(12) United States Patent
`McAuley et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,479,741 B2
`Jul. 9, 2013
`
`US00847974lB2
`
`(54) BREATHING ASSISTANCE APPARATUS
`
`(75)
`
`Inventors: Alastair Edwin McAuley, Auckland
`(NZ); Oliver Gleeson, Auckland (NZ);
`Evan Stuart Erstich, Auckland (NZ);
`Simon Eric Freeman, Auckland (NZ);
`Neil Glen Davies, Auckland (NL);
`Stephen John Schoenberg, Auckland
`(NZ); Kamman Law, Auckland (NZ);
`Craig Robert Prentice, Auckland (NZ)
`
`(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 1157 days.
`
`(21) Appl.No.: 12/353,640
`
`(22)
`
`Filed:
`
`Jan. 14, 2009
`
`(65)
`
`Prior Publication Data
`
`US 2009/0241961 A1
`
`Oct. 1, 2009
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 12/307,993, filed as
`application No. PCT/NZ2007/000185 on Jul. 13,
`2007.
`
`(30)
`
`Foreign Application Priority Data
`
`Jul. 14, 2006
`Nov. 6, 2006
`
`(NZ) ...................................... .. 548575
`(NZ) ...................................... .. 551103
`
`(51)
`
`Int. Cl.
`A61M 11/00
`(52) U.S. Cl.
`USPC .......... .. 128/207.18; 128/206.24; 128/207.11;
`128/207.13
`
`(2006.01)
`
`(58) Field of Classification Search
`USPC ........... .. 128/207.18, 206.21, 206.24, 206.27,
`128/207.11, 207.13
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,042,478 A
`5,148,802 A
`5,245,995 A
`5,477,852 A
`6,119,694 A
`6,581,594 B1
`
`8/1991 Kopala et al.
`9/1992 Sanders et al.
`9/1993 Sullivan et al.
`12/1995 Landis et al.
`9/2000 Correa et al.
`6/2003 Drew et al.
`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`00/74758
`12/2000
`2004/041341
`5/2004
`
`WO
`WO
`
`(Continued)
`OTHER PUBLICATIONS
`
`Examination Report; Australian Application No. 2007273324; dated
`May 22, 2012; 3 pages.
`
`(Continued)
`
`Primary Examiner — Steven Douglas
`(74) Attorney, Agent, or Firm — Knobbe, Martens, Olson &
`Bear LLP
`
`ABSTRACT
`(57)
`Headgear for use with a respiratory mask is described. The
`headgear includes 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 elongate
`member is disposed to sit 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.
`
`36 Claims, 21 Drawing Sheets
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`
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`RIVID 1002
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`1
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`RMD 1002
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`US 8,479,741 B2
`Page 2
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`U.S. PATENT DOCUMENTS
`
`2006/0196511 A1
`
`9/2006 Lau et al.
`
`10/2003 Lovell
`963L718 B1
`1/2004 Robeitson et al.
`6,679,257 B1
`6/2005 Ging et al.
`6,907,882 B2
`10/2005 Gradon et al.
`6,951,218 B2
`5/2007 LOVell etal.
`7,210,481 B1
`5/2007 Lovell et a1.
`7,219,669 B1
`1/2008 Gunaratnam et al.
`7,318,437 B2
`3/2011 Matula et al.
`.......... .. 128/200,24
`7,896,003 B2 *
`9/2003 Wilkie et al.
`2003/0172936 A1
`11/2004 Gunaratnam et al.
`2004/0226566 A1
`4/2005 Ho et a1,
`2005/0076913 A1
`2005/0235999 A1 * 10/2005 Wood et al.
`
`............ .. 128/207.18
`
`13/388? ¥°“£“‘fy e‘ “1'
`338?/3333313 iii
`65007 H0 et 31'
`2007/0125385 A1
`“
`° ‘°' 3 '
`FOREIGN PATENT D
`OCUMENTS
`2/gggg
`$8 W0 Egg?/332;:
`4/2007
`W0
`2007/0417“
`OTHER PUBLICATIONS
`
`English Translation of Chinese Examination Repoit; 5 pages.
