CA2122591C - System for accommodating withdrawal of liquid from a bulk supply - Google Patents
System for accommodating withdrawal of liquid from a bulk supply Download PDFInfo
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- CA2122591C CA2122591C CA002122591A CA2122591A CA2122591C CA 2122591 C CA2122591 C CA 2122591C CA 002122591 A CA002122591 A CA 002122591A CA 2122591 A CA2122591 A CA 2122591A CA 2122591 C CA2122591 C CA 2122591C
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- Prior art keywords
- conduit
- container
- liquid
- bag
- accordance
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
Abstract
A system accommodates the transfer or withdrawal of liquid from a bulk supply.
The system includes a connector (50) connected to the supply container (20), a first conduit (56) extending from the first connector, a second connector (116) on the first conduit connected to a syringe (120), a second conduit (132) having an end connected with the first conduit and another end connected to a receptacle (140), a first check valve (102) in the first conduit pre-vents flow into the supply container, a second check valve (150) in the second conduit pre-vents flow out of the receptacle (140), and a flexible, open-mouthed barrier (80) penetrated by the,conduits and sealed shout the conduits. The barrier is-bag-like and accommodates an arrangement permitting access to the first connector and container. The bag (80) can be ar-ranged in extended orientations enclosing the first connector and container.
The bag is seal-able in the extended orientation to form a protection system around the supply container and receptacle.
The system includes a connector (50) connected to the supply container (20), a first conduit (56) extending from the first connector, a second connector (116) on the first conduit connected to a syringe (120), a second conduit (132) having an end connected with the first conduit and another end connected to a receptacle (140), a first check valve (102) in the first conduit pre-vents flow into the supply container, a second check valve (150) in the second conduit pre-vents flow out of the receptacle (140), and a flexible, open-mouthed barrier (80) penetrated by the,conduits and sealed shout the conduits. The barrier is-bag-like and accommodates an arrangement permitting access to the first connector and container. The bag (80) can be ar-ranged in extended orientations enclosing the first connector and container.
The bag is seal-able in the extended orientation to form a protection system around the supply container and receptacle.
Description
V6~0 93/12002 PCI'/1JS92J1091~
2~.2~5J1 SYSTE1~I FOR ACCOMMODATING wITHDRAWAL
~F LIOUID FROM A BUL% SUPPLY
TECk~TICAL FIELD
The present invention relates to a fluid transfer system for accommodating the withdrawal of liquid from a bul~C supply for use in medical procedures.
The present invention is particularly well-suited for use with bulk reconstituted, toxic drugs, such. as 7.0 chemotherapeutic drugs.
BACRGROTJi~ID OF TIDE INVE~TTIflN
AND
TEC~iNICAL PROBLEMfS POSED BY THE PRIOR ART
Various medical procedures require the transfer of fluid from 'one fluid-containment system or fluid-conducting system to another flu~.d~-containment system or fluid-conducting syst~~n. Typically, one of the two s~rs~ems includes a c~ntainex for a bulk supply o~ liquid, s~zch as a ~ulx supply of a reconstituted, ~~? liqu~.d, chemothexap~u~ic drug. The other system, which i cap be as simple as a syringe; may b~'connected to the f irSt System ~~r ~nly a Short per7.od Of t3.me, Or interam~tter~tly, to 'facilitate the' withdrawal of a desired am~unt-~r dose of thr liqu~:d for ~dministratiora ~~ ~~transm~~~lon t~a patient.
. Tn those medical applications where the (first system includes a container fa~~ ~ bu~.k supply of a toxic ~~~~d~ 1.t 3,5 C~euiralal~, if not neCeSSary, to prei~L'nt i inad'~t'erte'nt eXp~Sllre of p~rSOnIlel t0 t$~e, t~X7.0 liquid.
For example; a hospital pharmacy may prepare highly toxic, chemotherapeutie drugs far use in treating cancer . patients. Typically, a ~tial of a highly concentrated, ~.~axic drug is rec~i~re~ from the pharmaceutical supplier b~ the hospital pharmacy;: and the hospital personnel 35 then admix the concentrated drug with a suitable diluent W~ 93/1.2002 PC'I'/~JS92/1091f~
_ 2 _ to provide a bulk reconstituted supply having a reduced concentration or effective dose per unit volume that permits the administration of a prescribed amount or ' volume directly to the patient. , The preparation of the bulk reconstituted, liquid drug is typically carried out in a protective environment, such as in a laminar 'flow hood which is specially designed to maintain a negative pressure within the hood so as to prevent the escape of toxic vapors. ,"
The bulk reconstituted, liquid drug is usually stored in a suitable container which may be a flexible, thermoplastic, sealed bag., A suitable. discharge structure, dispensing structure, or fitment is typically provided on the bulk container to accommodate withdrawal of a desired amount of the liquid from the container.
It is, of course, desirable to ensure that the means for withdrawing a prescribed amount of the toxic liquid drug will not result in spills or leaks from the bulk ! ~0 coast finer.
Accordins~ly, it would be advantage~us to provide a barrier system which could be employed with a container of a bulk supply of a toxic drug and which would functi~n to contain a leak or leaks of the liquid drug from the container, or from as~c~ciated ccannections thereto, so as to prevent exposure ~f personnel to the d~ .
It ~rould also be desirable to provide such a barrier system ~rith means'for accommodating its 3~ disposition in association with, or its connection to, the bulk supply container in a manner that can be d relat~.vely easily and qusckly effecteda It w~uld also be beneficial if such a barrier system could be provided with a structure that would accommodate movement or transport of the bua.k supply 'Wf~ 93/120(i2 PCH'l1JS92A1~9~~
_ . ~ 3 ~122~~~.
from one location to another while still maintaining the efficacy of the barrier system against leakage.
Further, it would be desirable to provide such a barrier system with means for accommodating withdrawal of the bulk reconstituted, liquid drug by means of a suitable, conventional syringe, especially a syringe having ~ luer fitment.
It would also be advantageous for such a barrier system to function to prevent inadvertent l0 .injection of the liquid drug, or other material, back into the bulk container so as to reduce the probability of contamination of the bulk supply.
In addition, it would be beneficial if the barrier system could accommodate the use of,_~ syringe to withdraw the liquid drug from the bulk supply and to pump a desired volume of the liquid drug into a selected a conduit for ~d~inistrat~.on to a patient or for delivery to another container or containment system.
_ den a bulk-container of liquid is employed for supply~.ng small quantities or doses of the liquid -, drug via withdrawal by a syringe, it would be desirable ~o pr~vide means for accommodating the asp~.ration or dasdharge from the syringe ~f an excess amount of the liquid, er of a' portion of the la.quid in rahich an air 2~ bubble is entrained, that may have been drawn into the syr .l.nge a Tt would b~ desirable t~ prov~.de Such a cap~bi.lity regardless o~ whethex or not the bulk supply ~f liquid is toxica accordingly, it'would be des~.rable to provide, a suitable receiving compartment or receptacle for excess liquid ~ndJor for a mixture of liqu~.d and air., in conjunction raith a syringe~operated transfer or ~rithdrawal system operable ~n a bulk supply. It would be beneficial if such a receptacle could be provided as a unitary or integral part of the withdrawal system and WCs 33/1202 PL~'/iJS9z/1o918 could also be adapted for use with a barrier system that prevents exposure of personnel to leakage.
Further, in view of the dangers associated with toxic drugs, contamination, and infection, it. would be desirable to provide a barrier system and/or receptacle system which would facilitate its use as a .disposable item. To this end, such a system or systems should be relatively inexpensive. Accordingly, such systems should incorporate an improved component design that accommodates relatively simple manufactur~.ng ~~
processes and assembly processes to keep the total cost as low as ponds.6.ble s The systems should also function to effectively seal at connection points or attachment points to prevent leakage of fluids and to prevent ingress of airborne or liquid-carried contaminants.
Addaait~nally, the systems 'should preferably function effectively with a var~.ety of f~.uids throughout a range ~f fluid pressures.
Advantage~usly, the systems should have a suitably long shelf life and active use life. Further, such systems should pre~exably be adaptable to function effectively after repeated connectior~~ to a syringe.
Sg3I~lARY ~F THE INVENTION
t ~~ The present invention provides a novel fluid trane~er .cyate~a for accoynm~clatia~g th.e wa.thdrawal of liquid form, a hulk supply., Ln the preferred form, the iawent~:on permits a bulk supply of hazardous liquid to r ,be prepared, such as by thh admixing of a highly 3~ concentrated, t~xic drugwith a diluent, while preventing or minimizing exposure ~f personnel to the ha~aard~uw~J.l~.qu~.d w Thl.J ~~J facl~~.tatedby the use of a I10'ttt:l barrier syS'Gem w$ll.ch iS imperVl.ous t0 the ll~uid .
~'he harrier system of the pgesent invention 35 functions effectively to protect personnel from spills i~V~ 93112002 PCT/tJS92/109~~
or leaks of a hazardous liquid during withdrawal of the liquid from a bulk supply and/or during preparation of the bulk supply. The barrier system conveniently permits manual operations to be performed on various components, such as a small container of a highly concentrated, toxic drug and a larger container of a diluent liquid.
The barrier system accommodates the movement 'or transport of a bulk supply of liquid from one location to another while maintaining the efficacy of the barrier system protection against leakage. Further, the barrier system accommodates the convenient withdrawal of liquid from the bulk supply by means of conventional components, such as a suitable syringe, r, Another aspect of the invention, which can provide operational advantages with or without a ,;
protective barxier system ~f the type referred to above, relates to a system for accommodating the collection of unwanted or excess lis~u~.d that has been inadvertently withdrawn or otherwise withdrawn from a bulk supply. In particular, when a syr~.ng~ is used for withdrawing liquid from a bulk supply container, the system permits a p~r~;ion of he liquid in tae syringe, which nay be an y excess amount, or which may contain an air bubble, to be discharged frown tla~ syringe to a hovel waste receptacle.
The liquid transfer and waste--receiving system is adapted to be ~e~nveni~ntly used in conjuhction with a bulk supply ~f liquid: The waste-receiving system is especially well-suited for use in conjunction with, and as a ~.n~tegral part of, the above--discussed 'personnel p~rQtection barrier system.
Both systems, whether provided separately or ' ~s ~n integra2 combination sys~e~n, can incorporate improved comp~nent designs which accommadate relatively simple manufacturing processes and assembly processes so TWO X3/12002 PCTI~.J~~2/90g1~
21~~a~1.- 6 -as to keep the total cost as low as possible. The systems can function effectively with a variety of fluids through a range of fluid pressures. The systems accommodate designs that provide a suitably long shelf life and active use life.
In one preferred forna of the invention, a protection system is provided for a container from which a hazardous liquid can be removed. The system includes conduit means for being connected to, and extending ~.0 .from, the container to define a flow path for the liquid from the container to a discharge location exterior of ~..
the container. A flexible~barrier, which is impervious to the liquid, is penetrated by, and sealed to, the conduit means. The flexible barrier accommodates at 2.5 least two arrangementsa (1) an initial arrangement in a ;., ',s retracted orientation permitting access to, and manipulation ~f, at 3east a portion~of the conduit means and cantainer: and (~) a subseguent arrangement in an extended orientation.envelop3ng a port~.on of the conduit 2c3 teens and the connected container.
The lic~id transfer car withdrawal system, which may operate separately from, and independently of, the above-descr~.bed barrier system, accommodates the withdrawal of liquid from a container with a syringe.
25 The withdrawal system'includes ~ first conduit means for ~eia~g connected at ores end to, and for extending from, the csantainerv The'first conduit weans is connected at another end to the syringe to define a flow path for the liquid between the contaixrer and the syringe.
~~ A second c~nduit means is provided for de fining a flow patYa f~r the ~.ic~uid from a first end eonnected to, and in fluid communication writh, the first conduit means:- The receptacle is connected to the second end of the second conduit mc~ns and is in fluid ' 3~ commuhi,cation therewith. ~4 first one way, non-return ~V~D 93/2002 P~'T/US92/1091A
- ' - ~.~~2~~~
valve is provided in the first conduit means in the flow path between the container and the second conduit means to prevent flow into the container. A second one-way, non-return valve is provided in the second conduit means to prevent flow out of the receptacle to the first C'rondu,l.t means o Numerous other advantages and features of the present invention will become readily apparent from the following detaa.led description of the invention, from .the claims, and from the accompanying drawings.
BRIEF DESCRIP'X°ION OF THE DRAWINGS
In the accompanying drawings that form part of the specification, and in which like numerals are employed to designate like parts throughout the same, FIG. 1 is a partially exploded, perspective view of the components of a preferred form of the present invention shown in a first ox~.entation in conjunction with a drug vial and diluent bag, and a potion of a coanponent of, the -invention has been broken ~~ away to better illustrate interior details FIG. 2 is a view similar to FIG. 1, but FIG. 2 shows the components after various fluid connections have been made end after the components have been rearranged in a°se~ond orientation to provide protection against fhaid leak~ge~
FIG.,3-is an enlarged, fragmentary, side-elevational view taken generally along the plane 3-3 in FI~e~C
FIG. 4 is an enlarged, fragmentary, side 30 elevational vie~ri taken generally along the plane 4-4 iri F~~e~%
FIG. ~ is an enlarged, fragmentary, elevational view taken genera~.ly along the plane 5-S in FIG. zs vv~ 9~rizoo2 Pcrru~gzr'o9~s $_ _ FIG. 6 is a simplified, diagrammatic, front elevation view of a second embodiment of the invention wherein the components are shown in a first arrangement prior to use: and FIG. 7 is a simplified, diagrammatic view 'similar to FIG. 6, but showing a side elevation after the com~aonents have been connected~to a bag containing a bulk reconstituted supply of an admixed drug from an yattached vial and wherein the system components are in a v 7.0 second arrangement providing an enveloping barrier against leakage.
