(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2005/0011524A1
`(43) Pub. Date:
`Jan. 20, 2005
`Thomlinson et al.
`
`US 2005.0011524A1
`
`(54) NASAL INTERFACE APPARATUS
`(76) Inventors: Marguerite Thomlinson, Irvine, CA
`(US); Edmond Chu, San Diego, CA
`(US); Jim Ventress, Tustin, CA (US)
`Correspondence Address:
`COHEN SAKAGUCH & ENGLISH LLP
`2040 MAIN STREET, 9TH FLOOR
`IRVINE, CA 92614 (US)
`(21) Appl. No.:
`10/887,747
`(22) Filed:
`Jul. 9, 2004
`Related U.S. Application Data
`(60) Provisional application No. 60/488,939, filed on Jul.
`17, 2003. Provisional application No. 60/549,606,
`filed on Mar. 2, 2004. Provisional application No.
`60/570,755, filed on May 13, 2004.
`
`
`
`Publication Classification
`
`(51) Int. Cl." ............................ A62B 7/00; A61M 15/08
`(52) U.S. Cl. ........................................................ 128/207.18
`(57)
`ABSTRACT
`A nasal interface device for use in the nares of a patient for
`positive airway preSSure applications includes a pair of nasal
`prongs, each prong having a bore, a first end, a Second end,
`and at least one deformable flap disposed proximate to the
`first end of each prong. The device further includes a body
`having a distal portion and a proximal portion forming a
`chamber, the proximal portion having apertures to receive
`the Second ends of the nasal prongs, the chamber being in
`communication with the bores of the nasal prongs, and at
`least one exhalation port disposed within the body. The
`device includes at least one gas inlet on the distal portion of
`the body, the at least one gas inlet in communication with the
`chamber. In one preferred aspect of the invention, the at least
`one flap is deformable within the nares of a patient thereby
`creating a Substantially airtight Seal.
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`Jan. 20, 2005
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`NASAL INTERFACE APPARATUS
`
`RELATED APPLICATIONS
`0001. This application claims priority to U.S. provisional
`patent application Ser. No. 60/488,939 filed on Jul. 17, 2003,
`60/549,606 filed on Mar. 2, 2004, and 60/570,755 filed on
`May 13, 2004. The above-identified applications are incor
`porated by reference as if set forth fully herein.
`
`FIELD OF THE INVENTION
`0002 The present invention relates generally to devices
`used to delivery positive airway pressure to a patient for the
`treatment of Sleep apnea. More specifically, the present
`invention relates to nasal interface devices used to deliver
`positive airway pressure to a patient for the treatment of
`Sleep apnea.
`
`BACKGROUND
`0.003 Sleep apnea is a potentially lethal affliction in
`which breathing Stops recurrently during sleep. Sleep apnea
`may be of the obstructive type (Sometimes known as the
`pickwickian Syndrome) in which the upper airway is
`blocked in spite of airflow drive; the central type with
`decreased respiratory drive, or a mixed type. Breathing may
`cease for periods long enough to cause or to exacerbate
`cardiac conditions, and may be accompanied by Swallowing
`of the tongue. Sleep apnea frequently results in fitful periods
`of both day and night sleeping with drowsiness and exhaus
`tion, leaving the patient physically and mentally debilitated.
`0004.
`In recent years it has been found that various forms
`of positive airway pressure during sleep can be an effective
`form of therapy for the apnea sufferer. Ventilation can be
`applied in the form of Continuous Positive Airway Pressure
`(CPAP) in which a positive pressure is maintained in the
`airway throughout the respiratory cycle, Bilevel Positive
`Airway Pressure (BIPAP) in which positive pressure is
`maintained during inspiration but reduced during expiration,
`and Intermittent Mechanical Positive Pressure Ventilation in
`which pressure is applied when an episode of apnea is
`Sensed. Positive airway pressure devices have traditionally
`employed either a face mask which only covers the patient's
`nose, or nasal interface between the ventilation device and
`the patient's airway.
`
`SUMMARY OF THE INVENTION
`0005 The invention provides a nasal interface. In one
`embodiment, this interface includes at least one, and pref
`erably two nasal prongs, where each prong has a bore and at
`least one flap at or near an end of the prong, a body having
`a distal portion and a proximal portion and where the distal
`portion and proximal portion form a chamber when
`assembled. The proximal portion has apertures to receive the
`prongs, the nasal prongs releasably engage with the proxi
`mal portion, and the chamber communicates with the bores.
