US007210481B1
`
`(12) United States Patent
`Lovell et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,210,481 B1
`May 1, 2007
`
`(54) NOSE MASK
`
`(75)
`
`Inventors: John R. Lovell, Edgewater, NJ (US);
`Paul R. Chiesa, Candia, NH (US);
`Thomas M. Moulton, Hampton, NH
`(US)
`
`(73) Assignee: SleepNet Corporation, Manchester,
`NH (US)
`.
`.
`.
`.
`Subject. to any d1scla1mer,.the term of this
`Patent IS extended Or adlusted under 35
`U.S.C. 154(b) by 0 days.
`
`.
`( * ) Notice:
`
`2,254,854 A
`2,376,871 A
`D156,060 S
`D161,337 S
`2,540,567 A
`2,625,155 A
`2,693,178 A
`2,818,861 A *
`2,837,090 A
`2,868,196 A
`2,902,033 A
`2,917,045 A
`
`9/1941 O’Conne11
`5/1945 Fink
`11/1949 Wade
`12/1950 Hill
`2/1951 Bennett
`1/1953 Engelder
`11/1954 Gilroy
`1/1958 Russell ................ .. 128/206.24
`6/1958 Bloom et a1.
`1/1959 Stampe
`9/1959 Gallehera Jr.
`12/1959 Schildknecht et a1.
`
`(21) Appl. No.:
`(22) PCT Filed:
`
`09/979,972
`May 26, 2000
`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`(86) PCT No.:
`
`PCT/US00/14524
`
`CA
`
`618807
`
`4/1961
`
`§ 371 (e)(1),
`(2), (4) Date: Nov. 28, 2001
`
`(87) PCT Pub. No.: W000/74758
`
`PCT Pub. Date: Dec. 14, 2000
`
`(51)
`
`Int. Cl.
`(2006.01)
`A62B 18/02
`(2006.01)
`A62B 18/08
`(2006.01)
`A61M 15/08
`(52) U.S.Cl.
`......................... .. 128/205.25;128/206.24;
`128/207.18
`
`(58) Field of Classification Search ............................. ..
`128/201.22—201.24, 204.18, 205.25, 205.27—207.18
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`428,592 A
`1,206,045 A
`1,610,793 A
`1,632,449 A *
`2,248,477 A
`
`5/1890 Chapman
`11/1916 Smith
`12/1926 Kaufman
`6/1927 McKessson .......... .. 128/206.24
`7/1941 Lombard
`
`(Continued)
`OTHER PUBLICATIONS
`
`Hea1thdyne® Technologies Soft SeriesTM Mask advertisement,
`page, undated.
`
`1
`
`(Continued)
`
`Primary Examiner—Glenn K. Dawson
`(74) Attorney, Agent, or Firm—Devine, Millimet & Branch,
`P.A.; Paul C. Remus
`
`(57)
`
`ABSTRACT
`
`Anasal mask (301) includes a shell (308) forming a chamber
`(390) having an inlet (332) and at least one outlet and a seal
`(302). The seal (302) is disposed proximate the outlet for
`contacting and sealing with external skin proximate at least
`one naris at a base of a nose of a user donning the mask.
`Substantially all of the sealing occurs between the seal (302)
`and the external skin.
`
`12 Claims, 12 Drawing Sheets
`
`302
`
`304
`
`308 ""
`
`390
`
`332
`
`310
`
`304
`
`306
`
`FPH EX. 2006
`
`ResMed v. Fisher & Paykel
`
`IPR2016-01718
`
`FPH EX. 2006
`ResMed v. Fisher & Paykel
`IPR2016-01718
`
`

`
`US 7,210,481 B1
`Page 2
`
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`
`....... .. 128/206.24
`
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`10/1996 Rapoport
`RE35,339 E
`10/1996 Berthon-Jones etal.
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`5,647,357 A *
`3/1997 Landjs 5131.
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`8/1997 Jacobelli
`5,660,174 A
`9/1997 Ogden etal.
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`11/1997 Rudolph
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`1/1998 Berthon-Jones
`5,704,345 A
`3/1998 Handke et a1.
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`4/1998 Brydon
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`5/1998 Kidd
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`3/1999 135111
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`10/1999 Schwartz etal.
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`12/1999 1101115
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`2/2000 Calluaud et al.
`6,029,660 A
`2/2000 Ber1h0n_J0neS
`5029555 A
`4/2000 Kwok
`D423,095 S
`4/2000 Kwok etal.
`6,044,844 A
`7/2000 Colla etal.
