US009333315B2
`
`(12) United States Patent
`US 9,333,315 B2
`(10) Patent N0.:
`
`McAuley et al. May 10, 2016 (45) Date of Patent:
`
`
`(54) BREATHING ASSISTANCE APPARATUS
`
`(71) Applicant: Fisher & Paykel Healthcare Limited,
`Auckland (NZ)
`
`(72)
`
`Inventors: Alastair Edwin McAuley, Dallas, TX
`(US); Craig Robert Prentice, Auckland
`(NZ); Oliver Gleeson, Auckland (NZ)
`
`(58) Field of Classification Search
`CPC . A61M 15/08; A61M16/06; A61M16/0616;
`A61M16/0633; A61M16/0666; A61M
`16/0683; A61M16/0825; A61M16/208;
`A61M 2210/0618; A61M 2240/00; A62B
`18/00; A62B 18/02; A62B 18/08; A62B
`18/084; A62B 35/00
`See application file for complete search history.
`
`(73) Assignee: Fisher & Paykel Healthcare Limited,
`Auckland (NZ)
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl.No.: 14/846,226
`
`(22)
`
`Filed:
`
`Sep. 4, 2015
`
`(65)
`
`Prior Publication Data
`
`US 2015/0374946 A1
`
`Dec. 31, 2015
`
`301,111 A
`472,238 A
`
`7/ 1884 Genese
`4/1892 Van Orden
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`CA
`CN
`
`131 16 62
`217 253 8
`
`12/1992
`7/1994
`
`(Continued)
`OTHER PUBLICATIONS
`
`Related US. Application Data
`
`(63) Continuation of application No. 14/333,134, filed on
`Jul. 16, 2014, which is a continuation of application
`No.
`10/598,026,
`filed
`as
`application No.
`PCT/NZ2005/000023 on Feb. 18, 2005, now Pat. No.
`8,783,257.
`
`(30)
`
`Foreign Application Priority Data
`
`Feb. 23, 2004
`Aug. 6, 2004
`
`(NZ) ........................................ 531332
`(NZ) ........................................ 534606
`
`(51)
`
`Int. Cl.
`A61M16/06
`A61M16/16
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) US. Cl.
`CPC ....... A61M16/0666 (2013.01); A61M 16/0057
`(2013.01); A61M16/0069 (2014.02);
`
`International Preliminary Report on Patentability (IPRP), Interna-
`tional Application No. PCT/NZ2009/000219, mailed Apr. 12, 2011,
`9 pages.
`
`(Continued)
`
`Primary Examiner 7 Annette Dixon
`(74) Attorney, Agent, or Firm 7 Knobbe, Martens, Olson &
`Bear, LLP
`
`(57)
`
`ABSTRACT
`
`A nasal cannula can be shaped to fit within a user’s nares,
`where the nasal cannula includes at least one prong allowing
`high flow delivery of humidified gases and creates positive
`airway pressure in the patient’ 5 airway. The prongs can have
`angled ends such that, in use, gases flowing through the
`prongs are directed to the user’s nasal passages. The nasal
`cannula body can be partially swiveling and preferably has a
`ball joint connector. The nasal cannula can have at least one
`flared end prong that preferably seals within a patient’ 5 nare.
`
`(Continued)
`
`19 Claims, 10 Drawing Sheets
`
`
`
`RMD
`EXHIBIT 1003 - PAGE 1
`
`RMD
`EXHIBIT 1003 - PAGE 1
`
`

`

`US 9,333,315 B2
`
`Page2
`
`(51)
`
`Int. Cl.
`A61M16/08
`A61M16/00
`A61M16/I0
`
`2006.01
`(2006 01)
`(
`~
`)
`(2006.01)
`
`(52) US“
`CPC ....... A6IMI6/0616 (2014.02);A61M16/0683
`(2013.01); A61M16/08 (2013.01); A61M
`16/0816 (2013.01);A61M16/0825 (201402);
`A6IMI6/0875 (2013.01); A6IMI6/I09
`(2014.02);A61M16/16(2013.01);A6IM
`2205/02]6(2013.01)
`
`(56)
`
`.
