(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0118406 A1
`(43) Pub. Date:
`Jun. 24, 2004
`Lithgow et al.
`
`US 20040118406A1
`
`(54) CUSHION FOR A RESPIRATORY MASK
`ASSEMBLY
`
`486, ?led on Sep. 7, 2001. Provisional application
`No. 60/342,854, ?led on Dec. 28, 2001.
`
`(76) Inventors: Perry David Lithgow, GlenWood
`(AU); Robert Henry Frater, Lind?eld
`(AU); Joanne Elizabeth Drew,
`BalgoWlah Heights (AU); Memduh
`Guney, Killara (AU); Timothy
`Tsun-Fai Fu, Carlingford (AU); Philip
`Rodney Kwok, ChatsWood (AU);
`Donald Darkin, Dural (AU)
`
`Correspondence Address:
`NIXON & VANDERHYE, PC
`1100 N GLEBE ROAD
`8TH FLOOR
`ARLINGTON, VA 22201-4714 (US)
`
`(21) Appl. No.:
`
`10/655,622
`
`(22) Filed:
`
`Sep. 5, 2003
`
`Related US. Application Data
`
`(63) Continuation-in-part of application No. 10/235,846,
`?led on Sep. 6, 2002.
`
`(60) Provisional application No. 60/424,686, ?led on Nov.
`8, 2002. Provisional application No. 60/483,622, ?led
`on Jul. 1, 2003. Provisional application No. 60/317,
`
`Publication Classi?cation
`
`(51) Int. Cl? ......................... .. A62B 18/02; A62B 18/08
`(52) US. Cl. ........ ..128/206.24; 128/206.26; 128/206.21
`
`ABSTRACT
`(57)
`Arespiratory mark assembly for delivering breathable gas to
`a patient includes a frame and a cushion. The cushion has a
`non-face contacting portion structured to be connected to the
`frame, a face-contacting portion structured to engage the
`patient’s face, and an intermediate portion that interconnects
`the non-face contacting portion and the face-contacting
`portion. The intermediate portion includes a gusset portion
`that applies a ?rst component of force to the patient’s face
`through the face-contacting portion. A spring structure is
`coupled With the face-contacting portion of the cushion. The
`spring structure applies a second component of force to the
`patient’s face through the face-contacting portion. The ?rst
`and second components of force applied by the gusset
`portion and spring structure, respectively, determine a con
`tact force of the cushion applied to the patient’s face through
`the face-contacting portion. The intermediate portion may
`also include an elastic cuff portion. Further, in the case of an
`oral mask, the sealing section may include a portion that is
`designed to promote a better seal in the chin region of the
`mask.
`
`Page 1
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`Fisher & Paykel Ex. 1217
`IPR Petition - USP 8,944,061
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`Patent Application Publication Jun. 24, 2004 Sheet 7 0f 45
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`Page 8
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`Patent Application Publication Jun. 24, 2004 Sheet 9 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 10 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 11 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 12 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 13 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 14 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 15 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 17 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 18 0f 45
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`Patent Application Publication Jun. 24, 2004 Sheet 19 0f 45
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`Patent Application Publication Jun. 24,2004 Sheet 20 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 21 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 23 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 24 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 25 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 26 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 27 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 28 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 29 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 30 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 31 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 32 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 37 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 38 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 39 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 40 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 42 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 43 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 44 of 45
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`Patent Application Publication Jun. 24,2004 Sheet 45 of 45
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`US 2004/0118406 Al
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`Jun. 24, 2004
`
`CUSHION FOR A RESPIRATORY MASK
`ASSEMBLY
`
`CROSS REFERENCE TO PRIORITY
`APPLICATIONS
`
`[0001] This application claims the benefit of U.S. Provi-
`sional Application No. 60/424,686 filed Nov. 8, 2002, U.S.
`Provisional Application No. 60/483,622 filed Jul. 1, 2003,
`and the present application is a Continuation-In-Part of U'S.
`Non-Provisional application Ser. No. 10/235,846 filed Sep.