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`3/2000 Kwok
`13423987 S
`3/2000 Schwartz 51 31.
`5,098,205 A
`9/2000 Kwok etal.
`6,112,746 A
`11/2000 schwmz 5131.
`5,152,137 A
`1/2001 Lawson etal.
`6,176,538 131*
`.......... .. 296/78.1
`2/2001 Rudolph .... ..
`6,192,886 131*
`. 128/207.13
`
`3/2001 Belferetal.
`.
`6,196,223 131*
`. 128/206.25
`6,631,718 131* 10/2003 Lovell
`................. .. 128/206.24
`
`EORETGN PATENT DOCUMENTS
`
`CA
`DE
`DE
`DE
`EP
`EP
`FR
`FR
`FR
`FR
`WO
`WO
`WO
`WO
`WO
`WO
`
`623129
`42 12 259
`195 48 380
`198 07 961
`0 549 299
`0 747 078
`780018
`2 658 725
`2 720 280
`2 749 176
`93/24169
`97/09090
`98/18514
`98/48878
`99/43375
`99/58181
`
`7/1961
`1/1993
`7/1996
`8/1999
`6/1993
`12/1996
`4/1935
`8/1991
`12/1995
`12/1997
`12/1993
`3/1997
`5/1998
`11/1998
`9/1999
`11/1999
`
`OTHER PUBLTCATTONS
`
`Lifecare® Form #544, 1 page, (Jul. 1991).
`Medical Industries America Universal Deluxe C.P.A.P. Headgear
`advertisement, 1 page, undated.
`Puritan Bennett Companion® Nasal CPAP Masks advertisement, 1
`page, undated,
`ResCare Sullivan® Bubble MaskTM System Series 3 advertisement,
`3 pages, undated,
`Respironics Inc. Monarch Mini Mask information sheet,
`(Feb. 26, 1996).
`Respironics Inc. Pamphlet, “ProfileTM Custom Nasal Mask Instruc-
`tions for Use,” (Dec. 14, 1998).
`
`1 page,
`
`2,931,356 A
`3,042,035 A
`3,117,574 A
`3,288,138 A
`3,315,672 A
`3,330,273 A
`3,725,953 A
`4,062,357 A
`15248497 S
`4,167,185 A
`4,201,205 A
`4,226,234 A
`4,231,363 A
`4,266,540 A
`4,337,767 A
`4,354,488 A
`4,369,284 A
`4,412,537 A
`4,414,973 A
`4,417,575 A
`4,446,576 A
`4,454,880 A
`4,458,679 A
`4,572,323 A
`4,593,688 A
`D285,496 S
`4,655,213 A
`4,665,570 A
`4,674,134 A
`4,707,863 A
`4,770,169 A
`4,782,832 A
`4,799,477 A
`4,799,526 A
`4,807,617 A
`4,811,730 A
`4,856,118 A
`D304,384 S
`4,915,106 A
`4,919,128 A
`4,944,310 A
`D310,431 S
`4,960,121 A
`4,971,051 A
`4,989,271 A
`5,003,631 A
`5,003,633 A
`5,018,519 A
`5,074,297 A
`5,093,940 A
`5,109,839 A
`5,138,722 A
`5,146,914 A
`5,181,506 A
`5,199,424 A
`D335,322 S
`5,243,971 A
`5,245,995 A
`5,269,296 A
`5,331,691 A
`5,334,646 A
`5,343,878 A
`5,349,949 A
`5,390,373 A
`5,400,781 A
`5,429,583 A
`5,477,852 A
`5,485,837 A
`5,511,541 A
`5,517,986 A
`5,522,382 A
`
`................ .. 2/14
`
`.... .. 128/205.25
`
`....... .. 128/207.18
`
`4/1960 Sohwaiz
`7/1962 Coanda
`1/1964 Replogle
`11/1966 Saolis
`4/1967 Cunningham et al.
`7/1967 Bennett
`4/1973 Johnson et al.
`12/1977 Laeidal
`7/1978 SloSel<
`9/1979 Lewis
`5/1980 Battlioloinew
`10/1980 Gnndeison
`11/1980 Grimes
`5/1981 Panzik et al.
`7/1982 Yahata
`10/1982 Bartos
`1/1983 Chen
`11/1983 Tiger
`11/1983 Matheson et al.
`11/1983 Hilton etal~
`5/1984 HiSatal<a
`6/1984 Muto et al.
`7/1984 Ward
`2/1986 Randall
`6/1986 Payton
`9/ 1986 Beinian
`4/1987 Rapoport et al.
