(12) United States Patent
`Ging et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,907,882 B2
`Jun. 21, 2005
`
`US006907882B2
`
`(54) ERGONOMIC AND ADJUSTABLE
`RESPIRATORY MASK ASSEMBLY WITH
`HEADGEAR ASSEMBLY
`
`(75)
`
`Inventors: Anthony M. Ging, Summer Hill (AU);
`Saad Nasr, Brighton Le Sands (AU)
`
`(73) Assignee: ResMed Limited, North Ryde (AU)
`.
`.
`.
`.
`.
`( * ) Notice:
`Subject. to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U~5~C~ 154(b) by 79 days
`
`(21) APP1. N0.: 10/390,531
`
`(22)
`
`Filed:
`
`Mar. 19, 2003
`_
`_
`_
`P1101‘ Pllb1lCatl0Il Data
`
`(60)
`
`US 2003/0196655 A1 Oct. 23, 2003
`Related U.S. Application Data
`Provisional application No. 60/377,254, filed on May 3,
`2002, provisional application No. 60/397,195, filed on Jul.
`22, 2002, and provisional application No. 60/402,509, filed
`on Aug. 12, 2002.
`
`3,056,402 A
`
`10/1962 Dickinson
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`199 62 515
`1258266
`
`7/2001
`11/2002
`
`880942
`2264646
`2379886
`wo 87/01950
`WO 98/04310
`
`W0 98/12965
`WO 96/61088
`WO 00/69521
`WO 00/78383
`WO 00/78384
`WO 01/32250
`WO 01/62326
`W0 02/11804
`
`10/1961
`9/1993
`3/2003
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`4/1998
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`OTHER PUBLICATIONS
`
`DE
`EP
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`GB
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`wo
`W0
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`W0
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`W0
`
`European Search Report for EP 032525552, dated Jan. 13,
`2004, 5 pages.
`
`(30)
`
`Foreign Application Priority Data
`
`Apr. 23, 2002
`
`(AU) ............................................ .. PS1926
`
`Primary Examiner—Henry Bennett
`Assistant Examiner—Teena Mitchell
`
`Int. Cl.7 .......................... .. A62B 18/08; A62B 9/04
`(51)
`(52) U.S. Cl.
`............................ .. 128/207.11; 128/202.27
`(58) Field of Search ..................... .. 128/206.16, 206.17,
`128/206.18, 206.21, 206.23, 206.24, 206.26,
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`205.25, 201.22, 201.23, 201.24, 202.27,
`24/305, 319, 326, 327, 335, 572.1, 573.11,
`581.1
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
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`
`12/1913 Johnston et al.
`7/1916 Greene
`12/1926 Kaufman
`6/1958 Bloom etal ......... .. 128/206.24
`4/1960 Schwarz
`
`(74) Attorney, Agent, or Firm—NiXon & Vanderhye, P.C.
`
`(57)
`
`ABSTRACT
`
`Arespiratory mask assembly for delivering breathable gas to
`a patient includes a frame having a main body and a side
`frame member provided on each lateral side of the main
`body. Each side frame member includes an integrally formed
`first connector portion. A headgear assembly is removably
`attachable to the frame. The headgear assembly has a second
`connector portion adapted to be removably coupled with the
`first connector portion provided on the frame. The second
`connector portion is manually movable to a releasing posi-
`tion to detach the headgear assembly from the frame. The
`headgear assembly is rotationally adjustable with respect to
`the frame.
`
`26 Claims, 56 Drawing Sheets
`
`
`
`RIVID 1030
`
`1
`
`RMD 1030
`
`

`
`US 6,907,882 B2
`Page 2
`
`US. PATENT DOCUMENTS
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`439443310 A
`7/1990 Sullivan
`....... .. 128/206.24
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`5,069,205 A * 12/1991 Urso ................... .. 128/201.24
`5,243,971 A
`9/1993 Sullivan et 211.
`5,245,995 A
`9/1993 Sullivan et al.
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`9/1994 S°h°g°fi“
`........... .. 128/207.11
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`1/1996 Brostrom et al.
`............ .. 2/452
`5535739 A
`7/1996 Rap°p°“ 64 41‘
`5’697’363 A
`12/1997 Ha“
`5’704’345 A
`1/1998 B°“h°“'J°“°S
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`3/1998 Handke et 41'
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`9/2000 Kwok et 211.
