111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US007614398B2
`
`(12) United States Patent
`Virr et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,614,398 B2
`Nov. 10,2009
`
`(54) HUMIDIFIER WITH STRUCTURE TO
`PREVENT BACKFLOW OF LIQUID
`THROUGH THE HUMIDIFIER INLET
`
`(75)
`
`Inventors: Alexander Virr, Balmain (AU); Ian
`Malcolm Smith, Westleigh (AU); Perry
`David Lithgow, Glenwood (AU);
`Richard Llewelyn Jones, Hornsby
`Heights (AU); Andrew Cheung,
`Burwood (AU)
`
`(73) Assignee: ResMed Limited, Bella Vista (AU)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.c. 154(b) by 515 days.
`
`(21) Appl. No.: 11/181,807
`
`(22) Filed:
`
`Jui. 15, 2005
`
`(65)
`
`Prior Publication Data
`
`US 2005/0247314 Al
`
`Nov. 10, 2005
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 10/467,382, filed as
`application No. PCT/AU02/00155 on Feb. 14, 2002,
`now Pat. No. 6,935,337.
`
`(30)
`
`Foreign Application Priority Data
`
`Feb. 16,2001
`Aug. 27, 2001
`
`(AU)
`(AU)
`
`..................................... PR3117
`..................................... PR7288
`
`(51)
`
`Int. CI.
`F23D 11/00
`(2006.01)
`F23D 14/00
`(2006.01)
`A61M 15/00
`(2006.01)
`(52) U.S. CI. ............................. 1281203.26; 128/204.14
`(58) Field of Classification Search ............ 128/203.16,
`128/203.17,206.12,203.26,205.17,203.27,
`128/204.14,204.17
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`1,974,843 A * 9/1934 Blashfield ................... 2611123
`3,806,102 A * 4/1974 Valenta et al.
`.............. 2611142
`3,864,440 A * 2/1975 Giocoechea ............. 2611122.1
`4,051,205 A * 9/1977 Grant .......................... 261170
`4,222,971 A * 9/1980 Eilert .......................... 261192
`4,243,396 A *
`111981 Cronenberg ................. 96/311
`4,532,088 A * 7/1985 Miller ........................ 2611142
`4,807,616 A * 2/1989 Adahan ................. 128/204.21
`4,913,140 A
`4/1990 Orec et al.
`4,953,546 A * 9/1990 Blackmer et al. ...... 128/203.16
`5,231,979 A * 8/1993 Rose et al. ............. 128/204.14
`5,558,084 A * 9/1996 Daniell et aI ........... 128/203.17
`5,598,837 A
`2/1997 Sirianne et al.
`6,398,197 Bl
`6/2002 Dickinson
`6,435,180 Bl * 8/2002 Hewson et al. ......... 128/204.18
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`
`0589429 Bl
`
`3/1994
`
`(Continued)
`
`Primary Examiner-Justine R Yu
`Assistant Examiner-Kristen C Matter
`(74) Attorney, Agent, or Firm-Nixon & Vanderhye PC
`
`(57)
`
`ABSTRACT
`
`A humidifier includes a base configured to retain a body of
`liquid therein, a top cover, and a seal disposed between the top
`cover and the base. At least a portion of the base is constructed
`of a heat conducting material. The top cover defines both an
`inlet and an outlet communicated with an interior of the base.
`The inlet is configured to receive pressurized breathable gas
`and the outlet is configured to deliver the pressurized breath(cid:173)
`able gas with added humidity.
`
`7 Claims, 20 Drawing Sheets
`
`156
`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`US 7,614,398 B2
`Page 2
`
`u.s. PATENT DOCUMENTS
`6,554,260 Bl * 4/2003 Lipscombe et al.
`......... 2611142
`6,718,974 Bl * 4/2004 Moberg ................. 128/204.14
`6,935,337 B2 * 8/2005 Yirr et al.
`128/203.16
`7,137,388 B2 * 1112006 Yirr et al.
`.............. 128/203.17
`
`2004/0060559 Al
`
`4/2004 Yirr et al.
