Note: Descriptions are shown in the official language in which they were submitted.
W(~ 96l09082 2 i 9 9 ~ 7 9 - PCTluSg4rl0505
-1-
APPARATUS AND METHOD FOR VENTILATING AND ASPIRATING
BACKGROUND OF THE INVENTION
This invention relates to means for vçntil~ting and aspirating the
l~;s~ ol~/ tracts of me~ l p~ti~nt~. It is particularly directed to an improved
ventil~tic)n circuit adapter.
State of the Art: Cull~,nlly available means for v~ntil~ting and a~il~ling
con~este~ lungs and obstructed l,l~ passage ways may be cl~sified as either
"simple" or "complex." Devices of both classes have cignific~nt drawbacks and
limit~tions. The available devices of simple construction tend to expose both the
patient and the service provider to microbial co..~ Although these devices
are relatively less ~el si~e, their use potentially provides d~gen~usly in~ te
patient ventil~tiQn during the aspirating procedure. More elaborate devices tend to
be physically obstructive and ecol~ol.,ically ~luhil,i~ive to use.
In common merlic~l practice, a mP~ic~l practitiQnP,r inserts a tr~-~h~Al
suctioning 5~th~te- into a mPAi~l patient's lungs. The c,~th~ter may be positioned
within a tr~he~l tube, endotr~ch~l tube or nasol~halyllg~al tube int~lb~t~ at a
tracheotomy incision, mouth or nasal opçning"G~ei~i~rely. The end of the
ç~thP,ter ~cces~ible by the m~li-~l pr~ctitinnpr is ~Ggdl~ed as its "pr~ lal" end.
The end of the c~lht~lel remote from the pr~rtiti~ner~ that is, within the patient, is
regarded as its "distal" end. In a typical procedure, negative ~ Ul~ is exerted at
the ~ uh~lal end of the c ~ . Ul~de~,hGd lG~ila~ly fluids and mucoid
secretions are thereby ev~-u~t~ from the mPAic~l patient through the distal end of
the C~ r,l~,r.
In a relatively simple practice, a source of vacuum p~Gs~ur~ remains
~tt~t hPA to the p~Lunal c~ rl~- end. Negative pleSi~ul'G iS not co..~ tPA to
the distal c~thPter end initially. Rather, negative pl~ UlG iS co.~ ted to an
ape,~ulG near the ~ ~ullal c~ll.rl . end. When aspiration of the patient is desired,
the practitioner plugs the a~)Gl~UlG, n~ lly with a f~ger or thumb. Negative
Ul~ iS ~ ,r~y ;~I!J;~ POUS1Y diverted from the small al)GlLu,e near the
al c~ll.klel end through the c~th~ter lumen to the distal end of the c~th~o-ter.In this fashion, undesired lG~..aluly fluids are aspirated from the l~ alOly tract
wo 96/09082 2 1 g 9 4 7 9 ~ = PCIIUS94/10505
of the patient. The suctioning c~$h~t~ is then disconn~ted from the vacuum
source and discarded after a single use.
Ventil~til~n of the patient ~imlllt~n.o~usly with this a~ildlu~g p~celulk is
generally impr~ctir~l. Such vçntil~tion inh~lGnLly l~UileS ~ t~nce from
S y~ lition~l pe~ lnel as well as mech~nir~ t~nce, neither of which is available
as a matter of course. Accol~ingly, the a~ildlillg pn)cedul~ must oldi,l~ily be
completed within a short period of time. Olll~ .~ise, the patient may e"~ lienceoxygen ~lefiriency and be exposed to the res~-lting potential for heart ~lhyLh,.~ia
and/or failure.
More complex a~il~ling devices are available, which while avoiding some
of the disadvantages ~tt~.n-l~nt to the stmctnr~lly more simple devices, impose
additional disadv~nt~ges For example, they are signiflcantly more expensive to
construct, and their greater m~mber of moving parts increases the risk of
disfunction during use. They are also larger and more cumbt;l~oll,e to use,
imposing a greater physical illt ,.r~ ~ence with other, related procedures.