`References C‘ted
`
`6,019,101 A
`6,050,260 A
`6,119,694 A
`6,192,886 B1
`D440,302 S
`6298 850 B1
`6,347,631B1
`13,455,891 5
`6,418,928 B1
`2433181 3,
`6,439,234 B1
`6,478,026 B1
`6,491,034 B1
`6,561,188 B1
`6,561,191 Bl
`6,581,594 B1
`6,581,601 B2
`6,588,424 B2
`6,631,718 Bl
`6,637,434 B2
`6,644,315 B2
`6,651,658 B1
`6,659,102 B1
`6,662,803 B2
`6,679,257 B1
`6,679,265 B2
`6,851,425 B2
`6’892’729 B2
`6’907’882 B2
`6,951,218 B2
`7,004,165 B1
`3232632 3
`7096’864 B1
`’
`’
`7,201,169 B2
`7,207,333 B2
`7,210,481 B1
`7,219,669 B1
`7,318,437 B2
`7,353,827 B2
`7,896,003 B2
`8,042,539 B2
`8,443,807 B2
`D686,313 s
`8’479’741 B2
`8,783,257 B2
`2002/0046755 A1
`2002/0053347 A1
`2002/0059935 A1
`2002/0096178 A1
`2003/0005933 A1
`2003/0079749 A1
`2003/0164170 A1
`2003/0172936 A1
`2003/0196656 A1
`2003/0196659 A1
`2003/0196664 A1
`2003/0200970 A1
`2004/0067333 A1
`2004/0211427 A1
`2004/0226566 A1
`2005/0011524 A1
`2005/0028822 A1
`2005/0076913 A1
`2005/0150497 A1
`2005/0205096 A1
`2005/0235999 A1
`2006/0060200 A1
`2006/0107958 A1
`2006/0124131 A1
`
`2006/0137690 A1
`2006/0174887 A1
`2006/0196511 A1
`2006/0237018 A1
`
`2/2000 CotIleretal.
`4/2000 Danlell et al.
`9/2000 Correa et al.
`2/2001 Rudolph
`4/2001 Wolfe
`10/2001 Argraves
`2/2002 Hansenetal
`4/2002 Biedrzycki
`7/2002 Bordew1ck et 31.
`$88; 3:33:01; 31
`8/2002 Culti,et a1.
`11/2002 Wood
`12/2002 Gunaratnam et al.
`5/2003 Ellis
`5/2003 Kwok
`6/2003 Drew etal.
`6/2003 Ziaee
`7/2003 Bardel
`10/2003 Lovell
`10/2003 Noble
`11/2003 Ziaee
`11/2003 Hill etal.
`12/2003 Sico
`12/2003 Gradon etal.
`1/2004 Robertson etal.
`1/2004 Strickland etal.
`2/2005 Jaffreetal.
`”005 Smith et 31'
`”005 Gmg et 31'
`10/2005 Gradonetal.
`2/2006 Salcido
`$882 Efizfigms
`1
`8,2006 M
`flyéreta'
`4/2007 Wllkle .................. A61M 16/06
`128/207.13
`4/2007 Tohara
`5/2007 Lovellet
`5/2007 Lovell etal.
`1/2008 Gunaratnarn etal.
`4/2008 Geist
`3/2011 Matulaetal.
`10/2011 Chandran etal.
`5/2013 McAuley etal.
`7/2013 Matula etal.
`”013 MCAuleyetal'
`7/2014 McAuleyetal.
`4/2002 Voss
`5/2002 Ziaee
`5/2002 Wood
`7/2002 Ziaee
`1/2003 Izuchukwu
`5/2003 Stricklandetal.
`9/2003 Drewetal.
`9/2003 Wilkieetal.
`10/2003 Moore
`10/2003 Gradonetal.
`10/2003 Jacobson
`10/2003 Stenzler ............ A61M 16/0666
`128/207.18
`4/2004 Arnarasinghe
`10/2004 Jones etal.
`11/2004 Gunaratnarn etal.
`1/2005 Thomlinson ...... A61M 16/0666
`128/207.18
`2/2005 Sleeper et al.
`4/2005 Ho etal.
`7/2005 Eifleretal.
`9/2005 Matulaetal.
`10/2005 Woodetal.
`3/2006 Ho etal.
`”006 Sleeper
`6/2006 Chandran ............. A61M 16/06
`12800628
`
`6/2006 Gunaratnarn etal.
`8/2006 Chandran etal.
`9/2006 Lau etal.
`10/2006 McAuley etal.
`
`RMD
`EXHIBIT 1003 - PAGE 2
`
`U'S' PATENT DOCUMENTS
`.
`$33; $111“
`ones
`#904 Mom“
`343947, 3““
`1
`/
`mi“
`9/1942 1300150“ etla~
`3132‘; 2.3“ eg ZHL
`5/1950 V1516“ ‘1
`11/1954 £131;le
`3/1956 Matheson etal.
`7/1958 H d
`“/1958 Hfldzgfl
`1/1970 Greenfield
`11/1974 Ball etal.
`5/1978 Se ersten
`10/1978 Legisetal
`~
`.
`13/133;
`121113 et 3L
`/
`0mg"?
`5/1980 13.120111?”
