CA2197103A1

CA2197103A1 - Vial adaptor for a liquid delivery device

Info

Publication number: CA2197103A1
Application number: CA 2197103
Authority: CA
Inventors: Gregory E. Sancoff; Mark C. Doyle; Frederic P. Field
Original assignee: Individual
Current assignee: Winfield Medical
Priority date: 1995-06-07
Filing date: 1996-05-15
Publication date: 1996-12-19
Also published as: WO1996040327A1; US5766147A; AU5859096A

Abstract

A device is disclosed which provides for direct incorporation of a substance from a separate container, such as a drug vial, into the contents of a liquid delivery device (206), which has a connecter (202) to provide communication between the device (206) and the container, and means for closing the connection (208) prior to dispensing the contents of the device (206). A
method for permitting a substance in a container to be transferred to a liquid delivery device (206), and contents of the device (206) to be administered to a patient is also disclosed.

Description

2~ 97 ~3 W O 96/40327 -1- PC~rAUS96/06884 VIAL ADAPTOR FOR A IIOUID DELIVERY DEVICE

1. Field of ths Invention:
The present invention reiates to liquid delivery devices such as medicine dispensers, More particuiarly it 5 relates to liquid delivery devices havin,q an adapter that permits a substance in a viai or other separate container to be transferred to such delivery device before the contents of the device are dispersed.
2. DescriDtion of ' Prior Art:
There are a number of types of liquid delivery devices or dispensers that are intended to provide for the delivery of a liquid medication to a patient under controlled conditions. One WQII known device-of this type is the l0 common l.V. baû which uses gravity to dispense the fluid contained therein. Other devices are shown in U.S. Patents No. 5,080,652 and No. 5,398,85l to G.E. Sancoff, et aL These delivery devices utdrae different mechanisms to cause a fiquid contained therein (often a solution containine one or more medications) to be dispensed either continually or intermittently from the container, normahy through a conduit which terminates at its distal end with an attachment for intravenous, subcutaneous, or , ' administration to a patient, Such devices may be stored in an empty condition 8nd then filled with the bquid medication shortly before or at the time of administration ef the medication to the patient. Altcrnatively, containers can be stored in a sealed condition but filled with a liquid medication or Dquid madium; at the time of administration the device is opened and the medication dispensed to the patient as indicated above. In many mstances it is desirable to incorporate additional or different medications into the liquid medication already present in the device. In other instances where the device is filled with a neutral liquid medium, it is necessary to add the medication to that medium prior to dispensins the contents to the patient. The latter commonly occurs when the particular medicatiDn to be delivered has a short shelf life or where it is effective oniy for a short period after being dbpersed in the liquid medium.
In both of these cases, it is necessary to establish some sort of fluid connection between the device and the container holdin,q the additional or separate medicine. With many devices this is either difficult or impossibla to do, and thus requires a second administration of the additional or other medicine to the patient.
A primary failinq of the prior art vial adapters has been the failure to provide a resealable attachment.
Therefore, when a vial is disposed on the diluent source it cannot be removed without the loss of diluent or medication. Moreover, removal of the vial is preferable so as to minimrae the volume of diluent and medicament lost in line.
AccordinDly, a need exists for an infusion device with a vial adapter associated therewith that allows for the efficient and expeditious transfer of a medication into the infusion device and that further allows the vial or other container initially containin~q the medication to be removed, or the connection between the two to be reversibly sealed, and the device put on line to the patient.
SUMMARY OF THE INVENTION
The present invention provides several embodiments ef resealable adapters that can be used for the introduction of a medicament from a dru~ vial for example, into an infusion device or IV baD fellowed by the delivery WO 96140327 ~ 1 ~7 1 03 z PCT/US96/06884 of the medicament to A patiant. A prnfoend foature nf the present invention is that, in a preferred embodiment, it provides an openable and closeable channel through which the medicament can be delivered to thc infusion device, thereafter allowing the vial to be nemoved andlor the dcvice to be pressurized to deliver the fluid.
This aspect of the prescnt invention stands in stark contrast to the prior art. In the prior art, many complicated structures were used to achieve the objective of the present invention.
A first aspect of the present invention provides a method for penmntins a substance in a vial to be transferred to a liquid delivery device, and contents of the delivery device to be administered to a patient. The method comprises the steps of connecting the vial to the dalivery device, introducing the substance frem the vial into the delivery device, closing the connection between the vial and the delivery device, and pressurizing the contents of the delivery device for administration to the patiant. The vial can be removed from the delivery device after the connection between the vial and the device is closed.
The introducin~q step preferably comprises introducin~q a liquid containad in the delivary devica into the vial, and thereafter introducino the liquid in the vial back into the delivery device.The closin~q step is preferably reversible, and can be achieved by means of a valve, or a clamp. The delivery device can be an l.V. baD or a pressure infusion device.
Another aspect of the present invention provides a method for permrtting a solid substance en a vial to be transferred to a liquid delive!y device containing a diluent, and contents of the device to be thereafter administered to a patient. This method comprises the steps of connecting the vial to the device, introduceng a portion of the diluent into the vial throuah the connection to dissolve the solid substance, returning the portion of the diluent and the dissolved solid substance into the device, closing the connection between the vial and the device, and administering the contents of the device to the patient. The contents of the device can be pressurrzDd prior to administration to the patient. If desired, the introducina and raturning steps can be repeated until the solid is substantially dissolved in the diluent. Preferably, the vial is removed from the device after the connection between the vial and the device is closed, however, the vial can also be left in place with the connection closed.
The closing step is preferably reversible, and can be accomplished by means of a valve or a clamp. Tha delivery device can be an l.V. bao or a pressure infusion device.
BRiEF E 1 ... OF THE DRAWIHGS
FIGURE 1 is a side elevation view, with portions cut away, of one configuration of the liquid delivery device of the present invention.
FIGURE 2 is a similar view with pressurized infusion in operation.
FIGURE 3 is an enlar~qed view of the upper portion of F16URE 2.
FIGURE 4 is a view similar to a portion of FIGURE 2 showinD manual compression of the delivery device.
FIGURE 5 i5 an enlarged sectional view taken on line 5-5 of FIGURE 1.
FIGURE 6 is a sectional view similar to that of FIGURE 5 showing an aiternative rim configuration.
FIGURE 7 is a side elevation veaw, wnh portions cut away, of an alternative device w'nh a separate adapter to hold the vial.

