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`Patent Application Publication Nov. 18, 2004 Sheet 2 of 109
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`36
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`40
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`24
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`28
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`FIG. 2
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`16
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`36
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`40
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`40
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`FIG. 3
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`46
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`FIG. 4
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`Patent Application Publication Nov. 18, 2004 Sheet 7 of 109
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`FIG. 18
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`Patent Application Publication Nov. 18, 2004 Sheet 8 of 109
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`SPACING
`FIG. 19
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`FIG. 20
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`ALAR
`ANGLE
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`FIG. 21
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`FIG. 25
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`Patent Application Publication Nov. 18, 2004 Sheet 12 of 109 US 2004/0226566 Al
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`232
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`216
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`I
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`224
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`FIG. 28
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`216
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`I
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`230
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`266
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`FIG. 29 .
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`Patent Application Publication Nov. 18, 2004 Sheet 16 of 109 US 2004/0226566 Al
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`HORIZONTAL
`LINE
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`FIG. 37
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`Patent Application Publication Nov. 18, 2004 Sheet 18 of 109 US 2004/0226566 Al
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`316
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`FIG. 39
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`332 324
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`316
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`i 328
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`FIG. 40
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`330
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`350
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`321 348
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`319
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`323
`FIG. 41
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`319
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`321
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`316
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`FIG. 42
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`Patent Application Publication Nov. 18, 2004 Sheet 20 of 109 US 2004/0226566 Al
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`366
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`FIG. 43
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`362
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`350
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`348
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`316
`FIG. 44
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`Patent Application Publication Nov. 18, 2004 Sheet 22 of 109 US 2004/0226566 Al
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`384
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`374
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`FIG. 47
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`374
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`FIG. 47B
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`Patent Application Publication Nov. 18, 2004 Sheet 23 of 109 US 2004/0226566 Al
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`384
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`386
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`374
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`FIG. 48
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`374
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`FIG. 48B
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`Patent Application \'ublication Nov. 111, 2004 Sbeet 24 of 109 US 21)04/0226566 ,\1
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`374
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`f\G. 49
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`Patent Application Publication Nov. 18, 2004 Sheet 27 of 109 US 2004/0226566 Al
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`498
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`420
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`499
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`432
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`426
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`FIG 52
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`Patent Application Publication Nov. 18, 2004 Sheet 28 of 109 US 2004/0226566 Al
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`493
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`450
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`496
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`493
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`FIG. 53
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`Patent Application Publication Nov. 18, 2004 Sheet 29 of 109 US 2004/0226566 Al
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`416
`428
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`FIG. 54
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`426
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`424
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`FIG. 55 460
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`424
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`426
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`461
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`FIG. 56
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`Patent Application Publication Nov. 18, 2004 Sheet 32 of 109 US 2004/0226566 Al
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`599
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`FIG. 59
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`Patent Application Publication Nov. 18, 2004 Sheet 35 of 109 US 2004/0226566 Al
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`550
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`516
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`FIG. 62
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`FIG. 63
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`Patent Application Publication Nov. 18, 2004 Sheet 36 of 109 US 2004/0226566 Al
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`516
`518
`FIG. 64
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`550
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`550
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`FIG. 65
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`Patent Application Publication Nov. 18, 2004 Sheet 39 of 109 US 2004/0226566 Al
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`FIG. 66
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`FIG. 67
