CA2236409A1 - Fluid transfer device - Google Patents
Fluid transfer device Download PDFInfo
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- CA2236409A1 CA2236409A1 CA 2236409 CA2236409A CA2236409A1 CA 2236409 A1 CA2236409 A1 CA 2236409A1 CA 2236409 CA2236409 CA 2236409 CA 2236409 A CA2236409 A CA 2236409A CA 2236409 A1 CA2236409 A1 CA 2236409A1
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Abstract
A device such as a drip chamber for transferring fluid(s) is disclosed. The device comprises a housing, a porous medium, and a degassing element, wherein the porous medium allows gas to pass therethrough, and the degassing element substantially degasses a liquid.
Description
~UID l'RANS~ER DEV~OE
T~h~ Al Field This ~e~io n relates to a device and method for ~ G ~ ¢ fluid, especially for ..~in;...;,;n~ the p~~nce of air bubbles in ~ ,d pa~ al fluids, e.g., saline 5 and/or !.A..~r.~ such as blood Co ~acl~ ld of the L~ tiun Many fluid lLa~r~ ~t~ s such as fluid ploc~ a,~i~t~ 5 r.. 1;O,, more l~r,. ..ll~r if they can be at least partially purged of air or gas before use. A.~ itio~qlly, some ~ r." s~ , e.g., for ~-~lll;n;~h(;l~ fluid to a pa~en~ should ...il-;~..i-,~ or 0 ~ ,nt air or gas from passlrLg beyond a certain location in the system. For example, some illlLa~r~,Ll,UUS av) i~ ,t~ s include a drip chamber or a bubble trap to ca~uLe air or gas so that it will not be ~ d to the patient. The drip ch-...~r can also be used to allow the opelator of the system to ...o~ o~ the rate at which the fluid is ~ d.
For example, the Op~aLûl may obsene the drip ~~h~ kcr to ensure that the patient is 15 ~ce;~ g the liquid at a given rate, e.g., a rate of so many drops of liquid per minute.
If desired, the rate can be ch~;d and the new rate can be ,...,~.itv~d by obsG.v~ the rate at which the drops of liquid pass through the chaLu~.
There are dLa~ac~ to conv~ ;on~l fluid LLa~Sr~ ~ LLS, especi~lly when used to ~La~r~,. fluid at a high rate. For ~pk, during a trauma situation, e.g., when the 20 patient lCCf~;~.,S one or more units of red cells andlor saline at a flow rate of several hU~L~dl cubic c- ~1;...- r~.~ per minntf ~ the fluid in the drip Ch --..h ~ can b XO~ foamy, and it can be r~ lt to ple~nt ~,~Lap~ed bubbles f~om passing with the blood and/or saline through the drip cll~-"l~ to the patient. The pl~,bl_m is incl~ since the blood may have to be ~all..ed before t-, ~ru~iO~-, and ~aLIlPi~lg the blood causes air to be 25 1f 1P~ into the blood, m~ki~ it more "foamy~ n A(l~lition~11y, the drip l'h~ hF~ can fill too quickly, and a high level of fluid in the ch~mher can provide ;... -rl;~ space for a drop to folm before it co..l; -l~ the fluid in the chamber, maldng it (1imrl11t to count drops. As a result, the op.~t--r cannot rl~t~....;.~f the flow rate. In some ~ ;ol-~, the fluid level and/or the ple~.lce of foam can be such that the opel~tol is unable to quicldy d~ if blood is actually being ",;,~;~r~ ~,d.
The present iu~.llion provides for ~ iold~ at least some of the disa~lv~-~tages of the prior art. These and other ~l~,~L~es of the present iu~e~lti~ will S be ap~ from the des~ tion as set forthbelow.
S~ of the Iu~
In accol~ with an e ubo~ f ~t of the present i~ Liun, a fluid ~ rf ~
device such as a drip ch ~ iS p~vided that is capable of ~ r . ;~ liq!lid at a high rate, and ~,~iilg gas, while coqlPsci~ bubbles that are le.llu~d from the liquid flow 10 path. In a more pl~,f~ d e~bo~ t the drip ch~ ~ canbe filled to a desired level of liq~id, wL~.~m the qml)llnt of liq!lid in the ~h~ is less than the tot. l liquid capa iLy of the ch-~..hPr~ and the G~c.aLo~ of the ~.h-...~ can observe a stream of liquid, or drops of liquid, ent~..;.~ the chqmbPr.
Brief Descli~tion of the DldwlllgS
Figure 1 is a cross-s~l ;- n~l view of an c~.lbo l;~ n~ of a venting device acconli~g to the present ..1~ ntion.
Figure 2 is a view of the device of Figure 1 along line A-A.
Figure 3 is a view of the device of Figure 2 along line B-B, sL~wi~g a porous .1;.- ., for passing gas l~. ~l~uugh located in the device.
Figure 4 is a cross ~ I;onal view of the upper cl~nhf-- and the porous m.o~lillmof the device of Figure 1.
Figure S is a cross ~ ~ nal view of the lower ch-~..ke of the device of Figure 1, ~L~w~ a ~g,~ el~ for co~l~srir~ gas bubbles located in the ch~mher.
Pigure 6 is a cross ~I;onal view of another en~ ..f n~ of a ~l~n~ , device 25 accol~iQg to the present invention.
Figure 7 is a s~ h- ..~l;r view of a system for !~ .n.~ g a fluid in accolddn~
with the invention, inrl...l;u~ the ~ g device ilh.~t~ in Pigure 1.
Pigure 8 is a srh. ~~. ~1;r view of a system for ~r~ g a fluid in accol~ce with the ill~ ~ion, in~ i~ the ~ g device ilhlstrated in Figure 1, and a fluid filter.
6~78 CA 02236409 1998-04-30 Specific De~li~ion of the Invention In accû~l~ce with the present in.~nLion, a device for l~d~r~ fluid is provided c~---p-;~;~ a h.)--~ co~ ing a fluid l~,se~ioi~ for gas and liquid; a vent and a ~kg~ic;~ e~ 1 co..,...~ ;r-l;.u with the h.~ , the vent Cf~...p.;.~ a S liquophobic porous ",~.1;,-.,. that allows gas in the h-3--~ to pass through the .n~,.l;---~.;
the ~leg~ e~ --..~ .l Cul~ a coq1PscP,r that co~lPsces gas l,~les and forms larger bubbles that rise in a cen~al portion of the h(~u~ing, the vent and the housi~ being cQo~-. ~ . ly ~ i to allow the gas to be vented from the h....~ . In an embo~ 1 the vent, the ~ s;.~ elP .~. n and the h.,..~;~ are COOpe~ali~- ly 10 ~l~d~g~ to allow the gas to be vented from the h...-~ . Preferably, the device allows id to fill the h-,--~;~ to a level that is less than the total liquid Cdpd~ily of the hrJ..~
Typically, the device for ~ r ~ fluid cn...p. ;-~ s a flow ...~ t~ device such as a drip ~~ha"-her that directs fluid non~ - ,l;any to a first surface of the ~1e~ .ei~
15 pl~ ~rn~ The device may also include a structure such as a cap, plug, and/or valve capable of e ~pag;~ with the huusillg, e.g., to cover and/or seal the vent.
The present invention also provides a drip cha.n~f r CO~ ;!C;n~ a housing inrl~ a ~ uophobic porous m~ 1m and a ~g~ e~ n~ ~1 the device allowing liquid to fill the h....~ to a pre~1etf ...;nf~l level, or less, wilhouL con~le~ely filling the 20 h.,..~iQ~ with liquid, the ~1eg~ elc .~ coqlP~eci~ gas bubbles and folll~~g larger bubbles that rise in the central portion of the h-JII~iQ~, and the liquophobic porous ,..f~ " allowing gas to pass from the housi~g.
In accGl~ ce with the hl~ io4 a system for ~ at least one fluid is p~ided, the system CO~U~l~ ~g the device for l.A,.~r. ..;.~ fluid, and a C~
25 ~ui~le for ho1~i~ a fluid to be I . A.,~r. . I~d, wll.,.~,~ the device is in fluid co...--.~ a~i~ n with the contain~. In an embo~im~nt, the device c~...l.. ;. es a drip chqmh~r, and the system also in~hlcles a filter, e.g., a blood filter, i~osed bel~e.l a co.~ in- ~ suitable for hol~ a fluid to be ~ r ~ .~,d, and the drip r1~an~hc~ In some embo 1--,--~ , the system inrhlcles a plurality of cont~in~ ~ e.g., suitable for holding 30 dirf,..,~ fluids to be l~ A~ d.
The present h~e~ltion also p~idcs a m.oth~l for ! ~ ,....~r~.. ;-.~ one or more fluids con~ passing a fluid CQ.. l.. ;.~in~ a liquid and a gas into a device cc.. l~ ;n~ a i~ inl~hJ~li~ a fluid l~se.~oi~ for gas and liquid; passing liquid into the housing and g gas from the device, wl~ venting ;n~ J~5 passing gas through a li~luophobic porous ,..e~ ." un~l the liquid collth~ the porous ...~ ..; coql~sci~ gas bubbles and allowing the co~l~ed bubbles to rise in a cen~al portion of the ho~ , and passL~g S liq!lid from the device. In a pl~,f~ ,d e ~,bo~ d, the mf th~ inrl---les di~,Cli~l~ the fluid non~ E~.n;~lly to a first surface of a ~ e ell ..f nr that cs~lesc~s bubbles, and obs~ g drops of liquid ent...;n~ the ceD~ral portion of the hn..~ , wll~,~ the k.~ i~ is filled to a level that is less than the total liquid Cdpaci~ of the ~us~g.
Typically, one of the fluids to be ~ r. ..~ is a biological fluid such as blood or 10 a blood colll~on~,~, and e~ ..- nt~ of the method also include ~.ln,in;.i~ the biological fluid to a patient.
Emba1;..~ .~i of the present in~ tion p~u~i~ for e~rr;.~ t ~--~t;on of gas or air from a fluid flow path, and the present i~ n~n is par~cularly suitable for those pal~,~lal fluid ~ ..;n;~ ;Qn plot~cols that require ~.~r.,llh~g at least one p~t~
15 fluid (e.g., a biological fluid such as blood or a blood COlll~O~) at a high flow rate during at least part of the p~t~col.
As used herein, the term "gas" inr~ es air. In accol~c~; with the invention, a biological fluid inclll~es any treated or u~a~d fluid ~co~ with living olg~n;~...~, particularly blood, in-~l..tl;ng whole blood, warm or cold blood, and stored or fresh 20 blood; treated blood, such as blood diluted with at least one phy~iologi~ ~l solution, inr~ i~ but not limited to saline, I~ ;f.~t, and/or ~ntiro~ nt sollltirmc; bloodCOl~ C~t~, such as platelet con~f--l~ (PC), platelet-rich plasma (PRP), platelet-poor plasma (PPP), platelet-free plasma, plasma, fresh frozen plasma (~), co~ ?o~
obt~i~d from plq~nq packed red cells (PRC), !.~n-:l;. n zone rnqtPriql or buffy coat 25 (BC); blood products derived from blood or a blood CO~o~ s~ or derived from bone ~ 'V; red cclls sep-~ from plasma and l~ ~ndf~l in a physiological fluid; and plqtPlPtC ~,p~.~.l~ from plasma a~d l~ . nd~d in a physiologlcal fluid. The biological fluid may have been treated to remove some of the lcu~oc~s before being pç~ed accoldillg to the L~.,~ion. As used herein, blood ~ or biological fluid refers to 30 the C~ fll~ rle~-;l~d above, and to similar blood p~ or biological fluids obt~i~ed by other means and with similar p~pe~lies.
A "unit" is the ~lu~ity of biological fluid from a donor or derived from one unit of whole blood. It may also refer to the qu~~ drawn during a single donation.
Typically, the volume of a u~it varies, the amount ~I;rr. ;.~g from ~onq~ion to donation.
Multiple units of some blood col~ ts, particularly pl~t~ and buffy coat, may be pooled or col,.b~d, typically by Cu~ ~g four or more units.
