(12) United States Patent
`Lovell et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,219,669 B1
`*May 22, 2007
`
`US007219669B1
`
`(54) NOSE MASK
`
`(75)
`
`Inventors: John R. Lovell, Manchester, NH (US);
`Paul R. Chiesa, Manchester, NH (US);
`(Tfilgnas M‘ M°“lt°"’ Hampton’ NH
`,
`.
`(73) Ass1gnee: SleepNet Corporation, Manchester,
`NH (US)
`.
`j
`j
`j
`Subject to any d1scla1mer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1031 days.
`
`.
`( * ) Not1ce:
`
`This patent is subject to a terminal dis-
`Claimen
`(21) Appl. No: 09/328,120
`
`2,376,871 A
`D156,060 S
`D151337 S
`:
`,
`,
`2,693,178 A
`2,837,090 A
`2,868,196 A
`2,902,033 A
`2,917,045 A
`2,931,356 A
`3,042,035 A
`3,117,574 A
`3,288,138 A
`3,315,672 A
`3,330,273 A
`
`5/1945 Fink
`11/1949 Wade
`12/1950 Hi“
`gennleg
`nge er
`11/1954 Gilroy
`6/1958 Bloom et a1.
`1/1959 St
`9/1959 G:1I1:I1)1:L Jr.
`12/1959 Schildknecht et al.
`4/1960 Schwarz
`7/1952 Coanda
`1/1964 Replogle
`11/1966 Sachs
`4/1967 Cunningham et al.
`7/ 1967 Bennett
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`(22)
`
`Filed:
`
`Jun. 8, 1999
`
`CA
`
`618807
`
`4/1961
`
`(51)
`
`Int Cl
`(2006.01)
`A62B 18/08
`(2006.01)
`A62B 18/02
`(2006.01)
`A61M 15/08
`(52) U.S. Cl.
`......................... ..
`128/206.24; 128/205.25;
`128/207.18
`
`(Continued)
`OTHER PUBLICATIONS
`.
`.
`.
`§:;:fl11:1§:1;<§dTechn0l0g1es Soft Ser1esTM Mask advertisement,
`’
`'
`.
`(Contmued)
`
`1
`
`(58) Field of Classification Search ............................. ..
`D8/206‘21T206‘26’ 26525; 446/222; 49/4771;
`277/345, 409, 935, 944—946; 285/10, 15,
`285/918
`
`Primary Exam-ner_G1enn K. Dawson
`(74) Alwrney Agent or Firm—DeVine Millimet & Branch
`PA. Paul CfRemu;
`’
`’
`
`(56)
`
`See application file for complete search history.
`References Cited
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`428,592 A
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`
`5/1890
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`
`Chapman
`Smith
`Kaufman
`McKesson
`Lombard
`O’C0nne1l
`
`(57)
`
`ABSTRACT
`
`A nasal mask includes a shell forming a chamber having an
`inlet and at least one outlet and a seal. The 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.
`
`11 Claims, 14 Drawing Sheets
`
`
`
`RIVID 1012
`
`1
`
`RMD 1012
`
`

