Ulllted States Patent
`
`[19]
`
`[11] Patent Number:
`
`6,119,694
`
`Correa et al.
`
`[45] Date of Patent:
`
`Sep. 19, 2000
`
`US006119694A
`
`5,074,297 12/1991 Venegas ........................... .. 128/204.18
`5,243,971
`9/1993 Sullivan et al.
`128/207.13
`Hahn . . . . . . . . . . . . . . .
`. . . . . . . . ..
`gm” 6‘. a1~
`ansoni ............................ ..
`.
`8/1997 Landis et al.
`...................... 128/207.13
`5/1998 Kidd ................................. .. 128/207.13
`
`
`
`,
`,
`5,657,752
`5,746,201
`
`FOREIGN PATENT DOCUMENTS
`
`2 268 388 12/1994 United Kingdom ............. A42B 7/00
`W0 998312;:
`3/£3: $158................................ 128/207.18
`
`OTHER PUBLICATIONS
`.
`.
`Us‘ Patent apph°a“°“ NO‘ 08/741524’ filed O°t'31’1996'
`primary Examme,._Aar0n J. Lewis
`Attorney, Agent, or Firm—Troutman Sanders LLP; Gerald
`R. B
`, E .
`57 055
`Sq
`ABSTRACT
`[
`]
`Anasalfmaskfasstemlély haldngf? Itlarelseal fortencloiing tfhe
`“ares? apa 16“ an apalm ac?‘ Supp“ m‘°'m.‘°'rS 0r
`engaging the cheekbones of a patient and supporting the
`nasal mask assem.bly..An associated headgear assembly
`constructed of semi-rigid members are selectively intercon-
`nected for defining a headgear. The nasal mask assembly is
`interconnected with depending arms of the headgear assem-
`bly by Contact connectors enabling the nasal mask to be
`adjusted linearly and angularly with respect to the headgear
`assembl
`
`y‘
`
`2 Claims, 4 Drawing Sheets
`
`RMD 1042
`
`[54] NASAL MASK AND HEADGEAR
`
`Inventors: José Luis Correa’ North Bergen; Diego
`Fontayne, Teaneck, both of N.J.; Karl
`-
`,
`-
`tI))Oatl£a(ffII{\,lg‘V’g)Ir’1{J2I‘\,m3';s T‘ Conms’ HI’
`’
`'
`'
`
`[73] Assignee: Respironics Georgia, Inc., Marietta,
`G .
`a
`[21] Applg No‘: 08/899,806
`
`Jul. 24, 1997
`Filed:
`[22]
`Int. Cl.7 ................................................... .. A63B 18/02
`[51]
`[52] U.s. Cl.
`................................. 128/207.13; 128/207.18
`[58] Fleld Of Search ....................... .. 128/206.18, 206.26,
`128/207-13> 207-18
`
`References Cited
`U.S. PATENT DOCUMENTS
`10/1996 Rapoport ............................ 128/204.18
`Re. 35,339
`7/1916 Greene
`128/207.13
`1,192,186
`3/1924 Lmaver
`128/207.13
`1,486,290
`3,776,244 12/1973 Morgan . ... ... .
`.. ..N 132/46
`4,149,540
`4/1979 Hasslinger
`128/327
`4,354,488 10/1982 Bartos
`128/205.25
`4,641,647
`2/1987 Behan ---- --
`128/207-18
`4>665>566
`5/1987 Ga”°W
`~~~~~~ ~~ 2/171
`4>741>054
`5/1988 Manes ““ “
`2/421
`4,766,610
`8/1988 Mattes
`.......... .. 2/6
`4,915,105
`4/1990 Lee ................. ..
`128/206.18
`5,038,776
`8/1991 Harrison et al.
`.. 128/207.11
`.
`5,069,205
`12/1991 Urso ................................. .. 128/201.24
`
`
`
`[56]
`
`1
`
`RMD 1042
`
`

`
`U.S. Patent
`
`Sep. 19,2000
`
`Sheet 1 of4
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`6,119,694
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`§
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`2 H
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`.
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`tag
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`2
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`

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`U.S. Patent
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`Sep. 19,2000
`
`Sheet 2 of4
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`6,119,694
`
`3
`
`

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`Sep. 19, 2000
`
`Sheet 3 of 4
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`6,119,694
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`4
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`

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`U.S. Patent
`
`Sep. 19, 2000
`
`Sheet 4 of4
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`6,119,694
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`5
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`

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`6,119,694
`
`1
`NASAL MASK AND HEADGEAR
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`This invention relates generally to a nasal mask for
`providing pressurized gas to a patient and more particularly
`to a nasal mask which only encloses the nares of a patient
`which utilizes a pair of lateral support arms which in
`combination with an associated headgear support the mask.