S Each of the colllpon~ of the i~ lion will now be d~ ;bed in more detail below. Like Co~ o~ts have lil~e l~,f~ ce ....~
In the ~ a~ c~bo~ .n i~ fd in Figures 1-6, device 100 inrl~ e~e a h~)..ei~ 14, having at least one iDlet 1 (Figure 6 shows an ~ ;r)n~l inlet 1') and an outlet 2; a lumen or central portion 21 for fluid flow ~.~n the inlet and the outlet; a 0 ~cg"C-c;~ Cl~ d 50; and a vent 3 providing a gas flow path.
The di~g~ ng el ~.. nl 50 coa 'S small b~ l)bles into larger l,~bks that rise into the central portion 21, and COlllpli3eS a porous ~llu~;t41~ having a first surface SOa and a second surface SOb. The vent 3 c~...p~;~çs a porous ..~ 10 that allows gas, but not liquid, to pass from the lumen or central portion 21 ~ uugh a port 4 into a gas p~sageway 5 and through a port 30. Typically, porous ",,.l;.. 10 is located in the hvu~i~g 14, and h~ a first surface 10a facing the inlet 1 and 1' (Figures 1 and 6), and a second surface lOb facing the outlet 2. Preferably, porous ,..P.l;..n. 10 has a portion of the first surface lOa near or ~dj ~c~nt to port 4 of gas p~sageway 5.
Typically, as ~ t' ~1 in Figures 1, 3, and 4, housing 14 in-~hl~les a first portion 16, having an i~let 1, and a groove 29. The first portion 16 also in~ Ps a nipple 22 having a port 23 leading to central portion 21. P~ef,.ably, the nipple n and port 23 direct the fluid non~ e~ ;ally toward the first surface 50a of the ~P~ ;ng el~ .l 50. If desired, the hvusing can be ~ang~d to allow liquid to enter the ce~al portion 21 in the form of dlùpl~.
As i~ t~ in Figures 1 and 5, hu~mg 14 also in~ dc5 a second portion 18 having an outlet 2, and a lip 19. In l:he ~ bodil l~ shown in Figure 1, the first portion 16 and the second portion 18 are sealed to form a first chqmh~-r 15 and a secondchC .. l~ ~ 20 enco~ya~ lumen 21 and porous ",.'.l;.. 10.
Preferably, as ill- ~ ~ in Figures 2 and 3, porous .n~.l;.. 10 iS ~nmll~r in shape, and surface lOa faces a series of ribs 25, 26, 28, and/or c~ n~lc 24, 27 in the first portion 16. Typically, in those e.~,bo~ ..- nl~ having an amlular porous ,..~-1;- -,. 10, the ribs 25, 26, and 28, and the cl~ n~lc 24 are gen~lly c~ nl . ;~.. In the m~ t~fl emho~limPnt first portion 16 also in~ludes radial c~nnflC 27.
Figures 7 and 8 illllc~te embo 1;... ~~1~ of qpical s~:itL~s 500, 501, utili7i~
device 100 during the ll~r~ of at least one fluid (e.g., a p~lltelal fluid) to a desired ~c~ ;on In these ~ c~ embo~ t~, the system in~ 5co~ ;nf~ 200 and 5 200' for holding one or more fluids such as pa~,al fluids, ~1~ the co.~ are in fluid co.. ~ n, via cr~lu~ such as cQI.~h~ 201 and 210, with the device 100, and the destination of the fluid, e.g., a patient. Figure 8 shows system 501 i"-l...1;.,~
~d~lition~l c~ 219 and 220, a filter 300, e.g., for filtPriT~ a p~. ,lt~,.dl fluid before ";..;~ it to the patient, as well as an ~ n~l vent 101 co...~ a gas inlet 10 and/or gas outlet, wL~,e~ the vent 101 ;~~r~ f~ s a porous ,,,f.l;,.." suitable for pa~s.n~
gas 1~ JU~.
The system also in~ln~e,s at least one, and more preferably at least two, flow con~ol devices 400 and 400' such as cl~mps. Typically, the system, which can be open or closed, in~l~ules one or more conl-~c~.~. For P~mple, in some embo~l;...r~ , the 15 system in~hl-les a "spike" for con.-f cl ;n~ a conduit to a cO..I;~il.f ~. Of course, in other embol;---- ~-l~, CO~ O~ t~ of the system can be connf~h~ in accGl~ce with other protocols known in the art, e.g., via sterile ~
It is i~ f~ that the present i~ ion is not to be limited to the above listed co~ one.lls of the system. For eYqn~rl~P, the system may have CO~.lt~ such as, but 20 not limited to, co...~Pcto,~, ~q.~ itit~nql co~ u s, ;.~jf~-l;.~n ports, and additional vents such as gas inlets and/or gas outlets.
As noted above, the embo~ of the device and system provide for ~enLillg gas, and vent 3 pl~u~ides a gas flow path, ~l~,~ l gas, but not liquid, passes ~ u.u~ a porous ".f.1;,~." 10. Typically, the gas passing Ihluu~ the porous ".f.1;~,. 10 passes out 25 of the device. A~ itiorqlly~ a deg~cc;i~g elF ..~ 50 provides for coqlesci~ gas such that smaller gas bubbles co~lesc~ into larger bubbles. As liquid flows through the device, the larger bubbles rise into the cer~al lumen 21. Thus, since gas bubbles are co-q-lP~ the liquid that flows lllLUU~ the outlet 2 of the device 100 is ~b~t~.l;ally deR~ csed In an e,ubo 1;-..~ some of the coqlPsced bubbles flow through the vent 3 30 and pass to the ~AL~"ior of the device.
The d~g~cs;..g rt -- d 50 can be f~cl~ nt~ from any mqtrriql that causes small bubbles in the liquid to coql~sce and separate ~om the liquid. In a pl~f~,lcd embo~ the ~ ;~ P~ co~yl~s a porous ~LIu.;~ such as a porous foam or sponge mqtr~ In ~ ;on, the deg~c.~;n~ P1~ n may be treated with an anti-fodl.liQg agen~ to aid in breaking down the film ~.~._.,n bul)bles. Suitable agents include, but are not limited to, a coll.~ d of cilironP and silica, such as Me~li 5 A~iroa.ll A, available from Dow Corni~ Mfg. Co.
The ~5~ e el~ t can have any ~uitable co~ o~, and is preferably di~po~ in the second portion 18 of the device 100, e.g., in the second rh ~ f - 20 and e~ ly across the fluid flow path from the inlet(s) l, l' (Figures l and 6) to the outlet 2.
Porous ll-P-l;----- 10, which is typically CQ-~ - ;~,s a membrane or film, inrl~ s a ophn~bic portion such as at least one 1iT~ophl bic porous c1~ or layer. The uol)hobic c~ or layer allows gas to pass lllUU~, but is not wettable, or poorly wettable, by the liquid being ~ r. .~d through the system.
In accol~e with one e"lbodhl~ t acco~ling to Figures 1-3, the porous ".~.1;..."
15 lO is disposed in the h.J..~ g 14 to vent gas through gas passag.,~ay S until the m~linm is collla~;~d or co~e~d by the liquid being l.,.n.~r .,~d. Liquid does not snb~ lly pass through the porous ...~-1; -... 10. Once the ",~.1;..." 10 is co~"ed by the liquid, the device 100 has been filled to the desired level, wi~ ul ove~i~ Under typic~l con-1;l;on~ of use (e.g., a-1n.;n;~ " to a patient), a volume of gas will be present in 20 ~e i~,ior of the h.,..~ 14, and the liquid level will remain at the desired level, or less.
A variety of mqt~riql~ may be used, provided the l.~ ; plO~ S of the porous ,.,~.1;..." 10 are ach.e~d. These p~pf ~ S include the nfcess~r~r s~ to handle the dirr~ S~S en~U~nt~ ~,Xi in use and the ability to provide the desired 25 pe~m~-qbility willlùu~the appli~qti~n of c;Aces;~ivc pl.,~ ul~,. In one pl~,R"
embo ~ f~ the ...P...klAnr, has a high surface tension and a high water inL~sio~
P~,.
Sl~itq-ble starting ~ h - ;~lc include ~ l.elic polymers in~ li~ poly~mi~les, pol~ , pol~ul,rms, particularly poly~ lene and pol~ l~l~.llene, p~rfh~ t~l 30 polyolefins, such as pol~ of~;l~lene, polysnlfon~s, polyviu~lidcn~ difluoride, polyacrylonitril~ and the like, and co...~ le ~,s of polymers. Within the class of pol~,....;~les, ~ui~ble polymers in'~h~de~ for ~ ~-..pl~, pol~ n.- :h~lene ~ a...i~P"
poly-~,apro!~~t~m, poly~ ;l~lene seb~ e, poly-7- ~-;nf h- ~t!~ s~ e, poly~ lene ~-lip~.,,iflr (nylon 46), polyl. ~; -- - lhjl~ P~"~;~1C;, and pol~h ~ a~l;p~ P (nylon 66).
Typically, the porous ,.,~;~.. 10 _as a pore size of about 5 ~ -,t~ ~ or less, 5 more p~,f~ .. bl~, about 3 ~..,lvl~l -t~,~s or less, even more preferably, about 2 llPic~..~-,t~ -~ or less. In those embo l;,n. .,t~ ;".-1.,.1;"~,, -h,.;,.;.~t. . ;~r fluid(s) to a p~tif~nt the ",.P.l;~", 10 typically has a b~çt~ l b~ rin~r pore ~hu~ , to preclude b ~r-teri~ from t,,~t ~ ;~p~ the system through the vent. Por ~ ..plP, the ,..~ 1;---" can have a pore size of about 0.2 i~ ,h,. or less. In those c~bo l;. -~ -t~ having plurality of layers, one or 10 more layers can have a bdc~ l blf~lri~ pore sl~
The device can include ~1~ n~l layers or P~ t~ e.g., for use as spacers and/or ~ul~po~ vith respect to the porous n-~l;....~ 10. An e- "pl ,~ ~u~Oll or spacer layer can be a mesh or screen.
Exemplary porous media 10, inr~ uopho~;c ~ , include those ~1icrlose~ in T"1~ lio~l Publir~tion No. WO 91/17809 and U. S. Patent Nos.
5,126,054 and 5,451,321. In an embo lim~nt ~L ;l~lf SS, S~lbi~t ~ ly alcohol-insoluble, ~ophilic pol~de membranes, such as those ~es-~ ~ ;l~d in U. S. Patent 4,340,479,are suitable. Other suitable porous media include pol~t h,.n~olu~l~lene (PTFE) membranes, inrblAi~ 0.2 micron PTFE membranes, such as those available from Pall20 Col~l~ion (East Hills, NY) under the name Hydrolon~ PlPE. Other suitable media include, for ~ntrl~ 0.2 micron PTFE l,.-- ,~h~ fs available from S~ ,o Fl~c~ric T~ s (Osaka, Japan) under the name Poreflon~. The porous media can col~ e d and/or ;l~t~ d media.
The h.~ 14 can be fablic~d from any suitable ~ ~,ious ".~t,., ;Zl, 25 preferably a rigid mq~ l, such as any thermoplastic m~tPri~l, which is co".~ ;hle with the fluid being plocessEA For example, the h.~ can be f~ tp~ from a metal, orfrom a polymer. In an ~ boA;~ n' the h..~ is a p~ ~, preferably a ~ .CpA~e,~
or t~nchl-~Pnt pol~ " such as an acrylic, pol~ l ne, pol~ ~, or a poly~l~ed resin. Such a h.~ iS easily and ~o~ ally fal~ and allows 30 obsc.~ u of the p~ss~e of the liquid ~ ,ugll the h~
The ~- - r~r~s of the h.,..~ C~ the fluid may be treated or u~ akd. For lc, the ;,-~f~ s of the ho..~ c~-"~ the fluid may be r~nd~.~d li~luo~hilic for 68478 i CA 02236409 1998-04-30 better ~ ~i.lg. Methods for h~a~hlg the surface of the _uu~ing include but are not limited to ~ ;on ~.,.rl;.,~ and gas plasma h~
The huusi~ may be co~l~;w~d for ease of use. Por t~'-, the h.J-.~ may include a bracket or hook for ease of ,--o~ or support during --l-..;n;~ ;on of a S pd~.~ fluid.