`
`2006/0060200 A1
`
`3/2006 H0 et al.
`
`* cited by examiner
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`2
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`FIGURE 5
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`1
`BREATHING ASSISTANCE APPAILATU S
`
`This application is a continuation of US. patent applica-
`tion Ser. No. 12/307,993, entitled “Breathing Assistance
`Apparatus” which has a filing date of Jan. 8, 2009, which is a
`National Pl1ase application of PCT/NZ2007/000185 l1aving
`an international filing date of Jul. 13, 2007, and which claims
`priority of New Zealand Patent Nos. 548575, filed on Jul. 14,
`2006 and 551103, filed on Nov. 6, 2006, all of which are
`hereby incorporated by reference in their entirety.
`
`BACKGROUND OF THE INVENTION
`
`1. 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.
`2. Summary ofthe 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 mining and
`fire fighting applications, to various medical diagnostic and
`therapeutic applications.
`Obstructive Sleep Apnoea (OSA) is a sleep disorder that
`affects up to at least 5% of the population ir1 wl1icl1 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 H20. The air is supplied to the airway by
`a motor driven blower whose outlet passes via an air delivery
`110 se 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
`provided in the delivery tube proximate to the mask or on the
`mask itself. More sophisticated forms ofpositive airway pres-
`sure devices, such as bi-level devices and auto-titrating
`devices, are described inU.S. Pat. No. 5,148,802 ofRespiron-
`ics, Inc. and U.S. Pat. No. 5,245,995 of Rescare Limited,
`respectively.
`One requisite of respiratory masks l1as been that they pro-
`vide an effective seal against the user’s face to prevent leak-
`age 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
`pressure sores caused by the mask about the nose and face and
`
`2
`in particular in the nasal bridge region of the user. This prob-
`lem is most crucial in those applications, especially medical
`applications, which require the user to wear such a mask
`continuously for hours or perhaps even days, hi such situa-
`tions, the user will not tolerate the mask for long durations
`and optimum therapeutic or diagnostic objectives thus will
`not be achieved, or will be achieved with great difficulty and
`considerable user discomfort.
`U.S. 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 caimula tip to be inserted into the
`nares of the patient. Each caimula is tapered from a substan-
`tially circular cross section outside the patients 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 i11 the sidewall of the
`calmula. The nasal members are connected to one or more
`flexible hoses that, in tur11, are connected to a source of
`positive air pressure. In use, positive air pressure is supplied
`to each carmula 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
`U.S. Pat. No. 5,477,852 is attached to headgear that is located
`about a patients head. This headgear could be considered by
`many patients as cumbersome and uncomfortable.
`Conventional nasal masks used for administrating CPAP
`treatment are also considered uncomfortable and cumber-
`some, and prior art nasal masks can be noisy due to air leaks.
`These disadvantages in many cases are a formidable obstacle
`to patient acceptance of such treatment. Therefore, a substan-
`tial number of patients either cannot tolerate treatment or
`choose to forego 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 increased treatment compliance.
`Innomed Teclmologies, Inc. manufactures a nasal cannula
`device called the NASALAIRETM.
`In this device air or oxygen travels down a wide bore
`conduit to nasal camiula. The NASALAIRETM creates a
`physical seal between the nares and itself, and relies on the
`absence of leaks around the cannula and the nares to deliver
`pressure supplied by a continuous positive airway pressure
`(CPAP) blower to the airway of tlie wearer.
`U.S. Pat. No. 6,119,694 of Respironics Georgia, Inc dis-
`closes a nasal mask having a nare seal and lateral support
`members to support the mask.
`WO2004/073778 of ResMed Limited discloses a nasal
`ma sk including a frame where headgear is provided with rigid
`sections that extend to the nasal mask.