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`Patent Application Publication Nov. 18, 2004 Sheet 40 of 109 US 2004/0226566 Al
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`516
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`616
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`FIG. 68
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`FIG. 69
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`Patent Application Publication Nov. 18, 2004 Sheet 41 of 109 US 2004/0226566 Al
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`FIG. 70
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`FIG. 71
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`Patent Application Publication Nov. 18, 2004 Sheet 42 of 109 US 2004/0226566 Al
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`561
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`526
`~
`
`FIG. 72
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`544
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`FIG. 73
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`554
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`542
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`552
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`FIG. 74
`
`FIG. 74B
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`542
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`546 545
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`542
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`552
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`FIG. 75
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`FIG. 76
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`Patent Application Publication Nov. 18, 2004 Sheet 46 of 109 US 2004/0226566 Al
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`526'
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`FIG. 76C
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`526a
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`542a
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`542b
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`FIG. 76D
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`Patent Application Publication Nov. 18, 2004 Sheet 49 of 109 US 2004/0226566 Al
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`576
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`570
`✓
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`571
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`576
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`FIG. 83
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`\'atent Application ru111ication ]'<ov, 111, 211114 s11eet 57 of 109
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`\JS 2004/0226566 Al
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`Patent Application Publication Nov.18, 2004 Sheet 59 of 109 VS 2004/0226566 Al
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`218
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`262
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`262
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`236
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`208
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`206
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`FIG. IOI
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`Patent Application Publication Nov. 18, 2004 Sheet 60 of 109 US 2004/0226566 Al
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`208
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`FIG. 102
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`Patent Application Publication Nov. 18, 2004 Sheet 64 of 109 US 2004/0226566 Al
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`FIG. 106
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`Patent Application Publication Nov. 18, 2004 Sheet 70 of 109 US 2004/0226566 Al
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`656
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`658
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`FIG. 10·7C
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`Patent Application Publication Nov. 18, 2004 Sheet 75 of 109 US 2004/0226566 Al
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`758
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`770
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`FIG. 107H
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`Patent Application Publication Nov. 18, 2004 Sheet 77 of 109 US 2004/0226566 Al
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`822
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`FIG. 107K
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`824
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`FIG. 107L
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`Patent Application Publication Nov. 18, 2004 Sheet 78 of 109 US 2004/0226566 Al
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`834
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`FIG. 107M
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`FIG. 107N
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`Patent Application Publication Nov. 18, 2004 Sheet 79 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 83 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 85 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 86 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 87 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 88 of 109 US 2004/0226566 Al
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`FIG. 112
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`Patent Application Publication Nov. 18, 2004 Sheet 92 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 106 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 108 of 109 US 2004/0226566 Al
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`Patent Application Publication Nov. 18, 2004 Sheet 109 of 109 US 2004/0226566 Al
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`US 2004/0226566 Al
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`Nov. 18, 2004
`
`1
`
`NASAL ASSEMBLY
`
`CROSS-REFERENCE TO PRIORITY
`APPLICATIONS
`
`[0001] This application claims the benefit of U.S. provi(cid:173)
`sional application No. 60/529,696, filed Dec. 16, 2003, No.
`60/494,119, filed Aug. 12, 2003, No. 60/448,465, filed Feb.
`21, 2003, No. 60/482,872, filed Jun. 27, 2003, and No.
`60/488,810, filed Jul. 22, 2003, each of which is incorpo(cid:173)
`rated herein in its entirety.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates to a nasal assembly
`used for treatment, e.g., of Sleep Disordered Breathing
`(SDB) with Continuous Positive Airway Pressure (CPAP) or
`Non-invasive Positive Pressure Ventilation (NPPV).
`
`BACKGROUND OF THE INVENTION
`
`[0003] Some nasal assemblies used in the treatment of
`SDB are designed for insertion into the nasal passages of the
`patient. Air or other breathable gas is supplied by a blower
`and passed along a flexible conduit to the nasal assembly.
`
`[0004] The nasal assembly generally includes a relatively
`rigid shell, e.g., a frame, and a pair of nozzles (which may
`be in the form of nasal pillows, nasal prongs, cannula, or
`nasal puffs) that are mounted on the rigid shell and struc(cid:173)
`tured to be inserted into the nasal passages of the patient.
`The nozzles are usually held in place using a headgear
`assembly, the relatively rigid shell and headgear assembly
`being joined using some form of connector.
`
`[0005] One form of known nasal assembly is described in
`U.S. Pat. No. 4,782,832 (Trimble et al.). Trimble discloses
`a nasal puff assembly 20 that includes a nasal puff 22
`adapted to be worn adjacent the nose of a patient, together
`with a harness assembly 24 adapted to be worn over the head
`of the patient. The harness assembly 24 is designed to
`operatively hold puff 22 adjacent and partially within the
`nasal passages of the patient.
