CA2460453C - Nebulizer apparatus and method - Google Patents

Abstract

An apparatus and method for providing a nebula or aerosol to a patient. In one aspect, a nebulizer is pressure sensitive so that nebulization is coordinated with a breathing cycle of the patient. The nebulizer includes a movable gas diverter that diverts pressurized gas across a liquid outlet. The diverter is moved in response to the patient's breathing cycle. In one aspect, a biasing member moves the diverter. According to another aspect of the nebulizer, an annular liquid orifice disperses an aerosol in a radial direction in response to a pressurized gas flow from an orifice located concentrically thereto. Multiple liquid orifices may be provided. In a further aspect of the nebulizer, a reservoir includes an upper, wide portion and a lower narrow portion to apply relatively uniform pressure at a liquid orifice.

Description

~V~ 97129799 P~'lC.~,97100096 1 NBB'ULZ~BR r~FPAR~1.TUS AND MFTF-T~D

2 BACKGROUND OF TF-IF ~N~'FN'f~Oh1 The present in~cTenta.on relates to a methr~d arid apparatus for delivering an aerosol;, nebulzza_d ?iquid s or solid medicine or a vapo~wN to a pat lent' s respiratory s tract, and more oart~.cu~.arl~, the present ~nvent~.on relates to an im~~roved nebu~i liar that provides and aerosol more effi=ciently and with improved particle 9 size uniformity.

lo Medical nebxlizers for gererat=~ng G. fine spray or g~ nebula of a liquid medicine that can be inhaled by a ~.z patient are well kr~o~Pn devices commonly used. for the a:~ treatment of certain conditions and diseases.

z4 Nebulizers have applications in treatments for conscious, spont,aneous7_y-breathing ~at~.ents and for is cantrolled ventilated paties.ts.

27 Tn sorne nebulizers, a gas and a liquid are mixed is together and directed against a baffle. ~s a result , the liguid is aerosoai;~ed, that is, the lic,~uid is 20 caused to form into small particles that are suspended 2~. in the air. "This aerosol of the la.quid can then be zz inhaled into a patient's respzrator~r tract. One stay to z~ mix the gas and liquid together in a nebulz~.e~ is to 2~ pass a quickly moving gas aver a liquid orifice tip of 2s a tube. The negative pressure created by tine flow of is pressurized gas is a factor that contributes to drawing 1 G~"~e ~ 3.~i9e1? ~ o~~. W~~ '~'~..= .,.~:-:!_~.~~.,".~.~."~
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1 depending on the desired area of parti~~le deposition in 2 the respiratory tract. In addition, it may be 3 advantageous for a nebulizer to be able to generate a 4 large amount of aerosol quickly and uniformly so that a s proper dosage can be administered. _.
s Accordingly, with these considerations taken into 7 account, there is a need for an improved nebulizer.
a SUMMARY OF THE INVENTION
9 The present invention provides an to apparatus for delivering nebulized liquid or solid 11 medication or vapor to a patient. According to one 12 aspect; the present invention includef> a nebulizer that i3 generates an aerosol during inhalation, and sometimes 14 during both inhalation and exhalation, and that can be is used both by ventilated patients and ,spontaneously is breathing patients.
17 According to another aspect of the invention, la there is provided a nebulizer~that is pressure 19 sensitive so that nebulization is coordinated with a 20 natural physiological cycle of the patient, such as the 21 patient's breathing cycle. The nebulizer includes a z2 movable gas diverter that diverts pressurized gas 23 across a liquid outlet. The diverter is moved in 24 response to the patient's breathing cycle. In one 2s embodiment, a biasing member such as 'membrane, moves 2s the diverter.

28 ' 1 According to yet another aspect of the invention, there is provided a 2 nebulizer comprising a housing comprising a cylindrically-shaped side wall 3 portion, wherein said housing defines a chamber for holding an aerosol; a cover 4 removably mounted on said housing; a chamber air outlet in communication with said chamber; an air inlet in communication with said chamber for allowing a 6 supply of air to enter said chamber; a liquid outlet located in said chamber; a gas 7 outlet located in said chamber adjacent to said liquid outlet; and a movable 8 diverter located in said chamber and spaced from said gas outlet and said liquid 9 outlet by a variable height nebulizing gap, wherein said movable diverter is movable between a nebulizing position and a non-nebulizing position so as to 11 divert pressurized gas from said gas outlet across said liquid outlet to produce said 12 aerosol in cycles in response to a patient's breathing.
13 According to another aspect of the present invention, there is provided a 14 nebulizer comprising: a housing defining a chamber fc>r holding an aerosol;
a chamber air outlet communicating with said chamber; a liquid outlet located in 16 said chamber; a gas outlet located in said chamber adjacent to said liquid outlet;
17 and a movable gas diverter comprising a shaft having .a circular end opposite said 18 gas outlet, said movable gas diverter biased by a biasing member to an initial 19 position, wherein said movable gas diverter is movable from said initial position to a predetermined distance from said gas outlet in response to a force from an 21 inhalation of a patient.
22 According to yet another aspect of the invention, there is provided a 23 nebulizer comprising: a housing comprising a lower portion configured for 24 holding a fluid for nebulizing, a cylindrically-shaped side wall portion and an upper portion, wherein said housing defines a chamber for holding an aerosol;
a 26 cover removably mounted on said upper portion of said housing; a chamber air 27 outlet communicating with said chamber; an air inlet i:n communication with said 28 chamber for allowing a supply of air to enter said chamber; a nozzle assembly 29 positioned in said lower portion of said housing, said nozzle assembly defining a gas outlet and a liquid outlet; and a movable diverter located in said chamber, said 31 movable diverter movable between a nebulizing position and a non-nebulizing 32 position in response to a force of an inhalation through said chamber air outlet.
- 3a -, BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a partial cross-sectional side view of a first embodiment of a nebulizer according to the present invention.
Figure ~A is a cross-sectional view of the nebulizer of Figure l shown in an inspiration cycle..
Figure 2 is a cross-sectional view of the nozzle assembly of the nebulizer of Figure 1.
Figure 3 is a cross-sectional top view of the nebulizer of Figure 1 taken along line 3-3' (without the baf f 1e for clarity) .
Figure 4 is perspective view of the top portion of the nebulizer of Figure 1.
Figure 4A is perspective view of the top of the nebulizer shown in the inspiration cycle of Figure 1A.
Figure 5 is a cross sectional view of a second embodiment of the nebulizer of the present invention.
Figure 6 is a cross sectional view of the bottom of the chimney of the embodiment of Figure 5.
Figure 7 is a cross sectional view similar to Figure 6 showing an alternative embodiment the bottom of the chimney of the nebulizer shown in Figure 5.
Figure 8 is a cross-sectional view of a portion of the nebulizer of Figure 5 showing the diverter ring.
Figure 9 is a cross sectional view similar to Figure 8 showing an alternative embodiment of the diverter ring arrangement for the embodiment ofvthe nebulizer of Figure 5.

Wi'~ 97!29799 ~~t."T1~~197100096 Figure 1~ is a Cross sectional vie'hr similar to 2 Figure 8 showing another alternative embodiment of the s d~.~rerter ring arranger~e~at .

Figure 11 is a cross sectional view of a third s 5 embodiment of the nebulizer of the present invention.

s Figure 22 is a tap view of the embodiment nozzle assembly of Figure l Figure ~3 is a cross sectional view of the embodiment of Figure ~.1. taken along lire I3-L3.

Figure ~.4 is a cross sectional view of a fourth embodiment of the ~xebulizer of the pre sent invention.

12 Figure 1.5 is a cross sectional view of a fa_fth l; embodiment of the nebulizer of the present invention.

Figure Z6 is a cross sectional view or a sixth is embodiment of the nebulizer of the present invention.

i6 Figures 17A and ~7E shows cross sect:ianal views of 2~ a seventr. embodiment of the present int~er3.tion.

3s DETAINED DESCRIPTIU1V ~F T~3E

as PRESENTLY PREFERRED E~iBUDIriZEN'I'S

2o I. First Embodimerxt al A first preferred. embodiment of 2t nebulizer 10 Zs as illustrated in Figure I. The nebulizer 10 is a small z3 ~rolume nebulizer arid includes a housing or contaira.e:~

a4 defining an internal chamber .4. The housing 3_2 is as formed of a cylindrically-shaped side wall portion 18, zs a top portion 20, and a bottom portion ~~. The a~r component parts of the housing 12 may be formed of za separate, multiple pieces of cnaterial that are as connected together by welding, adhesives, etc., or more 3o preferably, some of the component parts may be f orated 31 together of a single piece of material formed by axe 3a injection molding process. For example; the bottom, 33 and side portions 22 and ~.8 TC?ay be fG~rm~'.d Of ~ep_ara to s~ pieces that are connected together, or prefer~.bly, 35 these parts may be formed of one piece of molded 3s plastic. ~r~.y of s. nurrdber of plastics may be suitable, ?'z including polycarbonate, or polycarbonate blemds. A

e~~ ~7rz~7~9 ~~~r~~garooo9s bottom of the chamber 14 to the liquid outlet orifice 2 ~~ at the tOp Of the n0?Z.le a.SSembly 24. ~In an s alternative embodiment, the passageway .4:~ may be formed by spaces or regions between fins located on the outer s surface of the inner tubular member 32 and/or the znz~er surface of the outer tubular merr~ber 3(~ < ) ~1s shown in ~'zgure 3, ~h.e liqurd ou'c~.et ora.~ice ~~

a has an annular shape defined b~~ the top ends of the outer tubular member 3o and the inner tubular meWer 32 so of the nozzle assembly 24. The gas outlet orifice 3~

Z~. has a circular shape and is located concentrically of i2 the annular liquid orifice. Ir3 one embodiment, the gas 23 outlet orifice 3~ is approximately 0.022 inches in la diameter and the liquid outlet orifice ~6 has an outer ~5 diameter of approximately 0.11~~ to 0.1.?5 inches and an is i nner diameter of_ approximately f~ . C~84 :~.nca~es . rChese a~ dimensions are provided by way of example and the a8 nebulizer may be made is. other sizes w=Lth. different 19 dimensions as desired.

ao The top end 39 of the nozzle asseiaably 24 is formed 2i by the top ends of the outer and inner tubular members 22 30 and 32. In a present embodiment, the trip end 39 is z3 a generally flat surface navirzg a diameter of z~ approximately 0.~3 inches. In alternative embodiments, 2s the top end 39 rr~a~r have an ot~~er--than--flat shape, for z~ example, the inner tubular merc~ber 32 rr~ay be spaced z; above the outer t~ab~alar member 3o so that the liquid 28 orifice 46 iS located below t,~ze gaS orifice ~8.