DESCRIPTION OF ~'HE PREFERRED EMBODIMENTS
the present invention provides a novel transfer system,f~r accommodating the withdrawal of ~:5 Liquid from a bulk supply. ~'he invention is particularly er~ll~-suited for use witlh bulk reconstituted, toxic drugs, such as~chemotherapeutic drugs.
Onc asp~ctvof the invention relates ~Co a novel barrier systeyn for px~tecting personnel from leaks or spills of a hazardous liquid that is stored in a container from which the liquid can be removed. Another aspect of the inventian, which may be included as an integral part 'of, br ~rhich may be er~tireZy independent ;, ~5 ofo the b~rxi~r system, provides ~ unique lic,~uid transfer syste~a for accom~aodating 'the use ~f a syringe t~ draw liquid from a container. The liquid transfer syste~'prcvides a novel receptacle for receiving a Potion of the~withdrawn liquid which may be an excess 3C amount and/or which'may contain an entrained air bubbl'e~
Whxile this invention is susceptible of embodiment in many different forms, this specification end the accompanying drawings disclose only some specific forms as examples of the invention. The 35 x.n~ention is not intended to be lianited to the !N~ 93/12002 P~.'I'/US92/109~18 '~ ~ ~ - ~~.~2~~.~
embodiments so described, however. The scope of the i invention is pointed out in the appended claims.
For ease of description, the system components of this invention are described in an arbitrarily .
selected operating position, and ternns such as upper, lower, horizontal, etc., are used with reference to this position. It will be understood, However, that the components of this invention may be manufactured, stored, transported, and sold in a partially or fully 1~ disassembled state, as well as in orientations other than that described.
The figures illustrating embodiments of the components show structural details that will be recognized by one skilled in the art. However, the ~5 detailed descriptions of all such details are not necessary to an understanding of the invention, and accordingly, are not'herein presented.
The system components of th~,s invention may typically be used with certain c~nventional components 2~ the details of which, although not fully illustrated or described, will be apparent to those having skill in the art ~hd an understanding of the necessary functions of such components.
The fist embodiment of the presea~t invention 2~ is illustrated ixa FIGS. 1-5 wherein'a tgansfer system is designated generally by the reference numeral ~Ø The ' system 1~ malr be eonv~niently employed to accommodate 3 the preparation and use of a bulk reconstituted, toxic drug. A t~xic drug is typ~.cally provi~ted in a highly 3~ concentrated form contained in a small via1~12. The v~el 12 typically includes a removable closure 1~ which is initially sealingly mounted over the mouth of 'the container 12 and sealed thereto with a frangible web.
The closure 14 can be torn away to permit removal of the VSO 9311002 P~'1US92/1091~
--closure 14 so as to expose exterior threads 15 on the neck of the vial 12.
The opening or neck of the vial 12 typically contains an internal, removable, resilient, seal plug 23 5 (not visible in FrG. 1 but shown removed in FIG. ~) the seal plug 23 defines an outwardly opening receiving cavity or recess, and the seal plug 23 prevents the discharge, or removal, of the licxuid contents from the vial 12 unless and until the plug 23 is engaged and 10 removed in a certain manner by an appropriate mating structure, such as may be incorporated in a bulk supply' container or bag 20 described hereinafter.
A conventional vial 12 is sold in the U.S.A.
as part of the Add-Vantage~ brand bulk reconstituted, drug system sold in the U.S.A. by Abbott ?aaboratories, Inc., One Abbott Park Road, Abbott Park, Illinois 60064-~~00 UeSoA. ~he detG~~.led de~uZgn and w~9pec,.f~..c Structure of the vial 12 f~xm no part of the present invention.
The bulk supply container or bag 20 may be of any appropriate desagn that is suitable for use with the particular liquid ~,o be stored and that is suitable for use with the vial 12 if such a vial 12 is employed.
The bag 20 is preferably fabricated from a convent,aonal, , flexible, transparent, thex~noplasta.c 2a materials The bag 20 a~~rmal~y ~rould be furnished to a hospital or other user with a bulk supply of liquid healed therelne I~ thebag. 2~ ZS t~ b~.used for the administrate~n of a toxic drug, the bag 20 may domain a di3uent liguid and may be,adapted to be connected to the highly concentrated !drug vial 12. ~ ' To this end, the bag 20.includes a neck 26 defining an- operair~g to the bag interior. The opening is initially occluded with an outer closure 30 that is connected to the neck 26 with a frangible seal. The ~5 outer closure 30 can be torn away from the bag neck 26 'W~ 93/12002 PC~'fUS92/lfD9l~
11 _ ~1~~7~1 to perm~.t the vial 12 to be coupled to the neck 26. Ta this end, the neck 26 may include internal threads 27 for mating with the threads 15 on the neck of the vial 12.
Inside the bag neck 26 there is an inneb plug 3~ with an upwardly projecting member knot visible) for being received in the recess of the seal plug 23 inside the neck of the vial 12 and for tightly engaging the resilient seal plug 23. As the vial 12 and bag 20 are ,screwed together, the projecting member is driven into Engagement with the vial seal plug 23. Next, the bag plug 34 is manually disengaged from the bottom of the neck 26 by pushing the flexible walls of the bag 20 against the projecting flange of the plug 3A. and pulling tae plug 34 out of the neck 26. this causes the projecting member of the plug 34 to also pull the engaged seal plug 23 out of the neck of the vial 12.
the two~ engaged plugs then drop together to the bottom of the bag 20 as illustrated in ~'ZG. 2. .
The above-described structure of the bag neck and end closure is a conventional design provided on fags for use ~tith the above-described type o~ vial ~1.2.
Such ~ bag neck and cl~sure structure is employed with bags furnished with the above-described Add~~Tantage~
25 dgug ~dminis~rat~.~n system sold ~y Abbott Laboratories, anc. the detai~:ed design end specific structure of the deck 2C,:outer closure 30, and inner plug 34 form no part ~f~~he present invention. Designs for the cohnection st~acture for the bag 20 and vial 12 are also 'disci~sed in the Abb~tt Laboratories; Inc.,. UsS. Patent ~los: 4,~1A,2f7, 4,614p5~.5, and 4,757,911.
After he plugs have been dislodged frown the necks of the bag 20 end vial 12, the concentrated liquid dig from the vial 12 flows into the bag 20. ~'he flexible bag 20 may then be kneaded or otherwise '!~~ 93/1202 PC.'1'/1J592J109~~
manipulated to effect a thorough mixing so as to produce a bulk. reconstituted drug having a much lower concentration. The lower concentration is determined, of course, by the initial amount of the concentrated drug in the vial 32 and by the initial amount of the diluent in the bag 2~.
At the end of the bag 20~opposite the neck 26 there is a discharge structure or dispensing fitment 40 (FIG. 1). The fitment 4~ includes a suitable tube 42, .such as a rigid, thermoplastic tube which projects from the bottom of the bag 2~. The tube 42 extends through ~~
the flexible end wall of the bag 20, and the bag wall is sealed araund the periphery of the tube 42. This seal may be effected with conventional heat seal techniques, with adhesive, or by other means, the details of which form no part of the present invention.
The ttabe 42 is in fluid communication with the liquid in the interior of the bag 20. The liquid is prevented from discharging from the tube 42 by a 2~ suitable closure or fitmer~t 46 which is preferably in the form of a seal or "reseal" that accommodates penetration by a suitable hollow spike, boll~w needle, or cannula. Such a reseal 46 typically functions to perm~.t the insertion of a hollow needle or spike to e~tabl~.sh communicatibn with the liquid in the tube 42 while the reseal seals tightly around the periphery of the beadle. The x~eedlc can be later withdrawn, and the reseal. 46, owing to the inherent resiliehcy of the reseal material, closes at the penetration site from ~0 which the needle has'been removed so as to prevent egress of the lie~uid.
then a toxic drug is provided in a vial 1.2 for being admixed with a diluent liquid in a bag 2c3 as described above, the vial 12 and bag 20 are typically ~5 manipulated in a controlled environment, such as in a 'WCa 93/12002 pC1'/US92/1091~
2122a~~.
laminar flow hood (not illustrated). The hood is maintained under negative pressure to prevent the escape of toxic vapors if there should be any inadvertent leak and to othexw~tise provide protection to the person handling the components. although conventional vials arid bags are typically manufactured under strict quality control standards and function well 'to prevent inadvertent leakage when properly handled, there is a desire, because of the highly toxic nature of many of the drugs, to provide an improved system for eliminating or reducing the likelihood that personnel will be ..
exposed to the drugs during the reconstitution process and thereafter when tie reconstituted drug is stored and used..
To this end, one aspect of the present invention provides a novel protection system for use with a container of hazardous liquid, including the above-described pouch 20 and connected vial 12. In the preferred form ~f the protect~.on system illustrated in FIG. l, a first aonne~ting means 50 is provided for being connected t~ the container 20 to establish fluid communication between the exterior~of the container 20 and the liquid inside the container. In the preferred form illustrat~d,:the connecting means,50 includes a hollow, sharp sgike 52 which is mflunted to~one end of a hollow,- cylindrical fitment 54 (FIGSa 1 and 4). The other end of the fitm~nt 54 is sealed to a hollow, flexible tube or other suitable conduit 56 in a manner that estab33shes fluid cor4munication between the ihterior of the hollow spike 52 and the conduit 5'6. The attachment of the hollow spike 52 to the conduit 56 via the fitmer~t 5~ may employ conventional; interior, sealing end amounting configurations (not visible in the figures) well known to those of ordinary skill in the art. The detailed design and specific structure ~f such W~ 93/12002 ~'CTltJS92110918 ,.,.,, a connection, and the detailed design and specific structure of the hollow spike 52, form no part of the present invention.
D
A latch or clip 60 (FIGS. ~l~and ~) is provided to hold the spike 52 to the container 20. The clip 60 , has a pair of feet 62 at one end which are mounted to the conduit 56 adjacent the fitment 54. A spring arm 66 extends from the feet 62 and terminates in a tab 68. A
pair of latch bars ?0 extend outwardly from the spring arm 66 for frictionaliy engaging one side of a flange ?~
on the conduit 42.
Initially, the clip 60 is held outwardly (as shown in FIG. 1~ while the hallow spike 52 is forced into the reseal 46. Then the clip 60 is then pushed toward the tube 42 so that the arms ?0 engage the flange ?4 and prevent inadvertent withdrawal of the hollow spike 52.
Typ,icall~, the vial 12 and bag 20 would be screwed together before ~he hollow spike 52 is inserted y 2~ through the rsseal'~6.. ~iowever, the hollow spike 52 could be inserted-thr~ugh the res~~1 46 firsts and the vial 12 end bag 20 could be subsequently connected t~gether.
- ~ unique; flexible barrier 80 (FT~~s. 1 and 2) is pr~vided as an integral part of the system along with the c~nduit 56 and connecting-means 5d~: The flexible barrier 8o is penetrated 3~y the conduit 56 and is sealed - a~~ut the peripher~T of the conduit 56 at he penetration.
' Tha barrier 80 is preferably fabricated'from;a suitable materaal whack is sufficiently transparent to permit some degree of,visual inspection through the barrier. The barrier 80 pbeferalaly is fabricated from a~
synthetic, thermoplastic; polymer material, and preferably has the shape of an openended enclosure, ~c~ g~ia~on2 a'creus92ia~~a~
~12~~~~
bag, pouch, envelope, or the like. A preferred material for the barrier 80 is linear low density polyethylene or flexible polyvinyl chloride.
The barrier 80 is sufficiently flexible to a accommodate an initial arrangement in a retreated-orientation (FIG. 1~ which permits access to, and manipulation of, at least a portion of the connecting means 50 and a container, such as the container 20. The barrier 80 is also sufficiently flexible to accommodate a subsequent arrangement in an extended orientation (FIG. 2) for defining an enclosure around the connecting means 50 and connected container 20.
The open end of the barrier 80 is preferably provided with a sealing means for completely closing or sealing the open end of the barrier 80. To this Brad, one such sealirlc~ means i~ illustrated in FIGS. 1-3 and includes a pliable, but non-resilient, member carried in the wall of the barrier 80 and having end portions 92 projecting from the wall of the barra.er 80. After the barrier 80 has beea~ arranged to enclose the vial 12 and bag 20 as illustrated in FIG: 2, the open end of the barriex 80 can be closed and 'then folded over a few times (ass illustrated in FTGS. 2 and 3). The extending ends g2 of the pliable member can then be bent around each s~.de of the u~f~lded portion o~ the barrier to hold the f~3.d~ tightly against the unfolded portion of the barrier. Thi~'effects a generally leak-fight seal.
~ther forms of closures or'seals for the open end of the barrier 8~ may be employed, and such other forms may be of a ~u~.table special or conventional design.