The h...J~inp can be sealed as is known in the art, e.g., via welding and/or an adhesive. Por e~aInple, first portion 16 and second portion 18 can be bonded or welded ~g. !l.--(, e.g., after fitting lip 19 into groove 29. ~"l.l;l;.~ lly, the porous ,..~ - .. 10 can be sealed within the ho~;~ 14 to achieve CO~ e of use, rapid p~;...;.~p, and 10 ~rli.~ gas cl~A.~e. Suitable ~ ;hn~s for sealing, fitting, and/or bon~ g the "-~-1;. -" within or to the h.,~.~i~ are known in the art. For e~ let the porousi"~.. 10 can be col~ ~ioll sealed or inte.r~ fit within the huu~ing, or bonded to the ho!.c;-~. The porous ,..~l;.--,. can be welded to t_e h-.~J~ , e.g., heat welded or ulh~Lson~cally welded.
In a pl~;f~ d e~b~~ the h()llcin~ 14 is ~l~,~,1 to direct fluid non-lA~- n;~lly to the fir t surface 50a of the ~le~ r~ 50. For PY~mple, the housing can include a nipple 22, having a port 23, and the huu~ing can proride for dil~ g fluid ~.~h~ ;ally pe,~en~ rly to t_e first surface 50a of th-e rlf~g,qcsing cl~ ..- n The ~o~ g 14 can include an ~l~en~ of ribs, walls or p~;ecLions, or 20 may com~lisf; one or more r.h~n.rl.c, grooves, co~lui~, pass~es, or the like which may be s~ ,~i~, pqrallf l, curved, radial, spiral, or have a variety of other con~lr~tionc.
Typically, at least one ~ç~ ion faces the first surface 10a and/or faces the second surface 10b of the porous ~.~f~rl;.l.n 10. The ribs, w. lls or l~uje~lio~s may be used to define the rllqnnPlc, glOO~.,S, cQ~ul~ , or pqcc~Ps Typically, the huu~ 14 inrhl~lPs at least one rib, wall, or pl~;f~lion to support andlor po~ ;o~- the porous n~.li.. 10 within the hu -,;~ some emho lin~f .n~i, the hu~ -g inrllldes at least one rib, wall or pLUj~;~ to i~ro~ the ~ of gas flow, e.g., by ~pol~ g or pGi,i~ning the porous Illf'-l;ll"~ 10 within the housi,lg while providing cl~ e ~h.~,cn portions of the first surface 10a and the ho-- si.~ .
Typically, as i~ -, t~ in Figure 2, first portion 16 ;n~ludf s ribs 25 and ch~nflc 24, which are ~l~f~,.~l~ cQ.~nl~.r ribs ~d C~ e, to allow more erl;ci~nlflow of gas to the gas passa~ .~ 5. The first portion can also have radial rl~an.~Flc 27, 6&478 CA 02236409 1998-04-30 and at least one, more preferably, at least two, ~ ;n"~l ribs such as co.~ ;c ribs 26 and 28. Pigures 2 and 3 also ilhl~t~ rib 26, that plef~ably pO,;I;.?~.c the ,,,P.l;..." 10 with respect to first portion 16.
In the eInbo~limp-nt ill-.~ ~l in Figure 1, the first portion 16 and the second S portion 18 are sealed to form a first rh~ her 15 and a second ch~ lx 20, ,...p~csi~ lumen or central portion 21. The first and second ch~-..h~-~ can be similar in volume, or one rh~mhPr can be larger in volume than the other. For ~r , 1~, in some e.llbo~ accol.ling to Figure 1, the ratio of the volume of the first ~h-...l~ to the second ch~...~ can be in the range of about 1:1 to about 3:1.
In some c mbo~ c, the device 100 can also include a cap or closure, e.g., for cu~e~mg or sealing port 30. Por ~le, in accol~la~ with any e,ubo~ of the device 100 a cap can be used to cover port 30 to prevent the entry of gas, and to u~.,r port 30 to allow gas to exit the device.
The device 100 may be incGl~.?~at~d into a variety of fluid ll~r~. and/or processil~ S~lllS or sets. Embo~;n~ . of e~el~ t,,~s 500, 501, which are preferably pale~.~l fluid z.l.,,;n;~l",l;o~ sets, are ill~ ~ in Figures 7 and 8, Typical embo~l;... 11e of the system 500, 501 include at least one co~ r, more preferably, at least two co~ 200, 200' for holding the fluid(s) to be lla~r."l.,d, and one or more co~ that provide fluid c~,.. ~n;~ n ~l~xn the co.~ nf r, thedevice 100, and the ~e~ - of the fluid, e.g., a padent l~C~;Vi~g the !~ r. l~
fluid. As i~ in Pigure 8, the system 501 can also include at least one filter 300 for filttori~ the fluid to be l . ~ r. . . ~d.
The co.d~;nf . 200, 200' which can be used in the system can be co~~ ;h~d of 25 any ,..;~l- ;Al ct~ ;hle with the fluidto be !~ r~ d. A wide variety of suitable co.-1~ are already known in the art. Typically, co"t~;n ~ 200, 200' cc....~ ,s a flexible ~--~1; - ;al, for eA~lc, polyvinyl chloride (PVC). An f~Yf ~ / CO-~ f~ iS a flexible bag, e.g., as is used for ho~ ~ blood or blood co~n~ and/or saline.
~lh."~ , the co-l1;~ f .. may be CO~ OS~ of a non-flexible material. It is ;~r ~
30 that the i~ iull should not be limited by the type or co~ o;,;l;o~ of the co..~;~ ~ being employed.
As with the co~ ;n~ ~, the co~.~h~ 201, 210, 219, 220, and 230 can be 6 ~78 CA 02236409 1998-04-30 constructed of any mqtPriq-l that is co...p-~;ble with the fluid(s) to be Ll~f~ L
Typically, the co..~]~ COlll~l~ n.,Ai~le mqt~riql A pl~,fe.l~,d mqt~liql is PVC, for el ~n~l k~. As used herein, the coll-lui~ are any tubing or means which provide fluid CQ-----~n;~-l;O~ b~,h.e-,n the various COlul~v~ ~ of the a-l~ n ~t.
At least one flow control device 400, 400' such as a cl. mp (i~ l---l;"~, for e~...plf-, a roller clamp), seal, ~lopcorL, valve, ~la~f~. leg closure, or the lil~e, _ay be ~cs~; ~ with at least one of the co~i~ in order to f:~~ilitqt~ a desired Ç~ , i.e., to open, close, and/or m~~ e the desired flow of the fluid (e.g., pa~n~.~l fluid) and/or gas. In some e.llbo~1;n.Fn~, particularly for some of the ~ ..l~l;n.. .l~ that 10 include ~ t~ 8 fluid to a patient, the flow control device 400' dow~lL.,alu of the device 100 co...l.. ;.~c a roller clamp to control the flow rate.
As i~ al~ in Figure 8, the system 501 can also include at least one filter 300, to filter the fluid to be ll~f~ ,d. A variety of filters are ~LIi~ble for use in the system, e.g., IV filters, e.g., for ~.l."in;.~t~.. ;.,~ drugs and/or ..~l. ;F ~I~; and blood filters, 15 inrl in~ Clvaggf~ga~ filters and/or leukocyte depletion filters. Typically, the filter con~l..;.C~s a filter assembly, inrlllr~ a k.~ ing having an inlet and an outlet and providing a fluid flow path ~,en the inlet and the outlet, and a porous filter ".~1;~
for filtP~in~ the fluid di~oscd ~e~._.,n the inlet and the outlet and across the fluid flow path.
In some c.l~bo~ , inrhlrlin~ those embo~ that include at least one filter, the system may include at least one ~ lrlifff)nql vent c~.",l.. ;~in~ a gas inlet and/or gas outlet, wLc.~ the vent inrhllies a porous "~1;---,- ~ui~ble for pa~i~ gas ll,c~lluvu~. For ~ le, Figure 8 i~ s an ~lubodi~,~ of a syste~n 501 inrhl~fli~ a vent 101 such ~ a g~ outlet i~.~osed ~t..~ , and in fluid co~ ni~-l;
with, filter 30C) and device 100.
As noted earlier, the sys~em may have a~lfl;l;~ l c~..l~n~-nl~ such as, but not limited to, conn~v~ ;l;on~l co..l;.;..- ~ ecLion ports, and ~d~ n~l vents such ~g~ inlets and/or gas outlets.
~ ubof~ of a ~--I Il-f~ acco~lin to the ill~.,~ion include lorv~ the device 30 in a fluid flow path ~t~,e~l a source of fluid, e.g., a contai~, and the ;nr nfl~d de,l;n~ Jn of the fluid, e.g., a patient, and l.,.. ~ ~.;n~ the fluid lu~u~ the device.
For eYD~ le, l~f ~ - ;-.~ to the e ~- ,"~1D~ eInbo~1im~nt ill--~ r ~i in Figure 7, fluid flow control devices 400, 400' such as clamps u~ Le&ll and dOw~~ of the device 100are typically closed initially, and then the flow con~rol device u~ ,alu of device 100 is opened, to allow fluid to enter the h.~ ;r~. Since the flow control device dow~
of the device 100 I.,~ai~s closed, gas (e.g., gas ~ ~~1 into the hv~ by liquid S pa~siu~ (JU~ the CQ~ (S~) passes through the vent 3 as the device fills with liquid.
After the device fills to the desired level, the flow control device d~l.~ of device 100 is open~ and the fluid is p~sed to the desired ~lin~t;.Jn In those Fn~ eill fluid is passed at a high rate ~ vu~ the device 100, e.g., wl~m the patient ~ s one or more units of blood p~lu~ at a flow rate of at least about 100 cubic c~ lt;n.~r ~.~ (cc's) per minlltje, more ~l~,fi,~abl~, at least about 300 cc per minll~ even more p~f~,.ably, at least about 400 cc per milmte, the fluid passmg 11LVU~ the (i~g~ss;n~ el~ 50 is ~;~ as smaller bubbles coqlPs~e into larger bubbles that rise in the lumen or central portion 21 of the device. In an emho~limPnt, some of the coqlpsce~ bubbles pass through the vent 3.
In acc.l~n~e with pl~fe 1~,1 embo~ t~ of a method accof~i~ to the invention, the device allows the O~ atOl to observe fluid flow even at the higher flow rates. For e~n~ the O~aLOl can observe drops of liquid ~ -~t - ;.~ the device, or a stream of liquid f~ the device. Thus, the device does not "overf~" during use.
Mol~o~ , while the device is s~it~ble for ~.h..;..;-~in~ fluid at high flow rates, it is 20 also suitable for use at lower flow rates, and thus can be used during the entire fluid a~l~n;~ aLion p~ocol. The device should be co~ u~ to lla~r~,~ the fluid quic3~1y.
In a p~,f~ d e ..I~l;...- ~-~ for use with biological fluid, the device has a small hold up volume, e.g., about 15 cc or less.
Using Pigures 1 and 7 (ill..~ an e .ubo~l;...- ~~t of the device 100 and system 25 500, ~w~e.,Li~ ), for l.,f. .~,~ce, fluid is passed, e.g.; using a pump or by gravity, from co.~ f ~ 200 l~ u~ at least one conduit to device 100, ~vhile the flow control device 400' d~w~lL~ of device 100 is closed. Liquid and gas enter the h....~ o 14 via inlet 1. l?~,f~,.ably, device 100 (~igure 1) inrll~es â nipple 22 and a port 23, and fluid passes into lumen or central portion 21, and the fluid is dil~.,t~d non~ ;ally (e.g., 30 ~ b~ lly pc~ rly) to the first surface 50a of the ~k'~ el~ f .lt 50. If desired, fluid can be d ~ ,t~ into the ce~al portion 21 in the form of droplets.Pluid f,.~t..;.~ the lumen or cen~ portion 21 c~ t ~1~; the ~ega~ elo-nf-n~ 50 in the second ch~mher 20. Since the fluid flow path dow~~ of the device 100 le~a~c closed, the device acts as a l ~ ..~rùi~ ~ second ch~ ~he~ 20 fills with liquid. As the second ~.h---.l~, 20 and rlf'5~ ClP~ p~ 50 fill with liquid, gas is displaced. Some of this gas is vented from the device, i.e., the gas passes from the i l~.ior of the 5 h.~ ;n~ along a gas flow path lhL~u~ porous ".P.l;~..n 10 via surface 10b and surface 10a, and lll~u~ port 4 and gas pa~,_~.~ 5 to the t~ ;0~ of the h.,..c;n~ In those e.ubo~ r~ wL.~m the h.,..~ s ribs and ~.h~nn~lc~ e.g., ribs 25 and ch~ lc 24 and 27 as ill~ rl in Figure 2, gas pacses along ch~ c 24 and 27 through port 4 to gas p~c~ ..~ 5 to more e r~ vent the device.
