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`
`US 2l)030196658/\1
`
`(19) United States
`(12) Patent Application Publication (10) Pub. N0.: US 2003/0196658 A1
`Ging ct al.
`(43) Pub. Date:
`Oct. 23, 2003
`
`(S4) ER(}()N()M {C AND ADJ US’l‘ABI.F.
`RESPIRATORY MASK ASSEMBLY WITH
`FRAME
`
`(76)
`
`Inventors: Anthony M. (ling, Summer Hill (AU);
`Saad Nasr, Brighton Le Sands (AU);
`Philip R. Kwnk, Chatswood (AU);
`Rachael 1*}. Moore, Waverley (AU);
`Andrew M. l’riee, Baulkham Hills
`(AU)
`
`Correspondence Address:
`PILLSBURY WINTHROP, LLP
`l‘.(). BOX 10500
`MCLEAN, VA 22102 (US)
`
`(21) Appl. No.:
`
`10,391,440
`
`(22)
`
`Filed:
`
`Mar. 19, 2003
`
`Related U.S. Application Data
`
`(60)
`
`Prcwisional application No. 601’377,254, filed on May
`3, 2002. Provisional application No. {i0,’39';',l95, filed
`on Jul. 22, 2003. Provisional application No. 60;’-‘-I02.
`509, filed on Aug. 12, 2002.
`
`(30)
`
`Foreign Application Priority Data
`
`Apr. 23, 2002
`
`(AU) ............................................ .. l’Sl926
`
`Publication Classification
`
`Int. Cl.’ ................................................... .. /\62B 18100
`(51)
`(52) U.S. Cl.
`................................. 128/201.22; 123..-*20(124
`
`(57)
`
`AIlS'l‘RAC'I‘
`
`Arespiralory mask assembly [or delivering breathable gas to
`a patient includes a frame having a front surface and a rear
`surface. opposite the from surface, and adapted in use to [ace
`the patient. The frame dellnes an inner wall and an outer wall
`extending from lhe rear surface, the inner and outer walls
`being spaced to define a channel therebetwecn. Acushion is
`removahly attachable to the frame such that the cushion and
`frame are repeatahly engagable with and disengagable from
`one another. The cushion includes a side wall to be inserted
`into the channel of the frame, the
`wall having a llrst
`interlocking su rfaee that engages a second interlocking
`surface provided in the channel when the cushion and frame
`are engaged with one another. The lirst and second inter-
`locking surfaces interlock with one another to removably
`attach the cushion to the frame.
`
`RMD 1005
`
`RMD 1005
`
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`Oct. 23, 2003 Sheet 1 of 56
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`
`ERGONOM IC AND ADJUSTABLE RESPIRATORY
`MASK ASSl*ZMI}l..Y WITH FRAME
`
`CROSS—Iv‘.EFERENCE'. TO RELATED
`APl’LICKl‘IONS
`
`[(I00l] The present application claims priority to US.
`Provisional Applications ofMoore et al., Serial Nos. 6087?,
`254, 60f397,l95, and 605402.509, the entireties of which are
`hereby incorporated into the present application by refer-
`ence.
`
`FIELD OF THE INVENTION
`
`[0002] The invention relates to a nasal mask for use in the
`delivery of Non-invasive Positive Pressure Ventilation
`(NPPV) and for nasal continuous positive airway pressure
`(nasal CPAP) therapy of sleep disordered breathing (SUB)
`conditions such as obstructive sleep apnea (OSA).
`
`BACKGROUND OF THE INVENTION
`
`[0003] The application of nCPAP for treatment of OSA
`was taught by Sullivan in U.S. Pat. No. 4,944,310, incor-
`porated herein by reference in its entirety. In nCPAP treat-
`ment of OSA, pressurized air or other breathable gas is
`provided to the entrance of a patient’s airways at a pressure
`elevated above atmospheric pressure, typically in the range
`4 to 20 cm H20 to "splint” open the patient’s upper airways
`and prevent apncas.
`
`[0004] Apparatus to deliver nasal CPAP and NPPV
`therapy typically comprises a blower, an air delivery conduit
`and a patient interface. The blower may be programmed to
`deliver a range of different forms of therapy. In one form, a
`constant pressure of air or breathable gas is provided to the
`patient. It is also known for the level of treatment pressure
`to vary from breath to breath in accordance with patient
`need, that form of treatment being known as automatically
`adjusting nasal CPAP treatment as described in US. Pat. No.
