US20090126739A1 - Interchangeable Mask Assembly - Google Patents

Abstract

A system of breathing arrangements for delivering breathable gas to a patient includes at least first and second cushion components, e.g., full-face, nasal, nasal prongs, nose tip, and/or a combination of any of the above, including a nasal or full-face cushion and nasal prongs/nozzles combination, etc., 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. Various embodiments are directed to a full-face or nasal mask used with a frame having lateral connector portions having a stiffening member. The mask assembly may include a nose height adjustment device for the height of the cushion, or a cushion adjustment member by which the position of the cushion may be adjusted relative to the frame. The mask assembly may include a chin strap assembly.

Description

CROSS REFERENCE TO APPLICATIONS
• 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
• 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
• 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 H₂O) to be delivered to the user's or patient's or user's airways.
• 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'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.
• 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&S2=&id=233.
BRIEF SUMMARY OF THE INVENTION
• 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.
• 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.
• 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'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's nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user'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.
• 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'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's nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user'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's upper lip and nose in use.
• 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'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's nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user'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.
• 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'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's nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user'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.
• 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'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's nose in use, said cushion component having an aperture to communicate pressurized gas from the breathing chamber to the user'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.
• 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'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's face in use.
• 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
• Preferred embodiments of the invention will be described in relation to the following figures, in which:
• FIG. 1. is a schematic view of a mask assembly according to an embodiment of the present invention;
• FIGS. 2-13 are views of a mask assembly according to another embodiment of the present invention;
• FIG. 14 is a perspective view of a mask assembly according to another embodiment of the present invention;
• FIGS. 15-16 are views of a mask assembly according to yet another embodiment of the present invention;
• FIGS. 17-19 are views of a portion of a mask assembly according to still another embodiment of the present invention;
• FIG. 20 is a perspective view of a mask assembly according to another embodiment of the present invention;
• FIG. 21 is a perspective view of a mask assembly according to another embodiment of the present invention;
• FIG. 22 is a perspective view of a mask assembly according to another embodiment of the present invention;
• FIG. 23 is a perspective view of a mask assembly according to another embodiment of the present invention;
• FIG. 24 is a perspective view of a mask assembly according to another embodiment of the present invention;
• FIGS. 25-26 are views of a mask assembly according to another embodiment of the present invention; and
• FIGS. 27-31 are views of a mask assembly according to still another embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS
• 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.
1.0 First EmbodimentCommon Frame with Activa™ or UltraMirage™ Cushion Component
• FIG. 1 illustrates aninterchangeable mask system5 according to an embodiment of the present invention. Mask system includes acommon frame component10, one of twocushion components15,20, one of twoelbow components25,30, andheadgear35. The mask system is intended for use in positive pressure therapy for users with obstructive sleep apnea (OSA) or another respiratory disorder.
• Thecommon frame10 has amain body40 defining acentral opening45.Main body40 includes at least twolateral arms50, each of which can be coupled to aheadgear strap55 of headgear. The straps may be connected to the frame using a press-fit connector60, as is known in the art.Common frame10 may also include aforehead support65 that has abridge70 provided withforehead pads75 to rest against the user's forehead in use. Forehead support may be adjustably mounted to the common frame, in a manner known in the art.
• Common frame10 is configured to be selectively coupled to one ofcushion components15,20 and to one ofelbow components25,30.Cushion components15,20 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 component15 may be an Activa™ component, whilecushion component20 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 agusset portion80 and a cushion clip assembly (not shown) which is not incorporated in the UltraMirag™ cushion design.
• Common frame10 is also configured for use with eitherelbow component25, orelbow component30. 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.