`WO04/041341 of ResMed Limited discloses headgear for
`apatient mask that includes a sewn onrigid section to the back
`area of headgear straps to provide rigidity to the straps. US.
`Pat. No. 6,907,882 ofResMed Limited discloses a nasal mask
`and headgear that is attachable to the frame ofthe nasal mask.
`The headgear straps have rigid sections integral with the
`releasable comiectors that attach the headgear to the mask.
`
`DISCLOSURE OF THE INVENTION
`
`It is an object ofthe present invention to attempt to provide
`a patient interface that goes some way to overcoming the
`abovementioned disadvantages in the prior art or which will
`at 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:
`
`24
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`3
`a continuous and substantially curved elongate member
`extending in use below a patient’s nose,
`at least two headgear straps capable of attachment to the
`ends of said elongate member, and
`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.
`In a second aspect the present invention consists in a
`breathing assistance apparatus for use with delivery of respi-
`ratory gases to a user comprising:
`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,
`a continuous and substantially curved elongate member
`extending in use below a patient’s nose,
`at least two headgear straps capable of attachment to the
`ends of said elongate member, and
`a mask attachment on said elongate member disposed
`below said user’s nose, said attachment capable ofreceiving
`said mask.
`In a third aspect the present invention consists in a breath-
`ing assistance apparatus for use with delivery of respiratory
`gases to a user comprising:
`a mask comprising a body and a cushion, said cushion
`substantially fonning a seal with said patient’s airways,
`headgear comprising substantially flexible, soft straps and
`a substantially continuous curved elongate member to which
`said mask is attached, said elongate member extending over
`said user’s checks, and
`wherein said mask has an inlet extension tube and said
`curved elongate member is attached or rests beneath said inlet
`extension tube, anchoring said mask to said user’s face in use.
`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.
`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 inven-
`tion. Unless specifically stated otherwise, reference to such
`external documents is not to be construed a s an admis sion that
`such documents, or such sources of information, in any juris-
`diction, are prior art, or form part of the connnon general
`knowledge in the art.
`The invention consists in the foregoing and also envisages
`constructions of which the following gives examples.
`BRIEF DESCRIPTION OF TI IE FIGURES
`
`invention will now be
`Preferred forms of the present
`described with reference to the accompanying drawings.
`FIG. 1 is a block diagram of a humidified continuous
`positive airway pressure system as might be used in conjunc-
`tion with the nasal mask of the present invention.
`FIG. 2 is a perspective View of a lirst form of a patient
`interface that is nasal mask and headgear ofthe present inven-
`tion.
`FIG. 3 is an exploded view of the nasal mask and headgear
`of FIG. 2.
`FIG. 4 is a side view of a mask base of the nasal mask and
`headgear of FIG. 2.
`FIG. 5 is a perspective end view ofthe maskbase ofFIG. 4.
`
`4
`FIG. 6 is an end view of a body of the nasal mask and
`headgear of FIG. 2, particularly showing two nasal pillows.
`FIG. 7 is a perspective View of the body of FIG. 6.
`FIG. 8 is a perspectiveview ofa nasal mask ofthe first form
`5 of the present invention but having altemative headgear tha
`includes additional rigid extensions.
`FIG. 9 is perspective view of a second form of a pa '
`interface and ieadgear o the present invention.
`FIG. 10 is an exploded view of the patient interface
`. headgear of FIG. 9.
`FIG. 11 is an exploded view of a third form of a pa '
`interface and ieadgear o the present invention.
`FIG. 12 is an exploded view of a fourth form of a pa '
`interface and ieadgear o the present invention.
`FIG. 13 is a perspective view of a fifth forn1 of a pa '
`interface and ieadgear o the present invention.
`FIG. 14 is an exploded view of the patient interface
`headgear of FIG. 13.