`6, 2002, which in turn claims priority to U.S. Provisional
`Application No. 60/317,486 filed Sep. 7, 2001 and US.
`Provisional Application No. 60/342,854 filed Dec. 28, 2001.
`Each of the above identified applications is incorporated
`herein by reference in its entirety.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates to a cushion for a
`respiratory mask assembly used for providing ventilatory
`support, e.g., for treatment of Sleep Disordered Breathing
`(SDB) with Non-invasive Positive Pressure Ventilation
`(NPPV).
`
`BACKGROUND OF THE INVENTION
`
`[0003] The use of NPPV for treatment of SDB such as
`Obstructive Sleep Apnea (OSA) was pioneered by Sullivan
`(see U.S. Pat. No. 4,944,310). Apparatus for the treatment of
`SDB involves a blower which delivers a supply of air at
`positive pressure to a patient interface via a conduit. The
`patient interface may take several forms, such as a nasal
`mask assembly and a nasal and mouth mask assembly.
`Patients typically wear a mask assembly while sleeping to
`receive the NPPV therapy.
`
`[0004] Mask assemblies typically comprisea rigid shell or
`frame and a soft face-contacting cushion. The cushion
`spaces the frame away from the patient’s face. The frame
`and cushion define a cavity which receives the nose or nose
`and mouth. The frame and cushion are held in position on
`the patient’s face by a headgear assembly. The headgear
`assembly typically comprises an arrangement of straps
`which pass along both sides of the patient’s face to the back
`or crown of the patient’s head.
`
`[0005] U.S. Pat. No. 5,243,971 (Sullivan and Bruderer)
`describes a nasal mask assembly for Continuous Positive
`Airway Pressure (CPAP) having a ballooning/molding seal
`that conforms with the patient’s nose and facial contours.
`The mask assembly has a face-contacting portion mounted
`to a shell whichis sized and shapedto overfit the nose region
`of the patient. The face-contacting portion is in the form of
`a distendable membrane which is molded from an elastic
`plastics material. The distendable membrane and the shell
`together define a chamber. Pressurized gas admitted to the
`chambercauses the membraneto distend outwardly from the
`patient’s face. The contents of this patent are hereby incor-
`porated by reference.
`
`[0006] U.S. Pat. No. 6,112,746 (Kwoket al.) describes a
`nasal mask assembly and a mask cushion therefor. The
`cushion comprises a substantially triangularly shaped frame
`from which extends a membrane. The frame has a scalloped
`edge by which the cushion is affixed to a mask body. The
`membrane has an aperture into which the patient’s nose is
`
`received. The membraneis spaced away from the rim of the
`frame, and its outer surface is of substantially the same
`shape as the rim. The contents of this patent are hereby
`incorporated by reference.
`[0007]
`Ina traditional mask assembly including a cushion,
`a seal is formed between the cushion and the face of a patient
`as the result of a contact force which acts along a contact line
`of the cushion. The contact force typically is a function of
`tension in the headgear straps which acts through the frame
`of the mask assembly,
`the walls of the cushion and the
`seal-forming portion of the cushion. In a traditional mask
`assembly, the frame defines a cavity or volute adapted to
`receive at least a portion of the nose, with the cushion
`forming a perimeter of the cavity. Thus, in use, the portion
`of the patient’s face within the cavity is exposed to air or
`breathable gas at positive pressure and hence receives a
`force as the result of that positive pressure.
`[0008] PCT Patent Application AU01/00746, published as
`WO 01/97893 (Frater et al.), describes a mask assembly for
`delivering air to a patient that includes a suspension mecha-
`nism to allow relative movement between a face-contacting
`cushion and a maskshell. The suspension mechanism also
`provides a predetermined force to the cushion that
`is a
`function of mask pressure, displacement of the cushion, or
`both. The contents of this patent are hereby incorporated by
`reference.