`5/1987 Davis
`6/1987 Lnndin
`11/1987 lVloNeal
`9/1988 Schmoegner et al.
`11/1988 Trimble et al.
`1/1989 Lewis
`1/1989 Reeves .............. .. 160/168.1 R
`2/1989 Nesti
`3/1989 Milano
`8/1989 Sapiejewski
`10/1989 Deiobert
`4/1990 Aulgur et al.
`4/1990 Kopala et al.
`7/1990 Sullivan
`9/1990 Bellm
`10/1990 Nelson et al.
`11/1990 Tolfolon
`2/1991 Sapiejewski et al.
`4/1991 Richardson
`4/1991 Itoh
`5/1991 Brown
`12/1991 Venegas
`3/1992 Nishiyama
`5/1992 Blasdell et al.
`8/1992 Urella et al.
`9/1992 Sturrock
`1/1993 Tardilf, Jr. et al.
`4/1993 Sullivan et al.
`5/1993 Jones
`9/1993 Sullivan et al.
`9/1993 Sullivan et al.
`12/1993 Landis
`7/1994 Runckel
`8/1994 Chen
`9/1994 Scarberry et al.
`9/ 1994 Schegerin
`2/1995 Flory
`3/1995 Davenport
`7/1995 Le Mllollard
`12/1995 Landis et al.
`1/ 1995 S0165 Bee 6131,
`4/1996 Dearstine
`5/1996 Starr et al.
`6/1996 Sullivan et al.
`
`

`
`US 7,210,481 B1
`Page 3
`
`Smith et al., “Indications and Standards for Use of Nasal Continu-
`ous Positive Airway Pressure (CPAP) in Sleep Apnea Syndromes,”
`Am. J. Respi/1 Crit. Care Med., Vol. 150, pp. 1738-1745 (1994).
`Vital Signs, Inc. Pamphlet, “SoftNairTM” (1998).
`American Society f0f Testing and Materials (ASTM) “Designation
`D
`2240-97“
`:
`Standard
`Test Method
`for
`Rubber
`Property—Durometer Hardness,” pp. 1-4, (approved Feb. 10, 1997,
`updated Feb. 1999).
`
`Barracuda The Best Swim Goggles Packaging,
`unknown).
`Parker Laboratories, Inc., Aquaflex® Ultrasound Gel Pad sales
`literature, 1 page, (1991).
`3M Health Care sales brochure, “Just plain talk about the many uses
`of TegadermTM transparent dressing,” 12 pages (1990).
`
`1 page (date
`
`* cited by examiner
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 1 of 12
`
`US 7,210,481 B1
`
`40
`
`38
`
`18'
`
`18
`
`14
`
`FIG. 2A
`
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 2 of 12
`
`US 7,210,481 B1
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 3 of 12
`
`US 7,210,481 B1
`
`0
`V
`
`Q
`(‘O
`
`fiéw
`
` ¢
`QQ?
`
`V0
`
`0
`
`(D
`
`O
`
`-
`CD1-
`
`FIG.2B
`
`D" ~CO
`
`to1"
`
`V
`cu
`
`0
`1-
`
`1- l
`
`V-
`
`1-
`
`ON
`
`m
`"'
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 4 of 12
`
`US 7,210,481 B1
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 5 of 12
`
`US 7,210,481 B1
`
`FIG.3B
`
`6”
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 6 of 12
`
`US 7,210,481 B1
`
`FIG. 5
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 7 of 12
`
`US 7,210,481 B1
`
`70
`
`»
`
`72
`
`76
`
`74
`
`FIG. 6
`
`60
`
`62
`
`64
`
`FIG. 7
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 8 of 12
`
`US 7,210,481 B1
`
`/2
`
`40
`58
`@2‘ 38
`"\/‘Q
`/' §Tl
`56
`
`78
`
`/2
`
`58
`
`56
`
`4o
`78
`
`38
`80
`
`FIG. 8A
`
`FIG. 8B
`
`
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 9 of 12
`
`US 7,210,481 B1
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`<09..0_...._
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 10 of 12
`
`US 7,210,481 B1
`
`222202
`
`/201
`
`216
`
`FIG.10B
`
`210222,@) 208
`232 230
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 11 of 12
`
`US 7,210,481 B1
`
`306
`
`

`
`U.S. Patent
`
`May 1, 2007
`
`Sheet 12 of 12
`
`US 7,210,481 B1
`
`302
`
`304
`
`308 "“
`
`390
`
`332
`
`FIG. 13
`
`31°
`
`304
`
`306
`
`344
`
`FIG. 14
`
`(
`
`302
`
`306
`
`303
`
`31 o
`
`332
`
`346
`
`

`
`US 7,210,481 B1
`
`1
`NOSE MASK
`
`This application is the national phase of International
`(PCT) Patent Application Ser. No. PCT/US00/ 14524, filed
`May 26, 2000, published under PCT Article 21(2)
`in
`English, which claims priority to U.S. Ser. No. 09/328,120
`and U.S. Ser. No. 09/328,027, both filed Jun. 8, 1999. The
`entire disclosures of these three applications are incorpo-
`rated herein by reference.