`5,245,995 (Sullivan and Lynch),
`incorporated herein by
`reference in its entirety. NPPV is another form of treatment
`for breathing disorders. In its most basic fonn, a relatively
`higher pressure of gas may be provided in the patient mask
`during the inspiratory phase of respiration and a relatively
`lower pressure or atmospheric pressure being provided in
`the patient mask during the expiratory phase of respiration.
`In other modes,
`the pressure can be made to vary in a
`complex manner
`throughout
`the respiratory cycle, for
`example,
`the pressure at
`the mask during inspiration or
`expiration can be varied through the period of treatment.
`See, for example, US. Pat. No. 5,704,345 and international
`Patent Publication Nos. W0‘)8,t12965 and W0‘-)9f61088, all
`of which are incorporated by reference herein in their
`entireties. In this specification, the term NPPV therapy will
`be used to describe all these forms of NPPV and nasal CPAP
`
`therapy.
`
`[0005] The patient interface for NPPV therapy may take
`many forms, such as a nasal mask assembly, a nose and
`mouth mask assembly, nasal cushions or a nasal prongs or
`pillows assembly. A mask assembly typically includes a
`rigid shell, a soft face-contacting cushion, a forehead supv
`port and headgear for securing the mask to the head.
`
`the headgear
`In one known mask assembly,
`[0006]
`includes a cap portion with four straps.
`In use,
`the cap
`
`portion engages the occipital portion of the patient. Further-
`more, in use, the two lower straps extend between the cap
`portion and a nasal mask while the two upper straps extend
`between the cap portion and a forehead support. See, for
`example, U.S. Pat. No. 6,119,693 (Kwok, Matchett and
`Grant), incorporated herein by reference in its entirety.
`
`interfaces include quick or conve-
`[0007] Some patient
`nient
`release mechanisms for enabling a patient andfor
`clinician to disengage from the blower, blower tube andtor
`the maskfhearlgear assembly. Quick or convenient release
`mechanisms are useful where NPPV therapy needs to be
`temporarily interrupted or where a system failure causes a
`cessation of gas [low to the patient interface. For example,
`as disclosed in U.S. patent application Ser. No. 09r'482,'i'18,
`incorporated herein by reference in its entirety, the headgear
`and mask can be removed from the patient by pulling a
`conveniently located cord to decouple hook and loop fas-
`teners between engaging headstraps that are positioned, for
`example, at the rear of the headgear assembly. In another
`example, as disclosed in US. patent application Ser. No.
`09,604,220, incorporated herein by reference in its entirely,
`the heaclgearrmask assembly can be removed from the
`patient by detaching a connector member for the headstrap,
`which connector member is connected directly to the frame
`of the mask. See also US. Pat. No. 3,990,727, which
`discloses a quick detachable coupler that appears to be
`employed by the SleepNet“"‘ 10"‘ mask.
`
`[0008] Since the patient must be able to sleep while
`wearing the patient
`interface,
`it
`is desirable that
`it be
`comfortable. In addition, the patient interface should provide
`a good seal to prevent or reduce leaks, or to better control
`any leak that occurs and to maintain efficacy of treatment.
`Since the shape of people’s noses, faces and heads vary
`widely, from a commercial perspective, it is important to be
`able to manufacture patient interfaces which can accommo-
`date this range of facial shapes without having to carry
`excessive inventory through a large number of sizes. A
`number of patient interfaces have been designed with the
`goals of patient comfort, ease of use, adjustability and the
`ability to accommodate a wide range of patient face and
`head shapes in mind.
`
`[0009] U.S. Pat. No. 5,243,971 (Sullivan and Bruderer)
`provides a patient interface (both nasal and full-face masks)
`that is suitable for use in NPPV therapy. The mask has a face
`contacting portion mounted to a shell which is sized and
`shaped to overfit the nose region of an intended wearer, and
`the face contacting portion is in the form of a distendahle
`membrane which is molded from an elastic material. US.
`Pat. No. 5,243,971 is hereby incorporated by reference in its
`entirety.
`
`[0010] US. Pat. Nos. 6,357,-'-Ml and 6,1 12,746 (Kwok and
`Styles) each describe a nasal cushion which comprises a
`substantially triangularly shaped frame from which extends
`a membrane. These patenLs are hereby incorporated by
`reference in their entirety.
`
`[0011] Other nasal masks are disclosed in U.S. Pat. Nos.
