United States Patent
`US 7,658,189 B2
`(10) Patent No.:
`(12)
`Davidsonetal.
`(45) Date of Patent:
`*Feb. 9, 2010
`
`
`US007658189B2
`
`(54) COMPACT ORONASAL PATIENT
`INTERFACE
`
`(7)
`
`Inventors: Aaron Davidson, Newport (AU);
`
`Michael Gunaratnam, Marsfield (AU);
`Susan Lynch, Epping (AU); Milind
`Raje, Wentworthville (AU); Gary
`°
`,
`Robinson, East Killara (AU); Steven
`Lubke, Stanmore (AU); Gregory
`Smart, Randwick (AU); Philip Kwok,
`Chatswood (AU); Rupert Scheiner,
`Davidson (AU)
`
`(73) Assignee: ResMed Limited, Bella Vista (AU)
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days
`~~
`
`,
`
`This patent is subject to a terminal dis-
`laimer.
`camer
`.
`.No.:
`(21) Appl. No.: 11/474,415
`(22)
`Filed:
`Jum. 26, 2006
`oe
`.
`Prior Publication Data
`US 2006/0237017 Al
`Oct. 26. 2006
`;
`Related U.S. Application Data
`
`(65)
`
`(63) Continuation of application No. PCT/AU2004/
`001832, filed on Dec. 24, 2004.
`.
`Lo,
`(60) Provisional application No. 60/533,214,filed on Dec.
`31, 2003.
`
`(51)
`
`Int. Cl.
`(2006.01)
`A62B 18/02
`(2006.01)
`A62B 18/08
`(52) U.S.C cesses 128/205.25; 128/207.18;
`128/206.24
`
`(58) Field of Classification Search............ 128/205.25,
`128/206.11, 206.12, 206.18, 206.21, 206.24,
`128/206.26, 206.27, 206.28, 207.11, 207.13,
`
`See application file for complete search histor.
`
`,
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`443,191 A
`
`12/1890 Illing
`(Continued)
`
`AU
`
`FOREIGN PATENT DOCUMENTS
`51130/96
`10/1996
`
`(Continued)
`OTHER PUBLICATIONS
`Respironics Co.—Mask Family—http://masksfamily.respironics.
`com/ viewed on Jul. 24, 2006.
`
`(Continued)
`Primary Examiner—Danton DeMille
`(74) Attorney, Agent, or Firm—Nixon & Vanderhye P.C.
`(67)
`ABSTRACT
`A breathing arrangementincludesa patient interface,at least
`oneinlet conduit, and a headgear assembly.Thepatientinter-
`face includes a mouth covering assembly including a cushion
`structured to sealingly engage aroundexterior of a patient’s
`mouth in use, a nozzle assembly including a pair of nozzles
`structured to sealingly engage within nasal passages of a
`patient’s nose in use, and an element connecting the mouth
`covering assembly and the nozzle assembly. Theat least one
`inlet conduit is structured to deliver breathable gas into at
`least one of the mouth covering assembly and the nozzle
`assemblyfor breathing by the patient. The headgear assembly
`is removably connectedto at least one of the mouth covering
`assembly and the nozzle assembly so as to maintain the mouth
`covering assembly andthe nozzle assembly in a desired posi-
`tion on the patient’s face.
`
`65 Claims, 58 Drawing Sheets
`
`
`
`
`
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`US 7,658,189 B2
`
`Page 2
`
`U.S. PATENT DOCUMENTS
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`
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`
`..
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`
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`
`128/206.11
`
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`US 7,658,189 B2
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`
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`
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`ResMedUS/indexjsp?... viewed on Jul, 24, 2006.
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`products.php?category-MASKS viewed. on Jul. 24, 2006.
`Snapp Nasal Interface, Tiara Medical Systems, Inc.—http://www.
`tiaramed.com/asp_shops/shopdisplayproducts.asp?id=109
`&cat=Snapp%2A+Nasal+Interface viewed on Jul. 24, 2006.
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`
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`1
`COMPACT ORONASAL PATIENT
`INTERFACE
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation of PCT/AU04/01832,
`filed Dec. 24, 2004, which claims the benefit of U.S. Provi-
`sional Application No. 60/533,214, filed Dec. 31, 2003, each
`incorporated by referencein its entirety.
`FIELD OF THE INVENTION
`
`The present invention relates to a patient interface for use
`betweena patient anda structure to deliver a breathable gas to
`the patient, such as is used in gas delivery systemsfor respi-
`ratory therapy. Examples of such therapy are Continuous
`Positive Airway Pressure (CPAP)treatment, assisted respira-
`tion or Non-Invasive Positive Pressure Ventilation (NIPPV).