29 The nazzle assembly 2~, or a portion thereof, may 3o be formed as part of the housing 12 as a single piece 3~ of material in an zn~ection molding procevs. For ~2 example, the inner tubular member 32 ta~iay be formed of 33 the same piece of infected molded plastic as the bottom 3~ of the housing l2.

35 Referring again,to Figure 1, the nebulizer 10 a~.so as includes a chimney assembly C~e The chim:rley assembly 3~ 50 is located in a.n upper portion of the chamber ~.4 I c'Z'~~3~T~ .de aC..-C~'..'.._~.'a..,-_'~',~,r;;P,.,...._ 5~~ 'i S~'i "'"~~ .~~.>~.> '~''~C d:.f'y''..~Y%""s.'t3'~"v' EassE:~.~~/ ..~..

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~~ 97129799 PST»~97100096 1 An inner rim of the rnembran~ 64 is secured in a slot 2 formed by' two parts of the chimney assembly 50. 'The 3 membrane 64 has a rolled cross-secti.ona.~. profile as shown in Figure 1. This permits the membrane 64 to act as a rolling diaphragm. The membrane ~4 permits o limited movement of the chimney assembly ~J. The ~ chimney assembly ~~ is connected to the membrane 64 so s that the membrane 6~ biases the chimney assembly 5~1 s away from the nozzle assembly ~4 as shown in Figure ~..

1~ When installed irz the manner shown in l~'~.gure ~: , the 11 bottom of the chimney assembly 50 is approximately c3.~5 12 inches away from the top surface of the nozzle assembly 13 24 .

14 ZOCated at the top end Of tale C~'liCC~II~,.'~1' aSSembly 1~ is an actuator'68. The actuator 68 connects to th.e 16 tubular body 5~, of the chimney assembly ~0 and extends 1~ through the opening 5~ at the top of t:kre housirsg 12 in is the cover 21. The actuator 6E3 includes a closed top 19 side 70 with one ox' more side opening ports 72.

2o Re:~erring to ~'.c~ure 4, located on the sides of the 21 body of the aCttlator 68 are indiCatorS ~9A and 6~B.

22 The indicators ~9A arid b~B may be formed of colored a3 markings or parallel rings on the sides of the actuator 24 68. In a preferred embodi~nenc, the indicator 69A is as red and is located next to the top si~3.e ZI. of the 2s nebulizer body 12. The indicator 59B is preferably 27 green and is adjacent to and above the indicator 69A.

is Located in th:~ chamber ~.4 at the bottom end o~; the z9 chimney assembly ~~ is a bell-shaped baffle 74. The 3o baffle 74 extends from the open:ir~g 58 at the bottom of 31 the chimney passageway 51 outward tow~~.rd the inside 32 wall of the cylina.rical portion ~.8 of the hoesing 33 The baffle 74 includes a hor~_zontal portion 7~ and a s4 vertical portion. i6 that extends downward from the as horizontal portion 75 toward the top of the nozzle 3s assembly 24. The baffle 74 has an open bottom side _ g _ ~Y~O~'~..C~~..~~ ~.$'~. :~'7 ~ ~~G~ie'g"iT~:.~ 1'N'','"3~.~C~.
~.~~~ W~L'v.~..'~'d.Z:1 !' '~~r.L

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3z G2 . 'Tae d~ ~re~'c~__i~c; ~=:~v~~ ~:~ ~~ ~ve~.'ce~a ~:~ '~'_~!e i~s~~er '~a~.~'i .., gL ~ _ W~ 97129?99 ~'CTlCA9710009b of the cylindrical portion 28 0the housing 12.
a Specifically, the diverting ring 82 is positioned 3 adjacent to the baffle °14. The di~rert~.T~g ring 82 is sized to define a gap 86 around the baffle 74. The diverting ring 82 serves to impede large droplets of a 6 liquid that might form on the inner wal:L of the housing I2 and divert large droplets back down unto the s reservoir 23 at the bottom of take housi~a~g 1.2. In additionp the diverting ring 82 serves to provide a ?o relatively tortuous path for the flow of aerosol m particles from the lower portion of the: cb~amber 14 to ~a the upper portion. This tortuous path also serves to i3 reduce the presence of larger particle s as~d helps to make the particle size distribution more uniform.
~s mentioned above, the bottom of the chamber l4 ~s serves as a reservoir 23 for a liquid to be nebulized.
17 In a present embodiment, the reservoir has a funnel-ae like shape to direct the liquid ~o be ne:oulized in a is downward direction toward the inlet 44. The reservoir 2o portion of the chamber 24 is formed of at least two zz portions or stages. In a present embodiment, a.n upper a2 portion 88 of the reservoir is relatively wide having a 23 diameter approximately trae same as that of tree za cylindrical portion 18 of the housing ~2 (e. g. 2.30 a~ in) . The upper portion 88 is relativ~:yy s:~allow (e.g.
is 0.3125-0.25 in). '~'he upper portion 88 of the reservoir a7 tapers in a funnel--like manner toward a lower portion as 9o (or secondary well) of the reservoiro The lower 2s portion 90 is relatively narrow~ but relatively deep 30 (e. g. 0.25 in). The lower portion 90 of the reservoir 3i is slightly wider (e.gn 0.&25 in) than the outer 3z diameter of the nozzle assembly 24. The opening 44 33 from which the liguid is drawn is located at the bottom so of the lower portion 90 of the reservoir. in a present 35 embodiment, the reservoir 23 also includes an 36 intermediate portion 9~ located between the upper s7 portion 88 and the. lower portion ~0. The intermediate - 11. -poi C~oS'1 ~ o~ '~,_'~C w ~~e~"'tiC~_~ G,~ s J ~ ~' r .Cap sx ~SG~'. s:.~ ~ ~.. ~~o, o "vt% 't>'...,'.

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r i9 Y~se:C~OZ~C' ~C r~~e off""? ~ a.e.~.e ~,-~._~. '~:.~'R2 ~..os ~'J.L ~~s'1.e awt~~.'~~~e '.

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a..~:e ~..k.~'~R_L~.

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'GO ~.~~c.-~-.~~.f "w~v 22 I; qu~~ up 'cc ~.~e I~ ~~~~o'~r~_ee av ~~~e '~..o.~ ~.~.~ '~~~e 23 Z?OZZ~~? r~Ssegit'.s'.?Z~ ~~ ~ ~'~.~~~~='_"7.~' r'~ E"vl~w~.'a~'e~
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~ ~3e egll'~o~3'~'ft~

.

29 ~'e~LlCes ~~.'l~s ~7g7~~~,~l.e c"~C~2~'0~_:~ zr,~. ~?'tes'w"''-~'~w~' ~ '~~~'~ ~~l'? ~~.

3~J etTLC0~12T'te~.~ o~ ~ ".~~~.~'e i~, ,._ .'"~~~_~~,~w'~'C~i_'d ~ ~--,;,:~~,'~ra,. :~;o:~ ~.;.Ca~. ~~~~:

3~. v~.e Ii~u~c~ ~ s wi:.e~~~e~=t :~.:c~ ir:~~.e u~~e~ vo!~.y C~:_ ~ o~ '~.F~e 32 reserv~.~r s,~~. a =el~vi-~r4'~ ~- ,s'~-e~.~~ Ie~ ~o~v~_o:~.
o~ ~.~e 33 ~.1.C'111.C~. a..s S'GO~~~ '~ w";. '~: zae .' ;~h..~-..:~_"
~~o~: 'r ' C:~. ~ ~ C:~ 'w.~ie 34 ~'e6eY~YC~~' a .~'~.slCc ~..~C ~ ~'~~r~ ;fJC7'~"'w.3.o:~~ 't~c~r o~ 'i:.~.'~.e Y'~SC~:~' a o 3S ~.s '~e'~1.~E'. c'~.g7~ f'e~a'C?~7'a...~.~ ~,~~,%,~. x_CdF?y i.~"~.c 'S'~..~.:~~'~.i.~c. _~coYe.z o'b 36 f~~~e ~.1~1~1Cz 3.''~1 ~ ~e ~ese'~'Ef~.".a:e..~' ~,'~:~c ~~C-~.~
=:'e a'c.'.~~~c~..f_~l ~~ ~L~~~'~sj 3l r~s s;.lle ~.~~1.11C~ v.~ ~~..~'7.~~ ",.v~r'C.93:'?.:,~~_C3t:!
C'~'~ '~~~ lL~e'1'"Ci'C51__ ~s ~~'a''.~nl~t i 'Wi) 97!29'799 PCTl~r~9'710009b l down. T3.~~erefore, there is little change in the energy 2 needed to draw th~.s amount of liquid up from the s reservoir to the liquid orifice ~~ as this portion of the liquid is depleted. then all the !!.quid in the.

s upper portion 88 of the reservoir is nebulized, the s remaining liquid in the lower portion 9c~ of the 7 reservoir is drawn into the liquid passageway ~~ and 8 the ~'leit~~7.t Of the top Surface o~ the ~.~.ql~.~.d fa~.~S

rapidly. However, since the lower portian ~~ of t~ie z0 reservoir is relati~-ely narrow, it contains only a :.l small portion of the l~.t~uid being nebulized so there is 12 relatively little overall effect on aerosol particle 13 size and output fror_~ this portion of the liquid..