~ 2197~3 WO 96/40327 .3. PCT/US96/06884 FIGURE 8 is an enlargcd vi8w of the upper portion of Fl6URE 7.
Fl6URE 9 is a partially cut away view of an alternative adapter arran9ement in storage position.
Fl6URE 10 k a similar view with the vial in the adapter.
Fl6URE 11 is a side elevation view of a further cDnfiguration of tho apparatus.
Fl6URE 12 is a side cross sectional view of a vial adaptor in accordance with the present invention having its frangible strip in place, thereby preventing the two sections of the connector from movin9 relative to one another, thus maintaining the seal of the one-way valve.
Fl6URE 13 is the view en Fl6URE 12 with the frangible strip removed.
FIGURE 14 is the view in FIGURE 13 where the two sections of the adapter have been moved IDnsitudinally together thereby actuatina the one-way valve and allowing fluid ~ through the first and second lumen.
FIGURE 15 is a simiiar view as in FIGURE 12 in an embodiment where the two sections of the connector have threads.
FIGURE 16 is a similar view as in FIGURE 13 in the embodiment shown in FIGURE 15.
FIGURE 17 is a simaar view as in FIGURE 14 in the embodiment shown in FIGURES 15 and 16.
FIGURE 18 is a top view of a liquid delivery dovice haven9 a vial adaptor in accordance with the present invention and a clamp which closes the connection between the interior of the dispensing device and ths interior of the viaL
FIGURE 18a is a c,~a ' view taken alonD line 18a of FIGURE 18, whh the clamp in a closed position.
FIGURE 18b is a similar view to FIGURE 18a, with the clamp in an open position.
FIGURE 19 is similar to FIGURE 18, however, the clamp has been replaced with a valve.
FIGURE 19a is a tap view of the valve of FIGURE 19 in a closed position.
FIGURE 19b is a tDp view of the valve of FIGURE 19 in an open poshion.
FIGURE 20 is a top view cf an alternate embodiment of a liquid delrvery device having a vial adaptor in accordance with the present invention and a clamp which closes the connection between the interior of the dispensing device and the interior of the vial.
FIGURE 20a is a side view of the ciamp of FIGURE 20 closing the connection between the interior of the delivery device and the interior of the vial.
FIGURE 20b is a ~ ' view tahen along line 20b in Fl6URE 20, with the clamp in a closed position.
FIGURE 21 is a top view of an alternate embodiment of a liquid delivery device having a vial adaptor in accordance with the present invention.
FIGURE 21a is a side view of the vial adaptor and tubing of Fl6URE 21.
FIGURE 22 is an enlarged view of an alternate embodiment of the upper portion of the liquid delivery device, showing the vial adaptor in a retracted posrtion.

, . ... . . . . ..