`
`[0009] U.S. Pat. No. 5,074,297 (Venegas) describes a
`respiratory mask assembly for use with intermittent positive
`pressure breathing treatment which is said to facilitate the
`formation and automatic adjustment of the seal between a
`patient’s face and a facial unit of the respiratory mask. The
`respirator mask assembly comprisesa facial unit, an expand-
`able piston adjacent
`the facial unit and a rigid support
`structure attached to one end of the piston, and an attach-
`ment mechanism for securing the mask assembly to a
`patient. During the inspiration portion of the ventilation
`cycle a positive pressure is developed within the mask
`assembly, causing the piston to expand. Because the attach-
`ment mechanism and the support cooperate to resist signifi-
`cant expansion of the piston, a force is generated which
`presses the facial unit against the patient’s face and main-
`tains an air tight seal. When pressure within the mask unit
`decreases, the contact force on the facial unit is likewise
`decreased and the seal is eliminated.
`
`[0010] A common problem with prior art mask assem-
`blies, such as the mask assemblies taught by U.S. Pat. Nos.
`5,074,297, 5,243,971 and 6,112,746 and PCT Patent Appli-
`cation AU01/00746, is patient comfort. Patients can develop
`sores and red marksontheir faces after several hours use of
`a mask assembly. The nasal bridge area of the patient’s face
`has been identified as being particularly sensitive.
`[0011] Moreover, the face contacting portion may apply
`excessive pressure to the wearer’s face resulting in discom-
`fort and possibly skin irritation. This can occur when the
`face contacting portion is distorted beyond its normal range
`of elasticity to conform to certain facial contours,
`thus
`requiring the application of excessive forces to obtain a seal.
`In some cases, these excessive pressures and forces may
`cause the wearer’s face to distort to conform with the face
`
`contacting portion, which increases wearer discomfort,
`facial soreness and ulceration.
`
`{0012] Another common problem with prior art mask
`assemblies is buildup of CO,
`in the mask cavity. Mask
`Page 47
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`assemblies typically include a vent which allows the con-
`tinuous washout of exhaled gasses from the cavity. One
`factor affecting the washout of exhaled gases is the dead
`space within the mask cavity.
`
`[0013] Another common problem with these masks is a
`broken or ineffective seal.
`for example,
`the mask may
`become dislodged if the wearer rolls over when sleeping,
`thereby creating a drag force on the gas supply line whichis
`transmitted to the mask and breaking the seal between the
`mask and wearer.If a mask is used for the administration of
`Continuous Positive Airway Pressure (CPAP) treatment for
`the condition obstructive sleep apnea, such a leak can result
`in a pressure supplied to the entrance of the wearer’s airway
`that is below the therapeutic value. Thus, treatment becomes
`ineffective.
`
`[0014] Another problem with mask assemblies which
`include a gusset section is visual size, both perceived and
`actual.
`
`[0015] Another problem with existing full face masks
`occurs when wearers move their jaws during treatment,
`which often happens. As a result, air leaks are created below
`the mouth from the mid-region extending to the region at the
`sides or corners of the mouth.
`
`It would be desirable to design a respiratory mask
`[0016]
`that can be securely sealed to a wearer’s face without
`causing discomfort and minimize leak.
`
`SUMMARYOF THE INVENTION
`
`[0017] One aspect of the invention is directed towards a
`mask assembly having a cushion that provides more comfort
`to the patient.
`
`[0022] Another aspect of the invention is directed towards
`a mask assembly having a gusset portion which has minimal
`impingementof a patient’s vision.
`
`[0023] Another aspect of the invention is directed towards
`a mask assembly having a cushion with a gusset portion
`which hasa low profile.
`
`[0024] Another aspect of the invention is directed towards
`a mask assembly having a gusset portion which seals at a
`low pressure and which is comfortable at high pressures.
`
`[0025] Another aspect of the invention is directed towards
`a mask assembly having a cushion with gusset portion which
`provides stop structures to regulate pressure distribution.
`
`[0026] Another aspect of the invention is directed towards
`a mask assembly having a gusset portion providing addi-
`tional footprint area and a spring section with a spring
`constant constructed so that the forces on the face from the
`
`cushion are a function of the additional footprint area, the
`mask pressure and the spring constantof the spring section.