The canduit 5C may be characterized as generally extending from the first connecting means 50, ~wthrough the barrier 80, and to a discharge 1~cation exterior of, and spaced-away from, the bag 20. The condu~.t 56 inclhdes a one-way, non-return valve or check 'VNO 93!12002 PC I'JUS92110918 valve 102» The check valve 1,02 prevents flow into the container or bag 20.
The check valve 102 may be of a suitable special or conventional design. A suitable conventional v 5 valve is that sold in the U.S.A. under the designation Normally Closed Check halve by Burton Medical having an office at Uethlehem, Pennsylvania., In the preferred embodiment illustrated in FIGS. 1 and 2, a special or conventional Y-fitment or fitting 108 is provided in the first conduit 56 for reasons described in detail hereinafter» The Y-fitting..
108 is connected to the conduit 56 between an inlet leg of the ~~Y~~ and the common outlet leg of the ~~Y~° .
The Y-fitting 108 may be of a suitable special 1,5 or conventional design. One suitable conventional Y-fitting is made under the designation ~.ist No.~75-0128 Y-fitment by I~rbbott T.~boratories having an office at :,North Chicag~, Illinois.
A second c .~nnecting means lls is connected to the distal end Of the. first conduit 56, and the second connecting means lls is adapted to be connected to a sy~°inge 120 t~ establish fluid comnnunication between the bag 20 and the syringe 120. The seceand connecting means x,16 may be a sp~Gial or C~nventional device, and one 5 such suitalale device as ~ valve sold in the U . ~ s 1~ s under the designati~n "~3urron Reflux~' by ~urron Medical s~hich has an office at Ue~hlehem, Pennsylvania. Such ~ valve his an a.nternal~v~lve ~~~er (not visible that is normal~.~ biased to occlude a discharge port, and the 'discharge p~rt includes a'generally cylindrical receiving wall around the port for accommodating the a insertion of the distil end of the syr~~age 120.
In a preferred form illustrated in FIG. 1, the seeond connecting means 116, in the form of the above- a :'a 35 d~s~cribed valve, defines a conventional, female, lust wC~ 93WOOZ PC11'f~JS92/1o918 - ~~.2~~~1 fitment for receiving a mating, male, leer fitment on the distal end of the syringe 120. When the male leer fitment of the syringe 120 is inserted into the female luer fitment of the valve, the valve member within the valve is pushed away from its seat by an internal°cage engaged with the distal. end of the syringe luer fitment.
This opens the valve port and perm~.ts the liquid to be discharged through, or drawn through, the valve by operation of the syringe 120 in the usual manner to effect a suction within the syringe 120.
When the desired amount of liquid has been ...
drawn into the syringe 120, the syringe is pulled out of the valve (i.e., connecting means 116, and the internal valve member is biased to again occlude, and seal, the valve port.
A suitalble safety cap 126 may be provided for being mounted on the distal end of the valve or eonraecting means 116. To this end, the cap 126 may be of the convents.~nal ty_ pe nArmally px°ovided with, such a 2~ valve wherein the cap 126 includes a suitable a.nternal thread structure for engaging a mating thread form or partial tlhread form on the exterior of the distal end of the valve.
Irt the preferred form of the invention illustrated in FI~s-: 1 end 2, a second conduit or tube 132 is connected ~t a fi.r~t end to the sec~nd lec~ of the Y fitting 108 in fluid communication with the first G°O'ndu~.t 56.0 The seC'rond condul.t 1°32 e'xtend',~~'' baCr~C
through the barrier 80 t~ a'recep~acle 140. In the preferred form illustrated 'in~ FIGSs' 1' and 2,' the receptacle 140 has the form of ~ flexible pouch or bag defined by two sheets of flexible material with generally coterminous edges which arm dialed together about their peripheries.
The interior of the redeptacle or pouch 144 is in fluid VVVO 93/12002 P~'I'/~LJS9211~9'8 21~~~~~.
comxaunication with the interior of the second conduit 132.
At the location where the second conduit 132 penetrates the barrier 80, the barrier 80 is sealed around the periphery of the second conduit 132 by~
suitable special.or conventional means such as described above with respect to the barrier penetration seal for the first conduit 56.
The second conduit 132 includes a second, one-way, non-return valve 150 for preventing flow of, liquid from the receptacle.or pouch 140 into the first conduit, 56. The one-way, non-return valve 150 may be a special or conventional check valve identical to the valve 1.02 employed in the first conduit 56 as described above.
1.5 However, the second check valve 150 is, of course, oriented in the direction opposite to that of the orientation of the first check valve 102 so that the second check valve 150 prevents flow toward the Y-fitting ~arh~reas the first check valve 102 prevents flow away from the Y~f~.tt~ng lVBo The preferred form of the invention illustrated in DIGS. l and 2 also includes a three-way valve 180 which,, as illustrated i~ FIGS. 1 and 2, is located in the second conduit 132 between the receptacle 1~0 and the second check valve 150. As illustrated in FTG. 5, the three,°way valve 180 includes a body 182 with three outwardly projecting conduit members 191, 192, and 193 which each define a port.pommunicating with the ynterior of the valve body 182.
The v~lve'180 als~ includes a rotatable valve member 7.96 defining an internal, T-shaped flow passage 1~8~ Flotation of the valve member 196 permits the '' internal flow passage 198 in ache valve member 196 to be aligned between the port conduits 191 and 193 while occluding the post conduit 192 as illustrated in I~IG. 5.
WO 93/12002 3~CT/L1592/A0918 The valve member 196 can also be rotated to another position to establish fluid communication between the port conduits x.92 and 193 while occluding the port conduit x.91. Of course, the two other po.;itions of the valve member 196 are possible, but such other posi't'ions would n,ot typically be employed during the use of the invention, and such other positions are not described in detail herein.
~t least the port conduit 192 may be provided 1.0 with an exterior thread form 202 for receiving a.safety cap 20~. The safety cap 20~ includes an internal thread forms 206 for matingly engaging the thread forty 2~2 on the port conduit 7.92 and also includes an internal, hollow, cylindrical plug member 208 for being received 1.5 within, and occluding, the port 192.
The valve 180 may be a conventional valve such as the valve sold under the designation 4 Way ~topcoek by edex, Inc. having~an office at Hilliard, Ohio.
In operatioa~, then the connecting means 50 is 20 connected t~ the bag 20 and the barrier 8~ is closed ar~aand the bag 20 as described above with reference to FIB: ?, the receptacle 3.~~ is disposed generally adjacent the bag 20 and is also necessarily enveloped and enclosed bythe barrier 80.
A leak~tzght barrier or protection system is established when the ~.op of the barrier 8~ is folded t~~ether and x~lhd down a few turns and secured in position by thevpli~ble tabs 92 as described above and illustrated in ~'IOS. 2 anc'~ 3. With the leakstightness ,30 of the b~rriex system thus established, the'plug 3~ cai~
be removed fr~m the lower end of the neck 26 of the bag 2~ to permit the cbntents of the vial 22 to be discharged into the bag 20 and be mixed therein.
When the barrier 80 is in the fully sealed 35 orientation as illustrated in FIG. 2, the discharge WO 93»2002 PC'd'/1JS92/10918 valve 116 and the three-way valve 180 are, of course, exposed for manipulation. The syringe x.20 can be engaged with the distal end of the discharge valve 3.1.6, and a desired amount of liquid can be withdrawn from the bag 20 by operation of the syringe to establish suction within the syringe.
If an air bubble is entrained with the liquid flowing into the syringe, or if excess liquid is drawn into the syringe, the air bubble and/or excess liquid can be discharged into the receptacle 1~0. To this end, the. syringe 120 is operated to discharge the desired ...
amount of the liquid back through the valve 11.6. The check valve 102 in the first conduit 56 prevents back flow into the bulk supply bag 20, but the check valve 2.5 150 permits flow from the syringe 120 toward the receptacle 1~0: If the valve member 196 of the three-way valve 180 is aligned as illustrated in FIG. 5, the liquid discharged from the syringe 120 can pass into the receptacle ~.~0 within:th~ barrier 180~ In this. manner, a small amount of liquid containing an entrained air bubble or a small amount of excess liquid can be convenientl~r discharged to the receptacle 140 without requiring removal of the syringe 120 fr~m the valve 11.6.
Thus, ;the receptacle 14O functions as a waste receptacle within the barrier 80. Further, because the receptacle 14~ a.s separate from the bulk supply bag 20, aid ~ecab.se tire check val~re X02 does not permit flow hack ~.nto °the bag 2 ~ ~ there is no danger .hat the bulk supply in the bag 20 can bec~me contaminated with the 3~ ~~~id that had been previously withdrawn from the bag ~~, If desired, the system may be operated in a ~~pumping" mode sa as to pump liquid from the bulk supply bad ~0 to a separate container or remote location.
Specifically, the valve member 196 in the three-way V~~ 93112002 PCT/US92/1091~
_ 21 _ valve 180 can be oriented to establish communication between the second conduit 132 and the outlet port conduit 192 while occluding the port conduit 191. The outlet port conduit 192 can be connected directly to a ~5 separate fluid conduit system or to a separate container, such as to a container of an intravenous fluid. The syringe 120 can be operated to first withdraw liquid from the bag 20 into the syringe, and then the syringe can be operated to force the liquid from the syringe through the conduit 132 and three-way valve 180 to the other container or fluid conduit system (not illustrated'.
The first connecting means 50 has been illustrated as incorporating a hollow spike 52 for use with a suitable reseal 46, and the second connecting means 116 has been illustrated as a valve for use with a suitable syringe 120. It will be appreciated, however, that other systems xnay be provided for establishing a connection with the bu7.k.supply bag 20 and for.effecting a dispensing of the lic,~u~d from the end of the conduit 56. Thus, the (first connecting means 50, the conduit 5~, and'the second connecting means 116 (which could be a dispensing valve as previously described), may be characterized ~.og~ther in general terms as a first ., ,i 25 conduit system ~r means for being connected to, and extending frump the c~ntainer 20 to define a flow path for the liquid from the coa~tainer to a discharge location exterior of the container 20. Similarly, the second conduit 132 may be. characterized as a second conduit means for defining a flow path for the liquid between a first end connected in fluid communication with the first conduit means and a second end connected ..q to the receptacle 140.
Further, it will be appreciated that although ~5 one aspect of the present invention relates to the use w~ ~~i'zoox ~t:r~us~xrio~m 212 2 ~'~ ~. _ 22 -of the novel barrier 80 with both a first conduit means for withdrawing a liquid and a second conduit means connected to a receptacle for accommodating excess or , waste liquid, the second conduit means 1.32 and connected receptacle 140 may be omitted, or at least not used, in those situations where there is no need to hold excess liquid in a separate, sealed receptacle.
' Further, there may be applications involving liquids which are not directly hazardous to personnel 1 0 but which may be potentially damaging to the environment if not disposed of in an appropriate manner. In other ~.
applications, a liquid may not be directly hazardous and may not even pose a potential danger to the environment, but may be subject to strict inventory control. Thus, another aspect of tlae present invention contemplates that in either of these situations the system may be provided without the barrier S0. 'Without the barrier 80, the system would still conveniently accommodate the c~ll~:ction of the waste or excess liqu~.d in the.
receptacle 14~ so that the liquid in the receptacle ~.4~
would be readily susceptible to inventory control prodessing and/or proper disgosal.
~. second embod~.ment of the present intention is diagrammatically il.~.ustrated in ~TG. 6. This 2~ embodiment includes a barrier protection system in combination with a la.q~id transfer system that-incorporates deans for ransferr~.ng liquid to a syringe, to an~ther fluid conducting system or container, and to a waste receptacle.
3~ The second''embodiment includes a first co~nectinc~ means, much as-a hollow spike 252. The spike 252 is adapted to penetrate a closure anembex~, such as a ' reseal (not illustrated), in a bulk supply bag or contaia~~r 26~ (FIG. 7). Such a reseal and container may 351 Dae substantially the same as the reseal 46 and t eJV~ 9312002 PC'1'/LJS92/10~~8 21~~~~1 _ associated container 20 described above with reference to the~first embodiment of the invention illustrated in FIGS. 1--5. In FIG. 7, the reseal or other closure contained on or in the container 260 has been omitted for ease of illustration, and the hollow spike 252 is shown penetrating the bottom of the container 260.
Prior to use, the hollow.spike 252 may be covered with a suitable safety cap 253. The spike 252 is ~aounted on the end of a first conduit 256 which penetrates a barrier 280. The barrier 280 is~flexible, and may be fabricated from the same material as the ...
barrier 80 described above with reference to the first embodiment illustrated in FIGS. 1-5. The barrier 280 is sealed around the periphery of the first conduit 256 at the location where the f'irst,conduit 256 penetrates the barrier. The barrier 280 has a configuration that permits its arrangement in an initial, retracted orientation which pex~nits access to, and manipulation ~f, the cbnnecting means spike 252 and container 260.
Such an initial or~:enfiation is illustrated in FIG. 6.
The bag 280 accommodates subsequent axrangement in an extended ~rientation (FIG. 7) for , around the first connecting means defining an enclrssuxe ~~~ axed container 260. The top ~f 'the conta~.ner 260 may ~5 be adapted to be coupled to anotD~er container 262. The container 262 nay be substantially identical to the vial ~:2 described- abdv~ with reference to the first embodiment illustrated in FIGSa 1. and 2. Thus, the contents from the container 262 can be emptied into, and ~ anixed wrath, a d~:luent or other lic~!id conta~.ned in the:
container 260. ~f c~urse, the assembly of the container 26~ coupled to the container 262 may not be the only means for supplying liquid to the hollow spike 252.
ether contaia~ers c~uld be used, including a single container of a pre-mixed, bulk supply of liquid.
vv~ 93i' zooz ~crru~~zm o9's ~~.2~~91 - - 24 - :...