`2. Description of the Related Art
`Masks are used for various reasons. Typically masks are
`interconnected with a source of breathable fluid to be
`
`inhaled by a patient. These masks are used for anesthesia and
`also for providing positive air pressure to a patient in the
`treatment of obstructive sleep apnea. In the treatment of
`obstructive sleep apnea, positive air pressure is provided to
`a patient while the patient is sleeping.
`Accordingly, in the treatment of obstructive sleep apnea,
`mask comfort is important to ensure that the patient may
`sleep and also to ensure that the patient complies with the
`treatment. For the treatment of obstructive sleep apnea, the
`mask must provide a sufficient seal to enable pressure to be
`maintained within the airway of the patient. Typical masks
`are bulbous and enclose a large portion of the nose and
`engage the face of the patient. These masks tend to produce
`a claustrophobic effect on the patient. Furthermore, these
`masks generally irritate the bridge of the nose and parts of
`the patient’s face hindering patient comfort.
`Also, generally these masks are secured to a patient’s
`head by straps to ensure that a tight seal is had, thus further
`presenting pressure onto the patient’s nose. Additionally, the
`positioning and securing of the mask with the straps is
`cumbersome and time consuming. U.S. Pat. No. 5,517,986
`illustrates a headgear assembly for a gas delivery mask
`utilizing straps.
`Some masks have been developed which are not bulbous
`nor fit on a patient’s nose, but consist of a pair of elongated
`flange members which are inserted directly into the patient’s
`nares. U.S. Pat. No. 5,042,478 discloses such a mask. While
`this type of mask is suitable for its intended purpose, the
`presentation of air directly into the patient’s nares is awk-
`ward and generally uncomfortable to the patient.
`
`SUMMARY OF THE INVENTION
`
`Accordingly, it is an object of the present invention to
`provide a nasal mask which is comfortable to wear by a
`patient and which is easily secured for providing a seal
`around the nares of a patient.
`Furthermore, it is an object of the present invention to
`provide a nasal mask which solely encloses the nares of a
`patient.
`Also, it is an object of the present invention to provide a
`nasal mask and headgear assembly which is easy to position
`onto a patient and which is adjustable to accommodate the
`physical characteristics of an individual patient.
`Additionally, it is an object of the present invention to
`provide a nasal mask assembly which matingly adapts to the
`cheeks of a patient which in combination with a headgear
`assembly supports the mask.
`These objects are achieved, at least in part, by providing
`a nasal mask assembly for providing gas from a gas source
`to a patient that includes a nare seal having a surface for
`encircling the nares of a patent. The nare seal defines a gas
`opening permitting gas from the gas source to enter into the
`
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`nares of a patient. A nare seal support carries the nare seal.
`In a further embodiment of the present invention, the nare
`seal support includes a pair of leteral arms for engaging the
`patient’s face.
`
`DESCRIPTION OF THE DRAWING
`
`The construction designed to carry out the invention will
`hereinafter be described,
`together with other features
`thereof.
`
`The invention will be more readily understood from a
`reading of the following specification and by reference to the
`accompanying drawings forming a part thereof, wherein an
`example of the invention is shown and wherein:
`FIG. 1 is a top perspective view of a patient utilizing a
`nasal mask assembly and headgear assembly according to
`the present invention;
`FIG. 2 is a side perspective view of a patient utilizing the
`nasal mask assembly and headgear assembly according to
`the present invention;
`FIG. 3 is a rear view of the nasal mask assembly and
`headgear assembly according to the present invention;
`FIG. 4 is an exploded view of the nasal mask assembly
`according to the present invention;
`FIG. 5 is side view illustrating the pre inflation position of
`the nare seal according to the present invention;
`FIG. 5A is an operational view illustrating the pre and
`post inflation positions of the nasal mask with respect to a
`patient nares;
`FIG. 6 is a rear prospective view of the nasal mask
`assembly according to the present invention;
`FIG. 7 is a view taken along line 7—7 of FIG. 6
`illustrating the pre and post inflation of the nare seal accord-
`ing to the present invention.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`Now reference will be made with respect to the drawings
`for understanding of the preferred embodiment of the inven-
`tion.