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`~
`Ejifiiff, E1 * 333$ §}“‘°1"hk.
`’
`’
`/
`et£211S1.Zc.5.}4..1.(.)/.\fiT.C.Z....... 128/207.17
`:1 *
`6€§4’844246
`4/2382
`et al
`128/206 27
`6415487 B1
`7/2002 Gunmmam et a1" "
`"
`6429238 B1 *
`7/2002 nth OW
`'
`128/20711
`65164802 B2
`2/2003 Hanfen etgl' '
`' ' ' ' "
`'
`6’550’070 B2
`4/2003 Wie and
`’
`*
`D44864907 s
`2/2004 Gun: etal
`~
`6 691314 B1 *
`2/2004 Grflhztetai ~
`2001/6026474 A1
`9/2001 Hecker et a1’ """""""""" "
`2002/0056457 A1
`5/2002 Demers eta1
`2002/0108613 A1
`8/2002 Gunaratnam 6: al
`2002/0144684 A1
`10/2002 Moone
`2004/0045551 A1 *
`3/2004 Eaton et al
`
`D24/1101
`2-,5
`’
`
`A
`"""""" "
`
`128/206 21
`'
`
`* cited by examiner
`
`2
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`FIG. 5b
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`1. Nosol Root Width
`2.Nc1s0t Bridge Width
`3. Nose Width
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`4. Mouth Width
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`45
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`5. Nose Height
`6. Nose Bridge Length
`7. Nose Hp Protrusion
`8. Nasal Root Depth
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`46
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`1
`ERGONOMIC AND ADJUSTABLE
`RESPIRATORY MASK ASSEMBLY WITH
`HEADGEAR ASSEMBLY
`
`CROSS-REFERENCE TO RELATED
`APPI .l('1ATI(')NS
`
`The present application claims priority from Australian
`Application No. PS 1926, filed Apr. 23, 2002 and U.S.
`Provisional Application Ser. No. 06/377,254, filed May 3,
`2002, Ser. No. 60/397,195, filed Jul. 22, 2002 and Ser. No.
`60/402,509, filed Aug. 12, 2002,
`the specifications and
`drawings of which are incorporated herein by reference.
`FIELD OF THE INVENTION
`
`The invention relates to a nasal mask for use in the
`delivery of Non—invasive Positive Pressure Ventilation
`(NPPV) and for nasal continuous positive airway pressure
`(nasal CPAP) therapy of sleep disordered breathing (SDB)
`conditions such as obstructive sleep apnea (OSA).
`BACKGROUND OF THE INVENTION
`
`The application of nCPAP for treatment of OSA was
`taught by Sullivan in U.S. Pat. No. 4,944,310, incorporated
`herein by reference in its entirety. In nCPAP treatment of
`OSA, pressurized air or other breathable gas is provided to
`the entrance of a patient’s airways at a pressure elevated
`above atmospheric pressure, typically in the range 4 to 20
`cm H20 to “splint” open the patient’s upper airways and
`prevent apneas.
`Apparatus to deliver nasal CPAP and NPPV therapy
`typically comprises a blower, an air delivery conduit and a
`patient interface. The blower may be programmed to deliver
`a range of different forms of therapy. In one form, a constant
`pressure of air or breathable gas is provided to the Jatient.
`It is also known for the level of treatment pressure to vary
`from breath to breath in accordance with patient need, that
`form of treatment being known as automatically aejusting
`nasal CPAP treatment as described in U.S. Pat. No. 5,245,
`995 (Sullivan and Lynch), incorporated herein by re erence
`in its entirety. NPPV is another form of treatment for
`breathing disorders. In its most basic form, a re atively
`higher pressure of gas may be provided in the patient mask
`during the inspiratory phase of respiration and a re atively
`lower pressure or atmospheric pressure being provided in
`the patient mask during the expiratory phase of respiration.
`In other modes,
`the pressure can be made to vary in a
`complex manner throughout
`the respiratory cyc e. For
`example,
`the pressure at
`the mas< during inspiration or
`expiration can be varied through the period of treatment.
`See, for example, US. Pat. No. 5,704,345 and International
`Patent Publication Nos. W098/12965 and W099/61088, all
`of which are incorporated by re erence herein in their
`entireties. In this specification, the term NPPV therapy will
`be used to describe all these forms of NPPV and nasal CPAP
`therapy.