In any event, the barrier 280 is adapted to be sealed'at its open end by suitable means. FIG. 7 illustrates the use of,a interlocking, plastic rib sipper-type seal 292 which may be of a suitable special or conventional design, the details of which form no part of the present invention.
The barrier 280 preferably has a wedge-shaped, open-ended, envelope configuration which is substantially reversible from the inside-out orientation illustrated in FIG. 6 to the inverted orientation.
ill~.strated in FIG. 7. As schematically represented in.,.
FIG. 7, a first one-way, non-return valve or check valve 302 is mounted in the first conduit~or tube 256 to prevent flow back into the bag 280. The check valve 302 ,' Z5 may be a suitable special or conventional check valve and may be identical to the check valve 102 described above with .reference to the first eaabodiment of the invention il3:ustra~ed in FIGS. 1-5.
1~ sec~nd connecta.ng means or dispensing ,valve ., '2~ 31.6, which includes a removable safety cap 326, is mounted to the distal end of the first conduit 256. The valve 3Z& may be a suitable special or conventional valve- adapted for use with a syringe (not illustrated and may be ident~.cal to' the valve employed as the second 2~ cor9necting means 116 described above with reference to the eodiment illustrated in FIGS. 1-5.
'~ A second conduit means or tube 332 extends from the first conduit 256 td a receptacle 340. The .
.a receptacle 340 includes a sheet of flexible, 3~ theranoplast~.c material sealed about its periphery to the outs~.de sur~~ce of the barrier 280. The receptacle 340 functions in the same manner as the receptacle 140 in the first embodiment described above'with deference to '; FIGS. 1-5, and the receptacle 340 receives excess or 35 waste liquid and/or entrained air.
vv~o g3i' zooz Pc-rms~zi' 09~ ~
_ ' 25 ' ~~~u~~
A onewway, non~return valve or check valve 350 is provided in the second conduit 332 as schematically illustrated in FIG. ?. The check valve 350 prevents flow out of the receptacle 340. The check valve 350 may be a suitable special or conventional valve and may be identical to the check valve 150 described above with reference to the first embodiment of the invention illustrated in FIGS. 1~5.
A third conduit 410 is connected at one end in l0 fluid communication with the second conduit 332 between the first conduit 256 and the second check valve 350. w The third conduit 4~.0 terminates in a second end having a suitable dispensing structure or fitment 415 from which liquid may be discharged. The fitment 425, as schematically illustrated in FTG. 7, may be a conventional connection of the kind sold under the designation LIFE~SHI~Lmg°~ Co~nec~or ~.n the U.S.A. by Abbott Taaboratories having an office at PTorth Chicago, Illinoa.s. Such, a fitment 415 includes a hollow spike 4~.? surrounded by a cylindrical shield 41~. The fitment 415 is adapted to be connected to a suitable receiving port in an intraveno~x~ bag system (not illustrated).
The detailed design and structure of the fitment 415 form no part of the present invention.
In order tc-prevent flow from the third conduit 410 back'into the second conduit 332, a third one-way, n~n-ret~arra valve or check valve 426 i.s provided ~.n the third conduit ~1~. The check valve 426 may be identical to the check valv,~e 350 described above.
In the 'embodiment illustrated ix~ FTG. ?, there is ~o three--way valve, such as the three-way valve 180 illustrated in FTG. 5 for the previ~usly described first embodiment. Rather, a conventional slide clamp 430 is provided on the second conduit 332, and a second slide clamp 434 is provided on the third conduit 410. The V1VC193/ 12002 ~'~C1'liJ~921 ~ 091 ~
~~.2~~91 _ zs -slide clamps 430 and 434 may have a suitable special or conventional design. A suitable conventional clamp is made under the designation list No. ~5--~1S7 Slide Clamp by Abbott Laboratories having an office at North Chicago, Illinois. Each slide clamp functions as an .
isolation valve means for selectively closing or opening the conduit on which it is mounted:
' The two slide clamps 430 and 434 can be employed to selectively direct the flow to either the 1~ .receptacle 340 or the fitment 415. In particular, if it is desired to discharge excess or waste liquid, including liquid with entrained air, 'to the receptacle 340, then the slide clamp 434 is adjusted to close off the conduit 4~.0, and the clamp 430 is maintained in an open position on the second conduit 33z. Alternatively, if it is desired to transfer liquid to the third conduit 41~, the slide clamp 434 is adjusted to the open position, and then the slide clamp 430 is adjusted to the closed position so as to pinch the second conduit 2~ 33z closed.
~lith the system illustrated in ~'IG, ~, a syringe, such as the syringe 120 described above with reference to the first embodiment illustrated in FIGS.
~.-5,'may be employed for withdrawing liquid from the c~ntain~r 260. Further, lic~u~.d can be °°pumped°°
from the container 26~ through the third conduit 41~ by operation of the syringe in the same manner as described above with reference ~o the first embodiment.
The barrier system of the invention functions to prpt~ct~personnel from a hazardous liquid leak, and the barrier system can be relatively easily and quickly manipulated as necessary to provide the barrier protection around a variety of containers having various shapes and sizes.
' _,; , , :. ;; , ;. .. . . . .,' .. ~ : - .. ._,: v , ,~- ~., ~.. , ,., y:
dVC9 93/32002 fGT/US92/1~9'6~
- 27 - ~~.~~~~~.
Further, regardless of whether or not the barrier protection system is needed or employed, an additional feature of the invention provides a novel liquid transfer system for accommodating withdrawal of liquid from a container with a syringe. The system permits the syringe to be used as a pump to discharge precise amounts of the liquid directly to another fluid conduit system or to an intravenous container-~--all without apening the system to ambient atmosphere.
It will be readily apparent from the foregoing detailed description of the invention and from the illustrations thereof that numerous variations and modifications may be effected without departing from the true spirit and scope of the novel concepts or principles of this invention.
~F LIOUID FROM A BUL% SUPPLY
TECk~TICAL FIELD
The present invention relates to a fluid transfer system for accommodating the withdrawal of liquid from a bul~C supply for use in medical procedures.
The present invention is particularly well-suited for use with bulk reconstituted, toxic drugs, such. as 7.0 chemotherapeutic drugs.
BACRGROTJi~ID OF TIDE INVE~TTIflN
AND
TEC~iNICAL PROBLEMfS POSED BY THE PRIOR ART
Various medical procedures require the transfer of fluid from 'one fluid-containment system or fluid-conducting system to another flu~.d~-containment system or fluid-conducting syst~~n. Typically, one of the two s~rs~ems includes a c~ntainex for a bulk supply o~ liquid, s~zch as a ~ulx supply of a reconstituted, ~~? liqu~.d, chemothexap~u~ic drug. The other system, which i cap be as simple as a syringe; may b~'connected to the f irSt System ~~r ~nly a Short per7.od Of t3.me, Or interam~tter~tly, to 'facilitate the' withdrawal of a desired am~unt-~r dose of thr liqu~:d for ~dministratiora ~~ ~~transm~~~lon t~a patient.
. Tn those medical applications where the (first system includes a container fa~~ ~ bu~.k supply of a toxic ~~~~d~ 1.t 3,5 C~euiralal~, if not neCeSSary, to prei~L'nt i inad'~t'erte'nt eXp~Sllre of p~rSOnIlel t0 t$~e, t~X7.0 liquid.
For example; a hospital pharmacy may prepare highly toxic, chemotherapeutie drugs far use in treating cancer . patients. Typically, a ~tial of a highly concentrated, ~.~axic drug is rec~i~re~ from the pharmaceutical supplier b~ the hospital pharmacy;: and the hospital personnel 35 then admix the concentrated drug with a suitable diluent W~ 93/1.2002 PC'I'/~JS92/1091f~
_ 2 _ to provide a bulk reconstituted supply having a reduced concentration or effective dose per unit volume that permits the administration of a prescribed amount or ' volume directly to the patient. , The preparation of the bulk reconstituted, liquid drug is typically carried out in a protective environment, such as in a laminar 'flow hood which is specially designed to maintain a negative pressure within the hood so as to prevent the escape of toxic vapors. ,"
The bulk reconstituted, liquid drug is usually stored in a suitable container which may be a flexible, thermoplastic, sealed bag., A suitable. discharge structure, dispensing structure, or fitment is typically provided on the bulk container to accommodate withdrawal of a desired amount of the liquid from the container.
It is, of course, desirable to ensure that the means for withdrawing a prescribed amount of the toxic liquid drug will not result in spills or leaks from the bulk ! ~0 coast finer.
Accordins~ly, it would be advantage~us to provide a barrier system which could be employed with a container of a bulk supply of a toxic drug and which would functi~n to contain a leak or leaks of the liquid drug from the container, or from as~c~ciated ccannections thereto, so as to prevent exposure ~f personnel to the d~ .
It ~rould also be desirable to provide such a barrier system ~rith means'for accommodating its 3~ disposition in association with, or its connection to, the bulk supply container in a manner that can be d relat~.vely easily and qusckly effecteda It w~uld also be beneficial if such a barrier system could be provided with a structure that would accommodate movement or transport of the bua.k supply 'Wf~ 93/120(i2 PCH'l1JS92A1~9~~
_ . ~ 3 ~122~~~.
from one location to another while still maintaining the efficacy of the barrier system against leakage.
Further, it would be desirable to provide such a barrier system with means for accommodating withdrawal of the bulk reconstituted, liquid drug by means of a suitable, conventional syringe, especially a syringe having ~ luer fitment.
It would also be advantageous for such a barrier system to function to prevent inadvertent l0 .injection of the liquid drug, or other material, back into the bulk container so as to reduce the probability of contamination of the bulk supply.
In addition, it would be beneficial if the barrier system could accommodate the use of,_~ syringe to withdraw the liquid drug from the bulk supply and to pump a desired volume of the liquid drug into a selected a conduit for ~d~inistrat~.on to a patient or for delivery to another container or containment system.
_ den a bulk-container of liquid is employed for supply~.ng small quantities or doses of the liquid -, drug via withdrawal by a syringe, it would be desirable ~o pr~vide means for accommodating the asp~.ration or dasdharge from the syringe ~f an excess amount of the liquid, er of a' portion of the la.quid in rahich an air 2~ bubble is entrained, that may have been drawn into the syr .l.nge a Tt would b~ desirable t~ prov~.de Such a cap~bi.lity regardless o~ whethex or not the bulk supply ~f liquid is toxica accordingly, it'would be des~.rable to provide, a suitable receiving compartment or receptacle for excess liquid ~ndJor for a mixture of liqu~.d and air., in conjunction raith a syringe~operated transfer or ~rithdrawal system operable ~n a bulk supply. It would be beneficial if such a receptacle could be provided as a unitary or integral part of the withdrawal system and WCs 33/1202 PL~'/iJS9z/1o918 could also be adapted for use with a barrier system that prevents exposure of personnel to leakage.
Further, in view of the dangers associated with toxic drugs, contamination, and infection, it. would be desirable to provide a barrier system and/or receptacle system which would facilitate its use as a .disposable item. To this end, such a system or systems should be relatively inexpensive. Accordingly, such systems should incorporate an improved component design that accommodates relatively simple manufactur~.ng ~~
processes and assembly processes to keep the total cost as low as ponds.6.ble s The systems should also function to effectively seal at connection points or attachment points to prevent leakage of fluids and to prevent ingress of airborne or liquid-carried contaminants.
Addaait~nally, the systems 'should preferably function effectively with a var~.ety of f~.uids throughout a range ~f fluid pressures.
Advantage~usly, the systems should have a suitably long shelf life and active use life. Further, such systems should pre~exably be adaptable to function effectively after repeated connectior~~ to a syringe.
Sg3I~lARY ~F THE INVENTION
t ~~ The present invention provides a novel fluid trane~er .cyate~a for accoynm~clatia~g th.e wa.thdrawal of liquid form, a hulk supply., Ln the preferred form, the iawent~:on permits a bulk supply of hazardous liquid to r ,be prepared, such as by thh admixing of a highly 3~ concentrated, t~xic drugwith a diluent, while preventing or minimizing exposure ~f personnel to the ha~aard~uw~J.l~.qu~.d w Thl.J ~~J facl~~.tatedby the use of a I10'ttt:l barrier syS'Gem w$ll.ch iS imperVl.ous t0 the ll~uid .
~'he harrier system of the pgesent invention 35 functions effectively to protect personnel from spills i~V~ 93112002 PCT/tJS92/109~~
or leaks of a hazardous liquid during withdrawal of the liquid from a bulk supply and/or during preparation of the bulk supply. The barrier system conveniently permits manual operations to be performed on various components, such as a small container of a highly concentrated, toxic drug and a larger container of a diluent liquid.
The barrier system accommodates the movement 'or transport of a bulk supply of liquid from one location to another while maintaining the efficacy of the barrier system protection against leakage. Further, the barrier system accommodates the convenient withdrawal of liquid from the bulk supply by means of conventional components, such as a suitable syringe, r, Another aspect of the invention, which can provide operational advantages with or without a ,;
protective barxier system ~f the type referred to above, relates to a system for accommodating the collection of unwanted or excess lis~u~.d that has been inadvertently withdrawn or otherwise withdrawn from a bulk supply. In particular, when a syr~.ng~ is used for withdrawing liquid from a bulk supply container, the system permits a p~r~;ion of he liquid in tae syringe, which nay be an y excess amount, or which may contain an air bubble, to be discharged frown tla~ syringe to a hovel waste receptacle.