`
`TECHNICAL FIELD
`
`The present invention relates to respiratory apparatus and
`more specifically to a nasal mask useful for providing
`pressurized air or therapeutic gas to a patient suffering from
`an airflow limitation or other respiratory ailment.
`
`BACKGROUND INFORMATION
`
`Patients suffering from a variety of medical conditions
`often require supplementary respiratory support. Depending
`on the nature and severity of the condition, this respiratory
`support can range from providing an elevated oxygen con-
`centration cloud to the vicinity of the nose and mouth, to
`forcing ventilation of the lungs by intubating the trachea. In
`general, a supply of pressurized air or therapeutic gas is
`provided by a tube or conduit
`to a delivery apparatus
`designed to conform to particular body structure.
`One style of delivery apparatus is a mask which provides
`the gas to a nasal area of the patient. Nasal masks are often
`employed in the treatment of sleep apnea syndrome, char-
`acterized by intermittent upper airway obstruction during
`sleep. Due to the resulting blood oxygen desaturation and
`frequent arousals from sleep, persons suffering from this
`condition are often unable to achieve deep sleep for
`extended periods, are chronically tired, and are physically
`compromised.
`Because nasal masks are often worn by persons in
`unmonitored environments for extended periods, such as in
`the home during sleep, the nasal mask should be comfortable
`to wear and conform well to the nasal area. If the mask is
`
`deemed too bulky, too heavy, or to fit poorly, the patient will
`either not wear the mask, wear the mask improperly, or only
`wear the mask occasionally when the discomfort associated
`with the respiratory condition exceeds the discomfort of
`wearing the mask.
`One problem associated with nasal masks relates to the
`conformance of the mask to the nasal area, which is com-
`plexly contoured and differs from patient to patient. Cus-
`tomized masks manufactured to suit particular patients tend
`to be costly; therefore, masks for general use are typically
`made in several generic sizes, each size designed to accom-
`modate a range of patients. If the mask does not form a good
`seal around the patient’s nose, leakage can occur, reducing
`the effectiveness of the treatment. When poorly fitting masks
`are used with variably regulated air supply systems respon-
`sive to patient breathing, such as those developed for treat-
`ing sleep apnea, mask leakage can induce improper system
`response which may exacerbate the patient’s condition.
`Regulated air supply systems and delivery apparatus for
`treatment of sleep apnea are disclosed in Patent Cooperation
`Treaty international application number PCT/US93/05095,
`published on Dec. 9, 1993, as international publication
`number WO 93/24169; U.S. patent application Ser. No.
`08/184,976 filed Jan. 24, 1994; U.S. Pat. No. 5,199,424;
`U.S. Pat. No. 5,245,995; U.S. Pat. No. 5,522,382; U.S. Pat.
`
`2
`No. 5,645,054; U.S. Pat. No. 6,019,101; and U.S. Des. Pat.
`No. D398,987, the disclosures of all of which are herein
`incorporated by reference.
`One method of reducing leakage is to provide a compliant
`sealing flange or surface around a perimeter of the mask in
`combination with a strap to bias the mask into sealing
`engagement with the nasal contour of the patient. Typically,
`the greater the retention force applied by the strap, the better
`the seal; however, both the strap and the mask can cause
`excessive pressure on delicate areas, resulting in irritation
`and patient discomfort.
`The retention force required to prevent leakage is also a
`function of forces and torques induced in the mask. For
`example, the weight of the conduit supplying air or gas to the
`mask tends to pull the mask downward, away from the
`patient’s nasal area, when the patient is sitting. Additionally,
`any movement of the head from side-to-side or up and down
`can cause lifting of an edge or sliding of the mask and strap.
`The more rapid the movement, the more pronounced the
`effect. Mask slippage and displacement are exacerbated in
`masks employing large diameter, heavy, or stilf tubes which
`deliver relatively large volumetric flow rates of air, such as
`those employed in sleep apnea treatment systems.
