce the rigidity required within the cushion to maintain support of the membrane. The frame location in  FIGS. 2-13  is closer to the centroid as compared to the location of the centroid in  FIGS. 15-16 . In these embodiments, the positions of the cushions relative to the face remain generally constant. 
         [0078]    However, it is also possible to change the position of the cushion relative to the face and frame, while maintaining the frame in a constant position. The mask assembly  500  in  FIGS. 25 -26  includes a common Swift™ frame  505  supported by Swift™-like headgear  510 , in addition to a Vista™ like cushion  515  supported by the frame  505 . 
         [0079]    In  FIGS. 25-26 , the axis of location of the frame  505  is across the middle of the nose, although it could be higher or lower. As schematically shown, the axis of location of the frame onto the cushion may vary according to user preference (which will be influenced by head shape/headgear angles). In  FIGS. 25-26 , it can be seen that the headgear-frame angle remains constant and the frame is located at higher or lower cushion positions, position  2  in  FIG. 25  and position  3  in  FIG. 26 . Adjustment can be effected using mechanical expedients such as a sliding arrangement. Holes in the sides of the cushion may allow stretching in to accommodate positioning of the cushion in the various positions. 
         [0080]    Alternatively, the headgear and frame angle may rotate around the same cushion position. As a further alternative the headgear location point could be on a lobe or cam to move it relative to the cushion. A further embodiment is the use of weight to change the center of gravity of the cushion or frame/headgear system. 
         [0081]    8.0 Chin Strap 
         [0082]      FIGS. 27-31  illustrate a mask assembly  600  according to a further embodiment of the present invention. Mask assembly includes a frame  605  (e.g. polycarbonate shell), a headgear assembly  610 , a cushion component  615 , and a chin strap assembly  620  supported by the frame. 
         [0083]    Chin strap assembly  620  includes an extender  625  and chin strap  630 . Extender  625  is shown in  FIG. 30  and is preferably made of a rigid material, e.g., polycarbonate or a rigid plastic backed with headgear foam material. Extender  625  includes an aperture  635  by which a bevel clip  640  ( FIG. 29 ) may be used to selectively attach the extender  625  to the frame, e.g., using interference snap fit. Extender  625  includes a hole  640  for receiving a strap  645  of the chin strap. Each strap includes hook and loop fastening elements, e.g., Velcro®. 
         [0084]    Chin strap  630  includes a cushion sealing area  650 , and is made from a foamed headgear material. The chin strap is preferably elastic. Chin strap is bonded to the frame at a bond point or region  655 , e.g., as shown in  FIGS. 27 ,  28  and  31 . Bonding may be achieved, e.g., via adhesive, plasma or lamination methods. 
         [0085]    Another variant is to simply use only the extender and chin strap shown in  FIGS. 30 and 31 , respectively, along with another mask of choice, e.g., ResMed&#39;s Nightingale mask, more fully described in PCT Patent application no. PCT/AU04/01832, filed Dec. 24, 2004, incorporated by reference in its entirety. A further embodiment is the use of the Nightingale headgear with the chin strap assembly and the frame cushion. 
         [0086]    A further embodiment is the combination the full-face seal as shown in  FIG. 27 , along with nasal prongs as shown in  FIG. 19 . 
         [0087]    While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Also, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to realize yet other embodiments. 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, barriatric 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.