`13/13:: £31m eta~
`“1983 DE“
`..
`“984 Plllay ~~~~~~~~~~~~~~~~~~~ Afiéfi/fifiéof‘f
`.
`~
`513:: Eff:
`11/1988 Trimble etal.
`8/1989 T
`b.
`/
`aye 1
`4/1990 Li;
`$1338 E 11m
`e “1
`“/1990 “if?“
`51331 g
`“61“
`/
`5“ elti 31
`8/1991 KOPaaeF ~1
`11/1331 vKVurlrllagaleta~
`“/1991 R: ace
`/
`P0130“
`91333 Effieiman etal
`90992 Sanderseltal'
`8/1993 R0151? eta~ 1
`13/133;
`(5:111le eta~
`”/1993 Lining
`.
`51332 Elle?“
`”/1995 Lniua“ 1
`7/1996 Wan dseta~
`9/1996 Frgghlich etal
`1,1997 Gwalme
`2,1997 Schallerital
`3/1997 Reischeletal.
`@997 Landisetal.
`3/1998 Handke etal.
`5/1998 Goldstein
`3/1999 Barnett etal.
`7/1999 McCall etal.
`1/2000 Starr et al.
`
`~
`
`'
`
`31829128 A
`,
`7515091 A
`123?ng 2
`,
`,
`2,296,150 A
`3,333,282 A
`2,508,050 A
`2,693,800 A
`2,738,788 A
`2843121 A
`2,859,748 A
`3,490,452 A
`3,850,171 A
`4090510 A
`13,250,047 s
`,
`33233: 3
`,
`4,201,205 A
`jig/2g:
`4,367,735 A
`,
`,
`4,437,462 A *
`Egg; 2
`4,782,832 A
`4856 508 A
`,
`,
`4,915,105 A
`$323),ng .3
`,
`4,971,051 A
`gagfgaéggfi
`,
`,
`59425478 A
`333952;; 3
`50655756 A
`,
`,
`§’??§’§§$ A
`,
`,
`5,148,802 A
`53315979 A
`1553(5)??? ISA
`”69,296 A
`,
`,
`ngféi S
`54775852 A
`5,533,506 A
`5,551,419 A
`5595174 A
`5’601’078 A
`D378,610 s
`5,657,752 A
`5,724,965 A
`5,752,510 A
`5,884,624 A
`5,921,239 A
`6,017,315 A
`
`RMD
`EXHIBIT 1003 - PAGE 2
`
`

`

`US 9,333,315 B2
`
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2007/0089749 A1
`2007/0125385 A1
`2007/0125387 A1
`2007/0137653 A1
`2007/0163600 A1
`2007/0295335 A1
`2008/0041388 A1
`2008/0047560 A1
`2008/0060648 A1
`2008/0060657 A1
`2008/0099024 A1
`2008/0196728 A1
`2008/0264422 A1
`2009/0044808 A1
`2009/0120442 A1
`2010/0307502 A1
`2010/0313891 A1
`2011/0308520 A1
`2012/0125339 A1
`2012/0132209 A1
`2015/0013678 A1
`2015/0297855 A1
`2016/0038705 A1
`2016/0038706 A1
`2016/0038707 A1
`
`4/2007
`6/2007
`6/2007
`6/2007
`7/2007
`12/2007
`2/2008
`2/2008
`3/2008
`3/2008
`5/2008
`8/2008
`10/2008
`2/2009
`5/2009
`12/2010
`12/2010
`12/2011
`5/2012
`5/2012
`1/2015
`10/2015
`2/2016
`2/2016
`2/2016
`
`Ho et al.
`Ho et al.
`Zollinger et al.
`Wood
`Hoffman
`Nashed
`McAuley et al.
`Veliss et al.
`Thornton et al.
`McAuley et al.
`Gunaratnam et al.
`Ho
`Fishman
`Guney et al.
`Ho
`Rummery et al.
`Veliss et al.
`McAuley et al.
`Ho et al.
`Rummery et al.
`McAuley
`McAuley et al.
`McAuley et al.
`McAuley et al.
`Allan et al.