`
`US 7,219,669 B1
`Page 2
`
`8/1997
`8/1997
`9/1997
`11/1997
`1/1998
`4/1998
`5/1998
`9/1998
`12/1998
`3/1999
`3/1999
`4/1999
`10/1999
`12/1999
`1/2000
`2/2000
`2/2000
`2/2000
`2/2000
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`8/2000
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`9/2000
`11/2000
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`
`Landis et al.
`Jacobclli
`Ogden et al.
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`Berthon-Jones
`Brydon
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`Hollis
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`Kwok et al.
`Colla et al.
`Kwok
`Schwartz et a .
`Kwok ct al.
`Schwartz et a .
`Lovell
`....... ..
`
`A
`
`AASAAASSEAAA
`
`5,657,752
`5,660,174
`5,662,101
`D385.960
`5,704,345
`5,740,795
`5,746,201
`D398,987
`D402,755
`R1:'36,l65
`5,884,624
`5,896,857
`5,966,745
`6,006,748 A
`D419,658
`D421,298
`6.019.101
`6,029,660
`6,029,665
`L)423,096
`6,044,844
`6,091,973
`r)428,987
`6,098,205
`6,112,746
`6,152,137
`6,631,718
`
`SSAAASAASAAAB
`
`128/206.24
`
`128/2062]
`
`. 128/206.24
`
`FOREIGN PATENT DOCUMENTS
`623129
`' 961
`195 48 380
`' 996
`42 12 259
`' 998
`198 07 961
`' 999
`0 549 299 .
`' 993
`0 747 078 .
`' 996
`0 747 078
`' 996
`0 747 078 .
`' 996
`780018
`‘ 935
`2 658 725
`' 991
`2 720 280
`‘ 995
`2 749 176
`' 997
`VVO 93/24169
`' 993
`WO 97/09090
`' 997
`WO 98/18514
`' 998
`VVO 98/48878
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`' 999
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`2240-97“
`.
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`
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`............ .. 2/14 W
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`Gunderson
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`3/1992
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`1/1993
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`7/1994
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`2/1995
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`1/1996
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`7/1996
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`10/1996
`11/1996
`1/1997
`4/1997
`7/1997
`7/1997
`
`Schmocgncr ct al.
`Trimble et al.
`...... ..
`Lewis
`Nesti
`Milano
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`Derobert
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`Nelson et al.
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`
`....... ..
`
`=14
`
`-16
`
`P15
`
`AASAAAAAAAAAAAAAAAAASAAAAAAAAASAASAAAAAAAAAAAAASAAAAAAAAAAAAAAAAEAAAAAA
`
`3,725,953
`4,062,357
`D248,497
`4,167,185
`4,201,205
`4,226,234
`4,231,363
`4,266,540
`4,337,767
`4,354,488
`4,369,284
`4,412,537
`4,414,973
`4,417,575
`4,446,576
`4,449,526
`4,454,880
`4,458,679
`4,572,323
`4,593,688
`D285,496
`4.665.570
`4,674,134
`4,707,863
`4,770,169
`4,782,832
`4.799.477
`4,807,617
`4,811,730
`4,856,118
`D304,384
`4,915,106
`4,944,310
`D310,431
`4,960,121
`4,971,051
`4,989,271
`5,003,631
`5,003,633
`5.018.519
`5,074,297
`5,093,940
`5,109,839
`5,138,722
`5,146,914
`5,181,506
`5,199,424
`D335,322
`5,243,971
`5.245.995
`5,269,296
`5,331,691
`5,334,646
`5,343,878
`5,349,949
`5,390,373
`5,400,781
`5,429,683
`5,477,852
`5,485,837
`5,511,541
`5,517,986
`5.522.382
`5,540,223
`RE35,339
`5,560,354
`5,570,684
`5,592,938
`5,617,849
`5,645,054
`5,647,357
`
`2
`
`

`
`US 7,219,669 B1
`Page 3
`
`Inc., Aquaflex® Ultrasound Gel Pad sales
`Parker Laboratories,
`literature, 1991, 1 page.
`3M Health Care sales brochure, Justplain talk about the many uses
`of TegadermTM transparent dressing, 1990, 12 pages.
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`14, 2003).
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`ucts (1999).
`
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`(accessed May 14, 2003).
`E. Paul DeGarmo, Materials and Processing in Manufacturing, pp.
`9, 219, and 223 (5th edition 1979).
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`(5th edition 1994).
`
`* cited by examiner
`
`3
`
`

`
`U.S. Patent
`
`May 22, 2007
`
`Sheet 1 of 14
`
`US 7,219,669 B1
`
`.3.o.u_
`
`4
`
`

`
`U.S. Patent
`
`May 22, 2007
`
`Sheet 2 of 14
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`US 7,219,669 B1
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`5
`
`

`
`U.S. Patent
`
`May 22, 2007
`
`Sheet 3 of 14
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`US 7,219,669 B1
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`Fae.2A
`
`-10
`
`6
`
`

`
`U.S. Patent
`
`May 22, 2007
`
`Sheet 4 of 14
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`US 7,219,669 B1
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`7°~
`
`.3:
`
`7
`
`

`
`U.S. Patent
`
`May 22, 2007
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`Sheet 5 of 14
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`US 7,219,669 B1
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`F'G-3/4
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`
`

