Mail Stop Provisional Patent Application
`
`PTOISBIIIS (6-95)
`Approved for use through WI 1193. 0MB 0651-0037
`Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
`
`PROVISIONAL APPLICATION COVER SHEET
`This is a re-uest for filin ; a PROVISIONAL APPLICATION under 37 CFR 1.53 c _
`Docket Number
`
`4398-310
`
`Type a plus sign (+) inside
`this bOX—)
`
`+
`
`Lithgow
`Kwolt
`Gunaratnarn
`Soltolov
`Hitchcock
`Veliss
`Darkin
`Guuey
`
`David
`Rodney
`Kassipillai
`
`INVENTOR(S)IAPPLICANT(S)
`RESIDENCE (CITY AND EITHER STATE 0R FOREIGN COUNTRY
`Gienwood. Australia
`Chatswood, Australia
`Marsfield. Australia
`Earlwood. Australia
`North Ryde, Australia
`North Ryde, Australia
`Dural, Australia
`Killara, Australia
`
`”'lllllllllllllllilllll
`
`'1603
`
`5us.Pro
`29696
`
`155
`
`
`
`TITLE OF THE INVENTION (280 characters)
`
`NASAL ASSEMBLY
`
`CORRESPONDENCE ADDRESS
`
`Direct all correspondence to:
`
`IZI
`
`Customer Number:
`
`231 17
`
`Place Customer
`
`Number Bar
`Label Here -)
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`Typo Customer Number here
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`ENCLOSED APPLICATION PARTS {check at! that and J
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`E] Specification (63pgs)
`and Appendix (271335)
`DrawingIs)
`
`Number of Pages
`
`Number of Sheets
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`[El Applicant claims "small entity“ status.
`El "Small entity" statementattached.
`E Other (specify) |:'
`METHOD OF PAYMENT (check one
`p
`.
`' W
`A
`‘
`A A check or money order IS enclosed to cover the Provrsmnal filtng fees ($160.00)I($80.00)
`_l E The Commissioner is hereby authorized to charge any defigiengy, or credit any overpayment, in the
`fee(s) filed. or asserted to be filed. or which should have been filed herewith (or with any paper
`hereafler filed in Ms application by this firm) to our Account No. 14-1140. A d tplicate copy of this
`sheet is attached
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`PROVISIONAL
`FILING FEE
`AMOUNT (S)
`
`The invention was made by an agency of the United States Government or under a contact with an agency of the United States Government.
`IE No.
`El
`Yes. the name of the US. Govemment agency and the Government contract number are:
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`Respectfufly submitted.
`DATE
`December 16, 2003
`SIGNATURE
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`
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`REGISTRATION NO.
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`TYPED or PRINTED NAME
`
`Paul T. Bowen
`
`(WPPWP’I‘W)
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`33,009
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`I: Additional inventors are being named on separately numbered sheets attached hereto.
`
`PROVISIONAL APPLICATION FILING ONLY
`
`Burden Hour Statement: This form is estimated to take .2 hours to complete. Time will vary depending upon the needs of the individual case. Any comments on the
`amount of time you are required to complete this form should be sent to the Mail Stop Comments - Patents, Commissioner for Patents. P.O. Box I450. Alexandria. VA
`223l3-l450. and to the Office of Infomtation and Regulatory Affairs, Office of Management and Budget (Project 065 I-0031). Washington. DC 20503. DO NOT
`SEND FEES 0R COMPLETED FORMS TO THIS ADDRESS. SEND TO: Mail Stop Provisional Patent. Application, Commissioner for Patents, PO. Box 1450.
`Alexandria, VA 22313-1450.
`
`801 776
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`EXHIBIT 1017 - PAGE 1
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`Atty. Dkt. 4398-310
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`U.S. PATENT APPLICATION
`
`Inventor“):
`
`Perry David Lithgow
`Philip Rodney Kwok
`Michael Kassipillai Gunaratnam
`Richard Sokolov
`Robin Hitchcock
`Lee Veliss
`Donald Darkin
`
`Memduh Guney
`
`Invention:
`
`NAS AL ASSEMBLY
`
`NIXON & VANDERHYE RC.
