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Mixing apparatus

Info

Publication number
CA1208624A
CA1208624A CA 424721 CA424721A CA1208624A CA 1208624 A CA1208624 A CA 1208624A CA 424721 CA424721 CA 424721 CA 424721 A CA424721 A CA 424721A CA 1208624 A CA1208624 A CA 1208624A
Authority
CA
Grant status
Grant
Patent type
Prior art keywords
chamber
container
gas
liquid
trapping
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA 424721
Other languages
French (fr)
Inventor
Steffen A. Lyons
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Grant date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/2017Piercing means having three or more piercing ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2072Venting means for internal venting
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00Surgery
    • Y10S604/905Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

MIXING APPARATUS
ABSTRACT
Apparatus for selectively mixing two components such as a powder and a liquid in a quick and efficient manner.
The apparatus includes a compressible chamber with a liquid component therein, the compressible chamber includ-ing gas-trapping and reservoir compartments in open commu-nication. Included is means to access the gas-trapping compartment such that the chamber may be connected to a container having a mixing component such as a powder therein so as to form a selectively opened pathway between the container and the compressible chamber of the apparatus. The apparatus may include the container.
After the pathway is opened, the gas-trapping and reser-voir compartments are selectively positioned to facil-itate proper mixing of the liquid component in the chamber with the component in the container. Also disclosed is a method for separately storing and selectively mixing two components in the apparatus including the container, the method including the steps of pathway opening, liquid transfer, liquid exchange and liquid emptying from the container into the chamber.

Description

Description Mixing Apparatus Back~ound of the Invention Many drugs are mixed with a diluent before being delivered intravenously to a patient. The dilu~nt may be, for example, a dextrose solution, a saline solution or even water. Many such drugs are ~upplied in powder form and packaged in glass vials. Other drugs, such as some used i~ chemotherapy, are pacXaged in glass vials in a liquid state.
Powdered drugs may be reconstituted in a well known manner, utilizing a ~yringe which is used to inject liquid into the vial for mixing, the syringe eventually withdraw-ing the mixed solution ~rom the vial. When a drug must be diluted before delivery to a patient the drug is often injected into a container of dilu~nt, where the container may be connected ~o an ad~inistration se~ for delivery to a patient. More specifically, the diluent is often packagad in glass bottl~s, or flexible plastic containers such as are sold under the names MINI-BAG and VIAFLEX by Travenol Laboratories, Inc. of Deer~ield, Illinois. ~h2se containers have administration ports ~o~
connection to an administration ~et which d~livers the container contents from the contain2r to the patient. The drug i8 typically add~d to the containex through an injec-tion site on the container.

A

8~

Drugs may be packaged ~eparately from the diluent for various reasons. One of the mos~ important rea~ons is ~hat some drugs do not retain their efficacy when mixed with a diluent and thus cannot be stored for any substan-5 tial period of time. In some instances the drug anddiluent will not 6tay mixed for a significant length of time. Also, drugs are often packaged separately from the diluent because many firms which manufacture drugs are not engaged in the business of providing medical fluids in containers for intravenous delivery.
Therefore, a doctor, nurse, pharmaci6t or other medical personnel must mix the drug and diluent. This pre ents a number of problems. The reconstitution pro-cedure is time consuming. The operator must provide the proper diluent and a syringe before beginning. Often the powdered drug is "caked" at the bottom of the vial. Thus, when liquid is injected into the vial from a syringe the surface area of contact between the liquid and ~he powdered drug may be quite small initially, thus making the mixing procedure even more time consuming. Because of the limited vial volume, the increasing drug concentration in the diluent makes it harder to finish the reconstitu-tion process. The operator may attempt to solve this by repeatedly injecting solution into the vial, mixing and

2~ withdrawing the ~olution but ~his makes necessary addi-tional injection~ and movement o~ the syringe which increase the likelihood of contamination. Also, it is ~ometimes difficult to get all of the drug and/or liquid out of the vial, thus increasing the time required to ,~ perform the reconstitution procedure.
The reconstitution procedure 6hould be perormed under preferably sterile conditions. In addition to such a requirement making the operator justifiably more cautious and consuming more time, s~erile conditions are often hard