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`1 055431 A2
`* cited by examiner
`
`1112000
`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`u.s. Patent
`
`Nov. 10,2009
`
`Sheet 1 of20
`
`US 7,614,398 B2
`
`10
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`FIG. 1
`
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`14B
`FIG. 2
`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`u.s. Patent
`
`Nov. 10,2009
`
`Sheet 2 of20
`
`US 7,614,398 B2
`
`a.
`
`22
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`14A
`
`FIG. 3
`
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`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`u.s. Patent
`
`Nov. 10,2009
`
`Sheet 3 of20
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`US 7,614,398 B2
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`10
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`
`Apex Medical Corp.
`Exhibit 1001
`
`

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`u.s. Patent
`
`Nov. 10,2009
`
`Sheet 4 of20
`
`US 7,614,398 B2
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`32
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`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`u.s. Patent
`
`Nov. 10,2009
`
`Sheet 5 of 20
`
`US 7,614,398 B2
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`30
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`
`Apex Medical Corp.
`Exhibit 1001
`
`

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`u.s. Patent
`
`Nov. 10,2009
`
`Sheet 6 of20
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`Exhibit 1001
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`l!.s. Patel1t
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`NOll. 10,2009
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`Sheet 70[20
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`
`Apex Medical Corp.
`Exhibit 1001
`
`

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`u.s. Patent
`
`Nov. 10,2009
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`Sheet 8 of20
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`Exhibit 1001
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`u.s. Patent
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`Nov. 10,2009
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`Apex Medical Corp.
`Exhibit 1001
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`Nov. 10,2009
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`Nov. 10,2009
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`Exhibit 1001
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`Nov. 10,2009
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`Nov. 10,2009
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`Nov. 10,2009
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`u.s. Patent
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`Nov. 10,2009
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`US 7,614,398 B2
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`1
`HUMIDIFIER WITH STRUCTURE TO
`PREVENT BACKFLOW OF LIQUID
`THROUGH THE HUMIDIFIER INLET
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation of Ser. No. 10/467,382,
`filed 7 Aug. 2003, now U.S. Pat. No. 6,935,337, which is the
`US national phase of international application PCT/AU02/
`00155 filed 14 Feb. 2002, which designated the United States,
`and claims the benefit of Australia Application Nos. PR3117,
`filed Feb. 16,2001, andPR 7288, filed Aug. 27, 2001, each of
`which is incorporated herein by reference in its entirety.
`The present application claims priority to Australian Pro- 15
`visional Applications PR3117, filed on Feb. 16,2001 and
`PR7288, filed on Aug. 27, 2001, the specifications and draw(cid:173)
`ings of which are incorporated by reference in their entireties.
`The present invention relates to a humidifier for use with an
`apparatus for supplying breathable gas such as those used for 20
`Non-invasive Positive Pressure Ventilation (NIPPV) or Con(cid:173)
`tinuous Positive Airway Pressure (CPAP).
`An apparatus for NIPPV or CPAP typically comprises a
`blower whose output is connected to a patient interface, such 25
`as a mask, via an air delivery conduit. Some patients find
`NIPPV or CPAP more comfortable when provided with
`humidified air. To this end, manufacturers often supply
`humidifiers which may be attached in the air circuit between
`the blower outlet and the patient interface. Humidifiers typi- 30
`cally include a water reservoir and are configured such that
`ambient air from the blower entering the humidifier collects
`moisture through contact with the water, before continuing on
`to the patient interface.
`Typically, the blower and humidifier are separate compo(cid:173)
`nents connected via a flexible conduit. An air delivery conduit
`connects the humidifier outlet to a patient interface mask.
`Alternatively, the blower and humidifier may be rigidly-con(cid:173)
`nected together. Air from the blower outlet passes into the
`humidifier inlet where it is humidified and then passes to the
`air delivery conduit. A potential problem with either arrange(cid:173)
`ment is that if the humidifier is tilted relative to its normal
`orientation, water may run or spill from the humidifier into
`the blower outlet which may damage the electrical circuits of
`the blower and potentially cause infection control problems. 45
`It is one aspect of the present invention to substantially
`overcome or at least ameliorate the prior art disadvantages.
`It is another aspect to provide a humidifier for a CPAP
`apparatus that is adapted to substantially prevent liquid con(cid:173)
`tained thereto from undesirably exiting an inlet of the humidi- 50
`fier.