`In one embodiment, the interface exhalation ports within the
`distal portion of the body direct exhaled gas away from the
`chamber, and at least one gas inlet on the distal portion
`communicate with the chamber.
`0006. In another embodiment, this interface includes a
`pair of interchangeable nasal prongs made of a Soft and/or
`flexible material, where each prong has a bore and at least
`a first flap at or near an end of the prong and an optional
`
`Second (or more) flap(S) proximate to the first flap. In one
`embodiment, the device includes a first flap where the width
`of the first flap is smaller than a width of the second flap, and
`has a body having a distal portion and a proximal portion,
`and where the distal portion and proximal portion form a
`chamber when assembled. In one embodiment, the proximal
`portion is made of another Soft and/or flexible material and
`has apertures to receive the prongs. In one embodiment, the
`nasal prongs are releasably engaged with the proximal
`portion, and the chamber communicates with the bores. In
`one embodiment, the chamber has a plurality of exhalation
`ports within the distal portion of the body that direct exhaled
`gas away from the chamber. In one embodiment, the device
`includes at least one gas inlet on the distal portion commu
`nicating with the chamber, and a pair of Strap connections on
`the distal portion.
`0007. In another embodiment of the invention, a nasal
`interface for use in the nares of a patient for positive airway
`preSSure applications includes a pair of nasal prongs, each
`prong having a bore, a first end, a Second end, and at least
`one deformable flap disposed proximate to the first end of
`each prong. The device further includes a body having a
`distal portion and a proximal portion forming a chamber, the
`proximal portion having apertures to receive the Second ends
`of the nasal prongs, the chamber being in communication
`with the bores of the nasal prongs. At least one exhalation
`port is disposed within the body and at least one gas inlet is
`disposed on the distal portion of the body, the at least one gas
`inlet in communication with the chamber. A Substantially
`airtight Seal is created within the nares of the patient.
`0008. The invention also provides a method of providing
`ventilation for an individual. In one embodiment, this
`method includes providing a nasal interface with a pair of
`nasal prongs, where each prong has a bore and at least one
`flap at or near a tip of the prong, a body having a distal
`portion and a proximal portion, where the distal portion and
`proximal portion form a chamber when assembled. In one
`embodiment, the method includes a proximal portion having
`apertures to receive Second ends of the prongs, and wherein
`the nasal prongs releasably engage with the proximal por
`tion, and the chamber or body communicates with the bores.
`In one embodiment, the chamber includes at least one
`exhalation port within the distal portion of the body for
`directing exhaled gas away from the chamber, and at least
`one gas inlet on the distal portion communicating with the
`chamber. In one embodiment, the method includes opera
`tively connecting the nasal interface with a ventilation
`apparatus, and placing the nasal interface in Sealing contact
`using flaps with nares of the individual.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0009 FIG. 1 is a bottom view of an embodiment of a
`nasal interface of the invention.
`0010 FIG.2 is a side view of an embodiment of the nasal
`interface of FIG. 1.
`0011 FIG. 3 is a back view of an embodiment of the
`nasal interface of FIG. 1.
`0012 FIG. 4 is a front view of an embodiment of the
`nasal interface of FIG. 1.
`0013 FIG. 5 is a view of an embodiment of the nasal
`interface of FIG. 1 in use.
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`FIG. 12D is a side view of the proximal portion of
`
`FIG. 12C is a front view of the proximal portion of
`
`FIG. 6 is a top view of another embodiment of a
`0.014
`nasal interface of the invention.
`0015 FIG. 7 is a perspective view of the nasal interface
`of FIG. 6.
`0016 FIG. 8 is a perspective view of another embodi
`ment of a nasal interface of the invention.
`0017 FIG. 9 is an exploded view of the nasal interface
`of FIG. 1.
`0018 FIG. 10A is a perspective view of an embodiment
`of a nasal interface of the invention.
`0019 FIG. 10B is an exploded view of the nasal interface
`of FIG 10A.
`0020 FIG. 11 is an exploded view of the nasal interface
`of FIG. 8.
`0021
`FIG. 12A is a perspective view of the proximal
`portion of FIG. 8.
`0022 FIG. 12B is a top view of the proximal portion of
`FIG. 8:
`0023
`FIG 8.
`0024
`FIG 8.
`0025 FIG. 13A is a front perspective view of the proxi
`mal portion of FIG. 10B.
`0026 FIG. 13B is a top view of the proximal portion of
`FIG 10B.
`0.027
`FIG. 13C is an enlarged view of a proximal ridge
`of the proximal portion of FIG. 13F.