`ATTORNEYS ATLAW
`
`1100 NORTH GLEBE ROAD, 8’" FLOOR
`ARLINGTON, VIRGINIA 22201-4714
`(703) 816-4000
`Facsimile (703) 816-4100
`
`SPECIEICA TION
`
`2
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`801761
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`EXHIBIT 1017 — PAGE 2
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`EXHIBIT 1017 - PAGE 2
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`NASAL ASSEMBLY
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`FIELD OF THE INVENTION
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`[0001] The present invention relates to a nasal assembly used for treatment, e.g, of Sleep
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`Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non—
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`invasive Positive Pressure Ventilation (NPPV). The disclosures (text and drawings) of U.S.
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`provisional applications nos. 60l494,119, filed August 12, 2003, 60/448,465, filed February
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`21, 2003, 60/482,872, filed June 27, 2003, and 601488310, filed July 22, 2003, are
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`incorporated by reference in their entireties by cross-reference thereto.
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`BACKGROUND OF THE INVENTION
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`[0002] Some nasal assemblies used in the treatment of SDB are designed for insertion into
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`the nasal passages of the patient. Air or other breathable gas is supplied by a blower and
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`passed along a flexible conduit to the nasal assembly.
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`[0003] The nasal assembly generally includes a relatively rigid shell, e.g., a frame, and a pair
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`of nozzles (which may be in the form of nasal pillows, nasal prongs, cannula, or nasal puffs)
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`that are mounted on the rigid shell and structured to be inserted into the nasal passages of the
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`patient. The nozzles are usually held in place using a headgear assembly, the relatively rigid
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`shell and headgear assembly being joined using some form of connector.
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`[0004] One form of known nasal assembly is described in US. Patent No. 4,282,832
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`(Trimble et al.). Trimble discloses a nasal puff assembly 20 that includes a nasal puff 22
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`adapted to be worn adjacent the nose of a patient, together with a harness assembly 24
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`adapted to be worn over the head of the patient. The harness assembly 24 is designed to
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`operatively hold puff 22 adjacent and partially within the nasal passages of the patient.
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`[0005] The puff 22 is in the form of a generally Y~shaped rigid hollow plenum chamber 28 _
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`together with a pair of laterally spaced apart nares elements 30. Adj ustability of the nares
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`elements 30 may be provided by rotatabl y mounting the elements 30 to the plenum chamber
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`28 and mounting the elements 30 in slots permitting selective lateral positioning of the
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`elements 30 with respect to each other. Also, the harness assembly 24 may be adjusted to
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`adjust the fit and seal of the nares elements 30 during use. That is, the force required to
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`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,
`url-rinI-u nnn nAuaq—nalu nFl-‘anl- nnfianl— (1anan
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`EXHIBIT 1017 - PAGE 3
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`[0006] Other examples of nasal pillows or cannula mounted to rigid shells are disclosed in
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`U.S. Patent Nos. 5,724,965 and 6,431,172.
`
`[0007] A nasal mask assembly manufactured by Viasys, i.e., Spiritus, includes a plenum
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`chamber with a pair of adjacent or laterally spaced nares elements. A harness assembly is
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`engaged with the plenum chamber to adjust the lit and seal of the nares elements during use.
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`Similar to Trimble, adjustment of the fit or stability of the nasal assembly directly affects the
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`seal, which can adversely affect patient comfort.
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`[0008] A nasal mask assembly manufactured by InnoMed, i.e., Nasal Aire, includes a plenum
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`chamber with a pair of adjacent or laterally spaced nares elements. The nares elements are
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`structured to engage within the mucosal surfaces or internal passages of the patient’s nose to
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`maintain the nasal mask assembly on the patient’s face and to provide a seal. See, e.g.. U.S.
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`Patent No. 5,533,506.
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`[0009] A nasal mask assembly manufactured by Stevenson Industries (see US. Patent No.
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`6,012,455), i.e., CPAP-Pro, includes a dental anchor, a platform, and air supply tubes having
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`nasal pads, wherein the platform supports the air supply tubes. The dental anchor is sized to
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`be engaged between the teeth in the patient‘s mouth so as to retain the assembly in place.