`
`[0027] Another aspect of the invention is to provide an
`elastic cuff to the cushion. The elastic cuff may have a
`modulus of elasticity which is greater than a modulus of
`elasticity of the remaining portions of the cushion, such that
`it may vary more easily deform or stretch in response to
`localized pressure and/or force changes between the mask
`and the wearer’s face, thereby avoiding a compromisein the
`seal during movementofthe patient. The elastic cuff may be
`formed in one piece with the cushion, along an intermediate
`portion of the cushion between the contacting and non-
`contacting portions of the cushion. The elastic cuff may also
`be formed separate from the cushion and assembled to the
`contacting and/or non-contacting portions of the cushion.
`
`[0018] Another aspect of the invention is directed towards
`a mask assembly having a cushion that controllably distrib-
`utes facial contact pressure around the patient’s face.
`
`[0028] A further aspect of embodiments of the invention
`provides a full face mask with a cushion that forms a stable
`and reliable seal with a wearer’s face.
`
`[0019] Another aspect of the invention is directed towards
`a mask assembly having a cushion that controllably distrib-
`utes facial contact forces around a contact
`line on the
`
`patient’s face.
`
`[0020] Another aspect of the present invention provides a
`respiratory mask assembly for delivering breathable gas to a
`patient. The respiratory mask assembly according to one
`embodiment includes a frame and a cushion. The cushion
`
`has a non-face contacting portion structured to be connected
`to the frame, a face-contacting portion structured to engage
`the patient’s face, and an intermediate portion that intercon-
`nects the non-face contacting portion and the face-contact-
`ing portion. The intermediate portion includes a gusset
`portion that applies a first componentof force to the patient’s
`face through the face-contacting portion. A spring structure
`is coupled with the face-contacting portion of the cushion.
`The spring structure applies a second componentofforce to
`the patient’s face through the face-contacting portion. The
`first and second components of force applied by the gusset
`portion and spring structure, respectively, determine a con-
`tact force of the cushion applied to the patient’s face through
`the face-contacting portion.
`
`[0021] Another aspect of the invention is directed towards
`a mask assembly having a curvature which followsthe line
`of the patient’s face.
`
`[0029] An additional aspect of embodiments of the inven-
`tion provides a full face mask that effectively seals the
`region directly below and/or to the sides of the lowerlip.
`
`[0030] A further aspect of embodiments of the invention
`provides a full face mask that offers effective sealing at
`relatively high pressures.
`
`[0031] Another aspect of embodiments of the invention
`provides a full face mask that abuts the more stable bony
`regions of a wearer’s face.
`
`[0032] A further aspect of embodiments of the invention
`provides a full face mask that follows the natural contour of
`the face’s bony structure below the mouth.
`
`In one example, a full face respiratory mask com-
`[0033]
`prises a frame including a breathable gas port and cushion.
`The frame defines an inner chamberthat receives a wearer’s
`
`nasal region and mouth. The cushion includes a flange
`connected to the frame, an inner rim defining an opening to
`the inner chamber of the frame, and a sealing portion
`disposed between the flange and the inner rim that contacts
`the wearer’s face. The sealing portion includes a nasal seal
`section that spans a wearer’s face above the wearer’s nares,
`side seal sections extending from eachside of the nasal seal
`section on both sides of the wearer’s mouth, and a chin seal
`
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`
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`

`US 2004/0118406 Al
`
`Jun. 24, 2004
`
`section that extends between the side sections. The chin seal
`section is upwardly curved in an arch to follow the chin’s
`bony contour.
`
`In another example, a cushion for use in a full face
`[0034]
`respiratory mask, comprises a flange for connection to a
`mask frame, an inner rim defining an opening for surround-
`ing the wearer’s nares and mouth, and a sealing portion
`disposed between the flange and the inner rim that contacts
`the wearer’s face. The sealing portion includes a nasal seal
`section that spans a wearer’s face above the wearer’s nares,
`side seal sections extending from eachside of the nasal seal
`section on both sides of the wearer’s mouth, and a chin seal
`section that extends between the side sections, wherein the
`chin seal section is upwardly curved in an arch to follow the
`chin’s bony contour.