`It is another aspect to provide a humidifier that is capable of
`directly connecting to a CPAP apparatus.
`It is another aspect to provide a humidifier that has an inlet 55
`that is directly connectable with a CPAP apparatus to effec(cid:173)
`tively eliminate a supply tube.
`It is another aspect to provide a humidifier that is capable of
`heating the liquid contained therein.
`One embodiment of the present invention includes an
`apparatus for humidifYing breathable gas including a humidi(cid:173)
`fier body configured to retain a body ofliquid therein, an inlet
`communicated with an interior of the humidifier body and
`connectable to a blower outlet, and an outlet communicated
`with the interior of the humidifier body and connectable to a 65
`patient supply conduit. The interior of the humidifier is
`arranged such that liquid from the body ofliquid is prevented
`
`2
`from exiting the humidifier body through the inlet thereof
`when the humidifier body is rotated from a working, upright
`orientation.
`In this manner, the liquid is substantially prevented from
`5 entering the blower outlet and possibly damaging the blower.
`It is contemplated that the apparatus may also include a first
`chamber having an inlet and an outlet, the first chamber inlet
`preferably being connectable to a blower outlet, a second
`chamber having an inlet preferably connected to the first
`10 chamber outlet, and an outlet preferably connectable to the
`patient supply conduit, the second chamber preferably having
`the carrying capacity for the body ofliquid. The first chamber
`inlet and outlet and volumes of the first and second chambers
`may be adapted such that, when the humidifier is disposed in
`the working upright orientation, the body of liquid is con(cid:173)
`tained in the second chamber and, in other relative positions
`of the humidifier, the body ofliquid is retained in at least one
`of the second chamber and the first and second chambers at a
`level therewithin below a level of the first chamber inlet.
`A volume of the second chamber may be larger than a
`volume of the first chamber.
`The first chamber may be located substantially above the
`second chamber in the working upright orientation of the
`apparatus.
`The first chamber inlet and outlet may be located adjacent
`opposing sections of the first chamber.
`The second chamber outlet may be located closer to the
`first chamber outlet than the first chamber inlet.
`At least a portion of a base of the second chamber may be
`made of a heat conducting material.
`The heat conductive portion may be in the form of a metal(cid:173)
`lic cap which covers an opening of the base.
`The apparatus may also include a top cover, a base, and a
`divider disposed between the top cover and base, wherein the
`35 base defines a receptacle formed therewithin, which prefer(cid:173)
`ably retains the body of liquid in the working orientation of
`the apparatus.
`The top cover and the divider together may define the first
`chamber and the receptacle and the divider together form the
`40 second chamber.
`The first chamber inlet and the second chamber outlet may
`be formed in the top cover and is the first chamber outlet and
`the second chamber inlet may be formed in the divider, the
`first chamber outlet and the second chamber inlet may be
`defined by a single aperture in the divider which communi(cid:173)
`cates the first and second chambers.
`The divider may define first and second sections, the first
`section together with the top cover preferably defining the
`first chamber.
`The divider may include a plurality of apertures, separated
`by ribs, which may provide fluid communication from the
`second chamber to the second chamber outlet formed in the
`top cover.
`The top cover and the base may be formed from a relatively
`rigid polymer material and the divider may be formed from a
`relatively resilient material.
`The first chamber inlet may be connected to a blower
`outlet, the first chamber outlet may be connected to the sec(cid:173)
`ond chamber inlet, the second chamber outlet may be con-
`60 nected to the patient supply conduit, and a portion of the
`second chamber below and behind the second chamber inlet
`may define a volume thereof greater than a volume of the
`body of liquid.
`A portion of the second chamber between the first chamber
`inlet and the second chamber inlet and below the second
`chamber inlet may define a volume thereof greater than the
`volume of the body of liquid.
`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`US 7,614,398 B2
`
`3
`Portions of the first chamber and second chamber between
`the first chamber inlet and the second chamber outlet may
`define a volume thereof greater than the volume of the body of
`liquid.
`Another embodiment of the present invention includes a
`CPAP apparatus including an apparatus for humidifying
`breathable gas as described above.