The liquid transfer and waste--receiving system is adapted to be ~e~nveni~ntly used in conjuhction with a bulk supply ~f liquid: The waste-receiving system is especially well-suited for use in conjunction with, and as a ~.n~tegral part of, the above--discussed 'personnel p~rQtection barrier system.
Both systems, whether provided separately or ' ~s ~n integra2 combination sys~e~n, can incorporate improved comp~nent designs which accommadate relatively simple manufacturing processes and assembly processes so TWO X3/12002 PCTI~.J~~2/90g1~
21~~a~1.- 6 -as to keep the total cost as low as possible. The systems can function effectively with a variety of fluids through a range of fluid pressures. The systems accommodate designs that provide a suitably long shelf life and active use life.
In one preferred forna of the invention, a protection system is provided for a container from which a hazardous liquid can be removed. The system includes conduit means for being connected to, and extending ~.0 .from, the container to define a flow path for the liquid from the container to a discharge location exterior of ~..
the container. A flexible~barrier, which is impervious to the liquid, is penetrated by, and sealed to, the conduit means. The flexible barrier accommodates at 2.5 least two arrangementsa (1) an initial arrangement in a ;., ',s retracted orientation permitting access to, and manipulation ~f, at 3east a portion~of the conduit means and cantainer: and (~) a subseguent arrangement in an extended orientation.envelop3ng a port~.on of the conduit 2c3 teens and the connected container.
The lic~id transfer car withdrawal system, which may operate separately from, and independently of, the above-descr~.bed barrier system, accommodates the withdrawal of liquid from a container with a syringe.
25 The withdrawal system'includes ~ first conduit means for ~eia~g connected at ores end to, and for extending from, the csantainerv The'first conduit weans is connected at another end to the syringe to define a flow path for the liquid between the contaixrer and the syringe.
~~ A second c~nduit means is provided for de fining a flow patYa f~r the ~.ic~uid from a first end eonnected to, and in fluid communication writh, the first conduit means:- The receptacle is connected to the second end of the second conduit mc~ns and is in fluid ' 3~ commuhi,cation therewith. ~4 first one way, non-return ~V~D 93/2002 P~'T/US92/1091A
- ' - ~.~~2~~~
valve is provided in the first conduit means in the flow path between the container and the second conduit means to prevent flow into the container. A second one-way, non-return valve is provided in the second conduit means to prevent flow out of the receptacle to the first C'rondu,l.t means o Numerous other advantages and features of the present invention will become readily apparent from the following detaa.led description of the invention, from .the claims, and from the accompanying drawings.
BRIEF DESCRIP'X°ION OF THE DRAWINGS
In the accompanying drawings that form part of the specification, and in which like numerals are employed to designate like parts throughout the same, FIG. 1 is a partially exploded, perspective view of the components of a preferred form of the present invention shown in a first ox~.entation in conjunction with a drug vial and diluent bag, and a potion of a coanponent of, the -invention has been broken ~~ away to better illustrate interior details FIG. 2 is a view similar to FIG. 1, but FIG. 2 shows the components after various fluid connections have been made end after the components have been rearranged in a°se~ond orientation to provide protection against fhaid leak~ge~
FIG.,3-is an enlarged, fragmentary, side-elevational view taken generally along the plane 3-3 in FI~e~C
FIG. 4 is an enlarged, fragmentary, side 30 elevational vie~ri taken generally along the plane 4-4 iri F~~e~%
FIG. ~ is an enlarged, fragmentary, elevational view taken genera~.ly along the plane 5-S in FIG. zs vv~ 9~rizoo2 Pcrru~gzr'o9~s $_ _ FIG. 6 is a simplified, diagrammatic, front elevation view of a second embodiment of the invention wherein the components are shown in a first arrangement prior to use: and FIG. 7 is a simplified, diagrammatic view 'similar to FIG. 6, but showing a side elevation after the com~aonents have been connected~to a bag containing a bulk reconstituted supply of an admixed drug from an yattached vial and wherein the system components are in a v 7.0 second arrangement providing an enveloping barrier against leakage.
DESCRIPTION OF ~'HE PREFERRED EMBODIMENTS
the present invention provides a novel transfer system,f~r accommodating the withdrawal of ~:5 Liquid from a bulk supply. ~'he invention is particularly er~ll~-suited for use witlh bulk reconstituted, toxic drugs, such as~chemotherapeutic drugs.
Onc asp~ctvof the invention relates ~Co a novel barrier systeyn for px~tecting personnel from leaks or spills of a hazardous liquid that is stored in a container from which the liquid can be removed. Another aspect of the inventian, which may be included as an integral part 'of, br ~rhich may be er~tireZy independent ;, ~5 ofo the b~rxi~r system, provides ~ unique lic,~uid transfer syste~a for accom~aodating 'the use ~f a syringe t~ draw liquid from a container. The liquid transfer syste~'prcvides a novel receptacle for receiving a Potion of the~withdrawn liquid which may be an excess 3C amount and/or which'may contain an entrained air bubbl'e~
Whxile this invention is susceptible of embodiment in many different forms, this specification end the accompanying drawings disclose only some specific forms as examples of the invention. The 35 x.n~ention is not intended to be lianited to the !N~ 93/12002 P~.'I'/US92/109~18 '~ ~ ~ - ~~.~2~~.~
embodiments so described, however. The scope of the i invention is pointed out in the appended claims.
For ease of description, the system components of this invention are described in an arbitrarily .
selected operating position, and ternns such as upper, lower, horizontal, etc., are used with reference to this position. It will be understood, However, that the components of this invention may be manufactured, stored, transported, and sold in a partially or fully 1~ disassembled state, as well as in orientations other than that described.
The figures illustrating embodiments of the components show structural details that will be recognized by one skilled in the art. However, the ~5 detailed descriptions of all such details are not necessary to an understanding of the invention, and accordingly, are not'herein presented.
The system components of th~,s invention may typically be used with certain c~nventional components 2~ the details of which, although not fully illustrated or described, will be apparent to those having skill in the art ~hd an understanding of the necessary functions of such components.
The fist embodiment of the presea~t invention 2~ is illustrated ixa FIGS. 1-5 wherein'a tgansfer system is designated generally by the reference numeral ~Ø The ' system 1~ malr be eonv~niently employed to accommodate 3 the preparation and use of a bulk reconstituted, toxic drug. A t~xic drug is typ~.cally provi~ted in a highly 3~ concentrated form contained in a small via1~12. The v~el 12 typically includes a removable closure 1~ which is initially sealingly mounted over the mouth of 'the container 12 and sealed thereto with a frangible web.
The closure 14 can be torn away to permit removal of the VSO 9311002 P~'1US92/1091~
--closure 14 so as to expose exterior threads 15 on the neck of the vial 12.
The opening or neck of the vial 12 typically contains an internal, removable, resilient, seal plug 23 5 (not visible in FrG. 1 but shown removed in FIG. ~) the seal plug 23 defines an outwardly opening receiving cavity or recess, and the seal plug 23 prevents the discharge, or removal, of the licxuid contents from the vial 12 unless and until the plug 23 is engaged and 10 removed in a certain manner by an appropriate mating structure, such as may be incorporated in a bulk supply' container or bag 20 described hereinafter.
A conventional vial 12 is sold in the U.S.A.
as part of the Add-Vantage~ brand bulk reconstituted, drug system sold in the U.S.A. by Abbott ?aaboratories, Inc., One Abbott Park Road, Abbott Park, Illinois 60064-~~00 UeSoA. ~he detG~~.led de~uZgn and w~9pec,.f~..c Structure of the vial 12 f~xm no part of the present invention.
The bulk supply container or bag 20 may be of any appropriate desagn that is suitable for use with the particular liquid ~,o be stored and that is suitable for use with the vial 12 if such a vial 12 is employed.
The bag 20 is preferably fabricated from a convent,aonal, , flexible, transparent, thex~noplasta.c 2a materials The bag 20 a~~rmal~y ~rould be furnished to a hospital or other user with a bulk supply of liquid healed therelne I~ thebag. 2~ ZS t~ b~.used for the administrate~n of a toxic drug, the bag 20 may domain a di3uent liguid and may be,adapted to be connected to the highly concentrated !drug vial 12. ~ ' To this end, the bag 20.includes a neck 26 defining an- operair~g to the bag interior. The opening is initially occluded with an outer closure 30 that is connected to the neck 26 with a frangible seal. The ~5 outer closure 30 can be torn away from the bag neck 26 'W~ 93/12002 PC~'fUS92/lfD9l~
11 _ ~1~~7~1 to perm~.t the vial 12 to be coupled to the neck 26. Ta this end, the neck 26 may include internal threads 27 for mating with the threads 15 on the neck of the vial 12.
Inside the bag neck 26 there is an inneb plug 3~ with an upwardly projecting member knot visible) for being received in the recess of the seal plug 23 inside the neck of the vial 12 and for tightly engaging the resilient seal plug 23. As the vial 12 and bag 20 are ,screwed together, the projecting member is driven into Engagement with the vial seal plug 23. Next, the bag plug 34 is manually disengaged from the bottom of the neck 26 by pushing the flexible walls of the bag 20 against the projecting flange of the plug 3A. and pulling tae plug 34 out of the neck 26. this causes the projecting member of the plug 34 to also pull the engaged seal plug 23 out of the neck of the vial 12.
the two~ engaged plugs then drop together to the bottom of the bag 20 as illustrated in ~'ZG. 2. .
The above-described structure of the bag neck and end closure is a conventional design provided on fags for use ~tith the above-described type o~ vial ~1.2.
Such ~ bag neck and cl~sure structure is employed with bags furnished with the above-described Add~~Tantage~
25 dgug ~dminis~rat~.~n system sold ~y Abbott Laboratories, anc. the detai~:ed design end specific structure of the deck 2C,:outer closure 30, and inner plug 34 form no part ~f~~he present invention. Designs for the cohnection st~acture for the bag 20 and vial 12 are also 'disci~sed in the Abb~tt Laboratories; Inc.,. UsS. Patent ~los: 4,~1A,2f7, 4,614p5~.5, and 4,757,911.
After he plugs have been dislodged frown the necks of the bag 20 end vial 12, the concentrated liquid dig from the vial 12 flows into the bag 20. ~'he flexible bag 20 may then be kneaded or otherwise '!~~ 93/1202 PC.'1'/1J592J109~~
manipulated to effect a thorough mixing so as to produce a bulk. reconstituted drug having a much lower concentration. The lower concentration is determined, of course, by the initial amount of the concentrated drug in the vial 32 and by the initial amount of the diluent in the bag 2~.
At the end of the bag 20~opposite the neck 26 there is a discharge structure or dispensing fitment 40 (FIG. 1). The fitment 4~ includes a suitable tube 42, .such as a rigid, thermoplastic tube which projects from the bottom of the bag 2~. The tube 42 extends through ~~
the flexible end wall of the bag 20, and the bag wall is sealed araund the periphery of the tube 42. This seal may be effected with conventional heat seal techniques, with adhesive, or by other means, the details of which form no part of the present invention.
The ttabe 42 is in fluid communication with the liquid in the interior of the bag 20. The liquid is prevented from discharging from the tube 42 by a 2~ suitable closure or fitmer~t 46 which is preferably in the form of a seal or "reseal" that accommodates penetration by a suitable hollow spike, boll~w needle, or cannula. Such a reseal 46 typically functions to perm~.t the insertion of a hollow needle or spike to e~tabl~.sh communicatibn with the liquid in the tube 42 while the reseal seals tightly around the periphery of the beadle. The x~eedlc can be later withdrawn, and the reseal. 46, owing to the inherent resiliehcy of the reseal material, closes at the penetration site from ~0 which the needle has'been removed so as to prevent egress of the lie~uid.
then a toxic drug is provided in a vial 1.2 for being admixed with a diluent liquid in a bag 2c3 as described above, the vial 12 and bag 20 are typically ~5 manipulated in a controlled environment, such as in a 'WCa 93/12002 pC1'/US92/1091~
2122a~~.
laminar flow hood (not illustrated). The hood is maintained under negative pressure to prevent the escape of toxic vapors if there should be any inadvertent leak and to othexw~tise provide protection to the person handling the components. although conventional vials arid bags are typically manufactured under strict quality control standards and function well 'to prevent inadvertent leakage when properly handled, there is a desire, because of the highly toxic nature of many of the drugs, to provide an improved system for eliminating or reducing the likelihood that personnel will be ..
exposed to the drugs during the reconstitution process and thereafter when tie reconstituted drug is stored and used..
