11111111111111101111111111111111111,1111111111111111111111111110111111
`
`(12) United States Patent
`Ho et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,357,136 B2
`Apr. 15, 2008
`
`(54) PATIENT INTERFACE ASSEMBLY AND
`SYSTEM USING SAME
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`(75)
`
`Inventors: Peter Ho, Pittsburgh, PA (US); Jerome
`Matula, Apollo, PA (US); Richard J.
`Lordo, Butler, PA (US); Lance Busch,
`Trafford, PA (US); Derrik Andrews,
`Markleton, PA (US); Luke Stonis,
`Columbus, OH (US); Chris Von
`Dolhen, St. Louis Park, MN (US)
`
`Assignee: RIC Investments, LLC, Wilmington,
`DE (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 142 days.
`
`Appl. No.: 10/918,832
`
`Filed:
`
`Aug. 13, 2004
`
`853,439 A *
`1,081,745 A
`
`5/1907 Clark
`12/1913 Johnston et al.
`
` 128/207.18
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`WO
`WO
`WO
`
`WO 00/74758 Al
`WO 01/00266 A2
`WO 02/096342 A2
`
`12/2000
`1/2001
`12/2002
`
`OTHER PUBLICATIONS
`
`Website, "Breeze DreamSeal", 1 page, Dec. 11, 2003.
`
`(Continued)
`
`Primary Examiner Teena Mitchell
`Assistant Examiner Shumaya B. Ali
`(74) Attorney, Agent, or Firm Michael W. Haas
`
`Prior Publication Data
`
`(57)
`
`ABSTRACT
`
`US 2005/0076913 Al
`
`Apr. 14, 2005
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/496,059, filed on Aug.
`18, 2003.
`
`(51) Int. Cl.
`A61M 16/06
`A62B 18/08
`
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl.
`
` 128/207.11; 128/207.13;
`128/206.11
` 128/207.11,
`(58) Field of Classification Search
`128/207.18, 204.11, 204.12, 204.24, 204.25,
`128/205.11, 205.25, 206.11, 206.18, 207.13,
`128/200.24, 200.29, 201.11, 201.27, 202.27,
`128/204.18, 206.27, 207.17, 911, 912, DIG. 26
`See application file for complete search history.
`
`A patient interface assembly that includes a patient interface
`device, a headgear, and coupling member joining the inter-
`face device to a headgear. In one embodiment, a spring
`biases the interface device against the face during use. In a
`further embodiment, the patient interface device is a nasal
`cushion having a formable support mounted to the nasal
`cushion for providing support and adjustment of the nasal
`cushion to improve fit and comfort. The headgear assembly
`in one embodiment is a semi-rigid, minimal contact harness
`and includes an adjustment assembly that allows for a
`simultaneous adjustment of multiple straps. An adjustment
`assembly on the headgear provides a gross adjustment of the
`position of the interface relative to the patient and a biasing
`force to urge the patient interface device against the patient's
`face. In a further embodiment, a pair of rigid connecting
`members couple the patient interface device to the headgear.
`
`10 Claims, 25 Drawing Sheets
`
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`EXHIBIT 1013 - PAGE 1
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`US 7,357,136 B2
`Page 2
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`128/201.11
`
`604/94.01
`
`128/201.24
`128/201.25
`
`U.S. PATENT DOCUMENTS
`
`11/1919 Darrow
`1,323,217 A
`10/1941 Hawkins
`2,259,817 A
`2,818,067 A * 12/1957 Rebikoff et al.
`3,978,854 A
`9/1976 Mills, Jr.
`4,354,488 A
`10/1982 Bartos
`4,367,735 A
`1/1983 Dali
`4,782,832 A
`11/1988 Trimble et al.
`4,808,160 A *
`2/1989 Timmons et al.
`4,919,128 A
`4/1990 Kopala et al.
`4,938,209 A
`7/1990 Fry
`5,042,478 A
`8/1991 Kopala et al.
`5,069,205 A * 12/1991 Urso
`5,181,507 A *
`1/1993 Michel et al.