`The patient interface for NPPV herapy may take many
`forms, such as a nasal mask assembly, a nose and mouth
`mask assembly, nasal cushions or a nasal prongs or pillows
`assembly. A mask assembly typical y includes a rigid shell,
`a soft face-contacting cushion, a forehead support and
`headgear for securing the mask to he head.
`In one known mask assembly, the headgear includes a cap
`portion with four straps. In use, the cap portion engages the
`occipital portion of the patient. Furthermore, in use, the two
`lower straps extend between the cap portion and a nasal
`
`2
`mask while the two upper straps extend between the cap
`portion and a forehead support. See, for example, U.S. Pat.
`No. 6,119,693 (Kwok, Matchett and Grant), incorporated
`herein by reference in its entirety.
`Some patient
`interfaces include quick or convenient
`release mechanisms for enabling a patient and/or clinician to
`disengage from the blower, blower tube and/or the mask,’
`headgear assembly. Quick or convenient release mecha-
`nisms are useful where NPPV therapy needs to be tempo-
`rarily interrupted or where a system failure causes a
`cessation of gas flow to the patient interface. For example,
`as disclosed in U.S. patent application Ser. No. 09/482,718,
`incorporated herein by reference in its entirety, the headgear
`and mask can be removed from the patient by pulling a
`conveniently located cord to decouple hook and loop fas-
`teners between engaging headstraps that are positioned, for
`example, at the rear of the headgear assembly. In another
`example, as disclosed in U.S. patent application Ser. No.
`09/504,220, incorporated herein by reference in its entirety,
`the headgear/mask assembly can be removed from the
`patient by detaching a connector member for the headstrap,
`which connector member is connected directly to the frame
`of the mask. See also US. Pat. No. 3,990,727, which
`discloses a quick detachable coupler that appears to be
`employed by the SleepNetTM IQTM mask.
`Since the patient must be able to sleep while wearing the
`patient interface, it is desirable that it be comfortable. In
`addition, the patient interface should provide a good seal to
`prevent or reduce leaks, or to better control any leak that
`occurs and to maintain eflicacy of treatment. Since the shape
`of people’s noses, faces and heads vary widely, from a
`commercial perspective, it is important to be able to manu-
`facture patient interfaces which can accommodate this range
`of facial shapes without having to carry excessive inventory
`through a large number of sizes. A number of patient
`interfaces have been designed with the goals of patient
`comfort, ease of use, adjustability and the ability to accom-
`modate a wide range of patient face and head shapes in
`mind.
`
`U.S. Pat. No. 5,243,971 (Sullivan and Bruderer) provides
`5 a patient interface (both nasal and full—face masks) that is
`suitable for use in NPPV therapy. The mask has a face
`contacting portion mounted to a shell which is sized and
`shaped to overfit the nose region of an intended wearer, and
`the face contacting portion is in the form of a distendable
`membrane which is molded from an elastic material. U.S.
`Pat. No. 5,243,971 is hereby incorporated by reference in its
`entirety.
`U.S. Pat. Nos. 6,357,441 and 6,112,746 (Kwok and
`Styles) each describe a nasal cushion which comprises a
`substantially triangularly shaped frame from which extends
`a membrane. These patents are hereby incorporated by
`reference in their entirety.
`Other nasal masks are disclosed in U.S. Pat. Nos. 5,724,
`965 and 6,119,694,
`incorporated by reference in their
`entirety. Each describes a nasal cushion that engages with
`the tip of the nose or that portion of the nose in the horizontal
`plane just above the upper lip of the patient. In PCT/US00/
`11329 (WO 00/69521),
`incorporated by reference in its
`entirety, a triangular-shaped nasal cushion includes a tapered
`profile that narrows towards the face of the patient. Some of
`these prior art masks/cushions has experienced significant
`challenges from the perspective of patient comfort, potential
`nasal vent occlusion, stability and/or sealing (especially at
`the nasal bridge and cheek regions).
`A number of adjustable forehead supports have been
`developed with the aim of achieving a serviceable seal while
`
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`US 6,907,882 B2
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`3
`increasing patient comfort and accommodating the greatest
`number of patients in the population. For example, U.S. Pat.