To this end, one aspect of the present invention provides a novel protection system for use with a container of hazardous liquid, including the above-described pouch 20 and connected vial 12. In the preferred form ~f the protect~.on system illustrated in FIG. l, a first aonne~ting means 50 is provided for being connected t~ the container 20 to establish fluid communication between the exterior~of the container 20 and the liquid inside the container. In the preferred form illustrat~d,:the connecting means,50 includes a hollow, sharp sgike 52 which is mflunted to~one end of a hollow,- cylindrical fitment 54 (FIGSa 1 and 4). The other end of the fitm~nt 54 is sealed to a hollow, flexible tube or other suitable conduit 56 in a manner that estab33shes fluid cor4munication between the ihterior of the hollow spike 52 and the conduit 5'6. The attachment of the hollow spike 52 to the conduit 56 via the fitmer~t 5~ may employ conventional; interior, sealing end amounting configurations (not visible in the figures) well known to those of ordinary skill in the art. The detailed design and specific structure ~f such W~ 93/12002 ~'CTltJS92110918 ,.,.,, a connection, and the detailed design and specific structure of the hollow spike 52, form no part of the present invention.
D
A latch or clip 60 (FIGS. ~l~and ~) is provided to hold the spike 52 to the container 20. The clip 60 , has a pair of feet 62 at one end which are mounted to the conduit 56 adjacent the fitment 54. A spring arm 66 extends from the feet 62 and terminates in a tab 68. A
pair of latch bars ?0 extend outwardly from the spring arm 66 for frictionaliy engaging one side of a flange ?~
on the conduit 42.
Initially, the clip 60 is held outwardly (as shown in FIG. 1~ while the hallow spike 52 is forced into the reseal 46. Then the clip 60 is then pushed toward the tube 42 so that the arms ?0 engage the flange ?4 and prevent inadvertent withdrawal of the hollow spike 52.
Typ,icall~, the vial 12 and bag 20 would be screwed together before ~he hollow spike 52 is inserted y 2~ through the rsseal'~6.. ~iowever, the hollow spike 52 could be inserted-thr~ugh the res~~1 46 firsts and the vial 12 end bag 20 could be subsequently connected t~gether.
- ~ unique; flexible barrier 80 (FT~~s. 1 and 2) is pr~vided as an integral part of the system along with the c~nduit 56 and connecting-means 5d~: The flexible barrier 8o is penetrated 3~y the conduit 56 and is sealed - a~~ut the peripher~T of the conduit 56 at he penetration.
' Tha barrier 80 is preferably fabricated'from;a suitable materaal whack is sufficiently transparent to permit some degree of,visual inspection through the barrier. The barrier 80 pbeferalaly is fabricated from a~
synthetic, thermoplastic; polymer material, and preferably has the shape of an openended enclosure, ~c~ g~ia~on2 a'creus92ia~~a~
~12~~~~
bag, pouch, envelope, or the like. A preferred material for the barrier 80 is linear low density polyethylene or flexible polyvinyl chloride.
The barrier 80 is sufficiently flexible to a accommodate an initial arrangement in a retreated-orientation (FIG. 1~ which permits access to, and manipulation of, at least a portion of the connecting means 50 and a container, such as the container 20. The barrier 80 is also sufficiently flexible to accommodate a subsequent arrangement in an extended orientation (FIG. 2) for defining an enclosure around the connecting means 50 and connected container 20.
The open end of the barrier 80 is preferably provided with a sealing means for completely closing or sealing the open end of the barrier 80. To this Brad, one such sealirlc~ means i~ illustrated in FIGS. 1-3 and includes a pliable, but non-resilient, member carried in the wall of the barrier 80 and having end portions 92 projecting from the wall of the barra.er 80. After the barrier 80 has beea~ arranged to enclose the vial 12 and bag 20 as illustrated in FIG: 2, the open end of the barriex 80 can be closed and 'then folded over a few times (ass illustrated in FTGS. 2 and 3). The extending ends g2 of the pliable member can then be bent around each s~.de of the u~f~lded portion o~ the barrier to hold the f~3.d~ tightly against the unfolded portion of the barrier. Thi~'effects a generally leak-fight seal.
~ther forms of closures or'seals for the open end of the barrier 8~ may be employed, and such other forms may be of a ~u~.table special or conventional design.
The canduit 5C may be characterized as generally extending from the first connecting means 50, ~wthrough the barrier 80, and to a discharge 1~cation exterior of, and spaced-away from, the bag 20. The condu~.t 56 inclhdes a one-way, non-return valve or check 'VNO 93!12002 PC I'JUS92110918 valve 102» The check valve 1,02 prevents flow into the container or bag 20.
The check valve 102 may be of a suitable special or conventional design. A suitable conventional v 5 valve is that sold in the U.S.A. under the designation Normally Closed Check halve by Burton Medical having an office at Uethlehem, Pennsylvania., In the preferred embodiment illustrated in FIGS. 1 and 2, a special or conventional Y-fitment or fitting 108 is provided in the first conduit 56 for reasons described in detail hereinafter» The Y-fitting..
108 is connected to the conduit 56 between an inlet leg of the ~~Y~~ and the common outlet leg of the ~~Y~° .
The Y-fitting 108 may be of a suitable special 1,5 or conventional design. One suitable conventional Y-fitting is made under the designation ~.ist No.~75-0128 Y-fitment by I~rbbott T.~boratories having an office at :,North Chicag~, Illinois.
A second c .~nnecting means lls is connected to the distal end Of the. first conduit 56, and the second connecting means lls is adapted to be connected to a sy~°inge 120 t~ establish fluid comnnunication between the bag 20 and the syringe 120. The seceand connecting means x,16 may be a sp~Gial or C~nventional device, and one 5 such suitalale device as ~ valve sold in the U . ~ s 1~ s under the designati~n "~3urron Reflux~' by ~urron Medical s~hich has an office at Ue~hlehem, Pennsylvania. Such ~ valve his an a.nternal~v~lve ~~~er (not visible that is normal~.~ biased to occlude a discharge port, and the 'discharge p~rt includes a'generally cylindrical receiving wall around the port for accommodating the a insertion of the distil end of the syr~~age 120.
In a preferred form illustrated in FIG. 1, the seeond connecting means 116, in the form of the above- a :'a 35 d~s~cribed valve, defines a conventional, female, lust wC~ 93WOOZ PC11'f~JS92/1o918 - ~~.2~~~1 fitment for receiving a mating, male, leer fitment on the distal end of the syringe 120. When the male leer fitment of the syringe 120 is inserted into the female luer fitment of the valve, the valve member within the valve is pushed away from its seat by an internal°cage engaged with the distal. end of the syringe luer fitment.
This opens the valve port and perm~.ts the liquid to be discharged through, or drawn through, the valve by operation of the syringe 120 in the usual manner to effect a suction within the syringe 120.
When the desired amount of liquid has been ...
drawn into the syringe 120, the syringe is pulled out of the valve (i.e., connecting means 116, and the internal valve member is biased to again occlude, and seal, the valve port.
A suitalble safety cap 126 may be provided for being mounted on the distal end of the valve or eonraecting means 116. To this end, the cap 126 may be of the convents.~nal ty_ pe nArmally px°ovided with, such a 2~ valve wherein the cap 126 includes a suitable a.nternal thread structure for engaging a mating thread form or partial tlhread form on the exterior of the distal end of the valve.
Irt the preferred form of the invention illustrated in FI~s-: 1 end 2, a second conduit or tube 132 is connected ~t a fi.r~t end to the sec~nd lec~ of the Y fitting 108 in fluid communication with the first G°O'ndu~.t 56.0 The seC'rond condul.t 1°32 e'xtend',~~'' baCr~C
through the barrier 80 t~ a'recep~acle 140. In the preferred form illustrated 'in~ FIGSs' 1' and 2,' the receptacle 140 has the form of ~ flexible pouch or bag defined by two sheets of flexible material with generally coterminous edges which arm dialed together about their peripheries.
The interior of the redeptacle or pouch 144 is in fluid VVVO 93/12002 P~'I'/~LJS9211~9'8 21~~~~~.
comxaunication with the interior of the second conduit 132.
At the location where the second conduit 132 penetrates the barrier 80, the barrier 80 is sealed around the periphery of the second conduit 132 by~
suitable special.or conventional means such as described above with respect to the barrier penetration seal for the first conduit 56.
The second conduit 132 includes a second, one-way, non-return valve 150 for preventing flow of, liquid from the receptacle.or pouch 140 into the first conduit, 56. The one-way, non-return valve 150 may be a special or conventional check valve identical to the valve 1.02 employed in the first conduit 56 as described above.
1.5 However, the second check valve 150 is, of course, oriented in the direction opposite to that of the orientation of the first check valve 102 so that the second check valve 150 prevents flow toward the Y-fitting ~arh~reas the first check valve 102 prevents flow away from the Y~f~.tt~ng lVBo The preferred form of the invention illustrated in DIGS. l and 2 also includes a three-way valve 180 which,, as illustrated i~ FIGS. 1 and 2, is located in the second conduit 132 between the receptacle 1~0 and the second check valve 150. As illustrated in FTG. 5, the three,°way valve 180 includes a body 182 with three outwardly projecting conduit members 191, 192, and 193 which each define a port.pommunicating with the ynterior of the valve body 182.
The v~lve'180 als~ includes a rotatable valve member 7.96 defining an internal, T-shaped flow passage 1~8~ Flotation of the valve member 196 permits the '' internal flow passage 198 in ache valve member 196 to be aligned between the port conduits 191 and 193 while occluding the post conduit 192 as illustrated in I~IG. 5.
WO 93/12002 3~CT/L1592/A0918 The valve member 196 can also be rotated to another position to establish fluid communication between the port conduits x.92 and 193 while occluding the port conduit x.91. Of course, the two other po.;itions of the valve member 196 are possible, but such other posi't'ions would n,ot typically be employed during the use of the invention, and such other positions are not described in detail herein.
~t least the port conduit 192 may be provided 1.0 with an exterior thread form 202 for receiving a.safety cap 20~. The safety cap 20~ includes an internal thread forms 206 for matingly engaging the thread forty 2~2 on the port conduit 7.92 and also includes an internal, hollow, cylindrical plug member 208 for being received 1.5 within, and occluding, the port 192.
The valve 180 may be a conventional valve such as the valve sold under the designation 4 Way ~topcoek by edex, Inc. having~an office at Hilliard, Ohio.
In operatioa~, then the connecting means 50 is 20 connected t~ the bag 20 and the barrier 8~ is closed ar~aand the bag 20 as described above with reference to FIB: ?, the receptacle 3.~~ is disposed generally adjacent the bag 20 and is also necessarily enveloped and enclosed bythe barrier 80.
A leak~tzght barrier or protection system is established when the ~.op of the barrier 8~ is folded t~~ether and x~lhd down a few turns and secured in position by thevpli~ble tabs 92 as described above and illustrated in ~'IOS. 2 anc'~ 3. With the leakstightness ,30 of the b~rriex system thus established, the'plug 3~ cai~
be removed fr~m the lower end of the neck 26 of the bag 2~ to permit the cbntents of the vial 22 to be discharged into the bag 20 and be mixed therein.
When the barrier 80 is in the fully sealed 35 orientation as illustrated in FIG. 2, the discharge WO 93»2002 PC'd'/1JS92/10918 valve 116 and the three-way valve 180 are, of course, exposed for manipulation. The syringe x.20 can be engaged with the distal end of the discharge valve 3.1.6, and a desired amount of liquid can be withdrawn from the bag 20 by operation of the syringe to establish suction within the syringe.
If an air bubble is entrained with the liquid flowing into the syringe, or if excess liquid is drawn into the syringe, the air bubble and/or excess liquid can be discharged into the receptacle 1~0. To this end, the. syringe 120 is operated to discharge the desired ...
amount of the liquid back through the valve 11.6. The check valve 102 in the first conduit 56 prevents back flow into the bulk supply bag 20, but the check valve 2.5 150 permits flow from the syringe 120 toward the receptacle 1~0: If the valve member 196 of the three-way valve 180 is aligned as illustrated in FIG. 5, the liquid discharged from the syringe 120 can pass into the receptacle ~.~0 within:th~ barrier 180~ In this. manner, a small amount of liquid containing an entrained air bubble or a small amount of excess liquid can be convenientl~r discharged to the receptacle 140 without requiring removal of the syringe 120 fr~m the valve 11.6.
Thus, ;the receptacle 14O functions as a waste receptacle within the barrier 80. Further, because the receptacle 14~ a.s separate from the bulk supply bag 20, aid ~ecab.se tire check val~re X02 does not permit flow hack ~.nto °the bag 2 ~ ~ there is no danger .hat the bulk supply in the bag 20 can bec~me contaminated with the 3~ ~~~id that had been previously withdrawn from the bag ~~, If desired, the system may be operated in a ~~pumping" mode sa as to pump liquid from the bulk supply bad ~0 to a separate container or remote location.
Specifically, the valve member 196 in the three-way V~~ 93112002 PCT/US92/1091~
_ 21 _ valve 180 can be oriented to establish communication between the second conduit 132 and the outlet port conduit 192 while occluding the port conduit 191. The outlet port conduit 192 can be connected directly to a ~5 separate fluid conduit system or to a separate container, such as to a container of an intravenous fluid. The syringe 120 can be operated to first withdraw liquid from the bag 20 into the syringe, and then the syringe can be operated to force the liquid from the syringe through the conduit 132 and three-way valve 180 to the other container or fluid conduit system (not illustrated'.