`5,724,965 and 6,119,694, incorporated by reference in their
`entirety. Each describes a nasal cushion that engages with
`the tip of the nose or that portion of the nose in the horizontal
`plane just above the upper lip of the patient. In PCT,r’US00t’
`11329 (WO 00169521),
`incorporated by reference in its
`entirety, a triangular-shaped nasal cushion includes a tapered
`
`58
`
`58
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`
`Oct. 23, 2003
`
`profile that narrows towards the face of the patient. Some of
`these prior art masI<s.»'cu.shions has experienced significant
`challenges from the perspective of patient comfort, potential
`nasal vent occlusion, stability andfor sealing (especially at
`the nasal bridge and cheek regions).
`
`[0012] A number of adjustable forehead supports have
`been developed with the aim of achieving a serviceable seal
`while increasing patient comfort and accommodating the
`greatest number of patients in the population. For example,
`U.S. Pat. No. 6,119,693 (Kwok, Matchctt and Grant)
`describes an adjustable forehead support for a nasal mask or
`full-face mask. The forehead support may be adjusted for the
`different shapes and sizes of a facial profile. The angle of the
`seal relative to the face may be adjusted with this invention.
`U.S. Pat. No. 6,119,693 is hereby incorporated by cross-
`reference in their entirety. In International Patent Applica-
`tion PCTt’AU(|0r’U(I(!97 (WO 00.38384), a forehead support
`is disclosed that is adapted to be secured to a respiratory
`mask. International Patent Application PC"I'lAUOUl0O{J97
`(W0 00f78384) is hereby incorporated by cross-reference in
`its entirety.
`
`to
`[0013] Accordingly, a need has developed in the art
`provide a mask assembly that is capable of overcoming the
`drawbacks or limitations of the prior art.
`
`BRIEF SUMMARY OF Tl-IE INVENTION
`
`invention is directed
`[0014] One aspect of the present
`towards a comfortable patient interface for delivering NPPV
`therapy.
`
`[0015] Another aspect of the invention is to provide a
`patient interface that will result in improved patient com-
`pliance with NPPV therapy.
`
`invention to
`It is another aspect of the present
`[0016]
`create a cushion that is capable of sealing on a smaller area
`ofthe nose as compared to known rnasks,while retaining or
`exceeding the comfort level of the ResMed Mirage® and
`Ultra Mirage® cushions.
`
`invention to
`is a further aspect of the present
`It
`[0017]
`reduce the perceived andlor actual size andfor weight of a
`nasal mask and provide a less intrusive mask for the user.
`
`[0018] Another aspect of the present invention is to pro-
`vide a mask assembly in which the mask and headgear have
`a reduced amount of connections that are provided in a
`convenient and intuitive location for quick attachment and!
`or detachment by the patient, while not being easily
`detached accidentally.
`
`[0019] Another aspect of the invention is to provide a
`mask assembly in which it is not necessary to provide a
`forehead support or an adjustment mechanism for the fore-
`head support, while maintaining stability of the mask in use.
`
`[0020] Another aspect is to provide a nasal mask capable
`of fitting a wide range of patients, so as to decrease or
`minimize inventory requirements and the number of differ-
`ently sized maskstcushions that are required for production.
`
`invention is to
`[0021] Yet another aspect of the present
`provide a nasal mask that olIers more comfort to the patient,
`e.g., by better avoiding the application of unwanted local-
`ized pressure points in the facial contacting regions espe-
`cially to the sensitive nasal bridge region of the patient,
`
`while maintaining a good seal, with or without the assistance
`of positive pressure to form or maintain the seal. Another
`aspect of the present invention is to avoid contact with the
`upper nasal bridge region, while avoiding localized pressure
`points along the lower nasal bridge region where the bony
`portion transitions into a portion of the nose containing more
`cartilage.
`[0022] Another aspect of the present invention is to avoid
`application of unwanted localized contact pressure or forces
`that may increase undesirably the impedance of airflow
`through the patient’s naresfnaris and nasal passages, espe-
`cially through the nasal vent.
`[0023] Still another aspect is to provide a headgear assem-
`bly which can provide added stability to the ntaskfcushion
`assembly. In embodiments, the headgear may be made of or
`include at least one layer which imparts a degree of stiffness
`to the headstraps to assist in the stabilization of the mask.’