`5,269,296 A
`12/1993 Landis
`5,477,852 A
`12/1995 Landis et al.
`5,517,986 A
`5/1996 Starr et al.
`5,533,506 A
`7/1996 Wood
`5,538,000 A
`7/1996 Rudolph
`5,558,089 A
`9/1996 Castiglione
`5,724,965 A
`3/1998 Handke et al.
`5,752,510 A
`5/1998 Goldstein
`5,921,239 A
`7/1999 McCall et al.
`6,012,455 A
`1/2000 Goldstein
`
`2/2000 Cotner et al.
`6,019,101 A
`6,119,693 A * 9/2000 Kwok et al.
`6,119,694 A
`9/2000 Correa et al.
`6,347,631 B1
`2/2002 Hansen et al.
`6,431,172 B1
`8/2002 Bordewick
`6,463,931 B1
`10/2002 Kwok et al.
`6,497,232 B2
`12/2002 Fecteau et al.
`6,516,802 B2
`2/2003 Hansen et al.
`6,520,182 Bl* 2/2003 Gunaratnam
`6,532,961 Bl* 3/2003 Kwok et al.
`6,561,191 B1
`5/2003 Kwok
`6,581,594 Bl* 6/2003 Drew et al.
`6,595,214 B1
`7/2003 Hecker et al.
`6,662,803 B2 * 12/2003 Gradon et al.
`6,712,072 B1
`3/2004 Lang
`6,851,428 B2 * 2/2005 Dennis
`6,854,465 B2 * 2/2005 Bordewick et al.
`2002/0104540 Al *
`8/2002 Kwok et al.
`2003/0075180 Al
`4/2003 Raje et al.
`
`OTHER PUBLICATIONS
`
` 128/207.11
`
` 128/206.27
` 128/206.21
`
` 128/204.18
`
` 128/205.25
`
` 128/205.25
` 128/207.11
` 128/205.25
`
`Website, "ADAM Circuit (nasal pillows)", 3 pages, Dec. 11, 2003.
`
`* cited by examiner
`
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`EXHIBIT 1013 - PAGE 2
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`

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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 1 of 25
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`US 7,357,136 B2
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`14
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`FIG. 1
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 2 of 25
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`US 7,357,136 B2
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`FIG. 2
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`U.S. Patent
`U.S. Patent
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`Apr. 15, 2008
`Apr. 15, 2008
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`Sheet 3 of 25
`Sheet 3 of 25
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`US 7,357,136 B2
`US 7,357,136 B2
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`d'
`o
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`FIG.4
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 4 of 25
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`US 7,357,136 B2
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`30
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`54
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`42
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`50
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`FIG. 5
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 5 of 25
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`US 7,357,136 B2
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`70
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`72
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`72
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`FIG. 6
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 6 of 25
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`US 7,357,136 B2
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`72
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`72
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`FIG. 7
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`FIG. 8
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 7 of 25
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`118
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`96
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`106
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`76
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`FIG. 9
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`Apr. 15, 2008
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`Sheet 8 of 25
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`96
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`FIG. 10
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`97
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`FIG. 11
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 9 of 25
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`US 7,357,136 B2
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`97
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`FIG. 12
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`107
`r j ..,_
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`88
`FIG. 13
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`U.S. Patent
`U.S. Patent
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`Apr. 15, 2008
`Apr. 15, 2008
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`Sheet 10 of 25
`Sheet 10 of 25
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`US 7,357,136 B2
`US 7,357,136 B2
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`U.S. Patent
`U.S. Patent
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`Apr. 15, 2008
`Apr. 15, 2008
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`Sheet 11 of 25
`Sheet 11 of 25
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`US 7,357,136 B2
`US 7,357,136 B2
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`
`
`
`mi
`1ai
`'7///// ‘1
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`
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`FIG.15
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`U.S. Patent
`U.S. Patent
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`Apr. 15, 2008
`Apr. 15, 2008
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`Sheet 12 of 25
`Sheet 12 of 25
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`US 7,357,136 B2
`US 7,357,136 B2
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`FIG.16
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`Apr. 15, 2008
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`Sheet 13 of 25
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`30
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`55
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`FIG. 17A
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`30
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`34
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`30
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`55 61
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`63
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`34
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`FIG. 17B
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`28
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`FIG. 17C
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`Apr. 15, 2008
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`Sheet 14 of 25
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`US 7,357,136 B2
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`56
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`FIG. 18
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`131
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`FIG. 20
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`58'
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 15 of 25