`Another embodiment of the present invention includes a
`humidifier for a CPAP apparatus having a humidifier body
`defining a fluid reservoir and a fluid passage therein. The 10
`humidifier body has first and second chambers with a dividing
`member therebetween. The dividing member includes an ori(cid:173)
`fice therethrough to communicate the first and second cham(cid:173)
`bers with one another. Air from a blower (not shown) arrives
`in the first chamber via a first chamber inlet and departs from 15
`the second chamber via a second chamber outlet. The fluid
`passage includes the inlet, outlet, the orifice, and, at least,
`portions of the first and second chambers. The humidifier is
`designed to carry a body ofliquidhaving a maximum volume,
`V max' In a working orientation of the humidifier, the liquid 20
`body lies in a bottom portion of the second chamber. With
`respect to the working orientation of the humidifier the orifice
`lies forward of and to the side of the inlet. The first and second
`chambers are configured such that a volume of a first portion
`of the second chamber, which lies directly beneath the fist 25
`chamber, is greater than V max' Additionally, the volume of a
`second portion of the second chamber, which is disposed to
`the side of the first chamber, is greater than V max' Further(cid:173)
`more, the volume of a portion of the second chamber forward
`of the inlet plus a portion of the first chamber forward of the 30
`inlet is greater than V max' Additionally, the volume of a por(cid:173)
`tion of the second chamber to the side of the inlet plus a
`portion of the first chamber to the side of the inlet is greater
`than V max'
`Yet another embodiment of the present invention includes 35
`a humidifier for a CPAP apparatus having first and second
`chambers, wherein an inlet to the humidifier is communicated
`with the first chamber, an outlet from the humidifier is com(cid:173)
`municated with the second chamber, and the first and second
`chambers are intercommunicated via an orifice extending 40
`therebetween. The inlet and orifice are arranged relative to
`one another such that a level of a volume of liquid present
`within the humidifier is below at least one of the inlet and
`orifice for any orientation of the humidifier.
`Although certain embodiments of the invention are illus- 45
`trated and described herein as having certain features, one
`skilled in the art would recognize that alternative embodi(cid:173)
`ments of the invention could be provided based on at least one
`or more features, either individually or in combination, of the
`illustrated and described embodiments.
`The benefits of the present invention will be readily appre(cid:173)
`ciated and understood from consideration of the following
`detailed description of embodiments of this invention, when
`taken with the accompanying drawings, wherein:
`FIG. 1 is a schematic view of a humidifier according to one
`embodiment of the present invention in a working, upright
`orientation;
`FIGS. 2-5 are schematic views of the humidifier shown in
`FIG. 1 in corresponding non-working, upright orientations;
`FIG. 6 is a perspective view of a humidifier according to
`another embodiment of the present invention in a working,
`upright orientation;
`FIG. 7. Is an exploded perspective view of the humidifier
`shown in FIG. 6;
`FIG. 8 is a partial sectional view of the humidifier shown in
`FIG. 6;
`
`4
`FIG. 9 is schematic view of the humidifier shown in FIG. 6
`showing an air flow path through the humidifier;
`FIGS. 10-13 are schematic views of the humidifier shown
`in FIG. 6 in corresponding non-working, upright orientations;
`FIG. 14 is a perspective view of a humidifier and counect(cid:173)
`ing structure according to another embodiment of the present
`invention;
`FIG. 15 is a perspective view of the connecting structure
`shown in FIG. 14;
`FIG. 16 is a bottom plan view of the humidifier shown in
`FIG. 14;
`FIG. 17 is a rear perspective view of the humidifier and
`connecting structure shown in FIG. 14;
`FIG. 18 is a bottom perspective view of the connecting
`structure shown in FIG. 14;
`FIG. 19 is a perspective view of a humidifier and heater
`according to another embodiment of the present invention;
`FIG. 20 is a perspective view of the heater shown in FIG.
`19;
`FIG. 21 is a bottom view of the humidifier shown in FIG.
`19;
`FIG. 22 is a cross-sectional view taken along line 22-22 in
`FIG. 21; and
`FIG. 23 is a rear perspective view of the humidifier and
`heater shown in FIG. 19.
