(12) United States Patent
`Rudolph
`
`(10) Patent N0.:
`
`(45) Date of Patent:
`
`US 6,192,886 B1
`*Feb. 27, 2001
`
`US006192886B1
`
`FOREIGN PATENT DOCUMENTS
`
`208855 *
`701690
`865111 *
`950429
`0549 299A2
`780746
`848215 *
`276496 *
`
`5/1940 (CH).
`12/1940 (DE) .............................. .. 128/207.13
`1/1953 (DE) ..
`128/206.17
`10/1956 (DE) ..
`128/207.11
`6/1993 (EP)
`..
`128/207.18
`5/1935 (FR)
`..
`. A61M/16/00
`9/1960 (GB)
`............................. .. 128/206.24
`7/1930 (IT) ............................... .. 128/206.18
`OTHER PUBLICATIONS
`
`
`
`Page 43 of Hosptial Accessories Catalog, 1993-94 showing
`Sullivan Nasal Bubble Masks and ADAM Nasal CPAP
`Circuit.
`
`(List continued on next page.)
`
`Primary Examiner—John G. Weiss
`Assistant Examiner—V. Srivastava
`
`(74) Attorney, Agent, or Firm—John C. McMahon
`
`(57)
`
`ABSTRACT
`
`A nasal mask configured to be as unobtrusive as possible
`while providing an air-tight seal around the nose of a wearer
`comprises a flexible nasal cup having a nasal opening
`formed by an inner circumferential edge or rim thereof and
`opening into a nasal chamber. The cup also includes inner
`and outer sealing flanges extending around the rim for
`forming an air-tight seal during use. The nasal cup is sized
`such that, when the nasal cup is positioned over a wearer’s
`nose, the rim generally extends across the wearer’s upper
`lip, around the alae of the nose, and across the dorsum of the
`nose. Opposite ends of a malleable strip are secured to the
`outer sealing flange and the strip extends across the portion
`of the outer sealing flange adapted to be positioned over the
`nasal dorsum. The strip is manually adjustable so that a user
`may selectively adjust the shape of the mask about the nose
`to improve the seal across the nose. An airflow passageway
`extends through the mask at an outer end thereof and is in
`flow communication with the nasal chamber for delivering
`air to and removing exhaled air from the nasal chamber. The
`nasal mask is specifically shaped to provide adequate air-
`flow to the wearer’s nose.
`
`(54) NASAL MASK
`
`(75)
`
`Inventor: Kevin A. Rudolph, Overland Park, KS
`(US)
`
`(73) Assignee: Hans Rudolph, Inc., Kansas City, MO
`(US)
`
`( * ) Notice:
`
`This patent issued on a continued pros-
`ecution application filed under 37 CFR
`1.53(d), and is subject to the twenty year
`patent
`term provisions of 35 U.S.C.
`154(a)(2).
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 08/734,469
`
`(22) Filed:
`
`Oct. 17, 1996
`
`(51)
`
`Int. Cl.7 .................................................. .. A61M 16/06
`
`(52) U.S. Cl.
`
`.............................. .. 128/207.13; 128/207.18;
`128/206.24; 128/207.17; 128/205.25
`
`(58) Field of Search ....................... .. 128/207.13, 204.18,
`128/206.24, 206.25, 206.18, 204.12, 207.17,
`206.27
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`1/1988 Stark ............................. .. 128/206.24
`H397 *
`12/1991 Sullivan .
`D. 322,318
`7/1899 MCHatton ..................... .. 128/206.18
`628,111 *
`12/1913 Johnston et al.
`.
`1,081,745
`12/1918 Miller ......................... .. 128/207.13
`1,288,647
`1,837,591 * 12/1931 Shindel
`..
`.... .. 128/206.34
`2,087,042 *
`7/1937 Phillips
`.. 128/206.18
`2,241,535 *
`5/1941 Boothby et al.
`.. 128/207.13
`2,477,706 *
`8/1949 Taylor ...... ..
`.. 128/207.13
`2,820,651 *
`1/1958 Phillips ..
`.... .. 128/204.18
`3,234,939 *
`2/1966 Morton, Jr.
`................... .. 128/206.27
`
`
`
`(List continued on next page.)