The complex, closed-system devices are sh~r~ctt ri~ti~lly com~ ed of a
manifold structure en~h1ing introduction of venti1~ting gases and ;..le~
e~ch~1~tion of patient breath .sim-~1t~n~ously with insertion and operation of the
t~ hP~1 suctioning c~ ,.. These systems almost universally involve at least one
collapsible, plastic envelope entirely s.~ u~ding the r~thPt~r and pu~o~ g to
provide a sterile barrier be~weell the oll,~ vise exposed extPrn~1 surface of the
c~ r and the ambient atmosphere. In pr~rtice~ a pr~thi-~ner m~m1~11y
c~xtern~11y collapses the envelope onto the to.l~tP.rn~1 surface of the ç~ and
advances the c~ er into the throat of a patient, retr~cting the c~th~tP in a
similar fashion following the a~,hdLion procedure.
These closed-system devices under present medical protocol are oldindlily
used at least hourly for up to 48 hours for each patient before being replaced.
Problems ~ttPn~1~nt to such r ~ucllt and lcl~Calcd in-dwelling use are numerous,among other problems constriction of the c~ lel lumen and valve flow path with
dried and drying phlegm and other rc~loly secretions, creation of co-~ nt-
allowing pinholes in the collapsible pldstic barrier and the need to physically move
the lengthy and cumbersome devices from one location on the body of the patient
t
Wo~6/09082 21 9 9 4 7~ PCrrUSs4l1050s
--3-
to another when the devices ull~,.r~,l;e with other procedures. Associated with the
dried and drying secretions inside the lumen are like secretions on the exterior of
the c~ .ele~ wall which ~cc~lm~ te at the manifold wiper seal; such thick and
undesired l~,~LalOl y secretions not only restrict the facile movement of the
c .~ through the manifold, but also can be unavoidably reintroduced to the
patient in ~ubs~lu~~l repeat procedures.
M~tP.ri~l prior art structures and mPtll- -ls are descl;l)ed among other places
in United States Patent Numbers 5,133,345 to Lambert; 5,107,829 to Lambert;
5,083,561 to Russo; 5,065,754 to Jensen; 5,029,580 to Radford et al.; 5,025,806
to Palmer et al.; 4,981,466 to Lambert; 4,967,743 to Lambert; 4,938,741 to
T~mbert; 4,872,579 to Palmer; 4,838,255 to Lambert; 4,836,199 to Palmer;
4,834,726 to Lambert; 4,825,859 to Lambert; 4,805,611 to T-Totlgkin~ 4,696,296
to Palmer; 4,638,539 to Palmer; 4,569,344 to Palmer; 4,327,723 to Franlchousel,
and 3,991,762 to Radford.
Other closed-system, sterility preserving devices which involve sterile
ba~ formed of n~bber-like m~tPri~l~ and inten~le~l for l~e"t ~ ;on by rigid
c~nn~ P include: rubber like caps fitted on "y" injection site structures and located
at the end of indwelling intravenous c~ el~, such as those distributed by
IIARMAC ~ Speci~1ti~s, Inc. of Buffalo, New York under the product
llu-nb~l H1429104; rubber-like caps fitted on housing structure ~n~hor~ble at
injection sites, such as those distributed by Baxter T-TP~lth~re Corp. of DePrfiPl~,
Illinois under product number 2N3399 and their tr~dem~rk "TntPrTinkclM);" and
threaded lock c~nn~ used in co,ljunclion with the Baxter TntPrTinkc~ for
nP~llP1~P~ injection by Becton Dicl~inson & Co. of Franldin Lakes, New Jersey
under product number 303369 and their tr~d~Pm~rk 'lTnterT inkCFM). ~
United States Letters Patent No. 4,351,328 to Bodai r~ oses a mPthod and
a~dla~us for accomplishing çn-lot~- hP~l s~lctionin~ of a patient without the need
for disco~mP~ the patient from a le~i.alcr. The disclosed a~p~halus pellllil
the ~ e of positive end e~)ila~ S~ul~, without ull~lu~lions during
suctioning. A notable feature of the device is the ease with which a suctioning
tube may be removed from an ~soci~te(l vPntil~tion manifold.
WO 9G~9C ~2 ~ . . PCT/US9411050S
~g~ ~79", . ;L. ~ _4~
There remains a need for a venti1~ting and ~crir~ting device, wherein a
closed-system, multiple use manifold for a single patient is coupled with a single-
patient, single use c~thPtP-r, which structure is comprised of relatively few pa~ts, is
easily assembled and is not susceptible to disfunction.