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`[0010] PCT Application Publication No. W0 00/ 13751 discloses a device that includes gas
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`delivery elements positioned into engagement with the patient’s nose by a mouthpiece fitted
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`to the patient’s teeth.
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`I
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`[0011] A common problem with known nasal assemblies, such as those discussed above, is
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`patient comfort. For example, the prongs tend to irritate the patient‘s nose due to the tension
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`applied by the headgear assembly that pulls the rigid shell and prongs towards the patient's
`nose.
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`[0012] Another problem is achievement of a sealing fit with the patient’s nasal passages
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`without sacrificing patient comfort.
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`[0013] Another problem is imitation of the inside of the patient’s nostrils caused by contact
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`with the prongs, e.g., an edge thereof.
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`[0014] Another problem is imitation of the inside of the patient’s nostrils caused by air jetting
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`(air flow irritation) from the prongs.
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`[0015] Another problem is adjustment of the nasal assemblies relative to the nose andfor
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`head of the patient so as to accommodate various shapes and angles of patient’s noses.
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`[0016] Still another problem is the direct association between sealing and stability forces that
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`can affect patient comfort.
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`SUMNIARY OF THE EWENTION
`
`[0017] One aspect of the invention is directed towards a nasal assembly that provides more
`comfort to the patient.
`-
`
`[0018] Another aspect of the invention is directed towards a nasal assembly that provides an
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`effective seal with the patient‘s nasal passages. Preferably, the nasal assembly is a nozzle
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`assembly including nozzles which comfortably come into contact with the external rim of the
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`nares and avoid the sensitive internal passages (e.g., mucosal surfaces or internal passages) of
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`the nasal passage.
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`[0019] Still another aspect of the invention is directed towards a nasal assembly that does not
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`rely on tension from the headgear assembly to provide an effective seal between the nozzles
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`and the patient‘s nasal passages.
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`[0020] Still another aspect of the invention is directed towards a nasal assembly that is
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`unobtrusive.
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`[0021] Still another aspect of the invention is directed towards a nasal assembly that is easy
`to use.
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`[0022] Still another aspect of the invention is directed towards a nasal assembly that
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`maintains a headgear adjustment setting.
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`[0023] Still another aspect of the invention is directed towards a nasal assembly that helps
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`decouple sealing and stability forces. Specifically, one aspect of the invention is directed
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`towards a nasal assembly that is structured such that the stability forces that act to maintain
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`the nasal assembly on the patient’s face are separated or at least better distinguished from the
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`sealing forces that act to maintain a seal between the nasal assembly and the patient‘s face.
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`[0024] Yet another aspect of the invention is directed towards a nasal assembly that provides
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`a greater range of movement for nozzles of the nasal assembly.
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`[0025] Another aspect of the invention provides a nasal assembly for delivering breath able
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`gas to a patient. The nasal assembly includes a frame having a main body and a side frame
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`member provided on each lateral side of the main body, each side frame member including an
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`integrally formed first connector portion. A nozzle assembly includes a gusset or base
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`portion and a pair of nozzles. The nozzle assembly is coupled with the main body of the
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`frame with the pair of nozzles structured to sealingly engage with nasal passages of a
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`patient‘s nose in use. A pair of inlet conduits are structured to deliver breathable gas into the
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`frame and nozzle assembly for breathing by the patient. A pair of second connector portions
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`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
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`EXHIBIT 1017 - PAGE 5
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`connectors. A headgear assembly is removably connected to at least one of the second
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`connector portions and the angle connectors so as to maintain the frame and the nozzle
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`assembly in a desired adjusted position on the patient’s face.