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`US 7,357,136 B2
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`59
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`59
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`58
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`FIG. 19A
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`59
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`FIG. 19B
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 16 of 25
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`US 7,357,136 B2
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`78'
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`128
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`78'
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`128
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`FIG. 21A
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` F
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`FIG. 21B
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 17 of 25
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`US 7,357,136 B2
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`78'
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`128
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`FIG. 21C
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`130
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`128
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`FIG. 21D
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 18 of 25
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`US 7,357,136 B2
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`136"
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`FIG. 22A
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 19 of 25
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`US 7,357,136 B2
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`136"
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`FIG. 22B
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 20 of 25
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`US 7,357,136 B2
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`180
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`182
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`138'
`
`-----
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 21 of 25
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`US 7,357,136 B2
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`FIG. 23
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 22 of 25
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`US 7,357,136 B2
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`FIG. 24
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 23 of 25
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`US 7,357,136 B2
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`136'
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`FIG. 25
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 24 of 25
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`US 7,357,136 B2
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`222
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`164
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`220
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`218
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`214
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`208
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`FIG. 26
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`U.S. Patent
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`Apr. 15, 2008
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`Sheet 25 of 25
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`US 7,357,136 B2
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`222
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`164
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`204
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`136
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`216
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`r j
`200
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`FIG. 27
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`

`1
`PATIENT INTERFACE ASSEMBLY AND
`SYSTEM USING SAME
`
`US 7,357,136 B2
`
`2
`SUMMARY OF THE INVENTION
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application claims priority under 35 U.S.C. § 119(e)
`from provisional U.S. patent application No. 60/496,059,
`filed Aug. 18, 2003, the contents of which are incorporated
`herein by reference.
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`The present invention pertains to a patient interface
`assembly, a system for supplying a flow of gas to a patient
`that incorporates such an assembly, and to a patient interface
`device and a headgear for use in such an assembly.
`2. Description of the Related Art
`There are numerous situations where it is necessary or
`desirable to deliver a flow of breathing gas, non-invasively,
`to the airway of a patient, i.e., without intubating the patient
`or surgically inserting a tracheostomy tube in their trachea.
`For example, it is known to ventilate a patient using a
`technique known as non-invasive ventilation. It is also
`known to deliver continuous positive airway pressure
`(CPAP) or variable airway pressure, which varies with the
`patient's respiratory cycle or a monitored condition of the
`patient, to treat a medical disorder, such as sleep apnea
`syndrome, in particular, obstructive sleep apnea (OSA),
`congestive heart failure, stroke, Cheynes-Stokes respiration,
`etc. Non-invasive ventilation and pressure support therapies
`involve the placement of a patient interface device, which is
`typically a nasal or nasal/oral mask, on the face of patient to
`interface the ventilator or pressure support device with the
`airway of the patient, so that a flow of breathing gas can be
`delivered from the pressure/flow generating device to the
`airway of the patient.
`Because such patient interface devices are typically worn
`for an extended period of time, a variety of concerns must
`be taken into consideration. For example, in providing CPAP
`or other positive pressure therapy to treat OSA, the patient
`normally wears the patient interface device all night long
`while he or she sleeps. One concern in such a situation is that
`the patient interface device is as comfortable as possible,
`otherwise the patient may avoid wearing the interface
`device, defeating the purpose of the prescribed pressure
`support therapy.
`Typically patient interface devices include a mask shell
`having a cushion attached to the shell that contacts the
`surface of the patient. The mask shell and cushion are held
`in place by a headgear that wraps around the head of the
`patent. The mask and headgear form the patient interface
`assembly. A typical headgear includes flexible, adjustable
`straps that extend from the mask to attach the mask to the
`patient. Other techniques for attaching a patient interface
`device use a vice-like device that anchors at the front and
`back of the patient's head to support the mask on the user.