`
`FOREIGN PATENT DOCUMENTS
`
`CN
`CN
`CN
`CN
`CN
`EP
`EP
`EP
`FR
`FR
`GB
`GB
`GB
`JP
`JP
`JP
`JP
`WO
`W0
`WO
`W0
`W0
`WO
`WO
`WO
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`WO
`W0
`
`1784250
`1901961 A
`1988930 A
`101214402
`101541380
`0747078
`2 130 563 A1
`1646910
`2658725
`2749176
`190 224 431
`880 824
`1 467 828
`H09-010311
`2005-529687
`2007-516750
`2007-527271
`WO98/18514
`WO 99/04842 A1
`WO99/58181
`WO 00/69497
`WO 00/74758
`W001/41854
`W001/97892 A1
`W002/074372
`WO 2004/041341
`WO 2004/073778
`WO 2005/021075
`WO 2005/051468
`WO 2005/086946
`WO 2007/022562 A1
`WO 2007/041786
`WO 2007/147088 A2
`WO 2008/007985 A1
`WO 2008/070929 A1
`WO 2008/106716 A1
`WO2008/148086
`WO 2009/052560 A1
`
`6/2006
`1/2007
`6/2007
`7/2008
`9/2009
`12/1996
`12/2009
`8/2015
`8/1991
`12/1997
`12/1902
`10/1961
`3/1977
`1/1997
`10/2005
`6/2007
`9/2007
`5/1998
`2/1999
`11/1999
`11/2000
`12/2000
`6/2001
`12/2001
`9/2002
`5/2004
`9/2004
`3/2005
`6/2005
`9/2005
`3/2007
`4/2007
`12/2007
`1/2008
`6/2008
`9/2008
`12/2008
`4/2009
`
`W0
`W0
`W0
`
`WO 2009/059353 A1
`WO 2009/092057 A1
`WO 2009/139647 A1
`
`5/2009
`7/2009
`11/2009
`
`OTHER PUBLICATIONS
`
`International Search Report, International Application No. PCT/
`NZ2009/000219, mailed Feb. 2, 2010, 3 pages.
`English Translation ofChinese Examination Report; Application No.
`2007800266164; 5 pages.
`English Translation of First Office Action for Chinese Application
`No. 201210080441.8 dated Mar. 24, 2014, in 4 pages.
`Examination Report; Australian Application No. 2007273324; dated
`May 22, 2012; 3 pages.
`International Search Report for International Application No. PCT/
`NZ2007/000185, dated Oct. 31, 2007, in 3 pages.
`Second Chinese Office Action for Chinese Patent Application No.
`201210080441.8 dated Dec. 1, 2014 in 11 pages (with English trans-
`lation).
`for Patent Application No.
`Australian Examination Report
`2012265597 dated Dec. 19, 2013, in 5 pages.
`Canadian Examination Report for Application No. 2655839 dated
`Oct. 4, 2013, in 2 pages.
`English Translation of Chinese Examination Report; Chinese Appli-
`cation No. 2007800266164; 5 pages.
`International Search Report; PCT/NZ2009/000072; dated Jul. 28,
`2009; 3 pages.
`UK Search and Examination Report; Mar. 14, 2013; Application No.
`GB1210075.6; 2 pages.
`UK Examination Report; dated May 9, 2013; Application No.
`GB1119385.1; 4 pages.
`Australian Examination Report; dated Mar. 4, 2014; Application No.
`2010246985; 5 pages.
`English Translation of JP Examination Report; dated Feb. 10, 2014;
`Application No. 2012-510418; 4 pages.
`Chinese Examination Report; dated Mar. 27, 2014; Chinese Appli-
`cation No. 2010800280290; 16 pages.
`GB Combined Search and Examination Report; dated May 7, 2014;
`Application No. GB1406402.6; 6 pages.
`GB Combined Search and Examination Report; dated May 7, 2014;
`Application No. GB1406401.8; 4 pages.
`JP Examination Report, Application No. 2012-538784; 3 pages.
`Australian Examination Report; dated Aug. 14, 2015; Application
`No. 2015202814; 8 pages.
`Chinese Examination Report; dated Jul. 17, 2015; Application No.
`2010800611221; 10 pages.
`Chinese Examination Report; dated Sep. 14, 2015; Application No.
`2010800280290; 3 pages.
`European Extended Search Report; dated Sep. 4, 2015; Application
`No. 108302514; 7 pages.
`European Extended Search Report; dated Sep. 8, 2015; Application
`No. 107746232; 7 pages.
`Japanese Examination Report; dated Jul. 22, 2015; Application No.
`2015-098324; 8 pages.
`Japanese Examination Report; dated Aug. 5, 2015; Application No.
`2012-538784; 8 pages.
`Australian Examination Report; dated Jan. 9, 2015; Application No.
`2010241390; 4 pages.
`English Translation of Chinese Examination Report; dated Sep. 3,
`2014; Application No. 2010800611221; 9 pages.
`Second Chinese Office Action; dated Jan. 19, 2015; Application No.
`2010800280290; 16 pages.
`EPO Search Report; dated Apr. 2, 2014; Application No. 09819444.
`2; 8 pages.