`
`As shown in FIG. 1, a positive pressure device Aprovides
`gas under positive pressure to a patient 8 through a conduit
`10. Conduit 10 is in fluid communication with nasal mask
`
`assembly B which provides the pressurized gas to the nares
`of the patient. Headgear assembly C maintains the position-
`ing of nasal mask assembly B with the patient’s nares. In this
`manner, the patient’s vision is not obstructed.
`As shown in FIGS. 1 and 2, nasal mask assembly B
`includes flexible nare seal 14 and nare seal support 15. Nare
`seal 14 seals the nares of the patient when positive pressure
`is applied to nasal mask assembly B. Nare seal support 15
`includes first and second support arms 16 and 18 which
`extend outwardly from central support 17. First and second
`support arms 16 and 18 preferably traverse the face of the
`patient and rest against the cheekbones of the patient. In this
`manner, the force required to maintain a tight seal between
`nare seal 14 and the nares of the patient are transferred to a
`sturdy bone structure. A conduit receptor 19 attaches to
`conduit 10 for communicating pressurized gas from the
`conduit into the interior of nare seal 14.
`
`As further shown in FIGS. 1 and 2, nasal mask assembly
`B is secured to headgear assembly C. Headgear assembly C
`includes first headgear member 20 and second headgear
`member 22 which are interconnected to define a support
`structure for supporting nasal mask assembly B in fluid
`
`6
`
`

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`6,119,694
`
`3
`communication with the patient’s nares. First headgear
`member 20 and second headgear member 22 are preferably
`mirror images. First headgear member 20 is generally “Y”
`shaped having a first forward lateral arm 26 and a first
`rearward lateral arm 28 disposed rearwardly of forward
`lateral arm 26. First headgear member 20 also includes first
`depending arm 30. In the preferred embodiment, first for-
`ward lateral arm 26, first rearward lateral arm 28 and first
`depending arm 30 are of a unitary construction such that first
`depending arm 30 depends downward from the junction of
`forward lateral arm 26 with rearward lateral arm 28. Second
`
`headgear member 22, being of a mirror image of first
`headgear member 20, includes second forward lateral arm
`32, second rearward lateral arm 34 and second depending
`arm 36 and is also preferably of unitary construction.
`First and second headgear members are designed to
`matingly attach to one another. In this manner, first and
`second headgear members are assembled such that first and
`second forward lateral arms 26 and 32 encircle the forehead
`
`of the patient while first and second rearward lateral arms 28
`and 34 encircle the sides and back of the patient’s head. First
`and second depending arms 30 and 36 depend downward
`along the patient’s head in front of the patient’s ears. Also,
`when first and second headgear members 20 and 22 are
`assembled, they define head opening 45 which receives the
`crown of the patient leaving a predominant portion of the
`patient’s head unencumbered.
`In the preferred embodiment, first forward lateral arm 26
`includes pegs 38 and second forward lateral arm 32 includes
`peg receptacles 40. Also,
`first rearward lateral arm 28
`includes peg receptacles 42 and second rearward lateral arm
`34 includes pegs 44 enabling first and second headgear
`members 20 and 22 to be selectively interconnected depend-
`ing on the head parameters of the patient to provide a secure
`fit. By providing sufficient interconnecting elements, head-
`gear assembly C may be constructed to fit an adult, child or
`even an infant. Furthermore,
`first and second headgear
`members 20 and 22 are formed from a semi-rigid plastic
`material providing a semi-rigid support. The semi-rigid
`support retains its shape when assembled and transfers
`support forces along the entire periphery of headgear assem-
`bly C.
`As further shown in FIGS. 3 and 4, nasal mask assembly
`B attaches to headgear assembly C via contact connectors 46
`and 48. Preferably, contact connectors 46 and 48 include
`hook and loop fasteners such as Velcro trademark with a
`respective member being attached to the inside surface of
`first and second depending arms 30 and 36 and a corre-
`spondingly mating member attached to the exterior of sup-
`port arms 16 and 18. In this manner, support arms 16 and 18
`of nasal mask assembly B may be readily attached linearly
`and at any angle with respect to headgear assembly C for
`cooperating with the physical characteristics of the patient.
`Also, since headgear assembly C is semi-rigid and retains its
`shape, removal of the mask may be achieved by merely
`releasing either first or second support arm 16 or 18 from its
`respective mating attachment of the respective first or sec-
`ond depending arm. Strap connectors 50 and 52 attach
`support strap 54 to headgear assembly C. Support strap 54
`includes slit 55 and may be positioned under the chin of the
`patient or encircling the scalp. Strap connectors 50 and 52
`preferably include hook fasteners such as Velcro trademark
`and matingly engage support strap 54 which is preferably
`assembled from the fastening component of Velcro trade-
`mark.