`
`[0006] The puff 22 is in the form of a generally Y-shaped
`rigid hollow plenum chamber 28 together with a pair of
`laterally spaced apart nares elements 30. Adjustability of the
`nares elements 30 may be provided by rotatably mounting
`the elements 30 to the plenum chamber 28 and mounting the
`elements 30 in slots permitting selective lateral positioning
`of the elements 30 with respect to each other. Also, the
`harness assembly 24 may be adjusted to adjust the fit and
`seal of the nares elements 30 during use. That is, the force
`required to maintain a sufficient seal is directly associated
`with the force required to maintain a desired fit. Thus,
`adjustment of the fit or stability of the nasal assembly
`directly affects the seal, which can adversely affect patient
`comfort.
`
`[0007] Other examples of nasal pillows or cannula
`mounted to rigid shells are disclosed in U.S. Pat. Nos.
`5,724,965 and 6,431,172.
`
`[0008] A nasal mask assembly manufactured by Viasys,
`i.e., Spiritus, includes a plenum chamber with a pair of
`adjacent or laterally spaced nares elements. A harness
`assembly is engaged with the plenum chamber to adjust the
`fit and seal of the nares elements during use. Similar to
`
`Trimble, adjustment of the fit or stability of the nasal
`assembly directly affects the seal, which can adversely affect
`patient comfort.
`
`[0009] A nasal mask assembly manufactured by InnoMed,
`i.e., Nasal Aire, includes a plenum chamber with a pair of
`adjacent or laterally spaced nares elements. The nares ele(cid:173)
`ments are structured to engage within the mucosal surfaces
`or internal passages of the patient's nose to maintain the
`nasal mask assembly on the patient's face and to provide a
`seal. See, e.g., U.S. Pat. No. 5,533,506.
`
`[0010] A nasal mask assembly manufactured by Steven(cid:173)
`son Industries (see U.S. Pat. No. 6,012,455), i.e., CPAP-Pro,
`includes a dental anchor, a platform, and air supply tubes
`having nasal pads, wherein the platform supports the air
`supply tubes. The dental anchor is sized to be engaged
`between the teeth in the patient's mouth so as to retain the
`assembly in place.
`
`[0011] PCT Application Publication No. WO 00/13751
`discloses a device that includes gas delivery elements posi(cid:173)
`tioned into engagement with the patient's nose by a mouth(cid:173)
`piece fitted to the patient's teeth.
`
`[0012] A common problem with known nasal assemblies,
`such as those discussed above, is patient comfort. For
`example, the prongs tend to irritate the patient's nose due to
`the tension applied by the headgear assembly that pulls the
`rigid shell and prongs towards the patient's nose.
`
`[0013] Another problem is achievement of a sealing fit
`with the patient's nasal passages without sacrificing patient
`comfort.
`
`[0014] Another problem is irritation of the inside of the
`patient's nostrils caused by contact with the prongs, e.g., an
`edge thereof.
`
`[0015] Another problem is irritation of the inside of the
`patient's nostrils caused by air jetting (air flow irritation)
`from the prongs.
`
`[0016] Another problem is adjustment of the nasal assem(cid:173)
`blies relative to the nose and/or head of the patient so as to
`accommodate various shapes and angles of patient's noses.
`
`[0017] Still another problem is the direct association
`between sealing and stability forces that can affect patient
`comfort.
`
`SUMMARY OF THE INVENTION
`
`[0018] One aspect of the invention is directed towards a
`nasal assembly that provides more comfort to the patient.
`
`[0019] Another aspect of the invention is directed towards
`a nasal assembly that provides an effective seal with the
`patient's nasal passages. Preferably, the nasal assembly is a
`nozzle assembly including nozzles which comfortably come
`into contact with the external rim of the nares and avoid the
`sensitive internal passages ( e.g., mucosal surfaces or internal
`passages) of the nasal passage.
`
`[0020] Still another aspect of the invention is directed
`towards a nasal assembly that does not rely on tension from
`the headgear assembly to provide an effective seal between
`the nozzles and the patient's nasal passages.