Second ch~ hc~ 20 (shown in Figure 1) co.~ s to fill with liquid, and e~ally, the level of liquid will reach surface 10b of porous ."~1;~" 10. Once liquid covers the surface 10b, gas flow lllUugll the vent 3 stops, wi lluul liquid s~ r ..,~;ally pasi,iug t~rough the ~, ~1;---" 10. Once the gas flow stops, the device 100 is filled to the desired level.
~ some embo~;.. ~ .l i, gas flow stops when the device 100 is about 2/3 filled with liquid. Illu~ ivcly, when passing a red blood cell-co~ fluid such as packcd red cells (PRC) or whole blood into the device, the device has a total Ca~a~ of, for e~ample, about 15 cc, and gas flow stops when the device co~i~s about 10 cc of liquid. In a~ cmbo~ when passing a plat~let co~t~ini~g fluid such as platelet 20 con~F~ ~ (PC) into the device 100, the device has a total Cd~ily of, for e~lc, about 9 cc, and gas flow stops when the device cont~inc about 6 cc of liquid.
Once the device is filled, the ~ "~ of the sy-stem can be prim~, and the Liquid can be del;~ ,d as desired. For e~ , using Figure 7 for ~f~ ce, the flow control device 400' duw~ll~,~ ûf device 100 (e.g., a flow control device such as a 25 roller clamp) can be opened, and the fluid can be ~ ~d to a patient. Typically, a volume of gas will be present in the in~erior of the h....~ 14, and the liquid level will re ain at the desired level, or less, during ~.n;..;.~h,.~;ol~
As noted earlier, it may be nFce~ to ~I...;n;~h ( fluid at a high flow rate during at least a portion of the patient treatment or ~l",;~ h ~;on ~lotûcol. Such a 30 prot~col may include ~ g stored blood or blood coll~l~n~ i (e.g., to the pa~ l'S
body t~ ) and pdSS~ the ~.alll,ed fluid through the device 100. As the blood is ~ 1, gas is l~,ledscd in~o the blood. While the volume of gas l~,l~d into the blood is SOll~ .haLul~p ~li~;~ble, the ~cg~c.ci,~ 50 in device 100 provides for reliably coqlPsci~ smaller gas l,~l~les into large bubbles, . nd the larger ~bbles rise in the lumen 21 of the device. Thus, once the system is primed, the fluid pa~ g through second surface 50b of ~le~~~in~ elP~ .n 50 and exiting the device 100 through outlet 2 5 is s~ ly de$~sed Typically, the ope.ator of the system will be able to obs.,~c fluid flow, e.g., ~ plet~ of liquid, or a liquid stream er~ering the device during the ..;ni~ plo~ocol.
In an e ..hol;n.- n~, after q,~l-,-;n;.~ n of the fluid is ~ lly completed, someof the liquid ~t~i~ in the device can be ~ ;n;cr ~,d to the patient. For example, gas can be allowed to enter the device 100 through port 30 (Figures 1 and 6), and some of the liquid l~ ~i~ in the device can be passed to the patient. In those embo~l;... ,l~
wll~ port 30 was capped after the ini~l ~,nti~g of the device 100, the O~ Ol of the system will uL~u~r or uncap the port to l~O~ some of the fluid l-,~i~ in thedevice 100. After allowing gas to enter the device, the op~- -tOI can m~ml~lly stop the 15 flow of liquid before g~ can reach the patient.
If desired, the device 100 can initially be filled to a desired level with one fluid, e.g., a non-biological fluid such as saline, and after the ~~evice vents gas and fills with this liquid, the liquid is a~ ed and then a second fluid, e.g., a biological fluid that is co~ ,.Lible with the non-biological fluid, is passed through the device and 20 ~.l...;n;~ d For c~ , using the system 500 shown i~ Figure 7 for l.,f~ cc, a p~,~,al fluid such as saline can be passed from con~i~r 200 to device 100, and gas is ventcd, and then the fluid is ~.l...;n;~ ,d as ~.~s~ ;l~d above. Sul~se.lu."~ n~ f,r pd~ l fluid, e.g, a biological fluid such as packed red blood cells, is passed from co.~1~;nf ~ 200' ~ uugh the device 100 and then to the patient in a genP~lly similar 25 ,.,~nnf ~ as ~ r. ;l).3~i with respect to the first fluid. In a pl.,f. ,l~d embo~ , the Opf~d~O~ of the system can observe fluid flow through the device with each of the first and second fluids during î-l.";ni.~l...l;on As noted earlier, and as shown in Figure 8, the system 501 can also in~ p a filter 300 such as a lcuLuc~lc ~lf.~letion f~ter. For ~ plfe~cQl~t~;n , 200' co.n~ a 30 lcu~ c-co--~;--;-.~ biological fluid such as blood or a blood CO~ lf~ll, and the l~;olo~ l fluid can be ~l...in;.~l as following. Using Figure 8 for l~,f. ,~,~ce, the flow control devices 400, 400' are typically initially closed, and the flow control device 6~78 CA 02236409 1998-04-30 400 ~l~n the co~ cr of leu~ cG.~ ;n;.~ biological fluid and the filter 300 is opened. If desired, the co.nA~I~f,~ of biological fluid may be s~ to more err~ r~ y prime the filter 300. Gas displaced during the p. ;...;n~ of the filter 300 is passed through co~uil 219 ahead of the biological fluid, and passed lL~u~ the vent 101. If 5 desired, the vent 101 can p~v~ide for sep~ gas from the biological fluid flow path.
After gas is passed 1~ U~ the vent 101, the flow control device 400 ~s~i~h ~l with c~ h~;l 220 is openP~l and the biological fluid, along with some air ~plac~ fromco~L ~o, enters the device 100.
Device 100 vents g~ and fills with liquid ~ ~ ~l ;l~d earlia. After the device 10 a~lu~ l;r~lly ven~i and fills to a desired level, the flow co~ol device 400' duw~ll~
of device 100 can be opened, the rest of the system can be primPd and the liquid can be ;~-1.";";.~ip ~ to the patient.
In a v~n~ n of the t~b~l~n- ~~ of the ~A ~s ill..~l."~ in Figures 7 and 8, the device 100 can include ~p . Z~h- inlets for the ~rr~ ~nL par~ fluids. Por 15 example, the embodiment of the device 100 ill~ d in Figure 6 can be utilized in such s~L~s. The ~:~tL~S can be o~.d~d as gen~lly ~sçrih~l above, with the ~c~lir~ ion that one fluid enters the device via inlet 1, and the other fluid enters the device via inlet 1'.
In a variation of the device ill--~l.,t,~d in Figure 1, a conduit is co...~r-c~ed to port 30, and the device laclcs a porous ",~li~n, 10 in the h.. c;n~ 14. The end of the co~.huL
not co..,-Fc~l to the port 30 is typically closed, or colln~eled to another co~ t of the system, such that gas P .h ~ ;.~ the device is passed from the h.)--~i~ through the port 30 and into the coldluiL, wL~lem the conduit plo~ides a bubble trap.
All of the lefe.e~ces cited herein, inf~ pllh~ qtionc, p~ntc, and patent appli~ ionc are hereby i~col~lat~d in their e~i,.,~es by l~,f~ ce.
While the invention has been ~e~ d in some detail by way of il~ ................ and e~k, it should be ~ tood that the iu~ ~ioll is ~;cep~ible to various mo~lifi~ 7n.c and ~ n ';ve forms, and is not ~i~ 't~;~ to the ~pec;fi~ e,l.bo~ set forth. It should be ~n~ ~o(l that these Sp~;lir P...~1;.n. ~ are not ;nh ~fled to limit 30 the i l~_~ioQ but, on the cO~L,~, the intPntiQn is to cover all mn~ ,.l ;on.c, e~uivalents, and ~l~ ~" ~ s falling within the spirit and scope of the i~ ~io~.
T~h~ Al Field This ~e~io n relates to a device and method for ~ G ~ ¢ fluid, especially for ..~in;...;,;n~ the p~~nce of air bubbles in ~ ,d pa~ al fluids, e.g., saline 5 and/or !.A..~r.~ such as blood Co ~acl~ ld of the L~ tiun Many fluid lLa~r~ ~t~ s such as fluid ploc~ a,~i~t~ 5 r.. 1;O,, more l~r,. ..ll~r if they can be at least partially purged of air or gas before use. A.~ itio~qlly, some ~ r." s~ , e.g., for ~-~lll;n;~h(;l~ fluid to a pa~en~ should ...il-;~..i-,~ or 0 ~ ,nt air or gas from passlrLg beyond a certain location in the system. For example, some illlLa~r~,Ll,UUS av) i~ ,t~ s include a drip chamber or a bubble trap to ca~uLe air or gas so that it will not be ~ d to the patient. The drip ch-...~r can also be used to allow the opelator of the system to ...o~ o~ the rate at which the fluid is ~ d.
For example, the Op~aLûl may obsene the drip ~~h~ kcr to ensure that the patient is 15 ~ce;~ g the liquid at a given rate, e.g., a rate of so many drops of liquid per minute.
If desired, the rate can be ch~;d and the new rate can be ,...,~.itv~d by obsG.v~ the rate at which the drops of liquid pass through the chaLu~.
There are dLa~ac~ to conv~ ;on~l fluid LLa~Sr~ ~ LLS, especi~lly when used to ~La~r~,. fluid at a high rate. For ~pk, during a trauma situation, e.g., when the 20 patient lCCf~;~.,S one or more units of red cells andlor saline at a flow rate of several hU~L~dl cubic c- ~1;...- r~.~ per minntf ~ the fluid in the drip Ch --..h ~ can b XO~ foamy, and it can be r~ lt to ple~nt ~,~Lap~ed bubbles f~om passing with the blood and/or saline through the drip cll~-"l~ to the patient. The pl~,bl_m is incl~ since the blood may have to be ~all..ed before t-, ~ru~iO~-, and ~aLIlPi~lg the blood causes air to be 25 1f 1P~ into the blood, m~ki~ it more "foamy~ n A(l~lition~11y, the drip l'h~ hF~ can fill too quickly, and a high level of fluid in the ch~mher can provide ;... -rl;~ space for a drop to folm before it co..l; -l~ the fluid in the chamber, maldng it (1imrl11t to count drops. As a result, the op.~t--r cannot rl~t~....;.~f the flow rate. In some ~ ;ol-~, the fluid level and/or the ple~.lce of foam can be such that the opel~tol is unable to quicldy d~ if blood is actually being ",;,~;~r~ ~,d.
The present iu~.llion provides for ~ iold~ at least some of the disa~lv~-~tages of the prior art. These and other ~l~,~L~es of the present iu~e~lti~ will S be ap~ from the des~ tion as set forthbelow.
S~ of the Iu~
In accol~ with an e ubo~ f ~t of the present i~ Liun, a fluid ~ rf ~
device such as a drip ch ~ iS p~vided that is capable of ~ r . ;~ liq!lid at a high rate, and ~,~iilg gas, while coqlPsci~ bubbles that are le.llu~d from the liquid flow 10 path. In a more pl~,f~ d e~bo~ t the drip ch~ ~ canbe filled to a desired level of liq~id, wL~.~m the qml)llnt of liq!lid in the ~h~ is less than the tot. l liquid capa iLy of the ch-~..hPr~ and the G~c.aLo~ of the ~.h-...~ can observe a stream of liquid, or drops of liquid, ent~..;.~ the chqmbPr.