• Common frame10 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.
2.0 Second EmbodimentCommon SWIFT™ Frame with VISTA™ Cushion Component—Below the Nose
• FIGS. 2-13 show amask system90 according to another embodiment of the present invention. As shown inFIG. 2,mask system90 includes acommon frame95, acushion component100 and acommon headgear assembly105.
• Common frame is similar to ResMed'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 inFIG. 3, common frame includes a main body110 including twolateral connectors115. Eachlateral connector115 is provided with a seal portion120 (FIG. 4). Eachseal portion120 has achannel125 structured to receive and support a ring shapedportion130 of ayoke135 of theheadgear assembly105. Eachseal portion120 also includes anaperture140 to receive either anelbow145 or aplug150. In an alternative, eachseal portion120 may receive anelbow145, i.e., receive two sources of gas (without the plug).
• FIG. 3 is an exploded view ofcushion component100,frame95 and aclip element175, together defining acushion sub-assembly155.FIG. 4 shows thecushion sub-assembly155 in the assembled condition, along withyoke135,seal portion120 andelbow145.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.
• Cushion component100 includeslateral sides160 configured to engage withcorresponding channels165 formed in theframe95.Cushion component100 includes an aperture196 (schematically illustrated) to receive the user's nose.End portions170 ofcushion component100 are wrapped aroundframe95, andclip element175 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 thecushion170, theframe95 and theclip element175.
• FIG. 11 is a top view of the mask assembly in use on a user's head, whileFIG. 12 is a front view. As seen,common frame95 is positioned just below and partially under the user'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's face.
• In the embodiment described above, thecushion component100 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.
• Further,cushion component100 has anupper portion200 that is configured to contact the transition between the bony and cartilage portions of the user's nose. Generally, with regard to its footprint, the cushion component is similar to ResMed's VISTA™ cushion, as described in U.S. patent application Ser. No. 11/124,251, filed May 9, 2005, incorporated herein by reference.
• Cushion component100 has a thickenedportion205 that acts as a pseudo or “soft” frame to provide support for the rest of the membrane of the cushion. Effectively, the thickenedportion205 of the cushion enlarges the “frame” area of the common Swift™ frame. In this example, the thickenedportion205 has the shape of a semi-circle or trapezoid. See, e.g.,FIGS. 2 and 12.
• Common headgear assembly105 is similar to the headgear assembly described in relation to ResMed's U.S. patent application Ser. No. 10/781,929. However,common headgear105 has some differences. For example, as shown inFIG. 13, the vectors of the headgear straps210 are changed.
• InFIGS. 6-13, theelbow145 is omitted for clarity, although theplug150 is illustrated. As shown inFIGS. 3,7-8, and11, the mask assembly includes agas washout vent215. Thevent215 could be on the frame and/or the cushion component. As shown inFIG. 8, theyoke130 includes analignment indicator220 that aligns with one of a corresponding array ofindicators225 on the cushion/frame subassembly. The cushion/frame subassembly is rotatable relative to the headgear to ensure proper fit.
3.0 Third EmbodimentCommon Swift™ Frame with Mirage™ Cushion Component
• FIG. 14 illustrates amask assembly230 include acommon frame235, aheadgear assembly240 and acushion component245. This embodiment is similar to the prior embodiment, especially as the common frame is the same as described above in relation toFIGS. 2-13. The main difference is that thecushion component245 takes the form of a nasal mask, e.g., ResMed's Mirage™ type cushion, as described in U.S. Pat. No. 6,112,746, incorporated herein by reference in its entirety. In this embodiment, thecushion component245 is configured to form a breathing cavity that surrounds the nose of the user. The cushion component includes anupper apex portion250 that makes contact with the bridge of the user's nose, between the eyes.
• Thecushion component250 may include a thickenedsection255 in order to help prevent flopping of the cushion away from the user's face. The thickenedsection255 may include acutout260 in each corner to reduce force on the nasal bridge region.
4.0 Fourth EmbodimentCommon Swift™ Frame with Vista™ Cushion Component—Over the nose
• FIGS. 15-16 show amask assembly275 according to another embodiment of the present invention.Mask assembly275 includes acommon frame280, aheadgear assembly285, and acushion component290 like that described in relation toFIGS. 2-13 above. One difference in the present embodiment is the positioning of thecommon frame280 relative to the user's face/nose. Specifically, thecommon frame280 is positioned above the lower portion of the user's nose, such that the tip of the nose extends below theclip element295. Further, as shown inFIG. 16, the vectors formed by the headgear straps300 are slightly different than as shown in described in relation toFIG. 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.
5.0 Fifth EmbodimentVista/Swift Prongs Combination
• FIGS. 17-19 show a portion of anothermask assembly305 according to an embodiment of the present invention.FIG. 17 shows a common Swift frame and cushion assembly310 in isolation, includingprong elements315 for engagement with the user's nares.FIG. 18 shows a supplemental Vista™ style cushion320 adapted for use with the Swift™ cushion/frame assembly310. The mask assembly is supported on the user's head using a headgear assembly as described above.