`
`1 Claim, 2 Drawing Sheets
`
`
`
`RMD 1021
`
`1
`
`RMD 1021
`
`

`
`US 6,192,886 B1
`Page 2
`
`5,558,089 *
`5611334 *
`,
`,
`5617 849 >x<
`5,724,965 *
`5,738,094 *
`’
`’
`
`US. PATENT DOCUMENTS
`4,167,185 *
`9/1979 Lewis .............................. 128/206.24
`4,328,797 *
`5/1982 Ro11ins,IIIeta1
`. 128006.24
`494149973 * 11/1983 Mathew“ Ct a1~
`~ 123/20624
`4,655,213 *
`4/1987 Rapoportetal.
`. 128/207.13
`4,657,010 *
`4/1987 Wright
`....... ..
`. 128/206.24
`4,674,492
`6/1987 Niemeyer ..
`. 128/202.22
`;V1111§0X ~~~~~~~~~~~~~~~~~~~~~~~~~~~- 123006-24
`*
`»»
`“IV”
`5,074,297 * 12/1991 Venegas __________________________ 123/20418
`5,117,819 *
`6/1992 Sewidio eta].
`.............. .. 128/204.18
`5,237,986 *
`8/1993 Seppala .......... ..
`. 128/201.23
`5,243,971 *
`9/1993 Sullivan et a1,
`,
`, 128/204.18
`5,265,595
`11/1993 Rudolph
`. 128/204.18
`.
`. 128/204.23
`5,522,382
`6/1996 Sullivan et a .
`
`8/1996 Johnson ........................ .. 128/207.18
`5,549,103 *
`
`
`
`
`
`9/1996 Casti lione ................... .. 128/206.24
`3/1997 M hg
`'
`128 207.18
`4/1997 Spliicngeltt et al
`125206 24
`3/1998 Handke et 211..
`II’ 128/207.18
`4/1998 Hoftman ......................
`128/206.24
`'
`
`OTHER PUBLICATIONS
`
`"
`
`
`
`Photographs of a nasal mask produced by Hans Rudolph,
`1.
`'tfh'h
`'
`fiIifH’°OfV:h;Cat::than19n‘:.y°arpn°rt°the
`g
`.
`plone app ma 10”‘
`COPY Of Packaglng Of A11-Seasons Dust Mask Of Ace
`Harware Corporation, sold more than one year prior to the
`filing date of the aboVe—captioned application.
`
`* cited by examiner
`
`2
`
`

`
`Feb. 27, 2001
`
`Sheet 1 of 2
`
`US 6,192,886 B1
`
`3
`
`

`
`U.S. Patent
`
`Feb. 27, 2001
`
`Sheet 2 of 2
`
`US 6,192,886 B1
`
`4
`
`

`
`US 6,192,886 B1
`
`1
`NASAL MASK
`
`BACKGROUND OF THE INVENTION
`
`The present invention relates to an improved nasal mask
`for delivering positive air pressure to the nasal passages to
`facilitate treatment of breathing disorders such as sleep
`apnea, ventilation difficulties or anesthetic gas administra-
`tiori.
`
`,
`
`Obstructive sleep apnea is caused by obstruction of the
`upper airway during sleep which results ir1 the absence of
`airflow through the nose or mouth for at least 10 seconds.
`Obstructive sleep apnea episodes are usually most severe
`during periods of REM (Rapid Eye Movement) sleep, when
`muscle tone is inhibited. The upper airway then narrows as
`a result of the relaxation of a number of muscles. The suction
`pressure of inspiration then causes further narrowing or
`collapse of the airway. The lack of airflow causes the oxygen
`level
`in the blood to drop causing arousal which then
`restores upper airway muscle tone allowing normal breath-
`ing.
`Ileavy snoring and daytime sleepiness are the most com-
`mon symptoms associated with obstructive sleep apnea
`syndrome. Other complaints include night-time thrashing,
`sleep walking, enuresis, disorientation, personality changes,
`intellectual deterioration, sexual dysfunction, hypnagogic
`hallucinations, automatic behavior and morning headaches.
`The prevalence of episodes of obstructive apnea and the
`frequency of occurrence increase with age. Men are much
`more commonly affected than women and nearly 50% of
`elderly men have 20 or more apneie episodes each night.