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`[0026] Other aspects, features and advantages of this invention will become apparent from
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`the following detailed description when taken in conjunction with the accompanying
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`drawings, which are a part of this disclosure and which illustrate, by way of example,
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`principles of this invention.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0027] The accompanying drawings facilitate an understanding of the various embodiments
`
`of this invention. In such drawings:
`
`{0028] Fig. 1' is a perSpective view illustrating a partial nasal assembly constructed in
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`accordance with an embodiment of the invention mounted to a patient’s head and engaged
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`with nasal passages of the patient;
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`[0029] Fig. 2 is a front view of a frame of the nasal 3.356me y shown in Fig. l with some parts
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`removed for clarity;
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`[0030] Fig. 3 is a cross-sectional view of the frame shown in Fig. 2;
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`[0031] Fig. 4 is a side view of the frame shown in Fig. 2;
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`[0032] Fig. 5 is a front view of a nozzle assembly of the nasal assembly shown in Fi g. I;
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`[0033] Fig. 6 is a front cross-sectional view of the nozzle assembly shown in Fig. 5;
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`[0034] Fig. 7 is a side view of the nozzle assembly shown in Fig. 5;
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`[0035] Fig. 8 is a side cross~sectional view of the nozzle assembly shown in Fig. 5;
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`[0036] Fig. 9 is a perspective view of an embodiment of an inlet conduit and headgear
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`connector assembly of the nasal assembly shown in Fig. 1;
`
`[0037] Fig. 10 is a rear perspective view of the inlet conduit and headgear connector
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`assembly shown in Fig. 9;
`
`[0038] Fig. 11 is a perspective view of another embodiment of an inlet conduit and headgear
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`connector assembly adapted to be used with the nasal assembly shown in Fig. 1;
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`[0039] Fig. 12 is a rear perspective view of the inlet conduit and headgear connector
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`assembly shown in Fig. 11;
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`[0040] Fig. 13 is a side view illustrating an over-the~head inlet conduit routing for the nasal
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`assembly showu in Fig. 1',
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`[0041] Fig. 14 is a side view illustrating an under-the-chin inlet conduit routing for the nasal
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`assembly shown in Fig. 1;
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`[0042] Fig. 15 is a perSpective view illustrating a connector for use in routing the inlet
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`conduits over the head of the patient;
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`[0043] Fig. 16 is a perspective view illustrating a connector for use in routing the inlet
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`conduits under the chin of the patient;
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`[0044] Fig. 17 is a perspective view illustrating a flow generator connector for use in
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`connecting the nasal assembly shown in Fig. l to a pressurized supply;
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`[0045] Fig. 18 is a side view illustrating an embodiment of headgear components for use with
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`the nasal assembly shown in Fig. 1;
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`[0046] Fig. 19 is a schematic view illustrating a patient’s nose having a substantially flat alar
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`angle;
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`[0047] Fig. 20 is a schematic view illustrating a patient’s nose having a substantially steep
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`alar angle;
`
`[0048] Fig. 21 is a schematic view illustrating an embodiment of a sealing zone of a nozzle;
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`[0049] Fig. 22 is a graph illustrating average nostril ratios opening/entrance;
`
`[0050] Fig. 23 is a schematic view illustrating an embodiment for calculating a base major
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`axis of a nozzle;
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`[0051] Fig. 24 is a schematic view illustrating an embodiment for calculating a base minor
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`axis of a nozzle;
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`[0052] Fig. 25 is a partial perspective view illustrating another embodiment of a nasal
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`assembly mounted to a patient‘s head and engaged with nasal passages of the patient;
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`[0053] Fig. 26 is a partial front perspective view of the nasal assembly shown in Fig. 25;
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`[0054] Fig. 27 is a cross-sectional view of the nasal assembly shown in Fig. 25;
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`[0055] Fig. 28 is a front perspective view of a frame of the nasal assembly shown in Fig. 25;
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`[0056] Fig. 29 is a rear perspective view of the frame shown in Fig. 28;
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`[0057] Fig. 30 is a partial front perSpective view of a half of the nozzle assembly of the nasal
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`assemny shown in Fi g. 25;
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`[0053] Fig. 31 is a side cross—sectional view of the nozzle assembly shown in Fig. 30;
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`[0059] Fig. 32 is a perspective view illustrating an embodiment of an inlet conduit and
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`headgear connector assembly of the nasal assembly shown in Fig. 25;
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`[0060] Fig. 33 is a rear perspective view of the inlet conduit and headgear connector
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`assembly shown in Fig. 32;
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`[0061] Fig. 34 is a cross-sectional view of the inlet conduit and headgear connector assembly
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`shown in Fig. 32 with the flexible arms in phantom;
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`{0062] Fig. 35 is a perspective view of a flow generator connector for use in connecting tubes
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`for use with the nasal assembly shown in Fig. 25 to a pressurized supply;
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`[0063] Fig. 36 is a side view illustrating the routing of the inlet conduits of the nasal
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`assembly shown in Fig. 25;
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`[0064] Fig. 37 is a side view illustrating the nasal assembly shovm in Fig. 25 mounted to a
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`patient’s head;
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`[0065] Fig. 38 is a perspective view illustrating another embodiment of a nasal assembly
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`mounted to a patient’s head and engaged with nasal passages of the patient;
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`[0066] Fig. 38B is a perSpective view illustrating an inlet conduit and an inlet conduit and
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`headgear connector of the nasal assembly shown in Fig. 38;
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`[0067] Fig. 39 is a perspective view of the nasal assembly shown in Fig. 38;
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`[0068] Fig. 40 is a perspective view of a frame of the nasal assembly shown in Fig. 38;
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`[0069] Fig. 41 is a perspective view of a nozzle assembly of the nasal assembly shown in Fig.