`No. 6,119,693 (Kwok, Matchett and Grant) describes an
`adjustable forehead support for a nasal mask or full-face
`mask. The forehead support may be adjusted for the different
`shapes and sizes of a facial profile. The angle of the seal
`relative to the face may be adjusted with this invention. U.S.
`Pat. No. 6,119,693 is hereby incorporated by cross-reference
`in their entirety. In International Patent Application PCT,’
`AU00/00097 (WC) 00/78384), a forehead support is dis-
`closed that is adapted to be secured to a respiratory mask.
`International Patent Application PCT/AU00/00097 (WO
`00/78384) is hereby incorporated by cross-reference in its
`entirety.
`Accordingly, a need has developed in the art to provide a
`mask assembly that is capable of overcoming the drawbacks
`or limitations of the prior art.
`BRIEF SUMMARY OF THE INVENTION
`
`One aspect of the present invention is directed towards a
`comfortable patient interface for delivering NPPV therapy.
`Another aspect of the invention is to provide a patient
`interface that will result in improved patient compliance
`with NPPV therapy.
`It is another aspect of the present invention to create a
`cushion that is capable of sealing on a smaller area of the
`nose as compared to known masks, while retaining or
`exceeding the comfort level of the ResMed Mirage® and
`Ultra Mirage® cushions.
`It is a further aspect of the present invention to reduce the
`perceived and/or actual size and/or weight of a nasal mask
`and provide a less intrusive mask for the user.
`Another aspect of the present invention is to provide a
`mask assembly in which the mask and headgear have a
`reduced amount of connections that are provided in a
`convenient and intuitive location for quick attachment and,’
`or detachment by the patient, while not being easily
`detached accidentally.
`Another aspect of the invention is to provide a mask
`assembly in wl1icl1 it is not necessary to provide a forehead
`support or an adjustment mechanism for
`the forehead
`support, while maintaining stability of the mask in use.
`Another aspect is to provide a nasal mask capable of
`fitting a wide range of patients, so as to decrease or minimize
`inventory requirements and the number of differently sized
`masks/cushions that are required for production.
`Yet another aspect of the present invention is to provide
`a nasal mask that offers more comfort to the patient, e.g., by
`better avoiding the application of unwanted localized pres-
`sure points in the facial contacting regions especially to the
`sensitive nasal bridge region of the patient, while maintain-
`ing a good seal, with or without the assistance of positive
`pressure to form or maintain the seal. Another aspect of the
`present invention is to avoid contact with the upper nasal
`bridge region, while avoiding localized pressure points
`along the lower nasal bridge region where the bony portion
`transitions into a portion of the nose containing more
`cartilage.
`Another aspect of the present invention is to avoid appli-
`cation of unwanted localized contact pressure or forces that
`may increase undesirably the impedance of airflow through
`the patient’s nares/naris and nasal passages, especially
`through the nasal vent.
`Still another aspect is to provide a headgear assembly
`which can provide added stability to the mask/cushion
`
`4
`assembly. In embodiments, the headgear may be made of or
`include at least one layer which imparts a degree of stiffness
`to the headstraps to assist in the stabilization of the mask,’
`cushion assembly, which may obviate the need for a fore-
`head support and thereby decrease visual obstructions near
`the patient’s eyes and better enhance or at least not hinder
`the patient’s ability to don, wear or remove eye glasses with
`the mask system in use. At least a portion of the headstrap
`itself may be formed of a relatively more rigid material in
`comparison to relatively flexible headstraps, instead of pro-
`viding a multiple layer structure. The headgear may include
`a relatively large, hand—manipulable clip member that can be
`quickly and easily attached and/or detached from the head
`strap and/or the mask frame. Alternatively, the headgear may
`be magnetically coupled with the mask frame.
`Another aspect of the present invention is to provide a
`convenient or quick release mechanism which requires little
`effort or dexterity to operate.