~91~
WO 96/40327 4 PC r/US96/06884 DET~"Fn DESCRIPTION OF THE PREFE~f~ED ~
The present invention is related to an attachment or an adapter that aliows for the addition of a medication from a container holding the medication to a solution contained within a liquid delivery or dispensing device. It will 5 be understood that often drugs or medications, foDowin9 their manufacture, are packa9ed within containers that allow the medication to be kept sterile. Glass vial5 are frequently used; Dlass is highly inert, very stable, is readily sterilizabb, and can be used whh virtually any medication, whzther it is a solid or liquid. The vials usually have a rubber septum at their mouths that allow for the reconstitution, dilution, andlor simple transfer of the medication from the vial through use of a needle and syringe.
The present invention allow5 for similsr ease of tran5fer without the need for the use of a needb and syringe. Rather, the invention allows a vial to be essentially attached to a liquid deDvery device and the medication contained in the vial transferred to the device easily and without The connection between the vial and the device can then be closed, allowing the infusion device to be pressurked h necessary to deliver the liquid contained therein without pressurizing the drug vial, which might resuU in loss of solutien, leakage, or vial explosion.
15 The connection between the vial and the liquid delivery davice can be reopened at any time. This is accomplished in the broadest sense by having a first connector sized to fit around the mouth of a drug vial that has a piercing means to perforate the septum in the vial a channel extending from the connector that will allow the ~
of the medicatien from the vial to the delivery device, and a second connector that is attached te the device.
Preferably, the channel additionally contains means for reversibly preventing . of the medication from 20 the drug vial to the device andlor of the dauent from the device to the druD vial.
As discussed above, the medication contained in the dru~ vial can be a liquid or a solid and the principle of the invention is to move the medication from the vial to the liquid deDvery device. vllhen the medication is a liguid, it will be understood that it will easily flDw through the channel into the delivary devise. DilutiDn of the liquid contents of the vial may still be desired, however, te Dnable the complets transfer of the contents of the vial. When 25 the medication is a solid, it is necessary to reconstnute the soDd. This may be accomplished either through adding a solvent to the solid while it is in the vial er a solvent in the device can be communicated through the channel to the vial and the reconstituted medication can be communicated back te the device.
The latter process is preferred, since, many medications are less stable in selution and begin to lese their efficacy the longer they are maintained in solution. This is a primary reasen that such medications have been 3û packaged and sold as solids in the first place. Therefore, it will be understood that it is hi~qhly advantageous to be able to reconstitute solid medications, just prior to administration to the patient.
It is ako desirable to close the channel between the device and the drug vial te allow the contents of the device te be pressurized to facilitate delivery of the contents from the device. Should the channel remain open, liquid from the device can be forced back into the vial, resulting in loss of medicatien, leakage, and explosion of the drug 35 vial. Also, it is often desirable to remove the drug vial from the device after transfer of the vial contents to the .. . . . . . . . .

2~97lo3 ~ WO 96/40327 -5- PCT/US96/06884 nevice is complete. Accordin~qly, the present mvention provides an openable and closeable channel between the druD
vial and the device.
The vial adaptor structure that meets the -' :' ' requirements of the present invention will be best understood by reforence to the drawinqs. FIGURES l, 2, 4 and 11 show overall views of different embodiments of the present device whh the connectin9 structure incorporated therein and showin~q the connection with tho separate container, here illustrated as a viaE In FIGURES 1 and 2, the device shown is that described and claimed in U.S Patent No. 5,398,851. Tho details of the operation of that dovico, includin3 the means for dispensin~q the contained bquid, may be understood by reference thersto. Howover, the vial sdaptor and connectinp structure of the pre5ent inventicn is adapted for use with any device which is used to deliver fluid includinq a conventional l.Y.
ba~q. The device described below is for the purpose of illustration only.
A liquid delivery device 2 of this type is commonly formed of two parts 4 and 8 which are joined in a convenient manner, as by matin~q flanaes 8. The device 2 is hoDow with an interior 10 shown as filled with a liquid 12. The liquid 12 may be a medication itself, Ot h may be an inert carrier liquid into which a medication is subsequently incorporated, as will be described below.
It will be understood that the descriptions herein as to ~medication~ is merely for the purpose of example, and that a variaty of other types of fluids and added materials, such as intravenous nutrients, may be mixed and dispensed whh the device of this invention. Those skilled in the art will be well aware of the many materials which can be handled by this device, and can readily determine the optimum manner of handlins any particular combination of materials, Dispensin~q of the liquid is by means of motion of membrane 14 by the pressure of gas which is evolved by the reaction of two chemicals which are initially separated but are brouDht to~qether and allowed to react and evolve the Das. The chemicals are conveniently housed in a weO 16 attached to the wall of portion 6 of container 2. One of the chemicals is illustrated in the form of a solid pellet 18 and the other is in the form of liquid 20. The two are separated by membrane 22. When a flexible cap 24 surrounding liquid 20 is flexed, as shown in flGURE
2, a sharp protuberance 26 on the inside of dome 24 perforates membrane 22, allowin~q liquid chemical 20 to flow into contact with chamical 18, evolvino ~as which escapes throu~qh openinos 28 as indicated by arrows 30, thus pushin~q membrane 14 forward as indicated m FIGURE 2 and causin~q the liquid to be dispensed through outlet 32 (visible in FIGURE 111. Membrane 14 is secured at its periphery by bein~q clamped between the flanqes 8 (desi,qnated as 8a and 8b in FIGURES 5 and 6J.
3D If desired, the device 2 can have a skirt 34 surroundinq the well 16 to allow the device to be placed on end and to protect the well 16 and dome 24 asainst accidental activation of the chemicals. Also present may be ,qas relief valve 36 which serves to control any overpressure from the evolving gas and also to allow the device 2 to be maintained at a predetermined pressure durin~q administration of the medication.
For the purposes of illustration herein, the liquid 12 will hereafter be referred to simply as the carrier liquid, and it will be assumed that there is no medication initially present in the liquid 12. It will of course be unde~stood that this is solely for the purpose of illustration and that as noted above in fact there are many instances in which , . ... .. .... .