Brief Descli~tion of the DldwlllgS
Figure 1 is a cross-s~l ;- n~l view of an c~.lbo l;~ n~ of a venting device acconli~g to the present ..1~ ntion.
Figure 2 is a view of the device of Figure 1 along line A-A.
Figure 3 is a view of the device of Figure 2 along line B-B, sL~wi~g a porous .1;.- ., for passing gas l~. ~l~uugh located in the device.
Figure 4 is a cross ~ I;onal view of the upper cl~nhf-- and the porous m.o~lillmof the device of Figure 1.
Figure S is a cross ~ ~ nal view of the lower ch-~..ke of the device of Figure 1, ~L~w~ a ~g,~ el~ for co~l~srir~ gas bubbles located in the ch~mher.
Pigure 6 is a cross ~I;onal view of another en~ ..f n~ of a ~l~n~ , device 25 accol~iQg to the present invention.
Figure 7 is a s~ h- ..~l;r view of a system for !~ .n.~ g a fluid in accolddn~
with the invention, inrl...l;u~ the ~ g device ilh.~t~ in Pigure 1.
Pigure 8 is a srh. ~~. ~1;r view of a system for ~r~ g a fluid in accol~ce with the ill~ ~ion, in~ i~ the ~ g device ilhlstrated in Figure 1, and a fluid filter.
6~78 CA 02236409 1998-04-30 Specific De~li~ion of the Invention In accû~l~ce with the present in.~nLion, a device for l~d~r~ fluid is provided c~---p-;~;~ a h.)--~ co~ ing a fluid l~,se~ioi~ for gas and liquid; a vent and a ~kg~ic;~ e~ 1 co..,...~ ;r-l;.u with the h.~ , the vent Cf~...p.;.~ a S liquophobic porous ",~.1;,-.,. that allows gas in the h-3--~ to pass through the .n~,.l;---~.;
the ~leg~ e~ --..~ .l Cul~ a coq1PscP,r that co~lPsces gas l,~les and forms larger bubbles that rise in a cen~al portion of the h(~u~ing, the vent and the housi~ being cQo~-. ~ . ly ~ i to allow the gas to be vented from the h....~ . In an embo~ 1 the vent, the ~ s;.~ elP .~. n and the h.,..~;~ are COOpe~ali~- ly 10 ~l~d~g~ to allow the gas to be vented from the h...-~ . Preferably, the device allows id to fill the h-,--~;~ to a level that is less than the total liquid Cdpd~ily of the hrJ..~
Typically, the device for ~ r ~ fluid cn...p. ;-~ s a flow ...~ t~ device such as a drip ~~ha"-her that directs fluid non~ - ,l;any to a first surface of the ~1e~ .ei~
15 pl~ ~rn~ The device may also include a structure such as a cap, plug, and/or valve capable of e ~pag;~ with the huusillg, e.g., to cover and/or seal the vent.
The present invention also provides a drip cha.n~f r CO~ ;!C;n~ a housing inrl~ a ~ uophobic porous m~ 1m and a ~g~ e~ n~ ~1 the device allowing liquid to fill the h....~ to a pre~1etf ...;nf~l level, or less, wilhouL con~le~ely filling the 20 h.,..~iQ~ with liquid, the ~1eg~ elc .~ coqlP~eci~ gas bubbles and folll~~g larger bubbles that rise in the central portion of the h-JII~iQ~, and the liquophobic porous ,..f~ " allowing gas to pass from the housi~g.
In accGl~ ce with the hl~ io4 a system for ~ at least one fluid is p~ided, the system CO~U~l~ ~g the device for l.A,.~r. ..;.~ fluid, and a C~
25 ~ui~le for ho1~i~ a fluid to be I . A.,~r. . I~d, wll.,.~,~ the device is in fluid co...--.~ a~i~ n with the contain~. In an embo~im~nt, the device c~...l.. ;. es a drip chqmh~r, and the system also in~hlcles a filter, e.g., a blood filter, i~osed bel~e.l a co.~ in- ~ suitable for hol~ a fluid to be ~ r ~ .~,d, and the drip r1~an~hc~ In some embo 1--,--~ , the system inrhlcles a plurality of cont~in~ ~ e.g., suitable for holding 30 dirf,..,~ fluids to be l~ A~ d.
The present h~e~ltion also p~idcs a m.oth~l for ! ~ ,....~r~.. ;-.~ one or more fluids con~ passing a fluid CQ.. l.. ;.~in~ a liquid and a gas into a device cc.. l~ ;n~ a i~ inl~hJ~li~ a fluid l~se.~oi~ for gas and liquid; passing liquid into the housing and g gas from the device, wl~ venting ;n~ J~5 passing gas through a li~luophobic porous ,..e~ ." un~l the liquid collth~ the porous ...~ ..; coql~sci~ gas bubbles and allowing the co~l~ed bubbles to rise in a cen~al portion of the ho~ , and passL~g S liq!lid from the device. In a pl~,f~ ,d e ~,bo~ d, the mf th~ inrl---les di~,Cli~l~ the fluid non~ E~.n;~lly to a first surface of a ~ e ell ..f nr that cs~lesc~s bubbles, and obs~ g drops of liquid ent...;n~ the ceD~ral portion of the hn..~ , wll~,~ the k.~ i~ is filled to a level that is less than the total liquid Cdpaci~ of the ~us~g.
Typically, one of the fluids to be ~ r. ..~ is a biological fluid such as blood or 10 a blood colll~on~,~, and e~ ..- nt~ of the method also include ~.ln,in;.i~ the biological fluid to a patient.
Emba1;..~ .~i of the present in~ tion p~u~i~ for e~rr;.~ t ~--~t;on of gas or air from a fluid flow path, and the present i~ n~n is par~cularly suitable for those pal~,~lal fluid ~ ..;n;~ ;Qn plot~cols that require ~.~r.,llh~g at least one p~t~
15 fluid (e.g., a biological fluid such as blood or a blood COlll~O~) at a high flow rate during at least part of the p~t~col.
As used herein, the term "gas" inr~ es air. In accol~c~; with the invention, a biological fluid inclll~es any treated or u~a~d fluid ~co~ with living olg~n;~...~, particularly blood, in-~l..tl;ng whole blood, warm or cold blood, and stored or fresh 20 blood; treated blood, such as blood diluted with at least one phy~iologi~ ~l solution, inr~ i~ but not limited to saline, I~ ;f.~t, and/or ~ntiro~ nt sollltirmc; bloodCOl~ C~t~, such as platelet con~f--l~ (PC), platelet-rich plasma (PRP), platelet-poor plasma (PPP), platelet-free plasma, plasma, fresh frozen plasma (~), co~ ?o~
obt~i~d from plq~nq packed red cells (PRC), !.~n-:l;. n zone rnqtPriql or buffy coat 25 (BC); blood products derived from blood or a blood CO~o~ s~ or derived from bone ~ 'V; red cclls sep-~ from plasma and l~ ~ndf~l in a physiological fluid; and plqtPlPtC ~,p~.~.l~ from plasma a~d l~ . nd~d in a physiologlcal fluid. The biological fluid may have been treated to remove some of the lcu~oc~s before being pç~ed accoldillg to the L~.,~ion. As used herein, blood ~ or biological fluid refers to 30 the C~ fll~ rle~-;l~d above, and to similar blood p~ or biological fluids obt~i~ed by other means and with similar p~pe~lies.
A "unit" is the ~lu~ity of biological fluid from a donor or derived from one unit of whole blood. It may also refer to the qu~~ drawn during a single donation.
Typically, the volume of a u~it varies, the amount ~I;rr. ;.~g from ~onq~ion to donation.
Multiple units of some blood col~ ts, particularly pl~t~ and buffy coat, may be pooled or col,.b~d, typically by Cu~ ~g four or more units.
S Each of the colllpon~ of the i~ lion will now be d~ ;bed in more detail below. Like Co~ o~ts have lil~e l~,f~ ce ....~
In the ~ a~ c~bo~ .n i~ fd in Figures 1-6, device 100 inrl~ e~e a h~)..ei~ 14, having at least one iDlet 1 (Figure 6 shows an ~ ;r)n~l inlet 1') and an outlet 2; a lumen or central portion 21 for fluid flow ~.~n the inlet and the outlet; a 0 ~cg"C-c;~ Cl~ d 50; and a vent 3 providing a gas flow path.
The di~g~ ng el ~.. nl 50 coa 'S small b~ l)bles into larger l,~bks that rise into the central portion 21, and COlllpli3eS a porous ~llu~;t41~ having a first surface SOa and a second surface SOb. The vent 3 c~...p~;~çs a porous ..~ 10 that allows gas, but not liquid, to pass from the lumen or central portion 21 ~ uugh a port 4 into a gas p~sageway 5 and through a port 30. Typically, porous ",,.l;.. 10 is located in the hvu~i~g 14, and h~ a first surface 10a facing the inlet 1 and 1' (Figures 1 and 6), and a second surface lOb facing the outlet 2. Preferably, porous ,..P.l;..n. 10 has a portion of the first surface lOa near or ~dj ~c~nt to port 4 of gas p~sageway 5.
Typically, as ~ t' ~1 in Figures 1, 3, and 4, housing 14 in-~hl~les a first portion 16, having an i~let 1, and a groove 29. The first portion 16 also in~ Ps a nipple 22 having a port 23 leading to central portion 21. P~ef,.ably, the nipple n and port 23 direct the fluid non~ e~ ;ally toward the first surface 50a of the ~P~ ;ng el~ .l 50. If desired, the hvusing can be ~ang~d to allow liquid to enter the ce~al portion 21 in the form of dlùpl~.
As i~ t~ in Figures 1 and 5, hu~mg 14 also in~ dc5 a second portion 18 having an outlet 2, and a lip 19. In l:he ~ bodil l~ shown in Figure 1, the first portion 16 and the second portion 18 are sealed to form a first chqmh~-r 15 and a secondchC .. l~ ~ 20 enco~ya~ lumen 21 and porous ",.'.l;.. 10.
Preferably, as ill- ~ ~ in Figures 2 and 3, porous .n~.l;.. 10 iS ~nmll~r in shape, and surface lOa faces a series of ribs 25, 26, 28, and/or c~ n~lc 24, 27 in the first portion 16. Typically, in those e.~,bo~ ..- nl~ having an amlular porous ,..~-1;- -,. 10, the ribs 25, 26, and 28, and the cl~ n~lc 24 are gen~lly c~ nl . ;~.. In the m~ t~fl emho~limPnt first portion 16 also in~ludes radial c~nnflC 27.
Figures 7 and 8 illllc~te embo 1;... ~~1~ of qpical s~:itL~s 500, 501, utili7i~
device 100 during the ll~r~ of at least one fluid (e.g., a p~lltelal fluid) to a desired ~c~ ;on In these ~ c~ embo~ t~, the system in~ 5co~ ;nf~ 200 and 5 200' for holding one or more fluids such as pa~,al fluids, ~1~ the co.~ are in fluid co.. ~ n, via cr~lu~ such as cQI.~h~ 201 and 210, with the device 100, and the destination of the fluid, e.g., a patient. Figure 8 shows system 501 i"-l...1;.,~
~d~lition~l c~ 219 and 220, a filter 300, e.g., for filtPriT~ a p~. ,lt~,.dl fluid before ";..;~ it to the patient, as well as an ~ n~l vent 101 co...~ a gas inlet 10 and/or gas outlet, wL~,e~ the vent 101 ;~~r~ f~ s a porous ,,,f.l;,.." suitable for pa~s.n~
gas 1~ JU~.
The system also in~ln~e,s at least one, and more preferably at least two, flow con~ol devices 400 and 400' such as cl~mps. Typically, the system, which can be open or closed, in~l~ules one or more conl-~c~.~. For P~mple, in some embo~l;...r~ , the 15 system in~hl-les a "spike" for con.-f cl ;n~ a conduit to a cO..I;~il.f ~. Of course, in other embol;---- ~-l~, CO~ O~ t~ of the system can be connf~h~ in accGl~ce with other protocols known in the art, e.g., via sterile ~
It is i~ f~ that the present i~ ion is not to be limited to the above listed co~ one.lls of the system. For eYqn~rl~P, the system may have CO~.lt~ such as, but 20 not limited to, co...~Pcto,~, ~q.~ itit~nql co~ u s, ;.~jf~-l;.~n ports, and additional vents such as gas inlets and/or gas outlets.