`Other known risk factors include obesity, chronic
`alcoholism, chronic obstructive pulmonary disease and post-
`menopausal state. Altogether more than 30,000 patients are
`treated each year for obstructive sleep apnea.
`The most effective and frequent therapy for obstructive
`sleep apnea is application of continuous positive airway
`pressure (CPAP). For such therapy, a patient is fitted with a
`tight fitting nasal mask connected through an airway to a
`blower which supplies air at a slight positive pressure to the
`nasal passages. The application of the slight positive pres-
`sure is immediately effective in reversing airway obstruction
`in most patients with obstructive sleep apnea. Although the
`therapeutic results of nasal CPAP are often dramatic and
`immediate, it is only effective when used properly and on a
`regular basis. Failure to apply nasal CPAP for even a single
`night results in recurrence of hypersomnolence the next day.
`Problems associated with wearing existing masks or posi-
`tive airway pressure delivery systems during periods of
`attempted sleep are sufflcient to deter many patients from ,
`continuing CPAP therapy. Some problems include excessive
`noise and irritation resulting from leaks around improperly
`fitting masks or general discomfort caused by the design of
`the mask or the CPAP delivery system. Leakage of air
`between the mask and the face often allows air to blow on
`the eyes which wakes the patient and/or substantially irri-
`tates the eyes.
`SUMMARY OF THE INVENTION
`
`The present invention comprises a nasal mask configured
`to be as unobtrusive as possible while providing an air-tight
`seal around the nose of a wearer. The mask comprises a
`flexible nasal cup having a nasal opening extending across
`an inner circumferential edge thereof and having a nasal
`chamber formed therein. The nasal cup is sized for insertion
`over a portion of the wearer’s nose (preferably almost the
`entire nose), such that the inner circumferential edge of the
`
`2
`cup generally extends across the upper lip, around the alae
`of the nose, and across the dorsum of the nose,
`The nasal mask includes an inner and an outer sealing
`flange extend inward and outward respectively from the
`inner circumferential edge of the nasal cup. The sealing
`flanges cooperate to provide an improved seal. An airflow
`passageway extends through the mask at an outer end
`thereof and in communication with the nasal chamber for
`delivering air to and removing exhaled air from the nasal
`chamber. The nasal mask is specifically shaped to provide
`adequate air—flow to the wearer’s nose.
`The nasal mask includes a malleable pliable strip secured
`to the outer sealing flange so as to extend up and over the
`portion of the mask extending over the rear of the wearer’s
`nose. The pliable strip may be bent or shaped to modify the
`shape of the mask to adjust the fit of the mask and improve
`the seal of the mask across the nose.
`OBJECTS AND ADVANTAGES OF THE
`INVENTION
`
`The objects of the present invention include providing a
`nasal mask which is as unobtrusive as possible while pro-
`viding an air-tight seal;
`to provide such a mask Which
`provides adequate air—flow around the wearer’s nose;
`to
`provide such a mask which may be firmly secured to a
`wearer’s face; to provide such a mask having means for
`adjusting the fit of the mask across the nose of a wearer’s
`face; to provide such a mask comprising a nasal cup into
`which the nose of a wearer may be inserted such that an
`inner circumferential edge of the nasal cup extends across
`the upper lip below the wearer’s nose, around the alae of the
`nose and across the dorsum of the nose; to provide such a
`mask having inner and outer sealing flanges extending
`inward and outward from the inner circumferential edge of
`the nasal cup respectively for providing a seal; to provide
`such a mask in which the outer sealing flange does not
`extend across portions of the eye sockets; to provide such a
`mask in which an upper edge of the mask engages the nose
`below the root of the nose; to provide such a mask in which
`the nasal cup is formed from flexible material; to provide
`such a mask in which the nasal cup is adapted to be secured
`to tubing for supplying gas under pressure to the interior of
`the mask; to provide such a mask in which the tubing is
`swivelably connected to the nasal cup;
`to provide such a
`mask which is relatively easy to assemble; to provide such
`a mask which is relatively easy to put on by a wearer; to
`provide such a mask which is relatively inexpensive to
`manufacture and which is particularly well adapted for its
`intended purpose.