Also, a need ~~ ns for a tr~chP~1 suctioning device which unobl~lsively
enables ongoing closed-system venti1~tion and repe~tçd aspiration of a single
patient without interim obstruction of ~ed~h~ ~al procedures.
SVMMARY OF 1~ INVENTION
The present invention provides an improved a~lus and method for
cim~ f~usly venti1~ting and a~ihaLi-l~, a me~ 1 patient. It may be embodied as
a sealed venti1~tion circuit adapter that enables ciml~lt~nPous patient ventil~tion and
safe tr~hP~1 suctioning.
The adapter of this invention may be embodied to accommo-1~tç any of a
wide variety of commercially available suction c~thettors. ~ ,1h~lel~ with flared
tips, obvious depth m~rkingc, and normally closed vacuum control valves are
P1GSGIII1Y considered to be most useful. CU~1Gnl1Y pl~f~ d embo-limPntc of the
adapter comprise two p ulJaly COIIIPOIIG~ a manifold assembly, and a c~thPt~Pr
carder. The mal~ifold assembly will or~lin~iiy be ~tt~hçd to a patient for an
PxtP.n~1PA period, typically 24-48 hours. The c--lh~,r carrier is advantageouslyconstructed as a single proce~ 1 use disposable device; it is ideally constructed
to accept illl~ a.l~f~bly a vadety of commercially available c~
The invention enables a practitioner to insert a flexible c~ k~. tube into
either lung of a patient in one smooth motion without risk of co..~...;oa~i( n or
infection and without ~ccict~n~e from others. ~ itiQn~11y, a practitioner is able to
activate vacuum 1)~S~U1~ with either hand and without ~ t~nce from others.
A standard flexible tr~chP~1 suctioning c~hrlP~ tube is ~tt~hP11 at the
ph~llal (pr~u~;~;o~ r) end to a fitting cylinder for insertion into a vacuum source.
The cylinder in~1~1des an offset ol)el~ing which when plugged transfers
co... ~ ti-~n of the vacuum pressure from outside the C~lhr.l~.. - to the intPrn~1
lumen of the CA~ el. The distal (patient) end of the c~thPter tube is structured to
permit l~,~halOly secretions to be suctioned into the lumen of the c~thPter tube.
WO 9~/u9082 ~ pCrlUS94110505
~ --5-
The c~thP.ter tube is slidable len~ ~ise through a passageway in a multi-
function manifold positioned at the distal end of the a~p~lus. The ma~ufold
preferably in~ de.s a port at the distal end for ~tt~rhmPnt to and co.. u,i~ tion
with an indwelling inh~b~tion device, such as a t~chP~l tube, Fn-lot~chP~l tube or
S naso~la~ eal tube. The manifold also ~-c~dbly in~ es a vçntil~tin~ stmcture
extending radially from and in fluid co"""ll"ic~tinn with the p~s~geway, for
selectively introducing ambient air, ~JAygP~ ~ air and other l1~F1~ eUI;~- gasses
into the lr~ lOly system of the patient. Other conduits may also be provided
for the intro~ctinn of other suitable gases and lavage solution~ to the ~e~ oly
system.
Specific~lly, this invention provides an advantageous ventil~tion circuit
adapter for int~ e.ing a suction c~ with an i..lul)~lion device. The adapter
may be vi~ lbed as comprising two major colllpon.,.lls; .~l-ecir.c~lly, a manifold
assembly and a ç~ e, carrier. In pr~tire~ the adaptor may be assoc,aled in a
p~ ~ or kit with one or more c~ le~ ely, a manifold assembly
may be ~sociqfed with a plurality of cn~ le~ calTiers.
The manifold g~ner~lly has a body with an open i~ ior. A distal end
portion of the body is adapted to couple with an i--~ ion device. A p~ nal
end portion of the body is formed as an open port defined by a co.~ ous wall.
The manifold may take various forms, but its p~ùk"llal end portion should be
a~lu~ ly axially ~lignP~ with its distal end portion so that a cathPtPr may be
inserted through the plu~ihllal end portion to exit from the distal end portion. A
directi~nl~l barrier is carried by the p~u~llllal end portion of the manifold
assembly. It is constructed and a-lanEed to effect a seal against fluid flow through
the open interior of the manifold lc,wal~s the pl~il,lal end portion but to pass a
c~th~tPr introduced through the ~JlU~illlal end portion.