`FIG. 1 schematically illustrates one embodiment of the
`humidifier of the present invention, indicated at 10. The
`humidifier 10 includes a humidifier body 12 defining a fluid
`reservoir and fluid passage therein. Additionally, there are
`two chambers 14, 16 defined by the humidifier body 12 and a
`dividing member 18. The dividing member 18 includes an
`orifice 20 therethrough to communicate the chambers 14, 16
`to one another. Air from a blower (not shown) arrives in the
`first chamber 16 via a first chamber inlet 22. Air departs from
`the second chamber 14 via a second chamber outlet 24. The
`fluid passage includes the inlet 22, outlet 24, the orifice 20,
`and, at least, portions of the chambers 14, 16. The humidifier
`lOis designed to carry a body ofliquid 26 having a maximum
`volume, V max'
`In a working orientation represented in FIG. 1, the liquid
`body 26 lies in a bottom portion of the second chamber 14.
`With respect to the orientation of the humidifier 10 depicted
`in FIG. 1, e.g., the orifice 20 lies forward of and to the side of
`the first chamber inlet 22 (e.g., at a diagonally opposite end of
`the chamber 16). As shown, the volume of a first portion 14A
`of the second chamber 14, which lies directly beneath the first
`chamber 16, is greater than V max due to its relatively increased
`height. Additionally, the volume of a second portion 14B of
`the second chamber 14, which is disposed to the side of the
`first chamber 16, is greater than V max' Furthermore, the vol(cid:173)
`ume of a portion of the second chamber 14 forward of the inlet
`22 plus a portion of the first chamber 16 forward of the inlet
`22 is greater than V max' Additionally, the volume of a portion
`of the second chamber 14 to the side of the inlet 22 plus a
`55 portion of the first chamber 16 to the side of the inlet 22 is
`greater than V max' Hence, in order to minimize the volume of
`the humidifier 10, the first chamber inlet 22 is positioned as
`far to one side of the humidifier body 12 and as far rearward
`of the humidifier body 12 as possible.
`The embodiment of the humidifier 10 shown in FIGS. 1-5
`is configured to prevent liquid from the liquid body 26 from
`exiting through the inlet 22 thereof, such as when inadvert(cid:173)
`ently rotated from an upright, normal working position (gen(cid:173)
`erally illustrated in FIG. 1). For this reason, it is preferable for
`65 the humidifier 10 to be capable of being rotated from the
`upright, working position by about 1200 without allowing
`liquid to exit from the inlet 22. It is more preferable for the
`
`50
`
`60
`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`US 7,614,398 B2
`
`5
`humidifier 10 to be capable of being rotated from the upright,
`working position by about 80° -110° without allowing liquid
`to exit from the inlet 22. It is contemplated that for the
`embodiment of the humidifier 10 shown in FIG. 1, it may be
`especially preferable for the humidifier 10 to be capable of 5
`being rotated from the upright, working position by about 90°
`without allowing liquid to exit from the inlet 22, since the
`humidifier 10 is readily able to be placed on one side thereof
`due to the substantially fiat, normal sides thereof. However, of
`course, it may be desirable for the humidifier 10 to be capable 10
`of being rotated more or less than 90°, depending on the
`particular configuration of the humidifier 10. It is noted that
`while the humidifier 10 is designed to prevent liquid from
`exiting the inlet thereof when inadvertently oriented in other
`than the upright working position, it may be possible to pur- 15
`posefully enable liquid to exit from the inlet, such as by
`jostling or rapidly and/or repeatedly rotating the humidifier
`10. In situations wherein it is highly undesirable for liquid to
`exit the inlet of the humidifier, the configuration (e.g., vol(cid:173)
`ume) of the chambers, size and placement of the inlet and 20
`outlet, and size and placement of the aperture intercommuni(cid:173)
`cating the chambers may be altered from the illustrated
`embodiment to decrease the possibility of liquid exiting the
`inlet of the humidifier.
`As shown in FIG. 2, the arrangement of the chambers 14,
`16, inlet 22, and outlet 24 means that, if the humidifier 10 is
`rotated in a clockwise direction by up to 90° about axis u, then
`the liquid body 26 will accumulate in the second portion 14B
`of the second chamber 14 and a portion of the first chamber 16
`adjacent the outlet 24. In this situation, liquid of the liquid
`body 26 may run out of the outlet 24, but will not run out of the
`inlet 22 back into the blower.