`
`[0021] Still another aspect of the invention is directed
`towards a nasal assembly that is unobtrusive.
`
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`Nov. 18, 2004
`
`2
`
`[0022] Still another aspect of the invention 1s directed
`towards a nasal assembly that is easy to use.
`
`[0033] FIG. 5 is a front view of a nozzle assembly of the
`nasal assembly shown in FIG. 1;
`
`[0023] Still another aspect of the invention is directed
`towards a nasal assembly that maintains a headgear adjust(cid:173)
`ment setting.
`
`[0024] Still another aspect of the invention is directed
`towards a nasal assembly that helps decouple sealing and
`stability forces. Specifically, one aspect of the invention is
`directed towards a nasal assembly that is structured such that
`the stability forces that act to maintain the nasal assembly on
`the patient's face are separated or at least better distin(cid:173)
`guished from the sealing forces that act to maintain a seal
`between the nasal assembly and the patient's face.
`
`[0025] Yet another aspect of the invention is directed
`towards a nasal assembly that provides a greater range of
`movement for nozzles of the nasal assembly.
`
`[0026] Another aspect of the invention provides a nasal
`assembly for delivering breathable gas to a patient. The
`nasal assembly includes a frame having a main body and a
`side frame member provided on each lateral side of the main
`body, each side frame member including an integrally
`formed first connector portion. A nozzle assembly includes
`a gusset or base portion and a pair of nozzles. The nozzle
`assembly is coupled with the main body of the frame with
`the pair of nozzles structured to sealingly engage with nasal
`passages of a patient's nose in use. A pair of inlet conduits
`are structured to deliver breathable gas into the frame and
`nozzle assembly for breathing by the patient. A pair of
`second connector portions are removably and rotatably
`connected to respective first connector portions of the frame.
`The second connector portions are in communication with
`the inlet conduits via angle connectors. A headgear assembly
`is removably connected to at least one of the second con(cid:173)
`nector portions and the angle connectors so as to maintain
`the frame and the nozzle assembly in a desired adjusted
`position on the patient's face.
`
`[0027] Other aspects, features and advantages of this
`invention will become apparent from the following detailed
`description when taken in conjunction with the accompa(cid:173)
`nying drawings, which are a part of this disclosure and
`which illustrate, by way of example, principles of this
`invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0028] The accompanying drawings facilitate an under(cid:173)
`standing of the various embodiments of this invention. In
`such drawings:
`
`[0029] FIG. 1 is a perspective view illustrating a partial
`nasal assembly constructed in accordance with an embodi(cid:173)
`ment of the invention mounted to a patient's head and
`engaged with nasal passages of the patient;
`
`[0030] FIG. 2 is a front view of a frame of the nasal
`assembly shown in FIG. 1 with some parts removed for
`clarity;
`
`[0031] FIG. 3 is a cross-sectional view of the frame shown
`in FIG. 2;
`
`[0032] FIG. 4 is a side view of the frame shown in FIG.
`2;
`
`[0034] FIG. 6 is a front cross-sectional view of the nozzle
`assembly shown in FIG. 5;
`
`[0035] FIG. 7 is a side view of the nozzle assembly shown
`in FIG. 5;
`
`[0036] FIG. 8 is a side cross-sectional view of the nozzle
`assembly shown in FIG. 5;
`
`[0037] FIG. 9 is a perspective view of an embodiment of
`an inlet conduit and headgear connector assembly of the
`nasal assembly shown in FIG. 1;
`[0038] FIG. 10 is a rear perspective view of the inlet
`conduit and headgear connector assembly shown in FIG. 9;
`[0039] FIG. 11 is a perspective view of another embodi(cid:173)
`ment of an inlet conduit and headgear connector assembly
`adapted to be used with the nasal assembly shown in FIG.
`1;
`
`[0040] FIG. 12 is a rear perspective view of the inlet
`conduit and headgear connector assembly shown in FIG. 11;
`[0041] FIG.13 is a side view illustrating an over-the-head
`inlet conduit routing for the nasal assembly shown in FIG.
