US009539405B2
`
`(12) United States Patent
`US 9,539,405 B2
`(10) Patent No.:
`(45) Date of Patent:
`*Jan. 10, 2017
`McAuley et al.
`
`(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)
`
`(73) Assignee: Fisher & Paykel Healthcare Limited,
`Auckland (NZ)
`
`(58) Field of Classification Search
`CPC ..................... A61M 16/0057; A61M 16/0069;
`A61M16/06;A61M16/0611;A61M
`16/0616; A61M16/0633;A61M
`16/0666; A61M 16/0683; A61M 16/08;
`A61M16/0816; A61M16/0825;A61M
`16/0875;A61M16/109;A61M
`16/16;A61M16/208;A61M 2016/0661;
`A61M 2205/0216; A61M
`2209/088; A61M 2210/0618
`(Continued)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`This patent is subject to a terminal dis-
`claimer.
`
`301,111 A
`472,238 A
`
`7/1884 Genese
`4/1892 Van Orden
`
`(Continued)
`
`(21) Appl. No.: 15/087,775
`
`(22)
`
`Filed:
`
`Mar. 31, 2016
`
`(65)
`
`Prior Publication Data
`
`US 2016/0213876 A1
`
`Jul. 28, 2016
`
`Related US. Application Data
`
`(63) Continuation of application No. 14/887,200, filed on
`Oct. 19, 2015, which is a continuation of application
`(Continued)
`
`(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)
`
`FOREIGN PATENT DOCUMENTS
`
`CA
`CN
`
`131 16 62
`217 253 8
`
`12/1992
`7/1994
`
`(Continued)
`
`OTHER PUBLICATIONS
`
`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
`
`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.
`(Continued)
`
`
`
`RMD
`EXHIBIT 1005 - PAGE 1
`
`RMD
`EXHIBIT 1005 - PAGE 1
`
`

`

`US 9,539,405 B2
`
`Page 2
`
`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.
`
`20 Claims, 10 Drawing Sheets
`
`Related U.S. Application Data
`
`No. 14/791,142, filed on Jul. 2, 2015, now Pat. No.
`9,339,622, which is a continuation of application No.
`14/333,134, filed on Jul. 16, 2014, which is a contin-
`uation of application No. 10/598,026, filed as appli-
`cation No. PCT/NZ2005/000023 on Feb. 18, 2005,
`now Pat. No. 8,783,257.
`
`(51)
`
`Int. Cl.
`A61M 16/08
`A61M 16/00
`A61M 16/10
`(52) U.S. 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);
`A61M16/0875 (2013.01); A61M16/109
`(2014.02); A61M 16/16 (2013.01);A61M
`2205/0216 (2013.01)
`
`(58) Field of Classification Search
`USPC ............ 128/203.22, 205.25, 206.11, 206.24,
`128/206.26, 206.27, 207.11, 207.13,
`128/207.18
`
`See application file for complete search history.
`
`(56)
`
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`RMD
`EXHIBIT 1005 - PAGE 2
`
`RMD
`EXHIBIT 1005 - PAGE 2
`
`

`

`US 9,539,405 B2
`
`Page 3
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`(56)
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`

`

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`US 9,539,405 B2
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`Humidifier User Manual.
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`www.resmed.com/us/dam/documents/articles/resmedoriginspdf).
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`2015, in the matter of an Opposition by Fisher & Paykel Healthcare
`Limited of Australian patent application 2009221630 in the name of
`ResVIed Limited.
`The American Heritage Dictionary of the English Language, Fourth
`Edition (2006) (selected portions).
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`WeddingBandscomiMen’s Wedding Ring
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`
`* cited by examiner
`
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`Figure 3
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`i‘sfi
`a
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`1’39
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`Figure 5
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`US 9,539,405 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 and made a part of the present disclosure.
`
`BACKGROUND
`
`Field
`
`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 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 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
`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 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
`
`10
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`15
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`20
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`25
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`30
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`35
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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 like are noisy (due
`to air leaks). These disadvantages in many cases are a
`formidable obstacle to patient acceptance of such treatment.
`Therefore, a substantial number of patients either cannot
`tolerate treatment or choose to forego treatment.
`It
`is
`believed a substantial 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 deliver-
`ing oxygen, or oxygen or air mixture, it has proven benefi-
`cial to humidify the gases first. In WOOl/4l854 of Vapo-
`therrn, 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 of the cannula
`
`resulting in high resistance gas flow and excessive velocity
`and noise upon exiting the cannula. Furthermore, the nar-
`rowness 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
`
`oxygen 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 con-
`tinuous positive airway pressure (CPAP) blower to the
`airway of the wearer.
`
`SUMMARY
`
`invention to provide a
`is an object of the present
`It
`breathing assistance apparatus which goes someway to
`overcoming the above mentioned disadvantages or which
`will at least provide the public a useful choice.
`Accordingly in a first aspect the present invention 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 invention consists in a
`breathing assistance apparatus comprising:
`nasal cannula, shaped to fit within a user’s nares,
`a pressurised source of gases,
`
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`US 9,539,405 B2
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`3
`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
`least one prong allowing high flow delivery of said humidi-
`fied 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 invention relates,
`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 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.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Preferred forms of the present invention will now be
`described with reference to the accompanying drawings.
`FIG. 1 is a block diagram of a system providing humidi-
`fied 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.
`
`10
`
`15
`
`20
`
`25
`
`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.
`
`30
`
`FIG. 6 is an exploded view of the nasal cannula of FIG.
`
`2
`
`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
`cannula of FIG. 9.
`
`FIG. 12 is a front view of the prongs of the 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 of a fifth embodi-
`
`ment of the nasal cannula of the present invention where the
`connection between a body part and connector of the can-
`nula 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 of the 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
`
`Whether used in a hospital environment or in a home
`environment, the nasal cannula of the present invention will
`generally have associated three main pieces of apparatus.
`Firstly, an active humidifier, which that controls the tem-
`perature of a heater plate heating a body of water to achieve
`a desired temperature and humidity of the gases being
`humidified. Secondly, a transport conduit from the humidi-
`
`35
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`
`50
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`65
`
`4
`
`fier 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 embodi-
`ments the cannula may have a single prong. The cannula
`prongs are shaped such that a step is created between them
`so that the