As noted above, the embo~ of the device and system provide for ~enLillg gas, and vent 3 pl~u~ides a gas flow path, ~l~,~ l gas, but not liquid, passes ~ u.u~ a porous ".f.1;,~." 10. Typically, the gas passing Ihluu~ the porous ".f.1;~,. 10 passes out 25 of the device. A~ itiorqlly~ a deg~cc;i~g elF ..~ 50 provides for coqlesci~ gas such that smaller gas bubbles co~lesc~ into larger bubbles. As liquid flows through the device, the larger bubbles rise into the cer~al lumen 21. Thus, since gas bubbles are co-q-lP~ the liquid that flows lllLUU~ the outlet 2 of the device 100 is ~b~t~.l;ally deR~ csed In an e,ubo 1;-..~ some of the coqlPsced bubbles flow through the vent 3 30 and pass to the ~AL~"ior of the device.
The d~g~cs;..g rt -- d 50 can be f~cl~ nt~ from any mqtrriql that causes small bubbles in the liquid to coql~sce and separate ~om the liquid. In a pl~f~,lcd embo~ the ~ ;~ P~ co~yl~s a porous ~LIu.;~ such as a porous foam or sponge mqtr~ In ~ ;on, the deg~c.~;n~ P1~ n may be treated with an anti-fodl.liQg agen~ to aid in breaking down the film ~.~._.,n bul)bles. Suitable agents include, but are not limited to, a coll.~ d of cilironP and silica, such as Me~li 5 A~iroa.ll A, available from Dow Corni~ Mfg. Co.
The ~5~ e el~ t can have any ~uitable co~ o~, and is preferably di~po~ in the second portion 18 of the device 100, e.g., in the second rh ~ f - 20 and e~ ly across the fluid flow path from the inlet(s) l, l' (Figures l and 6) to the outlet 2.
Porous ll-P-l;----- 10, which is typically CQ-~ - ;~,s a membrane or film, inrl~ s a ophn~bic portion such as at least one 1iT~ophl bic porous c1~ or layer. The uol)hobic c~ or layer allows gas to pass lllUU~, but is not wettable, or poorly wettable, by the liquid being ~ r. .~d through the system.
In accol~e with one e"lbodhl~ t acco~ling to Figures 1-3, the porous ".~.1;..."
15 lO is disposed in the h.J..~ g 14 to vent gas through gas passag.,~ay S until the m~linm is collla~;~d or co~e~d by the liquid being l.,.n.~r .,~d. Liquid does not snb~ lly pass through the porous ...~-1; -... 10. Once the ",~.1;..." 10 is co~"ed by the liquid, the device 100 has been filled to the desired level, wi~ ul ove~i~ Under typic~l con-1;l;on~ of use (e.g., a-1n.;n;~ " to a patient), a volume of gas will be present in 20 ~e i~,ior of the h.,..~ 14, and the liquid level will remain at the desired level, or less.
A variety of mqt~riql~ may be used, provided the l.~ ; plO~ S of the porous ,.,~.1;..." 10 are ach.e~d. These p~pf ~ S include the nfcess~r~r s~ to handle the dirr~ S~S en~U~nt~ ~,Xi in use and the ability to provide the desired 25 pe~m~-qbility willlùu~the appli~qti~n of c;Aces;~ivc pl.,~ ul~,. In one pl~,R"
embo ~ f~ the ...P...klAnr, has a high surface tension and a high water inL~sio~
P~,.
Sl~itq-ble starting ~ h - ;~lc include ~ l.elic polymers in~ li~ poly~mi~les, pol~ , pol~ul,rms, particularly poly~ lene and pol~ l~l~.llene, p~rfh~ t~l 30 polyolefins, such as pol~ of~;l~lene, polysnlfon~s, polyviu~lidcn~ difluoride, polyacrylonitril~ and the like, and co...~ le ~,s of polymers. Within the class of pol~,....;~les, ~ui~ble polymers in'~h~de~ for ~ ~-..pl~, pol~ n.- :h~lene ~ a...i~P"
poly-~,apro!~~t~m, poly~ ;l~lene seb~ e, poly-7- ~-;nf h- ~t!~ s~ e, poly~ lene ~-lip~.,,iflr (nylon 46), polyl. ~; -- - lhjl~ P~"~;~1C;, and pol~h ~ a~l;p~ P (nylon 66).
Typically, the porous ,.,~;~.. 10 _as a pore size of about 5 ~ -,t~ ~ or less, 5 more p~,f~ .. bl~, about 3 ~..,lvl~l -t~,~s or less, even more preferably, about 2 llPic~..~-,t~ -~ or less. In those embo l;,n. .,t~ ;".-1.,.1;"~,, -h,.;,.;.~t. . ;~r fluid(s) to a p~tif~nt the ",.P.l;~", 10 typically has a b~çt~ l b~ rin~r pore ~hu~ , to preclude b ~r-teri~ from t,,~t ~ ;~p~ the system through the vent. Por ~ ..plP, the ,..~ 1;---" can have a pore size of about 0.2 i~ ,h,. or less. In those c~bo l;. -~ -t~ having plurality of layers, one or 10 more layers can have a bdc~ l blf~lri~ pore sl~
The device can include ~1~ n~l layers or P~ t~ e.g., for use as spacers and/or ~ul~po~ vith respect to the porous n-~l;....~ 10. An e- "pl ,~ ~u~Oll or spacer layer can be a mesh or screen.
Exemplary porous media 10, inr~ uopho~;c ~ , include those ~1icrlose~ in T"1~ lio~l Publir~tion No. WO 91/17809 and U. S. Patent Nos.
5,126,054 and 5,451,321. In an embo lim~nt ~L ;l~lf SS, S~lbi~t ~ ly alcohol-insoluble, ~ophilic pol~de membranes, such as those ~es-~ ~ ;l~d in U. S. Patent 4,340,479,are suitable. Other suitable porous media include pol~t h,.n~olu~l~lene (PTFE) membranes, inrblAi~ 0.2 micron PTFE membranes, such as those available from Pall20 Col~l~ion (East Hills, NY) under the name Hydrolon~ PlPE. Other suitable media include, for ~ntrl~ 0.2 micron PTFE l,.-- ,~h~ fs available from S~ ,o Fl~c~ric T~ s (Osaka, Japan) under the name Poreflon~. The porous media can col~ e d and/or ;l~t~ d media.
The h.~ 14 can be fablic~d from any suitable ~ ~,ious ".~t,., ;Zl, 25 preferably a rigid mq~ l, such as any thermoplastic m~tPri~l, which is co".~ ;hle with the fluid being plocessEA For example, the h.~ can be f~ tp~ from a metal, orfrom a polymer. In an ~ boA;~ n' the h..~ is a p~ ~, preferably a ~ .CpA~e,~
or t~nchl-~Pnt pol~ " such as an acrylic, pol~ l ne, pol~ ~, or a poly~l~ed resin. Such a h.~ iS easily and ~o~ ally fal~ and allows 30 obsc.~ u of the p~ss~e of the liquid ~ ,ugll the h~
The ~- - r~r~s of the h.,..~ C~ the fluid may be treated or u~ akd. For lc, the ;,-~f~ s of the ho..~ c~-"~ the fluid may be r~nd~.~d li~luo~hilic for 68478 i CA 02236409 1998-04-30 better ~ ~i.lg. Methods for h~a~hlg the surface of the _uu~ing include but are not limited to ~ ;on ~.,.rl;.,~ and gas plasma h~
The huusi~ may be co~l~;w~d for ease of use. Por t~'-, the h.J-.~ may include a bracket or hook for ease of ,--o~ or support during --l-..;n;~ ;on of a S pd~.~ fluid.
The h...J~inp can be sealed as is known in the art, e.g., via welding and/or an adhesive. Por e~aInple, first portion 16 and second portion 18 can be bonded or welded ~g. !l.--(, e.g., after fitting lip 19 into groove 29. ~"l.l;l;.~ lly, the porous ,..~ - .. 10 can be sealed within the ho~;~ 14 to achieve CO~ e of use, rapid p~;...;.~p, and 10 ~rli.~ gas cl~A.~e. Suitable ~ ;hn~s for sealing, fitting, and/or bon~ g the "-~-1;. -" within or to the h.,~.~i~ are known in the art. For e~ let the porousi"~.. 10 can be col~ ~ioll sealed or inte.r~ fit within the huu~ing, or bonded to the ho!.c;-~. The porous ,..~l;.--,. can be welded to t_e h-.~J~ , e.g., heat welded or ulh~Lson~cally welded.
In a pl~;f~ d e~b~~ the h()llcin~ 14 is ~l~,~,1 to direct fluid non-lA~- n;~lly to the fir t surface 50a of the ~le~ r~ 50. For PY~mple, the housing can include a nipple 22, having a port 23, and the huu~ing can proride for dil~ g fluid ~.~h~ ;ally pe,~en~ rly to t_e first surface 50a of th-e rlf~g,qcsing cl~ ..- n The ~o~ g 14 can include an ~l~en~ of ribs, walls or p~;ecLions, or 20 may com~lisf; one or more r.h~n.rl.c, grooves, co~lui~, pass~es, or the like which may be s~ ,~i~, pqrallf l, curved, radial, spiral, or have a variety of other con~lr~tionc.
Typically, at least one ~ç~ ion faces the first surface 10a and/or faces the second surface 10b of the porous ~.~f~rl;.l.n 10. The ribs, w. lls or l~uje~lio~s may be used to define the rllqnnPlc, glOO~.,S, cQ~ul~ , or pqcc~Ps Typically, the huu~ 14 inrhl~lPs at least one rib, wall, or pl~;f~lion to support andlor po~ ;o~- the porous n~.li.. 10 within the hu -,;~ some emho lin~f .n~i, the hu~ -g inrllldes at least one rib, wall or pLUj~;~ to i~ro~ the ~ of gas flow, e.g., by ~pol~ g or pGi,i~ning the porous Illf'-l;ll"~ 10 within the housi,lg while providing cl~ e ~h.~,cn portions of the first surface 10a and the ho-- si.~ .
Typically, as i~ -, t~ in Figure 2, first portion 16 ;n~ludf s ribs 25 and ch~nflc 24, which are ~l~f~,.~l~ cQ.~nl~.r ribs ~d C~ e, to allow more erl;ci~nlflow of gas to the gas passa~ .~ 5. The first portion can also have radial rl~an.~Flc 27, 6&478 CA 02236409 1998-04-30 and at least one, more preferably, at least two, ~ ;n"~l ribs such as co.~ ;c ribs 26 and 28. Pigures 2 and 3 also ilhl~t~ rib 26, that plef~ably pO,;I;.?~.c the ,,,P.l;..." 10 with respect to first portion 16.
In the eInbo~limp-nt ill-.~ ~l in Figure 1, the first portion 16 and the second S portion 18 are sealed to form a first rh~ her 15 and a second ch~ lx 20, ,...p~csi~ lumen or central portion 21. The first and second ch~-..h~-~ can be similar in volume, or one rh~mhPr can be larger in volume than the other. For ~r , 1~, in some e.llbo~ accol.ling to Figure 1, the ratio of the volume of the first ~h-...l~ to the second ch~...~ can be in the range of about 1:1 to about 3:1.
In some c mbo~ c, the device 100 can also include a cap or closure, e.g., for cu~e~mg or sealing port 30. Por ~le, in accol~la~ with any e,ubo~ of the device 100 a cap can be used to cover port 30 to prevent the entry of gas, and to u~.,r port 30 to allow gas to exit the device.
The device 100 may be incGl~.?~at~d into a variety of fluid ll~r~. and/or processil~ S~lllS or sets. Embo~;n~ . of e~el~ t,,~s 500, 501, which are preferably pale~.~l fluid z.l.,,;n;~l",l;o~ sets, are ill~ ~ in Figures 7 and 8, Typical embo~l;... 11e of the system 500, 501 include at least one co~ r, more preferably, at least two co~ 200, 200' for holding the fluid(s) to be lla~r."l.,d, and one or more co~ that provide fluid c~,.. ~n;~ n ~l~xn the co.~ nf r, thedevice 100, and the ~e~ - of the fluid, e.g., a padent l~C~;Vi~g the !~ r. l~
fluid. As i~ in Pigure 8, the system 501 can also include at least one filter 300 for filttori~ the fluid to be l . ~ r. . . ~d.