`1;
`
`[0042] FIG. 14 is a side view illustrating an under-the(cid:173)
`chin inlet conduit routing for the nasal assembly shown in
`FIG.1;
`
`[0043] FIG. 15 is a perspective view illustrating a con(cid:173)
`nector for use in routing the inlet conduits over the head of
`the patient;
`
`[0044] FIG. 16 is a perspective view illustrating a con(cid:173)
`nector for use in routing the inlet conduits under the chin of
`the patient;
`
`[0045] FIG. 17 is a perspective view illustrating a flow
`generator connector for use in connecting the nasal assembly
`shown in FIG. 1 to a pressurized supply;
`
`[0046] FIG. 18 is a side view illustrating an embodiment
`of headgear components for use with the nasal assembly
`shown in FIG. 1;
`
`[0047] FIG. 19 is a schematic view illustrating a patient's
`nose having a substantially flat alar angle;
`
`[0048] FIG. 20 is a schematic view illustrating a patient's
`nose having a substantially steep alar angle;
`
`[0049] FIG. 21 is a schematic view illustrating an embodi(cid:173)
`ment of a sealing zone of a nozzle;
`
`[0050] FIG. 22 is a graph illustrating average nostril ratios
`opening/entrance;
`
`[0051] FIG. 23 is a schematic view illustrating an embodi(cid:173)
`ment for calculating a base major axis of a nozzle;
`
`[0052] FIG. 24 is a schematic view illustrating an embodi(cid:173)
`ment for calculating a base minor axis of a nozzle;
`
`[0053] FIG. 25 is a partial perspective view illustrating
`another embodiment of a nasal assembly mounted to a
`patient's head and engaged with nasal passages of the
`patient;
`
`RMD
`EXHIBIT 1011 - PAGE 112
`
`

`

`US 2004/0226566 Al
`
`Nov. 18, 2004
`
`3
`
`[0054] FIG. 26 is a partial front perspective view of the
`nasal assembly shown in FIG. 25;
`[0055] FIG. 27 is a cross-sectional view of the nasal
`assembly shown in FIG. 25;
`[0056] FIG. 28 is a front perspective view of a frame of
`the nasal assembly shown in FIG. 25;
`[0057] FIG. 29 is a rear perspective view of the frame
`shown in FIG. 28;
`[0058] FIG. 30 is a partial front perspective view of a half
`of the nozzle assembly of the nasal assembly shown in FIG.
`25;
`[0059] FIG. 31 is a side cross-sectional view of the nozzle
`assembly shown in FIG. 30;
`[0060] FIG. 32 is a perspective view illustrating an
`embodiment of an inlet conduit and headgear connector
`assembly of the nasal assembly shown in FIG. 25;
`[0061] FIG. 33 is a rear perspective view of the inlet
`conduit and headgear connector assembly shown in FIG.