-3 to maintain. In some instances, a laminar flow hood may be required under which the reconstitution procedure is performed.
Some drugs ~uch a5, for e~ample, some chemotherapy drugs, are toxic. E~posure of the operator to the drugs during reconstitution may be dangerous, especially if the operator wor~s with such drugs on a daily basis and is repeatedly exposed to themO
A further problem is that the reconstitution procedure provides a source of confusion as to which container contains which drug, beoause the diluent container must be marked with the drug with which it has been injected or at least the name of the patient to whom it should be delivered.
It can be seen that a clo ed -~ystem for separate storage of a drug and diluent would be most beneficial.
Certain factors have until recently prohibited such a closed ~ystem on a commercially feasible, reasona~ly inexpensive basi~, however. One factor w~i~h has made difficult the manufacture of a closed ~ystem having ~eparate, 6electively communicating compartments for a drug and a diluent has been the ~terilization procedure.
As an e~ample, in the ca~e of diluent in a ~lexible plastic container, the container with the diluent therein is sterili~ed by steam terilization, or autoclaving.
However, the heat generated during ~uch a sterilization procedure would destroy the effieacy of many drugs~ On the other hand, other sterilization means such as the use of ethylene oxide gas may not harm the drug but may harm 3~ the diluent.

The e considerations mandate that, ~bsent means to protect the drug and diluent during different steriliza-tion 6teps, the system be formed by combi~ing ~eparate drug and diluent receptacles after they have been separately sterilized. This requires the manufacture of a sterile or at least an aseptic connection between the two recep~acles. Sterile connectors are known, such as show~, for example, in U.S. Patent ~os. 4,157,723, 4,325,417 and 4,265,280, all assigned to the a3signee of the present inventio~. The conneotor~ aisclosed therein provide hig~ly reliable, ~erile connections. They do however employ a separate radiant energy 60urce to make the connection and therefore a power ~upply to operate the energy 60urce.
Another requirement o~ ~uch a closed 6y~tem is that it ~hould prev~nt water vapor transmission from the receptacle holding the diluent to the receptacle holding the powdered drug. As discussed earlier, the ~torage of ~ome powdered drugs with even a small amount of liquid destroys drug eXficacy.
Finally, uch a closed system should also be con-Ptructed in a manner which will facilitate.easy and thorough mixing of the drug and the diluent.

A~

Summary of the Invention The present inv~ntion i~ directed to apparatus for selectively and efficiently mixing two compon~nts. The apparatus of the invention is especially useful in recon-stituting a drug in a vial in a quicX and efficientmanner.
The apparatus includes a compressible chamber which includes both a selectively gas-trapping compartment and a reservoir compartment in open communication with the ga~-trapping component. A liquid first component such as a diluent is stored in the chamber. In one em~odiment of the invention, the apparatus further includes a container, 6uch as a drug vial, having a second component stored therei~. At least one of the container and the compressible chamber also includes a gas. The appratus includes a selectively opened pathway between the con-tainer and the gas-trapping compartment of the compressible chamber, such that after the pathway is opened, the gas-trapping and rsservoir compartments may be selectively positioned relative to each other to facilitate proper mixing of the fir6t and second mixing components.
In another embodiment of the invention, the apparatus includes the compressible chamber but does not include the container with the second component therein. Here, the compressible chamber includes means to access the gas-trapping compartment of the compressible chamber such ~hat the chamber access means may be connected to a con-tainer ~uch as a drug vial having a pierceable stopper therein, to form a selectively opened pathway between the container and the compressible chamber of the apparatu~.
After the pathway is opened, ths gas-trapping and reservoir compartments may be selectively posi~ioned rela-tive to each other to quickly, efficiently and properly mix the first liquid component in the apparatus with tne second component.
The access mean~ may include a needle mounted in ~elec~ive communication with the gas-trapping compartment, by means of a frangible cannula separating the needle from the gas-trapping compartment. The needle may be used to pierce the stopper of a drug vial, enabling efficient reconstitution of the drug.
The compressible chamber of the apparatus includes an internal wall having a closed end and an open end, defin-ing the gas-trapping and reservoir compartments, segregat-ing the compartments along it~ lenyth and at the closed end, and defining an open flow path between the compart-ments. After the pathway between the chamber and the con-tainer iB opened, the internal wall permit~ sele~tiveentrapment of at least a portion of the gas in the gas-trapping compartment adjacent to the open pathway.
The invention is also directed to a method for separately storing and selectively mixing two components in the apparatus as ~irst described above, as well as a method for selectively mixing two components utilizing the alternate embodiment of the apparatus. The methods include the 6teps of opening the pathway, transferring and exchanging liquid from the chamber into a container and emptying the liquid from the container into the chamber.
The method is not limited to 6terile mixing.

