IN THE UNITED STATES
`
`PATENT AND TRADEMARK OFFICE
`
`PATENT
`
`) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )
`
`Serial No.:
`
`' Not yet assigned
`
`Applicant:
`
`McAuley et al.
`
`Filed:
`
`Herewith
`
`For:
`
`BREATHING
`
`ASSISTANCE
`APPARATUS
`
`Examiner:
`
`Not yet assigned
`
`Art Unit:
`
`Not yet assigned
`
`20
`
`Attorney Docket N0.:
`1 171/48067/202-PCT-US
`
`PRELIMINARY AMENDMENT
`
`25
`
`Commissioner
`
`for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`30
`
`Prior to examination of the aboVe—identified patent application, kindly amend the
`
`application as follows:
`
`RMD1009
`
`1
`
`RMD 1009
`
`

`
`IN THE SPECIFICATION:
`
`After the title, please add the following paragraph:
`
`This application is a National Phase filing of PCT/NZ2007/O00185,ehaving an
`
`International filing date of July 13, 2007, which disclosure is herein incorporated by reference.
`
`2
`
`

`
`IN THE CLAIMS:
`
`(Original) Headgear for use with a respiratory mask comprising:
`
`a continuous and substantially curved elongate member extending in use below a patient’s
`
`at least two headgear straps capable of attachment to the ends of said elongate member,
`
`a mask attachment on said elongate member disposed to sit below or on one of said user's
`
`nose, mouth, upper lip and an inlet to the mask, said attachment capable of receiving said mask.
`
`2.
`
`(Original) Headgear according to claim I wherein said at least two straps are
`
`substantially flexible, soft straps each extending down a user's cheekbones in use and terminating
`
`at each of said strap's ends in said user's upper lip area and said a substantial portion of said
`
`elongate member is attached to each of said straps.
`
`3.
`
`(Original) Headgear according to claim 2 wherein the length of said at least two straps
`
`that extends in use along said user's cheekbones is attached to said elongate member, said
`
`elongate member providing rigidity to said length of said at least two straps.
`
`4.
`
`(Original) Headgear according to claim 1 wherein said elongate member has two ends
`
`each of which is attached to one of said at least two straps, said elongate member having at least
`
`one pad extending along the inner side of the elongate member in at least the areas where the
`
`-3-
`
`3
`
`

`
`elongate member is incident on said patient's cheekbones.
`
`5.
`
`(Original) Headgear according to claim 4 wherein said at least one pad are substantially
`
`the same width as said elongate member.
`
`6.
`
`(Currently Amended) Headgear according to any-orrire-f-claims claim 1 to-S wherein said
`
`continuous elongate member is substantially rigid compared to said straps.
`
`7.
`
`(Currently Amended) Headgear according to anyeoneof-claiins claim 1 orfi wherein said
`
`continuous elongate member includes two side arms and a central section.
`
`8.
`
`(Original) Headgear according to claim 7 wherein said side arms and said central section
`
`are formed as a single item.
`
`9.
`
`(Original) Headgear according to claim 7 or 8 wherein said at least one pad is two pads
`
`one each extendingusubstantially along the length ofeach said side arm.
`
`10.
`
`(Original) Headgear according to claim 7 wherein said side arms and said central section
`
`are formed as two separate items.
`
`11.
`
`(Currently Amended) Headgear according to any-oieelaints claim 7 to-1-6 wherein said
`
`side arms have at least one weakened or narrow area to allow for manipulation of said side arms.
`
`-4-
`
`4
`
`

`
`12.
`
`(Currently Amended) Headgear according to any-of-claims claim 7 to-1+ wherein a mask
`
`base is capable of frictionally fitting to said central section, such that said central section places
`
`said mask base near a breathing orifice of a user.
`
`13.
`
`(Original) Headgear according to claim 12 wherein said mask base is integrally formed
`
`with said central section.
`
`14.
`
`(Currently Amended) Headgear according to any-ofela-in-rs claim 1 to-l-3 wherein said
`
`curved elongate member is moulded in a three dimensional manner to fit the contours of said
`
`10
`
`patient's cheeks.
`
`15.
`
`(Original) A breathing assistance apparatus for use with delivery of respiratory gases to a
`
`user comprising:
`
`a mask having a base and body, said body having two flexible nasal pillows that in use
`
`15
`
`rest in a substantially sealed manner against said user's nares,
`
`a continuous and substantially curved elongate member extending in use below a patient's
`
`at least two headgear straps capable of attachment to the ends of said elongate member,
`
`a mask attachment on said elongate member disposed below said user's nose, said
`
`attachment capable of receiving said mask.
`
`5
`
`