`Other objects and advantages of this invention will
`become apparent from the following description taken in
`conjunction with the accompanying drawings wherein are
`set
`forth, by way of illustration and example, certain
`embodiments of this invention.
`The drawings constitute a part of this specification and
`include exemplary embodiments of the present invention
`and illustrate various objects and features thereof.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective View of the nasal mask assembly,
`including a nasal mask,
`in accordance with the present
`invention secured to a wearer over the wearer’s nose.
`FIG. 2 is an enlarged and exploded perspective view of
`the nasal mask and associated airflow tubing assembly.
`FIG. 3 is a fragmentary front elevational view of the mask
`secured to the face of a wearer, as shown in FIG. 1, with
`portions of the airflow tubing assembly broken away to
`show detail.
`
`5
`
`

`
`US 6,192,886 B1
`
`3
`FIG. 4 is an enlarged rear elevational view of the nasal
`mask with a malleable positioning strip thereof in an initial
`non compressed state.
`FIG. 5 is an enlarged rear elevational view of the nasal
`mask with the positioning strip in a partially compressed
`state.
`
`FIG. 6 is an enlarged top plan View ofthe nasal mask with
`portions broken away to show detail thereof.
`FIG. 7 is an enlarged and fragmentary cross—sectional
`view of the nasal mask positioned on a patient,
`taken
`generally along line 7—7 of FIG. 1.
`FIG. 8 is an enlarged and fragmentary cross—sectional
`view of the nasal mask showing a connector, taken along
`line 8—8 of FIG. 2.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`As required, detailed embodiments of the present inven-
`tion are disclosed herein, however, it is to be understood that
`the disclosed embodiments are merely exemplary of the
`invention, which may be embodied in various forms.
`Therefore, specific structural and functional details dis-
`closed herein are not to be interpreted as limiting, but merely
`as a basis for the claims and as a representative basis for '
`teaching one skilled ir1 the art
`to variously employ the
`present invention in virtually any appropriately detailed
`structure.
`
`'
`
`Referring to the drawings in more detail, the reference
`numeral 1 refers to a nasal mask assembly of the present
`invention. The nasal mask assembly 1 includes a nasal mask
`5, an annular swivel connector 6, an airflow tubing assembly
`7, a flexible cap 8, adjustable straps 9 and strap fasteners 10.
`The nasal mask 5 is shown secured to the face 11 of a user
`in FIG. 1. Directional references herein will generally be
`with reference to the nasal mask 5 as oriented in FIG. 7 with
`the front a11d rear of the mask 5 being to the right and left
`of the sheet respectively and the top and bottom of the mask
`5 being to the top and bottom of the sheet respectively. Other
`directional references are generally based on the same
`orientation.
`
`The nasal 111ask 5 is preferably constructed of silicone or
`other like material that is flexible and resilient and which
`does not cause substantial skin irritation to the wearer. The
`nasal mask 5 includes a cup-like structure, or nasal cup 13
`generally formed from a continuous wall 14 having an inner
`surface 15, an outer surface 16 and a rim or first end 17. The
`continuous wall generally defines a nasal cavity or chamber
`18 therein.
`
`Anasal opening 19 generally extends across the rim 17 of
`the nasal cup 13 and opens into the nasal chamber 18. A
`connector receiving opening 20, adapted to receive the
`swivel connector 6 for securement thereto, is formed in the
`nasal cup 13 at front end 21 thereof opposite the rim 17. The
`nasal cup 13 is sized for placement over a wearer’s nose 25
`such that the nose 25 extends through the nasal opening 19
`and into the nasal chamber 18. The rim 17 generally extends
`across the wearer’s upper lip 26, around the alae 27 of the
`nose and across the nasal dorsum 28, below the root 29
`thereof.
`An inner sealing flange 32 extends inward from the rim 17
`of the nasal cup 13 generally transverse thereto so as to
`engage a wearer’s face 11 when the nasal cup 13 is posi-
`tioned thereagainst. The inner sealing flange 32 preferably
`extends completely around the rim 17. The inner sealing
`flange 32 is generally an extension of and comprises a thin
`
`4
`layer of the flexible and resilient material used to construct
`the rest of the nasal cup 13.