`BACKGROUND OF THE INVENTION
`
`Comfort and effectiveness remain a continuing challenge
`for engineers and designers of the interface between a
`mechanical ventilator and a patient. Such patient interfaces
`are currently employed for a variety ofpurposes including the
`delivery of non-invasive ventilation or for the delivery of
`pressurized air to persons whosuffer from sleep disordered
`breathing conditions such as Obstructive Sleep Apnea (OSA).
`Innon-invasive positive pressure ventilation, a supply ofairat
`positive pressure is provided by a blowerto a patient interface
`through an air delivery conduit. The patient interface may
`take the form ofa nasal mask, nose & mouth mask,full face
`maskor nasal prongs.
`A mask may comprise (1) a rigid or semi-rigid portion
`which attaches directly to the air delivery conduit and (ii) a
`soft patient contacting portion. The rigid or semi-rigid por-
`tion, knownas a shell or frame, may define a nose-receiving
`cavity, or a mouth covering chamber. Other formsofpatient
`interface, such as nasal cannulae, comprise a pair of nasal
`prongs, nasal inserts or nozzles.
`Thesoft patient contacting portion is typically knownas a
`cushion or membraneandis generally shaped during manu-
`facture to match the facial contours of a patient in order to
`provide the optimum seal.
`An inherent characteristic of patient interfaces such as
`nasal masks or nozzle assemblies is that they do not seal the
`mouth region. A numberofpatients thus find that during sleep
`when muscles relax, mouth leak may occur. Alternatively
`some patients are naturally mouth breathers and thus find a
`nasal patient interface ineffective. Mouth leak is undesirable
`as among otherdifficulties, it may result in noise, increased
`treatment pressure to compensatefor the leak or an increased
`load onthe nasal passages and potentially nasal obstruction or
`a runny nose.
`Patient interfaces such as full face masks or nose and
`mouth masks address this issue by sealing around both the
`nose and the mouth. Since nasal bridge anthropometry varies
`greatly betweenpatients, the soft patient contacting portion or
`cushion must adaptto the shapesof individualpatients. Typi-
`cally this is not achieved for the entire range of patients and
`some form of leak occurs. The problem is heightened during
`sleep whenthejaw movesandthe head position changes. This
`action can often serve to dislodge the mask and cause leak.
`Since leak can be noisy andresults in less-effective treatment,
`users often compensate by tightening the headgear more than
`is required. This is detrimental for patient comfort and can
`cause skin breakdown.
`
`20
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`25
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`30
`
`35
`
`40
`
`45
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`50
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`55
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`2
`A further problem encountered by patients who are using
`full face, nasal or nose and mouth masksis that the portion of
`the patient interface that seals around the nasal bridge pre-
`vents the patient from wearing spectacles. Additionally it may
`give the sensation of being closed in, leading to a feeling of
`claustrophobia, particularly when combined with a mouth-
`sealing portion. A further disadvantage is that any leaks that
`mayoccur can affect the sensitive area surrounding the eyes.
`One form of nasal assembly known as a nasal puff is
`described in U.S. Pat. No. 4,782,832 (Trimble et al.). This
`device has a pair ofnasal puffs together with a plenum cham-
`ber held in place with a harness assembly adapted to be worn
`over the head of the patient. The device does not provide a
`mouthseal.
`
`Another form of known nozzle assembly is described in
`USS. Pat. No. 6,431,172 (Bordewick et al.). The patent dis-
`closes a device with nares elements mounted on an inflatable
`
`plenum chamber. Again this does not provide any structure
`for sealing the mouth.
`Onetypical example ofa knownnasal maskis described in
`USS. Pat. No. 5,243,971 (Sullivan et al.). This has a ballooning
`seal in ordertofit the patient’s nose and facial contours but
`does not provide a mouth seal. The contents of this patentare
`hereby incorporated by cross-reference.
`International publication number WO 01/97893 A1 (Frater
`et al.), the content of which is hereby incorporated by cross-
`reference, describes a mask system for delivering air to a user
`including a suspension mechanism. This suspension mecha-
`nism allows relative movement between a face-contacting
`portion and a maskshell.
`A known example ofa full face mask is described in USS.
`Pat. No. 6,513,526 B2 (Kwoket al.), incorporated herein by
`referencein its entirety. Whilst providing a facial contour and
`sealing mechanism that
`incorporates both the nasal and
`mouth, this mask cannot flex to adapt to changes in jaw
`movementand headposition throughoutthe night.
`A known example of a nose and mouth mask is described
`in US. Pat. No. 5,560,354 (Berthon-Jonesetal.), the content
`of which is hereby incorporated by cross-reference.