`FIG. 15 is a perspective view ofa sixth form ofa pa '
`interface and ieadgear o ‘the present invention.
`FIG. 16 is a perspective view of a seventh fomi of a pa '
`interface and ieadgear o the present invention.
`FIG. 17 is a cross-sectional View of the patient interface 0
`FIG. 16.
`FIG. 18 is a front View ofa nasal pillow of FIG. 6.
`FIG. 19a is a front view of the nasal pillows of FIG. 6.
`FIGS. 1% to 19d are graphs of the gradients of various
`nasal pillow connecting surfaces.
`FIG. 20 is a perspective view of an eighth form of a patient
`interface and headgear of the present invention.
`FIG. 21 is a perspective view of the interface and headgear
`of FIG. 20 showing inner pads on the arms of the headgear.
`FIG. 22 is an exploded view ofthe interface and headgear
`of FIG. 20.
`FIG. 23 is a perspective view of a ninth form of a patient
`interface and headgear the present invention.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS OF THE INVENTION
`
`The breathing assistance apparatus ofthe present invention
`including masks and headgear as described in the preferred
`embodiments of this invention can be used in respiratory care
`generally or with a ventilator. lt is described below with
`reference to use in a humidified CPAP system.
`A humidified Continuous Positive Airway Pressure
`(CPAP) system is shown in FIG. 1. A patient 1 is receiving
`htnnidified and pressurised gases through a patient interface 2
`connected to a humidified gases transportation pathway or
`inspiratory conduit 3. Alternative delivery systems may also
`be used such as, VPAP (Variable Positive Airway Pressure)
`and BiPAP (Bi-level Positive Airway Pressure) or numerous
`other forms of respiratory therapy. A nasal mask 2 is illus-
`trated in FIG. 7 but other masks such as oral, full face or nasal
`caimula may be used. An inspiratory conduit 3 is connected to
`an outlet 4 of a humidification chamber 5 that contains a
`volume of water 6. The inspiratory conduit 3 may contain
`heating means or heater wires (not shown) that heat the walls
`of the conduit to reduce condensation of humidified gases
`witl1i11 the conduit 3.
`The hlnnidification chamber 5 is preferably formed from a
`plastics material and preferably has a highly heat conductive
`base (for example an aluminium base) that is in direct contact
`with a heater plate 7 of humidifier 8. The humidifier 8 is
`provided with control means or an electronic controller 9 that
`may comprise a microprocessor based controller executing
`computer software connnands stored in associated memory.
`
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`5
`The controller 9 preferably receives input from sources
`such as user input means or a dial 10 through which a user of
`the device may, for example, set a predetermined required
`value (preset value) of humidity or temperature of the gases
`supplied to patient 1. Tl1e controller 9 may also receive input
`from other sources, for example temperature and/or flow
`velocity sensors 11, 12, through a connector 13 and a heater
`plate temperature sensor 14. In response to the user set
`l1un1idity or temperature value input via the dial 10 and the
`other inputs, the controller 9 determines when (or to what
`level) to cncrgisc the heater plate 7 to heat the water 6 within
`the humidification chamber 5. As the volume of the water 6
`within the 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
`outlet 4 with the flow ofgases (for example air) provided from
`a gases supply means or blower 15 that enters the chamber 5
`through an inlet 16. Exhaled gases from the patient’s mouth
`are passed directly to the ambient surroundings in FIG. 1.
`The blower 15 is provided with variable pressure regulat-
`ing means or variable speed fan 21 that draws air or other
`gases through a blower inlet 17. The speed of the variable
`speed fan 21 is controlled by an electronic controller 18 (or
`alternatively the function of the controller 18 may be 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 the fan speed via dial 19.