`32;
`[0062] FIG. 34 is a cross-sectional view of the inlet
`conduit and headgear connector assembly shown in FIG. 32
`with the flexible arms in phantom;
`[0063] FIG. 35 is a perspective view of a flow generator
`connector for use in connecting tubes for use with the nasal
`assembly shown in FIG. 25 to a pressurized supply;
`[0064] FIG. 36 is a side view illustrating the routing of the
`inlet conduits of the nasal assembly shown in FIG. 25;
`[0065] FIG. 37 is a side view illustrating the nasal assem(cid:173)
`bly shown in FIG. 25 mounted to a patient's head;
`[0066] FIG. 38 is a perspective view illustrating another
`embodiment of a nasal assembly mounted to a patient's head
`and engaged with nasal passages of the patient;
`[0067] FIG. 38B is a perspective view illustrating an inlet
`conduit and an inlet conduit and headgear connector of the
`nasal assembly shown in FIG. 38;
`[0068] FIG. 39 is a perspective view of the nasal assembly
`shown in FIG. 38;
`[0069] FIG. 40 is a perspective view of a frame of the
`nasal assembly shown in FIG. 38;
`[0070] FIG. 41 is a perspective view of a nozzle assembly
`of the nasal assembly shown in FIG. 38;
`[0071] FIG. 42 is a perspective view illustrating the
`nozzle assembly shown in FIG. 41 mounted to the frame to
`shown in FIG. 40;
`[0072] FIG. 43 is a cross-sectional view of the nasal
`assembly shown in FIG. 38;
`[0073] FIG. 44 is a side cross-sectional view of the nasal
`assembly shown in FIG. 38;
`
`[0076] FIG. 47 is a cross-sectional view of an embodi(cid:173)
`ment of an inlet conduit engaged with an embodiment of an
`angle connector for delivering breathable gas;
`[0077] FIG. 47B is a perspective view illustrating another
`embodiment of an inlet conduit;
`[0078] FIG. 48 is a cross-sectional view illustrating
`another embodiment of an inlet conduit engaged with
`another embodiment of a flow generator connector for
`delivering breathable gas;
`[0079] FIG. 48B is perspective view illustrating another
`embodiment of an inlet conduit;
`[0080] FIG. 49 is a perspective view illustrating an
`embodiment of an inlet conduit of the nasal assembly shown
`in FIG. 38;
`[0081] FIG. 50 is a side view illustrating the nasal assem(cid:173)
`bly shown in FIG. 38 prior to engagement with nasal
`passages of the patient;
`[0082] FIG. 51 is a front view illustrating the nasal
`assembly shown in FIG. 38 (in cross-section) engaged with
`nasal passages of the patient;
`
`[0083] FIG. 52 is a perspective view illustrating another
`embodiment of a nasal assembly mounted to a patient's head
`and engaged with nasal passages of the patient with two inlet
`configurations shown;
`
`[0084] FIG. 53 is a perspective view illustrating the nasal
`assembly shown in FIG. 52;
`
`[0085] FIG. 54 is a cross-sectional view illustrating a
`nozzle assembly being engaged with a frame of the nasal
`assembly shown in FIG. 52;
`
`[0086] FIG. 55 is a perspective view illustrating an inlet
`conduit and headgear connector assembly of the nasal
`assembly shown in FIG. 52;
`
`[0087] FIG. 56 is a cross-sectional view illustrating the
`inlet conduit and headgear connector assembly of the nasal
`assembly shown in FIG. 52;
`
`[0088] FIG. 57 is a cross-sectional side view illustrating
`the nasal assembly shown in FIG. 52 about to be engaged
`with nasal passages of the patient;
`
`[0089] FIG. 58 is a front view illustrating the nasal
`assembly shown in FIG. 52 (in cross-section) being engaged
`with nasal passages of the patient;
`
`[0090] FIG. 59 is a perspective view illustrating another
`embodiment of a nasal assembly mounted to a patient's head
`and engaged with nasal passages of the patient;
`
`[0091] FIG. 60 is a perspective view of the nasal assembly
`shown in FIG. 59 removed from a patient's head;
`
`[0092] FIG. 61 is an exploded view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the frame,
`nozzle assembly, and clip thereof;
`
`[0074] FIG. 45 is a side view illustrating the nasal assem(cid:173)
`bly shown in FIG. 38 mounted to a patient's head showing