`USS. Patent Publication No. 2002/0069872 Al (Gradon et
`al.) describes a mouthpiece whichseals the oral cavity against
`‘mouth leak’. This mouthpiece includes both intra-oral and
`extra-oral sealing meansand can be kept in place without the
`need for straps. International patent WO 01/95965 (Gradonet
`al.) describes a similar mouthpiece for supplying humidified
`gases to a user.
`USS. Pat. No. 6,571,798 B1 (Thornton) describes an oral
`device for improving a patient’s breathing together with a
`connecting post that provides a standard interface to a CPAP
`patient interface. The oral device is said to extend the lower
`jaw ofthe patient and thus open the breathing passage. The
`oral device is clenched between the teeth which may lead to
`discomfort and ifmask pressures are high can lead to the slow
`creep of gums around the teeth due to the sustained load.
`USS. Pat. No. 1,873,160 (Sturtevant) describes a cylindrical
`air chamberheldin position by a mouth portion that extends
`between the lips and teeth. The mouth portion may prove
`irritating and lead to discomfort when used for long periods.
`A problem with patient interfaces which incorporate oral
`appliances is that they can be uncomfortable for patients.
`Therefore, a need has developed in the art to address the
`problemsof the prior art.
`
`SUMMARY OF THE INVENTION
`
`In accordance with a first aspect of the invention there is
`provided a comfortable, effective patient interface which pro-
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`3
`4
`FIGS. 6a-6 show a single chamberpatient interface with
`vides a supply of air or breathable gas to a patient’s nasal
`mouth gusset portion in accordance with a further embodi-
`passages and which prevents or reduces mouth leak.
`mentof the invention;
`In accordance with a secondaspectofthe invention thereis
`FIGS. 7a-b show viewsof a single chamberpatient inter-
`provided a patient interface which can accommodate move-
`face with mouth gusset portion in accordance with a further
`mentofthe jaw ofthe patient.
`embodimentof the invention;
`In accordance with anotheraspect of the inventionthereis
`provided a patient interface that provides an effective seal
`FIGS. 7c-fshow viewsof an alternative embodiment of a
`with both the patient’s mouth and the patient’s nasal pas-
`single chamberpatient interface in accordance with a further
`sages.
`embodimentof the present invention;
`In one form the invention comprises a mouth covering
`FIG. 8 showsa patient interface in accordance with an
`chamber, a nozzle assembly anda structure to provide flex-
`embodimentof the invention connected to a headgear routed
`ibility therebetween.
`around the top ofthe ears;
`Anotheraspect of the invention relates to reducing contact
`FIG. 9 showsa patient interface in accordance with an
`embodimentofthe invention connected to different forms of
`area when compared to most known full face masks. This
`allows a far reduced headgeartension to be applied, signifi-
`headgear routed aroundthe top of the ears;
`cantly improving patient comfort. Patient comfort is further
`FIGS. 10-12 illustrate various headgear arrangements
`enhancedsincethe patientis less likely to feel claustrophobic,
`according to further embodimentsof the invention;
`particularly with the removal of any massthat is close to the
`FIGS. 13-18d illustrate another embodimentof a single
`eyes.
`chamberpatient interface;
`In accordance with anotheraspect of the inventionthereis
`FIGS. 19-24d illustrate another embodimentof a single
`provided a patient interface adapted to connect to an air
`chamberpatient interface;
`delivery conduit.
`FIGS. 25a-25e illustrate other embodiments of a single
`In accordance with anotheraspect of the inventionthereis
`chamberpatient interface;
`provided a patient interface comprising a first chamber which
`FIGS. 26-28 illustrate another embodiment of a single
`incorporates a mouth covering chamber, a second chamber
`chamberpatient interface with no nozzles;
`which incorporates a nozzle assembly and a flexible element
`FIGS. 29 and 30 illustrate embodiments of a single cham-
`connecting the first and second chambers.
`ber patient interface with blocked nozzles;
`In accordance with anotheraspect of the inventionthereis
`FIGS. 31-33c illustrate another embodimentof a single
`provided a patient interface comprising a mouth covering
`30
`chamberpatient interface with a gusset portion;
`chamber, a pair of nozzles andaflexible attachment member
`FIGS. 34-38 illustrate embodiments of a single chamber
`therebetween.