`FIGS. 2 and 3 show a first embodiment of a patient inter-
`face of the present invention. This patient interface is a nasal
`mask 2. The nasal mask 2 is cor11prised of a mask base 22 and
`body 23. The body 23 is substantially tubular with two nasal
`pillows 24, 25 extending from it. The nasal pillows 24, 25 are
`preferably frustoconical in shape and in use rest against a
`patient‘s nares, to substantially seal the patient’s nares. The
`body 23 has a11 external lip 28 that frictionally fits in a channel
`in the mask base 22.
`The body 23 and nasal pillows 24, 25 of the nasal mask of
`the present invention are shown in further detail in FIGS. 6
`and 7. The body and pillows are preferably integrally moul-
`ded in a substantially flexible plastics material. In the pre-
`ferred form this material is silicone, but other appropriate
`materials, such as, rubber, thermoset elastoiner or theme-
`plastic elastomer, such as KratonTM may be used.
`The nasal pillows 24, 25 are preferably an elliptical cone
`and as such are tubular and allow for a passage ofgases to flow
`from the tubing 3 and through the mask body 23. The pillows
`24, 25 are preferably angled toward one another and each
`l1ave a preferably elliptical outlet 26, 27 that may be slightly
`offset from the centre ofeach pillow 24, 25, as shown in FIG.
`6.
`
`FIGS. 18 and 19:; show a nasal pillow 24 with an offset
`outlet in more detail. The pillow 24 has a11 outer profile 200
`and inner profile 201 with respective centre points 202, 203.
`The inner profile 201 (outlet of the nasal pillow 24) is offset
`inward, by a horizontal spacing 204 and vertical spacing 205.
`Meaning the outlet 201 of the nasal pillow is offset horizon-
`tally 204 towards the middle of the nose and vertically 205
`towards the user’s upper lip. Offsetting the outlet 201 down-
`wards in this manner allows the outlet to be inserted into a
`user’s nostril without the outer profile 200 pushing the user’s
`upper lip. (Jffsetting the outlet 201 inwards allows the pillow
`to better seal on the septum ofthe nser’s nose in use.
`The outlet 201 may also be angled compared to the outer
`profile 200. For example in FIG. 18, there is a horizontal angle
`difference between the outer profile 200 and outlet 201 shown
`as 206. A similar vertical angle difference between the outer
`profile 200 and outlet 201 is shown as 207.
`
`6
`With the outer profile and inner profile having different
`sections or offsets allows the gradient of the connecting sur-
`face between the profiles to be changeable. This is shown in
`the graphs ofFIGS. 19b, 19c and 1901. The comiecting surface
`between the imier 201 a11d outer 200 profiles can have differ-
`ing gradients, 208, 209, 210. The different gradients 208, 209,
`210 of the coimecting surface are possible due to the differ-
`ence in offset difference 211, 212 (horizontal, vertical or
`angled) between the iimer 201 and outer 200 profiles.
`There may also be a difference in the rate of change of the
`gradient (as illustrated in the difference between 208 and
`210). This allows easier insertion ofthe pillow 24 into a user’s
`nostrils due to more lead in and better sealing that may be
`achieved due to more ergonomic contouring of the connect-
`ing surface that contacts the user’s nostril.
`Referring back to FIG. 7, the external lip 28 on the mask
`body 23 is an area of reduced circumference around the
`tubular part ofthe body 23. A projection 47 may be provided
`on the lip 28 that fits with a corresponding recess or channel
`(discussed below) on the mask base 22 to ensure correct
`assembly of the nasal mask.
`The mask base 22 is shown in further detail i11 FIGS. 4 and
`5. The mask base 22 is a ring or sleeve type attachment. The
`base 22 is preferably made from a substantially hard (rigid)
`plastics material, such as polypropylene, polycarbonate or
`acetyl. However, other appropriate materials may be used.
