US009974914B2
`
`(12) United States Patent
`US 9,974,914 B2
`(10) Patent N0.:
`
` McAuley et al. (45) Date of Patent: May 22, 2018
`
`
`(54) BREATHING ASSISTANCE APPARATUS
`
`(71) Applicant: Fisher & Paykel Healthcare Limited,
`Auckland (NZ)
`
`(58) Field of Classification Search
`CPC .............. A61M16/06;A61M16/0616;A61M
`16/0633; A61M 16/0666; A61M 16/0683;
`(Continued)
`
`(72)
`
`Inventors: Alastair Edwin McAuley, Dallas, TX
`(US); Craig Robert Prentice, Auckland
`(NZ); Oliver Gleeson, Auckland (NZ)
`
`(56)
`
`References Cited
`U. S. PATENT DOCUMENTS
`
`(73) Assignee: Fisher & Paykel Healthcare Limited,
`Auckland (NZ)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 299 days.
`
`(21) Appl. N0.: 14/333,134
`
`(22)
`
`Filed:
`
`Jul. 16, 2014
`
`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
`
`(65)
`
`Prior Publication Data
`
`US 2015/0013678 A1
`
`Jan. 15, 2015
`
`Related US. Application Data
`
`(63) 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.
`A61M 16/06
`A61M 16/16
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) US. Cl.
`CPC
`
`A61M 16/0666 (2013.01); A61M 16/0057
`(2013.01); A61M 16/0069 (2014.02);
`(Continued)
`
`International Preliminary Report on Patentability (IPRP), Interna-
`tional Application No. PCT/NZ2009/000219, dated Apr. 12, 2011,
`9 pages.
`
`(Continued)
`
`Primary Examiner 7 Annette Dixon
`(74) Attorney, Agent, or Firm 7 Knobbe, Martens, Olson
`& Bear, LLP
`
`ABSTRACT
`(57)
`In one embodiment, a nasal cannula is 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’s airway. The
`prongs have angled ends such that, in use, gases flowing
`through the prongs are directed to the user’s nasal passages.
`The nasal cannula body is partially swivelling and prefer-
`ably has a ball joint connector. In another embodiment the
`nasal cannula may have at least one flared end prong that
`preferably seals within a patient’s nare.
`
`28 Claims, 10 Drawing Sheets
`
`
`
`RMD
`EXHIBIT 1001 - PAGE 1
`
`RMD
`EXHIBIT 1001 - PAGE 1
`
`

`

`US 9,974,914 B2
`
`Page 2
`
`(51)
`
`Int. Cl.
`A61M 16/08
`A61M 16/00
`A61M 16/10
`(52) us. Cl.
`CPC
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`A61M 16/0616 (2014.02); A61M 16/0683
`(2013.01); A61M16/08 (2013.01); A61M
`16/0816 (2013.01); A61M 16/0825 (2014.02);
`A61M 16/0875 (2013.01); A61M 16/109
`(2014.02); A61M 16/16 (2013.01); A61M
`2205/0216 (2013.01)
`
`(58) Field of Classification Search
`CPC ............ A61M 16/0825; A61M 16/208; A61M
`2016/0661; A61M 2210/0618; A61M
`2240/00; A63B 2208/03; A63B 33/00;
`Y10S 128/912
`USPC ............ 128/204.18, 204.23, 205.25, 206.11,
`128/207.13, 207.18, 858, 912
`See application file for complete search history.
`
`(56)
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`
`>>>>>VJ>>>>>
`
`*
`
`
`
`03>D>>>>>>>>>>>>>>>>>>>>>>>>>>m>>>>>>>>>>>>>>mm>>>m>>>>>>>>m>>mm *
`
`1
`
`S
`B1 *
`
`4/1990
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`7/1990
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`
`RMD
`EXHIBIT 1001 - PAGE 2
`
`RMD
`EXHIBIT 1001 - PAGE 2
`
`

`

`US 9,974,914 B2
`
`Page 3
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`(56)
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`RMD
`EXHIBIT 1001 - PAGE 3
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`RMD
`EXHIBIT 1001 - PAGE 3
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`

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`US 9,974,914 B2
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`Page 4
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`RMD
`EXHIBIT 1001 - PAGE 4
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`U.S. Patent
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`May 22, 2018
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`Sheet 1 of 10
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`US 9,974,914 B2
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`Figure1
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`U.S. Patent
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`May 22, 2018
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`Sheet 2 of 10
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`US 9,974,914 B2
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`Figure 3
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`U.S. Patent
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`May 22, 2018
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`Sheet 3 of 10
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`US 9,974,914 B2
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`24
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`35
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`21
`
`a
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`fl "
`“f
`
`3: ‘5’ .W
`
`Figure 5
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`U.S. Patent
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`May 22, 2018
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`Sheet 4 of 10
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`US 9,974,914 B2
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`Figure 6
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`U.S. Patent
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`May 22, 2018
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`Sheet 5 of 10
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`US 9,974,914 B2
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`Figure 7
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`49
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`Figure 8
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`U.S. Patent
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`May 22, 2018
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`Sheet 6 of 10
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`US 9,974,914 B2
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`Figure 10
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`May 22, 2018
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`US 9,974,914 B2
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`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 INVENTION
`
`Field of the Invention
`
`The present invention relates to apparatus for treating
`sleep apnoea. More specifically, the present invention pro-
`vides a nasal positive airway pressure device.
`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
`collapse, sealing the airway. The sleep pattern of an OSA
`sufferer is characterised by repeated sequences of snoring,
`breathing difliculty, lack of breathing, waking with a start
`and then returning to sleep. Often the sufferer is unaware of
`this 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 Rescare 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 sub-
`stantially circular cross-section outside the patient’s nostril
`to a substantially oval cross-section at the tip inserted into
`the nostril. An inflatable culf surrounds each cannula with
`
`the interior space of the culf communicating with the lumen
`of the cannula through at least one aperture in the sidewall
`of the 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 culfs 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
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`that is located about a patient’s head; this headgear could be
`considered by many patients as cumbersome and uncom-
`fortable.
`
`Conventional nasal masks used for administrating CPAP
`treatment are also considered uncomfortable and cumber-
`
`some, and prior art nasal masks and the