`0028 FIG. 13D is a rear perspective view of the proxi
`mal portion of FIG. 10B.
`0029 FIG. 13E is a front view of the proximal portion of
`FIG 10B.
`0030 FIG. 13F is a cross sectional view of the proximal
`portion of FIG. 13E along line B-B.
`0031 FIG. 13G is a back view of the proximal portion of
`FIG 10B.
`0032 FIG. 13H is a cross sectional view of the proximal
`portion of FIG. 13E along line A-A.
`0.033
`FIG. 13 is an enlarged view of an opening in the
`proximal portion of FIG. 13E.
`0034 FIG. 14A is a top view of the distal portion of FIG.
`8.
`0035 FIG. 14B is a perspective view of the distal portion
`of FIG. 8.
`FIG. 14C is a front view of the distal portion of
`0036)
`FIG 8.
`0037 FIG. 14D is a side view of the distal portion of
`FIG 8.
`0038 FIG. 15A is a front perspective view of a distal
`portion of FIG. 26.
`0039 FIG. 15B is rear perspective view of the distal
`portion of FIG. 15A.
`
`FIG. 15C is a top view of the distal portion of FIG.
`
`0040
`15A.
`0041 FIG. 15D is a front view of the distal portion of
`FG 15A.
`0042 FIG. 15E is a side view of the distal portion of
`FG 15A.
`0043 FIG. 15F is a back view of the distal portion of
`FG 15A.
`0044 FIG. 15G is a cross sectional view of the distal
`portion of FIG. 15E alone line A-A.
`004.5 FIG. 16A is a top view of the distal portion of FIG.
`15A.
`0046 FIG. 16B is an enlarged view of the exhalation
`ports of the distal portion of FIG. 16C.
`0047 FIG. 16C is a front view of the distal portion of
`FIG. 16A.
`0048 FIG. 16D is a cross sectional view of the distal
`portion of FIG. 16C along line B-B.
`0049 FIG. 16E is a back view of the distal portion of
`FIG. 16A.
`0050 FIG. 16F is a cross sectional view of the distal
`portion of FIG. 16C along line A-A.
`0051 FIG.16G is a perspective view of the distal portion
`of FIG. 16A.
`0052 FIG. 16H is an enlarged cross sectional view of an
`exhalation port of the distal portion of FIG. 16F.
`0053 FIG. 17A is a front perspective view of the distal
`portion of FIG. 10B.
`0054 FIG. 17B is a rear perspective view of the distal
`portion of FIG. 10B.
`0055 FIG. 17C is a top view of the distal portion of FIG.
`1OB.
`0056 FIG. 17D is an enlarged view of a lip on the distal
`portion of FIG. 17C.
`0057 FIG. 17E is a front view of the distal portion of
`FIG 10B.
`0.058 FIG. 17F is a cross sectional view of the distal
`portion of FIG. 17E along line A-A.
`0059 FIG. 17G is a cross sectional view of the distal
`portion of FIG. 17E along line B-B.
`0060 FIG. 17H is a back view of the distal portion of
`FIG 10B.
`0061
`FIG. 18A is a perspective view of one embodiment
`of a nasal prong of the invention.
`0062 FIG. 18B is a side view of the nasal prong of FIG.
`18A.
`0063 FIG. 18C is a bottom view of the nasal prong of
`FIG. 18A.
`0064 FIG. 18D is a view of the nasal prong of FIG. 18B
`rotated 90 degrees around its longitudinal axis.
`0065 FIG. 18E. is a top view of the nasal prong of FIG.
`18A.
`
`RMD
`EXHIBIT 1010 - PAGE 63
`
`

`

`US 2005/0011524 A1
`
`Jan. 20, 2005
`
`0.066 FIG. 19A is a perspective view of one embodiment
`of dual nasal prongs of the invention.
`0067 FIG. 19B is a side view of the dual nasal prongs of
`FIG. 19A.
`0068 FIG. 19C is a cross sectional view of one of the
`prongs of FIG. 19B along line B-B.
`0069 FIG. 19D is a top view of the dual nasal prongs of
`FIG. 19A.
`0070)
`FIG. 19E is a side view of one nasal prong of FIG.
`19A.
`0071 FIG. 19F is a bottom view of the dual nasal prongs
`of FIG. 19A.
`0072 FIG. 19G is a cross sectional view of the prongs of
`FIG. 19D along line A-A.
`0073 FIG. 19H is an enlarged view of tip of a nasal
`prong of FIG. 19G.