`
`* cited by examiner
`
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`US. Patent
`
`May 10, 2016
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`Sheet 1 of 10
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`US 9,333,315 B2
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`US. Patent
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`US 9,333,315 B2
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`Figure 3
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`EXHIBIT 1003 - PAGE 5
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`US. Patent
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`US 9,333,315 B2
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`24
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`35
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`21
`
`2
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`/
`
`22
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`
`
`Figure 5
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`US. Patent
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`US 9,333,315 B2
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`49
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`53
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`Figure 8
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`éé
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`1b
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`Figure 13
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`US 9,333,315 B2
`
`1
`BREATHING ASSISTANCE APPARATUS
`
`INCORPORATION BY REFERENCE TO ANY
`PRIORITY APPLICATIONS
`
`Any and all applications for which a foreign or domestic
`priority claim is identified in the Application Data Sheet as
`filed with the present application are hereby incorporated by
`reference under 37 CFR 1.57.
`
`BACKGROUND OF THE INVENTIONS
`
`1. Field of the Inventions
`
`The present inventions relate to apparatuses for treating
`sleep apnoea. For example, the present inventions can provide
`a nasal positive airway pressure device.
`2. Description of the Related Art
`Obstructive Sleep Apnoea (OSA) is a sleep disorder that
`affects up to at least 5% of the population in which muscles
`that normally hold the airway open relax and ultimately col-
`lapse, sealing the airway. The sleep pattern ofan OSA sufferer
`is characterised by repeated sequences of snoring, breathing
`difficulty, lack of breathing, waking with a start and then
`returning to sleep. Often the sufferer is unaware ofthis pattern
`occurring. Sufferers of OSA usually experience daytime
`drowsiness and irritability due to a lack of good continuous
`sleep.
`In an effort to treat OSA sufferers, a technique known as
`Continuous Positive Airway Pressure (CPAP) was devised. A
`CPAP device consists of a gases supply (or blower) with a
`conduit connected to supply pressurised gases to a patient,
`usually through a nasal mask. The pressurised air supplied to
`the patient effectively assists the muscles to keep the patient’ s
`airway open, eliminating the typical OSA sleep pattern.
`The procedure for administering CPAP treatment has been
`well documented in both the technical and patent literature.
`Briefly stated, CPAP treatment acts as a pneumatic splint of
`the airway by the provision of a positive pressure, usually in
`the range 4 to 20 cm H.sub.20. The air is supplied to the
`airway by a motor driven blower whose outlet passes via an
`air delivery hose to a nose (or nose and/or mouth) mask
`sealingly engaged to a patient’s face by means of a harness or
`other headgear. An exhaust port is provided in the delivery
`tube proximate to the mask. More sophisticated forms of
`positive airway pressure devices, such as bi-level devices and
`auto-titrating devices, are described in US. Pat. No. 5,148,
`802 of Respironics, Inc. and US. Pat. No. 5,245,995 of Res-
`care Limited, respectively.
`US. Pat. No. 5,477,852 ofAirways Ltd, Inc. discloses a
`nasal positive airway pressure device that has a pair of nasal
`members each having a cannula tip to be inserted into the
`nares of the patient. Each cannula is tapered from a substan-
`tially circular cross-section outside the patient’s nostril to a
`substantially oval cross-section at the tip inserted into the
`nostril. An inflatable cuff surrounds each cannula with the
`
`interior space of the cuff communicating with the lumen of
`the cannula through at least one aperture in the sidewall ofthe
`cannula. The nasal members are connected to one or more
`flexible hoses that, in turn, are connected to a source of
`positive air pressure. In use, positive air pressure is supplied
`to each cannula tip through the air hoses and nasal members.
`The positive air pressure inflates the cuffs to hold the nasal
`members in place and to effect treatment. The nasal device of
`US. Pat. No. 5,477,852 is attached to headgear that is located
`about a patient’s head; this 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 uncomfortable and cumber-
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`some, and prior art nasal masks and the like are noisy (due to
`air leaks). These disadvantages in many cases are a formi-
`dable obstacle to patient acceptance of such treatment. There-
`fore, a substantial number of patients either cannot tolerate
`treatment or choose to forego treatment. It is believed a sub-
`stantial number of such patients could benefit from a nasal
`positive airway pressure apparatus that is more convenient to
`use and comfortable to wear, thereby resulting in increased
`treatment compliance.
`As oxygen is supplied as a dry gas it is well known in the art
`to either heat and/or humidify gases before delivering them
`for breathing by a patient. In particular when delivering oxy-
`gen, or oxygen or air mixture, it has proven beneficial to
`humidify the gases first. In WOOl/41854 of Vapotherm, Inc.