?~ra.ot'~er advantage provided. by the funnel shape of z5 the reservoir is that the relatively narrow size of the as lower portion 9~ of the reservoir has less surface area m thereby directing t'~ze liquid toward the opening 44.

is 'his causes most or all of the liquid too be directed to opening 44 with little waste.

2o The nebul izer ~.C~ of Figures 1-3 may also include a 2~ sensor 89. The sensor 89 may be attached t-o t~.e 22 housing 12 at any suitable location, such as on the 2s cover 2~., as shown in Figure ~_. The '~ensor 89 monitors a4 the operating cycles of the nebulizer :~_g. The sensor 2~ 89 may monitor openating cycles by mor~itoring the 2s movement of the c~zimney portion 50 relative to the 2a housing body 1~. s'he ser'.sor X39 may utilizL an~r as suitable technolagy, such as electronic., pneumatic, or as mechanical . For e~ ample, the sensor tray be respo~.sive so to a change in local capacitance as the chimney moves 3a. closer and further from the top of the housing.

Alternatively, the sensor may- be responsive to a 33 embedded magnet, or ~Ttay 't'TteaSlfre an ppt~lCal, parameter,.

a~ etc. The sensor S~ monitors the cycles of. operation 3s and provides a count that can be observed by the user 36 or a medical care protrider. This ena.~;les the user or 3-t care provider to estimate hog- much medication has been - ~.3 - VV~ 97!29799 ~CT/~.~97100095 manufacturer, or ir~yet another alternative, the 2 nebulizer may be provided with a resealable fill po~-t.~
The source of pressurized gas 2°~ is connected to the fitting 28. The source of pressurized ~c~as ~7 may be an external source that provides gas at a rate of 4 to 10 s liters per minute :~.n a range from 35 p.s.i to ~0 p.s.i, 7 although other rates and pressures could also be suitable. Gas is delivered through the passageway 3~
and is expelled frond the gas outlet ori.f~.~:e 38 into the ao chamber ~.4. However, at this stage, prior to is inhalation by the patient, 'the gas travels upward from i2 the gas outlet oriyice 38 and nebulization does not occur since the d~.~erter &0 is in the non-nebulr_zing i~ position. The membJ_ane 5~ holds the ch~.mr~ey assembly 15 50, including the diverter 60, away from vhe nozzle 2~. _ a.s When in the non-nebulizing position, t:ne distance i7 between the diverter 60 and the top of v~~e nozzl a is !e approximately 0.15 inches. At this distance, the gap m between the diverter &0 and the nozzle ~4 is such that 20 the flow of gas does not create sufficient negative aW pressure over the liquid orifice 46 to c~.x~aw out the a2 liquid.
23 ~'o generate an aerosol with the nebulizer, the 2~ patient places the mouthpiece 100 to his/her mouth.
2s When the patient inhales, air is withdrawn from the 26 chamber 14 reduca.nc~ the pressure inside the housing I2.
z7 The lower pressure in the chamber 14 causes the membrane 64 to flex drawing tl~e chimney ~0 down.. The a9 lower position of the chimney 50 is shown in Figure ~A.
3a Downward movement. of the chim~.ey 50 i°a limited by the 3~ stop pins 80. When the stop pins 80 limit the downward 32 movement of the ch:Lmney ~0, t'~e diverter 60 is spaced a 33 predetermined distance 'h' from the top surface 39 of ache nozzle assembly ~~. In a present embodiment, the 35 gap 'h° is approximately 0.033 inches.
ss The pressuri zed gas, which may be continuously 3~ injected into the nebu~_izer through t:te fitting 38, is 1 d1'~3'2:~'i~ed S~.dC'i~Q'~S ~~3~:~°~9~.:~_i'~5~'=w r ~0~ ~'4' ~'~~
d~."~~'e'~~~"
2 ~3.%2CE: ~..he ~aS C~'_~.~e~. t~~r__t_~~?.v;' .3e~~ ~2_'..z~'~~~e~"' ~S.~d °"yCJ~~..:.
3 ~.o~ 39 a:re ~e~ae.~"a ~ :~.~ ~'~ ..-:°~.w-~.~.~~r gay es~~
v°~.:~~ '~ a~.e ~~~~~~s.~ a 4 38 ~.~ c~.i~per~e~ e°~e~~.~;~ ~_~ ~.~~ a~:~~'~ a~~r~~.~.~e.~~ ~ :~6 ~'at~~.a..~. ~;a'~ L~:~ °'e, , n~:':3.~ ? ° ~"~~:~~
'~12L:.~3.C~.x.sC s'~"~ ~.asrc ~°C~e~"iTC~~~C' 6 a.S Lh2~ ~1"~~. ~~,~ SJ~~.e j~c~Sn'a~eafa~r eat a~.d C~.?~ ~~ ~;.~e c9 -~?Y°GfSS'l.I°..LfC G'a't~.~G-d i~. .~~~"~~ ~'~2C'E~r_:~~
~e'~-'."~- -,t'~c3~ :1_z~~' ~~>e~.t' ~ ~''Te ~.1~.I~~. ~3's.2~a~e.~ ~51"'~:~°! ~:.'.v < ':~~r.~ 3. ~ ~~qpE3.~.~;.
C7'?"~'ir~u ,:~C ''the ~.0 ~"LJ.~!'eY°~Cd C~c'3 S a.~ t..~ 4'~~.~F ~.5 ~,'~3.'~e~~'°~'~J.~i '~~e"u ~, i~. ? ~'~ o'°~'~ ~~' '~ ~ "~,~
y° °~; t~bc:.
~~ Y'C aCdlCa~-S ~.~"G ~_~~°c~er '~J~_~,~,.-'.~',E? a~~C.e ~~ '~..he 'c.."'~'_~.'t'~.= o via 12 a ~Jl ~.'a.~ie~1'G eST~CICl.>.'.Y'~.eY~.r. t t'_'.~'3:s »_ ."r,~?.i~~
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a3 the lic~~zid ~~°? :~~~ ce ~ ~ ~~~~ :~:.v ~.el.e ~~_ °?~
~i~'n';~a~~~.:~
aga:~~~~~ ~.."~e u~.vez~.e~ ~~~ ~~s~s~e~;-e_~~ ~..~ are ~.~°te,~:~-~a'~~'~e M:
s ~~_~. '~~°~t c~.:r~.~,::~.~ d~ ~.v~ v~~;~ ~a~ ~~~.ea~~. ~~a'~ '-°.
25 embod~.rne~~. ~ she ~' ~. a ~6 direC~.ed a~ai.~~=~. u~.e ~. ~~~,~~° f~:e-r a~ As °che ~_:~c~~_~ y w ~.a~,.~~~i_7.~e~ ~'~, v°.~a~re:~~
~.~'~'~.c v~-~~e 18 ChaYtlb~~' .L~4 a~C:7~?~ ~ ~Sc"~FN_~'' c~"i°.~,",'L~.z>Ca 1.~1~
.~t~e,v'~~" e''~~~.C,C.-' ~°1 '.Aria 19 ba~~~.~ '~~_ .dj:~ ''~.~'x~ ~~.laW.tv G~. ~_?°1_~"~ce.3.eS~ ~.s~e ~e:.~'~i.3.~L:.~'~e~.
20 21~1Z~L~ ~~'a~e°~ ~ ~','~'~J~'°d u:. Y?"~::i.~~i! '<.~f";G
~'c'~.~~ t~,. f~ .~C:'~~I~~:~~ 'i~.''f~
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G5°?..~~ ?_:.i"!~'C~~.~~.'~
22 ~hE Pl'lOLg.'~~11X~'Jl.~Ce ~~ v ~ ''~.-O ? ~.G~ °i~~-c=...''r.°~v~:?'i:' .'~-~ ~e~'~i~ t.a~~:.''~C,7:~°4v"
'~.:!°~C'6.:. "
23 3fJ'hea'1 '~'t1e ~c~.'''~3.~~~ C~cc"l.~e °: '~~.~'. .=~ha,.d_~~..-, '~'.~'3e ~'St°L~~~"x'°u .~_.'3 2~ ~~'7.G C'Ilc''uT3b°~..Y' ~ ~ ~".a_.~"'-a 'C..f' fu' o ''~T~'? ~
."l.c."''-.~ ~ .~,C~T '~v~ 2 > iC 'rS~~~Y.E~JJ~'°~~.~
25 1S aC~c~.l~ ~'°u~~ylr~.C~~;s~ ~:°mS .:~~C'~~YV. ~ ~l~
~"h=i.~T!7.':~~1~ ~~ ~.~~~J'c°'~.W'a~."~;
26 1.Y~G~'e3S~Il~ l=Sle ~..:! s'"'"'.."~.; r'~5~~'~~... i:~
e's'~%t~.°~:i~. i;x"!e ~"1'~~'~~'i~c°.."?" :'s~ ~~?c~.
~c.'..~i~,,.~"'-.
2 t ~0~3 e~311g~~CG 3 ~ "'~~°r ':_.hi .~ sC'ar~,~ ~ ~
G';.SSP~°~I ~~ p '~8.~'?..i'°l_ ~.'C~.'~o.~~ ~''d-y 2~ Tleb~S.l~ra'G-l.C~i '~.?~ 'i.~.~,C .~'"t~Li_3_~ ~,.,C~ S.:°~!.e~~. "
_t . ~3 ~ ~'f,.~~.-.i~°~.~ '~.,_s.,v''~~
"2 29 e1"~' Od3.~YlC%l~~u f a ~.~. L~ C° ~ :;.C~'" ~ ~~ ~.e~.''C;su.~.
~'~: ~a_L"~~ ;. C r° °'~'tm.h~'~
bsa s~.~c~ de~r~ee wc3aw ~~e ~.~ ~_:'~.-~.~ed , :~wa ca~.c ~~ ~..-~
~~~~a°~. ~ ~
3~. ~r~~h each o~~'ae~ a:~°a~ vhe ~'~e°~~.~;Y°a:~e ; ~~~a ~c~°~e $~ ~~e d~ ~e~°~~.e~
~ 599 r_ 3G °~~ lStl.O a ~'lOS"t-.!».''"~,~'b'd.~...~1..'..r.'.3,..~F.~~
~~~.J'~.?'~L..~E~,~?..~ '~~~y.V.r~''"Jb. ? kys~._ T'~e'~''f6~.~~.~.ev 33 ~,~~~~a~3.~.'a~~~ f~:~~' ~ -a~..~ '~i-..' ~°~'~e.~~.3~.,1.. Vie.
'.~~a:.."~ v~ add :a.~~!"~e ~.fG~...~_ ~a...J.~.
34 'the b~ea~'nixag Lyc=~.'e c~:~ r~.;~ J~~.~ e~'c 35 ~~ 'C~'i~ ~?c?.~~CY.?'e. -Vila a_~c-'°~ ~_;W'~~°~ vile ?re~?.ar, i ~Y"~"~ ~~
36 YlGb'l~.sa.~a~3.0~.7 OCC'a.~.~5 S~i.~.L:° 'tyw~ ~I,~ ~Te~"L.S_~: ~v ;.S ~.:=1 the 37 ~o~-neb~? a.~ir~g ~c~~_z~~~. ~~:.e vc vv~_~e b~a~~~r~~ ~~_ the ~. f ._ w_~ -~'t'~ 9719799 )'C'T/~A9 7/tiQ096 x membrane 6~ . Upward travel of the chimxiey 5Q is a limited by the cover ~1>