`See, e.g., U.S. Pat. No. 6,516,802. While such conventional
`interface devices are generally well accepted, there remains
`a class of patients that do not find these devices to be
`sufficiently comfortable, too bulky, or otherwise inadequate.
`Thus, alternative techniques for interfacing a pressure sup-
`port system to the airway of a patient are desired.
`
`30
`
`Accordingly, the present invention provides a patient
`interface assembly that addresses the above-identified con-
`5 cerns and that overcomes shortcomings of conventional
`patient interface assemblies. The patient interface assembly
`of the present invention provides the patient with improved
`patient interface stability and overall comfort. The present
`invention further provides a system for delivering a flow of
`10 gas to a patient that addresses the above identified concerns
`and that does not suffer from the shortcomings of conven-
`tional techniques. This is achieved by providing a system for
`delivering a flow of gas to a patient that includes a gas flow
`generating device capable of producing a flow of gas and a
`15 conduit having a first end portion operatively coupled to the
`gas flow generating device and a second end portion. The
`conduit carries the flow of gas from the gas flow generating
`device. The system includes a patient interface assembly
`comprising a patient interface device operatively coupled to
`20 the second end portion of the conduit and a headgear.
`The patient interface device, in one embodiment of the
`present invention, is a nasal interface device having a nasal
`cushion and a pair of laterally spaced nares elements for
`insertion into the nostrils of the patient. A formable support
`25 is preferably mounted to the nasal cushion for providing
`support for the nasal cushion while allowing for adjustments
`to provide increased fit and comfort of the nasal cushion.
`The nasal cushion is coupled to a coupling elbow or cradle
`having exhaust diffusion plates.
`The headgear assembly of the present invention includes
`a substantially rigid, minimal contact harness assembly. The
`headgear of an exemplary embodiment includes an adjust-
`ment assembly that allows for a simultaneous adjustment of
`multiple straps.
`35 A length adjustment assembly in one embodiment adjusts
`the distance between an adjustment assembly and the nasal
`interface device to accommodate patients having different
`facial sizes. The adjustment assembly is a position adjust-
`ment mechanism which provides a force adjustment by an
`40 integrated spring. The adjustment assembly allows a canti-
`levered support to support the patient interface device with-
`out a set of headgear straps located at the patient interface
`device.
`In a further embodiment, the coupling member couples
`45 the patient interface device to the headgear and a spring,
`associated with the coupling member, biases the patient
`interface device against such a patient's face when the
`patient interface assembly being donned by such a patient.
`This ensures that the patient interface device is properly
`so seated on the user.
`In yet another embodiment, a rigid coupling member
`couples the patient interface device to the headgear. The
`rigid coupling member includes a first rigid arm connected
`between a first side of the patient interface device and a first
`55 side of the headgear and a second rigid arm connected
`between a second side of the patient interface device and a
`second side of the headgear. Preferably the length of the first
`and second arms is adjustable to properly fit the patient
`interface assembly on the patient.