`Another aspect of the present invention is to provide a
`frame which includes and/or integrates a quick release
`mechanism so that the clip member of the head straps can be
`easily detached from the frame. The quick release mecha-
`nism may include at least one connector portion formed in
`one piece with the frame. A mating connector portion can be
`provided on a portion of the headgear. The mask system is
`attached to a source of pressurized air which is delivered via
`an air delivery conduit. The conduit may be directly attached
`to the mask with its lumen in fluid communication with the
`mask chamber in order to supply pressurized air to the
`entrance of the patient’s airway. Preferably an intermediate
`piece connects the air delivery conduit to the mask. Prefer-
`ably the intermediate piece is an elbow joint, which will be
`better described below. The frame may include an extended
`tube protruding from the outside surface of the mask, which
`can improve the seal between the elbow joint and the mask
`frame and also improve the stability of the connection
`between the mask frame and the elbow joint. The extended
`tube may include a flange for attachment
`to the elbow
`assembly. Preferably the elbow assembly may be easily
`manipulated to quickly and readily detach the elbow joint
`from the mask frame during a temporary interruption in
`patient treatment. The elbow assembly may include a vent to
`atmosphere. Preferably the vent is in fluid communication
`with the system air path via an exhaust passage which is
`separated from the incoming gas path, for example, by using
`a baffle provided within a portion of the elbow joint.
`Another aspect of the invention is to provide a generally
`trapezoidal shaped mask cushion for a patient interface.
`Another aspect of the invention provides a respiratory
`mask assembly for delivering breathable gas to a patient.
`The respiratory mask assembly according to one embodi-
`ment includes a frame having a main body and a side frame
`member provided on each lateral side of the main body.
`Each side frame member includes an integrally formed first
`connector portion. A headgear assembly is removably
`attachable to the frame. The headgear assembly has a second
`connector portion adapted to be removably coupled with the
`first connector portion provided on the frame. The second
`connector portion is manually movable to a releasing posi-
`tion to detach the headgear assembly from the frame. The
`headgear assembly is rotationally adjustable with respect to
`the frame.
`
`Of course, portions of the described aspects of the present
`invention may form sub—aspects of the present invention.
`Also, various ones of the sub-aspects and/or aspects may be
`combined in various manners and also constitute additional
`
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`US 6,907,882 B2
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`5
`aspects or sub-aspects of the present invention. These and
`other features and aspects of the present invention will be
`described in or be apparent from the detailed description
`below read in conjunction with the attached Figures, Where
`like reference numerals indicate like components.
`BRIEF DESCRIPTION OF THE DRAVVINGS
`
`The accompanying drawings facilitate an understanding
`of the various embodiments of this invention.
`In such
`drawings:
`FIG. 1 is a perspective view of a nasal mask assembly
`according to one preferred embodiment of the present inven-
`tion;
`FIG. 1b shows a headgear assembly according to an
`embodiment of the invention;
`FIG. 2 is a partial side view of the nasal mask assembly
`of FIG. 1;
`FIG. 3 is a partial front View of the nasal mask assembly
`of FIG. 1'
`
`top plan View of the nasal mask
`
`FIG. 4 is a partial
`assembly of FIG. 1;
`FIG. 5 is a front perspective View of a frame component
`of the nasal mask assembly of FIG. 1;
`FIG. 5a is a top view of the frame of FIG. 5;
`FIG. 5b is a schematic view showing various forces acting
`on the nasal mask assembly which may affect a patient;
`FIG. 5c is a rear perspective View of the frame of FIG. 5;
`FIG. 6a is a top view of an elbow assembly and frame
`according to another embodiment of the present invention;
`FIG. 6b is an exploded view of the embodiment of FIG.
`6a;
`FIG. 7 is a partial sectional view of the frame of FIG. 5;
`FIG. 8 is a side view of a left side yoke of the nasal mask
`assembly of FIG. 1;
`FIG. 8a is an enlarged view of a right side yoke according
`to another embodiment of the present invention;
`FIG. 9a is a top View of a locking clip of the nasal mask
`assembly of FIG. 1;
`FIG. 9b is a bottom view of the locking clip of FIG. 901;
`FIG. 10a is a side View of a clip and frame in a nearly fully
`connected condition, according to the present invention;
`FIG. 10b is a bottom view of the clip of FIG. 1011;
`FIG. 10c is a top View of the clip of FIG. 10a;
`FIG. 10d is a perspective View of the clip of FIG. 10a;
`FIGS. 10e—10g illustrate the clip a11d yoke of the present
`invention in various connected positions;
`FIG. 11 is a perspective view of a buckle of the nasal mask
`assembly of FIG. 1;
`FIG. 12 is a bottom view of a cross-over strap of the nasal
`mask assembly of FIG. 1 in a relaxed state;
`FIG. 13 is a bottom view of the cross-over strap of FIG.