During inhalation, some air flow may be provided, through the nebuli~er in a path through the chimney ~0.

This air flow into the chamber 14 may be provided rc~m s ambient in a path provided through the ports 72, the chimney inlet 56, the chimney passageway ~~, and the s chimney outlet ~8. This air f~..ow may continue during 9 both inhalation wfaen the C~limnCy ~~ is 3.?~ the lOWer zo position and exhalation when the chimney ~.s in. the ~.a higher position. T~3_ternatively, the air flf~w through az the chimney 50 may be stopped or reduced during i3 inhalation when the chimney ~0 is in tl~e lower 14 positi on. Control of th.e airflow through the nebuli~er z5 during inhalation or exhalation may be effected by zs suitable selections of the dimensions of tY~.e chimney z~ inlet 56, the chimney outlet 58, the actuator ports 7~, the diverter ring 8~, and other components that affect ~s airflow through the chamber, such as a.a:~y f~.lters.

~a In the embodicrent described above, the membrane 64 2i provides an elastic: triggering- threshold that pexm~.ts z2 cyclical nebuli~ation to occur that coincides with the z3 breathing of the patient. This threshold is set to a~ fall within r~orma~. human breathing parameters so that as the diverter moves into and out of proximity with the 26 nozzle top as a result of the patient's normal ~7 breathing. In one embodiment a this level may Icae zs approximately less than or equal ~o ~..a cm of water.

z9 It can be appreciated that the threshold may be so established at different leve~.s to account for 3a different classes of patients. For example, if the 32 nebula.~er is designed to be used with. infants or neo-33 natals, the elastic threShL'ld Of the 'I2'lembrane may be 3~ lower than the th~~eshola used for adults. Similarly, a 3s different threshold may be used for geriatric patients.