The co.d~;nf . 200, 200' which can be used in the system can be co~~ ;h~d of 25 any ,..;~l- ;Al ct~ ;hle with the fluidto be !~ r~ d. A wide variety of suitable co.-1~ are already known in the art. Typically, co"t~;n ~ 200, 200' cc....~ ,s a flexible ~--~1; - ;al, for eA~lc, polyvinyl chloride (PVC). An f~Yf ~ / CO-~ f~ iS a flexible bag, e.g., as is used for ho~ ~ blood or blood co~n~ and/or saline.
~lh."~ , the co-l1;~ f .. may be CO~ OS~ of a non-flexible material. It is ;~r ~
30 that the i~ iull should not be limited by the type or co~ o;,;l;o~ of the co..~;~ ~ being employed.
As with the co~ ;n~ ~, the co~.~h~ 201, 210, 219, 220, and 230 can be 6 ~78 CA 02236409 1998-04-30 constructed of any mqtPriq-l that is co...p-~;ble with the fluid(s) to be Ll~f~ L
Typically, the co..~]~ COlll~l~ n.,Ai~le mqt~riql A pl~,fe.l~,d mqt~liql is PVC, for el ~n~l k~. As used herein, the coll-lui~ are any tubing or means which provide fluid CQ-----~n;~-l;O~ b~,h.e-,n the various COlul~v~ ~ of the a-l~ n ~t.
At least one flow control device 400, 400' such as a cl. mp (i~ l---l;"~, for e~...plf-, a roller clamp), seal, ~lopcorL, valve, ~la~f~. leg closure, or the lil~e, _ay be ~cs~; ~ with at least one of the co~i~ in order to f:~~ilitqt~ a desired Ç~ , i.e., to open, close, and/or m~~ e the desired flow of the fluid (e.g., pa~n~.~l fluid) and/or gas. In some e.llbo~1;n.Fn~, particularly for some of the ~ ..l~l;n.. .l~ that 10 include ~ t~ 8 fluid to a patient, the flow control device 400' dow~lL.,alu of the device 100 co...l.. ;.~c a roller clamp to control the flow rate.
As i~ al~ in Figure 8, the system 501 can also include at least one filter 300, to filter the fluid to be ll~f~ ,d. A variety of filters are ~LIi~ble for use in the system, e.g., IV filters, e.g., for ~.l."in;.~t~.. ;.,~ drugs and/or ..~l. ;F ~I~; and blood filters, 15 inrl in~ Clvaggf~ga~ filters and/or leukocyte depletion filters. Typically, the filter con~l..;.C~s a filter assembly, inrlllr~ a k.~ ing having an inlet and an outlet and providing a fluid flow path ~,en the inlet and the outlet, and a porous filter ".~1;~
for filtP~in~ the fluid di~oscd ~e~._.,n the inlet and the outlet and across the fluid flow path.
In some c.l~bo~ , inrhlrlin~ those embo~ that include at least one filter, the system may include at least one ~ lrlifff)nql vent c~.",l.. ;~in~ a gas inlet and/or gas outlet, wLc.~ the vent inrhllies a porous "~1;---,- ~ui~ble for pa~i~ gas ll,c~lluvu~. For ~ le, Figure 8 i~ s an ~lubodi~,~ of a syste~n 501 inrhl~fli~ a vent 101 such ~ a g~ outlet i~.~osed ~t..~ , and in fluid co~ ni~-l;
with, filter 30C) and device 100.
As noted earlier, the sys~em may have a~lfl;l;~ l c~..l~n~-nl~ such as, but not limited to, conn~v~ ;l;on~l co..l;.;..- ~ ecLion ports, and ~d~ n~l vents such ~g~ inlets and/or gas outlets.
~ ubof~ of a ~--I Il-f~ acco~lin to the ill~.,~ion include lorv~ the device 30 in a fluid flow path ~t~,e~l a source of fluid, e.g., a contai~, and the ;nr nfl~d de,l;n~ Jn of the fluid, e.g., a patient, and l.,.. ~ ~.;n~ the fluid lu~u~ the device.
For eYD~ le, l~f ~ - ;-.~ to the e ~- ,"~1D~ eInbo~1im~nt ill--~ r ~i in Figure 7, fluid flow control devices 400, 400' such as clamps u~ Le&ll and dOw~~ of the device 100are typically closed initially, and then the flow con~rol device u~ ,alu of device 100 is opened, to allow fluid to enter the h.~ ;r~. Since the flow control device dow~
of the device 100 I.,~ai~s closed, gas (e.g., gas ~ ~~1 into the hv~ by liquid S pa~siu~ (JU~ the CQ~ (S~) passes through the vent 3 as the device fills with liquid.
After the device fills to the desired level, the flow control device d~l.~ of device 100 is open~ and the fluid is p~sed to the desired ~lin~t;.Jn In those Fn~ eill fluid is passed at a high rate ~ vu~ the device 100, e.g., wl~m the patient ~ s one or more units of blood p~lu~ at a flow rate of at least about 100 cubic c~ lt;n.~r ~.~ (cc's) per minlltje, more ~l~,fi,~abl~, at least about 300 cc per minll~ even more p~f~,.ably, at least about 400 cc per milmte, the fluid passmg 11LVU~ the (i~g~ss;n~ el~ 50 is ~;~ as smaller bubbles coqlPs~e into larger bubbles that rise in the lumen or central portion 21 of the device. In an emho~limPnt, some of the coqlpsce~ bubbles pass through the vent 3.
In acc.l~n~e with pl~fe 1~,1 embo~ t~ of a method accof~i~ to the invention, the device allows the O~ atOl to observe fluid flow even at the higher flow rates. For e~n~ the O~aLOl can observe drops of liquid ~ -~t - ;.~ the device, or a stream of liquid f~ the device. Thus, the device does not "overf~" during use.
Mol~o~ , while the device is s~it~ble for ~.h..;..;-~in~ fluid at high flow rates, it is 20 also suitable for use at lower flow rates, and thus can be used during the entire fluid a~l~n;~ aLion p~ocol. The device should be co~ u~ to lla~r~,~ the fluid quic3~1y.
In a p~,f~ d e ..I~l;...- ~-~ for use with biological fluid, the device has a small hold up volume, e.g., about 15 cc or less.
Using Pigures 1 and 7 (ill..~ an e .ubo~l;...- ~~t of the device 100 and system 25 500, ~w~e.,Li~ ), for l.,f. .~,~ce, fluid is passed, e.g.; using a pump or by gravity, from co.~ f ~ 200 l~ u~ at least one conduit to device 100, ~vhile the flow control device 400' d~w~lL~ of device 100 is closed. Liquid and gas enter the h....~ o 14 via inlet 1. l?~,f~,.ably, device 100 (~igure 1) inrll~es â nipple 22 and a port 23, and fluid passes into lumen or central portion 21, and the fluid is dil~.,t~d non~ ;ally (e.g., 30 ~ b~ lly pc~ rly) to the first surface 50a of the ~k'~ el~ f .lt 50. If desired, fluid can be d ~ ,t~ into the ce~al portion 21 in the form of droplets.Pluid f,.~t..;.~ the lumen or cen~ portion 21 c~ t ~1~; the ~ega~ elo-nf-n~ 50 in the second ch~mher 20. Since the fluid flow path dow~~ of the device 100 le~a~c closed, the device acts as a l ~ ..~rùi~ ~ second ch~ ~he~ 20 fills with liquid. As the second ~.h---.l~, 20 and rlf'5~ ClP~ p~ 50 fill with liquid, gas is displaced. Some of this gas is vented from the device, i.e., the gas passes from the i l~.ior of the 5 h.~ ;n~ along a gas flow path lhL~u~ porous ".P.l;~..n 10 via surface 10b and surface 10a, and lll~u~ port 4 and gas pa~,_~.~ 5 to the t~ ;0~ of the h.,..c;n~ In those e.ubo~ r~ wL.~m the h.,..~ s ribs and ~.h~nn~lc~ e.g., ribs 25 and ch~ lc 24 and 27 as ill~ rl in Figure 2, gas pacses along ch~ c 24 and 27 through port 4 to gas p~c~ ..~ 5 to more e r~ vent the device.
Second ch~ hc~ 20 (shown in Figure 1) co.~ s to fill with liquid, and e~ally, the level of liquid will reach surface 10b of porous ."~1;~" 10. Once liquid covers the surface 10b, gas flow lllUugll the vent 3 stops, wi lluul liquid s~ r ..,~;ally pasi,iug t~rough the ~, ~1;---" 10. Once the gas flow stops, the device 100 is filled to the desired level.
~ some embo~;.. ~ .l i, gas flow stops when the device 100 is about 2/3 filled with liquid. Illu~ ivcly, when passing a red blood cell-co~ fluid such as packcd red cells (PRC) or whole blood into the device, the device has a total Ca~a~ of, for e~ample, about 15 cc, and gas flow stops when the device co~i~s about 10 cc of liquid. In a~ cmbo~ when passing a plat~let co~t~ini~g fluid such as platelet 20 con~F~ ~ (PC) into the device 100, the device has a total Cd~ily of, for e~lc, about 9 cc, and gas flow stops when the device cont~inc about 6 cc of liquid.
Once the device is filled, the ~ "~ of the sy-stem can be prim~, and the Liquid can be del;~ ,d as desired. For e~ , using Figure 7 for ~f~ ce, the flow control device 400' duw~ll~,~ ûf device 100 (e.g., a flow control device such as a 25 roller clamp) can be opened, and the fluid can be ~ ~d to a patient. Typically, a volume of gas will be present in the in~erior of the h....~ 14, and the liquid level will re ain at the desired level, or less, during ~.n;..;.~h,.~;ol~
As noted earlier, it may be nFce~ to ~I...;n;~h ( fluid at a high flow rate during at least a portion of the patient treatment or ~l",;~ h ~;on ~lotûcol. Such a 30 prot~col may include ~ g stored blood or blood coll~l~n~ i (e.g., to the pa~ l'S
body t~ ) and pdSS~ the ~.alll,ed fluid through the device 100. As the blood is ~ 1, gas is l~,ledscd in~o the blood. While the volume of gas l~,l~d into the blood is SOll~ .haLul~p ~li~;~ble, the ~cg~c.ci,~ 50 in device 100 provides for reliably coqlPsci~ smaller gas l,~l~les into large bubbles, . nd the larger ~bbles rise in the lumen 21 of the device. Thus, once the system is primed, the fluid pa~ g through second surface 50b of ~le~~~in~ elP~ .n 50 and exiting the device 100 through outlet 2 5 is s~ ly de$~sed Typically, the ope.ator of the system will be able to obs.,~c fluid flow, e.g., ~ plet~ of liquid, or a liquid stream er~ering the device during the ..;ni~ plo~ocol.
In an e ..hol;n.- n~, after q,~l-,-;n;.~ n of the fluid is ~ lly completed, someof the liquid ~t~i~ in the device can be ~ ;n;cr ~,d to the patient. For example, gas can be allowed to enter the device 100 through port 30 (Figures 1 and 6), and some of the liquid l~ ~i~ in the device can be passed to the patient. In those embo~l;... ,l~
wll~ port 30 was capped after the ini~l ~,nti~g of the device 100, the O~ Ol of the system will uL~u~r or uncap the port to l~O~ some of the fluid l-,~i~ in thedevice 100. After allowing gas to enter the device, the op~- -tOI can m~ml~lly stop the 15 flow of liquid before g~ can reach the patient.