`The base 22 has an internal circumferential recessed area or
`channel 45 on one side and a seini-tubular projection 29 on its
`other side. When assembling the mask body 23 to the mask
`base 22 the channel 45 receives the lip 28. These parts are
`maintained together by friction fit, however other types of
`fitting may be provided for, such as a snap or bump fitted part
`or the body may be over moulded to a clip that causes the
`fitting to the mask body 23. In this form the friction fitting of
`the lip 28 to the recessed area 45 is assisted by elongate
`projections 49 extending along the central part 50 ofthe mask
`base 22. The projection 47 on the mask body 23 allows for
`correct fitting or keying of the mask base to the mask body,
`such that when the lip 28 is fitted into the recessed area 45, the
`, projection 47—enters the recess 48 formed in the mask base
`22.
`The semi—tubular projection 29 is curved in this embodi-
`ment such that a ball jointed connector end 46 such that a
`connector 30 can be fitted into it. The projection 29 forms a
`socket for the connector end 46 and the comiector end can
`swivel within the socket. The connector 30 is attached to a
`tube 31 to allow for gases to be passed to the nasal mask 2. The
`tubing 31 may be attached to i11spiratory conduit 3 or the
`tubing 31 may simply be the inspiratory conduit 3.
`In alternative embodiments the projection 29 may not be
`semi-circular but the inner surface of the base 22 may be
`curved and fonn a socket for receiving the cormector end 46.
`The base 22 has an extension or partial lip 32 extending
`beneath the semi—tubular projection (socket) 29. A slot 33 is
`created between the socket 29 and extension 32. The exten-
`sion ar1d slot is used to fit the mask base 22 to the headgear 21.
`In this embodiment the extension 32 is substantially curved to
`follow the shaped of the projection 29. However, in other
`forms the extension may be substantially straight or other-
`wise shaped.
`In use, the nasal mask is assembled with headgear 21. The
`headgear 21 in the preferred form is comprised of headgear
`straps 35, 36, 37, 38 and a substantially curved and elongate
`member 34. The member 34 is curved and substantially rigid,
`or at least more rigid than the headgear straps.
`The headgear straps 35, 36, 37, 38 are preferably made
`from a composite foam layered material, such as Breathop—
`
`26
`
`

`
`US 8,479,741 B2
`
`7
`rene1‘M. The headgear 21 preferably includes a first strap 35
`and a second strap 3 6. The first strap 35 extends in use over the
`forehead or top front area ofa patient’ s head. The second strap
`36 extends around the back of the patient‘s head. The head-
`gear 21 also has side straps 37, 38 that in use extend down the
`cheeks ofa patient and the ends ofthe straps terminate in the
`upper lip area of the patient in use.
`Referring to FIG. 2, the curved and elongate member 34 is
`comprised ofa central section 42 and contoured side arms 41,
`54. A substantial length of each of the side arms 41, 54
`overlaps and is attached to the side straps 37, 38. However, the
`side straps 37, 38 only extend partially along the length of the
`side arms 41, 54 so as to terminate beneath the cheek or near
`the upper lip region. As the side straps 37, 38 are made from
`a soft foam type material they provide a comfortable fitting of
`the headgear and curved member 34, while the substantially
`rigid side arms 41, 54 provide rigidity and stability to the
`headgear 21 and nasal mask 2. The attachment between the
`side straps and rigid extension side arms may be made by
`gluing, sewing or other appropriate fastening.
`Preferably the side arms of the curved member 34 are
`integrally moulded with the central section 42. The curved
`member 34 is preferably three dimensionally moulded to a
`shape to substantially match the cheek contours of a human.
`The side anns 41. 54 are preferably of thinner width (cross-
`section) than the central section 42. As the side arms 41, 54
`are moulded ofa plastics material to be substantially thin they
`are capable of being bent or adjusted to allow for better and
`more comfortable fit to a patient. The side anns 41. 54 may
`also include weakened or narrow areas 39 to allow for addi-
`tional bending, moulding or twisting of the arms 41, 54 to
`better fit the headgear to individual patients. For example, in
`the embodiment shown in FIGS. 2 and 3, the narrowed area 39
`corresponds to the cheek bone area of a patient and allows for
`the side arms 41, 54 to easier bend or twist to fit the contours
`of the patients face.