The first connecting means 50 has been illustrated as incorporating a hollow spike 52 for use with a suitable reseal 46, and the second connecting means 116 has been illustrated as a valve for use with a suitable syringe 120. It will be appreciated, however, that other systems xnay be provided for establishing a connection with the bu7.k.supply bag 20 and for.effecting a dispensing of the lic,~u~d from the end of the conduit 56. Thus, the (first connecting means 50, the conduit 5~, and'the second connecting means 116 (which could be a dispensing valve as previously described), may be characterized ~.og~ther in general terms as a first ., ,i 25 conduit system ~r means for being connected to, and extending frump the c~ntainer 20 to define a flow path for the liquid from the coa~tainer to a discharge location exterior of the container 20. Similarly, the second conduit 132 may be. characterized as a second conduit means for defining a flow path for the liquid between a first end connected in fluid communication with the first conduit means and a second end connected ..q to the receptacle 140.
Further, it will be appreciated that although ~5 one aspect of the present invention relates to the use w~ ~~i'zoox ~t:r~us~xrio~m 212 2 ~'~ ~. _ 22 -of the novel barrier 80 with both a first conduit means for withdrawing a liquid and a second conduit means connected to a receptacle for accommodating excess or , waste liquid, the second conduit means 1.32 and connected receptacle 140 may be omitted, or at least not used, in those situations where there is no need to hold excess liquid in a separate, sealed receptacle.
' Further, there may be applications involving liquids which are not directly hazardous to personnel 1 0 but which may be potentially damaging to the environment if not disposed of in an appropriate manner. In other ~.
applications, a liquid may not be directly hazardous and may not even pose a potential danger to the environment, but may be subject to strict inventory control. Thus, another aspect of tlae present invention contemplates that in either of these situations the system may be provided without the barrier S0. 'Without the barrier 80, the system would still conveniently accommodate the c~ll~:ction of the waste or excess liqu~.d in the.
receptacle 14~ so that the liquid in the receptacle ~.4~
would be readily susceptible to inventory control prodessing and/or proper disgosal.
~. second embod~.ment of the present intention is diagrammatically il.~.ustrated in ~TG. 6. This 2~ embodiment includes a barrier protection system in combination with a la.q~id transfer system that-incorporates deans for ransferr~.ng liquid to a syringe, to an~ther fluid conducting system or container, and to a waste receptacle.
3~ The second''embodiment includes a first co~nectinc~ means, much as-a hollow spike 252. The spike 252 is adapted to penetrate a closure anembex~, such as a ' reseal (not illustrated), in a bulk supply bag or contaia~~r 26~ (FIG. 7). Such a reseal and container may 351 Dae substantially the same as the reseal 46 and t eJV~ 9312002 PC'1'/LJS92/10~~8 21~~~~1 _ associated container 20 described above with reference to the~first embodiment of the invention illustrated in FIGS. 1--5. In FIG. 7, the reseal or other closure contained on or in the container 260 has been omitted for ease of illustration, and the hollow spike 252 is shown penetrating the bottom of the container 260.
Prior to use, the hollow.spike 252 may be covered with a suitable safety cap 253. The spike 252 is ~aounted on the end of a first conduit 256 which penetrates a barrier 280. The barrier 280 is~flexible, and may be fabricated from the same material as the ...
barrier 80 described above with reference to the first embodiment illustrated in FIGS. 1-5. The barrier 280 is sealed around the periphery of the first conduit 256 at the location where the f'irst,conduit 256 penetrates the barrier. The barrier 280 has a configuration that permits its arrangement in an initial, retracted orientation which pex~nits access to, and manipulation ~f, the cbnnecting means spike 252 and container 260.
Such an initial or~:enfiation is illustrated in FIG. 6.
The bag 280 accommodates subsequent axrangement in an extended ~rientation (FIG. 7) for , around the first connecting means defining an enclrssuxe ~~~ axed container 260. The top ~f 'the conta~.ner 260 may ~5 be adapted to be coupled to anotD~er container 262. The container 262 nay be substantially identical to the vial ~:2 described- abdv~ with reference to the first embodiment illustrated in FIGSa 1. and 2. Thus, the contents from the container 262 can be emptied into, and ~ anixed wrath, a d~:luent or other lic~!id conta~.ned in the:
container 260. ~f c~urse, the assembly of the container 26~ coupled to the container 262 may not be the only means for supplying liquid to the hollow spike 252.
ether contaia~ers c~uld be used, including a single container of a pre-mixed, bulk supply of liquid.
vv~ 93i' zooz ~crru~~zm o9's ~~.2~~91 - - 24 - :...
In any event, the barrier 280 is adapted to be sealed'at its open end by suitable means. FIG. 7 illustrates the use of,a interlocking, plastic rib sipper-type seal 292 which may be of a suitable special or conventional design, the details of which form no part of the present invention.
The barrier 280 preferably has a wedge-shaped, open-ended, envelope configuration which is substantially reversible from the inside-out orientation illustrated in FIG. 6 to the inverted orientation.
ill~.strated in FIG. 7. As schematically represented in.,.
FIG. 7, a first one-way, non-return valve or check valve 302 is mounted in the first conduit~or tube 256 to prevent flow back into the bag 280. The check valve 302 ,' Z5 may be a suitable special or conventional check valve and may be identical to the check valve 102 described above with .reference to the first eaabodiment of the invention il3:ustra~ed in FIGS. 1-5.
1~ sec~nd connecta.ng means or dispensing ,valve ., '2~ 31.6, which includes a removable safety cap 326, is mounted to the distal end of the first conduit 256. The valve 3Z& may be a suitable special or conventional valve- adapted for use with a syringe (not illustrated and may be ident~.cal to' the valve employed as the second 2~ cor9necting means 116 described above with reference to the eodiment illustrated in FIGS. 1-5.
'~ A second conduit means or tube 332 extends from the first conduit 256 td a receptacle 340. The .
.a receptacle 340 includes a sheet of flexible, 3~ theranoplast~.c material sealed about its periphery to the outs~.de sur~~ce of the barrier 280. The receptacle 340 functions in the same manner as the receptacle 140 in the first embodiment described above'with deference to '; FIGS. 1-5, and the receptacle 340 receives excess or 35 waste liquid and/or entrained air.
vv~o g3i' zooz Pc-rms~zi' 09~ ~
_ ' 25 ' ~~~u~~
A onewway, non~return valve or check valve 350 is provided in the second conduit 332 as schematically illustrated in FIG. ?. The check valve 350 prevents flow out of the receptacle 340. The check valve 350 may be a suitable special or conventional valve and may be identical to the check valve 150 described above with reference to the first embodiment of the invention illustrated in FIGS. 1~5.
A third conduit 410 is connected at one end in l0 fluid communication with the second conduit 332 between the first conduit 256 and the second check valve 350. w The third conduit 4~.0 terminates in a second end having a suitable dispensing structure or fitment 415 from which liquid may be discharged. The fitment 425, as schematically illustrated in FTG. 7, may be a conventional connection of the kind sold under the designation LIFE~SHI~Lmg°~ Co~nec~or ~.n the U.S.A. by Abbott Taaboratories having an office at PTorth Chicago, Illinoa.s. Such, a fitment 415 includes a hollow spike 4~.? surrounded by a cylindrical shield 41~. The fitment 415 is adapted to be connected to a suitable receiving port in an intraveno~x~ bag system (not illustrated).
The detailed design and structure of the fitment 415 form no part of the present invention.
In order tc-prevent flow from the third conduit 410 back'into the second conduit 332, a third one-way, n~n-ret~arra valve or check valve 426 i.s provided ~.n the third conduit ~1~. The check valve 426 may be identical to the check valv,~e 350 described above.
In the 'embodiment illustrated ix~ FTG. ?, there is ~o three--way valve, such as the three-way valve 180 illustrated in FTG. 5 for the previ~usly described first embodiment. Rather, a conventional slide clamp 430 is provided on the second conduit 332, and a second slide clamp 434 is provided on the third conduit 410. The V1VC193/ 12002 ~'~C1'liJ~921 ~ 091 ~
~~.2~~91 _ zs -slide clamps 430 and 434 may have a suitable special or conventional design. A suitable conventional clamp is made under the designation list No. ~5--~1S7 Slide Clamp by Abbott Laboratories having an office at North Chicago, Illinois. Each slide clamp functions as an .
isolation valve means for selectively closing or opening the conduit on which it is mounted:
' The two slide clamps 430 and 434 can be employed to selectively direct the flow to either the 1~ .receptacle 340 or the fitment 415. In particular, if it is desired to discharge excess or waste liquid, including liquid with entrained air, 'to the receptacle 340, then the slide clamp 434 is adjusted to close off the conduit 4~.0, and the clamp 430 is maintained in an open position on the second conduit 33z. Alternatively, if it is desired to transfer liquid to the third conduit 41~, the slide clamp 434 is adjusted to the open position, and then the slide clamp 430 is adjusted to the closed position so as to pinch the second conduit 2~ 33z closed.
~lith the system illustrated in ~'IG, ~, a syringe, such as the syringe 120 described above with reference to the first embodiment illustrated in FIGS.
~.-5,'may be employed for withdrawing liquid from the c~ntain~r 260. Further, lic~u~.d can be °°pumped°°
from the container 26~ through the third conduit 41~ by operation of the syringe in the same manner as described above with reference ~o the first embodiment.
The barrier system of the invention functions to prpt~ct~personnel from a hazardous liquid leak, and the barrier system can be relatively easily and quickly manipulated as necessary to provide the barrier protection around a variety of containers having various shapes and sizes.
' _,; , , :. ;; , ;. .. . . . .,' .. ~ : - .. ._,: v , ,~- ~., ~.. , ,., y:
dVC9 93/32002 fGT/US92/1~9'6~
- 27 - ~~.~~~~~.
Further, regardless of whether or not the barrier protection system is needed or employed, an additional feature of the invention provides a novel liquid transfer system for accommodating withdrawal of liquid from a container with a syringe. The system permits the syringe to be used as a pump to discharge precise amounts of the liquid directly to another fluid conduit system or to an intravenous container-~--all without apening the system to ambient atmosphere.
It will be readily apparent from the foregoing detailed description of the invention and from the illustrations thereof that numerous variations and modifications may be effected without departing from the true spirit and scope of the novel concepts or principles of this invention.
Claims (29)
1. A protection system for a container from which a hazardous liquid can be removed, said system comprising:
conduit means for being connected to, and extending from, said container to define a flow path for said liquid from said container toga discharge location exterior of the containers; and a flexible barrier that is impervious to said liquid and that is penetrated by, and sealed to, said conduit means for accommodating (1) an initial arrangement in a retracted orientation permitting access to, and manipulation of, at least a portion of said conduit means and container, and (2) a subsequent arrangement in an extended orientation enveloping said portion of said conduit means and the connected container.
conduit means for being connected to, and extending from, said container to define a flow path for said liquid from said container toga discharge location exterior of the containers; and a flexible barrier that is impervious to said liquid and that is penetrated by, and sealed to, said conduit means for accommodating (1) an initial arrangement in a retracted orientation permitting access to, and manipulation of, at least a portion of said conduit means and container, and (2) a subsequent arrangement in an extended orientation enveloping said portion of said conduit means and the connected container.
2. The protection system in accordance with claim 1 said conduit means includes a first connecting means for being connected to said container, a first conduit extending from said first connecting means, and a second connecting means on the said first conduit for being connected to a syringe.
3. The protection system in accordance with claim 1 in which said flexible barrier comprises thermoplastic material having a generally tubular configuration that is closed at one end scaled about said conduit means end that is open at the other end.
4. The protection system in accordance with claim 3 further including a releasable sealing means at the open end of said tubular configuration for sealing closed the open end.
5. The protection system in accordance with claim 1 in which said conduit means includes a first conduit;
said system further includes a second conduit connected at one end to said first conduit; and said system further includes a receptacle connected to said second conduit in fluid communication therewith.
said system further includes a second conduit connected at one end to said first conduit; and said system further includes a receptacle connected to said second conduit in fluid communication therewith.
6. The protection system in accordance with claim 1 further including a receptacle in fluid communication with said conduit means, said receptacle being integral with said conduit means and flexible barrier.
7. The protection system in accordance with claim 6 in which said receptacle is carried on an exterior surface of the said barrier when said barrier is arranged in said extended orientation enveloping said portion of said conduit means and the connected container.
8. The protection system in accordance with claim 6 in which said receptacle is disposed relative to said barrier for being located within, and enclosed by, said barrier when said barrier is arranged in said extended orientation enveloping said portion of said conduit means and the connected container.
9. The protection system in accordance with claim 1 in which said conduit means includes a connecting means for being connected to said container, a flexible conduit connected to said connecting means, and a distal end terminating in a discharge location exterior of the container; and said system further includes a one-way, non-return valve in said flexible conduit to prevent flow of liquid back into said container.
10. A protection system for a container from which a hazardous liquid can be removed, said system comprising:
connecting means for being connected to said container to establish fluid communication between the exterior of the container and the liquid inside the container;
a conduit extending from said connecting means to define a flow path for said liquid from said connecting means to a discharge location exterior of the container; and a flexible barrier penetrated by said conduit, said barrier being sealed about the periphery of said conduit at the penetration and being impervious to said liquid, said barrier accommodating an initial arrangement in a retracted orientation permitting access to, and manipulation of, at least a portion of said connecting means and container, and said barrier accommodating a subsequent arrangement in an extended orientation for defining an enclosure around said portion of said connecting means and the connected container.
connecting means for being connected to said container to establish fluid communication between the exterior of the container and the liquid inside the container;
a conduit extending from said connecting means to define a flow path for said liquid from said connecting means to a discharge location exterior of the container; and a flexible barrier penetrated by said conduit, said barrier being sealed about the periphery of said conduit at the penetration and being impervious to said liquid, said barrier accommodating an initial arrangement in a retracted orientation permitting access to, and manipulation of, at least a portion of said connecting means and container, and said barrier accommodating a subsequent arrangement in an extended orientation for defining an enclosure around said portion of said connecting means and the connected container.