I~f~ly, the &~;~ l barrier is configured to be "Iselled in the
plU~Ulllal end portion in sealing relationship with the open interior, and colll~lises
a nor n~lly closed valving structure. The normally closed valve structure may beconstructed and arranged to effect a sliding seal a.l, .lge~ent with the ~-xt~.rn~l
surface of a c~thP.ter passed through the body of the manifold; that is, from the
p~U~ end portion towards the distal end portion through the valve structure.
2 1 9 9 4 7 9 PCTIUS94/lOS05
;- "S, t' '- -6-
Preferably, the valve and c~ lP~ carrier are mllt~l~lly adapted to effect this sliding
seal. The valve structure may carry ~l~PtP~ction means constructed and ~ gP~ to
signal the precise location of the tip of a c~tllPter positioned within the valve
structure. For example, these means may signal, by resi~t~nre to travel or sound,
the p,c;sellce of the tip when it is moved to the pio~lily of the valve stlucture
from a location closer to the distal end portion of the manifold ~sembly.
The manifold assembly desirably inrln-1Ps a vPnti1~tioî~ port in fluid flow
co.. ~ tion with the open interior of the manifold body. The central axis ofthe ventil~tion port will onli~ ;ly be oriented transverse the central axes of the
pçuxilllal end portion and the distal end portion of the manifold. A lavage portmay also be provided in fluid flow co---...~ ir~ti~ n with the open interior. The
central axis of the lavage port should also be oriPnte~l transverse the central axes
of the ~ al end portion and the distal end portion.
The ~ .Ihr~er carrier typically inrlnde~ a leading end portion adapted to
couple with the ~lo~ al end portion of the manifold and a trailing end portion
C~lyillg a c~ rle~ introducer structure. The introducer structure is constructedand arranged to intPrf~çe with the directional barrier when the leading end portion
of the carrier is coupled with the plù~ lal end portion of the manifold. For
exam. ple, it may colllp~ise an introducer tip constructed as a continuous wall to
define an interior passageway configured to receive and pass a c~thPter and an
~xtt~.rior surface configured to in~erf~re with the directional barrier. The
directional barrier is further preferably structured to effect a resilient seal against
an intPrn~l surface of the continuous wall. The interior passageway may include
an entry constmcted and ~rrAngP~ to effect a sliding seal with the exterior surface
of a ç~theter. In any event, the exterior surface of the intrûducer tip and the
directional baIrier are mnh~lly ~ pt~P~l to effect a sealed rel~tion~hir when the
leading end portion of the c--~h~le~ carrier is coupled with the plo~ al end portion
of the manifold body.
The directional barrier may be structured to effect a resilient seal both
against an intPrn~l surface of the open interior of the manifold body and between
the ~JlUXilllal end portion of the body and the catheter carrier.
w096~0go82 2199~79 P~s~41l0~0s
-7-
A fluid collector may be carried by the trailing end portion of the ÇA~ e~
carrier. This collector functions to ~ c~m~ tP sputum fluids and the like wiped
from a c~ er as it is withdrawn through the barrier seal. In one embo~imP.nt
the collector in~ des a chamber poeitilmPd in ~ v~llal~ axial ~1ignmP.nt with
5 the distal end portion ol)~o~ile the manifold with respect to the leading end
portion. A ~lv~ al closing mPn~ber for the ch~mber carries an entry
a~lux;..~ ly axially aligned with the introducer tip. The closing mPmher may be
structured to effect a sliding seal with the exterior surface of a c~thP.tP.r.
The çh~mber is desirably structured as a hollow cylin-lnt~.~l extPn.~ion from
the trailing end portion of the carrier. The closing member is ~le~ b1y structured
as an end panel of the eYtpn~ion with a central o~el~ing ~ rted to receive a
c-11.r.l~J in friction-slipping engagement. The term "friction slipping," as used in
this disclosure, refers to a ~litl~ble association in which the exterior surface of the
ç.l1.P1er is engaged about its cih-;ulllfe~llce by the interior surface of the central
opening of the end panel. Fluids arlhPring to the ç~thP.ter are thus removed by a
wiping action as the c-l1.r,l~,~ is withdrawn through the o~,nin~. The end panelcollvel iel~lly comprises a removable cap structured and arranged to effect a sealed
closure of the cy1in(1rir~1 extPn~ion
In use, the manifold assembly is i,lt~l~osed b~lweel a patient's indwelling
tube at the distal end of the manifold and a vPnti1~ting circuit. These junctions
preferably embody a swivel configuration to permit left or right bedside p1~ce.mPnt
of the VPntil~tic)n cil~;uill~r, and free rotation of the ventil~tinn circuit with patient
head movement to reduce the risk of e~t~-b~ti~n.