`For nasal masks used by patients when sleeping, the strap
`and seal arrangement should also accommodate unconscious
`or reflexive head and body movements. The discomfort
`associated with masks which apply too much pressure to the
`head, neck, or nasal area discourage use of the mask during
`sleep when it is most needed. As a result,
`treatment is
`compromised and the patient is ill served by the apparatus.
`Accordingly, there exists a need to overcome the limita-
`tions of known designs by providing an improved nasal
`mask which provides a consistent, reliable nasal area seal
`while being comfortable to wear. Other desirable features
`would include ease of manufacture and low cost.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`SUMMARY OF THE INVENTION
`
`40
`
`Devices of the present invention allow for comfortable
`delivery of a breathable gas to a user. More particularly,
`devices of the invention seal with the external skin surround-
`
`45
`
`50
`
`55
`
`60
`
`65
`
`ing the nares at the base of the nose and/or along the inner
`rim of the nares of a user. The seal is both comfortable for
`
`the patient and reliable. Both the softness of a gel seal
`according to the invention and the design of devices accord-
`ing to the invention which invite minimal contact between
`the user’s epidermal areas and the device, combine to create
`this comfortable and reliable seal about the user’s nares.
`
`In one aspect of the invention a nasal mask includes a
`shell and a first seal. The shell forms a chamber having an
`inlet and at
`least one outlet. The first seal
`is disposed
`proximate the outlet for contacting and sealing with external
`skin proximate at least one naris at a base of a nose of a user
`donning the mask. Substantially all of the sealing occurs
`between the seal and the external skin.
`
`Certain embodiments of this aspect of the invention may
`include any or all of the following features. Anasal mask can
`include both a second seal and a second outlet. The first seal
`
`can be integral with the second seal. The nasal mask also can
`include a malleable element disposed within the shell.
`Additionally, a seal of a nasal mask can include a bladder.
`The bladder can be filled with silicone gel, molded in a
`predetermined configuration, and/or bonded to the shell.
`A conduit can be attached to the inlet of a nasal mask. The
`
`conduit can include an angled portion, a rotary connection,
`and/or a ball and socket connection. Additionally, the con-
`duit can have a side wall defining a lumen within the side
`
`

`
`US 7,210,481 B1
`
`3
`wall. The side wall can contain at least one opening in
`communication with the lumen.
`
`A headgear apparatus can be attached to the mask for
`retaining the mask on a user. A retainer can be disposed
`about the inlet and cooperate with the headgear apparatus to
`retain the mask on a user. One or more connectors can attach
`
`the headgear apparatus to the mask. One or more of the
`connectors can attach to the retainer.
`
`Another aspect of the invention includes a system for
`treating a respiratory ailment in a recumbent or sleeping
`user. The system includes a nasal mask as described above
`connected to a controlled, breathable gas source with a
`conduit. The nasal mask may include any of the features
`described above.
`
`Another aspect of the invention comprises a seal for use
`with a nasal mask including a bladder filled with a molded
`material in a predetermined configuration. The material has
`a durometer value less than about ten on a Shore OOO scale.
`
`5
`
`10
`
`15
`
`The seal is configured typically with a slight crown to seal
`against external skin proximate at least one naris at a base of
`a nose of a user. The material can be silicone.
`
`20
`
`The bladder can have at least one protrusion on a side
`thereof for contacting the external skin proximate at least
`one naris at a base of a nose of a user and/or can be
`
`substantially planar on a side thereof for contacting a shell
`of the nasal mask. The seal can have a thickness and can
`
`form at least one aperture therethrough disposable proximate
`a naris. A thickness of the bladder proximate the aperture can
`be less than a thickness of the seal remote therefrom.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The invention, in accordance with preferred and exem-
`plary embodiments,
`together with further advantages
`thereof,
`is more particularly described in the following
`detailed description, taken in conjunction with the accom-
`panying drawings.
`In the drawings, like reference characters generally refer
`to the same parts throughout the different views. Also, the
`drawings are not necessarily to scale, emphasis instead
`generally being placed upon illustrating principles of the
`invention.