Z'~971~3 WO 96/40327 ~6- PCTIUS96/06884 the hquid 12 may itself be a medication. The medicating substsnca 48 is initially containcd in sepsrDte container 38, here illustrated as a vial. The medication 48 will be present withm interior 40 of vial 38 and may be either in liquid form or in the form of a readily soluble solid material usually a powder or Dranulated material. The vial 38 normally has a reduced collar area 42 wWening to a lip 44, and is sealed by a membrane or cap 46. The purpose 5 of the structure of the invention herein is to penmh the medication 48 to be transferred frDm the vial 38 to the interior of the device 2 to be incorporated into the carrier fluid 12. The connection bctwccn the interiors of thc vial 38 and thc dcvicc 2 can thcn bc clcscd to aUcw tha fluid ta bc prcssurcd for delivcry to the paticnt.
Thc conccpt is bcst undcrstood by rcfcrence tc FIGURE 3. At the top of portion 4 is formed a sleevc-likc mcmbcr or ccnncctor 50 which surrounds an openin9 52 badin~q from ths interior 10 of dcvicc 2 to thc cxtcrior of the dcvice 2 in the open hollow middlc of the slccvc 50. Thc inside diamctcr of thc 51ccvc 50 is sufficicntly large to bc able to accommodate either the cntirc diamctcr of vial 38 as shown or at Icast thc uppcr neck portion includCng neck 42 and rim 44 (as illustrated in FIGURES 10 and 111 The opcninq 52 of the devicc is closcd by any convcnicnt mcans, such as a plug, an clastomcric scptum, or a valvc; aitcrnatively, or in addition, thc slceve or cocncctor can bc scalcd at either end by means of a plug, valve, elastomeric septum or clamp, as will bc dcscribcd in morc detaii bclow. Also present will bc a fluid - member, normally in the form of a nccdlc 58, thc structure of which wiU also be dcscribcd belew.
In ene fonm of usage hcrcin thc vial 38 is pcsitioncd abovc the opening 60 of sleevc 50 and is pushsd downward to makc contact with needle 58. Needlc 58 penctratcs through thc cap 46 of vial 38 acd ako pcnctratcs through thc closurc 54 so that thc oppositc cnds of nacdlc 58 arc positioncd respcctivcly in ths medicatien 48 within interior 40 and in the canisr liquid 12 in interior 10. Fluid may be ehher by a hoCow axial conduit 62 through nccdlc 58, as shown in FIGURE 10, or throu~qh a conduit formed by a groove 64 formed in one side of the needle 58. Thcre is also alternativcly a scccnd groovc or conduit 66 (shown in FIGURE 31 which passcs through only a portion of the needle 58 and terminates in a junction with a cDndoit 68 which in turn extends to an opening 70 in sleevc which provides access to the ambient atmosphcre. Thus as thc mcdication 48 is wrthdrawn from thc vial 38, air or othcr ambicnt gas can pass into the intcrior 40 through conduits 66 and 68 and hole 70 so that the formation of a vacuum and subsequcntly rcstrictcd flow of mcdication 48 is prcvcnted. Typically thcrc will also be a filter 72 prcscnt to rcmovc any unwantcd matcrial from thc ambicnt air as rt passcs from holc 70 into conduh 68.
It will bc undcrstood that other typcs cf vial opcncrs can bc uscd in thc prcscnt invcntion in placc of thc ncedlc 58. Such opcncrs can includc, for cxamplc, vial cap rcmovcrs, cuttcrs, ampculc opcners, and the lika.
Within sleeve 50, therc is prcfcrably a vial sccuring dcvicc 74 which contains mcans (illustratcd in FIGURE

3 as flangc 76) to engage a corrcsponding dcpression or groove 78 in thc ncck 42 of vial 38. The flange 7û, and usually the entire member 74, will havc some degrcc of rcsiliency so that thc vial 38 can bc pushcd forward so that rnm 44 passcs thc flange or shouldcr 76 and allows thc grooved area 78 to cooperate whh the flange 76 to prevent unwanted " of thc vial 38 from sccurcmcnt within thc slccvc 50. Othcr mcans of sccurcment can be .