`These and other features and characteristics of the present
`invention, as well as the methods of operation and functions
`of the related elements of structure and the combination of
`parts and economies of manufacture, will become more
`apparent upon consideration of the following description
`65 and the appended claims with reference to the accompany-
`ing drawings, all of which form a part of this specification,
`wherein like reference numerals designate corresponding
`
`60
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`US 7,357,136 B2
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`3
`parts in the various figures. It is to be expressly understood,
`however, that the drawings are for the purpose of illustration
`and description only and are not intended as a definition of
`the limits of the invention. As used in the specification and
`in the claims, the singular form of "a", "an", and "the"
`include plural referents unless the context clearly dictates
`otherwise.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a side perspective view of a patient interface
`assembly according to the principles of the present inven-
`tion;
`FIG. 2 is a front view of the patient interface assembly of
`FIG. 1;
`FIG. 3 is an exploded view of a nasal interface device and
`cradle in the patient interface assembly of FIG. 1;
`FIG. 4 is a side view of the nasal interface device and
`cradle of FIG. 3;
`FIG. 5 is an exploded view of the nasal interface device
`and formable support in the patient interface assembly of
`FIG. 1;
`FIG. 6 is an exploded view of the cradle and an exhaust
`diffusion plate adapted to be disposed on the cradle in the
`patient interface assembly of FIG. 1;
`FIG. 7 is a perspective view of the exhaust diffusion plate
`of FIG. 6;
`FIG. 8 is a cross-sectional view of the exhaust diffusion
`plate of FIG. 7;
`FIG. 9 is an exploded view of a length adjustment
`assembly and an angle adjustment assembly provided in the
`patient interface assembly of FIG. 1;
`FIG. 10 is a side view of the length adjustment assembly
`and the angle adjustment assembly of FIG. 9;
`FIG. 11 is a rear perspective view of the length adjustment
`assembly and the angle adjustment assembly of FIG. 9;
`FIG. 12 is a cross-sectional view of the length adjustment
`assembly and the angle adjustment assembly of FIG. 9;
`FIG. 13 is a side view of specific components of the angle
`adjustment assembly;
`FIGS. 14-16 are perspective, front (partially in section),
`and top views, respectively, of the headgear and a mounting
`assembly in the patient interface assembly of FIG.1;
`FIGS. 17A and 17B are cross-sectional views and FIG.
`17C is a top view of a nasal interface device according to a
`further embodiment of the present invention;
`FIG. 18 is a perspective view of a nasal interface device
`and an alternate embodiment for the formable support;
`FIG. 19A shows an exploded view of a nasal interface
`device and cradle according to another alternate embodi-
`ment, and FIG. 19B shows a perspective view of a nasal
`cushion and support according to the embodiment of FIG.
`19A;
`FIG. 20 is a cross-sectional side view of an alternate
`embodiment having a ball and socket connection;
`FIG. 21A is a perspective view of an alternate embodi-
`ment for the length adjustment assembly and the angle
`adjustment assembly, FIG. 21B is a side view of the length
`adjustment assembly and the angle adjustment assembly of
`FIG. 21A, FIG. 21C is a cross-sectional side view of the
`length adjustment assembly and the angle adjustment assem-
`bly of FIG. 21A, FIG. 21D is a perspective view of the
`interior of the press and release buttons of the length
`adjustment assembly and the angle adjustment assembly of
`FIG. 21A;
`FIGS. 22A and 22B are side and perspective views,
`respectively, of an alternate embodiment of the patient
`
`4
`interface assembly of the present invention shown being
`worn by a patient, and FIG. 22C is a detailed view of the
`angle adjustment assembly of FIG. 22A;
`FIG. 23 is a side view of an alternate embodiment of the
`5 headgear assembly according to the principles of the present
`invention;
`FIG. 24 shows another alternate embodiment of the angle
`adjustment assembly;
`FIG. 25 shows another alternate embodiment of the
`10 headgear adjustment assembly for adjusting the fit of the
`headgear;
`FIG. 26 is a perspective view of a still further embodiment
`of a patient interface assembly according to the principles of
`the present invention; and
`FIG. 27 is a perspective view of the patient interface
`assembly of FIG. 26 shown being worn by a patient.
`
`15
`
`DETAILED DESCRIPTION OF THE
`PRESENTLY PREFERRED EMBODIMENTS OF
`THE INVENTION
`
`20
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`FIGS. 1-16 illustrate an exemplary embodiment of a
`patient interface assembly 10 according to the principles of
`the present invention. The patient interface assembly 10
`25 supports a patient interface device 12 on a patient's head.