36 The nebuli~er may be used also for veterinary 3~ applications, such as ecuine or canine. In veterinary _ I~ _ ~~ ~~l~~~r~~ Tt~~~,i ~~J'~i~~' s a~~%~-1'~..'~3:.3.f~'~~~ ::E-'~,.a...~..:i~e ~'ta::>" ~'~:~~ v a'~r'-..~~.~~'~e'..~.~'~d' ';Ptø'~Qe ~'ca~"A~F' a.:.:~.
°~~:?.C.~ tl'~:~'=,~''..~'"?~"' = ~;. ,~~ ~-s c-~.~13_Y~la.~.~' ..
2 ~~1~'WS~lU~~.-~~ ~~'~. s_ ~;'S:.eC~~ ~''.'C; ,~ N :.. G._ C~Tl ~e d~S7.t~'~.d~-.G~ ',~.~~""''t'" ~5'e'L.e~:v.~~c''~~:'~:' 'a.a~~'~. ~r..
't~ ~~,~'~-o ~°~~:0~~~.Ze~"'~. '~~ c~_~' rd C ~.'~'..,~°e~:~.3..a.~~'.,,-' ~,.~3S:~C '~~.~e C~°~dt2~?e:~°,a ~3.a.~s1 ~.5 8 37e~°i2~."t.~e~" ~dc~. a~e ~?#~."a-.Czae f''d~..~3~.,~~~
~~ia~"~'d.3.~~:.s'~~~.e ~~~.. ~'g~~~i'3~ ~..'~'L~.
~.~?.~'eS~C'3~d ~Tl~.'~y ''..3'e ~s~~~~$:~~ ~'~;i? ,~e~.~:.C'ar~.s;~?~. ~~.
'z:.~e ~°~ ~~ C'~.
ope~3~~~ ~~ a~~.: '~~ :__~~:::.o v~~e Ca~~en~~~' ~~~~sC~ ~~o~~.~.
12 d~SO C03A'~.~'~v.~ '-~~..."d:.' e..'!'C!"~
°°~5~?~~~t'~..i".~~~: .. ''W ~' ~ kAIC?'~.I~..~.
,t'?s.~..~'Y'.'~13.'L ''.:?"'te 13 a .ie~' ~.~ od~~~~5~ :'i~~~.. ?~.I~,~z~~,s_'7~',ta~~~« "..L
~,a~..~~:~s~,.~o ~~r.
a~p~opxa~~e a.~.y9~.~Sr~e~.:_. o~. ~~i~'e o~e~°Wi:-i s~~ '~~~~'u~~lo'i da ,, ~.s ~lc~~f.~ Co~~~°ol ~._r~~°o~x~ '~.,'ay~: ate~~.~v~e~' ~~a.:~
~e y~'~s"~r=den:
is fox' e~a~?p~e, i'r ~a~~' ~e ':e~i:eW~~.e ~.~a.~ a~.~ 'oa,'~. i a~~. ~~o~~
17 13~~Aa.~~ e''71 e'~~r'~s~ '~~.C:v ~..i.'w~:.'.Si..a_"ti' ia.'=~ ~,..vC'.=
veC;'.d~_~~ ~~
~(~ a.d'~~~o~. p G~'. ~9..,~.~~f~..A,J~_e ~~.ozPl t ~d..'s~.. ~y;.~,r9~ ~..~e ~,~~rYJls~!~.~'~L.''~~~' Jr~r'"'~t?'L
~9 ~~~25:'~~~13.~'12i:.G a '~Y.~~e ~°~.e:~~°.''~'~~~ .".~
i:~''sW.~ .~r.'7.~ ~~.'~ ~" 'yr~'3e ~l ~r.'~L.C~ a 22 °~'~e ~e.'~?~.?~1~~:~ "~11~.~' .~~'.s"~: "~Ts:2e T'c°'~.lw.et~ '~~la.~''.:a, ~ '~'~~ ~~~n~°~C~, o'r n.ebuli~e~ ~~ar~5~a'.~~-~~ ~ ~~e ac-°- ~a~:'.o~~° 7~3 i ~
~?~e~~ed d~:~~
25 ~CO~Id~.Y'd '~srle C.'o°il~_~" ~Gi.. ,=tr A'~~s''~~...'~~ed u~:3~r"ve~ L.sl~~.. c~~.,'de~.a.L.'6'3.~' B6 ~~ 3.~" Co$l~IeCLP..L~ '~y~°~' ~'~'.' ~'~'V:'~l~se'~.%' ~~~o '.r~~'e~"~:LX'?.C;' ~t'~~~
27 ~C'G'~d4~~.'~C3'Y' 9 ~ ~~'~~~'v ''~ !~'i.G ~.i°~~'e~'''S~ea;. ~'~
~Cio~;~':l~ °'.?_ ~ L. C7 '~...?'~Ce 28 '1"lE''~DLI~ ~.~~.Y2~ ~30~1'i:.r~.;sZ'1 :~...._~.~~'.-°''.~ i~,...~
t:.~'".:,L~. .'~:ld.".3~'~'~,'<,'~.~.. ~~ o ~.'e~.e'v'1-SC- ~?"..~°
29 ~~e cr.C~~.c'T. ~O~' s G =':~ ~.a,~.s.°..4; ~.'.~'i"._. ~' ~~,;,Mi.nse'? Se'~,Y ~ ~.'~ ~:'~ °.'.°'~ ~'' G f..2e 't=
3Q ~~e ~7..2sa"u-~El~ o'r '~~:a;~
F't'Ie~YYYSG3'd"'.'31~".°','°~~. ~'~- 'S:.i.'te~°e~E,Y
'~',a_".:.~~"'..~-:!w»
3~ ~e~uli~~t:~o~ '~.o c~e~~e,;
32 ~.e~°~'~°~33~ 'Lo .~''"! C~F7~~'e~ P~: ~ i~z~. ~f~ p i~!'ys:
~~"gd:~.i~"'...''ew, G o-t ~ eJ ~t-'.~, 33 ~~d 693 ~~'a~i do a oo~~e's~i~:~'~~~. '~f~a.y '~.o c:Q~:~iv~ '~.=~e 3k O~eYc'3'~~OI3 oL s:.i'~e ~e~~'S'C1~'?',~:~.,~-._~'., °,~~
s'~°A~tS'~~o:~.'~H ~.~~3~-Te; ~:a~"~es~
3~ 'C~2e dl.~T~tr-X''~2~ ~~' i''~" ~~Sca'~:~~ e~'FSi'.~'~"~ii =~'~C:~$':R
~v~'"v3e 'Aao~ o~d '~tg~~
36 TloZZl2 2~ " ~.C3 c"~..>,°..'~"~.~.~C°.~ ~ ~~" ~:~~n!_:t't~3 ~eT~e?"c'~:~'~~ . ~f~8'3.v..~ '~'.~.~e 37 ~.l~Pf:~'~Ejg C~ t7 i~ a"~- ~3c°1-.~:2Cf ~.i,~~'~'~I '_ '~e we;:'d.'l~~t~oL' 6 c~ .. '.s'~e - :i i z ~V~ 97129799 ~C"~"IC~97I0009C
z actuator 6B, which is connected to the diverter 6G
z through the chimney SCE, ~.s in an upper position and the red indicator 69A on the side of the act~~.ator 68 is visible along the top side ~I of the nebulizer 10, as shown in Figure ~. ~tnen the patient inhales s sufficiently to bring the diverter 60 into a lower 'a position, the red indicator s9~ on the side ~f the s actuator 68 is withdrawn through the opening ~6 in the top side ~~. of the nebulizer 10. 'the red indicator 69A.
is no longer visible, however, the green indicator 698, m which is located above the red :~_nda.catox: 69A, remains ~2 visible at the top ~1 of the nebulizer. 'Thus, a as patient or medical attendant can readily determine 14 whether the nebulizev is operating. In embodiments of Zs the nebulizer for children, the actuator andJor i6 indicators can be designed with comic figures.
~,7 'The breath actuation of the nebulizer ~_s is convenient and efficient. By cycling the nebulization is of the liquid, the r~ebulizer can be more efficient 2o thereby reducing the cost of the therapy.
m An important advantage fo;~lows from the feature of a2 this nebulizer that nebulization can be c.~rcled so as to occur i:n coordination with a physiological cycle of the patient. Specifica~.ly, by nebulizing only during are as inhalation, for example, the dosage of medication z~ delivered to the patient can be more accurately ~°r delivered arid monitored. This enables this embodimerat 2s of the nebulizer to provide for dosimetric medication a9 delivery to an exte~it that has been otherwise so unavailable. By luniting the medicatior_ delivery to 31 the inhalation cycle of the patient, a dosimetric 3z portion of the med~.cat~_on can be provided.
33 In addition, the nebulizer Lo provides for high 34 output and uniform nebulization due to the arraragerczent 3~ of the gas and :Liquid orifices 38 and 46 relative to 3s the diverter 6~. "The annular configuration of the s~ liquid orifice 46 relative to the gas orifice provides i for aerosol generation in a approximately 360°
2 direction. This enables a relatively high and uniform rate of nebulization. The uniformity it: enhanced 4 because the nebulization is farmed with little or no s impaction of liquid against the diverter.
s In alternative embodiments of the nebulizer, the a cover 12 may include an air filter that covers the air a inlet 56. The filter would serve to kee=p contaminants out of the chamber and deter the escape of nebulized io liquid. Such a filter may be removable to permit 1i simple, inexpensive replacement.
is In a still further embodiment, the nebulizer may i3 be used in conjunction with an aerosolization spacer, i4 such as an Aerochamber~ sold by Trudell Medical is Partnership of L,ondon,.Ontario. The Aerochamber spacer is is described in U.S. Pat. No. 4,470,412.. ' In this alternative embodiment,, the output of is the nebulizer would be directed into the inlet of the ao Aerochamber from which the patient inha:Les the aerosol ai through an outlet of the Aerochamber.
as Another advantage provided by this embodiment of Zs the nebulizer is that less aerosol is likely to escape an to the surrounding environment. This potentially as benefits attending care providers who would otherwise as be exposed to aerosol medication that is released from 2~ nebulizers that generate on a continuous basis.
za In a present embodiment, the membrane ~4 is biased as to keep the chimney in an upper, non-ne:bulizing so position except during inhalation. Thus, in the s1 periods of time between inhalations and exhalations, or s2 if the patient pauses and removes the mouthpiece, sa nebulizing does not take place. In alt=ernative a4 embodiments, the membrane 64 may bias t=he chimney ss downward so that the nebulizer generates an aerosol or . ss nebula except during exhalation. This alternative may 37 not be as efficient as the prior alternative, but may ~'~ 97!29799 ~C'~"I~r~.97100096 z still provide significant advantages ove:~~ nebulizers z that generate aerosol continuously.

3 In further alternative embodiments .ef the nebulizer, the gas orifice 38, the gas passageway 34f or a portion thereof, may have a shape that rnodifi~s s the force of the pressurized ga:~ against the diverter ~ ~~. For example, the gas orifice 38 may have a conical $ shape that facilitates the change of di5_wc9~ion of tkre gas when it is directed against the diverter, so that io the force of the gas would not move the diverter away m during inhalation thereby helping to direct the gas out oz into the chamber. I~~~. other embodiments, the conical 13 geometry may be varid to tailor gas fomcc and flow.

As mentioned above, the membrane 6z serves as a m biasing mender that moves the diverter. Freferablyg ~s the membrane is constructed of a silica~~ie rubber m material. Other materials capable of r~petitive 1a flexing, compression or expansion in response to the force of inhaled or exhaled air-, such as a spring, or zo elastic bellows, may also be used. The b~~asing member ii is constructed so that it will move the diverter a a2 predetermined distance affray from ox toward the nozzle 23 during the course of a patient's spontaneous or z~ ventilated breathing.

-as In a present er~bod ~ment, the diverter moves up and is down in response to the patient's breat:~ing. However, 2~ i n alternative embodiments, the nozzle ~~- car? move ze instead of the diverter, or alternatively, bath the z9 nozzle and the dive:~-ter can move. Also, ir;: a present ao embodiment, the diverter movement is up and down, but 3z in alternative embodiments, th.e movement can be side to 3z side, rotating, or pivoting. Alternatively, instead of 3s moving diverter into proximity- with a gas outlet, in alternative embodiments, the J._iquid j~a or orifice can be moved toward the gas jet or orifice, or is otherwise 36 directed. toward the gas jet or- orifice or vice versa.