`The nasal cup 13 also includes an outer sealing flange 33
`which extends outward from the rim 17 so as to engage a
`wearer’s face 11 when the nasal cup 13 is positioned
`thereagainst. The outer sealing flange 33 preferably extends
`around the sides and across the top of the nasal cup 13, but
`not around the bottom of the nasal cup 13. The outer sealing
`flange 33 is generally wider proximate the alae 27 of the
`nose 25 and narrower across the portion extending adjacent
`the eye sockets of the wearer such that the outer sealing
`flange 33 generally does not extend across portions of the
`eye socket which would result in user discomfort. The outer
`sealing flange 33 is generally an extension of and comprises
`a thin layer of the flexible and resilient material used to
`construct the rest of the nasal cup 13.
`The inner sealing flange 32 generally comprises two
`portions, an upper portion 34 and a lower portion 35. The
`upper portion 34 generally extends along the sides of the
`nasal cup 13 and across the upper periphery thereof so as to
`generally engage the wearer’s face 11 along the sides of the
`nose 25, over the nasal dorsum 28 and around, but not below
`the alae 27. The lower portion 35 generally extends across
`the bottom of the nasal cup 13 so as to generally engage the
`face 11 above the upper lip 26 of the wearer and to extend
`below the alae 27. Although it is preferable that the upper
`portion 34 and the lower portion 35 of the inner sealing
`flange 32 are generally contiguous, it is foreseen that a gap
`could extend between the upper portion 34 and the lower
`portion 35 generally around the alae 27 of the nose such that
`the inner sealing flange 32 only substantially completely
`extends around the rim 17. It is further foreseeable that other
`slight breaks in the inner sealing flange 32 could be incor-
`porated into the mask 5.
`The upper portion 34 of the inner sealing flange 32 is also
`formed to be thinner than the lower portion 35 and thinner
`than the outer sealing flange 33. The lower portion 35 of the
`inner sealing flange 32 is preferably approximately the same
`thickness as the outer sealing flange 33.
`The nasal cup 13 may be generally described as having a
`bulbous nose shape. The continuous wall [4 of the nasal cup
`13 generally curves outward and then back inward from the
`rim 17 along the sides and across the top of the cup 13 so as
`to generally bulge out around the alae 27 and across the
`bridge or dorsum 28 of the nose 25. The continuous wall 14
`then converges toward the front end 21 of the nasal cup 13.
`The Vertical cross-section of the of the nasal cup 13 may also
`be described as a rounded triangle (that is, generally trian-
`gular in shape with rounded corners). The nasal opening 19,
`whose outer edge is generally defined by the inner sealing
`flange 32, may also be generally described as a rounded
`triangle in shape. The bulbous shape of the nasal mask 5 that
`generally spaces the mask 5 from the nose 25 is to provide
`space for air flow around the nose 25 to facilitate breathing.
`The shape of the nasal mask 5 generally along the rim 17
`is adjustable by a strip 40 of pliable material secured thereto.
`The pliable strip 40 is preferably formed from a malleable
`metal such as aluminum alloy 3003 H14 or the like and
`includes mounting apertures 41 at opposite ends 42 thereof.
`The pliable strip 40 of aluminum alloy includes a sheath or
`cover 43 covering a substantial portion of the pliable strip
`40. Shrink tape is a preferred material for use as the sheath
`43. The sheath 43 covers burrs and the like on the strip 40
`and improves the aesthetics of the strip 40 which is generally
`formed by punching from a sheet of metal. T‘wo strip
`mounting buttons 45, each having a shaft 46 and a11 enlarged
`
`6
`
`

`
`US 6,192,886 Bl
`
`5
`head 47 are integrally formed on the outer sealing flange 33
`on opposite sides thereof and positioned to generally be
`placed proximate the base of the nose 25 when the nasal cup
`13 is placed over the nose 25. The strip mounting buttons 45
`are preferably formed from the same flexible and resilient
`material as the nasal cup 13. The strip 40 is secured to the
`nasal mask 5 by pressing the enlarged head 47 of the buttons
`45 through the apertures 41 in the opposite ends 42 of the
`strip 40. The strip 40 then preferably extends up and over the
`interface between the nasal cup 13 and the outer sealing
`flange 33 on the portion of the nasal mask 5 adapted to be
`positioned over the nasal dorsum 28.