`
`FIG. 1A is a schematic perspective view of one embodi-
`ment of the invention;
`FIG. 1B is a schematic exploded perspective view of the
`embodiment of FIG. 1A;
`FIG. 2A is a schematic front view of the embodiment of
`FIG. 1A;
`FIG. 2B is a schematic exploded front view of the
`embodiment of FIG. 1A;
`FIG. 3A is a schematic side view of the embodiment of
`FIG. 1A;
`FIG. 3B is a schematic exploded side view of the embodi-
`ment of FIG. 1A;
`FIG. 4A is a schematic top view of the embodiment of
`FIG. 1A;
`FIG. 4B is a schematic cross-sectional view of the
`
`embodiment of FIG. 1A taken along line A—A of FIG. 4A;
`FIG. 5 shows a user donning the nasal mask of FIG. 1A;
`FIG. 6 shows a schematic representation of a gas source
`in communication with a nasal mask;
`FIG. 7 is a section through one embodiment of a seal;
`FIG. 8A is a schematic perspective view of the seal of the
`embodiment of FIG. 1A;
`FIG. 8B is a schematic side view of the seal of FIG. 8A;
`FIG. 8C is a schematic top view of the seal of FIG. 8A.
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`FIG. 9 is a schematic perspective view of an alternative
`embodiment of the invention;
`FIG. 10A is a schematic exploded perspective view of the
`embodiment depicted in FIG. 9;
`FIG. 10B is a schematic exploded side view of the
`components of the embodiment depicted in FIG. 9;
`FIG. 11 is a schematic front view of the nasal mask of
`FIG. 9;
`FIG. 12 is a schematic perspective view of another
`alternative embodiment of the invention;
`FIG. 13 is a schematic cross-sectional view of the
`
`embodiment depicted in FIG. 12 taken along line C—C of
`FIG. 12; and
`FIG. 14 shows a user donning the nasal mask of FIG. 12.
`
`DESCRIPTION
`
`The present invention provides a comfortable, reliably
`sealing nasal mask for delivering a breathable gas to a user.
`In particular a seal bonded to a shell of the nasal mask is
`particularly soft. This seal rests comfortably on the external
`skin surrounding the nares at the base of the nose and/or
`along the inner rim of the nares of a user.
`The design of nasal masks according to this invention
`provides solutions to several common problems with current
`designs. First, the nasal mask’s contact with the user’s face
`is minimal compared with current masks. Second, the seal
`distributes contact pressure, unlike many current masks.
`Third, the design allows the user to comfortably lie in almost
`any position. Fourth, the design provides a comfortable fit
`and a reliable seal for a wide range of the population
`compared with many current masks which either must be
`stocked in multiple sizes or simply do not properly fit on
`users with faces of a certain shape.
`Referring to FIGS. 1A4lB, in one embodiment of a nasal
`mask 1 depicted in a variety of orientations, a seal 2 covers
`an upper shell 6. Typically, the seal 2 is bonded to at least a
`portion of the upper shell 6. Useful bonding agents include,
`but are not
`limited to,
`tetrahyrdofuran (“THF”) and/or
`ultraviolet cured adhesives. Alternative attachment methods
`
`are acceptable. For example, mechanically interlocking fea-
`tures, such as a tapered dovetail or
`flange, could be
`employed with mating recesses. A malleable element 4 is
`typically disposed within the upper shell 6 by a process such
`as, but without limitation, injection molding the upper shell
`6 around the malleable element 4. Alternatively, the mal-
`leable element 4 can be disposed within a lower shell 8,
`disposed on the surface of the upper shell 6, and/or disposed
`between the upper shell 6 and lower shell 8.
`The upper shell 6 is contoured such that two outlets 34, 36
`protrude from it symmetrically along its mid-line. The
`malleable element 4 has holes in it that correspond to and are
`disposed around the outlets 34, 36 in the upper shell 6. The
`lower portion of a shell 8 is aflixed to the upper portion of
`the shell 6. The two portions of the shell, for example, but
`without
`limitation, can be heated and welded together,
`welded together with a solvent and/or bonded together with
`a bonding agent. The shell portions 6, 8 typically, are
`manufactured from a flexible material, for example, but
`without limitation, by a molding process using a compliant
`polymer. Each of the two portions of the shell, for example,
`but without limitation, can be manufactured from a ther-
`mopolymer elastomer. A flange 42 seats the upper shell 6
`securely on the lower shell 8 and allows for a larger surface
`area for aflixing the upper shell 6 to the lower shell 8. The
`combination of the upper and lower shells 6, 8 produces a
`chamber 30. When in communication with a source of
`
`

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`US 7,210,481 B1
`
`5
`breathable gas, this chamber 30 contains the breathable gas.
`The gas in the chamber 30 is available to the user donning
`the nasal mask, and the gas, typically, is pressurized such
`that the gas is forced into the user’s airway, holding open the
`airway. The chamber 30 is substantially leakage-free due to
`the bond between the seal 2 and the upper shell 6 (or other
`attachment methods) and the compliance of the seal 2
`against a user’s skin
`The malleable element 4 is a double ring of a soft metal.