`Patient interface device 12 communicates a flow of breath-
`ing gas between the patient's airway and a pressure gener-
`ating device 14, such as a ventilator, CPAP device, or
`variable pressure device, e.g., a BiPAP® device manufac-
`30 tured and distributed by Respironics, Inc. of Pittsburgh, Pa.,
`or an auto-titration pressure support system. A BiPAP®
`device is a bi-level device in which the pressure provided to
`the patient varies with the patient's respiratory cycle, so that
`a higher pressure is delivered during inspiration than during
`35 expiration. An auto-titration pressure support system is a
`system in which the pressure varies with the condition of the
`patient, such as whether the patient is snoring or experienc-
`ing an apnea or hypopnea. For present purposes, pressure
`generating device 14 is also referred to as a gas flow
`40 generating device, because flow results when a pressure
`gradient is generated.
`Communicating a flow of breathing gas between the
`patient's airway and a pressure generating device 14
`includes delivering a flow of breathing gas to the patient
`45 from the pressure generating device and exhausting a flow of
`gas from the patient to ambient atmosphere.
`The system for delivering a breathing gas to a patient
`according to the present invention comprises a pressure or
`gas flow generating device 14 that produces a flow of gas,
`50 a conduit 16, which is also referred to as a patient circuit,
`having a first end portion 18 operatively coupled to the gas
`flow generating device and a second end portion 20. Conduit
`16 carries the flow of gas from pressure generating device 14
`during operation of the system to patient interface device 12
`55 coupled to second end portion 20 of conduit 16. A headgear
`22 according to the principles of the present invention,
`includes a mounting assembly 24 that couples patient inter-
`face device 12 to conduit 16, and an adjustable harness
`assembly 26.
`In the illustrated embodiment the patient interface device
`12 is a nasal interface device. However, the present inven-
`tion also contemplates that other devices for communicating
`a flow of gas to an airway of a patient, such as a nasal mask,
`oral mask, or mouthpiece, or combination nasal/oral masks,
`65 are suitable for use as patient interface device 12.
`Patient interface device 12 is generally a nasal interface
`having a nasal cushion 28 and a pair of laterally spaced nares
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`60
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`EXHIBIT 1013 - PAGE 29
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`US 7,357,136 B2
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`5
`elements 30 at its distal end for insertion into the nostrils of
`the patient. See FIGS. 3-4. The body of nasal cushion 28
`includes a hollow chamber and extends from an oval shaped
`opening 32 to laterally spaced outlet legs 34. Each outlet leg
`34 is provided with one of nares element 30. The body of
`nasal cushion 28 curves about an axis substantially perpen-
`dicular to a plane separating the two nares elements. Each
`nares element 30 has an opening 36 to communicate with the
`nasal passages of the patient. Each of nares elements 30 is
`substantially dome-shaped having an elliptical base propor-
`tional to anthropometrical data of a nostril opening. Nasal
`cushion 28 is preferably formed from a soft cushiony
`material, such as silicone, appropriately soft thermoplastic
`elastomers, closed cell foam, or thin materials.
`The curved surface of nasal cushion 28 includes an inner
`curved surface 38 and an outer curved surface 40 substan-
`tially concentric to inner curved surface 38. See FIG. 4. A
`formable support 42 is preferably mounted to outer curved
`surface 40. Formable support 42 provides support to nasal
`cushion 28 while allowing for adjustments to provide
`increased fit and comfort of the nasal cushion. In the
`illustrated embodiment, formable support 42 is substantially
`T-shaped having a stem portion 44 and a cross portion 46.
`See FIG. 5. Cross portion 46 extends from one end of stem
`portion 44 at a cross portion midpoint 48. Ends 50 of cross
`portion 46 curve from midpoint 48.
`In the illustrated embodiment, outer curved surface 40 of
`nasal cushion 28 includes mounting tabs 52 to mount to ends
`50 of cross portion 46 of support 42. Ends 50 of the cross
`portion 46 have through-holes 54 to mount to the corre-
`sponding mounting tabs 52. See FIG. 5.
`Formable support 42 is preferably formed from a form-
`able metal, such as aluminum. Support 42 can be conformed
`by pressing on the support with the patient's or caregiver's
`fingers. By manipulating the support, the angle of the nasal
`cushion with respect to the facial-frontal plane, and/or the
`angle of nare contact of the nares elements can be changed.