`In alternative embodiments the side arms may have weak-
`ened areas that are narrower in cross-section to that of the
`remainder of the side arms. A narrower cross-section area
`would also provide a weakened area that may be easily
`manipulated.
`In alternative embodiments of the present invention the
`side straps of the headgear may not extend under and along
`the length of the curved member but be attached to the distal
`ends of the straps. This attachment may be by hook and loop
`material, as is known in the art, or by other attachment meth-
`ods as known in the art. In this form. the arms of the curved
`member may have padding underneath them or no padding at
`all.
`Referring to FIG. 3, the curved elongate member has a
`central section 42 that in an assembled form supports the
`mask base and body such that the pillows 24, 25 rest against
`the patient’s nares. The central section 42 is a halfcircle that
`is integrally moulded with the side anns 41, 54. The central
`section 42 has a raised area 43 on its exterior, at the apex ofthe
`half circle. The raised area 43 is shaped to receive the mask
`base 22. To assemble, a patient merely needs to slide the mask
`base 22 into the central section 42 such that the raised area 43
`fits into the slot 33 on the mask base 22.
`The side arms 41, 54 of the curved member 34 preferably
`have varying cross-sectional thickness. The ends ofthe arms
`41, 54 attached to the central section 42 are thicker over the
`most curved parts 55, 56 of the arms, whereas the straighter
`parts of the arms 57, 58 have a narrow cross-section. There-
`fore, the thicker ends 55, 56 hold their shape better.
`In altemative embodiments, the mask base 22 may be
`formed integrally with the curved member 34. Therefore, the
`
`8
`central section and base would be one and would not be able
`to be separated from one another.
`An example of this is shown in FIGS. 20 to 22, the eighth
`embodiment of the patient interface and headgear 300. Here,
`the mask base 301 and the curved elongate member 302 are
`integrally formed, for example, by moulding or the like. The
`elongate member comprises arms 303, 304 similar to that
`described above. Also the mask body 305 has integral nasal
`pillows 306, 307 similarto that described above in relation to
`. FIG. 2.
`As can be seen in FIGS. 21 and 22 in this eighth embodi-
`ment the headgear straps 308, 309 do not extend down the
`arms 303, 304 as with other embodiments. In this embodi-
`ment the headgear straps 308, 309 attach through recesses
`310, 313 at the end of the arms 303, 304 extending along the
`arms are inner pads 311, 312 that rest against the patients
`cheekbones in use and provide comfort to the patient’s face.
`The pads 311, 312 only extend up to near the attachment
`recesses 309, 310. The pads are preferably made from a foam
`type material, such as the laminated material that the head-
`gear straps are made from. The pads 311, 312 preferably do
`not extend beyond the edges of the ar111s 303, 304.
`Referring back to FIGS. 2 and 3, alternatively, the curved
`member 34 may be formed as two separate pieces. That is, the
`central section 42 may be formed as two parts with a central
`split seam, the two left and right halves joined in use. The two
`left and right parts could either be joined along a seam as
`described above, with the base 22 slotting into the slot 33 as
`described above, or alternatively, each ofthe two left and right
`arms may be attached one to each side of the base 22.
`Where a “substantially continuous elongate member” or
`“curved member” is referred to in this specification, it refers
`to any of the options for the curved member 34 outlined
`above.
`The side arms 41, 54 may also include a loop 40 or
`detached section. This is where a section of the side arms 41
`is not attached to the strap 38, 37 lying underneath. Thus the
`detached section 40 of the side arms forms a loop to which a
`tubing attachment 44 (such as that shown attached to another
`strap in FIGS. 2 and 3) may be looped to the side arms 41, 54
`and the tubing 31 attached to either of the side arms.
`The connector 30 in the preferred form is a ball and socket
`jointed connector to allow for the tubing 31 to swivel