`
`16.
`
`(Original) A breathing assistance apparatus according to claim 15 wherein said at least
`
`two straps are substantially flexible, soft straps each extending down a user's cheekbones in use
`
`and terminating at each of said strap's ends in said user's upper lip area and said a substantial
`
`portion of said elongate member is attached to each of said straps.
`
`17.
`
`(Original) A breathing assistance apparatus according to claim 15 wherein the length of
`
`said at least two straps that extends in use along said user's cheekbones is attached to said
`
`elongate member, said elongate member providing rigidity to said length of said at least two
`
`straps.
`
`18.
`
`(Original) A breathing assistance apparatus according to claim 15 wherein said elongate
`
`member has two ends each of which is attached to one of said at least two straps, said elongate
`
`member having at least one pad extending along the inner side of the elongate member in at least
`
`the areas where the elongate member is incident on said patient's cheekbones.
`
`19.
`
`(Original) A breathing assistance apparatus according to claim 18 wherein said at least
`
`one pad are substantially the same width as said elongate member.
`
`20.
`
`(Currently Amended) A breathing assistance apparatus according to any-one-oilci-ahns
`
`claim 15 to-l9 wherein said continuous elongate member is substantially rigid compared to said
`
`straps.
`
`6
`
`

`
`21.
`
`(Currently Amended) A breathing assistance apparatus according to any-one-ofielaims
`
`claim 15 orafi wherein said nasal pillows are substantially elliptical and have gases outlets that
`
`are offset from the centre of said elliptical pillows.
`
`22.
`
`(Currently Amended) A breathing assistance apparatus according to one-of-cwl-aims claim
`
`15 150-22 wherein said breathing assistance apparatus includes humidification means adapted to,
`
`in use, be in fluid communication with said source of gases and said transportation means and
`
`adapted to in use hurnidify said gases.
`
`23.
`
`(Currently Amended) A breathing assistance apparatus according to anyeonceef-claims
`
`claim 15 toaé} wherein said continuous elongate member includes two side arms and a central
`
`section.
`
`24.
`
`(Original) A breathing assistance apparatus according to claim 23 wherein said side arms
`
`and said central section are formed as a single item.
`
`25.
`
`(Original) A breathing assistance apparatus according to claim 23 wherein said side arms
`
`and said central section are formed as two separate items.
`
`26.
`
`(Original) A breathing assistance apparatus according to claim 18 wherein said at least
`
`one pad is two pads one each extending substantially along the length of each said side arm.
`
`10
`
`15
`
`20
`
`7
`
`

`
`27.
`
`(Currently Amended) A breathing assistance apparatus according to arty-of-cl-ainrs claim
`
`23 to-26 wherein said side arms have at least one weakened or narrow area to allow for
`
`manipulation of said side arms.
`
`28.
`
`(Currently Amended) A breathing assistance apparatus according to any-of-claims claim
`
`23 150%? wherein said base frictionally fits to said central section, and said body to said base, such
`
`that said central section suspends said base below said user's nares, and when said body is
`
`attached to said base, said nasal pillows rest against said user's nares.
`
`29.
`
`(Currently Amended) A breathing assistance apparatus according to any-of-claims claim
`
`23 to£8 wherein said base is integrally formed with said central section.
`
`30.
`
`(Currently Amended) A breathing assistance apparatus according to airy-of-ciain-rs claim
`
`23 to7”}9 wherein said side arms attach one to each side of said base.
`
`31.
`
`(Currently Amended) A breathing assistance apparatus according to a1-ry~o=F-e-la-ims claim
`
`15 to-36 wherein said curved elongate member is moulded in a three dimensional manner to fit
`
`the contours of said user's cheeks.
`
`'
`
`32 - 37. (Cancelled)
`
`8
`
`