,~ ~1 97 ~

in the fomm of tabs 80 formed on the outer end of sleeve 50 as shown in FIGURE 10 or as radial slructures in the forms of truncated &ones 82 and 82' which are enga6ed by the hooks 84 of an external sleeve 86.
In some embodiments the sleeve will be in the form of a sleeve assembly which is formed of a sleeve 50 attached to the wall of portion 4 and a malalfemale couplinD member 88 which has a secondary sleeve 50' into 5 which the vial 38 fits (FIGURE 8). This use of the coupbng device 88 pemmits the entite assembhy to be removed from the device 2 so that the sbeva 50 and opening 52 can if desired be subsequently used as an outlet equivalent to outlet 32 once the contents of vial 38 have been incorporated into the fluid t2. In the embodiment shown in FIGURE 1, the needle 58 is inhially retained in a sliding piate 90 which is depressed downward by the poshioning of vial 38, eventually coming to rest against the bottom 92 of sleeve 50 once the needle 58 has penetrated through 1û the plug 54. The continued movement of vial 38 then causes the needle 58 to penetrate the cap 46 to establish a fluid between the vial 38 and the dispensing device 2.
Once the vial is in place and secured, as shown in FIGURE 3, the transfer of the contents 48 of vial 38 is commenced. The contents 48 may initially be under some pressure and therefore be forced through needle 58 into liquid carrier 12. Alternatively, however, ht is preferred to have the top portion 4 of the device 2 be somewhat 15 flexible, as illustrated in FIGURE 4 at 94. When the portion 94 is flexed as indicated by arrows 96, the fonmation of a reduced pressure in interior 10 causes the contents 48 of vial 38 to be rapidly drawn out of the interior 40 and into fluid 12. Mixing is preferably accompfished by moving or pumpinq the fluid back and forth between the interior 40 and the fluid 12.
It is desirable to have means for closing the channel between the drug vial and the delivery device after 20 the cDntents of the vial have been transferred to the device. In one embodiment, a one-way valve 56 is present in the sleeve 50, which valve 56 is activated by contact with needle 58 when the vial 38 is pressed into place. This may be best seen in FiGURES 8 and 9. In this case, valve 56 is in the form of a bottle shaped plu,q 96, which conforms to a funnel-shaped interior 98 in a plug 100 which is fitted into sleeve 50 with an interference fit so that it is retained by friction on the matins surfaces 10Z. The plug 98 can be buoyant so that any fluid in container 25 12 forces it up into the opening 98 and closes the vahve by contact between the surfaces 104. Or, in a preferred embodiment, the plug is restrained under mechanical pressure or is a compression fitting, which is opened by compression or force in a direction opposite the compression. When the nDedle 58 or needle-like structure 58' is pushed downward by the force of position of vial 38, the bottom 106 of the needle 58 or needle-like structure 58' contacts the top 108 of the plug 96 and forces h downward, thus opening the gap 98 to allow the liquid 12 to flow 30 upward into the vial or the material 48 to flow toward the device 2 either because the material 48 is a liquid initially or because it becomes dissolved in that portion of the liquid 12 which passes into the rnterior 40 of vial 38. The plug 96 is prevented from falling out of the position by shoulders 110 of plug 100.
In an alternate embodiment of the vial adaptor, illustrated in FIGURE 22, the vial 38 and vial securing device 74, which are connected, can be retracted after transfer of the medication to seal the device. The opening to the 35 delivery device is preferably sealed whh an elastomeric septum or closure 54, which is pierced by the needle 58 to allow ~ between the interior of the vial 38 and the interior of the device. To prevent the , . ... . ... . .. . . ..