`two inlet configurations;
`
`[0093] FIG. 62 is a perspective view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the clip being
`engaged with the frame and nozzle assembly;
`
`[0075] FIG. 46 is a schematic force diagram illustrating
`some of the forces that are developed when the nasal
`assembly shown in FIG. 38 is mounted to the patient's head;
`
`[0094] FIG. 63 is a perspective view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the engage(cid:173)
`ment between the frame, nozzle assembly, and clip;
`
`RMD
`EXHIBIT 1011 - PAGE 113
`
`

`

`US 2004/0226566 Al
`
`Nov. 18, 2004
`
`4
`
`[0095] FIG. 64 is a partial cross-sectional view of a
`portion of the nasal assembly shown in FIG. 59 illustrating
`the engagement between the frame, nozzle assembly, and
`clip;
`[0096] FIG. 65 is a top perspective view of a portion of the
`nasal assembly shown in FIG. 59;
`[0097] FIG. 65A is a partial enlarged view of the cushion
`shown in FIG. 65;
`[0098] FIG. 65B is a schematic diagram illustrating force
`distribution according to one aspect of the present invention;
`[0099] FIG. 66 is a rear perspective view of a portion of
`an alternative embodiment of a nasal assembly illustrating
`the engagement between the frame, nozzle assembly, and
`clip;
`[0100] FIG. 67 is a rear perspective illustrating the
`engagement between another embodiment of the frame,
`nozzle assembly, and clip;
`[0101] FIG. 68 is a perspective view illustrating the
`nozzle assembly shown in FIG. 66 being engaged with the
`frame shown in FIG. 66;
`[0102] FIG. 69 is a perspective view illustrating the
`nozzle assembly shown in FIG. 67 being engaged with the
`frame shown in FIG. 67;
`[0103] FIG. 70 is a perspective view illustrating the clip
`shown in FIG. 66 being engaged with the frame and nozzle
`assembly shown in FIG. 66;
`[0104] FIG. 71 is a perspective view illustrating the clip
`shown in FIG. 67 being engaged with the frame and nozzle
`assembly shown in FIG. 67;
`[0105] FIG. 72 is a perspective view of a second connec(cid:173)
`tor portion of the nasal assembly shown in FIG. 59;
`[0106] FIG. 73 is a cross-sectional view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the engage(cid:173)
`ment between the frame, second connector portion, and
`angle connector;
`[0107] FIG. 74 is a perspective view of an angle connector
`of the nasal assembly shown in FIG. 59;
`[0108] FIG. 74B is a perspective similar to FIG. 74 but at
`a different angle;
`[0109] FIG. 75 is a side view of the angle connector
`shown in FIG. 74;
`[0110] FIG. 76 is a cross-sectional view of the angle
`connector shown in FIG. 74;
`[0111] FIG. 76A illustrates another embodiment of the
`present invention;
`[0112] FIG. 76B is an exploded view of FIG. 76A;
`[0113] FIG. 76C illustrates a second connector portion of
`the assembly of FIG. 76A;
`[0114] FIG. 76D illustrates an angle connector used in the
`assembly of FIG. 76A;
`
`[0115] FIG. 77 is a perspective view of a flow generator
`connector of the nasal assembly shown in FIG. 59;
`
`[0116] FIG. 78 is a cross-sectional view of the flow
`generator connector shown in FIG. 77;
`
`[0117] FIG. 79 is a cross-sectional view of an embodi(cid:173)
`ment of an inlet conduit of the nasal assembly shown in FIG.
`59;
`
`[0118] FIG. 80 is a perspective view of headgear yoke of
`the headgear assembly of the nasal assembly shown in FIG.
`59;
`
`[0119] FIG. 81 is a perspective view illustrating engage(cid:173)
`ment between the headgear yoke (FIG. 80) and angle
`connector (FIG. 74);
`
`[0120] FIG. 82 is a cross-section through line 82-82 of
`FIG. 81;
`
`[0121] FIG. 83 is a perspective view of a headgear buckle
`of the nasal assembly shown in FIG. 59;
`
`[0122] FIG. 84 is a perspective view of the nasal assembly
`shown in FIG. 59 illustrating the routing of the headgear
`assembly;
`
`[0123] FIG. 85 is another perspective view of the nasal
`assembly shown in FIG. 59 illustrating the routing of the
`headgear assembly;
`
`[0124] FIG. 86 is a top view illustrating a nasal assembly