`Similarly, as shown in FIG. 3, if the humidifier 10 is rotated
`in a counter-clockwise direction (relative to the position illus(cid:173)
`trated in FIG. 1) by up to 90° about axis u, then the liquid
`body 26 will accumulate in the first portion 14A of the second
`chamber 14, but will not spill over orifice 20 into the first
`chamber 16.
`As shown in FIG. 4, if the humidifier 10 is rotated in a
`clockwise direction (relative to the position illustrated in FIG.
`1) up to 90° about axis ~, then the liquid body 26 will accu(cid:173)
`mulate in a rearward portion of the second chamber 14 but
`will not spill over orifice 20 into the first chamber 16.
`As shown in FIG. 5, if the humidifier 10 is rotated in a
`counter-clockwise direction (relative to the position illus(cid:173)
`trated in FIG. 1) up to 90° about axis ~, then the liquid body
`26 will accumulate in forward portions of the first and second
`chambers 14, 16 and will not spill back through first chamber
`inlet 22. Furthermore, liquid of the liquid body 26 will drain
`out of the humidifier 10 through second chamber outlet 24.
`In the embodiment illustrated in FIGS. 1-5, the humidifier
`10 has an exterior shape that is generally rectangular and the
`humidifier 10. As illustrated, the inlet 22 is positioned to
`correspond to a blower outlet being on the upper left-hand
`side when viewed from the front in an upright position. There(cid:173)
`fore the humidifier inlet 22 is positioned at the back of the
`humidifier 10 on the upper left-hand side, when viewed from
`the front in an upright position. The humidifier outlet 24 lies
`on the front upper right-hand side, when viewed from the
`front in an upright position. However, it is, of course, possible
`for the inlet and outlet to be repositioned corresponding to the
`position of the blower outlet.
`For each of the orientations of the humidifier 10 shown in
`FIGS. 1-5, the level of the liquid body 26 is always below the
`level of at least one of the inlet 22 and orifice 20 intercom(cid:173)
`municating the first and second chambers 16, 14. In this
`manner, in a case wherein the inlet 22 is disposed below the
`
`6
`level of the liquid body 26 (such as in orientations illustrated
`in FIGS. 3 and 4), the orifice 20 is disposed above the level of
`the liquid body 26, which prevents liquid from flowing there-
`through and exiting the inlet 22. Conversely, in a case wherein
`the orifice 20 is disposed-below the level of the liquid body 26
`(such as in orientations illustrated in FIGS. 2 and 5), the inlet
`22 is disposed above the level of the liquid body 26. Accord(cid:173)
`ingly, liquid may flow through the orifice 20, but is prevented
`from exiting through the inlet 22.
`FIG. 6 shows another embodiment of a humidifier 30
`according to the present invention. The humidifier 30
`includes an inlet 32 and an outlet 34, both of which are
`communicated with an interior of the humidifier 30. The
`interior of the humidifier 30 defines a reservoir for a body of
`liquid and a fluid passage. The fluid passage is communicated
`to each of the inlet 32 and outlet 34 and is configured such that
`fluid (e.g., breathable gas at an elevated pressure) flowing
`therethrough is exposed to the body of liquid. Additionally,
`the humidifier 30 is adapted for detachable connection to an
`NIPPY or CPAP apparatus (not shown) which includes a
`blower. When connected, the output of the blower is attached
`to the inlet 32. Air from the blower enters the inlet 32, flows
`through the fluid passage, and collects moisture through con(cid:173)
`tact with the liquid body, before continuing on to the outlet 34
`25 and then to the patient.
`It is also contemplated that the humidifier 30 may include
`an additional internal passage to allow monitoring of the
`CPAP pressure without degrading signal strength or necessi(cid:173)
`tating relatively large correction factors due to signal attenu-
`30 ation within the humidifier, such as described in co-pending
`Applications incorporated above, as well as co-pending
`Application No. WO 02/066107, entitled "Air Pressure Sig(cid:173)
`nal Monitoring in Apparatus for Treating Sleep Disordered
`Breathing", filed on even date herewith and hereby incorpo-
`35 rated by reference in its entirety.