`ciLshion assembly, which may obviate the need for a fore-
`head support and thereby decrease visual obstructions near
`the patient’s eyes and better enhance or at least not hinder
`the patient’s ability to don, wear or remove eye glasses with
`the mask system in use. At least a portion of the headstrap
`itself may be formed of a relatively more rigid material in
`comparison to relatively flexible headstraps, instead of pro-
`viding a multiple layer structure. The headgear may include
`a relatively large, hand—rnanipulable clip member that can be
`quickly and easily attached andlor detached from the head
`strap andlor the mask frame. Alternatively, the headgear may
`be magnetically coupled with the mask frame.
`[0024] Another aspect of the present invention is to pro-
`vide a convenient or quick release mechanism which
`requires little effort or dexterity to operate.
`[0025] Another aspect of the present invention is to pro-
`vide a frame which includes andfor integrates a quick release
`mechanism so that the clip member of the head straps can be
`easily detached from the frame. The quick release mecha-
`nism may include at least one connector portion formed in
`one piece with the frame. A mating connector portion can be
`provided on a portion of the headgear. The mask system is
`attached to a source of pressurized air which is delivered via
`an air delivery conduit. The conduit may be directly attached
`to the mask with its lumen in fluid communication with the
`mask chamber in order to supply pressurized air to the
`entrance ofthe patient‘s airway. Preferably an intermediate
`piece connects the air delivery conduit to the mask. Prefer-
`ably the ihtermediate piece is an elbow joint, which will be
`better described below. The frame may include an extended
`tube protruding from the outside surface of the mask. which
`can improve the seal between the elbow joint and the mask
`frame and also improve the stability of the connection
`between the mask frame and the elbow joint. The extended
`tttbe may include a flange for attachment
`to the elbow
`assembly. Preferably the elbow assembly may be easily
`manipulated to quickly and readily detach the elbow joint
`from the mask frame during a temporary interruption in
`patient treatment. The elbow assembly may include a vent to
`atmosphere. Preferably the vent is in fluid communication
`with the system air path via an exhaust passage which is
`separated from the incoming gas path, for example, by using
`a baffle provided within a portion of the elbow joint.
`[0026] Another aspect of the invention is to provide a
`generally trapezoidal shaped mask cusltion for a patient
`interface.
`
`59
`
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`
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`
`L»)
`
`[0027] Another aspect of the invention provides a respi-
`ratory rnask assembly for delivering breathable gas to a
`patient.
`"I'l:te respiratory mask assembly according to one
`embodiment includes a frame having a front surface and a
`rear surface, opposite the front surface, and adapted in use
`to face the patient. The frame defines an inner wall and an
`outer wall extending from the rear surface. the inner and
`outer walls being spaced to define a channel therebetween.
`Acttshion is removably attachable to the frame such that the
`cushion and frame are repeatably engagablc with and dis-
`engagable from one another. The cushion includes a side
`wall to be inserted into the channel of the frame, the side
`wall having a first interlocking surface that engages a second
`interlocking surface provided in the channel when the cush-
`ion and frame are engaged with one another. The first and
`second interlocking surfaces interlock with one another to
`removahiy attach the cushion to the frame.
`
`[0028] Of course, portions of the described aspects of the
`present
`invention may form sub—aspects of the present
`invention. Also, various ones of the sub-aspects andfor
`aspects may be combined in various manners and also
`constitute additional aspects or sub-aspects of the present
`invention. These and other features and aspects of the
`present invention will be described in or be apparent from
`the detailed description below read in conjunction with the
`attached Figures, where like reference numerals indicate like
`components.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0029] The accompanying drawings facilitate an under-
`standing of the various embodiments of this invention. In
`such drawings:
`
`[0030] FIG. I is a perspective view of a nasal mask
`assembly according to one preferred embodiment of the
`present invention;
`
`[0031] FIG. lb shows a headgear assembly according to
`an embodiment of the invention;
`
`[0032] FIG. 2 is a partial side view of the nasal mask
`assembly of FIG. 1;
`
`[0033] FIG. 3 is a partial front view of the nasal mask
`assembly of FIG. 1;
`
`[0034] FIG. 4 is a partial top plan view ofthe nasal mask
`assembly of FIG. 1;
`
`[0035] FIG. 5 is a front perspective view of a frame
`component of the nasal mask assembly of FIG. 1;
`
`[0036] FIG. 5a is a top view of the frame of FIG. 5;
`
`[0037] FIG. 5b is a schematic view showing various
`forces acting on the nasal mask assembly which may alffect
`a patient;
`
`[0038] FIG. 5:: is a rear perspective view of the frame of
`FIG. 5;
`
`[0039] FIG. 6a is a top view of an elbow assembly and
`frame according to another embodiment of the present
`invention;
`
`[0040] FIG. 6b is an exploded view of the embodiment of
`FIG. 6a,‘
`
`[0041] FIG. 7 is a partial sectional view of the frame of
`FIG. 5;
`
`[0042] FIG. 8 is a side view of a left side yoke of the nasal
`mask assembly of FIG. 1;
`
`[0043] FIG. 8:1 is an enlarged view of a right side yoke
`according to another embodiment of the present invention;
`
`[0044] FIG. 9a is a top view of a locking clip of the nasal
`mask assembly of FIG. 1;
`
`[0045]
`FIG. 9a;
`
`FIG. 9b is a bottom view of the locking clip of
`
`[0046] FIG. 10a is a side view of a clip and frame in a
`nearly fully connected condition; according to the present
`invention;
`
`[0047] FIG. 10b is a bottom view of tlte clip of FIG. 10a;
`
`[0048] FIG. 10c is a top view of the clip of FIG. 10:1;
`
`[0049] FIG. 10d is a perspective view of the clip of FIG.