`12 in a crossed-over state;
`FIG. 14 is a View of a cross-over buckle of the cross-over
`strap of FIG. 13;
`FIG. 15 is a perspective view of a strap loop for use with ,
`the nasal mask assembly of FIG. 1;
`FIG. 16a is a perspective view of the swivel elbow shown
`in FIG. 1;
`FIG. 16b is a side View of a swivel elbow of the nasal
`mask assembly of FIG. 1;
`FIG. 17 is a front view of the swivel elbow of FIGS. I66:
`and 16b;
`
`6
`FIG. 13 is a rear view of the swivel elbow of FIGS. 16:1
`and 16b;
`FIG. 18b is a side View of another embodiment of a swivel
`elbow;
`FIG. 180 is a front View of the swivel elbow of FIG. 18b;
`FIG. 18d is a rear view of the swivel elbow of FIG. 18b;
`FIG. 18.9 is a cross—sectional View of the swivel elbow of
`FIG. 18b;
`FIGS. 19a-1—19c-2 are sequential sectional views of the
`swivel elbow as shown in FIG. 18, illustrating connection
`with a flange extending from the front surface of the frame;
`FIG. 20 is a perspective View of a vent cover of the nasal
`mask assembly of FIG. 1;
`FIG. 21 is a rear view of the vent cover of FIG. 20;
`FIG. 22 is a bottom view of the vent cover of FIG. 20;
`FIG. 22b is a perspective view of another embodiment of
`a vent cover for connection with the swivel elbow of FIG.
`18b;
`FIG. 226 is a rear View of the vent cover of FIG. 22b;
`FIG. 22d is a bottom view of the vent cover of FIG. 22b;
`FIG. 223 is a side view of the vent cover of FIG. 22b_;
`FIG. 22f is a side View of illustrating the vent cover of
`FIG. 22b connected to the swivel elbow of FIG. 18b;
`FIG. 23 is a perspective view of a connector tube of the
`nasal mask of FIG. 6a;
`FIG. 24a is a face side View of a cushion of the nasal mask
`
`assembly of FIG. 1 showing Computer Aided Design (CAD)
`construction lines;
`FIG. 24b is a frame side View of the cushion of FIG. 2464
`showing CAD construction lines;
`FIGS. 24c—24f illustrate various perspectives of the cush-
`ion shown in FIG. 24a;
`FIG. 24g shows a mask c11shion in accordance with an
`embodiment of the invention incorporating a septum notch;
`FIG. 25:1 is a perspective view of the cushion shown in
`FIG. 1 showing CAD construction lines;
`FIG. 25b is a face side view of the cushion of FIG. 2511;
`FIG. 25c is a frame side View of the cushion of FIG. 2561
`showing CAD construction lines;
`FIG. 25d is a cross—section taken along line 25d—25d of
`FIG. 25b showing CAD construction lines;
`FIG. 256 is a cross—section taken along line 25e—25e of
`FIG. 25b;
`FIG. 25f is a cross—section taken along line 25f—25f of
`FIG. 25b;
`FIG. 25g is a cross—section taken along line 25g—25g of
`FIG. 25b;
`FIG. 25h is a cross—section taken along line 25h—25h of
`FIG. 25b;
`FIG. 251' is an enlarged view of FIG. 25d showing typical
`(TYP) dimensions of an embodiment (R-radius);
`FIG. 26 is a perspective view of an air tube of the nasal
`mask assembly of FIG. 1;
`FIGS. 27a—27e are partial sectional views of a frame and
`cushion of the nasal mask assembly of FIG. 1 showing a
`sequence of positions of assembly and disassembly of the
`frame and cushion;
`FIG. 28 is a partial sectional view of an alternative
`embodiment of the frame and cushion of the nasal mask
`assembly of FIG. 1;
`FIGS. 29a—29d show alternative sealing configurations of
`the cushion of FIGS. 27a—27e.