`
`REMARKS
`
`Applicant has amended the specification to reference the International‘ application and has
`
`amended the claims to provide proper dependencies in accordance with United States practice.
`
`Entry is requested.
`
`If the Examiner has any questions regarding this Amendment, the Examiner is invited to
`
`Contact one of the undersigned at 312/704—l890.
`
`Respectfully submitted,
`
`Linda L. Palomar, Reg. No. 37,903
`TREXLER, BUSHNELL, GIANGIORGI
`BLACKSTONE & MARR, LTD.
`105 W. Adams Street
`Suite 3600
`
`Chicago, Illinois 60603
`(312) 704-1890
`
`AS2911-LWPD
`
`9
`
`

`
`‘
`
`l 171/48067/202-PCT—US
`
`DECLARATION AND POWER OF ATTORNEY FOR PATENT APPLICATION
`
`My residence, post office address and citizenship are as stated below next to my name,
`
`I believe I am the original, first and sole inventor (if only one name is listed below) or an original, first and joint inventor (if
`plural names are listed below) of the subject matter which is claimed and for which a patent is sought on the invention entitled:
`BREATHING ASSISTANCE APPARATUS the specification of which
`
`(check one)
`
`]
`[
`[X ]
`
`is attached hereto.
`as Application Serial No. PCT/NZ2007/000185
`was filed on July 13, 2007
`and was amended on Januag 8, 2009.
`
`I hereby state that I have reviewed and understand the contents of the above identified specification, including the claims, as
`amended by any amendment referred to above.
`
`I acknowledge the duty to disclose information which is material to patentability as defined in Title 37, Code of Federal
`Regulations, §l.S6.
`
`I hereby claim foreign priority benefits under Title 35, United States Code, §l l9(a)—(d) of any foreign application(s) for patent
`or inventor's certificate listed below and have also identified below any foreign application for patent or inventor's certificate
`having a filing date before that of the application on which priority is claimed:
`
`Prior Foreign Application(s)
`
`Priority Claimed
`
`548575
`(Number)
`
`551103
`(Number)
`
`New Zealand
`(Country)
`
`New Zealand
`(Country)
`
`Prior Provisional Application(s)
`
`14 July 2006
`(Day/Month/Year Filed)
`
`06 November 2006‘
`(Day/Month/Year Filed)
`
`[X]
`Yes
`
`[X ]
`Yes
`
`[
`
`]
`No
`
`[
`
`]
`No
`
`I hereby claim the benefit under Title 35, United States Code, §l19(e) of any United States provisional application(s) listed
`below.
`
`(Application Number)
`
`(Filing Date)
`
`(Application Number)
`
`(Filing Date)
`
`I hereby claim the benefit under Title 35, United States Code, §l2O of any United States applieation(s) listed below; insofar as
`the subject matter of each of the claims of this application is not disclosed in the prior United States application in the manner
`provided by the first paragraph of Title 35, United States Code, {$1 12, I acknowledge the duty to disclose material information
`as defined in Title 37, Code ofFederal Regulations, §l.56(a) which occurred between the filing date ofthe prior application and
`the national or PCT international filing date of this application:
`
`(Application Serial No.)
`
`(Filing Date)
`
`(Status: patented, pending, abandoned)
`
`A83567.WPD
`TREXLER, BUSHNELL. GIANGIORGI. BLACKSTONE 8; MARR, LTD. 0 105 W. ADAMS ST. 0 CHICAGO. ILLINOIS 60603 I.(312) 704-1890
`
`10
`
`

`
`POWER OF ATTORNEY: As a named inventor, I hereby appoint the following attorney(s) and/or agent(s) to prosecute this
`application and transact all business in tlie Patent and Trademark Office connected therewith: Richard A. Giangiorgi, Reg.
`24,284; Raiford A. Blackstone, Jr., Reg. 25,156; David J. Marr, Reg. 32,915; Linda L. Palomar, Reg. 37,903; James R. Foley,
`Reg. 39,979; James A. O’Malley, Reg. 45,952; Timothy M. McCarthy, Reg. 42,855; and Paige A. Kitzinger, Reg. 45,219.
`
`SEND CORRESPONDENCE TO:
`
`TREXLER, BUSHNELL, GIANGIORGI, BLACKSTONE & MARR, LTD.
`105 W. ADAMS STREET, CHICAGO, IL 60603
`
`DIRECT TELEPHONE CALLS TO:
`
`(312) 704-1890
`
`Raiford A. Blackstone, Esg.
`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
`
`Full name of sole or first inventor
`
`ALASTAIR EDWIN McAULEY
`
`Inventor's signature
`Residence City Auckland
`Citizenship
`New Zealand
`Post Office Address
`58A Ngapuhi Road, Remuera Auckland, New Zealand
`
`New Zealand
`
`Country
`
`Date
`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
`
`Full name of second inventor
`Inventor's signature
`Residence City Auckland
`Citizenship
`New Zealand
`Post Office Address
`19A Ropata Avenue, Point England, Auckland, New Zealand
`
`Country
`
`New Zealand
`
`OLIVER GLEESON
`
`Date
`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
`
`Full name of third inventor
`
`EVAN STUART ERSTICH
`
`Inventor's signature
`Residence City Auckland
`Citizenship
`New Zealand
`Post Office Address
`100 Main Highway, Ellerslie, Auckland, New Zealand
`
`New Zealand
`
`Country
`
`Date -
`
`Aa3567_wPD
`TREXLER. BUSHNELL, GIANGIORGI. BLACKSTONE 8: MARR, LTD. 0 105 W. ADAMS ST. 0 CHICAGO, ILLINOIS 60603 0 (312) 704-1890
`
`11
`
`