In effect, alternative embodiments contemplate various ~'v'Y~ 371~~9~~' "c~ ~-;'r" 7 ?~ ,~ ~i ut =.~ ~:~a~'~i rJ~d.~~w"~
2 i"Cle~Ylu~" o~ ~;?i'°1.??~'~~C~' ~_C i ~ Ej~:3~a:..~~5?G' ~i'~~.' e~~~ ~:,~~~' m_3.~'t~m.
2 ~L°?'"~c~3~'~~.- ~~~a~C3 '~3~C?.~~..~'!1,~ ~~~ .~_'7 ~. '~;~~'?_"?
~~~' .~.~°.W~"~- "~ ~ a ~'i2 ~ i s'~..e:~':.~c~'~~_ ti ~. ~1'~~',".~~sl.es~.'~..~ ''~,~~.'i i:.9~'~~~.. ~~~'L'! r ~.:'~'rs ! a_..~V'~~
'~'dl°v ~~~ ~3~"Z~~G'~ a -~~,'...~.u1'.'~c7'c.._1."!?t~..~t_''f'y ~~'1~
_'_"~U,'''~,~:? "~..~'. ~"':,~~.! ~..a"'°'~.. ,"~uG~ry7 °ae .'tee ~o~'~Ci~'' ~~ 4~ n~'~.-'' °w re,u ~"~. "' ,P"~ 'p "',....i~e~ ~'~~~'?_ u...°~ ~,i~~~. ~~~ °~s.L~".<.'? t.._ '~~ a 'i~~ ~ y ~..~. ~.~-. d~ ~se a ,..
.s" ' .:,_ 'i ' eo~ne~'~e~ ~roa~~c~ v ~e es_'~~~~~~.~:'w o~ a~.~e ~o'~~~.x~y '~.~ ~:~~r~
~z ~ro~ii~e ~~x~~o~°v '~.~~e~'e".~o~.~'a 13 I~? ~~~ S e~.~'~Jtl~_'d~~~ t-.~ ~te ~5~7''v~s'.~~F''r :~~' ~i:~5~~-~...~
~_~7r~~' f ,.
y~ ~7Y0?'~1'~Yl.~~~ 'y'~~.Lt'~ E~~::~~ :~i~~,~.~..t. '~~i C.v4~ '56.5 e~
J"?e''~T~.'G.~_~j'~ ~'eS~i:~.='-~~ ~~'.~.~
15 1T1 ~.'b1e ~~i~.'C~~s_:~ "' ~'t o k-iGc~;i~'''.:~'~. t, s '~'~r~._dv~
~~'~"~ ~~''~~°C-'. °~t ~'~'"~~:i'11°"'..~ tf~c'"'''~i.
36 a~~0 'tee ~l: e~.~e~ .J;b'' c. ~~'.~ 'E"~2s ~~ _"~..~'~ ~,ao~~.~ ~!;
° ~J r'°~~L~.~'°:= ~ ..~'',~~_"
m ~ I a ~eco~~ ~en.~oi we? ~'~~~
second em~o~i~e~N~. ~:,-r ~ ~:~eW ~ 'i ~ ~~~ _~ o~xog~~.
zo ~igu~'e 5 " t~.c~o~°~. j ~~ ~'c.~ -.~._~; ec~~.~_~~~,_~ a ~" ~ei~~.~
i~e~
_ y ' 2 3. ~ ~ ~l ~'l~ 'o~~' c-'~.. a ioL.E S ~.~'~,.~.~ ~ ~ .!; ~s !:'.t~,'a. G'.~
;~ -n Y's ~ ~'~' C a'.-,tt ~ ;~,'1~~ r '! .~. 'i- .. ~'"i 22 ~.~&97'.'~.".L ~E'7i ~..~C3~ iJ~.. 1.. ~.E 1. ~ W ii~~:"'-" '~."3.~_ a'~'ae.~ '~~~ '"e~" r-u' ~ ~'e',~..UL'~r'o"°.s"t_' 23 ~ ~3 ~f7i' '1'10~~~~~ c4. ~_:iCT,3-! a~V i:.: ~t-~ :~?.P.~J~?..L3_~~~ ~
~~,~~~L.-t,.~~ ~i~
_ _ _ t,-.:~,.r~
2'~ , oWe~° ~~~'1..-0~. ~.~.~ ~.!'_e ~.'?t:"~..~.~~"?.".'.~ ..~~. _J
'?.~i :l .~2C.'%~'~'.i..e ~'''.'N"''a"7e~~°6~w~V A;%'' ~ " tl ~1:. ~.o ~ 'u a C'~,e'~'J' e.5° 4:..P~'',~:i ~ ';;r ~~y,~ ~_ %'E~~. y'~ ...~J'C: ~ .Lu~'E~..!. ~ d'~.L~ ~5~
_. g 26 3.C~~~1''L1~..'a~,~ ~~o ~.~~.' .C°5:~~~ Y_i.. ~0'S,.'""-~e~"~l;~t o~
1.~.5~~ ~-«u~"!'..
2~ ernboc~ime~t < ~e~~.~~'i~e~ ~:o-~~e a :~_~?.:~re ~::r?.e ~ ~_~~-~~' z~ exnboc~im.e~~,~ ~ ~~s~v.o~ o~~ 'a~e~ -~~~.~.~~e 30 a ~~app~.~' oz ~~e~~~.-new ~~~ V'=~'t ~~.~' rr~e~x~~ o'== o:~~e~s ~.o~~r_ 33 ~ubia~g ~~~ a :~oe~~~e~ i 4~. ~':~~:~ ~or~.:_e ~sset~~~~ ~ ~~~-~
~a:°~
34 G.~ d.~'ee s.~~3 ~L ~.'C1.~"!o~~~e ~~~'~~~1~.1~ <y~~a F ~~ 3.S'! ~._~'3.e 'r E y~''~
35 E~OdITrieI2~ o :C,5 ~~e ~"~~e °r t_ ~s~~~ Y~,bca~~.~e'~"~~. ~ ~~e 36 .~1Q'illC~ ~3''~.~l.~e~ i.Y'-G':u° f°~:.~e~_~' .~?~3.'w~~.~.
c? ~.:C~:(AC;C..~R''.,":~'~~c:' ~~ 97!29799 ~CTI~~97100096 3 arrangement with the liquid orifice having an annular a shape encircling the gas outlet orifice. Also, like the first embodiment; in the emR.oodiment of Figure 5 the reservoir 123 includes a relatively wide, but shallow, s primary or upper portion 133 and a relatively narrow, but deep, lower or secondary portion 190.
Although thus embodiment is shown without a bell-a shaped baffle similar to baffle 7~ of the first 9 embodiment, a baffle may be provided in this m embodiment. If a baffle were provided in this embodiment, it would have a construction similar to is that of the baffle 7~ of ~'igure 1.
In the embodiment of ~3gu~°e 5, a chimney 150 is located in an upper portion of the housing 'x.12. 'Ihe m cnim_ney includes a first Internal passclc~ewaYr 152, . In this embodiment, the internal passageway x_52 of the chimney assembly 15G serves as an outlE:~c 7_~3 from the ~.s chamber 1? 4 . The outlet connects to a c:ao~zt:~piece ~.
~s or other suitable means of delivering a.n aerosol_ tc~ a zo patients such as a mask. .A diverter 160 is located at 21 and connected to a ~_ower end o:~ the chimney 150. The za diverter 160 is located a predetermined distance from a3 the top of the nozzle assembly 124. In this 24 embodiment, this distance is approximately 0.033 25 inches. '~nlyke the first embodiment, Lhe chimney 2~ assembly 1S0 in t~L~.s embod:~ment 110 is not movable zz between upper and lower positions, Instead., the za chimney assembly 150 is feed in positl.ora. so that the a9 diverter 16G is maintained a suitable distance from the 3~ top of the nozzle assembly 124 to generate an aerosol.
3z In this embodiments at least one second air 3z passageway 153 is provided. The second air passageway 33 153 is located adjacent to the first air passageway 152 34 in the chimney assembly 150. The second air passageway 35 153 communicates with are inlet opening 101 and a ~s suction chamber 1~3. The suction. chacriber 163 is 3~ located around a lower end of the chi~r~ne~t asserr~bly 150 W~ 97129'799 ~~T'1~,A97100096 x varied. to affect the size and uniformitZr of the a particle distribution of the nebtz~.a or aerosol.
s Referring again to ~'igure 5, located irz a wall of the chimney 150 is at least one, and preferably a s plurality of openings 185. Opemings 18'v communicate s between the chamber 114 and the first air passageway 152 of the chimney assembly 150.
a Referring to Figures 5 and 8, a di.v°ert~ng ring a.82 may he provided in the chamber 1~.4 to reduce the 2o presence of large droplets and help ma~;e the aerosol ~a delivered to the patient more uniform. As menta.oned ~a above in connection with the first embodiment, the ~.s diverting ring provides 'this function, :ir. part, by i~ limiting the migration of droplets on the i~°tside wall a.s of the nebul.izer hotasing. In addition, by forming a is barrier can the inside wall of ;z:.he hous:Lngp the diverting r~.ng forces the nebu;lized aerosol to t~.ravel i~ along a relatively non-linear path to move from the lower part to the upper part of the chamber and out the 20 mouthpiece.
21 Referring to figure 5, to operate the nebulizer .
2z 110, a suitable amount of liquid medicine is placed in a3 reservoir of the chamber 114e The outlet 1~8 is 2~ connected to the mouthpiece 19~ in a suitable manner.
2s The source o.~: pressurized gas 127 is connected to t~~e zs fitting 128. The flow of gas from the top of the z7 nozzle assembly 124 is directed by the diverter 160 as ' across the annular liquid orifice surrounding the gas 2~ orifice causing the generation of an aerosol from the 30 liquid in the reservoir. The aerosol is generated in a s~ 360° direction into the chamber 114 around the nozzle 3z 124 and diverter 160.
~n air floe path is establishecL into the chamber s~ 114 from the inlet 161. The yas provided by the source 3s 32'~ also supplemer3ts the air supply into the chamber ~ss 114. Air flows irzto the chamber through the second 37 passageway 153 through the suction chamber 163 and _ 2,5 2 t7?~2~2~.Z~~ .a.~~a ~ ~.i y° -i w~~~;- ~~_.,=,s~~~ e~~''~~'~
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- a 6V~ 9'712999 ~'C°~JCI~97JOO~Dg6 dogs, etc. A larr.~~er size nebulizer ~cnay also b~ used a with humans for uses such as sp~.ztum induction.

a A fitting 238 connects to a pressL~r~.zed gas supply (not shown) and an outlet 298 provides nebulized ~ medicine from the chamber 214 too the pat~.en~r . The 6 C?llt~.et 2~8 may Connect to a mollthpieCe, mask, Or ~ vent~.~.ator, as appropriate. Like the first described a embodiment, the nebula.zer 2~.0 ~zas a mo,~a.ble chimney s 250 . In the charger 2~.4 of the nebuli.~cer 2~.0 , there to are a pa-uralzty of nozzle asSembl~.es 2'z4A, 2248, ax~cl 11 224C. Each of these nozzle assemblies nay be similar lz to the nozzle assembly 24 of tire first embodiment.

13 Each of the nozzle assemblies includes a ga.s supply h d m as 234A, an passageway, suc an annul~~.r l~_quid supply 15 paSv~agEy4Vc'~y, SLlCh aS 242A. At the top ~~T3ds Of each of is the nozzles 224A, 2248, and 224C, the c~as passageways 17 of each communicate with gas outlet ox-a_f.ices 238.A, as 238E, and 238C, respectively and the l:~quid passageways 19 of each communicate witi~ liquid outlet orifices 246.A, 2~ 246B, and 2460. The liquid inlets 24'~ ix~te~ each of the 21 nozzles assemblies cammunicate in commor~ with a zz reservoir 223 formed at the bottom of the chamber 214.