`Alternatively, the malleable element 4 can be constructed
`from any material that is formable and is capable of retaining
`the shape into which it is formed against the force of, for
`example, the flexible shell portions 6, 8 trying to regain their
`memory shape. The combination of the compliant and
`resilient shell portions 6, 8 and the malleable element 4 with
`sufiicient rigidity to hold the shell portions 6, 8 in a selected
`configuration produces a “custom-fit” as desired by a par-
`ticular user. Because the shell portions 6, 8 are resilient, the
`shell portions 6, 8 can be reformed any number of times as
`desired by a particular user. Typically, a user will adjust the
`fit of nasal mask 1 by bending the nasal mask 1 along its
`mid-line and the mid-line of the malleable element 4 con-
`
`tained within the nasal mask 1 into a “V” shape, as shown
`for example, in FIG. 8B. Bending the malleable element 4
`in this manner adjusts the fit of the outlets 34, 36 and
`complementary domes 38, 40 of the seal 2, which overlie the
`outlets 34, 36, to the external skin of the nares of a user
`donning a nasal mask, including the inner rim of the nares.
`The midline can be seen, for example, as line A—A in FIG.
`4A. Increasing the pitch of a side of the “V” will move the
`particular outlet and complementary dome closer to the
`other outlet and complementary dome, while decreasing the
`pitch of a side of the “V” will move the particular outlet and
`complementary dome away from the other outlet and
`complementary dome. Additionally, the malleable element 4
`can be bent in other directions, allowing the nasal mask 1 to
`be formed into a variety of configurations.
`The nasal mask 1 includes an inlet 32 into which a swivel
`
`connector 12 fits. The swivel connector 12 has a slightly
`concave shape on the end that fits into the inlet 32. A conduit
`elbow 14 fits onto the swivel connector 12 over a flange 28
`on the swivel connector 12. The connection between the
`inlet 32 and the swivel connector 12 and/or the connection
`between the swivel connector 12 and the conduit elbow 14
`
`can be a permanent and inseparable connection or the
`connection can be a selectively removable connection. The
`swivel connector 12 produces a swivel mount connection
`between the conduit elbow 14 and the inlet 32. In this type
`of connection, the conduit elbow 14 is capable of being
`rotated 360 degrees about an axis extending through the
`center of the inlet 32. In an alternative embodiment, the
`connection is characterized by a ball and socket connection.
`In this alternative type of connection, the conduit elbow has
`a second angular degree of freedom in addition to the single
`rotational degree of freedom of the swivel mount connec-
`tion. The conduit elbow 14 may be manufactured from, for
`example, but without
`limitation to, polycarbonate. The
`swivel connector 12 also can be manufactured from, for
`example, but without limitation, polypropylene.
`The conduit elbow 14 is shown with an angled portion of
`about ninety degrees, as well as apertures 20 as seen in FIG.
`2B, only one aperture being labeled for the sake of clarity.
`These apertures 20 allow the release of gases exhaled by the
`user. In current hose designs, a user can be disturbed by
`gasses escaping from the hose through the apertures because
`of noise or a “blowing” sensation. The apertures 20 of this
`embodiment of the invention are designed to prevent escap-
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`ing gases from disturbing a user. More than one aperture 20
`is used (in this embodiment three apertures 20 are used) in
`order to diffuse the flow of exhaled gas. Additionally, the
`apertures 20 do not have sharp edges at their perimeter so
`that noise of gas moving through the apertures 20 is reduced.
`The apertures 20 are positioned on a remote side of the
`conduit elbow 14 so that gas is vented in a single direction
`rather than multiple directions. The nasal mask 1 can option-
`ally include more than one inlet to allow for additional hoses
`and/or sources of gas to be connected. Also, one or more
`outlets can be included optionally to allow for drainage of
`any condensation formed within the chamber 30 of the shell
`6, 8 and/or to attach monitoring devices such as pressure,
`temperature, or flow sensors.
`In addition, a retainer 10 is disposed about the inlet 32.
`Two tabs 22, 22' included on the inlet 32 mate with two slots
`24, 26, respectively, and hold the retainer 10 in a particular
`angular orientation. The retainer 10 has four connection
`points, two lower connection points 18, 18' and two upper
`connection points 16, 16'. Typically, the tabs 22, 22' hold the
`retainer 10 in an orientation such that the upper connection
`points 16, 16' are above the lower connection points 18, 18'.