~lq~
WO96/40327 -8- P~l/u,.,~.'C
' between the vial 38 and the device, the vial 38 is movod in the diroction of the arrow, away from the devicc. Flsn3e 76 on the vial securinq device 74 contacts the corresponding flange 2ZO on the inside of the sleove 50. In this retracted poshion, the needle 58 is whhdrawn from the elastomeric closure 54 which reseals due to its inherently elastic nature.
Alternatively, the means for closinq the channel between the dru3 vial and the liquid delivery dcvice can comprise a clamp. As illu5trated in FIGURE 18, a channel 2ûO joins the vial adaptor 202 to a port 204 located in the fiquid delivery device, here illustrated as an l.V. bag 206. This channel 200 is surrounded by a clamp 208. A
drug vial ~not shown) is attached to the vial adaptor 202 which, as described above, ~ ' the upper portion of the vial and includes a needle which penetrates the cap of the vial to provide between the interior of the vial and the interior of the device 206. The clamp 208 is epened te allow exchanqe between the interier of the vial and the interior of the device 206, as shown in FIGURE 18b. After the contents of the vial are transferred to the device 206, the clamp 208 is closed, sealing the connection between the vial and the device 206 as shown in FIGURE 18a. This allows the liquid in the device 206 to be pressurked for delivery to the patient, and prevents the undesired flow of liquid from the device 206 into the vial. If desired, the vial can be removed from the vial adaptor after the contents have been transferred to the device 206.
In FIGURE 19, there k illustrated a valve 210 poshioned in the channel 200 joininD the vial adaptor 202 to the llquid delivery device 206. Unlike the vaiv3 described above, this vaba 210 k manually openable and closeable from the exterior of the device 206. When the valve 210 is open, the exchanqe of contents between the interiors of the vial and the device 206 is achieved, as shown in FIGURE 19b. The valve 210 k closed to prevent further fluid exchanDe between the device 2û5 and the vial durinp pressurkation of the contents of the device 206 to facilhate administration to the patient, as shown in FIGURE 19a. The closing of the valve 210 allows for the removal of the vial from the vial adaptor 202, If desired, even when the contents of the device 206 are pressurked.
Additional means ior closinq the channel 200 between the druq vial and the liquid delivery device 206 are illustrated in FIGURES 20 and 21. FIGURE 20 illustrates means by which the channel 200 is folded and clamped by means of a clamp 212 surroundina the channel 200, thereby reversibly sealinp the connection between the interiors of the vial and the device 206, as shown in more detail in FIGURES 20a and 20b. Altematively, as illustrated in FIGURE 21, the channel 200 is folded over and the vial adaptor 202 is reversibly attached to the device 206, which closes the channel 200 connectino the adaptor 202 to the device 206, as Illustrated In FIGURE 21a.
The attachment of the vial adaptor 202 to the device 206 can be achieved by means 214 such as tape, a strap, a clip or the like.
Other means for reversibly closin3 the channel between the druq vial and the liquid dellvery device will suq3est themselves to those of ordinary skill in the art. The means described hereln are for purposes of illustration, and not fimitation.
When it is desired to administer a liquid to a patient, the drup vial is attached to the vial adapter 202, the needle or other vial openinq device within the vial adaptor 202 opens the top ef the vial, and the channel 200 between the vial and the liquld delivery device 206 is opened, for example, by openln~q the clamp 208. The llquid ~91 1~3 WO 96/40327 -9- rrST/us96lo6884 inside the vial is transferred to the interiDr of the device 206 throu~h the needle and the channel 200. If the vial contains a solid, liquid frcm the interior of the device 206 can be first - ' through the channel 200 and the needle in the vial adaptor 202 and into the vial to dissolve the solid. The liquid containeng the dissolved solid is then transferred back into the device 206. This procedure can be repeated until substantially an of the solid has been dissolved and transforred to the device 206. The liquid contained in the device 206 is then administered to the patient. If desired, the connection between the vial and the device 206 can be re-closed before administration of the liquid inside the device 206, allowing the liquid to be pressurized for ease of ' Preferably, the vial is removed from the adaptor 202 before pressurization and administration of the liquid beoins. After the vial is removed, the liquid can be dispensed through a separate port in the dispensing device 206, or through the connector 200 as described above, eliminating the need fDr multiple ports in the device 206.
Turnin~q a,qain to FIGURE 9, it is often desirable to be able to have the vial 38 and delivery device 2 loosely attached together as for shipping and storing, but positioned apart so that the needle 58 or needle-like structure 58' i5 not penetrating into fluid with either of the vessels. The two vessels are positioned so that a simple push on the vial 38 will cause the two to come into operative position and the medication 48 and the carrier material 12 to be properly mixed. This penmhs, for enstance, medications and carrier materials to be shipped and stored toqether and to be immediately available as in an emergency situation. For instance, storage of medications in a hospital emerûency room must be such that the emer ency room personnel can immediately obtain the exact medications needed and do not need to look for two or more separate containors which may be stored at different locations or of which one may have simply not been properly replenished. In order to avoid premature activation of the medication system and to preserve the shelf life of the medication for the maximum period, it is necessary however to have the vessels connected but remain sufficiently far apart that neither one becomes inadvenently opened and the contents then exposed and subject to subsequent deterieration.
A structure to accomplish this is shown in FIGURE 9 in which there are two separate securing conical flanges 82 and 82' which are spaced scme distance apart. A second malelfemale device 88', with a tep section similar to that as shown in FIGURE ID (but without the vial itself beinq shownj is used for this purpose. In operation, the member 88' is pushed downward only to the point where the tabs 84 engage the flange 82'. In this position, the vial 38 and device 2 are held securely tocether but are spaced apart far enough that the needle 58 does not penetrate the cap 4B of vial 38. Nor is it pushed downward to engage and open ono-way valve 56.
Subsequently when it is desired to join the two materials, the member 88' is pushed further down so that the tabs 84 enaage the conical flange 82, which causes the noedle 58 to be pushed downward to open valve 56 and to also penetrate and open the cap 45 by the downward movement of vial 38, aD at illustrated in FIGURE 10. As will be understood, the valve 56 can be replaced by a clamp or other means for closin~q the connection between the interior of the vial 38 and the device 2. The tabs 84 on member 88' can, if desired, be fitted with levers 112 which permit one to use thumb or finqer pressure to spread the tabs 84 and release the member 88' when the vial 38 is empty.
In yet another embodiment, as shown in FIGURE 12 through 17, the vial adapter consists essentially of male and female fittinqs, such as common Luer type fittinqs or locking Luers. One of the fittinos is connected to , . .