`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imp1‘is0nment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
`
`A
`
`Full name of fourth inventor
`
`SIMON ERIC FREEMAN
`
`Inventor's signature
`Residence City Auckland
`Citizenship
`New Zealand
`Post Office Address
`53 Glenvar Road, Torbay, Auckland, New Zealand
`
`New Zealand
`
`Country
`
`Date
`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
`
`Full name of fifth inventor
`
`NEIL GLEN DAVIES
`
`Inventor's signature
`Residence City Auckland
`Citizenship
`New Zealand
`Post Office Address
`22A Browns Avenue, Pakuranga, Auckland, New Zealand
`
`New Zealand
`
`Country
`
`Date
`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that Such willful false statements may jeopardize the validity of the a.pplication or any patent issued thereon.
`
`Full name of sixth inventor
`
`S'l‘l:'}’HEN J01-IN SCHOENBBRG
`
`Inventor's signature
`Country
`Residence City Auckland
`Citizenship
`United States of America
`Post Office Address
`4/73 Waiatarua Road, Remuera, Auckland, New Zealand
`
`New Zealand
`
`Date
`
`Ibereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`bclicfarc believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
`
`Full name of seventh inventor
`
`KAMMAN LAW
`
`Inventor's signature
`Residence City Auckland
`Citizenship
`Post Office Address
`
`Country
`
`New Zealand
`
`New Zealand
`1616 Dominion Road Extension, Mt. Roskill, Auckland, New Zealand
`
`Date
`
`A8
`
`7.wPD
`356 TREXLER, BUSHNELL, GIANGIORGI, BLACKSTONE 8: MARR, LTD. I 105 W. ADAMS ST. 0 CHICAGO, ILLINOIS 60603 O (312) ?'04~1890
`l
`
`12
`
`

`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and
`belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and
`the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
`
`Full name of eighth inventor
`Inventor's signature
`Residence City Auckland
`Citizenship
`New Zealand
`Post Office Address
`95 Kiwi Esplanade, Mangere Bridge, Auckland, New Zealand
`
`CRAIG ROBERT PRENTICE
`
`Country
`
`New Zealand
`
`Date
`
`TREXLER. BUSHNELL, GIANGIORGI. BLACKSTONE & MARR, LTD. 0 105 W. ADAMS ST. I CHICAGO, ILLINOIS 60603 O (312) 704-1590
`A83567‘.WFD
`
`13
`
`