The directinn~1 barrier may be configured as an elongate ples~u,~ and
sterility barrier, and the normally closed valve may be in the shape of a duckbill,
with a normally closed central ~)~,~LU1~ interposed within the p~ geway of the
manifold. Whether the barrier is structured to include an a~lu,e of elongate
transverse ~limPn~ion or a simple slit in a membranous end of the barrier wall, the
barrier in comhin~ti~n with the adapter assembly provides an effective seal against
patient expectoration, co--~ mi~ti~n and plC;S:iUl~ lP~k:~ge.
The c~ er carrier may be configured as an adapter ~semh1y su~oullding
the c~ er, inr.~ ing an introducer tip and a concPnt~i~ outer introducer housing
WO9GI~5~2 . ~.' PCl[lUS94/10505
2 1 9 9 ~ 7 g
c~ nnP~tecl at one end by an adapter base. The introducer ho--xing fits snugly over
the outside of the p~ al end of the manifold. As the introducer housing is slid
over the manifold, first coupling structure carried by the external surface of the
manifold engages second coupling structure associated with the intPrn~l wall of the
introducer housing. The first and second coupling structures are m~ lly ~ rtP~l
to allow the prartitioner to slide the adapter assembly and manifold toward one
al~ulhel- until the manifold is seated against the adapter base. Then the housing is
rotated with respect to the adapter to positively lock the adapter and manifold
together during use of the device.
The introducer housing may be slid over the p~llal end of the manifold.
An initial sterile barrier is lh~.~y created. After the initial barrier is created, the
introducer housing is further slid toward the manifold, causing the introducer tip to
pe~ e the al~elLul~ of the directional barrier. Though this penPtr~tion may
prel;...;.-~.;ly partially co,llpl~,.llise the al)elLul~ seal, the initial sterile barrier
15 bt;lweel~ the manifold and adapter ",~ c a closed-system env~ ..el~l within
the manifold. After the introducer tip has p~n~ led the directional barrier, thec~thPter can be advanced, with ...i~ l frictional lGs;xl;~-ce, through the manifold
and indwelling tube into either lung of the patient.
Once the c~ ler and adapter are ~tt~rhPA to the manifold, a presuction
saline lavage is typically introduced through the lavage port in the manifold which
directs the lCS~ toly secretion flow into the patient tube through the distal end of
the manifold. The lavage port is ~ul~oserully located immPAi~tPly ~~jacPnt to the
patient tube and with a non-perpen-lir~ r fluid injection angle so as to optimally
direct the saline flow into the patient tube with little risk of back flow into the
ventil~tion circuit. One p,ere,l~d manifold design inco,~ dles a window through
which a practitioner may view the c~ ler, its suctioned conle~ and any depth
...~.l~;.~g~i which may be printed on the c~ rlel.
While the practitioner is yelro~ g the evacuation procedure, the C~l~.rler
may be ~ P~lly inserted and ret~rtP~ with selective introduction of lavage fluidthrough a lavage port on the manifold. The manifold is configured to prevent
lavage fluid from ~ ining through the ventil~tic n port, obviating the need for the
w096/09082 219g47~ PCrfUS94110505
g
manifold to be tilted during lavage and ~ tby averting the potential for
ieconnpctinn of the manifold from the indwelling en~ot~ch~l tube.
Upon repe~te~ adv~n~Gm~nt and retr~tion of the c~thPter during an
evacuation procedure, undesired ~ t secretions are prevented from flowing
t~ S into the ventil~tit n port or back toward the patient. Such sec-~ions are squeegeed
off of the extP~n~l surface of the c~ 1e~ during retraction.
The squeegee function is accomplit~h~A by a wiper seal snugly su.~ ding
the c~theter within the pru,~ al end of the adapter assembly. The wiper seal hastwo ~lh~ functions: to clean the e~tP-~n~l c .1~ wall.during retraction so as to10 ~ . practitioner exposure to patient co--li~i-l~; and to ~-.~ l;-i,- a plG:i~iUl~;
seal around the c~lht~le~ ~ en~ a continuolls closed, leak tight ventil~tion
circuit. The prGfelred wiper seal configuration interf~es with the ~ .Iht-~~ . tube
with low frictional lG~ e, facilit~tin~ facile c~th~ter illsG~lioll.