• Thesupplemental cushion320 includes at least onehole325 provided on its lateral side for insertion over the frame/cushion assembly310.Supplemental cushion320 also includes a centrally locatedhole330 that aligns with the gas washout vents335 of the frame/cushion assembly310.FIG. 19 shows the frame/cushion assembly310 and thesupplemental cushion320 in assembled form. To assemble the supplemental cushion over the frame, eachhole325 of thesupplemental cushion320 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, theprongs315 seal with the nares, while the supplemental cushion includes a face contacting portion that seals with the user' face.
6.0 Additional Embodiments
• As can be determined from the description above in relation to the embodiments ofFIGS. 2-13 and the embodiment ofFIGS. 15-16, one aspect of the invention is directed to the combination of a Swift™ frame with a Vista™ cushion 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.
6.1 Locked Elbow
• 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.
6.2 Stiffening Member for Cushion Component
• 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.
6.2.1 Stiffening Ribs
• Themask assembly340 inFIG. 20 includes acushion component345 that is similar in general shape to the Vista cushion in terms of its intended sealing footprint relative to the user's face, but it includes a plurality ofribs350 that extend from theclip element355 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.
• Themask assembly360 inFIG. 21 includes arib365 along the perimeter of the cushion to help support and/or push the cushion onto the user's face. Therib365 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's Mirage™ cushion, adapted for assembly to common frame. Common frame is similar to that described above and may be, e.g., a Swift™ frame. However, theclip element370 of the cushion assembly is slightly rotated such that it is positioned to face downwardly.
6.2.2 Thickened Cushion Portion
• 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 inFIG. 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.
6.3 Nose Tip Cushion Component
• FIG. 22 shows amask assembly380 according to another embodiment of the invention having aheadgear assembly385 and acommon Swift frame390 as described above, as well ascushion component395 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 ormore vent openings400 provided in the frame/cushion component.
6.4 Full-Face Cushion
• FIG. 23 shows amask assembly405 according to yet another embodiment of the present invention having aheadgear assembly410 andcommon Swift frame415 as described above, as well as acushion component420 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. Thecushion component420 would be adapted for use with a Swift™ type frame, as described above.
• Thecushion420 may include arib425 that extends from the bottom to the top of the cushion. Furthermore, theframe415 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 vents430.
7.0 Adjustable Positioning of the Cushion7.1 Adjustable Nose Height
• FIG. 24 shows amask assembly440 according to yet another embodiment of the present invention including a commonSwift™ frame445, aheadgear assembly450, and a Vista-like cushion455 supported by the frame.
• Theupper part460 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.
• In an alternative, theupper part460 of the cushion shown inFIG. 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.
• The lower part of thecushion465 may include a gusset portion, a double gusset, or a solid silicon structure.
7.2 Adjustable Cushion Height
• 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 inFIGS. 2-13 is closer to the centroid as compared to the location of the centroid inFIGS. 15-16. In these embodiments, the positions of the cushions relative to the face remain generally constant.
• 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. Themask assembly500 inFIGS. 25-26 includes acommon Swift frame505 supported by Swift™-like headgear510, in addition to a Vista™ likecushion515 supported by theframe505.
• InFIGS. 25-26, the axis of location of theframe505 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). InFIGS. 25-26, it can be seen that the headgear-frame angle remains constant and the frame is located at higher or lower cushion positions,position2 inFIG. 25 andposition3 inFIG. 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.
• 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.
8.0 Chin Strap
• FIGS. 27-31 illustrate amask assembly600 according to a further embodiment of the present invention. Mask assembly includes a frame605 (e.g. polycarbonate shell), aheadgear assembly610, acushion component615, and achin strap assembly620 supported by the frame.
• Chin strap assembly620 includes anextender625 andchin strap630.Extender625 is shown inFIG. 30 and is preferably made of a rigid material, e.g., polycarbonate or a rigid plastic backed with headgear foam material.Extender625 includes anaperture635 by which a bevel clip640 (FIG. 29) may be used to selectively attach theextender625 to the frame, e.g., using interference snap fit.Extender625 includes ahole640 for receiving astrap645 of the chin strap. Each strap includes hook and loop fastening elements, e.g., Velcro®.
• Chin strap630 includes acushion sealing area650, 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 orregion655, e.g., as shown inFIGS. 27,28 and31. Bonding may be achieved, e.g., via adhesive, plasma or lamination methods.
• Another variant is to simply use only the extender and chin strap shown inFIGS. 30 and 31, respectively, along with another mask of choice, e.g., ResMed'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.
• A further embodiment is the combination the full-face seal as shown inFIG. 27, along with nasal prongs as shown inFIG. 19.
• 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.