`FIG. 4 shows a rear view of the nasal mask 5 in a
`generally normal state wherein the shape of the nasal mask
`5 is in a relaxed state prior to modification by the pliable
`strip 40. FIG. 5 shows a rear View of the nasal mask 5 in
`which the ends 42 of the pliable strip 40 have been pressed
`toward each other relative to their positional relationship
`shown in FIG. 4, so as to modify the shape of the nasal mask
`5 into one of an infinite number of modified states. The
`shape of the nasal mask 5 in FIG. 5 has been modified such '
`that the nasal opening 19 has been narrowed to provide a
`snugger Ill for a particular nose and each of the various
`modified states available fits different nose shapes.
`The front end 21 of the nasal cup 13 is generally cylin-
`drical with the connector receiving opening or airflow
`passageway 20 extending therethrough in communication
`with the nasal chamber 18. The opening 20 is generally
`positioned toward the bottom of the nasal cup 13 so as to be
`generally in front of the naries 38 of the nose 25.
`The connector receiving opening 20 is defined by a
`grooved circular shoulder 50 extending through the wall 14
`at a front end thereof. A flange receiving groove 51 extends
`into the wall 14 along and parallel to the grooved circular
`shoulder 50.
`
`,
`
`The airflow tubmg assembly 7 is connected to the nasal
`mask 5 at the connector receiving opening 20 by the annular
`swivel connector 6 formed from a relatively rigid plastic and
`having an airflow passageway 55 extending therethrough. A
`shoulder receiving groove 56 is formed on an outer surface
`of the annular swivel connector 6 toward a rear end thereof
`so as to form an annular connecting flange 57 on the rear end
`of the annular swivel connector 6. The annular swivel
`connector 6 is snugly securable to the nasal mask 5 by
`insertion of the connecting flange 57 into the flange receiv-
`ing groove 51 of the nasal mask 5 such that the front portion
`of the grooved circular shoulder 50 extends into the shoulder
`receiving groove 56 and seals thereabout. The frictional
`engagement of the flange 57 by the nasal mask 5 resists
`rotation of the annular swivel connector 6 relative thereto.
`Two sampling ports 59 with caps 60 are formed on
`opposite sides of the connector 6 and flow communicate
`with the airflow passageway 55 extending therethrough. The
`airflow passageway 55 flow communicates with the nasal
`chamber 18 through the nasal opening 19.
`An annular ridge 62 is formed on and extends radially
`inward from an inner surface of the annular swivel connec-
`tor 6 at a front end thereof. The annular ridge 62 is sized to
`engage a ridge receiving groove 64 formed in a first end 65
`of an elbow 66 having an airflow passageway 67 extending
`therethrough. The first end 65 of the elbow 66 includes a
`beveled leading ridge 68 to allow the first end 65 of the
`elbow 66 to generally be snapped into the annular swivel
`connector 6 with the annular ridge 62 on the connector 6
`engaging the groove 64 in the first end 65 of the elbow 66.
`The elbow 66 freely rotates or swivels relative to the annular
`swivel connector 6.
`
`j
`
`_
`
`6
`Asecond end 70 of the elbow 66 includes a beveled ridge
`71 and a ridge receiving groove 72 sized for insertion into
`a first end 77 of a tube 78 having an airflow passageway 79
`extending therethrough and in inwardly directed annular
`ridge 80 at the first end 77 thereof. The annular ridge 80
`engages the ridge receiving groove 72 when the second end
`70 of the elbow 66 is inserted in the first end 77 of the tube
`78 for securing the tube 78 to the elbow 66 and to permit the
`tube 78 to swivel relative to the second end 70 of the elbow
`66. A flexible tube 82 is connected to a second end 83 of the
`tube 78. The flexible tube 82 is connected to apparatus for
`providing pressurized air to the wearer of the nasal mask
`assembly 1 through the annular swivel connector 6 and the
`airflow tubing assembly 7 which generally comprises the
`flexible tube 82, the tube 78 and the elbow 66.
`An exhalation discharge aperture, opening or port 85 is
`formed in the elbow 66 preferably in line with the airflow
`passageway 55 through the annular swivel connector 6. The
`exhalation discharge port 85 is sized to allow exhaled air to
`escape yet small enough to maintain adequate pressure to
`provide su icient continuous positive airway pressure to
`treat sleep apnea.