`0074 FIG. 20A is a front perspective view of one
`embodiment of dual nasal prongs of the invention.
`0075 FIG. 20B is a rear perspective view of the dual
`nasal prongs of FIG. 20A.
`0076 FIG.20C is a side view of the dual nasal prongs of
`FIG. 20A.
`0077 FIG. 20D is a cross sectional view of one of the
`prongs of FIG.20C along line B-B.
`0078 FIG. 20E is a top view of the dual nasal prongs of
`FIG. 20A.
`0079
`FIG. 20F is a side view of one nasal prong of FIG.
`20A;
`0080 FIG.20G is a bottom view of the dual nasal prongs
`of FIG. 20A.
`0081 FIG.20H is a cross sectional view of the prongs of
`FIG. 20E along line A-A.
`0082 FIG.20I is an enlarged view of the tip of the nasal
`prong of FIG. 20H.
`0083 FIG. 21A is a front perspective view of one
`embodiment of dual nasal prongs of the invention.
`0084 FIG. 21B is a rear perspective view of the dual
`nasal prongs of FIG. 21A.
`0085 FIG. 21C is a side view of the dual nasal prongs of
`FIG 21A.
`0.086 FIG. 21D is a cross sectional view of one of the
`prongs of FIG. 21C along line B-B.
`0087 FIG. 21E is a top view of the dual nasal prongs of
`FIG 21A.
`0088)
`FIG. 21F is a side view of one nasal prong of FIG.
`21A.
`0089 FIG.21G is a bottom view of the dual nasal prongs
`of FIG. 21A.
`0090 FIG. 21H is a cross sectional view of the prongs of
`FIG. 21E along line A-A.
`0091 FIG. 211 is an enlarged view of the tip of a nasal
`prong of FIG. 21H.
`
`0092 FIG. 22A is a front perspective view of one
`embodiment of dual nasal prongs of the invention.
`0093 FIG. 22B is a rear perspective view of the dual
`nasal prongs of FIG. 22A.
`0094 FIG.22C is a side view of the dual nasal prongs of
`FIG. 22A.
`0.095 FIG. 22D is a cross sectional view of one of the
`prongs of FIG. 22C along line B-B.
`0096 FIG.22E is a top view of the dual nasal prongs of
`FIG. 22A.
`0097 FIG.22F is a side view of one nasal prong of FIG.
`22A.
`0.098 FIG.22G is a bottom view of the dual nasal prongs
`of FIG. 22A.
`0099 FIG.22H is a cross sectional view of the prongs of
`FIG. 22E along line A-A.
`0100 FIG. 221 is an enlarged view of the tip of a nasal
`prong of FIG. 22H.
`0101 FIG. 23A is a front perspective view of one
`embodiment of dual nasal prongs of the invention.
`0102 FIG. 23B is a rear perspective view of the dual
`nasal prongs of FIG. 23A.
`0.103
`FIG. 23C is a side view of the dual nasal prongs of
`FIG. 23A
`0104 FIG. 23D is a cross sectional view of one of the
`prongs of FIG. 23C along line B-B.
`0105 FIG. 23E is a top view of the dual nasal prongs of
`FIG. 23A.
`01.06)
`FIG. 23F is a side view of one nasal prong of FIG.
`23A.
`0107 FIG.23G is a bottom view of the dual nasal prongs
`of FIG. 23A.
`0108 FIG.23H is a cross sectional view of the prongs of
`FIG. 23E along line A-A.
`0109 FIG. 231 is an enlarged view of the tip of a nasal
`prong of FIG. 23H.
`0110 FIG. 24A is a front perspective view of one
`embodiment of dual nasal prongs of the invention.
`0111 FIG.24B is a side view of the dual nasal prongs of
`FIG. 24A.
`0112 FIG.24C is a side view of one nasal prong of FIG.
`24A.
`0113 FIG.24D is a top view of the dual nasal prongs of
`FIG. 24A.
`0114
`FIG.24E is a side view of one nasal prong of FIG.
`24A.
`0115 FIG. 24F is a bottom view of the dual nasal prongs
`of FIG. 24A.
`0116 FIG.24G is a cross sectional view of the prongs of
`FIG. 24D along line A-A.
`0117 FIG. 24H is an enlarged view of the tip of a nasal
`prong of FIG. 24G.
`
`RMD
`EXHIBIT 1010 - PAGE 64
`
`

`

`US 2005/0011524 A1
`
`Jan. 20, 2005
`
`0118 FIG. 25A is a perspective view of an exhalation
`port of the invention.