`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`17 January 2008 (17.01.2008)
`
`(10) International Publication Numb er
`W0 2008/007985 A1
`
`Point England, Auckland, 1072 (NZ). FREEMAN, Si-
`mon, Eric [NYJNZ]; 53 Glenvar Road, Torbay, Auckland,
`0630 (NZ). DAVIES, Neil, Glen [NZ/NZ]; 22A Browns
`Avenue, Pakuranga, Auckland, 2010 (NZ). SCHOEN-
`BERG, Stephen, John [US/NZ]; 4178 Waiataxua Road,
`Remuera, Auckland, 1050 (NZ). LAW, Kaman [NZ/NZ];
`1616 Dominion Road Extension, Mt Roskill, Auckland,
`1041 (NZ). PRENTICE, Craig, Robert [NZINZ]; 95
`Kiwi Esplanade, Mangere, Auckland, 2022 (NZ).
`
`Agents: ADAMS, Matthew, D et al.; A .1 Park, 6th Floor
`Huddart Parker Building, PO Box 949, Wellington, 6015
`(NZ).
`'
`
`Designated States (unless otherwise indicated, for every
`kind of national’ protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH,
`CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, BE, EG,
`ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, 11:.
`IN, IS, JP, KE, KG, KM, KN, KP, KR, K7., LA, LC, l.K,
`LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW,
`MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PII, PL,
`
`[Continued on next page]
`
`(74)
`
`(81)
`
`(57) Abstract: Headgear for use with
`a respiratory mask is described. The
`headgear comprises a continuous and
`substantially curved elongate member
`extending in use below a user’s nose
`and at least two headgear straps capable
`of attachment to the ends of the elongate
`member. A mask attachment on the
`
`is disposed to sit
`elongate member
`below or on one of said user's nose,
`mouth, upper lip and an inlet
`to the
`mask. The attachment
`is capable of
`receiving the mask.
`
`(51) International Patent Classification:
`AQIIM 16/06 (2006.01)
`(21) International Application Number:
`PCP/NZ2007/000] 85
`
`(22) International Filing Date:
`(25) Filing Language:
`(26) Publication Language:
`(30) Priority Data:
`548575
`551103
`
`13 July 2007 (13.07.2007)
`English
`English
`
`14 July 2006 (14.07.2006) NZ
`6 November 2006 (06.11.2006) NZ
`
`(71) Applicant (far all designated States except‘ US): FISHER
`& PAYKEL HEALTHCARE LIIVIITED [NZ/NZ]; 15
`Maurice Paykel Place, East Tamaki, Auckland, 0213 (NZ).
`(72) Inventors; and
`.
`('75) lnventorslApplicants
`(for US only): MCAULEY,
`Alastair, Edwin [NZJNZ]; 58A Ngapuhi Road, Re»
`muera, Auckland, 1050 (NZ). ERSTICH, Evan, Stuart
`[NZINZ]; 100 Main Highway, Ellerslic, Auckland, 1051
`(NZ). GLEESON, Oliver [NZINZ]; 19A Ropata Avenue,
`
`(54) Title: BREATHING ASSISTANCE APPARATUS
`
`fl I
`
`<3
`
`In
`on
`ex
`r~
`
`= 3n
`
`oaoN §
`
`14
`
`

`
`WO 2008/007985 A1
`
`Il||||||||||l|l|||||||||||||||l||||||||||l|||||||||||l|ll|||||||||||l||||l|||l||||||||ll||l|I||
`
`PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY,
`TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA,
`ZM, ZW.
`
`. PT, RO, SE, SI, SK, TR), OAPI (BEBJ, CF. CG, CI, CM,
`GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published?
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH, " With iTlF9"1flfI'07ifl1'S€a"C71 MP0"
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`_
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`For Iwo—lettercode.s' and other abbrevialiorzs, refer to the "Guid-
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, 171,
`once Notes on Codes arzdAbbreviotion.s"’ appearing at the begin-
`FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, MT, NL, PL,
`hing ofeach regular issue ofthe PCT Gazelte.
`
`15
`
`