`Three strap securement buttons 90 are integrally formed
`on the outer surface 15 of the nasal cup 13 for securement
`of the strap fasteners 10 thereto. The buttons 90 are adapted
`to removably receive the strap fasteners 10 which cooperate
`with the adjustable securement straps 9 and the cap 8 to
`secure the nasal mask 5 in place against the face 11 of a user.
`The buttons 90 are integrally formed of the same flexible
`material as the rest of the mask 5 and comprise a post 91 and
`a circumferential flange or enlarged head 92. The post 91
`extends perpendicularly away from the outer surface 15 of
`the mask 5 and is generally cylindrical. The strap fasteners
`10 include a button receiving aperture 93 and a strap
`receiving slot 94. The strap fasteners 10 are secured to a
`respective button 90 by pressing the flexible button 90
`through a respective button receiving aperture 93 in the
`fastener 10. The strap fastener 10 is then rotatable about the
`post 91. A free end of the adjustable strap 9 is threaded
`through the strap receiving slot 94 and secured back on to
`itself by adjustable fastening means such as a hook and loop
`type fastener.
`Two of the buttons 90 are positioned on opposite sides of
`the nasal cup 13 generally on the portion of the cup 13
`covering the alae 27. The third button 90 is positioned along
`the upper periphery of the nasal cup 13. The buttons 90 are
`positioned on an outwardly sloping portion of the outer
`surface 15 of the cup 13 when looking at the cup 13 on a
`user’s face 11 as in the orientation of FIG. 3.
`It is to be understood that while certain forms of the
`present invention have been illustrated and described herein,
`it is not to be limited to the specific forms or arrangement of
`parts described and shown.
`What is claimed is:
`l. A nasal mask assembly including:
`a) a nasal mask comprising:
`i) a flexible nasal cup having a nasal opening formed
`along a rim thereof, a first airflow passageway
`extending through said cup generally opposite said
`nasal cup and a nasal chamber formed therein; said
`nasal cup sized and adapted for placement over the
`wearer’s nose such that said rim generally extends
`across the wearer’s upper lip. around both alae of the
`nose, and across the dorsum of the nose;
`ii) an inner seahng flange extending inward from said
`nasal cup rim substantially completely therearound;
`and
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`US 6,192,886 B1
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`iii) an outer sealing flange extending outward from said
`nasal cup rim along a portion of said rim extending
`around the alae of the nose, and across the dorsum of
`the nose and being discontinuous along a portion of
`said rim extending across the wearer’s upper lip; at
`least upper portions of said inner sealing flange
`extending along opposite sides of said nasal cup and
`adapted to engage a wearer’s face along the sides of
`the nose being thinner than said outer sealing flange;
`iv) a lower portion of said inner sealing flange which is
`adapted to be positioned to extend across an upper
`lip of a wearer is approximately the same thickness
`as the outer sealing flange;
`b) first and second strap securement buttons integrally
`formed on an outer surface of said mask on opposite
`sides thereof;
`c) a third strap securement button integrally formed on
`said outer surface of said mask on an upper surface
`thereof on a portion of the nasal mask extending across
`the dorsum of the nose; and
`d) first, second and third straps removably securable at
`first ends thereof to said first, second and third strap
`securement buttons for securing said nasal mask to the
`head of a wearer;
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`e) a malleable strip formed from metal and having a
`sheath covering a substantial portion thereof is secured
`to said nasal mask proximate said nasal opening so as
`to extend across a portion of the nasal mask extending
`across the dorsum of the nose whereby the shape of said
`strip can be manually modified to in turn modify the
`shape of the nasal mask and the fit of the cup at the
`nasal opening;
`f) a pair of strip mounting buttons each comprising a shaft
`and an enlarged head are integrally formed on said
`nasal mask on opposite sides thereof;
`g) each end of said strip includes an aperture that is sized
`for pressing said head of a respective strip mounting
`button therethrough for securing said strip thereto;
`h) an annular connector having a second airflow passage-
`way extending therethrough and removably securable
`to said nasal mask in flow communication with said
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`first airflow passageway; and
`i) a tubing assembly swively connected to said annular
`connector.
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