`
`[0051] FIG. 6B is a cross-sectional view of the cushion
`shown in FIG. 1 in accordance with an alternative embodi-
`ment of the invention;
`
`[0052] FIG. 6C is a perspective view similar to FIG.6;
`FIG.7 is a side view of the cushion shownin FIG.
`
`[0053]
`1;
`
`[0054]
`
`FIG. 7B is a perspective view similar to FIG. 7;
`
`FIG.8 is a perspective view of the cushion shown
`[0055]
`in FIG. 1;
`
`[0056]
`
`FIG. 8B is a perspective view similar to FIG.8;
`
`[0057] FIG. 9 is a bottom view of the cushion shown in
`FIG.1;
`
`[0058]
`
`FIG. 9B is a perspective view similar to FIG. 9;
`
`[0035] Principles of these examples may be applied to any
`type of cushion for use on a respiratory mask, including but
`not limited to silicone elastomer, gel, foam or any combi-
`nation thereof.
`[0060] FIG. 10B isafront view of a gusset portion of the
`cushion shownin FIG. 1 superimposed on a patient’s face,
`[0036] Principles of these examples may be applied to any
`the contact line of the membraneon the patient’s face shown
`type of respiratory mask, including CPAP systems or non-
`in dashed lines;
`positive ventilation masks, such as respirators.
`
`[0059] FIG. 10 is a front view of a gusset portion of the
`cushion shown in FIG. 1 superimposed on a patient’s face;
`
`features and advantages of this
`[0037] Other aspects,
`invention will become apparent from the following detailed
`description when taken in conjunction with the accompa-
`nying drawings, which are a part of this disclosure and
`which illustrate, by way of example, principles of this
`invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0038] The accompanying drawings facilitate an under-
`standing of the various embodiments of this invention. In
`such drawings:
`
`[0039] FIG. 1 is a front perspective view illustrating a
`mask assembly having a cushion constructed in accordance
`with an embodiment of the invention;
`
`[0040]
`
`FIG. 1B is a perspective view similar to FIG. 1;
`
`[0061] FIG. 11 is a front view of a gusset portion of the
`cushion shownin FIG.1;
`
`[0062] FIG. 11B is a perspective view similar to FIG.11;
`
`[0063] FIG. 12 is a front view illustrating different
`embodiments of a gusset portion of the cushion shown in
`FIG.1;
`
`[0064] FIG. 12B is a front view similar to FIG. 12
`illustrating different embodiments of a gusset portion of the
`cushion shownin FIG.1;
`
`[0065] FIG. 12C is a front view similar to FIG. 12
`illustrating a different embodimentof a gusset portion of the
`cushion shownin FIG.1;
`
`[0066] FIGS. 13A-13C are cross-sectional viewsillustrat-
`ing different embodiments of a spring structure within a
`gusset portion of the cushion shown in FIG. 1;
`
`[0041] FIG. 1C is a perspective view similar to FIG.1,
`but taken from another angle;
`
`[0067] FIG. 14 isa partial top view illustrating an embodi-
`ment of the cushion shown in FIG. 1;
`
`[0042] FIG. 2 is a rear perspective view of the mask
`assembly shown in FIG. 1;
`
`[0068] FIG. 15 is a cross-section taken along line 15-15 of
`FIG. 14;
`
`[0043] FIG. 2B is a perspective view similar to FIG. 2;
`
`FIG.3 is a rear view of the mask assembly shown
`[0044]
`in FIG.1;
`
`[0045] FIG. 3B is a perspective view similar to FIG.3;