`a system is disclosed that allows the delivery of humidified
`oxygen through a nasal cannula. This system uses a narrow
`bore conduit and nasal cannula with a high resistance to gas
`flows, thereby requiring the oxygen be of a high pressure. Air,
`as well as oxygen can also be passed down the conduit and
`nasal cannula and it too must be of a high pressure. This
`system allows the delivery of high flows of oxygen enriched
`air to the patient, but is limited in the flows achievable due to
`the narrow bore ofthe cannula resulting in high resistance gas
`flow and excessive velocity and noise upon exiting the can-
`nula. Furthermore, the narrowness of the nasal cannula in this
`system allows easy expiration of gases between the prongs
`and nares and therefore does not create any positive airway
`pressure.
`Innomed Technologies, Inc. manufactures a nasal cannula
`device called the NASALAIRETM. In this device air or oxy-
`gen travels down a wide bore conduit to nasal cannula. The
`NASALAIRETM creates a physical seal between the nares
`and itself, and relies on the absence of leaks around itself and
`the nares to deliver pressure supplied by a continuous positive
`airway pressure (CPAP) blower to the airway of the wearer.
`
`SUMMARY OF THE INVENTIONS
`
`It is an object of at least some of the present inventions to
`provide a breathing assistance apparatus which goes some-
`way to overcoming the above mentioned disadvantages or
`which will at least provide the public a useful choice.
`Accordingly in a first aspect the present inventions consists
`in a breathing assistance apparatus comprising:
`nasal cannula, shaped to fit within a user’s nares, and
`adapted to deliver said humidified gases to said user,
`a pressurised source of gases,
`transportation means adapted to, in use, be in fluid com-
`munication with said source of gases and said nasal cannula
`and adapted to in use convey said gases to said user,
`wherein said nasal cannula including at least one prong
`allowing high flow delivery of said humidified gases and
`creating a positive airway pressure in said patient’s airway,
`said at least one prong having an angled end, such that in use,
`gases flowing through said prong are directed to said user’s
`nasal passages.
`In a second aspect the present inventions consists in a
`breathing assistance apparatus comprising:
`nasal cannula, shaped to fit within a user’s nares,
`a pressurised source of gases,
`transportation means adapted to, in use, be in fluid com-
`munication with said source of gases and said nasal cannula
`and adapted to in use convey said gases to said user,
`wherein said nasal cannula are adapted to deliver said
`humidified gases to said user, said nasal cannula including at
`
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`US 9,333,315 B2
`
`3
`least one prong allowing high flow delivery of saidhumidified
`gases and creating positive airway pressure in said patient’s
`airway, said at least one prong having an end that is flared
`outwardly.
`To those skilled in the art to which the inventions relate,
`many changes in construction and widely differing embodi-
`ments and applications of the invention will suggest them-
`selves without departing from the scope of the inventions 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.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Preferred forms of the present inventions will now be
`described with reference to the accompanying drawings.
`FIG. 1 is a block diagram of a system providing humidified
`continuous positive airway pressure to a user as might be used
`in conjunction with a nasal cannula of the present invention.
`FIG. 2 is a perspective view of a first embodiment of the
`nasal cannula of the present invention.
`FIG. 3 is a side view of the nasal cannula of FIG. 2.
`
`FIG. 4 is a plan view of the nasal cannula of FIG. 2.
`FIG. 5 is a prong end view of the nasal cannula of FIG. 2
`FIG. 6 is an exploded view of the nasal cannula of FIG. 2.
`FIG. 7 is a side view of a second embodiment of a nasal
`
`cannula of the present invention.
`FIG. 8 is a side view of a third embodiment of a nasal
`
`cannula of the present invention.
`FIG. 9 is a perspective view of a fourth embodiment of a
`nasal cannula of the present invention.
`FIG. 10 is a side view of the nasal cannula of FIG. 9.
`
`FIG. 11 is an exploded perspective view of the nasal can-
`nula of FIG. 9.
`
`FIG. 12 is a front view ofthe prongs ofthe nasal cannula of
`FIG. 9.
`
`FIG. 13 is an exploded side view of the nasal cannula of
`FIG. 9.
`FIG. 14 is a side cross-sectional view ofa fifth embodiment
`
`of the nasal cannula of the present invention where the con-
`nection between a body part and connector of the cannula
`includes a plurality of channels.
`FIG. 15 is a cross-section throughAA of the nasal cannula
`of FIG. 14.
`FIG. 16 is a side cross-sectional view of a sixth embodi-
`
`ment ofthe nasal cannula of the present invention including a
`shield that protects an outlet vent from inlet gases.