`Alternatively, formable support 42 could be formed from
`Nitinol (Nickel Titanium Naval Ordinance Laboratory),
`which is known as shape memory metal, or a plastic with a
`low softening point temperature, such as EVA (Ethylene
`Vinyl Acetate) could be used. EVA is commonly used in boil
`and bite mouthpieces that athletes use. The EVA support in
`this case could be warmed in hot water and then formed.
`While the illustrated formable support 42 is T-shaped,
`alternatively, the support could be Y-shaped. T or Y-shaped
`supports 42 can be hollow or solid. While the illustrated
`embodiments show externally mounted supports, the sup-
`ports could also be molded within the nasal cushion itself.
`Alternatively, formable support 42 could be bonded to the
`cushion in discreet locations. An alternate shaped formable
`support 56 is illustrated in FIG. 19A. In the embodiment of
`FIG. 18, support 56 is formed from a formable wire gener-
`ally following the outline of outer curved surface 40 of nasal
`cushion 28. By having formable support 56 connected to
`nasal cushion 28 at discreet locations, there is some relative
`movement between nasal cushion 28 and support 56 during
`adjustment of the support.
`In FIGS. 19A and 19B, which illustrate further exemplary
`embodiments for the formable support, the support is
`mounted to outer curved surface 40 of nasal cushion 28
`using three pockets 59 provided on outer curved surface 40.
`Each pocket receives an end portion of the formable support.
`The configurations for attaching the formable support to the
`nasal cushion shown in FIGS. 3, 4, 18, and 19A-19B provide
`an advantage in that the formable support can be readily
`attached and detached from the nasal cushion. This allows
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`5
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`3
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`6
`formable supports of different stiffness to be used in the
`same nasal cushion and allows for easy replacement of the
`nasal cushion or the formable support.
`The present invention contemplates varying a property of
`the walls forming nasal cushion 28, outlet legs 34, and nares
`elements 30, such as the thickness and/or elasticity, to
`provide performance improvements in the patient interface,
`such as increased comfort, better mask/patient seal, and/or
`10 greater customization capability. For example, FIGS. 17A-
`17C illustrates a nasal cushion wall 55 that is relatively
`thick. A base portion 57 of a nares element wall 61 is also
`relatively thick, but tapers as the distance from base portion
`57 increases. Between the relatively thick walled based
`15 portion 57 of nares element wall 61 and nasal cushion wall
`55 is a relatively thin wall portion 63. Providing thin wall
`portion 63 between these two thick walls allows nares
`element 30 to articulate relative to nasal cushion 28 so that
`the nares element better fits the nostrils of the user. In
`20 addition, the formabilty of the nasal cushion is increased by
`providing a relatively deep spacing between outlet legs 34.
`It is to be understood that a similar function, whereby the
`nares elements are moveable relative the nasal cushion, can
`be achieved without varying the thickness of the walls. For
`25 example, a material having a relatively high degree of
`elasticity (stretchable) can be provided at location 63, while
`walls 55 and 61 are formed from a material of lower
`elasticity. Of course, a combination of varying wall thick-
`ness and elasticity are also contemplated by the present
`invention.
`In the illustrated embodiments, with the possible excep-
`tion of that shown in FIGS. 19A and 19B, stem portion 44
`of T-shaped formable support 42 is receivable in a corre-
`35 sponding notched portion 68 provided in oval shaped open-
`ing 60 of cradle 58. Alternatively, formable support 42 can
`be mounted to nasal cushion 28 by corresponding pockets on
`outer curved surface 40 of nasal cushion 28, as shown in
`FIGS. 19A and 19B.
`In the present invention, oval shaped opening 32 of nasal
`cushion 28 is coupled to a coupling elbow or cradle 58.
`Cradle 58 is substantially curved having an oval shaped
`opening 60 that connects to oval shaped opening 32 of nasal
`cushion 28. In the illustrated exemplary embodiment, cradle
`45 58 has a double wall construction 62 and forming a hollow
`chamber 64. An opposite end 66 of the cradle is substantially
`circular. See FIGS. 3-4. It is to be understood, however, that
`the present invention contemplates joining nasal cushion 28
`and cradle 58 using other configurations for the cooperating
`50 parts. For example, a groove (double wall) can be provided
`in the end of nasal cushion 28 so that the end of cradle 58
`fits into the groove formed in the cushion.