z3 Located at the bottom of chimney is a diverter z4 260. 'fhe diverter 260 may be formed of a single face z5 or surface, or may be formed of multiple faces or as surfaces that are aligned with the mults_ple nozzle z~ assemblies 224A-2240, or altex-natively, the diverter zs may be formed as a ring. Further, there may lee zs provided multiple diverters. ~n a preferred ao embodiment, there is a space or gap 26~. formed 31 centrally in the bottom of trie diverter 260 to permit sz aerasol generatiorw in 36~~ a~~ounrl each of the nozzles.

A membrane. 264 may be located at: tq~.e top of the z4 chimney 250 to provide a biasing function as in the embodiment of figure 1. l~ue to the larger size a~zd 3s weight of the chimney assembi.y 250 in t:~e embodiment of 37 Figure 11 relative to the embodiment of Figure 1, a - 2 -_ ~7~ ~~1~9~~~ ~'~:"~"~~~~~ ll~y~~Ddv _ '~3~c"1~~A.~~ ~eleTT.i~J~C'~ ~~~' ~l~.e:.~w ~~ , ~~5~~..f~~ kL~a~i' ~~ ;l~~.i_~7~i~~~~' ?;'3 w~'17.'.~~u'~lj=.'~,1~. ~ o~ ~:'y:i: t; r j.,.j..'. o.~~? ~:.:~.~3~
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3°~ raffle as ~l~o~:~ ~._.. rage ~_w~r eo~i~e~~~.n 1. i~ -W~~ 97129799 PCTI~~97100096 a IV. Fourth ~mbod3ment Figure 14 shows a fourth embodiment of a nebulizer s of the present invention. This embodirrient 310 of the nebulizer is adapted for use with a ventilator circuit 301. The ventilator cix'cuit 301 includes an 6 inspiratory airflow passageway 302 that delivers air . a from the ventilator to the patient . This e'~~nbod~:2nent of a the nebulizer 310 is located in the inspiratory airflow passageway 302 co~.nected between a first length of ~.~ inspira'tory tubing :303 that deivers a:i.r from the ventilator circui ~. :~0~. and a second le~:~gt:ka 304 j~hat 1z delivers air to the patient . '~'he seco~wd length of i3 inspiratory tubing 30~ ray connect to 'the pratie:~t by means of a mask, endotracheal tube, et:c,.

a5 Like the embodiment of Figure ~., the embodiment of 16 the nebulizer in .figure 1~ is pressure- or breath-a~ actuated. Accordingly, the nebulizer 3~.0 produces an la aerosol in a cyclical manner in coordination with the breathing or ventilation of the patient_ 'A'he n.ebulizer as 3I0 has a housing 3~.2 defznin~' a chamber 3~4. A nozzle m assembly 32~ extends up from the bottom of the chamber 22 314. Pressurized gas is delivered from a gas orifice z3 at the top end of the nozzle ~~.ssembly 32~: and liquid a~ from a reservoir 323 at the bottom of the chamber 3:L~

2s is drawn up to a liquid orifice also Located at the top ~s end of the nozzle assembly 32~'~ as ~.n t:he first 2~ embodiment. A chirr~ney assembly 350 a}wends dovun from a 2s top of the housing 3~.2. 'fhe chimney 350 connects to a~ the housing by means of a flexibler resilient membrane 30 364. A diverter 3~0 is located at the bottom of the chimney assembly 350 directly opposite from the gas and 32 liquid orifices at the top of the nozzle assembly 32~.

33 An inlet 356 of the chimney 350 connects to the length 3a of inspiration tubing 303 from the ventilator circuit 35 30i . T~7.e l.nlet 35~ COmmUnlCa~'l~es with a~ iYlternal 36 passageway 35~ Of the ChiFilney assE:mbl'~r 350.

3~ ~nspiratcry gas from the venta~lat.or 3U1 enters the ._ 2g _ ~: Jl s'~.t'~1J~3 t~~~~i'<y.
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33 2tTl~OC~lT'(iC <'Sf:., 'G~~ i1W'~.~~2'~'r' ~'-yn~ ~.'~'1 ~;'f .~~.~~.~'~ -" ~ '_L~ 'c3~'.3c~:La 34 .~flY' L..S'~ X3'1 ez 'ef2='3~.r4_m~'~..'v~~' t~:~_.~ i'.1..'.1.'z, c"~at2"C.'t ;.~'F.?'~~~'~1~~~ e'~.'"A.. G~:~a~.e~'~i~_i_ 1%1 c~. C~T~J.~~a t 3Ct~'~'l.a~~'~ "_';. ~~~ "~~.'t.I~.'~, ~
C~S.'~ ~~'_~~...'~, ,"'~~~~'~.'G'~ g?~~ sue' 36 '~~'1~ ~'2~a'Ca.~.~?'C~t' .~~C~.fir'' 'it.~~~- ,'~.'~'~'c.w~.?~~.~.' ~~ ~.~wE ~c'3'C~.G2~."C.., n '~'~ 97/29799 ~C'~IC X97100096 z A ventilator circuit .~Oi has an insp~.ratory 2 passageway 402 that is formed of a first length of 3 tubing 40~ that COTl~lectS t~ the VE'ntllc~.'~C7r ~~1 and a _ 4 second :Length of tuLaing 40~ that connecas to a mask s 405, or endotrachea. tube, and so on, ezssociated witch the patient. The ventilator circuit 9~~~ also includes 't an exhalation valve press~xre line X06. This exhalation a valve pressure line X06 connects to anexhalation vs.lve s .~07 associated with an expiratory passageway 408.

z0 During ventilatio~.af the patient, pressured gas is 11 delivered. in the exhalation valve pressure line 406 to z2 the exr~alation valve ~0'~ to assist in the cycling of z3 ventilation of the patient.

The nebul~.~er 4~.0 has a hauling 9: a.2 defining a z5 chamber X14, and ~.ncludes a nozzle assembler 42~, a z6 flexible, resilient membrane d~62, and a diverter ~6~, arranged generally as in the previously described a.~ embodimento znstead of a chimney, the neba~lizer X10 z9 has a post 450 to which the diverter ~~:~~ is connected.

zo Unli3te a chimney; the post X50 does not include aix-2z openings or an internal air passageway. Ihe diverter 22 ~~Cl iS Connected t~ a bottom Sl.de Of t~'lE'. post ~t~l.reC'C~_1T

23 adjacent from the vop of the nozzle assembly X24. The z4 embodiment of Figure 15 also differs from the previous 2s embodiment in the manner that the ventilator circuit 26 ~O1 is connected to the nebulizer 410 and the manner 2~ that the ventilator circuit ~O1 causes the nebulizer 2s ~4I0 to cycle nebulization. 'this embodi~ctent may also a9 include a bell-shaped baffle as shown in. the first 30 embodiment , 3z In. Figure 15, the nebul3zer hoizaing X12 includes 3a an inlet X56 into the chambes~ 41~ . The i:czlet 45C

33 connects to the first section 4C~3 of inspiratory twbing 3~ 402 from the ventilator circuit ~fll. Tb.e nebulizer s~ housing 412 also includes an outlet.~~8 from the 3s chambey~ 4~.4. The outlet X98 connects to the second section 4a~ of in:~pa.ratory tubing that leads to a EVE) 97/29799 PCT'IC'~,97/00096 air and aerosol. Like the embodiment of ~'igure 5, the 2 nebulizer 510 of Figure ~6 may also inc:~ude an inlet 3 or air entrainment 562. As in the other embodiment, liquid and gas outlets (not shown) located at the top of a nobble 524 directly adjacent a diver~:e:~ 56~

s dispense an aerosol into the c~.amber 5~_~.

The embodiment of t?~.e nebulizer 5.'L~7 includes a s breath-actuation feature that enables the nebulizer to s generate a nebula in cyclic manner in roordinato~on with to a physiological cyo:~a of the ps.tient. In the embodiment of Fig3.xre z5 J the b~~eath-ac't:~aation feature Za is external of the nebali~er housing 5I2. The breath-13 actuation feature ixzcl~zdes a valve 569 or other metering device located in-line With the inlet tubing 15 529 that provides t~~e pressurised gas from the source ~.6 527 t0 the Tle~7Lll3.~e~ inlet 528. A tub3.n~ ~~~ CJnneCt~

x~ from the outlet t~.bing 59~ to the inlet tubing 529.

~e The tubing 56? enables the val~re 569 tc~ sense the i9 pressure in the outlet tubing 593. In one embodiment, 2o the tubing 567 may be conventional tubing and the valve 569 senses the pressure through the tubing 567. The 22 valve 569 is adapted to open snd close: the delivery of 2~ pressurized gas to the ~ebula~,er 51.0 i.~~ coc~rdir.~ation a~ with the changes in the pressure in the outlet 5g9 as 2s sensed via the tubing 56'7. Specifical:~ys upon 2s inhalation, the pressures in the inlet 599 and the a~ connecting tubing 567 wall be lower, and t:~ae vs.lve 2s will open to a3~.o~ pressurised gas to 'oe, delivered =~o 29 the ne~7Ll~..ls er 53.~ t~le3eE;b~' CaLI alnC~ $lebtl.~i~atl.On t0 30 occur. After inhalation, the pressure i~.~ the pat..~..ent 3z outlet 5g9 and the connecting tubing 56T rises, and the 3z valve closes thereby ca~.sing ~.ebulizata.on to cease . In 33 this manner, the er~bod~.~nent o~ Figure ~ 6 can p:~-ovide similar breath-actuation features as the other 3s embodiments discussed above. The tubing 567 and valve ~s 569 may be either we-usable o:~ disposable and may be used with a nebuli~er 5I0 as shown in Figure I6, or may ~'O 97129799 ~C~lOr~97/a~095 diverter post 650 and the nozzle assembly 52~ so that z it can readily shift relative to these pa~ctse One or 3 more windows 637 are located in the wall of the ~shiel,d 633. TlZe windows 63i are located in the wall of the s cylindrical shield 633 such tha;. when tlae diaphragm x;64 6 is in an 'upper position has shown in Figure ~7~) the window 63! is not aligned r~:ith the gap :~efween ns~z~~.e s 6~4 and the diverter 66Q_ When the shield E~33 is in g this upper position, aerosol particles generated by the flaw of pressured gas across the liquid oa~if~ice impact ?i upon the inside wall of the cylindrical shield 633 and ~z tend to form into droplets that fail back into the ~3 xeservoire In addition or alterxaativea.yg depending on the specific dimensions, the sro~ield 633 m~~y impede the ~s flow of gas from the pressurized gas orifice acrc~ss the liquid orifice to t:~e extent that there is insufficient z vacuum to draw the Liquid out of the la.q3.xid, orif ice ~ .