`
`U.S. Patent
`
`May 22, 2007
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`Sheet 6 of 14
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`US 7,219,669 B1
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`U.S. Patent
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`May 22, 2007
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`Sheet 7 of 14
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`US 7,219,669 B1
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`

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`U.S. Patent
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`May 22, 2007
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`Sheet 8 of 14
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`US 7,219,669 B1
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`11
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`U.S. Patent
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`May 22, 2007
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`Sheet 9 of 14
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`US 7,219,669 B1
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`(,0
`
`12
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`

`
`U.S. Patent
`
`May 22, 2007
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`Sheet 10 of 14
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`US 7,219,669 B1
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`13
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`

`
`U.S. Patent
`
`May 22, 2007
`
`Sheet 11 of 14
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`US 7,219,669 B1
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`14
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`

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`U.S. Patent
`
`May 22, 2007
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`41f0214|.eehS
`
`US 7,219,669 B1
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`15
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`

`
`U.S. Patent
`
`May 22, 2007
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`Sheet 13 of 14
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`May 22, 2007
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`

`
`US 7,219,669 B1
`
`1
`NOSE MASK
`
`TECHNICAL FIELD
`
`The present invention relates to respiratory apparatus and
`more spccifically 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 arc 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 wom 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
`cithcr not wcar thc mask, wcar thc mask impropcrly, 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
`conformancc of the mask to thc 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 scvcral gcncric sizcs, each size designed to accom-
`moda e a range of patients. Ifthe mask does not form a good
`seal around the patient’s nose, leakage can occur, reducing
`the e "ectiveness of the treatment. VVl1en poorly fitting masks
`are used with variably regulated air supply systems respon-
`sive 0 patient breathing, such as those developed for treat-
`ing sleep apnea. mask leakage can induce improper system
`response which may exacerbate tl1e patient’s condition.
`Regulated air supply systems and delivery apparatus for
`trcatmcnt of slccp apnca 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.
`patent application Ser. No. 08/741,524 filed Oct. 31, I996;
`U.S. Pat. No. 5,645,054; 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 ir1to sealing
`engagement with the nasal contour of the patient. Typically,
`the greater the retention force applied by the strap, the better
`
`2
`the seal; however, both the strap and the mask can cause
`cxccssivc pressure on dclicatc arcas, rcsulting in irritation
`and patient discomfort.
`The retention force required to prevent leakage is also a
`function of forces and torques induced in tlie mask. For
`example, thc Weight ofthc conduit supplying air or gas to thc
`mask tends to pull the mask downward, away from the
`patient’s nasal area, when the patient is sitting. Additionally,
`any movement of tlie head from side-to-side or up and down
`. can cause lifting of an edge or sliding of the mask and strap.
`Thc more rapid the movement, the morc pronounccd thc
`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
`thosc employed in slccp apnca trcatmcnt systcms.
`For nasal masks used by patients when sleeping, the strap
`and seal arrangement should also accommodate unconscious
`or reflexive head and body movements. Tl1e 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 tl1e 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.
`
`SUMMARY OF THE INVENTION
`
`,
`
`Devices of the present invention al ow for comfortable
`delivery of a breathable gas to a user. More particularly,
`devices of the invention seal with the external skin surround-
`ing the nares at the base of the nose and/or along the inner
`rim of the narcs of a user. Thc 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
`thc uscr’s cpidcrmal arcas and the device, combine to crcatc
`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.
`Ccrtain embodiments of this aspcct of the invention may
`include any or all of the following features. A nasal 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 mallcablc clcmcnt 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 tl1e 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
`wall. Tl1e side wall car1 contain at least one opening ir1
`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.
`
`18
`
`