`
`WO 2008/007985
`
`PCTlNZ2007l0l]0185
`
`BREATHING ASSISTANCE APPARATUS
`
`BACKGROUND or THE INVENTION
`
`Technical Field
`The present invention relates to apparatus for treating sleep apnoea. More specifically,
`the present invention provides a nasal interface for the supply of respiratory gases, but most
`
`particularly positive pressure gases.
`
`Summary of the Prior Art
`In the art of respiration devices, a variety of respiratory masks which cover the nose
`
`and/or mouth of a human user in order to provide a continuous seal around the nasal and/or
`
`'oral areas of the face are well known. Masks that provide gas at positive pressure within the
`mask for consumption by the user are also well known. The uses for such masks range from
`high altitude breathing (i.e., aviation applications) to
`and tire fighting applications, to
`
`various medical diagnostic and therapeutic applications.
`
`Obstructive Sleep Apnoea (OSA) is a sleep disorder that affects up to at least 5% ofthe
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`population in which muscles that normally hold the airway open relax and ultirnately collapse,
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`sealing the airway. The sleep pattern of an OSA sufferer is characterised by repeated
`sequences of snoring, breathing difficulty, lack of breathing, waking with a start and then
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`returning to sleep. Often the sufferer is unaware ofthis pattern occurring. Sufferers of OSA
`usually experience daytime drowsiness and irritability due to a lack ofgood continuous sleep.
`In an effort to treat OSA sufferers, a technique known as Continuous Positive Airway
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`Pressure (CPAP) was devised. A CPAP device consists of a gases supply (or blower) with a
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`conduit connected to supply pressurised gases to a patient, usually through a nasal mask. The
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`pressurised air supplied to the patient effectively assists the muscles to keep the patient’s
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`airway open, eliminating the typical OSA sleep pattern.
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`The procedure for administering CPAP treatment has been well documented in both
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`the technical and patent literature. Briefly stated, CPAP treatment acts as apneumatic splint of
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`the airway by the provision of a positive pressure, usually in the range 4 to 20 cm H20. The
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`air is supplied to the airway by a motor driven blower whose outlet passes via an air delivery
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`hose to a nose, full face, nose and mouth, or oral mask that is sealingly engaged to a patient’s
`face, preferably by means of a harness or other headgear. An exhaust port is usually also
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`provided in the delivery tube proximate to the mask or on the mask itself. More sophisticated
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`forms ofpositive airway pressure devices, such as bi-level devices_ and auto-titrating devices,
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`are described in US Patent No. 5,148,802 of Respironics, Inc. and US PatentNo. 5,245,995 of
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`Rescare Limited, respectively.
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`One requisite of respiratory masks has been that they provide an effective seal against
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`the user’s face to prevent leakage of the gas being supplied. ' Commonly, in prior mask
`configurations, a good mask—to—face seal has been attained in many instances only with
`considerable discomfort for the user. A common complaint of a user of CPAP therapy is
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`pressure sores caused by the mask about the nose and face and in particular in the nasal bridge
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`region of the user. This problem is most crucial in those applications, especially medical
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`' applications, which require the user to wear such a mask continuously for hours or perhaps
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`even days.
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`In such situations, the user will not tolerate the mask for long durations and
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`optimum therapeutic or diagnostic objectives thus will not be achieved, or will be achieved
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`with great difficulty and considerable user discomfort.
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`US Patent No. 5,477,852 of Airways Ltd, Inc. discloses a nasal positive airway
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`pressure device that has a pair of nasal members each having a cannula tip to be inserted into
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`the-nares of the patient. Each cannula is tapered from a substantially circular cross section
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`outside the patient’s nostril “to a substantially oval cross section at the tip inserted into the
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`nostril. An inflatable cuff surrounds each cannula with the interior space of the cuff
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`communicating with the lumen ofthe cannula through at least one aperture in the sidewall of
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`the cannula. The nasal members are connected to one or more flexible hoses that, in turn, are
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`connected to a source of positive air pressure. In use, positive air pressure is supplied to each
`cannula tip through the airhoses and nasal members. The positive air pressure inflates the.’ I
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`cuffs to hold the nasal members in place and to effect treatment. The nasal device of US
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`Patent No. 5,477,352 is attached to headgear that is located about a patient’s head. This
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`headgear could be considered by many patients as cumbersome and uncomfortable.
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`Conventional nasal masks used for administrating CPAP treatment are also considered
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`uncomfortable and cumbersome, and prior art nasal masks can be noisy due to air leaks. These
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`disadvantages in many cases are a formidable obstacle to patient acceptance ofsuch treatment.
`Therefore, a substantial number ofpatients either cannot tolerate treatment or choose to forego
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`treatment. It is believed a number of such patients might benefit from a nasal positive airway
`pressure apparatus that is more convenient to use and comfortable to wear, thereby resulting in
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`increased treatment compliance.
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`Inc. manufactures a nasal cannula device called the
`Innomed Technologies,
`NASALAIRETM.
`this device air or oxygen travels down a wide bore conduit to nasal