`0119 FIG. 25B is a top view of the exhalation port of
`FIG. 25A.
`0120 FIG. 25C is a front view of the exhalation port of
`FIG. 25A.
`0121 FIG. 25D is a cross sectional view of the exhala
`tion port of FIG. 25C along line A-A.
`0122 FIG. 25E is a bottom view of the exhalation port
`of FIG. 25A.
`0123 FIG. 26 is an exploded view of one embodiment of
`a System of the invention.
`0.124
`FIG. 27 is an assembled view of the system shown
`in FIG. 26.
`0.125 FIG.28A is a perspective view of one embodiment
`of a Strap attachment plate of the invention.
`0126 FIG. 28B is a top view of the strap attachment
`plate of FIG. 28A.
`0127 FIG. 28C is a side view of the strap attachment
`plate of FIG. 28A.
`0128 FIG. 28D is a front view of the strap attachment
`plate of FIG. 28A.
`0129 FIG. 28E is a second front view of the strap
`attachment plate of FIG. 28A.
`0130 FIG. 29 is an assembled view of one embodiment
`of a System of the invention.
`0131 FIG. 30 is an assembled view of one embodiment
`of a System of the invention.
`0132 FIG. 31 is one embodiment of a system of the
`invention in use.
`0133 FIG. 32 is one embodiment of a system of the
`invention.
`0134 FIG.33A is a perspective view of one embodiment
`a tubing connector of the invention.
`0135 FIG. 33B is a top view of the tubing connector of
`FIG. 33A.
`0136 FIG.33C is a side view of the tubing connector of
`FIG. 33A.
`0137 FIG.33D is a bottom view of the tubing connector
`of FIG. 33A.
`0138 FIG. 34 is one embodiment of a strap system of the
`invention.
`0139 FIG.35 is an exploded view of one embodiment of
`a System of the invention.
`0140 FIG.36 is an exploded view of one embodiment of
`a System of the invention.
`FIG. 37 is an assembled view of the system of
`0141)
`FIG. 35.
`0142 FIG. 38 is an assembled view of the system of
`FIG. 36.
`0143 FIG. 39A is a top assembled view of one embodi
`ment of a nasal interface and tubing of the invention.
`
`014.4 FIG. 39B is a side assembled view of one embodi
`ment of a nasal interface and tubing of the invention.
`0145 FIG. 39C is a front view of one embodiment of a
`nasal interface of the invention.
`0146 FIG. 40A is a perspective view of one embodiment
`of a Sealing ring of the invention.
`0147 FIG. 40B is another perspective view of one
`embodiment of a Sealing ring of the invention.
`0148 FIG. 40C is a top view of one embodiment of a
`Sealing ring of the invention.
`0149 FIG. 40D is a front view of one embodiment of a
`Sealing ring of the invention.
`0150 FIG. 40E is a side view of one embodiment of a
`Sealing ring of the invention.
`0151 FIG. 40F is a back view of one embodiment of a
`Sealing ring of the invention.
`0152 FIG. 40G is a cross sectional view of the sealing
`ring of FIG. 40F along line B-B.
`0153 FIG. 41A is a top view of one embodiment of a
`Sealing ring of the invention.
`0154 FIG. 41B is a side view of one embodiment of a
`sealing ring of the invention along the line D-D in FIG. 41A.
`O155 FIG. 41C is a cross sectional view of the sealing
`ring of FIG. 41D along line B-B.
`0156 FIG. 41D is a front view of one embodiment of a
`Sealing ring of the invention.
`0157 FIG. 41E is a side view of one embodiment of a
`Sealing ring of the invention.
`0158 FIG. 41F is a back view of one embodiment of a
`Sealing ring of the invention.
`0159 FIG. 41G is a cross sectional view of the sealing
`ring of FIG. 41D along line A-A.
`0160 FIG. 41H is a perspective view of one embodiment
`of a Sealing ring of the invention.
`0.161
`FIG. 42A is a top view of one embodiment of a
`loop of the invention.
`0162 FIG. 42B is a side view of one embodiment of a
`Strap of the invention.
`0163 FIG. 42C is a side view of one embodiment of a
`Strap of the invention.
`0.164
`FIG. 42D is a perspective view of one embodiment
`of a Strap System of the invention.
`0165 FIG. 42E is a side view of one embodiment of a
`Strap of the invention.
`0166 FIG. 42F is a top view of one embodiment of a
`Strap and loop of the invention.