`
`US 7,219,669 B1
`
`3
`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 iii a predetermined configuration. The material l1as
`a durometer value less than about ten on a Shore DOC) scale.
`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.
`The bladder can have at least one protrusion 011 a side
`thereof for contacting the external skin proximate at least
`one r1aris 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 ca11 have a thickness and can
`form at least one aperture therethrough disposable proximate
`a naris. A thickness ofthe bladder proximate the aperture can
`be less than a thickness of the seal remote therefrom.
`
`BRIF.F DESCRIPTION OF THF DRAWINGS
`
`The invention, in accordance with preferred and exem-
`plary embodiments,
`together with further advantages
`thereof,
`is more particularly described ir1 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 diflerent views. Also, the
`drawings are not necessarily to scale, er11pl1asis instead
`generally being placed upon illustrating principles of the
`invention.
`F G. IA is a schematic perspective View of one embodi-
`ment of the invention;
`F G. 1B is a schematic exploded perspective view of the
`embodiment of FIG. IA;
`F G. 2A is a schematic front view of the embodiment of
`FIG. IA;
`F G. 2B is a schematic exploded front view of the
`embodiment of FIG. IA;
`F G. 3A is a schematic side view of the embodiment of
`FIG. 1A;
`F G. 3B is a schematic exploded side view of the embodi-
`ment of FIG. 1A;
`F G. 4A is a schematic top view of the embodiment of
`FIG. IA;
`F G. 4B is a schematic cross-sectional View of the
`embodiment of FIG. 1A taken along line A—A of FIG. 4A;
`G. 5 shows a user donning the nasal mask of FIG. 1A;
`G. 6 shows a schematic representation of a gas source
`ommunication with a nasal mask;
`G. 7 is a section through one embodiment of a seal;
`G. 8A is a schematic perspective view of tlie seal of the
`odiment of FIG. 1A;
`G. 813 is a schematic side view of the seal of FIG. 8A;
`G. 8C is a schematic top view of the seal of FIG. 8A.
`G. 9 is a schematic perspective view of an alternative
`embodiment of the invention;
`F G. 10A is a schematic exploded perspective view of the
`embodiment depicted ir1 FIG. 9,
`F G. 10B is a schematic exploded side view of the
`components of the embodnnent depicted in FIG. 9; and
`F G. ll is a schematic front View of the nasal mask of
`FIG. 9.
`
`(‘D’Tl’Tl'Tl§-'fi’fi(7’fi’fi
`
`4
`l_)I:'SCRII”I'I()N
`
`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 ir1 multiple sizes or simply do not properly fit on
`users with faces of a certain shape.
`Referring to FIGS. 1A4B, in one embodiment of a nasal
`mask 1 depicted in a variety of orientations, a seal 2 covers
`ar1 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,
`tetrahydrofuran (“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. Altematively, the inal-
`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 a Fixed 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 tl1er-
`n1opolyr11er elastomer. A flange 42 seats the upper shell 6
`securely on the lower shell 8 and allows for a larger surface
`area for a“1xing 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
`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
`
`.
`
`19
`
`

`
`US 7,219,669 B1
`
`5
`suflicient 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 maimer 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 fomied 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
`comiection 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 a11 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 altemative 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-
`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 ve11ted m 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.
`
`6
`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 comiection 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, b11t
`without
`limitation, a polycarbonate. Alternative embodi-
`ments may have a dilferent 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’; 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-
`stretch”, 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 comiection points 18,
`18' only one lower connection point 18 is shown, the other
`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
`
`20
`
`

`
`US 7,2l9,669 B1
`
`7
`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 tlie lower and upper
`retention straps 44, 46 through each of the lower and upper
`connection points 16, 16', 18, 18', respectively. A hook 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 ofthe 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 do11s 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 cormection 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 involuntary movements during sleep.
`Referring to FIG. 6, a breathable gas source 74 connected
`to a nasal mask 70 with a conduit 72 and optionally
`controlled with a controller unit 76 is
`schematically
`depicted. The breathable gas source 74 could be any of a
`variety of configurations, including, but not limited to, a
`constant flow air ptunp, a responsive variable flow air pump,
`a pressure regulated oxygen tank, or the like, as discussed in
`the references cited hereinabove.
`Now referring to FIG. 7. a section through the seal 2 is
`shown. Typically, the seal 2 is a bladder that is formed from
`a film 60, 64 and that is filled with a soft material 62.
`Typically, the fill material 62 has a durometer value of less
`than about ten on the Shore OOO scale. For example, certain
`types of silicone gel meet this durometer value, such as, but
`not limited to, molded silicone connnercially available from
`Bragel, Inc. Pomona, Calif. as a finished product or chemical
`silicone constituents, such a base and a cross—link, such as
`those available from Applied Sil