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`38;
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`[0070] Fig. 42 is a perspective view illustrating the nozzle assembly shown in Fig. 41
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`mounted to the frame to shown in Fig. 40;
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`[0071] Fig. 43 is a cross-sectional view of the nasal assembly shown in Fig. 38;
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`[0072] Fig. 44 is a side cross-sectional view of the nasal assembly shown in Fig. 38‘.
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`[0073] Fig. 45 is a side view illustrating the nasal assembly shown in Fig. 38 mounted to a
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`patient’s head showing two inlet configurations;
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`[0074] Fig. 46 is a schematic force diagram illustrating some of the forces that are developed
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`when the nasal assembly shown in Fig. 38 is mounted to the patient’s head;
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`[0075] Fig. 47 is a cross-sectional view of an embodiment of an inlet conduit engaged with
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`an embodiment of an angle connector for delivering breathable gas;
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`[0076] Fig. 473 is a perspective view illustrating another embodiment of an inlet conduit;
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`[0077] Fig. 48 is a cross-sectional view illustrating another embodiment of an inlet conduit
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`engaged with another embodiment of a flow generator connector for delivering breathable
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`gas;
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`[0078] Fig. 483 is perspective view illustrating another embodiment of an inlet conduit;
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`[0079] Fig. 49 is a perspective view illustrating an embodiment of an inlet conduit of the
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`nasal assembly shown in Fig. 38;
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`[0080] Fig. 50 is a side view illustrating the nasal assembly shown in Fig. 38 prior to
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`engagement with nasal passages of the patient;
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`[0081] Fig. 51 is a front View illustrating the nasal assembly shown in Fig. 38 (in cross-
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`section) engaged with nasal passages of the patient;
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`[0082] Fig. 52 is a perspective view illustrating another embodiment of a nasal assembly
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`mounted to a patient’s head and engaged with nasal passages of the patient with two inlet
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`configurations shown;
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`{0083] Fig. 53 is a perspective view illustrating the nasal assembly shown in Fig. 52;
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`[0084] Fig. 54 is a cross—sectional view illustrating a nozzle assembly being engaged with a
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`frame of the nasal assembly shown in Fig. 52-;
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`[0085] Fig. 55 is a perspective view illustrating an inlet conduit and headgear connector
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`assembly of the nasal assembly shown in Fig. 52;
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`[0086] Fig. 56 is a cross—sectional view illustrating the inlet conduit and headgear connector
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`assembly of the nasal assembly shown in Fig. 52;
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`[0087] Fig. 57 is a cross-sectional side view illustrating the nasal assembly shown in Fig. 52
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`about to be engaged with nasal passages of the patient;
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`[0088] Fig. 58 is a front view illustrating the nasal assembly shown in Fig. 52 (in cross-
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`section) being engaged with nasal passages of the patient;
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`[0089] Fig. 59 is a perspective view illustrating another embodiment of a nasal assembly
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`mounted to a patient’s head and engaged with nasal passages of the patient;
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`[0090] Fig. 60 is a perspective view of the nasal assembly shown in Fig. 59 removed from a
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`patient’s head;
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`[0091] Fig. 61 is an exploded view of a portion of the nasal assembly shown in Fig. 59