If desired, the device 100 can initially be filled to a desired level with one fluid, e.g., a non-biological fluid such as saline, and after the ~~evice vents gas and fills with this liquid, the liquid is a~ ed and then a second fluid, e.g., a biological fluid that is co~ ,.Lible with the non-biological fluid, is passed through the device and 20 ~.l...;n;~ d For c~ , using the system 500 shown i~ Figure 7 for l.,f~ cc, a p~,~,al fluid such as saline can be passed from con~i~r 200 to device 100, and gas is ventcd, and then the fluid is ~.l...;n;~ ,d as ~.~s~ ;l~d above. Sul~se.lu."~ n~ f,r pd~ l fluid, e.g, a biological fluid such as packed red blood cells, is passed from co.~1~;nf ~ 200' ~ uugh the device 100 and then to the patient in a genP~lly similar 25 ,.,~nnf ~ as ~ r. ;l).3~i with respect to the first fluid. In a pl.,f. ,l~d embo~ , the Opf~d~O~ of the system can observe fluid flow through the device with each of the first and second fluids during î-l.";ni.~l...l;on As noted earlier, and as shown in Figure 8, the system 501 can also in~ p a filter 300 such as a lcuLuc~lc ~lf.~letion f~ter. For ~ plfe~cQl~t~;n , 200' co.n~ a 30 lcu~ c-co--~;--;-.~ biological fluid such as blood or a blood CO~ lf~ll, and the l~;olo~ l fluid can be ~l...in;.~l as following. Using Figure 8 for l~,f. ,~,~ce, the flow control devices 400, 400' are typically initially closed, and the flow control device 6~78 CA 02236409 1998-04-30 400 ~l~n the co~ cr of leu~ cG.~ ;n;.~ biological fluid and the filter 300 is opened. If desired, the co.nA~I~f,~ of biological fluid may be s~ to more err~ r~ y prime the filter 300. Gas displaced during the p. ;...;n~ of the filter 300 is passed through co~uil 219 ahead of the biological fluid, and passed lL~u~ the vent 101. If 5 desired, the vent 101 can p~v~ide for sep~ gas from the biological fluid flow path.
After gas is passed 1~ U~ the vent 101, the flow control device 400 ~s~i~h ~l with c~ h~;l 220 is openP~l and the biological fluid, along with some air ~plac~ fromco~L ~o, enters the device 100.
Device 100 vents g~ and fills with liquid ~ ~ ~l ;l~d earlia. After the device 10 a~lu~ l;r~lly ven~i and fills to a desired level, the flow co~ol device 400' duw~ll~
of device 100 can be opened, the rest of the system can be primPd and the liquid can be ;~-1.";";.~ip ~ to the patient.
In a v~n~ n of the t~b~l~n- ~~ of the ~A ~s ill..~l."~ in Figures 7 and 8, the device 100 can include ~p . Z~h- inlets for the ~rr~ ~nL par~ fluids. Por 15 example, the embodiment of the device 100 ill~ d in Figure 6 can be utilized in such s~L~s. The ~:~tL~S can be o~.d~d as gen~lly ~sçrih~l above, with the ~c~lir~ ion that one fluid enters the device via inlet 1, and the other fluid enters the device via inlet 1'.
In a variation of the device ill--~l.,t,~d in Figure 1, a conduit is co...~r-c~ed to port 30, and the device laclcs a porous ",~li~n, 10 in the h.. c;n~ 14. The end of the co~.huL
not co..,-Fc~l to the port 30 is typically closed, or colln~eled to another co~ t of the system, such that gas P .h ~ ;.~ the device is passed from the h.)--~i~ through the port 30 and into the coldluiL, wL~lem the conduit plo~ides a bubble trap.
All of the lefe.e~ces cited herein, inf~ pllh~ qtionc, p~ntc, and patent appli~ ionc are hereby i~col~lat~d in their e~i,.,~es by l~,f~ ce.
While the invention has been ~e~ d in some detail by way of il~ ................ and e~k, it should be ~ tood that the iu~ ~ioll is ~;cep~ible to various mo~lifi~ 7n.c and ~ n ';ve forms, and is not ~i~ 't~;~ to the ~pec;fi~ e,l.bo~ set forth. It should be ~n~ ~o(l that these Sp~;lir P...~1;.n. ~ are not ;nh ~fled to limit 30 the i l~_~ioQ but, on the cO~L,~, the intPntiQn is to cover all mn~ ,.l ;on.c, e~uivalents, and ~l~ ~" ~ s falling within the spirit and scope of the i~ ~io~.
Claims (15)
1. A device for transferring fluid comprising:
a housing comprising a fluid reservoir for gas and liquid, the housing includingan inlet, a central portion, and an outlet;
a vent disposed in the housing, the vent comprising a porous medium that allows gas in the housing to pass through the medium without substantially passing liquid through the medium, said vent being cooperatively arranged to allow the gas to be vented from the housing;
a degassing element comprising a gas coalescing medium disposed in the housing and arranged to allow coalesced gas to rise into the central portion of the housing, said degassing element having a first surface and a second surface;
wherein the device directs fluid non-tangentially to the first surface of the degassing element.
a housing comprising a fluid reservoir for gas and liquid, the housing includingan inlet, a central portion, and an outlet;
a vent disposed in the housing, the vent comprising a porous medium that allows gas in the housing to pass through the medium without substantially passing liquid through the medium, said vent being cooperatively arranged to allow the gas to be vented from the housing;
a degassing element comprising a gas coalescing medium disposed in the housing and arranged to allow coalesced gas to rise into the central portion of the housing, said degassing element having a first surface and a second surface;
wherein the device directs fluid non-tangentially to the first surface of the degassing element.
2. A device for transferring fluid comprising:
a housing comprising a fluid reservoir for gas and liquid;
a vent disposed in the housing;
said vent comprising a porous medium that allows gas in the housing to pass through the medium without substantially passing liquid through the medium; and, a degassing element disposed in the housing;
said vent and said degassing element being cooperatively arranged to allow the gas to be vented from the housing.
a housing comprising a fluid reservoir for gas and liquid;
a vent disposed in the housing;
said vent comprising a porous medium that allows gas in the housing to pass through the medium without substantially passing liquid through the medium; and, a degassing element disposed in the housing;
said vent and said degassing element being cooperatively arranged to allow the gas to be vented from the housing.
3. The device of claim 1 or 2, allowing liquid to fill the housing to a level that is less than the total liquid capacity of the housing.
4. A device for transferring fluid comprising:
a housing suitable for holding gas and a liquid, the housing including an inlet,and an outlet;
a vent comprising a porous medium that allows gas but not liquid in the housing to pass through the medium, the porous medium including a liquophobic element, wherein the porous medium is downstream of the inlet; and a degassing element;
the device allowing a desired amount of liquid to be present in the housing while transferring fluid, wherein the amount is less than the total liquid capacity of the housing.
a housing suitable for holding gas and a liquid, the housing including an inlet,and an outlet;
a vent comprising a porous medium that allows gas but not liquid in the housing to pass through the medium, the porous medium including a liquophobic element, wherein the porous medium is downstream of the inlet; and a degassing element;
the device allowing a desired amount of liquid to be present in the housing while transferring fluid, wherein the amount is less than the total liquid capacity of the housing.
5. A drip chamber comprising:
a housing including an interior and an exterior;
a vent defining a gas flow path between the interior and the exterior of the housing;
a porous medium disposed in the gas flow path; and a degassing element comprising a gas coalescing medium having a first surface and a second surface disposed in the interior of the housing;
wherein the drip chamber directs fluid non-tangentially to the first surface of the degassing element.
a housing including an interior and an exterior;
a vent defining a gas flow path between the interior and the exterior of the housing;
a porous medium disposed in the gas flow path; and a degassing element comprising a gas coalescing medium having a first surface and a second surface disposed in the interior of the housing;
wherein the drip chamber directs fluid non-tangentially to the first surface of the degassing element.
6. A drip chamber comprising:
a housing including a porous medium that allows liquid to enter the housing without completely filling the housing with liquid;
the porous medium allowing gas to pass from the housing, wherein the medium includes a liquophobic element; and a degassing element, in fluid communication with the porous medium, the degassing element having a first surface and a second surface;
wherein the drip chamber directs fluid non-tangentially to the first surface of the degassing element.
a housing including a porous medium that allows liquid to enter the housing without completely filling the housing with liquid;
the porous medium allowing gas to pass from the housing, wherein the medium includes a liquophobic element; and a degassing element, in fluid communication with the porous medium, the degassing element having a first surface and a second surface;
wherein the drip chamber directs fluid non-tangentially to the first surface of the degassing element.
7. A drip chamber comprising:
a housing comprising a fluid reservoir for gas and liquid, the housing includingan inlet, a central portion, and a nipple extending from the inlet into the central portion, and an outlet;
a degassing element comprising a gas coalescing medium disposed in the housing and arranged to allow coalesced gas to rise into the central portion of the housing
a housing comprising a fluid reservoir for gas and liquid, the housing includingan inlet, a central portion, and a nipple extending from the inlet into the central portion, and an outlet;
a degassing element comprising a gas coalescing medium disposed in the housing and arranged to allow coalesced gas to rise into the central portion of the housing
8. A drip chamber comprising:
a housing comprising a fluid reservoir for gas and liquid, the housing includingan inlet, a central portion, and a nipple extending from the inlet into the central portion, and an outlet;
a vent disposed in the housing, the vent comprising a porous medium that allows gas in the housing to pass through the medium without substantially passing liquid through the medium;
a degassing element comprising a gas coalescing medium disposed in the housing and arranged to allow coalesced gas to rise into the central portion of the housing; and, said vent being cooperatively arranged to allow the gas to be vented from the housing.
a housing comprising a fluid reservoir for gas and liquid, the housing includingan inlet, a central portion, and a nipple extending from the inlet into the central portion, and an outlet;
a vent disposed in the housing, the vent comprising a porous medium that allows gas in the housing to pass through the medium without substantially passing liquid through the medium;
a degassing element comprising a gas coalescing medium disposed in the housing and arranged to allow coalesced gas to rise into the central portion of the housing; and, said vent being cooperatively arranged to allow the gas to be vented from the housing.
9. A method for transferring fluid comprising:
passing fluid through the device of any one of claims 1-4.
passing fluid through the device of any one of claims 1-4.
10. A method for transferring fluid comprising:
passing fluid through the drip chamber of any one of claims 5-8.
passing fluid through the drip chamber of any one of claims 5-8.
11. A method for transferring fluid comprising:
passing a fluid including liquid and gas into a device comprising a housing including a fluid reservoir for gas and liquid, including passing the fluid non-tangentially to a first surface of a degassing element;
venting gas from the device, wherein venting includes passing gas through a liquophobic porous medium until the liquid contacts the porous medium;
coalescing gas bubbles and allowing the coalesced bubbles to rise in a central portion of the housing; and passing liquid from the device.
passing a fluid including liquid and gas into a device comprising a housing including a fluid reservoir for gas and liquid, including passing the fluid non-tangentially to a first surface of a degassing element;
venting gas from the device, wherein venting includes passing gas through a liquophobic porous medium until the liquid contacts the porous medium;
coalescing gas bubbles and allowing the coalesced bubbles to rise in a central portion of the housing; and passing liquid from the device.
12. The method of claim 11, including observing drops of liquid entering the central portion of the housing, and passing the liquid from the device to a patient.
13. The method of claim 11 or 12, wherein the device is capable of allowing liquid to pass therethrough at a rate of up to about 500 cubic centimeters (cc's) per minute.
14. The method of claim 13, including passing liquid through the device at a flow rate of at least about 200 cc's per minute.
15. The device of any one of claims 1-4, being capable of transferring fluid therethrough at a rate of up to about 500 cubic centimeters per minute.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US6855997P | 1997-12-23 | 1997-12-23 | |
| US60/068,559 | 1997-12-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2236409A1 true CA2236409A1 (en) | 1999-06-23 |
Family
ID=29399107
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2236409 Abandoned CA2236409A1 (en) | 1997-12-23 | 1998-04-30 | Fluid transfer device |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2236409A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015154304A1 (en) * | 2014-04-11 | 2015-10-15 | 福建省百仕韦医用高分子股份有限公司 | Microfiltration medical infusion connector |
-
1998
- 1998-04-30 CA CA 2236409 patent/CA2236409A1/en not_active Abandoned
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015154304A1 (en) * | 2014-04-11 | 2015-10-15 | 福建省百仕韦医用高分子股份有限公司 | Microfiltration medical infusion connector |
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