`10a;
`
`[0050] FIGS. 10e—10g illustrate the clip and yoke of the
`present invention in various connected positions;
`
`[0051] FIG. 11 is a perspective view of a buckle of the
`nasal mask assembly of FIG. 1;
`
`[0052] FIG. 12 is a bottom view of a cross-over strap of
`the nasal mask assembly of FIG. 1 in a relaxed state;
`
`[0053] FIG. 13 is a bottom view of the eross—over strap of
`FIG. I2 in a crowd-over state;
`
`[0054] FIG. 14 is a view of a cross-over buckle of the
`cross-over strap of FIG. 13;
`
`[0055] FIG. 15 is a perspective view of a strap loop for use
`with the nasal mask assembly of FIG. 1;
`
`[0056] FIG. 16:: is a perspective view of the swivel elbow
`shown in FIG. 1;
`
`[0057] FIG. 16:’) is a side view of a swivel elbow of the
`nasal mask assembly of FIG. 1;
`
`[0058] FIG. 17 is a front view of the swivel elbow of
`FIGS. 160 and 16b;
`
`[0059] FIG. 18 is a rear view of the swivel elbow of
`FIGS. 160 and 16!);
`
`[0060] FIG. 18:‘) is a side view of another embodiment of
`a swivel elbow;
`
`[0061] FIG. 18c is a front view of the swivel elbow of
`FIG. 18b;
`
`[0062] FIG. 18:1 is a rear view of the swivel elbow of FIG.
`18!);
`
`[0063] FIG. 18:? is a cross-sectional view of the swivel
`elbow of FIG. 18!);
`
`[0064] FIGS. l9n—l—19c—2 are sequential sectional views
`of the swivel elbow as shown in FIG. 18,
`illustrating
`connection with a flange extending from the front surface of
`the frame;
`
`[0065] FIG. 20 is a perspective view of a vent cover of the
`nasal mask assembly of FIG. 1;
`
`[0066] FIG. 21 is a rear view of the vent cover of FIG. 20;
`
`60
`
`60
`
`

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`
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`
`[0067] FIG. 22 is a bottom view of the vent cover of FIG.
`20;
`
`[0090] FIGS. 29a—29d show alternative sealing configu-
`rations of the cushion of FIGS. 27::-27:3.
`
`[0068] FIG. 22:‘: is a perspective view of another embodi-
`ment of a vent cover for connection with the swivel elbow
`of FIG. 18b;
`
`[0069] FIG. 22:: is a rear view of the vent cover of FIG.
`22!);
`
`[0070] FIG. 22:)’ is a bottom view of the vent cover of
`FIG. 22b;
`
`[0071] FIG. 22:? is a side view of the vent cover of FIG.
`22!);
`
`[0072] FIG. 22f is a side view of illustrating the vent cover
`of FIG. 22!) connected to the swivel elbow of FIG. 18!);
`
`[0073] FIG. 23 is a perspective view of a oonnector tube
`of the nasal mask of FIG. 60;
`
`[0074] FIG. 240 is a face side view of a cushion of the
`nasal mask assembly of FIG. 1 showing Computer Aided
`Design (CAD) construction lines;
`
`[0075] FIG. 24!) is a frame side view of the cushion of
`FIG. 24¢: showing CAD construction lines;
`
`[0076] FIGS. 24c-24f illustrate various perspectives of the
`cushion shown in FIG. 240;
`
`[0077] FIG. 24g shows a mask cushion in accordance
`with an embodiment of the invention incorporating a septum
`notch;
`
`is a perspective view of the cushion
`[0078] FIG. 25::
`shown in FIG. 1 showing CAD construction lines;
`
`[0079] FIG. 25b is a face side view of the cushion ofFIG.