11. The protection system in accordance with claim 10 in which said connecting means includes a hollow spike adapted to penetrate a seal on said container and includes a clip for holding said hollow spike and container together.
12. The protection system in accordance with claim 10 further including a discharge valve on the distal end of said conduit for accommodating connection to a syringe.
13. A protection system for accommodating the withdrawal of hazardous liquids from a container with a syringe, said system comprising:
a first connecting means for being connected to said container to establish fluid communication between the exterior of the container and the liquid inside the container;
a first conduit extending from said first connecting means to define a flow path for said liquid from said first connecting means to a discharge location exterior of the container;
a second connecting means on said first conduit at said discharge location for being connected to said syringe to establish fluid communication between said first conduit and said syringe;
a second conduit defining a flow path for said liquid, said second conduit having a first end in fluid communication with said first conduit, said second conduit extending from said first conduit and terminating in a second end;
a flexible receptacle connected to said second end of paid second conduit in fluid communication therewith;
a first one-way non-return valve in said first conduit in the flow path between said first connecting means and said second conduit to prevent flow into said container;
a second one-way non-return valve in said second conduit to prevent flow out of said receptacle to said first conduit; and a flexible, open mouthed bag penetrated by at least said first conduit, said bag being sealed about the periphery of said first conduits at the penetration and being impervious to said liquid, said bag accommodating an initial arrangement an a retracted orientation permitting access to, and manipulation of, at least a portion of said first connecting means and container, said bag accommodating a subsequent arrangement in an extended orientation for defining an enclosure around said portion of said first connecting means and the connected container.
a first connecting means for being connected to said container to establish fluid communication between the exterior of the container and the liquid inside the container;
a first conduit extending from said first connecting means to define a flow path for said liquid from said first connecting means to a discharge location exterior of the container;
a second connecting means on said first conduit at said discharge location for being connected to said syringe to establish fluid communication between said first conduit and said syringe;
a second conduit defining a flow path for said liquid, said second conduit having a first end in fluid communication with said first conduit, said second conduit extending from said first conduit and terminating in a second end;
a flexible receptacle connected to said second end of paid second conduit in fluid communication therewith;
a first one-way non-return valve in said first conduit in the flow path between said first connecting means and said second conduit to prevent flow into said container;
a second one-way non-return valve in said second conduit to prevent flow out of said receptacle to said first conduit; and a flexible, open mouthed bag penetrated by at least said first conduit, said bag being sealed about the periphery of said first conduits at the penetration and being impervious to said liquid, said bag accommodating an initial arrangement an a retracted orientation permitting access to, and manipulation of, at least a portion of said first connecting means and container, said bag accommodating a subsequent arrangement in an extended orientation for defining an enclosure around said portion of said first connecting means and the connected container.
14. The system in accordance with claim 13 in which said bag includes closure means for sealing closed the open mouth of said bag.
15. The system in accordance with claim 13 in which said bag is penetrated by said second conduit;
said bag is sealed about the periphery of said second conduit at the penetration of the bag by said second conduit; and said receptacle comprises two sheets of flexible material with generally coterminous edges sealed together to define a flexible pouch that is adapted to be disposed adjacent laid container within, and enclosed by, said bag when said bag is in said extended orientation.
said bag is sealed about the periphery of said second conduit at the penetration of the bag by said second conduit; and said receptacle comprises two sheets of flexible material with generally coterminous edges sealed together to define a flexible pouch that is adapted to be disposed adjacent laid container within, and enclosed by, said bag when said bag is in said extended orientation.
16. The system in accordance with claim 13 in which said receptacle includes a sheet of flexible material sealed at its peripheral margins to the exterior surface of said bag to define a space between the sheet and the bag exterior surface for receiving a portion of said liquid.
17. The system in accordance with claim 13 in which said system further includes a three-way valve in said second conduit between said receptacle and said second one-way non-return valve, said three-way valve having three ports with two of said ports being directly connected in fluid communication with said second conduit and with the third port adapted to discharge liquid from said second conduit, said three-way valve having a valve member selectively positionable to establish fluid communication through said valve between any two of said three ports while occluding the third port.
18. The system in accordance with claim 13 further including a third conduit that (1) is connected at one end in fluid communication with said second conduit between said second one-way non-return valve and said first conduit and (2) terminates in a second end having a fitment from which said liquid may be discharged;
a first isolation valve means in said second conduit between said third conduit and said second one-way non-return valve for being selectively operated to open and close said second conduit; and a second isolation valve means in said third conduit for being selectively operated to open and close said third conduit.
a first isolation valve means in said second conduit between said third conduit and said second one-way non-return valve for being selectively operated to open and close said second conduit; and a second isolation valve means in said third conduit for being selectively operated to open and close said third conduit.
19. The system in accordance with claim 1 further including a third one-way non-return valve in said third conduit to prevent flow into said second conduit from said second end of said third conduit.
20. A protection system for accommodating the withdrawal of hazardous liquid from a container with a syringe, aid system comprising:
a first conduit means for being connected at one end to, and extending from, said container and for being connected at another end to said syringe to define a flow path for said liquid between said container and said syringe;
a second conduit means for defining a flow path for said liquid between a first end connected in fluid communication with said first conduit means and a second end;
a receptacle connected to said second end of said second conduit means and in fluid communication therewith;
a first one-way non-return valve in said first conduit means in the flow path between said container and said second conduit means to prevent flow into said container: and a second one-way non-return valve in said second conduit means to prevent flow out of said receptacle to said first conduit means.
a first conduit means for being connected at one end to, and extending from, said container and for being connected at another end to said syringe to define a flow path for said liquid between said container and said syringe;
a second conduit means for defining a flow path for said liquid between a first end connected in fluid communication with said first conduit means and a second end;
a receptacle connected to said second end of said second conduit means and in fluid communication therewith;
a first one-way non-return valve in said first conduit means in the flow path between said container and said second conduit means to prevent flow into said container: and a second one-way non-return valve in said second conduit means to prevent flow out of said receptacle to said first conduit means.
21. The system in accordance with claim 20 further including a flexible barrier that is impervious to said liquid and that is penetrated by, and sealed to, at least said first conduit means for accommodating (1) an initial arrangement in a refracted orientation permitting access to, and manipulation of, at least a portion of said first conduit means and container, and (2) a subsequent arrangement in an extended orientation enveloping said portion of said first conduit means and the connected container.
22. The system in accordance with claim 21 in which said barrier is a flexible, open-mouthed bag penetrated by said first conduit means and by said second conduit means;
said bag is sealed about the periphery of said first conduit means at the penetration of said bag by the first conduit means; and said bag is sealed about the periphery of said second conduit means at the penetration of said bag by said second conduit means.
said bag is sealed about the periphery of said first conduit means at the penetration of said bag by the first conduit means; and said bag is sealed about the periphery of said second conduit means at the penetration of said bag by said second conduit means.
23. The system in accordance with claim 22 in which said receptacle comprises two sheets of flexible material with generally coterminous edges sealed together to define a flexible pouch that is adapted to be disposed adjacent said container within, and enclosed by, said bag when said bag is in said extended orientation.
24. The system in accordance with claim 22 in which said receptacle includes a sheet of flexible material sealed at its peripheral margins to the exterior surface of said bag to define a space between said sheet and the bag exterior surface for receiving a portion of said liquid.
25. The system in accordance with claim 20 further including a three-way valve in said second conduit means between said receptacle and said second one-way non-return valve, said three-way valve having three ports with two of said ports being directly connected in fluid communication with said second conduit and with the third port adapted to discharge liquid from said second conduit means, said three-way valve having a valve member that is selectively positionable to establish fluid communication through said valve between any two of said three ports while occluding the third port.
26. The system in accordance with claim 20 further including a third conduit means that (1) as connected at one end in fluid communication with said second conduit means between said second one-way non-return valve and said first conduit means and (2) terminates in a second end having a fitment from which said liquid may be discharged;
a first isolation valve means in said second conduit means between said third conduit means and said second one-way non-return valve for being selectively operated to open and close said second conduit means; and a second isolation valve means in said third conduit means for being selectively operated to open and close said third conduit means.
a first isolation valve means in said second conduit means between said third conduit means and said second one-way non-return valve for being selectively operated to open and close said second conduit means; and a second isolation valve means in said third conduit means for being selectively operated to open and close said third conduit means.
27. A protection system for accommodating tree withdrawal of hazardous liquid from a container with a syringe, said system comprising:
a first connecting means for being connected to said container to establish fluid communication between the exterior of the container and the liquid inside the container;
a first conduit extending from said first connecting means to define a flow path for said liquid from said first connecting means to a discharge location exterior of the container;
a second connecting means on said first conduit at said discharge location for being connected to said syringe to establish fluid communication between said first conduit and said syringe;
a second conduit defining a flow path for said liquid, said second conduit having a first end in fluid communication with said first conduit, said second conduit extending from said first conduit and terminating in a second end;
a receptacle connected to said second end of said second conduit in fluid communication therewith;
a first one-way non-return valve in said first conduit in the flow path between said first connecting means and said second conduit to prevent flow into said container; and a second one-way non-return valve in said second conduit to prevent flow out of said receptacle to said first conduit.
a first connecting means for being connected to said container to establish fluid communication between the exterior of the container and the liquid inside the container;
a first conduit extending from said first connecting means to define a flow path for said liquid from said first connecting means to a discharge location exterior of the container;
a second connecting means on said first conduit at said discharge location for being connected to said syringe to establish fluid communication between said first conduit and said syringe;
a second conduit defining a flow path for said liquid, said second conduit having a first end in fluid communication with said first conduit, said second conduit extending from said first conduit and terminating in a second end;
a receptacle connected to said second end of said second conduit in fluid communication therewith;
a first one-way non-return valve in said first conduit in the flow path between said first connecting means and said second conduit to prevent flow into said container; and a second one-way non-return valve in said second conduit to prevent flow out of said receptacle to said first conduit.
28. The system in accordance with claim 27 in which said first connecting means is a hollow spike adapted to penetrate a seal and includes a clip for holding said hollow spike and container together.
29. The system in accordance with claim 27 in which said second connecting means is a valve adapted to be engaged with, and actuated to open by, said syringe.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/809,592 US5289858A (en) | 1991-12-18 | 1991-12-18 | System for accommodating withdrawal of liquid from a bulk supply |
| US809,592 | 1991-12-18 | ||
| PCT/US1992/010918 WO1993012002A1 (en) | 1991-12-18 | 1992-12-16 | System for accommodating withdrawal of liquid from a bulk supply |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2122591A1 CA2122591A1 (en) | 1993-06-24 |
| CA2122591C true CA2122591C (en) | 2003-04-29 |
Family
ID=25201710
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002122591A Expired - Fee Related CA2122591C (en) | 1991-12-18 | 1992-12-16 | System for accommodating withdrawal of liquid from a bulk supply |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US5289858A (en) |
| EP (1) | EP0617681B1 (en) |
| JP (1) | JP3507491B2 (en) |
| AT (1) | ATE168339T1 (en) |
| AU (1) | AU670564B2 (en) |
| CA (1) | CA2122591C (en) |
| DE (1) | DE69226281T2 (en) |
| DK (1) | DK0617681T3 (en) |
| ES (1) | ES2119883T3 (en) |
| WO (1) | WO1993012002A1 (en) |
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- 1991-12-18 US US07/809,592 patent/US5289858A/en not_active Expired - Lifetime
-
1992
- 1992-12-16 DE DE69226281T patent/DE69226281T2/en not_active Expired - Fee Related
- 1992-12-16 AU AU33251/93A patent/AU670564B2/en not_active Ceased
- 1992-12-16 EP EP93901212A patent/EP0617681B1/en not_active Expired - Lifetime
- 1992-12-16 AT AT93901212T patent/ATE168339T1/en not_active IP Right Cessation
- 1992-12-16 CA CA002122591A patent/CA2122591C/en not_active Expired - Fee Related
- 1992-12-16 WO PCT/US1992/010918 patent/WO1993012002A1/en active IP Right Grant
- 1992-12-16 DK DK93901212T patent/DK0617681T3/en active
- 1992-12-16 JP JP51117493A patent/JP3507491B2/en not_active Expired - Fee Related
- 1992-12-16 ES ES93901212T patent/ES2119883T3/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| DK0617681T3 (en) | 1999-04-19 |
| DE69226281T2 (en) | 1999-02-18 |
| EP0617681A4 (en) | 1995-02-15 |
| US5289858A (en) | 1994-03-01 |
| JP3507491B2 (en) | 2004-03-15 |
| JPH07502180A (en) | 1995-03-09 |
| AU670564B2 (en) | 1996-07-25 |
| AU3325193A (en) | 1993-07-19 |
| EP0617681A1 (en) | 1994-10-05 |
| ES2119883T3 (en) | 1998-10-16 |
| CA2122591A1 (en) | 1993-06-24 |
| EP0617681B1 (en) | 1998-07-15 |
| DE69226281D1 (en) | 1998-08-20 |
| ATE168339T1 (en) | 1998-08-15 |
| WO1993012002A1 (en) | 1993-06-24 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |