USOO7658189B2
`
`(12) United States Patent
`(10) Patent No.:
`US 7,658,189 B2
`
`Davidson et al.
`(45) Date of Patent:
`*Feb. 9, 2010
`
`(54) COMPACT ORONASAL PATIENT
`INTERFACE
`
`(75)
`
`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 of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(58) Field of Classification Search ............ 128/20525,
`128/20611, 206.12, 206.18, 206.21, 206.24,
`128/20626, 206.27, 206.28, 207.11, 207.13,
`128/207.18
`
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`443,191 A
`
`12/1890 Illing
`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`AU
`
`51130/96
`
`10/1996
`
`(Continued)
`OTHER PUBLICATIONS
`
`Respironics C0.7Mask Familyihttp://masksfamily.respir0nics.
`com/ viewed on Jul. 24, 2006.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(Continued)
`
`(21) Appl.No.: 11/474,415
`
`(22)
`
`Filed:
`
`Jun. 26, 2006
`
`(65)
`
`Prior Publication Data
`
`US 2006/0237017 A1
`
`Oct. 26, 2006
`
`Related US. Application Data
`
`(63) Continuation of application No. PCT/AU2004/
`001832, filed on Dec. 24, 2004.
`
`(60) Provisional application No. 60/533,214, filed on Dec.
`31,2003.
`
`(51)
`
`Int. Cl.
`(2006.01)
`A623 18/02
`(2006.01)
`A623 18/08
`(52) U.S.Cl.
`............................ 128/205.25;128/207.18;
`128/20624
`
`Primary ExamineriDanton DeMille
`(74) Attorney, Agent, or FirmiNixon & Vanderhye RC.
`
`(57)
`
`ABSTRACT
`
`A breathing arrangement includes a patient interface, at least
`one inlet conduit, and a headgear assembly. The patient inter-
`face includes a mouth covering assembly including a cushion
`structured to sealingly engage around exterior 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. The at least one
`inlet conduit is structured to deliver breathable gas into at
`least one of the mouth covering assembly and the nozzle
`assembly for breathing by the patient. The headgear assembly
`is removably connected to at least one of the mouth covering
`assembly and the nozzle assembly so as to maintain the mouth
`covering assembly and the 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
`
`Page2
`
`U.S. PATENT DOCUMENTS
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`
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`..
`.. 128/205.27
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`
`2/1923 Feinberg .....
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`6,571,798 B1
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`6,581,601 B2
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`6,581,602 B2
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`6,584,975 B1*
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`6,595,215 132
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`2003/0196658 A1
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`
`
`
`128/206.11
`
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`US 7,658,189 B2
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`2005/0011523 A1
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`Worboys et a1.
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`DE
`EP
`EP
`GB
`GB
`GB
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`
`146688
`3719009
`19944242
`0658356
`1481702
`0532214
`2368533
`2385533
`WO 01/97892
`WO 87/01950
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`WO 01/97893
`WO 03/090827
`
`2/1981
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`WO 2005/063328
`W0
`WO 2005/063328 A1
`W0
`WO PCT/AU2006/000031
`WO PCT/AU2006/000417
`WC PCT/AU2006/000770
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`
`7/2005
`7/2005
`1/2006
`3/2006
`6/2006
`7/2006
`4/2008
`
`OTHER PUBLICATIONS
`
`m/
`
`Productsihttp://resmed.c0m/p01ta1/site/
`ResMed C0.7Mask
`.
`.
`.
`ResMedUS/index.]sp?... Viewed on Jul. 24, 2006.
`fph
`E h
`dP k lC 7P d tF .1 iht .//
`‘5 era“
`ay e
`0'
`m “c my
`tp' WWW care.c0
`0sa/pr0ducts.asp/ viewed on Jul. 24, 2006.
`Hans Rudolph, Inc.iMask Productsihttp://Www.rud01phkc.c0m/
`products.php?categ0r}PMASKS viewed on Jul. 24, 2006.
`Snapp Nasal Interface, Tiara Medical Systems, Inc.ihtth//WWW.
`tiaramed.com/aspishops/shopdisplayproducts.asp?id:109
`&cat:Snapp%2A+Nasal+Interface viewed on Jul. 24, 2006.
`U.S.App1. No. 60/634,802, filed Dec. 10, 2004.
`U.S.App1. No. 60/645,672, filed Jan. 21, 2005.
`U.S.App1. No. 11/447,295, filed Jun. 2006, Lubke et a1.
`U.S.App1. No. 60/483,622, filed Jul. 2003, Kwok et a1.
`U.S.App1. No. 60/795,615, filed Apr. 2006, Judson et a1.
`U.S.App1. No. 10/584,711, filed Jun. 2006, Davidson et al.
`International Preliminary Report on Patentability for PCT/AU2004/
`001832 dated Jul. 3, 2006.
`International Search Report for PCT/AU2004/001832, mailed Mar.
`24, 2005.
`International Search Report filed in PCT/AU2006/000770 mailed
`Aug. 3, 2006.
`“IfYou Hate CPAP! You Need CPAP Pr0®,” www.cpapprocom Oct.
`29, 2005.
`
`* cited by examiner
`
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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 US. Provi-
`sional Application No. 60/533,214, filed Dec. 31, 2003, each
`incorporated by reference in its entirety.
`FIELD OF THE INVENTION
`
`The present invention relates to a patient interface for use
`between a patient and a structure to deliver a breathable gas to
`the patient, such as is used in gas delivery systems for 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 who suffer from sleep disordered
`breathing conditions such as Obstructive Sleep Apnea (OSA).
`In non-invasive positive pres sure ventilation, a supply ofair at
`positive pressure is provided by a blower to a patient interface
`through an air delivery conduit. The patient interface may
`take the form of a nasal mask, nose & mouth mask, full face
`mask or nasal prongs.
`A mask may comprise (i) 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, known as a shell or frame, may define a nose-receiving
`cavity, or a mouth covering chamber. Other forms of patient
`interface, such as nasal cannulae, comprise a pair of nasal
`prongs, nasal inserts or nozzles.
`The soft patient contacting portion is typically known as a
`cushion or membrane and is 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 number ofpatients 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 other difficulties, it may result in noise, increased
`treatment pressure to compensate for the leak or an increased
`load on the nasal pas sages 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 between patients, the soft patient contacting portion or
`cushion must adapt to the shapes of individual patients. Typi-
`cally this is not achieved for the entire range of patients and
`some form of leak occurs. The problem is heightened during
`sleep when thejaw moves and the head position changes. This
`action can often serve to dislodge the mask and cause leak.
`Since leak can be noisy and results 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.
`
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`A further problem encountered by patients who are using
`full face, nasal or nose and mouth masks is 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
`may occur can affect the sensitive area surrounding the eyes.
`One form of nasal assembly known as a nasal puff is
`described in US. 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
`mouth seal.
`
`Another form of known nozzle assembly is described in
`US. 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.
`One typical example of a known nasal mask is described in
`US. Pat. No. 5,243,971 (Sullivan et al.). This has a ballooning
`seal in order to fit the patient’s nose and facial contours but
`does not provide a mouth seal. The contents of this patent are
`hereby incorporated by cross-reference.
`International publication number WO 0 1 /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 mask shell.
`A known example of a full face mask is described in US.
`Pat. No. 6,513,526 B2 (Kwok et al.), incorporated herein by
`reference in 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
`movement and head position throughout the night.
`A known example of a nose and mouth mask is described
`in US. Pat. No. 5,560,354 (Berthon-Jones et al.), the content
`of which is hereby incorporated by cross-reference.
`US. Patent Publication No. 2002/0069872 A1 (Gradon et
`al.) describes a mouthpiece which seals the oral cavity against
`‘mouth leak’. This mouthpiece includes both intra-oral and
`extra-oral sealing means and can be kept in place without the
`need for straps. International patent WO 01/95 965 (Gradon et
`al.) describes a similar mouthpiece for supplying humidified
`gases to a user.
`US. 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 of the 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.
`US. Pat. No. 1,873,160 (Sturtevant) describes a cylindrical
`air chamber held in 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
`problems of 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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`vides a supply of air or breathable gas to a patient’s nasal
`passages and which prevents or reduces mouth leak.
`In accordance with a second aspect ofthe invention there is
`provided a patient interface which can accommodate move-
`ment of the jaw of the patient.
`In accordance with another aspect of the invention there is
`provided a patient interface that provides an effective seal
`with both the patient’s mouth and the patient’s nasal pas-
`sages.
`In one form the invention comprises a mouth covering
`chamber, a nozzle assembly and a structure to provide flex-
`ibility therebetween.
`Another aspect of the invention relates to reducing contact
`area when compared to most known full face masks. This
`allows a far reduced headgear tension to be applied, signifi-
`cantly improving patient comfort. Patient comfort is further
`enhanced since the patient is less likely to feel claustrophobic,
`particularly with the removal of any mass that is close to the
`eyes.
`In accordance with another aspect of the invention there is
`provided a patient interface adapted to connect to an air
`delivery conduit.
`In accordance with another aspect of the invention there is
`provided a patient interface comprising a first chamber which
`incorporates a mouth covering chamber, a second chamber
`which incorporates a nozzle assembly and a flexible element
`connecting the first and second chambers.
`In accordance with another aspect of the invention there is
`provided a patient interface comprising a mouth covering
`chamber, a pair of nozzles and a flexible attachment member
`therebetween.
`
`In accordance with yet another aspect ofthe invention there
`is provided a patient interface comprising a mouth covering
`chamber and a pair of nozzles flexibly attached thereto. The
`mouth covering chamber incorporates a 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.
`In accordance with yet another aspect ofthe invention there
`is provided a patient interface comprising a mouth receiving
`assembly and a 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 component of the patient-contacting portion.
`In accordance with yet another aspect ofthe invention there
`is provided a patient interface with a strap routed around the
`top of the ears.
`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.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIGS. la-d show a dual chamber patient interface in accor-
`dance with a first embodiment of the invention;
`FIGS. le-lh illustrate various embodiments as to connec-
`
`tion between the upper and lower chambers;
`FIGS. 2a-c show a dual chamber patient interface in accor-
`dance with a second embodiment of the invention;
`FIGS. 3a-c show a dual chamber patient interface in accor-
`dance with a third embodiment of the invention;
`FIGS. 4a-c show a single chamber patient interface in
`accordance with a further embodiment of the invention;
`FIGS. 5a-d show front and rear views of a further embodi-
`ment of the invention.
`
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`FIGS. 611-!) show a single chamber patient interface with
`mouth gusset portion in accordance with a further embodi-
`ment of the invention;
`FIGS. 711-!) show views of a single chamber patient inter-
`face with mouth gusset portion in accordance with a further
`embodiment of the invention;
`FIGS. 7c-f show views of an alternative embodiment of a
`single chamber patient interface in accordance with a further
`embodiment of the present invention;
`FIG. 8 shows a patient interface in accordance with an
`embodiment of the invention connected to a headgear routed
`around the top of the ears;
`FIG. 9 shows a patient interface in accordance with an
`embodiment of the invention connected to different forms of
`
`headgear routed around the top of the ears;
`FIGS. 10-12 illustrate various headgear arrangements
`according to further embodiments of the invention;
`FIGS. 13-18d illustrate another embodiment of a single
`chamber patient interface;
`FIGS. 19-24d illustrate another embodiment of a single
`chamber patient interface;
`FIGS. 250-256 illustrate other embodiments of a single
`chamber patient interface;
`FIGS. 26-28 illustrate another embodiment of a single
`chamber patient interface with no nozzles;
`FIGS. 29 and 30 illustrate embodiments of a single cham-
`ber patient interface with blocked nozzles;
`FIGS. 31-330 illustrate another embodiment of a single
`chamber patient interface with a gusset portion;
`FIGS. 34-38 illustrate embodiments of a single chamber
`patient interface with insertable nozzles;
`FIGS. 39-40 illustrate embodiments of a patient interface
`with a mouth appliance;
`FIGS. 41-42 illustrate an embodiment of a patient interface
`with a corrugated frame;
`FIGS. 43-56b illustrate embodiments of nozzle arrange-
`ments;
`FIGS. 57-62 illustrate embodiments of support members
`for nozzles;
`FIGS. 63-64 illustrate an embodiment of a patient interface
`with a boomerang-shaped cushion;
`FIG. 6511-650 illustrates an embodiment of a patient inter-
`face with an extended frame;
`FIGS. 66a-67 illustrate an embodiment of a patient inter-
`face with an insertable anti-asphyxia valve; and
`FIGS. 68-80 illustrate embodiments of headgear assem-
`blies.
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`FIGS. la-ld illustrate a first embodiment of the present
`invention. As shown in FIG. 1a, a headgear assembly 1
`includes a patient interface having a dual chamber assembly
`10 including an upper chamber 12 and a lower chamber 14.As
`shown in FIG. 1a, the lower chamber 14 is in a disconnected
`position, while FIGS. lb-ld shown the upper and lower
`chambers in a connected position.
`Referring to FIG. 1a, the upper chamber 12 includes a
`nozzle assembly 16 supported by a frame including a first
`connector on each lateral end thereof, as described in US.
`Pat. No. 7,318,437 and incorporated herein by reference in its
`entirety. The nozzle assembly 16 is secured to the frame via a
`clip 18 which in this embodiment supports a pressure mea-
`surement port 20. The nozzle assembly 16 may include a pair
`ofnozzles 17 (see FIGS. lcand 1d).
`
`RMD
`EXHIBIT 1015 - PAGE 63
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`RMD
`EXHIBIT 1015 - PAGE 63
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`

`US 7,658,189 B2
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`5
`One or 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 blower or 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. 1b) 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 may be 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 best fit.
`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 second portion 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 throug