`
`FIG.4 is a side view of the mask assembly shown
`[0046]
`in FIG.1;
`
`[0047] FIG. 4B is a perspective view similar to FIG. 4;
`
`[0048] FIG. 5 is a bottom view of the mask assembly
`shown in FIG. 1;
`
`[0049] FIG. 5B is a top view of the mask assembly shown
`in FIG.1;
`
`[0069] FIG. 16 is a cross-section taken along line 16-16 of
`FIG. 14;
`
`[0070] FIG. 17 isa cross-section taken along line 17-17 of
`FIG. 14;
`
`[0071] FIG. 18 is a cross-section taken along line 18-18 of
`FIG. 14;
`
`[0072] FIG. 19 isa cross-section taken along line 19-19 of
`FIG. 14;
`
`[0073]
`FIG.14;
`
`[0074]
`FIG.14;
`
`FIG.20 is a cross-section taken alongline 20-20 of
`
`FIG.21 is a cross-section taken along line 21-21 of
`
`[0050] FIG. 6 is a cross-sectional view of the cushion
`shown in FIG. 1;
`
`[0075] FIG. 22 is a cross-section taken along line 22-22 of
`FIG. 14;
`
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`US 2004/0118406 Al
`
`Jun. 24, 2004
`
`FIG.23 isa partial top view illustrating an embodi-
`[0076]
`ment of the cushion shown in FIG. 1;
`
`[0100] FIG. 47 is a force versus displacement graph for a
`prior art mask;
`
`[0077] FIG. 24 is a cross-section taken along line 24-24 of
`FIG.23;
`
`[0101] FIG. 47A is a cross-sectional view of a mask
`according to the prior art;
`
`[0078] FIG. 25 is a cross-section taken along line 25-25 of
`FIG.23;
`
`[0102] FIG. 48 is a force versus displacement graph for an
`embodiment of the present invention;
`
`[0079]
`FIG.23;
`
`FIG.26 is a cross-section taken along line 26-26 of
`
`[0080] FIG. 27 is a cross-section taken along line 27-27 of
`FIG.23;
`
`[0081]
`FIG.23;
`
`FIG.28 is a cross-section taken along line 28-28 of
`
`[0082] FIG. 29 is a cross-section taken along line 29-29 of
`FIG.23;
`
`[0083]
`FIG.23;
`
`[0084]
`FIG.23;
`
`FIG.30 is a cross-section taken alongline 30-30 of
`
`FIG.31 is a cross-section taken along line 31-31 of
`
`[0085] FIG. 32 is a cross-section taken along line 32-32 of
`FIG.23;
`
`[0086]
`FIG.23;
`
`FIG.33 is a cross-section taken along line 33-33 of
`
`[0087] FIG. 34 is a front perspective view of an embodi-
`ment of the cushion shown in FIG. 1;
`
`[0088] FIG. 35 is a rear perspective view of the cushion
`shown in FIG.34;
`
`[0089] FIG. 36 is a top view of the cushion shownin FIG.
`34;
`
`[0090] FIG. 37 is a side view of the cushion shown in
`FIG.34;
`
`[0091] FIG. 38 is a cross-section taken along line 38-38 of
`FIG.36;
`
`[0092] FIG. 39 is a cross-section taken along line 39-39 of
`FIG.36;
`
`[0093]
`FIG.36;
`
`[0094]
`FIG.40;
`
`FIG.40 is a cross-section taken along line 40-40 of
`
`FIG.41is a cross-section taken alongline 41-41 of
`
`[0095] FIG. 42 is an enlarged cross-sectional view of
`FIG.38;
`
`illustrates the relation
`[0096] FIG. 43 is a graph that
`between mask pressure and contact force on the patient’s
`face for a mask with at least a gusset portion wherein the
`gusset portion is held at a fixed extension;
`
`FIG.44 is a graphthat illustrates the effect a spring
`[0097]
`structure has on the total force applied to the patient’s face
`at a constant mask pressure;
`
`[0098] FIG. 45 is a cross-sectional view of another
`embodimentof the invention including an elastic nasal cuff.