1a In any event, the production ef aerosol pax~tic~:es ii~,to 3g the chamber 614 is reduced. However, when air is zo withdrawn from the chamber 614 such as when a patient ii inhales through the mouthpiece 700~ a f~ecrease in 22 pressure inside the chamber 61~~ causes the diaphragm 2~ 664 to flex downward ( as showrz in Figur a ~7A) . this z4 causes the cylindrical shield 633 to s>hift into a 3~c~wer z5 position_ When the: shield 633 is in a lower position, is the window 637 is aligned with the gap between the z7 nozzle 624 and the divertex 660 therek~y permitting 2a aerosol generated from the licguid orifice 'to escape z9 into the chamber 614 from which it carp be inhaled by 3d the patient.

3~ The above embodiments of t~xe nebulizer ha~;re been 3z descri:~ed for use :gin medical or therapeutic 33 appliCatiOns. It is noted that the princz.ples of the invention disclosed herein may have app~.icability to 3s other usages, such as industrial, manufacturing, or ss automotive ~e.g. carburetors).

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Claims (30)

CLAIMS:

1. A nebulizer comprising:
a housing comprising a cylindrically-shaped side wall portion, wherein said housing defines a chamber for holding an aerosol;
a cover removably mounted on said housing a chamber air outlet in communication with said chamber;
an air inlet in communication with said chamber for allowing a supply of air to enter said chamber;
a liquid outlet located in said chamber;
a gas outlet located in said chamber adjacent to said liquid outlet; and a movable diverter located in said chamber and spaced from said gas outlet and said liquid outlet by a variable height nebulizing gap, wherein said movable diverter is movable to vary said height nebulizing gap between a nebulizing position and a non-nebulizing position so as to divert pressurized gas from said gas outlet across said liquid outlet to produce said aerosol in cycles in response to a patient's breathing.

2. The nebulizer of claim 1, further comprising a diverter travel limiter positioned in said chamber, said diverter travel limiter positioned to maintain at least a minimum nebulizing gap during said patient's breathing.

3. The nebulizer of claim 2, wherein said diverter travel limiter comprises a stop pin positioned in said chamber and aligned to contact a portion of said diverter when said diverter reaches said minimum nebulizing gap.

4. The nebulizer of claim 1, further comprising a ventilator circuit removably attached to said chamber air outlet.

5. The nebulizer of claim 1, further comprising a mouthpiece removably attached with said chamber air outlet.

6. The nebulizer of claim 1, wherein said chamber air outlet comprises a hollow protrusion connected with said housing at a perpendicular angle to said cylindrically-shaped wall portion.

7. The nebulizer of claim 1, wherein said chamber air outlet comprises a hollow protrusion connected with said housing at a perpendicular angle to a longitudinal axis of said housing.

8. The nebulizer of claim 1, wherein said chamber air outlet is integrally formed with said housing.

9. The nebulizer of claim 1, further comprising an indicator mounted on said cover, wherein said indicator indicates whether said movable diverter located in said chamber is in one of said nebulizing position and said non-nebulizing position.

10. The nebulizer of claim 1, wherein said cover comprises a circular cross-section.

11. The nebulizer of claim 10, wherein said cover comprises an outer diameter greater than an outer diameter of said housing.

12. The nebulizer of claim 11, wherein a position of said diverter is manually adjustable at said cover.

13. A nebulizer comprising:
a housing defining a chamber for holding an aerosol;
a chamber air outlet communicating with said chamber;
a liquid outlet located in said chamber;
a gas outlet located in said chamber adjacent to said liquid outlet; and a movable gas diverter comprising a shaft having a circular end opposite said gas outlet, said movable gas diverter biased by a biasing member to an initial position, wherein said movable gas diverter is movable from said initial position to a predetermined distance from said gas outlet in response to a force from an inhalation of a patient.

14. The nebulizer of claim 13, further comprising an air inlet in communication with said chamber, said air inlet configured to allow a supply of air into said chamber.

15. The nebulizer of claim 13, wherein said circular end comprises a flat surface.

16. The nebulizer of claim 15, wherein said circular end comprises a diameter of approximately 0.18 inches.

17. The nebulizer of claim 15, wherein said flat surface is oriented perpendicular to said gas outlet.

18. The nebulizer of claim 17, wherein said shaft comprises a longitudinal axis parallel to a longitudinal axis of said gas outlet and said liquid outlet, and wherein said flat surface comprises a diameter greater than a diameter of said gas outlet and said liquid outlet.

19. The nebulizer of claim 18, wherein a cover is removably mounted to said housing.

20. The nebulizer of claim 19, wherein said chamber air outlet is integrally formed with said housing.

21. The nebulizer of claim 20, wherein said chamber air outlet comprises a tubular extension oriented perpendicular to a cylindrically-shaped sidewall portion of said housing.

22. A nebulizer comprising:
a housing comprising a lower portion configured for holding a fluid for nebulizing, a cylindrically-shaped side wall portion and an upper portion, wherein said housing defines a chamber for holding an aerosol;
a cover removably mounted on said upper portion of said housing a chamber air outlet communicating with said chamber;
an air inlet in communication with said chamber for allowing a supply of air to enter said chamber;
a nozzle assembly positioned in said lower portion of said housing, said nozzle assembly defining a gas outlet and a liquid outlet; and a movable diverter located in said chamber, and spaced for said gas outlet and said liquid outlet by a variable height nebulizing gap, said movable diverter movable to vary said height nebulizing gap between a nebulizing position and a non-nebulizing position in response to a force of an inhalation through said chamber air outlet.

23. The nebulizer of claim 22, wherein said movable diverter is connected with a flexible membrane.

24. The nebulizer of claim 23, wherein said flexible membrane comprises an annular shape.

25. The nebulizer of claim 23, wherein said flexible membrane is secured to said housing.

26. The nebulizer of claim 23, wherein said flexible membrane is secured to said cover.

27. The nebulizer of claim 22, wherein said nebulizing position comprises a spacing between said movable diverter and said nozzle assembly in a range of approximately 0.025 to 0.045 inches.

28. The nebulizer of claim 22, wherein said nebulizing position comprises a spacing between said movable diverter and said nozzle assembly in a range of approximately 0.030 to 0.040 inches.

29. The nebulizer of claim 22, wherein said nebulizing position comprises a spacing between said movable diverter and said nozzle assembly of approximately 0.033 inches.

30. The nebulizer of claim 22, wherein a diameter of said upper portion of said housing is greater than a diameter of said cylindrically-shaped side wall portion.