`In the illustrated embodiment, tabs 67 are provided on
`opposing sides of nasal cushion 28 at end 66. Corresponding
`55 tab receiving slots 69 are provided on cradle 58 for receiving
`tabs when the nasal cushion is properly coupled to the
`cradle. Tabs 67 and slots 69 assist in aligning the cushion
`with the receiving end of the cradle. To help retain cradle 58
`and cushion 28 in an engaged relation, tabs 67 and slots 69
`60 are configured and arranged so that the tab cannot be easily
`pulled apart. For example, in the illustrated embodiment,
`slot 69 has an "arrow" shape and tab 67 is a similar shape.
`This "arrow" shape allows the tab to be readily inserted into
`the slot due to the wedge-shaped tip of the arrow, but
`65 prevents disengagement due to the flat back end of the tab
`abutting the flat back ends of the arrow-shaped slot. Of
`course, other configurations for tab 67 and slot 69 are
`
`40
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`EXHIBIT 1013 - PAGE 30
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`US 7,357,136 B2
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`7
`provided for accomplishing these functions. In addition, the
`tab can be provided on the cradle and the slot provided in the
`cushion.
`As shown in FIGS. 4 and 6-8, an outer curved surface 70
`of cradle 58 includes an exhaust diffusion plate 72 having
`diffusion holes 74 for exhausting exhaled gas from the
`pressurized system to the atmosphere. Preferably, exhaust
`diffusion plate 72 includes diffusion holes 74 having a
`tapered diameter and arranged in a fan pattern. In the
`illustrated embodiment, exhaust diffusion plates 72 provide
`a substantially 180 degree radial diffusion. It is to be
`understood that the present invention contemplates forming
`the diffusion plate at other locations on the cradle and
`forming the holes in the diffusion plate in any desired
`configuration to achieve an almost infinite number of dif-
`ferent diffusion patterns. For example, multiple diffusion
`plates can be provided so that diffusion plates are provided
`at various locations on the cradle. In addition, the holes,
`which are otherwise provided in the diffusion plate, can be
`formed directly in the wall of the cradle. In which case, the
`diffusion plate(s) can be eliminated. Of course, a combina-
`tion of exhaust ports defined directly in the wall of the
`patient interface device and a diffusion plate(s) can also be
`used. Diffusion plate 74 is preferably formed from a rigid
`material. However, the present invention also contemplates
`that the diffusion plate can be formed from a material that is
`deformable.
`End 66 of cradle 58 is connected to a length adjustment
`assembly 76, which adjusts the distance between an angle
`adjustment assembly 78 and nasal interface device 12, to
`accommodate patients having different facial sizes. As
`shown in FIGS. 1-2 and 9-13, length adjustment assembly
`76 includes a tubular section 80 and an adjustment nut 82.
`Tubular section 80 is received within adjustment nut 82. A
`lower end 84 of tubular section 80 is connected to circular
`end 66 of cradle 58 using any conventional technique, such
`as a friction fitting. Threadings 86 are provided on the
`exterior of tubular section 80 and on an interior of adjust-
`ment nut 82. Length adjustment is accomplished by rotating
`adjustment nut 82 so that the threadings on adjustment nut
`82 engage the threadings on tubular section 80. Rotating
`adjustment nut 82 causes tubular section 80 to move up or
`down inside a pivot tube 88 coupled to adjustment nut 82.
`Pivot tube 88 is part of angle adjustment assembly 78, which
`is described in greater detail below.
`Angle adjustment assembly 78, which is best shown in
`FIGS. 9-13, is a position adjustment mechanism with pre-
`fixed angular locating positions to control the position or
`angle of the rigid gas flow conduit relative to the patient's
`face over a relatively large range of angles, e.g., a 45° range.
`In addition to this relatively large adjustment capability,