219710~ --the vial connector and one is connected to thQ delivery device. Further, preferably, one of the fhtin~qs contains a check valve, or other closure means, that acts to prevent the flow of liquid from the device. It will bc apprcciatcd, that in thcse constructicns, cithcr the male or the femalc fittinû càn bc conoccted tc thc vial connector end or vice vsrsa.
Thus, rcferrinû now to FIGURE 12, a drug vial adapter 150 is provided with a vial attachment cnd 151 that is srzod and shaped to rcceivc and lock in a dru~ vial Inot shown). The vial attachmcnt end 151 has an front open end 152 and a back closed end 153. As wiD be appreciated, dnus vials typically have a rim that scparatcs thcir mouth portion from thcir ncck portion. Thc vial attachmcnt cnd 151 of thc vial adapter 150 has a vial catch 154 that is fonmed around the circumference of the front open end 152 of the vial attachment end 151 which acts to lock a drug vial to the vial adapter 150. In the center of the vial attachment cnd 151, a spikc 155 is poshioncd.
Thus, a dru~q vial is ccntcrcd in the front open end 152 of thc vial attachment end 151 and pushed lon~qitudinally towards thc back closcd cnd 153 of thc vial attachmcnt cnd 151. Such action forces thc spikc 155 through a scptum or a similar scalin~q mcans in a dru9 vial. A rim on a dru~ vial will catch on th2 vial catch 154, holdinq the vial in position whh the spikc 155 cxtcnding thcrein.
Extending distally from the ùack closcd cnd 153 of thc vial attachmcnt cnd 151, thc vial adaptcr 150 has a stcm wa~ 156. Thc stcm wall 156 dafincs a main chann21 scction 157. ~rthin the main channel section 157, a rod 158 extcnds. Thc rod 158 is in ~ ~ whh thc spikc 155 through a first lumcn 159, thus allowinp fluid - ~ betwccn a vial into the main channel scction 157.
Distal to the vial attachmenteDd 151 and hs stem wall 156 is a connector 160. The connector 160 has a wall 161 and a recessed wall 162. The recessed wall is sized to fh whhin the main channel section 157 of the vial attachment end 151. Internal to the wall 161 and the recessed wall 162 of the connector 160, a second lumen 163 extends. Within the second lumen 163, there is a valve 164 that is kcpt in gcncral lonpitudinal position with , ' ' tabs 165 and 166. Thc valvc 164, on hs proximal cnd, has a rcccsscd stcm secticn 167 that extends proxrmally throu~qh the lumen 163 and the proximal most ' ' tab 166.
The distal end 168 of the rod 158 is sized to fit within ths distal cnd 169 of thc second lumcn 163, thus allowin~q fluid between the first lumen 159 and thc sccond lumcn 163. Howcvcr, the valve 164 acts to stop fluid flow from the proximzl end 170 to the distal end 169 of the connector 160 because pressure exerted a~qainst the distal end 171 of the valve 164 forces the proximal edqe 172 of the valve 164 auainst the proximal most ' ' tab 166.
The vial attachment end 151 of the vial adapter 150 is attached to the connector 160 through detachable wall section 173. The detachable wall section 173 acts to provide mechanical stability to the vial adapter as well as maintainin,q the channel section aseptic and sterile. In a prefened embodiment, the detachable wall section forms a seal bctwccn thc vial attachment end 151 of thc vial adaptcr 150 and thc conncctcr 160 of the vial adapter 150.
Thcre are other structures that would achieve similar results as the detachable wall section 173. For cxample, a resilient or flcxiblc scal bctwccn thc vial attachment end 151 of the vial adaptcr 150 and thc conncctGr 160 of thc vial adapter 150 would be equivalent. Alternativcly, a twist-off scal would providc the selectively fran~qible function .. ..... . . . . . . _ . . . _ _ .