`constructed in accordance with an embodiment of the inven(cid:173)
`tion;
`
`[0125] FIG. 87 is a side view of the nasal assembly shown
`in FIG. 86;
`
`[0126] FIG. 88 is a bottom view of the nasal assembly
`shown in FIG. 86;
`
`[0127] FIG. 89 is an exploded view of a portion of the
`nasal assembly shown in FIG. 86;
`
`[0128] FIG. 90 is a perspective view of a portion of an
`embodiment of a nasal assembly;
`
`[0129] FIG. 91 is a top view of a headgear connector
`according to an alternative embodiment of the invention;
`
`[0130] FIG. 92 is a perspective view of an upper portion
`of a central conduit of the nasal assembly shown in FIG. 90;
`
`[0131] FIG. 93 is a top view of the upper portion of the
`central conduit shown in FIG. 92;
`
`[0132] FIG. 94 is a perspective view of a lower portion of
`a central conduit of the nasal assembly shown in FIG. 90;
`
`[0133] FIG. 95 is a bottom view of the lower portion of
`the central conduit shown in FIG. 94;
`
`[0134] FIG. 96 is a perspective view of an inlet conduit of
`the nasal assembly shown in FIG. 86;
`
`[0135] FIG. 96A is a schematic view of a Y-shaped inlet
`connector of the nasal assembly shown in FIG. 86;
`
`[0136] FIG. 97 is a perspective view of an inlet connector
`of the nasal assembly shown in FIG. 86;
`
`[0137] FIG. 97A is a schematic view of the nasal assem(cid:173)
`bly shown in FIG. 86 with the nozzles in a first position
`adjacent to the nasal passages of the patient;
`
`[0138] FIG. 97B is a schematic view of the nasal assem(cid:173)
`bly shown in FIG. 86 with the nozzles in a second position
`in sealing engagement with the nasal passages of the patient;
`
`RMD
`EXHIBIT 1011 - PAGE 114
`
`

`

`US 2004/0226566 Al
`
`Nov. 18, 2004
`
`5
`
`[0139] FIG. 98 is a perspective view of another embodi(cid:173)
`ment of a nasal assembly;
`
`[0140] FIG. 99 is an enlarged perspective view of nozzles
`and a gusset portion of the nasal assembly shown in FIG. 98;
`
`[0141] FIG. 100 is an enlarged perspective view of inlet
`conduits of the nasal assembly shown in FIG. 98;
`
`[0142] FIG.101 is a front perspective view illustrating the
`nasal assembly shown in FIG. 98 mounted to a patient's
`head;
`
`[0143] FIG. 102 is a rear perspective view illustrating the
`nasal assembly shown in FIG. 98 mounted to a patient's
`head;
`
`[0144] FIG.103 is a front perspective view illustrating the
`nasal assembly shown in FIG. 98 engaged with nasal
`passages of the patient;
`
`[0145] FIG. 104 is a side perspective view illustrating the
`nasal assembly shown in FIG. 98 engaged with the nasal
`passages of the patient;
`
`[0146] FIG. 105 is a side view illustrating the nasal
`assembly shown in FIG. 98 engaged with the nasal passages
`of the patient;
`
`[0147] FIG.106 is a front perspective view illustrating the
`nasal assembly shown in FIG. 98 engaged with nasal
`passages of the patient;
`
`[0148] FIG. 107 is a perspective view of another embodi(cid:173)
`ment of a nasal assembly mounted to a patient's head;
`
`[0149] FIG. 107-1 is a perspective view of yet another
`embodiment of the present invention;
`
`[0162] FIG. 108C illustrates another tube retainer accord(cid:173)
`ing to an embodiment of the present invention;
`[0163] FIG. 109 is an isometric view illustrating a portion
`of the nasal assembly shown in FIG. 108;
`[0164] FIG. 110 is a cross-sectional view of a portion of
`a nasal assembly according to the present invention;
`[0165] FIGS. 110-1 and 110-2 illustrate cross-sectional
`views of a vent aperture according to the present invention;
`[0166] FIG. HOA is a partial enlarged cross-sectional
`view of the left hand side of FIG. 110;
`[0167] FIG. 110B is an partial enlarged cross-sectional
`view of the right hand side of FIG. 110;
`[0168] FIG. 111 is an exploded perspective view showing
`the interface between seal ring and elbow swivel according
`to an embodiment of the present invention;
`[0169] FIG. 112 is a partial cross-sectional view of a
`portion of the mask assembly shown in FIG. 108;
`[0170] FIG. 113 illustrates still another embodiment o