(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property
`Organization
`International Bureau
`
`(43) International Publication Date
`2 September 2004 (02.09.2004)
`
` (10) International Publication Number
`
`WO 2004/07 377 8 A1
`
`(51)
`
`(21)
`
`International Patent Classification7:
`
`A61M 16/06
`
`International Application Number:
`PCT/AU2004/000207
`
`(22)
`
`International Filing Date: 20 February 2004 (20.02.2004)
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): GUNARATNAM,
`Michael, Kassipillai [AU/AU]; 3 Keiley Street, Marsfield,
`New South Wales 212 (AU). KWOK, Philip, Rodney
`[AU/AU];
`15 Davies Street, Chatswood, New South
`Wales 2067 (AU). GUNEY, Memduh [AU/AU]; 52
`Eastgate Avenue, Killara, New South Wales 2071 (AU).
`LITHGOW, Perry, David [AU/AU]; 9 Staff Avenue,
`Glenwood, New South Wales 2768 (AU). DARKIN,
`Donald [GB/AU]; 2 Athella Place, Dural, New South
`Wales 2158 (AU). LYNCH, Susan, Robyn [GB/AU];
`Unit 7/14 Forest Grove, Epping, New South Wales 2121
`(AU). HITCHCOCK, Robin, Garth [AU/AU]; Unit 21,
`9-13 Castle Street, North Parramatta, New South Wales
`2151 (AU). VELISS, Lee, James [AU/AU]; Unit 18/1-5
`Station Street, West Ryde, New South Wales 2114 (AU).
`SOKOLOV, Richard [AU/AU]; 4 Bardwell Crescent,
`Earlwood, New South Wales 2206 (AU).
`
`[Continued on next page]
`
`(57) Abstract: A nasal assembly (10) for delivering
`breathable gas to a patient includes a frame (16) having
`an integrally formed first connector portion (24). A
`nozzle assembly (18) includes a gusset or base portion
`(48) and a pair of nozzles (50). At least one inlet
`conduit is structured to deliver breathable gas into the
`frame and nozzle assembly for breathing by the patient.
`A pair of second connector portions (26) are removably
`and rotatably connected to respective first connector
`portions of the frame and are in communication with
`respective inlet conduits, e.g., directly or via angle
`connectors. A headgear assembly (20) is removably
`connected to the pair of second connector portions
`and/or the angle connectors so as to maintain the frame
`and the nozzle assembly in a desired adjusted position
`on the patient’s face.
`
`RMD 1028
`
`English
`
`English
`
`(25)
`
`Filing Language:
`
`Publication Language:
`
`(26)
`
`(30)
`
`Priority Data:
`60/448,465
`60/482,872
`60/488,810
`60/494,1 19
`60/529,696
`
`21 February 2003 (21.02.2003)
`27 June 2003 (27.06.2003)
`22 July 2003 (22.07.2003)
`12 August 2003 (12.08.2003)
`16 December 2003 (16.12.2003)
`
`US
`US
`US
`US
`US
`
`(71)
`
`Applicant (for all designated States except US): RESMED
`LINHTED [AU/AU]; 97 Waterloo Road, North Ryde, New
`South Wales 2113 (AU).
`
`Title: NASAL ASSEMBLY
`
`(54)
`
`
`
`WO2004/073778A1|||||||||||||||||||||||||||||||||||||||||I|||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`1
`
`RMD 1028
`
`

`
`WO 2004/073778 A1
`
`(74) Agents: DAVIDSON, Geoffrey, Robert et al,; Halford &
`C0., 1 Market Street, Sydney, New South Wales 2000 (AU).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI,
`GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD,
`MG, MK, MN, MW, MX, MZ, NA, NI, NO, NZ, OM, PG,
`PH, PL, PT, RO, RU, SC, SD, SE, SG, SK, SL, SY, TJ, TM,
`TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU, ZA, ZM,
`ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZM, ZW),
`Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), Euro-
`pean (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR,
`GB, GR, HU, IE, IT, LU, MC, NL, PT, RO, SE, SI, SK,
`TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
`ML, MR, NE, SN, TD, TG).
`Published:
`
`— with international search report
`
`For two—letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes andAbbreviations ” appearing at the begin-
`ning of each regular issue of the PCT Gazette.
`
`2
`
`

`
`wo 2004/073778
`
`PCT/AU2004/000207
`
`NASAL ASSEMBLY
`
`FIELD OF THE INVENTION
`
`[0001] 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 Posifive Pressure Ventilation (NPPV).