`These connection points 16, 16', 18, 18' allow for connection
`between the retainer 10 and a headgear apparatus. The
`retainer 10 can be constructed from,
`for example, but
`without
`limitation, a polycarbonate. Alternative embodi-
`ments may have a different number of connection points
`and/or may have a mechanically different method of fasten-
`ing a headgear apparatus to a nasal mask. Fastening devices
`such as, but without limitation, snaps, hook and eye clo-
`sures, hook and loop fasteners, or the like, may be used.
`Now referring to FIG. 5, when the nasal mask 1 is donned
`by a user, the nasal mask 1 is maintained on the area around
`a user’s nares with a headgear apparatus 48. The headgear
`apparatus 48 is shown as straps 44, 46, 52 which rest on the
`head as indicated in FIG. 5. The straps 44, 46, 52 of the
`headgear apparatus 48 do not fall across the ears of a user.
`Avoiding contact between the straps 44, 46, 52 and the ears
`of a user increases the comfort level of a user wearing the
`headgear apparatus 48. The straps 44, 46, 52 may be
`manufactured from elastic materials such as, but not limited
`to, nylon webbing, nylon covered neoprene and Vel-
`stretchTM, available from Velcro USA Inc., Manchester,
`N.H., and may further include optional padding, if desired.
`The headgear apparatus 48 also can be reinforced with a
`beam element 50 that allows the headgear apparatus 48 to
`retain a roughly helmet shape when not placed on the head
`of a user. The beam element 50 may be plastically or
`elastically deformable and may be manufactured,
`for
`example, from a polymer, metal, or other suitable material.
`According to one embodiment, the beam element may have
`a substantially flat cross-section, so as not to create an
`uncomfortable ridge if rested upon. Maintaining the helmet
`shape allows a user to more easily don the headgear. Those
`skilled in the art appreciate that other equivalent headgear
`apparatus configurations and headgear apparatus materials
`may be employed.
`The headgear apparatus 48 is connected to the retainer 10.
`Specifically, the headgear apparatus 48 includes two upper
`retention straps 44, only one upper retention strap is shown,
`the other being hidden from view, and two lower retention
`straps 46, only one lower retention strap is shown, the other
`being hidden from view, each of which is attached to a
`corresponding one of two upper connection points 16, 16',
`only one upper connection point 16 is shown, the other 16'
`being hidden from view, or two lower connection points 18,
`18' only one lower connection point 18 is shown, the other
`
`

`
`US 7,210,481 B1
`
`7
`18' being hidden from view, respectively. The connection
`points 16, 16', 18, 18' are a unitary part of the retainer 10.
`Modes of construction other than unitary construction will
`be appreciated by those skilled in the art.
`This four point restraining system allows for the nasal
`mask 1 to be securely positioned against the nares of a user.
`The lower connection points 18, 18', in concert with the
`lower retention straps 46, generally maintain the nasal mask
`1 against a user’s face. The seal 2 rests against the external
`skin at the base of a user’s nose and/or along the rim of the
`nares (the “naric area”). The upper connection points 16, 16'
`in concert with the upper retention straps 44 provide addi-
`tional retention force on the upper portion of the nasal mask
`1, closest to a user’s eyes. This additional force retains the
`nasal mask 1 securely against the external skin surrounding
`the nares at the base of a user’s nose and/or along the rim of
`a user’ s nares. The upper retention straps 44 do not block the
`vision of a user.
`
`In use, a user would loop each of the lower and upper
`retention straps 44, 46 through each of the lower and upper
`connection points 16, 16', 18, 18', respectively. Ahook and
`loop system can be used to maintain the straps 44, 46 at a
`desired adjustment. The loops are located along the majority
`of the straps 44, 46 but not at a distal tip portion of the straps
`44, 46. Hooks are located on the distal tip portion such that
`when the distal tip of a strap is passed through a connector,
`the strap folds over on itself and the hooks engage the loops.
`Alternatively, the correct length of a strap can be adjusted
`and a snap on the distal tip can engage with a clip along the
`strap. Thus, a user only has to adjust a strap once rather than
`adjusting the straps each time a user dons the nasal mask.
`The properly adjusted retention straps 44, 46 of the
`headgear apparatus 48 secure proper contact between the
`seal 2 and the naric area. The additional force provided by
`the upper connection points 16, 16' and the upper retention
`straps 44 ensures that the nasal mask 1 rests securely against
`a user’s naric area during a wide range of sleeping behaviors
`such as entering and maintaining a preferred sleeping posi-
`tion or performing i