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`illustrating the frame, nozzle assembly, and clip thereof;
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`[0092] Fig. 62 is a perspective view of a portion of the nasal assembly shown in Fig. 59
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`illustrating the clip being engaged with the frame and nozzle assembly;
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`[0093] Fig. 63 is a perspective view of a portion of the nasal assembly shown in Fig. 59
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`illustrating the engagement between the frame, nozzle assembly, and clip;
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`[0094] Fig. 64 is a partial cross-sectional view of a portion of the nasal assembly shown in
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`Fig. 59 illustrating the engagement between the frame, nozzle assembly, and clip;
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`[0095] Fig. 65 is atop perspective view of a portion of the nasal assembly shown in Fig. 59;
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`[0096] Fig. 65A is a partial enlarged view of the cushion shown in Fig. 65;
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`[0097] Fig. 65B is a schematic diagram illustrating force distribution according to one aspect
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`of the present invention;
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`[0098] Fig. 66 is a rear perspective view of a portion of an alternative embodiment of a nasal
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`assembly illustrating the engagement between the frame, nozzle assembly, and clip;
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`[0099] Fig. 67 is a rear perspective illustrating the engagement between another embodiment
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`of the frame, nozzle assembly, and clip;
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`[00100]
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`Fig. 68 is a perspective view illustrating the nozzle assembly shown in Fig. 66
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`being engaged with the frame shown in Fig. 66;
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`[00101]
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`Fig. 69 is a perspective view illustrating the nozzle assembly shown in Fig. 67
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`being engaged with the frame shown in Fig. 67;
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`[00102]
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`Fig. 70 is a perspective view illustrating the clip shown in Fig. 66 being engaged
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`with the frame and nozzle assembly ShOWn in Fig. 66‘,
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`[00103]
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`Fig. 71 is a perspective view illustrating the clip shown in Fig. 67 being engaged
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`with the frame and nozzle assembly showu in Fig. 67;
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`[00104]
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`Fig. 72 is a perspective view of a second connector portion of the nasal assembly
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`shown in Fig. 59;
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`[00105]
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`Fig. 73 is a cross-sectional view of a portion of the nasal assembly shown in Fig.
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`59 illustrating the engagement between the frame, second connector portion, and angle
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`connector;
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`[00106]
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`Fig. 74 is a perspective view of an angle connector of the nasal assembly shown in
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`Fig. 59;
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`[0010?]
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`Fig. 74B is a persPective similar to Fig. 7'4 but at a different angle;
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`[00108]
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`Fig. 75 is a side view of the angle connector shown in Fig. 74;
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`[00109]
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`Fig. 76 is a cross-sectional view of the angle connector shown in Fig. 74;
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`[00110]
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`Fig. 76A illustrates another embodiment of the present invention;
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`[00111]
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`Fig. 76B is an exploded view of Fig. 76A;
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`[00112]