`
`CROSS-REFERENCE TO PRIORITY APPLICATIONS I
`
`[0002] This application claims the benefit of U.S. provisional applications nos. 60/529,696,
`
`filed December 16, 2003, 60/494,119, filed August 12, 2003, 60/448,465, filed February 21,
`
`2003, 60/482,872, filed June 27, 2003, and 60/488,810, filed July 22, 2003, each of which is
`
`incorporated herein in its entirety.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Some nasal assemblies used in the treatment of SDB are designed for insertion into
`
`the nasal passages of the patient. Air or other breathable gas is supplied by a blower and
`
`passed along a flexible conduit to the nasal assembly.
`
`[0004] The nasal assembly generally includes a relatively rigid shell, e.g., a frame, and a pair
`
`‘ of nozzles (which may be in the form of nasal pillows, nasal prongs, cannula, or nasal puffs)
`
`that are mounted on the rigid shell and structured to be inserted into the nasal passages of the
`
`patient. The nozzles are usually held in place using a headgear assembly, the relatively rigid
`
`shell and headgear assembly being joined using some form of connector.
`
`[0005] One form of known nasal assembly is described in U.S. Patent No. 4,782,832
`
`(Trimble et al.). Trimble discloses a nasal puff assembly 20 that includes a nasal puff 22
`
`adapted to be worn adjacent the nose of a patient, together with a harness assembly 24
`
`adapted to be worn over the head of the patient. The hamess assembly 24 is designed to
`
`operatively hold puff 22 adjacent and partially within the nasal passages of the patient.
`
`[0006] The puff 22 is in the form of a generally Y-shaped rigid hollow plenum chamber 28
`
`together with a pair of laterally spaced apart nares elements 30. Adjustability of the nares
`
`elements 30 may be provided by rctatably mounting the elements 30 to the plenum chamber
`
`28 and mounting the elements 30 in slots permitting selective lateral positioning of the
`
`elements 30 with respect to each other. Also, the harness assembly 24 may be adjusted to
`
`adjust the fit and seal of the nares elements 30 during use. That is, the force required to
`
`3
`
`

`
`W0 2004/073773
`
`PCT/AU2004/000207
`
`maintain a sufficient seal is directly associated with the force required to maintain a desired
`
`fit. Thus, adjustment of the fit or stability of the nasal assembly directly affects the seal,
`
`which can adversely affect patient comfort.
`
`[0007] Other examples of nasal pillows or cannula mounted to rigid shells are disclosed in
`
`U.S. Patent Nos. 5,724,965 and 6,431,172.
`
`[0008] A nasal mask assembly manufactured by Viasys, i.e., Spiritus, includes a plenum
`
`chamber with a pair of adjacent or laterally spaced nares elements. A harness assembly is
`
`engaged with the plenum chamber to adjust the fit and seal of the nares elements during use.
`
`Similar to Trimble, adjustment ofthe fit or stability of the nasal assembly directly affects the
`
`‘seal, which can adversely affect patient comfort.
`
`[0009] A nasal mask assembly manufactured by InnoMed, i.e., Nasal Aire, includes a plenum
`
`chamber with a pair of adjacent or laterally spaced nares elements. The nares elements are
`
`structured to engage within the mucosal surfaces or internal passages of the patient’s nose to
`
`maintain the nasal mask assembly on the patient’s face and to provide a seal. See, e.g., U.S.
`
`Patent No. 5,533,506.
`
`[0010] A nasal mask assembly manufactured by Stevenson Industries (see U.S. Patent No.
`
`6,012,455), i.e., CPAP—Pro, includes a dental anchor, a platform, and air supply tubes having
`
`nasal pads, wherein the platform supports the air supply tubes. The dental anchor is sized to
`
`be engaged between the teeth in the patient’s mouth so as to retain the assembly in place.
`
`[0011] PCT Application Publication No. W0 00/l 3751 discloses a device that includes gas
`
`delivery elements positioned into engagement with the patient’s nose by a mouthpiece fitted
`
`to the patient’s teeth.
`
`[0012] A common problem with known nasal assemblies, such as those discussed above, is
`
`patient comfort. For example, the prongs tend to irritate the patient’s nose due to the tension
`
`applied by the headgear assembly that pulls the rigid shell and prongs towards the patient’ s
`nose.
`
`[0013] Another problem is achievement of a sealing fit with the patient’s nasal passages
`
`without sacrificing patient comfort.
`
`[0014] Another problem is irritation of the inside ofthe patient’s nostrils caused by contact
`
`with the prongs, e.g., an edge thereof.
`
`[0015] Another problem is irritation of the inside ofthe patient’s nostrils caused by air jetting
`
`(air flow irritation) from the prongs.
`
`[0016] Another problem is adjustment of the nasal assemblies relative to the nose and/or
`
`head of the patient so as to accommodate Various shapes and angles ofpatient’s noses.
`2
`
`4
`
`

`
`WO 2004/073778
`
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`
`[0017] Still another problem is the direct association between sealing and stability forces that
`
`can affect patient comfort.
`
`SUMMARY OF THE INVENTION
`
`[0018] One aspect of the invention is directed towards a nasal assembly that provides more
`
`comfort to the patient.
`
`[0019] Another aspect of the invention is directed towards a nasal assembly that provides an
`
`effective seal with the patient’s nasal passages. Preferably, the nasal assembly is a nozzle
`
`assembly including nozzles which comfortably come into contact with the external rim of the
`
`nares and avoid the sensitive internal passages (e.g., mucosal surfaces or internal passages) of
`the nasal passage.
`’
`
`[0020] Still another aspect of the invention is directed towards a nasal assembly that does not
`
`rely on tension from the headgear assembly to provide an effective seal between the nozzles
`
`and the patient’s nasal passages.
`
`[0021] Still another aspect ofthe invention is directed towards a nasal assembly that is
`
`unobtrusive.
`
`[0022] Still another aspect of the invention is directed towards a nasal assembly that is easy
`to use.
`
`[0023] Still another aspect of the invention is directed towards a nasal assembly that
`
`maintains a headgear adjustment setting.
`
`[0024] Still another aspect of the invention is directed towards a nasal assembly that helps
`
`decouple sealing and stability forces. Specifically, one aspect of the invention is directed
`
`towards a nasal assembly that is structured such that the stability forces that act to maintain
`
`the nasal assembly on the patient’s face are separated or at least better distinguished from the
`
`sealing forces that act to maintain a seal between the nasal assembly and the patient’s face.
`
`[0025] Yet another aspect of the invention is directed towards a nasal assembly that provides
`
`a greater range of movement for nozzles of the nasal assembly.
`
`[0026] Another aspect of the invention provides a nasal assembly for delivering breathable
`
`gas to a patient. The nasal assembly includes a frame having a main body and a side frame
`
`member provided on each lateral side ofthe main body, each side frame member including an
`
`integrally formed first connector portion. A nozzle assembly includes a gusset or base
`
`portion and a pair of nozzles. The nozzle assembly is coupled with the main body of the
`
`frame with the pair of nozzles structured to sealingly engage with nasal passages of a
`
`patient’s nose in use. A pair of inlet conduits are structured to deliver breathable gas into the
`3
`
`5
`
`

`
`WO 2004/073778
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`
`frame and nozzle assembly for breathing by the patient. A pair of second connector portions
`
`are removably and rotatably connected to respective first connector portions of the frame.
`
`The second connector portions are in communication with the inlet conduits via angle
`
`connectors. A headgear assembly is removably connected to at least one of the second
`
`connector portions and the angle connectors so as to maintain the frame and the nozzle
`
`assembly in a desired adjusted position on the patient’s face.
`
`[0027] Other aspects, features and advantages of this invention will become apparent from
`
`the following detailed description when taken in conjunction with the accompanying
`
`drawings, which are a part of this disclosure and which illustrate, by way of example,
`
`principles of this invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0028] The accompanying drawings facilitate an understanding of the various embodiments
`
`of this invention. In such drawings:
`
`[0029] Fig. l is a perspective View illustrating a partial nasal assembly constructed in
`
`accordance with an embodiment of the invention mounted to a patient’s head and engaged
`
`with nasal passages of the patient;
`
`[0030] Fig. 2 is a front view of a frame of the nasal assembly shown in Fig. 1 with some parts
`
`removed for clarity;
`
`[0031] Fig. 3 is a cross-sectional View of the frame shown in Fig. 2;
`
`[0032] Fig. 4 is a side view of the flame shown in Fig. 2;
`
`[0033] Fig. 5 is a front view of a nozzle assembly of the nasal assembly shown in Fig. 1;
`
`[0034] Fig. 6 is a front cross-sectional view of the nozzle assembly shown in Fig. 5;
`
`[0035] Fig. 7 is a side View of the nozzle assembly shown in Fig. 5;
`
`[0036] Fig. 8 is a side cross-sectional View of the nozzle assembly shown in Fig. 5;
`
`[0037] Fig. 9 is a perspective View of an embodiment of an inlet conduit and headgear
`
`connector assembly of the nasal assembly shown in Fig. 1;
`
`[0038] Fig. 10 is a rear perspective View of the inlet conduit and headgear connector
`
`assembly shown in Fig. 9;
`
`[0039] Fig. 11 is a perspective View of another embodiment of an inlet conduit and headgear
`
`connector assembly adapted to be used with the nasal assembly shown in Fig. 1;
`
`[0040] Fig. 12 is a rear perspective View of the inlet conduit and headgear connector
`
`assembly shown in Fig. I l;
`
`6
`
`

`
`WO 2004/073778
`
`PCT/AU2004/000207
`
`[0041] Fig. 13 is a side view illustrating an oVer—the-head inlet conduit routing for the nasal
`
`assembly shown in Fig. 1;
`
`[0042] Fig. 14 is a side View illustrating an under-the-chin inlet conduit routing for the nasal
`
`assembly shown in Fig. l;
`
`[0043] Fig. 15 is a perspective view illustrating a connector for use in routing the inlet
`
`conduits over the head of the patient;
`
`[0044] Fig. 16 is a perspective view illustrating a connector for use in routing the inlet
`
`conduits under the chin of the patient;
`
`[0045] Fig. 17 is a perspective view illustrating a flow generator connector for use in
`
`connecting the nasal assembly shown in Fig. 1 to a pressurized supply;
`
`[0046] Fig. 18 is a side View illustrating an embodiment of headgear components for use with
`
`the nasal assembly shown in Fig. 1;
`
`[0047] Fig. 19 is a schematic view illustrating a patient’s nose having a substantially flat alar
`
`angle;
`
`[0048] Fig. 20 is a schematic view illustrating a patient’s nose having a substantially steep
`
`alar angle;
`
`[0049] Fig. 21 is a schematic View illustrating an embodiment of a sealing zone of a nozzle;
`
`[0050] Fig. 22 is a graph illustrating average nostril ratios opening/entrance;
`
`[0051] Fig. 23 is a schematic view illustrating an embodiment for calculating a base major
`
`axis of a nozzle;
`
`[0052] Fig. 24 is a schematic View illustrating an embodiment for calculating a base minor
`
`axis of a nozzle;
`
`[0053] Fig. 25 is a partial perspective view illustrating another embodiment of a nasal
`
`assembly mounted to a patient’s head and engaged with nasal passages of the patient;
`
`[0054] Fig. 26 is a partial front perspective View of the nasal assembly shown in Fig. 25;
`
`[0055] Fig. 27 is a cross-sectional view of the nasal assembly shown in Fig. 25;
`
`[0056] Fig. 28 is a front perspective view of a frame of the nasal assembly shown in Fig. 25 ;
`
`[0057] Fig. 29 is a rear perspective View of the frame shown in Fig. 28;
`
`[0058] Fig. 30 is a partial front perspective view of a half of the nozzle assembly of the nasal
`
`assembly shown in Fig. 25;
`
`[0059] Fig. 31 is a side cross-sectional view of the nozzle assembly shown in Fig. 30;
`
`[0060] Fig. 32 is a perspective View illustrating an embodiment of an inlet conduit and
`
`headgear connector assembly of the nasal assembly shown in Fig. 25 ;
`
`7
`
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`
`WO 2004/073778
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`PCT/AU2004/000207
`
`[0061] Fig. 33 is a rear perspective View of the inlet conduit and headgear connector
`
`assembly shown in Fig. 32;
`
`[0062] Fig. 34 is a cross-sectional view of the inlet conduit and headgear connector assembly
`
`shown in Fig. 32 with the flexible arms in phantom;
`
`[0063] Fig. 35 is a perspective view of a flow generator connector for use in connecting tubes
`
`for use with the nasal assembly shown in Fig. 25 to a pressurized supply;
`
`[0064] Fig. 36 is a side view illustrating the routing of the inlet conduits of the nasal
`
`assembly shown in Fig. 25;
`
`[0065] Fig. 37 is a side view illustrating the nasal assembly shown in Fig. 25 mounted to a
`patient’s head;
`
`[0066] Fig. 3 8 is a perspective View illustrating another embodiment of a nasal assembly
`mounted to a patient’s head and engaged with nasal passages of the patient;
`
`[0067] Fig. 38B is a perspective View illustrating an inlet conduit and an inlet conduit and
`
`headgear connector of the nasal assembly shown in Fig. 38;
`
`[0068] Fig. 39 is a perspective View of the nasal assembly shown in Fig. 38;
`
`[0069] Fig. 40 is a perspective view of a frame of the nasal assembly shown in Fig. 38;
`
`[0070] Fig. 41 is a perspective view of a nozzle assembly of the nasal assembly shown in Fig.
`
`3 8;
`
`[0071] Fig. 42 is a perspective View illustrating the nozzle assembly shown in Fig. 41
`
`mounted to the frame to shown in Fig. 40;
`
`[0072] Fig. 43 is a cross-sectional View of the nasal assembly shown in Fig. 38;
`
`[0073] Fig. 44 is a side cross-sectional View of the nasal assembly shown in Fig. 38;
`
`[0074] Fig. 45 is a side View illustrating the nasal assembly shown in Fig. 38 mounted to a
`
`patient’s head showing two inlet configurations;
`
`[0075] Fig. 46 is a schematic force diagram illustrating some ofthe forces that are developed
`when the nasal assembly shown in Fig. 38 is mounted to the patient’s head;
`
`[0076] Fig. 47 is a cross-sectional view of an embodiment of an inlet conduit engaged with
`
`an embodiment of an angle connector for delivering breathable gas;
`
`[0077] Fig. 47B is a perspective view illustrating another embodiment of an inlet conduit;
`
`[0078] Fig. 48 is a cross-sectional view illustrating another embodiment of an inlet conduit
`
`engaged with another embodiment of a flow generator connector for delivering breathable
`
`335;
`
`[0079] Fig. 48B is perspective view illustrating another embodiment of an inlet conduit;
`
`8
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`
`WO 2004/073778
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`PCT/AU2004/000207
`
`[0080] Fig. 49 is a perspective view illustrating an embodiment of an inlet conduit of the
`
`nasal assembly shown in Fig. 38;
`
`[0081] Fig. 50 is a side view illustrating the nasal assembly shown in Fig. 38 prior to
`
`engagement with nasal passages of the patient;
`
`[0082] Fig. 51 is a front view illustrating the nasal assembly shown in Fig. 38 (in cross-
`
`section) engaged with nasal passages of the patient;
`
`[0083] Fig. 52 is a perspective View illustrating another embodiment of a nasal assembly
`
`mounted to a patient’s head and engaged with nasal passages of the patient with two inlet
`
`configurations shown;
`
`[0084] Fig. 53 is a perspective View illustrating the nasal assembly shown in Fig. 52;
`
`[0085] Fig. 54 is a cross-sectional View illustrating a nozzle assembly being engaged with a
`
`frame of the nasal assembly shown in Fig. 52;
`
`[0086] Fig. 55 is a perspective View illustrating an inlet conduit and headgear connector
`
`assembly of the nasal assembly shown in Fig. 52;
`
`[0087] Fig. 56 is a cross-sectional View illustrating the inlet conduit and headgear connector
`
`assembly of the nasal assembly shown in Fig. 52;
`
`[0088] Fig. 57 is a cross-sectional side View illustrating the nasal assembly shown in Fig. 52
`
`about to be engaged with nasal passages of the patient;
`
`[0089] Fig. 58 is a front View illustrating the nasal assembly shown in Fig.‘ 52 (in cross-
`
`section) being engaged with nasal passages of the patient;
`
`[0090] Fig. 59 is a perspective View illustrating another embodiment of a nasal assembly
`
`mounted to a patient’s head and engaged with nasal passages of the patient;
`
`[0091] Fig. 60 is a perspective View of the nasal assembly shown in Fig. 59 removed from a
`
`patient’s head;
`
`[0092] Fig. 61 is an exploded View of a portion of the nasal assembly shown in Fig. 59
`
`illustrating the frame, nozzle assembly, and clip thereof;
`
`[0093] Fig. 62 is a perspective View of a portion of the nasal assembly shown in Fig. 59
`
`illustrating the clip being engaged with the frame and nozzle assembly;
`
`[0094] Fig. 63 is a perspective View of a portion of the nasal assembly shown in Fig. 59
`
`illustrating the engagement between the frame, nozzle assembly, and clip;
`
`[0095] Fig. 64 is a partial cross-sectional View of a portion of the nasal assembly shown in
`
`Fig. 5 9 illustrating the engagement between the frame, nozzle assembly, and clip;
`
`[0096] Fig. 65 is a top perspective View of a portion of the nasal assembly shown in Fig. 59;
`
`[0097] Fig. 65A is a partial enlarged View of the cushion shown in Fig. 65;
`7
`
`9
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`WO 2004/073778
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`
`[0098] Fig. 65B is a schematic diagram illustrating force distribution according to one aspect
`
`of the present invention;
`
`[0099] Fig. 66 is a rear perspective View of a portion of an alternative embodiment of a nasal
`
`assembly illustrating the engagement between the frame, nozzle assembly, and clip;
`
`[00100]
`
`Fig. 67 is a rear perspective illustrating the engagement between another
`
`embodiment of the frame, nozzle assembly, and clip;
`
`[00101]
`
`Fig. 68 is a perspective View illustrating the nozzle assembly shown in Fig. 66
`
`being engaged with the frame shown in Fig. 66;
`
`[00102]
`
`Fig. 69 is a perspective View illustrating the nozzle assembly shown in Fig. 67
`
`being engaged with the frame shown in Fig. 67;
`
`[00103]
`
`Fig. 70 is a perspective View illustrating the clip shown in Fig. 66 being engaged
`
`with the frame and nozzle assembly shown in Fig. 66;
`
`[00104]
`
`Fig. 71 is a perspective View illustrating the clip shown in Fig. 67 being engaged
`
`with the frame and nozzle assembly shown in Fig. 67;
`
`[00105]
`
`Fig. 72 is a perspective view of a second connector portion of the nasal assembly
`
`shown in Fig. 59;
`
`[00106]
`
`Fig. 73 is a cross-sectional View of a portion of the nasal assembly shown in Fig.
`
`59 illustrating the engagement between the frame, second connector portion, and angle
`
`connector;
`
`[00107]
`
`Fig. 74 is a perspective View of an angle connector of the nasal assembly shown in
`
`Fig. 59;
`
`[00108]
`
`Fig. 74B is a perspective similar to Fig. 74 but at a different angle;
`
`[00109]
`
`Fig. 75 is a side view of the angle connector shown in Fig. 74;
`
`[00110]
`
`Fig. 76 is a cross~sectional view of the angle connector shown in Fig. 74;
`
`[00111]
`
`Fig. 76A illustrates another embodiment of the present invention;
`
`[00112]
`
`Fig. 76B is an exploded View of Fig. 76A;
`
`[00113]
`
`Fig. 76C illustrates a second connector portion of the assembly of Fig. 76A;
`
`[00114]
`
`Fig. 76D illustrates a11 angle connector used in the assembly of Fig. 76A;
`
`[00115]
`
`Fig. 77 is a perspective View of a flow generator connector of the nasal assembly
`
`shown in Fig. 59;
`
`[00116]
`
`Fig. 78 is a cross-sectional View of the flow generator connector shown in Fig. 77;
`
`[00117]
`
`Fig. 79 is a cross-sectional view of an embodiment of an inlet conduit of the nasal
`
`assembly shown in Fig. 59;
`
`10
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`
`[00118]
`
`Fig. 80 is a perspective View of headgear yoke of the headgear assembly of the
`
`nasal assembly shown in Fig. 59;
`
`[00119]
`
`Fig. 81 is a perspective View illustrating engagement between the headgear yoke
`
`(Fig. 80) and angle connector (Fig. 74);
`
`[00120]
`
`Fig. 82 is a cross—section through line 82-82 of Fig. 81;
`
`[00121]
`
`Fig. 83 is a perspective View of a headgear buckle of the nasal assembly shown in
`
`Fig. 59;
`
`[00122]
`
`Fig. 84 is a perspective View of the nasal assembly shown in Fig. 59 illustrating
`
`the routing of the headgear assembly;
`
`[00123]
`
`Fig. 85 is another perspective View of the nasal assembly shown in Fig. 59
`
`illustrating the routing of the headgear assembly;
`
`[00124]
`
`Fig. 86 is a top View illustrating a nasal assembly constructed in accordance with
`
`an embodiment of the invention;
`
`[00125]
`
`Fig. 87 is a side View of the nasal assembly shown in Fig. 86;
`
`[00126]
`
`Fig. 88 is a bottom View of the nasal assembly shown in Fig. 86;
`
`[00127]
`
`Fig. 89 is an exploded View of a portion of the nasal assembly shown in Fig. 86;
`
`[00128]
`
`Fig. 90 is a perspective View of a portion of an embodiment of a nasal assembly;
`
`[00129]
`
`Fig. 91 is a top View of a headgear connector according to an alternative
`
`embodiment of the invention;
`
`[00130]
`
`Fig. 92 is a perspective View of an upper portion of a central conduit of the nasal
`
`assembly shown in Fig. 90;
`
`[00131]
`
`Fig. 93 is a top View of the upper portion of the central conduit shown in Fig. 92;
`
`[00132]
`
`Fig. 94 is a perspective view of a lower portion of a central conduit of the nasal
`
`assembly shown in Fig. 90;
`
`[00133]
`94;
`
`Fig. 95 is a bottom View of the lower portion of the central conduit shown in Fig.
`I
`
`[00134]
`
`Fig. 96 is a perspective View of an inlet conduit of the nasal assembly shown in
`
`Fig. 86;
`
`[00135]
`
`Fig. 96A is a schematic view of a Y-shaped inlet connector of the nasal assembly
`
`shown in Fig. 86;
`
`[00136]
`
`Fig. 97 is a perspective View of an inlet connector of the nasal assembly shown in
`
`Fig. 86;
`
`[00137]
`
`Fig. 97A is a schematic View of the nasal assembly shown in Fig. 86 with the
`
`nozzles in a first position adjacent to the nasal passages of the patient;
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`[00138]
`
`Fig. 97B is a schematic View of the nasal assembly shown in Fig. 86 with the
`
`nozzles in a second position in sealing engagement with the nasal passages of the patient;
`
`[00139]
`
`Fig. 98 is a perspective View of another embodiment of a nasal assembly;
`
`[00140]
`
`Fig. 99 is an enlarged perspective View of nozzles and a gusset portion of the nasal
`
`assembly shown in Fig. 98;
`
`[00141]
`
`Fig. 100 is an enlarged perspective view of inlet conduits of the nasal assembly
`
`shown in Fig. 98;
`
`[00142]
`
`Fig. 101 is a front perspective view illustrating the nasal assembly shown in Fig.
`
`98 mounted to a patient’s head;
`
`[00143]
`
`Fig. l02 is a rear perspective view illustrating the nasal assembly shown in Fig. 98
`
`mounted to a patient’s head;
`
`[00144]
`
`Fig. 103 is a front perspective View illustrating the nasal assembly shown in Fig.
`
`98 engaged with nasal passages of the patient;
`
`[00145]
`
`Fig. 104 is a side perspective View illustrating the nasal assembly shown in Fig. 98
`
`engaged with the nasal passages of the patient;
`
`[00146]
`
`Fig. 105 is a side View illustrating the nasal assembly shown in Fig. 98 engaged
`
`with the nasal passages of the patient;
`
`[00147]
`
`Fig. 106 is a front perspective View illustrating the nasal assembly shown in Fig.
`
`98 engaged with nasal passages of the patient;
`
`[00148]
`
`Fig. 107 is a perspective View of another embodiment of a nasal assembly
`
`mounted to a patient’s head;
`
`[00149]
`
`Fig. 107-1 is a perspective view of yet another embodiment of the present
`
`invention;
`
`[00150]
`
`Fig. 107-2 is a perspective view of yet another embodiment of the present
`
`invention;
`
`[00151]
`
`Figs. 107A-107C illustrate yet another alternative embodiment of the present
`
`invention;
`
`[00152]
`
`Figs. 107D and 107E illustrate still another embodiment according to the present
`
`invention;
`
`[00153]
`
`Fig. l07F illustrates another alternative embodiment of the present invention;
`
`[00154]
`
`Figs. 107G and 107H illustrate another alternative embodiment of the present
`
`invention;
`
`[00155]
`
`Fig. 1071 illustrates still another embodiment of the present invention;
`
`[00156]
`
`Fig. 107.1 illustrates yet another alternative embodiment ofthe present invention;
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`[00157]
`
`Figs. 107K and 107L illustrate yet another embodiment of the present invention;
`
`[00158]
`
`Figs. 107M-107Q illustrate cross-sections of alternative nozzles according to the
`
`present invention;
`
`[00159]
`
`Fig. 107R illustrates a perspective View of two nozzles like the nozzle shown in
`
`Fig: 107Q;
`
`[00160]
`
`Fig. 108 is a perspective View of yet another embodiment of a nasal assembly;
`
`[00161]
`
`Figs. 108A and 108B illustrate a tube retainer according to an embodiment of the
`
`present invention;
`
`[00162]
`
`Fig. 108C illustrates another tube retainer according to an embodiment of the
`
`present invention;
`
`[00163]
`
`Fig. 109 is an isometric View illustrating a portion of the nasal assembly shown in
`
`Fig. 108;
`
`[00164]
`
`Fig. 110 is a cross-sectional View of a portion of a nasal assembly according to the
`
`present invention;
`[00165]
`Figs. 110-1 and 110-2 illustrate cross-sectional views of a vent aperture according
`
`to the present invention;
`
`[00166]
`
`Fig. 110A is a partial enlarged cross-sectional View of the left hand side of Fig.
`
`1 10;
`
`[00167]
`
`Fig. 110B is an partial enlarged cross—sectional View of the right hand side of Fig.
`
`- 110;
`
`[00168]
`
`Fig. 111 is an exploded perspective view showing the interface between seal ring
`
`and elbow swivel according to an embodiment of the present invention;
`
`[00169]
`
`Fig. 112 is a partial cross-sectional view of a portion of the mask assembly shown
`
`in Fig. 108;
`
`[00170]
`
`Fig. 113 illustrates still another embodiment of the present invention with an
`
`integral plug and seal assembly;
`
`[00171]
`
`Figs. 114-126 illustrate yet another embodiment of the present invention;
`
`[00172]
`
`Figs. 127-130 illustrate still another embodiment of the present invention;
`
`[00173]
`
`Figs. 131-133 illustrate yet another swivel elbow according to an embodiment of
`
`the present invention; and
`
`[00174]
`
`Figs. 134-135 illustrate further alternative embodiments of the present invention.
`
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`DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
`
`[00175]
`
`The following includes descriptions of several main illustrated embodiments of
`
`the present invention. Each illustrated main embodiment includes features that may be used
`
`with and/or in the other embodiments, as would be apparent to those of ordinary skill in the
`art.
`
`FIRST ILLUSTRATED EMBODIMENT
`
`[00176]
`
`Fig. 1 shows an embodiment of a nasal assembly 10 structured to deliver
`
`breathable gas to nasal passages 12 of a patient’s nose 14. The nasal assembly 10 includes a
`
`frame 16 and a nozzle assembly 18 that may be permanently or removably connected to the
`
`frame 16. A headgear assembly 20 (see Fig. 18) is preferably removably attached to
`
`connection assembly 22 to maintain the frame 16 and nozzle assembly 18 in a desired
`
`adjusted position on the patient’s face. Inlet conduits (see Fig. 49 for example) are also
`
`removably attached to the frame 16 by a connection assembly 22 to deliver breathable gas
`
`into the frame 16 and nozzle assembly 18 for breathing by the patient. The headgear
`
`assembly 20 and inlet conduits are removably attached to the frame 16 by an inlet conduit
`
`and headgear connection assembly 22. The connection assembly 22 includes first connector
`
`portions 24 (see Figs. 2 and 3) provided by the frame 16 and second connector portions 26
`
`adapted to be removably coupled with the first connector portions 24. The second connector
`
`portions 26 are removably connected to the headgear assembly 20 and the inlet conduits, as
`
`will be further discussed.
`
`I
`
`[00177]
`
`As shown in Figs. 2-4, the frame 16 includes a main body 28 that provides a
`
`central opening 30 for accommodating the nozzle assembly 18. The frame 16 also includes
`
`side frame members 32 provided on each lateral side of the main body 28. The side frame
`
`members 32 are preferably formed in one piece with the main body 28 of the frame 16. In
`
`the illustrated embodiment, the flame 16 is a rigid or serni-rigid structure formed from a
`
`polymer material. However, the frame .16 may be semi-rigid to allow flexibility of the frame
`
`16 with respect to the patient’s face in use. The frame 16 may also be semi-rigid in certain
`
`regions for customized flex in certain regions of the frame 16.
`
`[00178]
`
`Each side frame member 32 includes a first connector portion 24 that is integrally
`
`formed therewith. As best shown in Figs. 2 and 3, the first connector portion 24 includes a
`
`connecting section 34 and an indexing section 36. The connecting section 34 is structured to
`
`12
`
`14
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`
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`interlock with the second connector portion 26 to p