A sputum collector co",~t~l",ent is located b~;Lw~ll the wiper seal and the
base of the adapter to accum~ tP the unde~iltd sec,~lio,ls. The sputum collectoror trap has two plUllaly funetion~. It traps the wiper seal bclweell the wiper trap
and the adapter housing, and acts as a c~thPtP.r guide during insertion and
retraction of the c~ll.~ ~ -. -Upon completion of an evacuation procedure, a pra~;~iLionel retracts the
c~ll.ete~. In some ~n~ngPmP.nt~, a structure, such as a flare at the distal tip of the
c~ ter, catches against a trap wall n~luwhlg in the c~ ter passageway within
the introducer tip. This fiare to trap wall contact further enh~nres and ...~
the closed-system envLu,llnenl within the manifold by providing a positive stop
which prevents a practitioner from inadv~.lelltly rPtr~rting a c.~ from the
manifold and ç~lhrler adapter.
After the pr~rtiti-~ner has pelr~,l",ed the l~LatOly evacuation pl~JCedUle,
the introducer housing may be axially rotated in the diIection o~ûsi~e to the
direction it was turned at the beg;i-~-h~g of the procedure, lhe~l)y to decouple the
adapter assembly so that it can be retracted from the manifold.
As the adapter assembly is being rPtr~ctecl from the manifold, the
introducer hon.~in~ I~IAh~ ;n~: a closed-system seal, even as the introducer tipwithin is pulled through the directional barrier. After the ~e~lul~ in the
WO 96/09082 2 1 9 9 4 7 9 PCIIUS94/10505
-10-
direction~1 barrier is closed, lhG1GI~Y ..~in~ ;ng a ~1CS~ G and sterility bar~ier,
the introducer housing is retr~ct~l ~ ul~ally off from the manifold. The single
use c~ lr. and adapter assembly may then be dropped onto the sterile field
barrier atop the patient, together with the surgical gloves, and the sterile field may
be wrapped around the gloves, c~ el~ and adapter assembly and discarded
a~l~lialely, leaving the closed-system, single-patient manifold in place for later
multiple uses.
A dust cap, typically tethered to the manifold, may be placed over the
pl~ illlal end of the manifold bGlweell suction procedures. The dust cap acts as a
~ le~;Li~e sterile barrier bGLweell the suction procedures as well as a seal against
P~S~U1G dirr.,.Glllials across the manifold to ~ e.lL back flow through the
normally closed direction~1 barrier.
It is ~ignific~nt that throughout the e~ ly of a lc~il~lol y evacuation
procedures, a sterile, closed-system environment is ...~ d within the
manifold. This invention thus makes it possible for such re~ ly e~.c.~l;on
pl~celulGs to be accomplished willwul the need for ancillary p~, ~on~el ~ ct~nce.
An individual n,~)ild1l)ly nurse or terhnici~n can pGlro~ the entire procedure.
Further, it is si~-il;c ~.~1 that this invention provides means wl~ Gl)y
throughout the enli~ly of such procedures, ongoing o,.ygelldlion or other
venti1~tion of the patient can be ~-~ ed, wiLlloul the need for l~led
disconnection, connection or other moving of vçnti1~ting tubes and other ~n~ ry
~ui~llle~
It is also ~ignifi~nt that the manifold, comprising the more costly portion
of the adapter of this invention, un~tlllsi~ely remains ~ h~1 to the patient andis reusable for numerous additional suctioning procedures with single-use c~l1.e1
and carrier ~emh1i~s of relatively nlq.gligihl~ se.
BRIEF DES~:~llON OF TH~ T~ T USTRAl~l~ DRAWINGS
In the dlawillgS, which illustrate what is ~iull~n~ly regarded as the best
mode for câllyiu~g out the invention:
WO g6109082 PCTIUS94110505
~ 79
E;IG. 1 is a partially exploded and partially broken away cross-sectiQn~
view in elevation of a pl~f~l~d embo-iimPnt of the invention in fli~A~semble~
- con-1iti~n;
FIG. 2 is an enlar~e,l.e..l of a portion of FIG. l;
S FIG. 3 is a view in elevation taken on the lGr~ nce line 3-3 of FIG. 2;
FIG. 4 is a view simil~ to FIG. 1, but showing the components in
assembled con-liti-n;
FIG. 5 is a partially exploded and par~ally broken away cross-sectional
view similar to FIG. 1 of an A1~ -A~ e embo~limPnt of the invention; and
FIG. 6 is a view similar to FIG. 5, showing the co~ onelll~ in assembled
con-liti~ n.