`FIG. 17 is a cross-section through BB ofthe nasal cannula
`of FIG. 16.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`Whether used in a hospital environment or in a home
`environment, the nasal cannula of the present inventions will
`generally have associated three main pieces of apparatus.
`Firstly, an active humidifier, which that controls the tempera-
`ture of a heater plate heating a body of water to achieve a
`desired temperature and humidity of the gases being humidi-
`fied. Secondly, a transport conduit from the humidifier to the
`patient is also required, which is preferably heated to reduce
`condensation, or “rain out”. Thirdly, a cannula designed to fit
`into the nasal cavity and deliver humidified, pressurized
`gases. In particular, in one embodiment the nasal cannula of
`the present invention has two flared end prongs that seal
`within a patient’s nares, although in some embodiments the
`cannula may have a single prong. The cannula prongs are
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`shaped such that a step is created between them so that the
`prongs abut the user’s nasal septum in use. Furthermore, the
`gripping action ofthe sides ofthe prongs to the user’s septum
`in use prevents the prongs from dislodging from the user’s
`nares. In another embodiment the prongs ofthe nasal cannula
`are angled toward one another as well as having an angled
`profile at the outlet of gases, such that gases flow from the
`prongs flows back into the nasal passage and is not forced up
`into the rest of the nasal cavity.
`With reference to FIG. 1 a humidified Continuous Positive
`
`Airway Pressure (CPAP) system is shown in which a patient
`1 is receiving humidified and pressurised gases through the
`nasal cannula 2 of the present invention. The cannula 2 is
`connected to a humidified gases transportation pathway or
`inspiratory conduit 3. It should be understood that delivery
`systems could also be VPAP (Variable Positive Airway Pres-
`sure) and BiPAP (Bi-level Positive Airway Pressure) or
`numerous other forms ofrespiratory therapy. Inspiratory con-
`duit 3 is connected to the outlet 4 of a humidification chamber
`
`5 that contains a volume ofwater 6. The inspiratory conduit 3
`may contain heating means or heater wires (not shown) which
`heat the walls of the conduit to reduce condensation of
`
`humidified gases within the conduit. The humidification
`chamber 6 is preferably formed from a plastics material and
`may have a highly heat conductive base (for example an
`aluminium base) which is in direct contact with a heater plate
`7 of humidifier 8. The humidifier 8 is provided with control
`means or electronic controller 9 that may comprise a micro-
`processor based controller executing computer software
`commands stored in associated memory.
`The controller 9 receives input from sources such as user
`input means or dial 1 0 through which a user ofthe device may,
`for example, set a predetermined required value (preset value)
`of humidity or temperature of the gases supplied to patient 1.
`The controller may also receive input from other sources; for
`example, temperature and/or flow velocity sensors 11 and 12
`through connector 13 and heater plate temperature sensor 14.
`In response to the user set humidity or temperature value
`input via dial 10 and the other inputs, controller 9 determines
`when (or to what level) to energise heater plate 7 to heat the
`water 6 within humidification chamber 5. A flow of gases (for
`example air) is provided to the chamber through inlet 16 from
`a gases supply means or blower 15. As the volume of water 6
`within humidification chamber 5 is heated, water vapour
`begins to fill the volume of the chamber above the water’s
`surface and is passed out of the humidification chamber 5
`through outlet 4. Exhaled gases from the patient’s mouth are
`passed directly to ambient surroundings in FIG. 1.
`The blower 15 is provided with variable pressure regulat-
`ing means or a variable speed fan 20 which draws air or other
`gases through the blower inlet 17. The speed of the variable
`speed fan 20 is controlled by the electronic controller 18 (or
`alternatively the function of the controller 18 could carried
`out by the controller 9) in response to inputs from the con-
`troller 9 and a user set predetermined required value (preset
`value) of pressure or fan speed via the dial 19.
`Flared Prong Nasal Cannula
`A first embodiment of a nasal cannula ofthe present inven-
`tion is shown in detail in FIGS. 2 to 6. Referring to FIGS. 2
`and 6, the nasal cannula 2 comprises three main components;
`the prong part 21, body part 22 and ball connector 23.
`The prong part 21 has two nasal prongs 24, 25, each of
`which are substantially shaped to follow the contours of the
`human nares and in use are placed inside a user’s nares. The
`prongs 24, 25 extend out from a hollow tubular body 26 that
`in use fits to the body part 22. Each of the prongs 24, 25 are
`integrally moulded with the tubular body 26 in a flexible
`
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`EXHIBIT 1003 - PAGE 15
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`US 9,333,315 B2
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`5
`plastics material or rubber, such as silicone, other thermoset
`elastomers or thermoplastic elastomers such as KratonTM.