`As shown in FIG. 7, the humidifier 30 includes a top cover
`36, a gasket 38, and a base 40. The gasket 38 is disposed
`between the top cover 36 and base 40, which are secured
`together via sliding clips 72. (See FIG. 6.) Of course, other
`40 suitable fastening arrangements and constructions are pos(cid:173)
`sible. For example, the top cover 36 and base 40 may be
`formed with snap-fit or other cooperating constructions.
`Alternatively, other types of mechanical fasteners may be
`utilized. It is contemplated that the top cover 36 may be
`45 formed from a relatively rigid polymer material, such as
`polysulfone (for example, grade UDEL P1700, manufactured
`by BP Amoco Polymers), and includes the inlet 32 and the
`outlet 34. The gasket 38 may be formed from a relatively
`resilient material, such as silicone rubber (for example,
`50 SILAS TIC 94595-IIC, manufactured by Dow Corning) andis
`divided into first and second sections 42 and 44 by a channel
`structure 46. The first section 42 includes a raised portion 48
`having a first aperture 50 extending vertically therethrough.
`The second section 44 includes a plurality of second apertures
`55 52 extending vertically therethrough and being separated
`from one another by ribs 54. The top cover 36 may also
`include a divider wall structure 56 (FIG. 8) which corre(cid:173)
`sponds to and is received within the charmel structure 46 of
`the gasket 38. The gasket 38 includes a sealing flange 58
`60 formed about a periphery thereof. The base 40 may be formed
`from the same or similar rigid polymer material as the top
`cover 36 and may include a receptacle 60 formed therewithin,
`a bottom portion 62, and side walls 64 extending upwardly
`from the bottom portion 62. The base 40 may also include a
`65 removable bridge structure 66, which divides the receptacle
`60 into two sections 68 and 70, which correspond to the
`sections 22 and 24 of the gasket 38.
`
`Apex Medical Corp.
`Exhibit 1001
`
`

`
`US 7,614,398 B2
`
`5
`
`8
`7
`inlet, such as by jostling or rapidly and/or repeatedly rotating
`As shown in FIG. 8, to assemble the humidifier 30, the
`the humidifier 30. In situations wherein it is highly undesir(cid:173)
`gasket 38 is attached the base 40. The flange 58 of the gasket
`able for liquid to exit the inlet of the humidifier, the configu(cid:173)
`38 forms a sealing engagement with an upper edge portion of
`ration (e.g., volume) of the chambers, size and placement of
`the side walls 64 of the base 40. The top cover 36 is then
`the inlet and outlet, and size and placement of the aperture
`attached to the base 40 via sliding clips 72 (FIG. 6) on oppo-
`intercommunicating the chambers may be altered from the
`site sides of the humidifier 30, such that the top cover 36
`illustrated embodiment to decrease the possibility of liquid
`covers and seals with the gasket 38. The removable bridge
`structure 66 vertically supports an intermediate portion of the
`exiting the inlet of the humidifier.
`For each of the orientations of the humidifier 30 shown in
`gasket 38. As shown, a downwardly facing surface of the
`FIGS. 10-13, the level of the liquid body 78 is always below
`channel structure 46 of the gasket 38 engages an upwardly 10
`the level of at least one of the inlet 32 and aperture 50 inter(cid:173)
`facing surface of the bridge structure 66. When assembled,
`communicating the first and second chambers 74, 76. In this
`the gasket first section 42, the top cover 36, and the divider
`wall structure of the top cover 36 together form a first cham(cid:173)
`manner, in a case wherein the inlet 32 is disposed below the
`level of the liquid body 78 (such as in orientations illustrated
`ber 74. The receptacle 60 of the base 40 together with the
`in FIGS. 10 and 12), the aperture 50 is disposed above the
`gasket 38 form a second chamber 76. The first chamber 74 is 15
`level of the liquid body 78, which prevents liquid from f1ow-
`thus located above the second chamber 76 and the volume of
`ing therethrough and exiting the inlet 32. Conversely, in a case
`the second chamber 76 is larger t