Claims (17)

1. 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.

2. The system ofclaim 1, wherein the common frame assembly includes a frame member having a main body and first and second lateral ends each provided with a connector portion.

3. The system ofclaim 1, further comprising an elbow provided to one of the connector portions and a plug provided to the other connector portion.

4. The system ofclaim 3, wherein the positions of the plug and the elbow are interchangeable.

5. The system ofclaim 1, further comprising first and second elbows provided to the first and second connector portions, respectively.

6. The system ofclaim 3, wherein each said elbow is structured to deliver a supply of pressurized breathable gas to the common frame.

7. The system ofclaim 3, wherein each of the first and second lateral ends of the frame is provided with a seal portion to support each said elbow and/or said plug.

8. The system ofclaim 1, further comprising a headgear assembly having lateral strap portions, each said strap portion having a yoke, wherein each said seal portion includes a channel to support the yoke.

9. The system ofclaim 2, wherein the frame member includes a channel portion provided adjacent each of the first and second ends, wherein each of the first and second cushion components includes a lateral edge that interfaces with the channel portion.

10. The system ofclaim 1, wherein at least one of the first and second cushion components includes a bisected lateral side that is wrapped around the frame.

11. The system ofclaim 10, further comprising a clip element to secure the bisected lateral sides of each of the cushion components to the frame.

12. The system ofclaim 1, wherein at least one of the first and second cushion components includes an aperture on each lateral side thereof, each said aperture being sized to be stretched over the connector portion and configured to form a seal with a portion of the common frame.

13. The system ofclaim 1, wherein the first and second component are selected from the group including a full-face cushion component, a nasal cushion component, a nose tip cushion component, a nasal prongs component, and a combination of a nasal prongs component and a nasal or full-face cushion component.

14. The system ofclaim 1, further comprising a common headgear assembly which interfaces with the common frame assembly and each of the first and second cushion components.

15-40. (canceled)

41. A method of designing a series of breathing arrangements for delivering breathable gas to a patient, comprising:

providing at least first and second cushion components that are different from one another in at least one aspect, and

providing a common frame assembly that is connectable with each of the first and second cushion components.

42. The method ofclaim 41, further comprising providing a common headgear assembly which interfaces with the common frame assembly and each of the first and second cushion components.

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