`cannula. The NASALAIRETM creates a physical seal between the nares and itselfl and relies
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`on the absence of leaks around the cannula and the nares to deliver pressure supplied by a
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`continuous positive airway pressure (CPAP) blower to the airway of the wearer.
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`US6,l 19,694 ofRespironics Georgia, Inc discloses anasal mask having a nare seal and
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`lateral support members to support the mask.
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`WOZOO4/O73 778 ofResMed Limited discloses anasal mask including a frame where
`headgear is provided with rigid sections that extend to the nasal mask.
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`W004/041341 ofResMed Limited discloses headgear for a patient mask that includes
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`a sewn on rigid section -to the back area of headgear straps to provide rigidity to the straps.
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`US6,907,'882 ofResMed Limited discloses anasal mask and headgear that is attachable
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`to the frame of the nasal mask. The headgear straps have rigid sections integral with the
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`releasable connectors that attach the headgear to the mask.
`DISCLOSURE on THE INVENTION
`
`It is an objcot ofthe present invention to attempt to provide a patient interface that goes
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`some way to overcoming the abovementioned disadvantages in the prior art or which will at
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`least provide the industry with a useful choice.
`
`In a first aspect the present invention consists in headgear for use with a respiratory
`mask comprising:
`H
`a continuous and substantially curved elongate member extending in use below a
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`patient’s nose,
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`and
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`at least two headgear straps capable of attachment to the ends of said elongate member,
`_
`a mask attachment on said elongate member disposed to sit below or on one of said
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`user’s nose, mouth, upper lip and an inlet to the mask, said attachment capable of receiving
`said mask.
`
`In a second aspect the present invention consists in abreathing assistance apparatus for
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`use with delivery of respiratory gases to a user comprising:
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`a mask having a base and body, said body having two flexible nasal pillows that in use
`rest in a substantially sealed manner against said user’s nares,
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`a continuous and substantially curved elongate member extending in use below a
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`patient’s nose,
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`at least two headgear straps capable of attachmentto the ends ofsaid elongate member,
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`and
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`a mask attachment on said elongate member disposed below said user’s nose, said
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`attachment capable of receiving said mask.
`
`In a third aspect the present invention consists in a breathing assistance apparatus for
`T
`use with delivery of respiratory gases to a user comprising: .
`
`a mask comprising a body and a cushion, said cushion substantially forming a seal with
`said patient’s airways,
`T
`
`headgear comprising substantially flexible, soft straps and a substantially continuous
`curved elongate member to which said mask is attached, said elongate memberextending over
`said user’s cheeks, and
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`wherein said mask has an inlet extension tube and said curved elongate member is
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`attached or rests beneath said inlet extension tube, anchoring said mask to said user’s face in
`use.
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`To those skilled in the art to which the invention relates, many changes in construction
`
`and widely differing embodiments and applications ofthe invention will suggest themselves
`
`without departing fiom the scope of the invention as defined in the appended claims. The
`disclosures and the descriptions herein are purely illustrative and are not intended to be in any
`sense limiting.
`it
`In this specification where reference has been made to patent specifications, other
`external documents, or other sources of information, this is generally for the purpose of
`
`providing a context for discussing the features of the invention. Unless specifically stated
`
`otherwise, reference to such external documents is not to be construed as an admission that
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`such documents, or such sources ofinformation, in anyjurisdiction, are prior art, or form part
`of the common general knowledge in the art.
`
`The invention consists in the foregoing and also envisages constructions ofwhich the
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`following gives examples.
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`BRIEF DESCRIPTION OF THE FIGURES
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`Preferred forms of the present invention will now be described with reference to the
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`accompanying drawings.
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`Figure 1 is a block diagram of a humidified continuous positive airway pressure
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`system as might be used in conjunction with the nasal mask of the present invention.
`
`Figure 2 is a perspective view of a first form of apatient interface that is nasal mask
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`and headgear of the present invention.
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`Figure 3 is an exploded View of the nasal mask and headgear of Figure 2.
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`Figure 4 is a side view ofa iirask base ofthe nasal mask and headgear of Figure 2.
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`Figure 5 is a perspective end view of the mask base of Figure 4.
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`Figure 6 is an end View of a body of the nasal mask and headgear of Figure 2,
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`particularly showing two nasal pillows.
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`Figure 7 is a perspective View ofthe body of Figure 6.
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`Figure 8 is a perspective view ofa nasal mask ofthe first form ofthe present invention
`but having alternative headgear that includes additional rigid extensions.
`
`Figure 9 is perspective viewuofa second form ofapatient interface and headgear ofthe
`
`present invention.
`
`Figure 10 is an exploded view ofthe patient interface and headgear ofFigure 9.
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`Figure 11 is an exploded view of a third form of a patient interface and headgear ofthe
`
`present invention.
`
`Figure 12 is an exploded View of a fourth form of a patient interface and headgear of
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`the presen