`0167 FIG. 43 is an exploded view of one embodiment of
`a width-expanding nasal interface of the invention.
`0168 FIG. 44 is an exploded view of one embodiment of
`a width-expanding nasal interface of the invention.
`0169 FIG. 45 is an exploded view of one embodiment of
`a width-expanding nasal interface of the invention.
`
`RMD
`EXHIBIT 1010 - PAGE 65
`
`

`

`US 2005/0011524 A1
`
`Jan. 20, 2005
`
`0170 FIG. 46 is an exploded view of one embodiment of
`a width-expanding nasal interface of the invention.
`0171 FIG. 47 is an exploded view of one embodiment of
`a width-expanding nasal interface of the invention.
`0172 FIG. 48 is an exploded view of one embodiment of
`a width-expanding nasal interface of the invention.
`0173 FIG. 49 is an assembled view of one embodiment
`of a width-expanding nasal interface of the invention.
`0174 FIG. 50 is one embodiment of a pair of nasal
`inserts of the present invention.
`0175 FIG. 51A is a top view of one embodiment of a
`pair of nasal inserts of the present invention.
`0176 FIG. 51B is a side view of one embodiment of a
`pair of nasal inserts of the present invention.
`0177 FIG.51C is a perspective view of one embodiment
`of a pair of nasal inserts of the present invention.
`0178 FIG.52 is a top view of one embodiment of a nasal
`interface of the present invention.
`0179 FIG.53 is a top view of one embodiment of a nasal
`interface of the present invention.
`0180 FIG. 54A is a top view of one embodiment of a
`nasal interface of the present invention.
`0181 FIG. 54B is a side view of one embodiment of a
`nasal interface of the present invention.
`0182 FIG.55 is an exploded view of one embodiment of
`a nasal interface of the present invention.
`0183 FIG. 56 is an assembled view of one embodiment
`of a nasal interface of the present invention.
`0184 FIG. 57 is an exploded view of one embodiment of
`a nasal interface of the present invention.
`0185 FIG. 58 is an assembled view of one embodiment
`of a nasal interface of the present invention.
`0186 FIG. 59 is an exploded view of one embodiment of
`a nasal interface of the present invention.
`0187 FIG. 60 is an assembled view of one embodiment
`of a nasal interface of the present invention.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`0188 The present invention is directed to nasal inter
`faces, nasal interface components, Systems including nasal
`interfaces and methods of use.
`0189 As used herein, the terms “proximal portion” and
`“distal portion” refer to the components of the invention that
`form the body of the nasal interface. Specifically, the com
`ponent of the invention that is closest to the user and
`typically contains openings for one or more nasal prongs is
`referred to as the “proximal portion' and the component that
`is furthest from the user and typically includes at least one
`gas inlet, is referred to as the “distal portion.”
`0190. Nasal interfaces, nasal interface components, nasal
`interface Systems and methods of use are described in detail
`hereafter.
`
`0191 I. Nasal Interfaces
`0.192 A. Assembled Nasal Interfaces/Bodies
`0193 As noted briefly above, the invention provides
`nasal interfaces Suitable for ventilation applications, Such as
`continuous positive airway pressure (CPAP) applications,
`and bi-level positive airway pressure (BIPAP) applications,
`and intermittent (non-continuous) positive pressure (IPPB)
`applications. FIGS. 1 through 8 show views of assembled
`nasal interfaces of embodiments of the present invention.
`0194 The individual components of the nasal interface,
`including the nasal prongS 10 and 12, distal portion 16 and
`proximal portion 14, can be assembled to form a nasal
`interface (also referred to herein as “a nasal interface body”
`or “interface body”) of the present invention. In preferred
`embodiments, the nasal interface components of the inven
`tion can typically be assembled or disassembled without the
`use of any tools or fastenerS or adhesives. In Some embodi
`ments, fastenerS and/or adhesives may be used to assemble
`a nasal interface if a more permanent assembly is desired.
`0.195 AS described further below, in some embodiments,
`the nasal interface accommodates and holds adjacent ele
`ments in a removably or releasably locking or Sealing
`engagement. For example, to form a nasal interface accord
`ing to one embodiment of the present invention, proximal
`portion 14 can slide onto the distal portion 16 to form a nasal
`interface that is held together in a friction fit and/or mechani
`cal fit, as shown in the figures. The assembled nasal interface
`may be of any shape, including cylindrical, rectangular, or
`any other regular or irregular shape.
`0196. The ease of assembly and disassembly also facili
`tates cleaning of the