`patient interface with insertable nozzles;
`FIGS. 39-40 illustrate embodiments of a patient interface
`with a mouth appliance;
`FIGS. 41-42illustrate an embodimentofa patient interface
`with a corrugated frame;
`FIGS. 43-565 illustrate embodiments of nozzle arrange-
`ments;
`FIGS. 57-62 illustrate embodiments of support members
`for nozzles;
`FIGS. 63-64illustrate an embodimentofa patient interface
`with a boomerang-shaped cushion;
`FIG. 65a-65cillustrates an embodimentofa patientinter-
`face with an extended frame;
`FIGS. 66a-67 illustrate an embodimentofa patient inter-
`face with an insertable anti-asphyxia valve; and
`FIGS. 68-80 illustrate embodiments of headgear assem-
`blies.
`
`20
`
`25
`
`35
`
`40
`
`45
`
`Tn accordancewith yet another aspect ofthe invention there
`is provided a patient interface comprising a mouth covering
`chamberanda pair of nozzles flexibly attached thereto. The
`mouth covering chamberincorporatesa rigid portion defining
`the mouth covering chamber and a resilient or compliant
`patient-contacting portion. The pair of nozzles are mounted
`upon the patient-contacting portion.
`Tn accordancewith yet another aspect ofthe invention there
`is provided a patient interface comprising a mouth receiving
`assembly anda pair of nozzles flexibly attached thereto. The
`mouth receiving assembly incorporates a rigid portion defin-
`ing a mouth covering chamber, a gusset portion and a patient-
`contacting portion. The pair of nozzles are mounted upon a
`flexible componentofthe patient-contacting portion.
`Tn accordancewith yet another aspect ofthe invention there
`is provided a patient interface with a strap routed around the
`top oftheears.
`These and other aspects of the invention will be described
`in or apparent from the following detailed description of
`preferred embodiments, in which like elements designate like
`parts.
`
`50
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIGS. 1a-d show a dual chamberpatient interface in accor-
`dance with a first embodimentof the invention;
`FIGS. 1e-1h illustrate various embodiments as to connec-
`
`FIGS. 1a-1d illustrate a first embodiment of the present
`invention. As shown in FIG. la, a headgear assembly 1
`includesa patient interface having a dual chamber assembly
`10 including an upper chamber12 anda lower chamber 14. As
`shown in FIG.1a, the lower chamber14is in a disconnected
`position, while FIGS. 15-1d shown the upper and lower
`tion between the upper and lower chambers;
`chambers in a connected position.
`FIGS. 2a-c show a dual chamberpatient interface in accor-
`Referring to FIG. 1a, the upper chamber 12 includes a
`dance with a second embodimentofthe invention;
`nozzle assembly 16 supported by a frame includingafirst
`FIGS. 3a-c show a dual chamberpatient interface in accor-
`connector on each lateral end thereof, as described in U.S.
`dance with a third embodimentofthe invention;
`Pat. No. 7,318,437 and incorporated herein by referencein its
`FIGS. 4a-c show a single chamber patient interface in
`entirety. The nozzle assembly 16 is securedto the frame via a
`accordance with a further embodimentof the invention;
`clip 18 which in this embodiment supports a pressure mea-
`FIGS. 5a-d show front and rear views of a further embodi-
`surementport 20. The nozzle assembly 16 mayinclude a pair
`ment of the invention.
`of nozzles 17 (see FIGS. 1cand 14).
`
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`5
`Oneor more inlet conduits 22 is supplied with breathable
`gas under pressure via a joint 24 coupled to an air delivery
`tube, which in turn is communicated with a bloweror air
`delivery device. The lower chamber 14 is connected to the
`joint 24 via an inlet conduit 35. The joint 24 may include three
`branches (see FIG. 15) for connection to the inlet conduits 22
`and 35.
`Each inlet conduit 22 is connected to an elbow connector
`26, which is preferably connected to yoke 28 of strap 30 of
`headgear assembly 31 via a locking portion 32. Each elbow
`connector 26 is coupled to a second connector 34. Each
`respective first connector of the frame maybe selectively
`rotated with respect to the second connectors 34 to allow the
`nozzle assembly 16 to be adjusted according to patient
`requirements, to achieve the bestfit.
`As best shown in FIG. 1a, where the upper and lower
`chambers are disassembled, a first portion 36 of the lower
`chamber 14 may be connected to a secondportion 37 of the
`upper chamber 12. Connection may be achieved via a conduit
`41 (See FIG. 1e), or preferably a flexible element that con-
`nects the upper chamber 12 to the lower chamber 14. The
`flexible element may comprise one or more thin silicone
`conduits through whichair can pass. It may take the form of
`any other flexible element through which air can pass how-
`ever, examples including a spring 43 (FIG. 1/), bellows 45
`(FIG. 1g) or piston mechanism 47 (FIG. 1h). The flexible
`element provides a range of adjustment to adaptto the differ-
`ent geometry of a wide rangeofpatients and in addition a