`The prongs 24, 25 are substantially oval tubular members that
`allow for a passage of gases. In particular, as shown in FIG. 5,
`the prongs are oval in shape and angled in the same manner as
`a human’s nares. The prongs 24, 25 are angled toward one
`another (or toward the vertical axis Y) at the top 27, 28 of the
`prongs and away from one another at the bottom 29, 30 ofthe
`prongs. Furthermore, the ends 31, 32 of the prongs flare
`outwardly and preferably are formed such that the ends of the
`prongs are thinner in cross-section than the rest of the prongs.
`The flared thinner section ends 31, 32 ofthe prongs assist with
`the sealing ofthe prongs 24, 25 in use within the user’s nares.
`When in use and with gases flowing through the prongs the
`force of the gas pressure will force the prong ends 31,32 to
`flare outwardly and seal against the inside ofthe user’s nares.
`The prongs 24, 25 each include a step 33, 34 formed along
`their lengths. Each of the steps 33, 34 are formed on the
`prongs 24, 25 in an opposing manner such that in use, when
`the prongs are within a user’s nares the steps 33, 34 abut the
`user’s nasal septum and form a ledge that prevents dislodge-
`ment of the prongs. The prongs 24, 25 also have protrusions
`35, 36 formed on their outer edges that abut the sides of the
`user’s nares (opposite to the nasal septum). The protrusions
`35, 36 assist in preventing the dislodgement of the prongs,
`especially if the user moves his or her head. The protrusions
`35, 36 also maintain the prongs within the user’s nares in a
`correct orientation such that in use gases flow through the
`prongs and directly up the user’s nasal passages.
`The body part 22 is a tubular passageway in which the
`prong part 21 is connected at one end and a ball joint 37 at the
`other end. The ball joint 37 extends from the connector 23 and
`slots into a complementary shaped (partial sphere) socket end
`39. The body part 22 also has a number ofapertures 38 formed
`in it, which act as a bias flow outlet vent. Therefore, any gases
`exhaled by the user through their nose will exit through the
`apertures 38.
`The connector 23 is preferably connected to the inspiratory
`conduit 3 (see FIG. 1) that supplies gases flow to the cannula
`2. The inspiratory conduit 3 may be moulded directly to the
`connector 23 or other connection mechanisms may be used,
`such as a friction fit formed between the connector and con-
`duit.
`
`Although a ball and socket joint, as described above,
`between the body part 22 and connector 23 is preferred other
`connections may be utilised, such as a flexible piece of sili-
`cone, or other appropriate connection. The connection
`between the cannula body and connector must be able to be
`flexed or rotated to allow for the inspiratory conduit 3 to be
`moved without causing the dislodgement ofthe nasal cannula
`2 from the user’s nares.
`
`In the preferred form of the nasal cannula 2 of the present
`invention the body part 22 and connector 23 are preferably
`made from a hard or rigid plastics material, such as polypro-
`pylene, polycarbonate or acetyl. In other forms the body part
`22 and connector 23 may be of different plastics materials to
`allow for increased slidability between these parts.
`The prong part 21 may be supplied in various different
`sizes such that different sized user’s may remove an existing
`prong part and simply attach a different sized flexible plastics
`prong part over the body part 22.
`To provide additional comfort for the user or ensure the
`nasal cannula ofthe present invention do not fall from a user’ s
`nares, the nasal cannula may be used in combination with a
`headgear strap, which in one embodiment is a small flexible
`tube. For example, FIG. 1 shows a headgear strap 40 extend-
`ing from the nasal cannula 2. The ends of the headgear strap
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`that attach to the cannula may attach to extensions (or loops)
`41 on the body part 22 ofthe cannula shown in FIG. 2, or may
`attach about other appropriate areas of the cannula, for
`example, about the connector 23.
`The abovementioned embodiment ofthe nasal cannula 2 of
`
`the present invention is preferably a wide bore pronged can-
`nula used for high flow conditions.
`A second embodiment of the present invention is shown in
`FIG. 7. In this embodiment ofthe nasal cannula 42 the prongs
`43, 44 are preferably small bore prongs for use with lower
`flow conditions. The prongs 43, 44 are similarly shaped to the
`prongs 24, 25 detailed above, but may not seal in the same
`manner as the abovementioned prongs due to the smaller size
`of the prongs. In fact these prongs may not seal at all in use
`within the user’s nares.
`Furthermore, in this second embodiment the nasal cannula
`42 is smaller and weighs less as it is only comprised ofa prong
`body 45 and prongs 43, 44, where the body 45 is connected to
`a small tube that is formed with corrugations or bellows 48
`that connect to an inspiratory tube or conduit 47 (similar to the
`inspiratory conduit 3 described above) that receives a sup