`
`[0099] FIG. 46 is a force versus displacement graph for
`ResMed’s Activa™ mask;
`
`[0103] FIG. 49 is a cross-sectional view of yet another
`nasal cuff embodimentof the present invention;
`
`[0104] FIG. 50 is a front perspective view of a full face
`mask positioned on a wearer in accordance with a preferred
`embodiment of the invention;
`
`[0105] FIG. 51 is a front perspective view of the mask
`frame and cushion in accordance with a preferred embodi-
`ment of the invention;
`
`[0106] FIG. 52 is a rear perspective view of the cushion
`in accordance with a preferred embodimentofthe invention;
`
`[0107] FIG. 53 is a front view of the cushion of FIG. 52;
`
`[0108] FIG. 54 is a rear view (from the wearer’s side) of
`the cushion of FIG. 52;
`
`[0109] FIG. 55 is a bottom view of the cushion of FIG.
`52; and
`
`[0110] FIG. 56 is a cross section side perspective view of
`the cushion taken along line 56-56 of FIG. 54.
`
`DETAILED DESCRIPTION OF ILLUSTRATED
`EMBODIMENTS
`
`[0111] FIGS. 1-5B show a respiratory mask assembly 10
`that includes a frame 12 and a cushion 14 that may be
`permanently or removably connected to the frame 12. A
`forehead support 16 is movably mounted to an upperportion
`of the frame 12. A headgear assembly (not shown) can be
`removably attached to the frame 12 to maintain the frame 12
`and cushion 14 in a desired adjusted position on the patient’s
`face. For example, the headgear assembly may includea pair
`of upper and lower straps with the upper straps removably
`connected to clip structures 18 provided on the forehead
`support 16 and the lower straps removably connectedto clip
`structures 20 provided on the frame 12. However,
`the
`headgear assembly and frame 12 may be removably attached
`to one another in any suitable manner.
`
`In the illustrated embodiment, the mask assembly
`[0112]
`10 is a nasal maskstructured to deliver breathable gas to a
`patient’s nose. However, the mask assembly 10 may be nasal
`and mouth mask or the mask assembly may be a full-face
`mask.
`
`[0113] Aswivel elbow assembly 22 is removably attached
`to a front portion of the frame 12. The elbow assembly 22
`is structured to be connected to a conduit that is connected
`to a pressurized supply. The pressurized supply supplies
`pressurized breathable gas through the conduit and elbow
`assembly 22 and into the cushion 14 for breathing by the
`patient.
`
`[0114] As shown in FIGS. 1-9B, the cushion 14 includes
`a non-face-contacting portion 24 (FIGS. 6 and 6C) struc-
`tured to be connected to the frame 12, a face-contacting
`portion 26 structured to engage a patient’s face, and an
`intermediate portion 28 that
`interconnects the non-face
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`Jun. 24, 2004
`
`contacting portion 24 and the face-contacting portion 26. A
`seal-forming portion 68 (see FIG. 10B) of the cushion 14is
`designed to seal on the patient’s face. The cushion 14
`achieves a seal by applying a contact force along the
`seal-forming portion 68 as will be described in further detail
`below. In one form, the seal-forming portion 68 is a strip
`with an area. For example, the strip 68 that contacts the
`patient’s face could be that area between the dashed sets of
`lines in FIG. 10B. The contact force applied to sensitive
`regions on the patient’s face can be minimized. Some
`portions of the patient’s face require special attention to
`achieve a balance of comfort and seal.
`
`generally triangular shape and is structured to contact the
`nasal bridge, cheek, and lip regions of the patient. However,
`the face-contacting portion 26 may have any other suitable
`shape, e.g., a generally trapezoidal shape. In the illustrated
`embodiment, the cushion 14 includesa pair of cheek regions
`44 to provide a seal in the crease between the cheeks and the
`sides of the nose, a lip region 46 to provide a seal below the
`nose and above the upper lip of the patient, and a nasal
`bridge region 42. The nasal bridge region 42 spans across the
`bridge and sloping sides of the bridge that intersect with the
`nasal crease formed between the cheeks andthe sides of the
`
`nose. The transition between the lip region 46 and each
`cheek region 44 is where the cushion 14 begins to tur
`around the bottom of the nose towardsthe