DETAILED DESCRIPIIQN OF THE PREFERRED El!.D3ODIMENT
Figures 1-4, illnstrAtP. one confi~ulalion of a device, clesi~nAI~A ~P.nP.rAlly
100, embodying the invention. A manifold assembly, de~ A~P~d generally 105,
comprises a body 110 with a distal end 115 and a ~JIU~illlal end 120. The body
110 def~es a space 125 belween the distal end 115 and ~ llal end 120. A
lavage port 130 located on the body 110 of the manifold assembly 105 opens into
and is in co-.~ irAtion with the manifold space 125. .Simil~rly, a ventil~tir)n
port 135 located on the body 110 is in cc""",l-~ tion with the manifold space
125. Tl~c~t~ at the distal end 115 of the body 110 is an endol~A~-hPAl port 140
o~ening toward the patient and ~AttArhAble to an indwelling ~lxture (not shown),such as a tr~hPA1, endotrA~hPAl or nasu~hal~llgeal tube.
A cap 145, capable of covering the ~ .ulal end 120 of the body 110, may
be AttA('~hfyi to the body 110 with a tether 150. Situated within the space 125 of
the body 110 is a directional barrier 155 preferably formed of a pliant, durable,
rubber-like mAtP.riAl with strong riim~Pn~iQnal memory. The directional barrier 155
inrhldes a central a~ u~e 157. The direction~l barrier 155 is seated around its
entire cross-sec~;u~-Al ~ hely against a rim 160 e~tPn~ling inwardly from the
intern~l wall of the body 110. The barrier 155 and the rim 160 intP.~ce in a
~.,A~ f . that achieves a sealing and anciloling of the directional barrier 155 relative
to the body 110. A seal P.~tf.n~ion 165 may protrude slightly from the directional
WO 96/09082 PCI~/US94110505
2~ 9 ~ 79
-12-
barrier 155 axially beyond the proximal end 120 of the body 110 to provide
itir)n~l sealing effect between the cap 145 and the body 110 when the cap 145
is in position to cover the ~ru~iulal end 120 of the body 110.
At least one positioning and locking post 170 extends radially uulwald from
the body 110 of the manifold assembly 105. The post 170 intP~CtS with a locking ''
ch~nnPl 175 formed in the intern~l wall of the introducer hon~ing 180 of a ç;~ r,~
adapter 185, as illl-st~tP~l more clearly in Figure 2. The ch~nnPl 175 çxt~P.n~ls
aYially from the adapter front 190 in the direction of the adapter base 195,
prûviding relative positioning of the manifold assembly 105 and the c ll.~te~
adapter 185. The c.h~nnPl 175 then continues ci~.;u,llfelGlllially at a~lu~ ely a
right angle from the aYially directed çh~nnP.l 175, providing a means of locking the
manifold assembly 105 and the c~ lP~ adapter 185 together when the post 170
has been moved axially and then radially within the ch~nnPl 175. The seal
~x~ iOn 165 is shown configured to seal against the intP.rn~l wall of the
introducer housing 180 as the c-'1. te~ adapter 185 and manifold assembly 105 are
in the process of being assembled. The seal eYten~ n 165 is further structured to
seal against the adapter base 195 when the c~theter adapter 185 is locked to
m~nifold assembly 105. In this ~tt~hPd position, the resiliP-n~ of the seal
eYtton~ion 165 biases the adapter 185 aYi~lly to Ill~ locking 1:J1GS~;U1~ between
the locking post 170 of the manifold ~em~ly 105 and the ch~nnPl 175 of the
introducer housing 180.
The c~ e~ adapter 185 compri~es an introducer tip 200 ~
conrPntric with and inside of the introducer housing 180. The introducer tip 200is seated ~in~t and may be formed integr~lly with the adapter base 195. A
c~thP.tP.r passageway 205 is formed through the length of the introducer tip 200,
opening at the leading edge 210 and through a c~l.rle, opening 215 in the adapter
base 195. The c~ .ele~ opening 215 may be formed with a cross-sectional
~limen~ion slightly larger than but corresponding to the outside cross-sectit n~1
~limen~ion of a tracheal suctioning c~ r,l~ 220.