`
`As shown in FIGS. 2, 3, 4, 5, 5A, 6 and 7, nare seal 14
`is a soft membrane preferably made from a material iden-
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`4
`tified as HSIIRTV manufactured by Dow Corning. Nare seal
`14 has a top surface 56 which is preferably sloped for
`engaging the lower portion of a patient’s nose including the
`nostrils. Nare seal 14 also includes a rearward side surface
`58 which is generally perpendicular with top surface 56 for
`engaging the portion of a patient between the patient’s
`mouth and nose which will be hereinafter referenced as the
`“upper lip”. Nare seal 14 also includes left nasal seal side 60,
`right nasal seal side 62 and nasal seal bottom 64 which in
`combination with top surface 56 and rearward side surface
`58 define nasal seal interior 66.
`
`As shown in FIGS. 4, 5A, 6 and 7, central support 17
`defines central orifice 68 which communicates with hollow
`
`bore 70. Bias ports 72 and 73 are defined within the interior
`wall of bore 70 on opposing sides. Nasal seal bottom 64
`defines air opening 74. Nare seal 14 is mounted onto nare
`seal support 15 such that air opening 74 encircles central
`orifice 68. Bore 70 communicates with conduit receptor 19
`to create a gas passageway enabling gas from positive
`pressure device A to enter into nare seal interior 66 and
`ultimately breathed by a patient. Gas defiector 76 is posi-
`tioned within the interior of bore 70 for defiecting gas
`received by conduit connector into nare seal interior. Gas
`defiector 76 includes stem 78 having opposing flanges 80,
`82, 84 which is received by bore interior 70 and laterally
`opposing defiecting wings 86 and 88 which extend into nare
`seal interior. Gas defiector 76 deflects the gas from the
`positive pressure source into nare seal interior so that the gas
`encircles the patient’s nares to provide a comfortable breath-
`ing environment.
`Top surface 56 and rearward side surface 58 define orifice
`90 which encircles the nares of the patient when gas is
`supplied under positive pressure. Orifice 90 is preferably
`diamond shaped and centrally located on top surface 56 and
`rearward side surface 58 such that a front portion 92 of top
`surface 56 engages the bottom tip of a patient’s nose while
`left and right side portions 94 and 96 of top surface 56
`engages the sides of a patient’s nostrils and bottom and left
`and right side portions 98, 100 and 102 of rearward side
`surface 58 engage the upper lip of the patient for sealing nare
`seal 14 around the patient’s nares.
`As shown in FIGS. 5, 5A and 7, nare seal 14 has a first
`uninflated position illustrated by broken lines 104 when gas
`is not being provided to the patient. In the first uninflated
`position,
`top surface 56 rests against the bottom of the
`patient’s nose and rearward surface 58 rests against the
`upper lip of the patient. When gas is being provided, nare
`seal 14 has a second inflated position illustrated by solid
`lines 106 wherein top surface 56 deflects upward and
`rearward surface 58 deflects rearwardly against the patient’s
`upper lip to encircle the patient’s nares and seal the area
`surrounding the patient’s nares.
`As further shown in FIGS. 3 and 4, nare seal support 15
`includes support arms 16 and 18 and central support 17.
`Preferably, nare seal support 15 is formed from an integral
`unitary plastic piece wherein support arms 16 and 18 extend
`outward from central support 17 for engaging the face of the
`patient preferably at the cheek bones and ultimately for
`connecting with headgear assembly C. Support arms 16 and
`18 are configured for transferring the force required to
`maintain nare seal 14 in a sealed orientation with the
`
`patient’s nares to the cheekbones of the patient. Support
`arms 16 and 18 are mirror images of one another. Support
`arm 16 includes a first portion 108 which extends rearwardly
`from central support 17 a general distance and deflects at an
`obtuse angle at deflection point 110. Second portion 112 of
`support arm 16 continues rearwardly from deflection point
`
`7
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`

`
`6,119,694
`
`5
`110 and terminates at distal end 114. Second portion 112 has
`a curved interior surface for matingly contouring with a
`patient’s face. Arespective of contact connector 48 is carried
`by the exterior of distal end 114. Distal end 114 includes an
`interior surface which is convex for positioning contact
`connector 48 generally perpendicular to contact connector
`located at first depending arm 30. A first facial pad 116 is
`carried by the interior of support arm 16 for contact with a
`patient’s face. Support arm 18 being a mirror image of
`support arm 16 has similar components such as first portion
`118, deflection point 120, second portion 122, distal end 124
`and contact connector 46.