`25a,‘
`
`[0080] FIG. 25c is a frame side view of the cushion of
`FIG. 25:: showing CAD construction lines;
`
`[0081] FIG. 25d is a cross—scction taken along line 25d-
`25d of FIG. 25!) showing CAD construction lines;
`
`[0082] FIG. 25e is a cross-section taken along line 259-
`25e of FIG. 25:5;
`
`[0083] FIG. 25fis a cross-section taken along line 25f-25f
`of FIG. 25b;
`
`[0091] FIGS. 30 and 31 show various dimensions used to
`design a mask according to FIG. I;
`
`[0092] FIGS. 32:1-I-32c-2 illustrate an additional embodi-
`ment ol‘ the present invention for engagement between the
`frame and cushion, the cushion showing CAD construction
`lines;
`
`[0093] FIG. 32d is an enlarged cross—sectional view of the
`frame shown in FIGS. 320-l-32c-2;
`
`[0094] FIG. 329 illustrates an additional embodiment of
`the present invention for engagement between the frame and
`cushion;
`
`[0095] FIG. 33 is a perspective view of another embodi-
`ment of a frame of the nasal mask assembly;
`
`[0096] FIG. 34 is a top view of another embodiment of the
`yokes of the headgear assembly of the nasal mask assembly;
`
`[0097] FIG. 35 is an enlarged view of a right side yoke of
`the headgear assembly shown in FIG. 34;
`
`[0098] FIG. 36 is a perspective view illustrating the frame
`of FIG. 33 magnetically coupled to the headgear assembly
`of FIGS. 34 and 35;
`
`[0099] FIG. 37 is a schematic view illustrating the mag-
`netic coupling of the frame of FIG. 33 and the headgear
`assembly of FIGS. 34 and 35;
`
`FIUS. 38/-\-3813 show various perspectives of
`[0100]
`another embodiment of the cushion, the cushion showing
`CAD construction lines;
`
`FIGS. 39A-39D show various perspectives of
`[0101]
`another embodiment of the cushion, the cushion showing
`CAD construction lines;
`
`[0102] FIG. 40 is a perspective view of another embodi-
`ment of a frame of the nasal mask assembly;
`
`[0103] FIG. 41 is a bottom view of the frame shown in
`FIG. 40;
`
`[0104] FIG. 42 is a top view of an embodiment of the
`cushion structured to be engaged with the frame shown in
`FIG. 40, the cushion showing CAD construction lines; and
`
`[0084] FIG. 25g is a cross-section taken along line 255;-
`25g of FIG. 25b;
`
`[0105] FIG. 43 is a rear view of the cushion shown in
`FIG. 42., the cushion showing CAD construction lines.
`
`[0085] FIG. 25:’: is a cross—scction taken along line 25)‘:-
`25h of FIG. 25!);
`
`[0086] FIG. 25:‘ is an enlarged view of FIG. 25:! showing
`typical (TYP) dimensions of an embodiment (R-radius};
`
`[0087] FIG. 26 is a perspective view of an air tube ol’ the
`nasal mask assembly of FIG. I;
`
`[0088] FIGS. 27::-279 are partial sectional views of a
`frame and cushion of the nasal mask assembly of FIG. 1
`showing a sequence of positions of assembly and disassem-
`bly of the frame and cushion;
`
`[0089] FIG. 28 is a partial sectional view of an alternative
`embodiment of the frame and cushion of the nasal mask
`assembly of FIG. 1;
`
`DETAILED DES(.'RIP'I'lON OF PREFERRED
`ILMBODIMENTS
`
`[0106] Two main embodiments are described in the fig-
`ures. Although many of the features antifor parts of each
`embodiment are the same, there are several parts andior
`elements that are dilferent. For example, while FIG. 1 shows
`one embodiment of an elbow assembly 60 according to the
`present invention, FIGS. fir:-6b show another arrangement
`of the elbow assembly 60. Other differences between the
`embodiments will be described below. Moreover, several
`alternative approaches are also described with respect
`to
`various parts
`andfor
`elements,
`and
`those
`alternative
`approaches should be considered as additional preferred
`embodiments of the present invention.
`
`61
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`
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`
`[0107] As shown in FIGS. 1-4