Trap walls 225 extend axially from, and are formed integ~lly with, the
adapter base 195. A pliant and resilient washer-like wiper seal 230 with a hole
233 Ill~lGlluvugh is placed against the distal edge 235 of the trap walls 225. A
WO 96109082 21 9 9 ~ 79 PCTJUS94110505
~ f .
-13-
trap cap 240 is Att~ch~l to the trap walls 225 and holds the wiper seal 230 in
place. The trap cap 240 inrl~l(les a ~u~l)GlL opening 245 which provides c~
guidAnr,e and relief of stIain on the c~ lel 220 imposed by non-axial forces
encuul.L.~d during insertion and retraction of the c.~lh~l~ . 220. In combination,
S the wiper seal 230, the trap cap 240 and the trap wall 225 cûnlli~ul~ to the
sterility and ~ S~ulG barrier function of the manifold 185 during use. The trap
walls 225, logGll,er with the wiper seal 230 and the trap cap 240, defme a sputum
collector 250.
Upon retraction of the c~thPtPr 220, sputum, phlegm and other undes~d
lGs~ y secretions are sq~leegePd from the eYtp~rn~l surface of the c~thPtpr 220
by the wiper seal 230. The ~liAmeter of the hole 233 is desirably sized slightlysmaller than the outer ~ m-o,ter of the c~thetr.r 220 to fr~ilitAtP. this function.
These undesired ~ ul~ liquids are then di~led into the sputum collector 250
where they are retained from lP~k~ge back toward the patient or out toward the
~G~ihaLo~y practitioner. With the practitioner being e~lui~ed with protective hand
ware and the patient being covered by a sterile field barrier under the retrArt~l
C~Ih~(GI 220, ~-lequ~te ~n~leclion from cross-co~ l i( n is lll~.~y achieved.
The c-~lh~le~ passageway 205 na.,uws at a re~ çing con~trirtcr 255 near the
c~ ler opening 215. A flare 260 at the c~th~t~r nozzle 265 catches against the
re~ring con~trirtor 255 upon retraction of the c~th~t~Pr 220. The embodiment
t~tyl by Figure 6 provides a c~he~e. advancer 270. A prActitinner can press
the walls of the advancer 270 down upon a c~theter 220 for selectiveIy advancingand ~ CI the c~ er 220. In this fashion, the practitioner can manipulate the
ç~thr.ter wilhoul touching it and wi~.Jul the need for special hand ware.
As best shown by Figures 4 and 6, the device 100 and its l~e~;LivG
co~ onenls allow a ~ alOly prArtitioner to ...~ a closed-system within the
single-patient, mllltiple use manifold assembly lOS throughout attachment of theç-l1.~le~ adapter 185 to the manifold assembly lOS, evacuation of a m~AirAl patient
through ambidextrous ActllAtinn of the vacuum plGS~ulG by selectively plllg~ing an
~e~ g 272 in an actuator cylinder 274, retraction of the t~rhPAl c~ le- 220 and
detA~hmt-nt of the single-use, disposable CAtllPt~r adapter 185. The practitioner
may then, with ...i,~i...Al waste and cost, discard the cAth~ter 220 and adapter
WO 9~ P'~ r ~ PCT/US94110S05
21~g~7~9 _14_
structure 185 and place the cap 145 over the ~ al end 120 of the manifold
assembly 105 until next use, leaving no partially obstructed c~th~t~.r, plastic
envelope and complicated valve structure to inlGlreIG with other procedures and
ry equipment.
S The present invention may be embodied in other cpe~ific forms wilhouLde~alLing from its spirit or ecce~ l c-h~r~cteri.cti~s Further objects and
advantages of this invention will becomP a ~ Glll from a con~i~ler~ti~n of the
drawings and e~ esç-;p!;~)n of it. The desçrihed embo~lim~ntc are to be
considered in all respects only as i111-str~tive, and not restrictive. The scope of the
invention is, t~ rcJlG~ in~ t~ by the a~pended claims, rather than by the
rolGgoing desr-rirtion. All ch~ng,o.s which come within the mP~ning and range ofequivalency of the claims are to be embraced within their scope.