21971o3 W O 96/40327 -1~ PC~r/US96/06884 which is desired. Some reduction in structural rigidity would be observed. However, such a sleeve would serve to seal the connection. Similarly, an o ring or other similar structure could be provided on the sleeve. Such structure would provide an adequate seal, however, there would also be seen a reduced mechanical strensthening, Alternatively, it will be understood that, instead of utilizing the detachable wall section, the device can be fitted with one or more detents on the connector and a detent release lever on the vial attachment end, along wrth threading. This configuration would provide simdar mechanical strength properties as the detachable wa~ section and cDuld be easily adapted to provide for aseptic or sterile closure. Moreover, such an arrangement can be completely removed from the connector 160, providing a similar advantage as the detachable wall section 173.
In the preferred embodiment, however, the detachable wall section 173 has means, such as franoible strips 174 and pull tab 175 that allow the removal of the detachable wall section 173 from the vial adapter 150. This is ' since the entire vial attachment end 151 can be removed, if desired, from the vial adapter 15û, leaving only the connector 160. This allows the cennector 160 to be used for attachment to another connector, such as a cDnnector on an IV set.
In FIGURE 13, the detachable wall 5ectien 173 has been removed leaving a void section 176 in the vial adapter 150. This veid section 176, as will be seen in FIGURE 14, allows the vial attachment end 151 to move distally toward the connector 160, with the stem wall 156 sliding over the recessed wall area 162 on the connector 160. This distal movement operates to move the distal end 168 of the rod 158 toward the distal end 177 of the valve 164, forcing the proximal edge 172 of the valve 164 away from the proximal most c ' . ' tab 166 and allowinD fluid to flow from the second lumen 163 in the connector 160 into the first lumen 159 and out the distal end 178 of the spike 155.
As wDI be understood, in the ' . d;~ua~d design in FIGURES 15 through 17, as easily as the vial attachment end 151 ef the vial adapter 150 will slide distally teward the connector 160, it can slide proximally, falling apart. Therefore, in a preferred embodiment, ths inside wall 178 of the stem wa~ 156 and the outside wall 179 of the recessed wall section are threaded, or are otherwise constructed so as to protect against detachment.
Moreover, these designs tend to simplify the depression of the valve 164 in order to allow of fluid through the second and first lumens. FIGURES 15 through 17 show a model having threads 181 on the stem wall and threads 180 on the recessed wall section 162. The detachable wall section 173 is removed by pullinD on pull tab 175 in the direction of arrow A. The detachable wall section will separate along frangible wall sections 174.
Thereafter, in FIGURE 1 G, the vial attachment end 151 is turned in the direction of arrow 8, which turns the stem wall 156 around the recessed wall section 162 and the threads 180 and 181 will draw the stem wall 156 distally on the connector. This action, as will be seen in FIGURE 17, will reduce the size of the void space 176 and also allow fluid between the first and second lumens 159 and 163, respectively, as discussed in more detail in connection with FIGURE 14.
It will be appreciated that there are valves and closure systems that can be opened without the longitudinal motion of the vial attachment end and the connector in relation to one another. For example, there are a variety of bayonet type valve actuators. In bayonet style actuaters, upen the axial twisting of ene of the ends relative to .... ........... ... ... ... . .. ..

~1971~3 the Dther, structure similar to the rod 158 can be caused to extcnd and dopress the distal end of the valve. In addition, a variety of axial pressure valves are made that, when prsssure is exerted external to the valve, will dsform the shape of the lumen surroundin3 the valve closure. Alternatively, the connection between the vial adaptot and the connector can be closed by means of a clamp, valve or other closure means as described above, It will be evident from the above that there are numerous embodiments of this invention which, while not expressly described herein, are clearly within the scope and spirit of the invention. The above description and drawinûs are therefore intendcd to be exemplary only, and the scope of the invrntion is to be determined solely from the appended claims.

Claims

WHAT WE CLAIM IS:

1. A method for permitting a substance in a vial to be transferred to a liquid delivery device, and contents of the delivery device to be administered to a patient, comprising:connecting said vial to said delivery device;
introducing said substance into said delivery device;
closing the connection between said vial and said delivery device; and pressurizing the contents of said delivery device for administration to said patient.

2. The method of Claim 1, further comprising removing said vial from said delivery device after said closing step.

3. The method of Claim 1, wherein said introducing step comprises introducing a liquid contained in said delivery device into said vial, and thereafter introducing said liquid in said vial back into said delivery device.

4. The method of Claim 1, wherein said closing step is reversible.

5. The method of Claim 1, wherein said closing step is accomplished by means of a valve.

6. The method of Claim 1, wherein said closing step is accomplished by means of a clamp.

7. The method of Claim 1, wherein said delivery device is an I.V. bag.

8. The method of Claim 1, wherein said delivery device is a pressure infusion device.

9. A method for permitting a solid substance in a vial to be transfered to a liquid delivery device containing a diluent, and contents of the device to be thereafter administered to a patient, comprising:
connecting said vial to said device;
introducing a portion of said diluent into said vial through said connection to dissolve said solid substance;
returning said portion of said diluent and said dissolved solid substance into said device;
closing the connection between said vial and said device; and administering the contents of said device to said patient.

10. The method of Claim 9, further comprising pressuring the contents of said device prior to said administering step.

11. The method of Claim 9, further comprising repeating the introducing and returning steps until said solid is substantially dissolved in said diluent.

12. The method of Claim 9, further comprising removing said vial from said device after said closing step.

13. The method of Claim 9, wherein said closing step is reversible.

14. The method of Claim 9, wherein said closing step is accomplished by means of a valve.

15. The method of Claim 9, wherein said closing step is accomplished by means of a clamp.

16. The method of Claim 9, wherein said device is an I.V. bag.

17. The method of Claim 9, wherein said device is a pressure infusion device.