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`Fig- 76C illustrates a second connector portion of the assembly of Fig. 76A;
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`[00113]
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`Fig. 76D illustrates an angle connector used in the assembly of Fig. 76A;
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`[00114]
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`Fig. 77 is a perspective view of a flow generator connector of the nasal assembly
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`shown in Fig. 59;
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`[00115]
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`Fig. 78 is a cross-sectional view of the flow generator connector shown in Fig. 77;
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`[00116]
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`Fig. 79 is a cross-sectional view of an embodiment of an inlet conduit of the nasal
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`assembly showu in Fig. 59;
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`[00117]
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`Fig. 80 is a perspective view of headgear yoke of the headgear assembly of the
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`nasal assembly shown in Fig. 59;
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`[00118]
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`Fig. 81 is a perspective view illustrating engagement between the headgear yoke
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`(Fig. 80) and angle connector (Fi g. 74);
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`[00119]
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`Fig. 82 is a cross-section through line 82-82 of Pi g. 81;
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`[00120]
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`Fig. 83 is a perspective view of a headgear buckle of the nasal assembly shown in
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`Fig. 59;
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`[00121]
`
`Fig. 84 is a perspective view of the nasal assembly shown in Fig. 59 illustrating
`
`the routing of the headgear assembly;
`
`[00122]
`
`Fig. 85 is another perSpective view of the nasal assembly shown in Fig. 59
`
`illustrating the routing of the headgear assembly;
`
`[00123]
`
`Fig. 86 is a top view illustrating a nasal assembly constructed in accordance with
`
`an embodiment of the invention;
`
`[00124]
`
`Fig. 87 is a side view of the nasal assembly shown in Fig. 86;
`
`[00125]
`
`Fig. 88 is a bottom view of the nasal assembly shown in Fig. 86;
`
`[00126]
`
`Fig. 89 is an exploded view of a portion of the nasal assembly shown in Fig. 86;
`
`[00127]
`
`Fig. 90 is a perspective view of a portion of an embodiment of a nasal assembly;
`
`[00128]
`
`Fig. 91 is a top view of a headgear connector according to an alternative
`
`embodiment of the invention;
`
`[00129]
`
`Fig. 92 is a perspective view of an upper portion of a central conduit of the nasal
`
`assembly shown in Fig. 90;
`
`[00130]
`
`Fig. 93 is a top view of the upper portion of the central conduit shown in Fig. 92;
`
`[00131]
`
`Fig. 94 is a perspective View of a lower portion of a central conduit of the nasal
`
`assembly shown in Fig. 90;
`
`[00132]
`
`Fig. 95 is a bottom view of the lower portion of the central conduit shown in Fig.
`
`94;
`
`[00133]
`
`Fig. 96 is a perspective view of an inlet conduit of the nasal assembly shOWn in
`
`Fig. 86;
`
`[00134]
`
`Fig. 96A is a schematic view of a Y-shaped inlet connector of the nasal assembly
`
`shown in Fig. 86;
`
`[00135]
`
`Fig. 97 is a perspective view of an inlet connector of the nasal assembly shown in
`
`Fig. 86;
`
`[00136]
`
`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;
`
`[00137]
`
`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;
`
`[00138]
`
`Fig. 98 is a perspective view of another embodiment of a nasal assembly;
`
`[00139]
`
`Fig. 99 is an enlarged perspective view of nozzles and a gusset portion of the nasal
`
`assembly shOWn in Fig. 98;
`
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`EXHIBIT 1017 - PAGE 11
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`[00140]
`
`Fig. 100 is an enlarged perspective view of inlet conduits of the nasal assembly
`
`shown in Fig. 98;
`
`[00141]
`
`Fig. 101 is a front perspective view illustrating the nasal assembly shown in Fig.
`
`98 mounted to a patient’s head;
`
`[00142]
`
`Fig. 102 is a rear perspective view illustrating the nasal assembly shown in Fig. 98
`
`mounted to a patient’s head;
`
`[00143]
`
`Fig. 103 is a front perspective view illustrating the nasal assembly shown in Fig.
`
`98 engaged with nasal passages of the patient;
`
`[00144]
`
`Fig. 104 is a side perspective view illustrating the nasal assembly shown in Fig. 98
`
`engaged with the nasal passages of the patient;
`
`[00145]
`
`Fig. 105 is a side view illustrating the nasal assembly shown in Fig. 98 engaged
`
`with the nasal passages of the patient;
`
`[00146]
`
`Fig. 106 is a front perspective view illustrating the nasal assembly shown in Fig.