`
`Thus, it can be seen that an advantageous construction of
`a nasal mask and headgear assembly may be had according
`to the invention. The small profile of the nare seal provides
`sufficient sealing for maintaining positive pressure within
`the airway of the patient while minimizing intrusion onto the
`face of the patient providing for a comfortable sleeping
`environment. The headgear assembly, in combination with
`the contact connectors, enables the nare seal to be quickly
`and easily attached and detached should the patient need to
`remove the mask upon waking during the sleep period as
`well as reattached for subsequent sleeping. The lateral arms
`of the mask support removes any supporting force from the
`patient’s nose and positions the force onto a bone structure
`which is more suitable for supporting the nare seal.
`While a preferred embodiment of the invention has been
`described using specific terms, such description is for illus-
`trative purposes only, and once the innovative features of the
`invention are known, it is to be understood that changes and
`variations may be made without departing from the spirit or
`scope of the following claims:
`What is claimed is:
`
`1. A nasal mask assembly for providing gas from a gas
`source to a patient comprising:
`(1) a nasal mask comprising:
`(a) a nare seal having a surface for encircling nares of
`a patient, said nare seal defining a gas opening
`permitting gas from a gas source to enter nares of a
`patient, said nare seal being sized so as to minimize
`a contact area between said nare seal and a nasal area
`
`of a patient, and
`(b) a nare seal support carrying said nare seal, said nare
`seal support including:
`a central support portion supporting said nare seal,
`a first
`lateral arm having a first end operatively
`coupled to a first side of said central support
`portion, a second end, and a first attachment
`portion at said second end of said first lateral arm,
`a second lateral arm having a first end operatively
`coupled to a second side of said central support
`portion, a second end, and a second attachment
`portion at said second end of said second lateral
`arm,
`said first lateral arm including a first lateral arm
`connector disposed at said attachment portion of
`said first lateral arm; and
`said second lateral arm including a second lateral
`arm connector disposed at said attachment portion
`of said first lateral arm; and
`
`6
`
`(2) a head gear assembly comprising:
`(a) a first depending arm carrying a first connector, and
`(b)
`a second depending arm carrying a second
`connector, wherein said first lateral arm connector
`releaseably attaches said first lateral arm to said first
`depending arm and said second lateral arm connector
`releaseably attaches said second lateral arm to said
`second depending arm, wherein said first connector
`and said second connector releaseably attach to said
`first lateral arm connector and said second lateral
`
`arm connector, respectively, at various angles so that
`said nare support is selectively positionable at vary-
`ing angles relative to a patient, thereby enabling said
`nare seal to be positioned at various positions for
`encircling nares of a patient.
`2. A nasal mask assembly for providing gas from a gas
`source to a patient comprising:
`(1) a nare seal having a first surface adapted to engage a
`lower portion of a patient’s nose and a second surface,
`said first and said second surfaces defining a nare seal
`interior, said nare seal being sized so as to minimize a
`contact area between said nare, seal and a nasal area of
`such a patient, said first surface having a first gas
`opening defined therein permitting gas flow between
`said nare seal interior and an airway of a patient, said
`second surface having a second gas opening defined
`therein permitting gas from a gas source to enter said
`nare seal interior, and wherein said nare seal interior
`includes a plurality of spatial regions;
`(2) a nare seal support carrying said nare seal, said nare
`seal support including:
`(a) a central support portion supporting said nare seal
`with said second surface of said nare seal operatively
`coupled to said central support portion,
`(b) a first lateral arm having a first end operatively
`coupled to a first side of said central support portion
`and a second end, and
`(c) a second lateral arm having a first end operatively
`coupled to a second side of said central support
`portion and a second end, and wherein said first
`lateral arm and said second lateral arm each include
`
`an attachment portion at said second end of each
`lateral arm on a second surface opposite said first
`surface to engage a headgear assembly for securing
`said nasal mask assembly to a head of patient; and
`(3) a gas distribution assembly interposed between a gas
`source and said nare seal interior, wherein said gas
`distribution assembly comprises a plurality of channels,
`each being adapted to distribute gas from such a gas
`source to one of said plurality of spatial regions in said
`nare seal interior so that gas entering said interior in a
`first direction from such a gas source is diverted in a
`second direction before entering a patient’s nares,
`wherein said gas distribution assembly includes at least
`one flange disposed in a direction of travel of such gas
`so as to divert such gas from said first direction in said
`second direction.
`
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