`
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`US 6,907,882 B2
`
`7
`FIGS. 30 and 31 show various dimensions used to design
`a mask according to FIG. 1;
`FIGS. 32a-1—32c-2 illustrate an additional embodiment of
`the present invention for engagement between the frame and
`cushion, the cushion showing CAD construction lines;
`FIG. 32d is an enlarged cross-sectional view of the frame
`shown in FIGS. 3251-1-326‘-2;
`FIG. 32e illustrates an additional embodiment of the
`present invention for engagement between the frame and
`cushion;
`FIG. 33 is a perspective view of another embodiment of
`a frame of the nasal mask assembly;
`FIG. 34 is a top view of another embodiment of the yokes
`of the headgear assembly of the nasal mask assembly;
`FIG. 35 is an enlarged view of a right side yoke of the
`headgear assembly shown in FIG. 34;
`FIG. 36 is a perspective View illustrating the frame of
`FIG. 33 magnetically coupled to the headgear assembly of
`FIGS. 34 and 35;
`FIG. 37 is a schematic view illustrating the magnetic
`coupling of the frame of FIG. 33 and the headgear assembly
`of FIGS. 34 and 35;
`FIGS. 38A—38D show various perspectives of another
`embodiment of the cushion,
`the cushion showing CAD
`construction lines,
`FIGS. 39A—39D show various perspectives of another
`embodiment of the cushion,
`the cushion showing CAD
`construction lines,
`FIG. 40 is a perspective view of another embodiment of
`a frame of the nasal mask assembly;
`FIG. 41 is a bottom view of the frame shown in FIG. 40;
`FIG. 42 is a top view of an embodiment of the cushion
`structured to be engaged with the frame shown in FIG. 40,
`the cushion showing CAD construction lines; and
`FIG. 43 is a rear View of the cushion shown in FIG. 42,
`the cushion showing CAD construction lines.
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`Two main embodiments are described in the figures.
`Although many of the features and/or parts of each embodi-
`ment are the same, there are several parts and/or elements
`that are different. For example, while FIG. 1 shows one
`embodiment of an elbow assembly 60 according to the
`present invention, FIGS. 6a—6b show another arrangement
`of the elbow assembly 60. Other differences between the
`embodiments will be described below. Moreover, several
`alternative approaches are also described with respect to
`various parts and/or elements, and those alternative
`approaches should be considered as additional preferred
`embodiments of the present invention.
`As shown in FIGS. 1-4, a nasal mask assembly 10
`according to one preferred embodiment of the present inven-
`tion includes a frame 20 and a cushion 40 that is preferably
`detachably connected to the frame 20. Alternatively,
`the
`cushion 40 can be permanently attached to the frame 20
`using, e.g., co-molding or over-molding techniques, glue
`and/or mechanical fastening means. A swivel elbow assem-
`bly 60 and a headgear assembly 80 can be attached to the
`frame 20. FIG. 1 shows the nasal mask assembly 10 gen-
`erally as it is intended to be mounted onto a human head. Of
`course, the depiction in FIG. 1 is slightly spaced away from
`the head, or “floating”, for ease of understanding. FIG. lb
`shows the headgear assembly laid flat with the frame 20
`
`8
`removed therefrom. FIG. 2 illustrates the mask assembly 10
`from the left side view, FIG. 3 illustrates a front view
`thereof, and FIG. 4 illustrates a top view thereof. In FIGS.
`2-4, the rear portion of the headgear assembly 80 has been
`removed for clarity.
`Mask Frame
`As shown in FIG. 5, frame 20 includes an elongated body
`22 having a central bore 24 for connecting to the swivel
`elbow assembly 60. FIG. 5a is a top view of the frame 20 in
`. which the cushion 40,
`the elbow assembly 60 and the
`headgear assembly 80 have been detached. The frame 20
`includes a main body 2011, which is designed to accommo-
`date the cushion 40, and a pair of side frame members 20b
`that are preferably formed in one piece with the main body
`2001 of the frame 20. FIG. 5a shows that both side frame
`members preferably have the same configuration. The main
`body 20a and the side frame members 20b have been
`designed to have a curvature that generally follows the facial
`contour of the patient’s face on each side of the nose. In
`accordance with one embodiment of the invention,
`the
`curvature follows a smooth transition from the two side
`members having an inclusive angle of 120°. With the
`cushion 40 in place, the main body 20a is spaced away from
`the patient’s face in the nose region to prevent contacting the
`patient’s nose, while the side frame members 20b are
`generally parallel the cheek regions. A space is maintained
`between each side frame member 20b and the cheek of the
`patient since contact is not desired in this area. However, if
`desired, the side frame members 20b may be con