`
`98 engaged with nasal passages of the patient;
`
`[00147]
`
`Fig. 107 is a perspective view of another embodiment of a nasal assembly
`
`mounted to a patient's head;
`
`[00148]
`
`Fig. 107-1 is a perspective view of yet another embodiment of the present
`
`invention;
`
`[00149]
`
`Figs. 107A- 107C illustrate yet another alternative embodiment of the present
`
`invention;
`
`[00150]
`
`Figs. 107D and 1071-3 illustrate still another embodiment according to the present
`
`invention;
`
`[00151]
`
`Fig. 1071-1 illustrates another alternative embodiment of the present invention;
`
`[00152]
`
`Figs. 107G and 107H illustrate another alternative embodiment of the present
`
`invention;
`
`[00153]
`
`Fig. 107I illustrates still another embodiment of the present invention;
`
`[00154]
`
`Fig. 107] illustrates yet another alternative embodiment of the present invention;
`
`[00155]
`
`Figs. 107K and 107L illustrate yet another embodiment of the present invention;
`
`[00156]
`
`Figs. 107M-107Q illustrate cross-sections of alternative nozzles according to the
`
`present invention;
`
`[00157]
`
`Fig. 107R illustrates a perspective view of two nozzles like the nozzle shown in
`
`Fig. 107Q;
`
`[00158]
`
`Fig. 108 is a perspective view of yet another embodiment of a nasal assembly;
`
`[00159]
`
`Figs. 108A and 108B illustrate a tube retainer according to the present invention;
`10
`
`12
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`EXHIBIT 1017 - PAGE 12
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`[00160]
`
`Fig. 109 is an isometric view illustrating a portion of the nasal assembly shown in
`
`Fig. 108;
`
`[00161]
`
`Fig. 110 is a cross-sectional view of a portion of a nasal assembly according to the
`
`present invention;
`
`[00162]
`
`Figs. 110-1 and 110-2 illustrate mess-sectional views of a vent aperture according
`
`to the present invention;
`
`[00163]
`
`Fig. 110A is a partial enlarged cross-sectional view of the left hand side of Fig.
`
`110;
`
`[00164]
`
`Fig. 1108 is an partial enlarged cross-sectional view of the right hand side of Fig.
`
`l 10;
`
`[00165]
`
`Fig. 111 is an exploded perspective view showing the interface between Seal ring
`
`and elbow swivel according to an embodiment of the present invention;
`
`[00166]
`
`Fig. 112 is a partial cross-sectional view of a portion of the mask assembly shown
`
`in Fig. 103;
`
`[00167]
`
`Fig. 113 illustrates still another embodiment of the present invention with an
`
`integral plug and seal assembly; and
`
`[00168]
`
`Figs. 114-126 illustrate yet another embodiment of the present invention.
`
`DETAILED DESCRIPTION OF ILLUSTRATED ENIBODIMENTS
`
`[00169]
`
`The following includes descriptions of several main illustrated embodiments of
`
`the present invention. Each illustrated main embodiment includes features that may be used
`
`with andfor in the other embodiments, as would be apparent to those of ordinary skill in the
`art.
`
`FIRST ILLUSTRATED EMBODIMENT
`
`[00170]
`
`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 assembiy 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
`11
`
`13
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`EXHIBIT 1017 - PAGE 13
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`EXHIBIT 1017 - PAGE 13
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`

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`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) previded 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.
`
`[09171]
`
`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 frame 16 is a rigid or semi-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.
`
`[00172]
`
`Each side frame member 32 includes a first connector portion 24 that is integrally
`
`formed therewith. As best shown in Fi gs. 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
`
`interlock with the second connector portion 26 to prevent axial disengagement of the second
`
`connector portion 26 from the first connector portion 24. The indexing section 36 is
`
`structured to ratchet/detent with the second connector portion 26 to allow selective
`
`circumferential adjustment of the second connector portion 26 with respect to the first
`
`connector portion 24 about an axis during fit whilst remaining "locked" in adjusted position
`
`during usage.
`
`[00173]
`
`Specifically, the connecting section 34 of each side frame member 32 includes a
`
`series of grooves or slots 37 that separates the connecting section 34 into a plurality of
`
`resiliently flexible arms 38 that are structured to flex radially inwardly and outwardly. Each
`
`arm 38 provides a rib portion 40 at the free end thereof. In use, the rib portions 40 of the
`
`plurality of arms 38 are adapted to engage with correSponding portions of the second
`
`connector portion 26 for coupling the first and second connector portions 24, 26 with one
`
`another. For example, the first and second connector portions 24, 26 interlock with one
`
`another to prevent accidental disengag