-6a-Various aspects of the inven~i~n ~re as follows:
Apparatus for separately storing and selectively mixing two components, comprising:
(a) a compressible chamber containing a liquid, firat component and including 5i) a selectively gas-trapping compartment, (ii) a reservoir compartment, and (iii) an open flow path between 6aid gas-trapping and reser~oir compartments;
(b) a container containing a second component, at least one of said container and ~aid compressible chamber also containing a gas;
(c~ a selectively opened pathway between said con-tainer and said gas-trapping compartment of said compressible cham~er;
(d) whereupon after said pathway i6 opened, caid gas-trapping and reservoir compartments may be selectively positioned relative to each other to facilitate proper mixing of the first and second mixing components.
Apparatus for mixing a liquid, ~irst component stored therein with a second component stored in a con-tainer, comprising:
(a) a compressible chamber containing ~aaid liquid first component and a gas and includi~g ~i) a selectively gas-trapping compartment, (ii~ a reservoir compartment, and (iii) an open ~low path between aid gas-trapping and reservoir compartments;
(b) means to access said gastra~ping compartment of ~aid compresQible chamber uch that aid compressible chamber access means may be connected to the container to form a selectively opened pathway between the container and said compressible chamber:
(c) whereupon after ~aid pathway is opened, said gas-trapping and re~er~oir compartments may be selectively positioned rela~ive to each other to ~acilitate the proper mi~ing of ~aid first component and the ~econd component.
A

-6b-A method for separately storing and ~electively mixing two components in an apparatus, the apparatus including a compressible chamber having a ~electively gas-trapping compartment and a reservoir compar~ment in open communication with the gas-trapping compartment, the compressible chamber further including an i~ternal wall having a closed end and an open end and segregating the ga~ trapping and reservoir compartments except for an open flow pa h between the compartments adjacent the open end, the compressible chamber containing a liquid, first component, the apparatus further including a container containing a second component, at least one of the compressible chamber and the container also containing a gas, the apparatus also including a selectively opened pathway betwPen the container and the gas-trapping compartment, the steps comprising:
(a) opening the pathway be~we~n the compressible chamber and the container;
(b) transferring ome of the liquid first component into ~he container through the pathway after some gas is in the container;

a~

2~
-6c (c) exchanging ~ome of the liquid in the contain3r with some of the liquid in the chamber by (i) manipulating the chamber until liquid in the gas-trapping compartment i5 adjacent the chamber access means and the chamber access means is above the gas-trapping COmpartmeAt, (ii) compressing the chamber, thereby urging some liquid from the chamber into the container, and (iii) stopping said compression, thereby ~rging some liquid from the co~tainer into the chamber; and (d) emptying the liquid in the container into the chamber.

A method for 6elec~ively mixing a liquid first component in ~n apparatus with a second component in a container, the apparatus including a compressi~le c'namber having a 6electively gas-trapping compartment and a reservoir compartment in open ~ommunication with the gas-trapping compartmen~, the compressible chamber further including an internal wall, having a closed end and an open end and ~egregating the gas trapping and reserYoir compartments except for an open ~low path between the compartments adjacent the open end, the apparatus furt~er includi~g mean~ to access the gas-trapping compartment of the compressible chamber such that the access means may be connected to the container to ~orm a selec~ively opened pathway between the container and the apparatus, the s~eps comprising:
~a~ connecting the chamber access means ~o t~e con-tainer;
(b) opening the pathway between th~ compres-~ible chamber and the container;

A

-6d-(c) transferrin~ Rome of the liquid first component into the container through the path~ay after ~ome gas is in the COntaiAer, (d) exchanging some of the liquid in the container with some of the liquid in the chamber by ~i) manipulating the ~hamber until liquid in .he gas-trapping compartment is adjacent the c~amber access mean~ and the chamb2r access means is above the gas-trapping compartment, (ii) compressing the chamber, thereby urging some liquid ~rom the chamber into the container, and (iii) stopping ~aid compression, ther2by urging some liquid from the container into the chamber: and (a) emptying ~he liquid in the co~tainer into the chamber.
A method fsr separately ~torins and selectively mixing two components in an apparatus, the apparatus including a compressible ch~mber having a selectively ga~-trapping co~partment and a reser~oir compartm~nt in open communication with the gas~trapping compar~ment, the compressible chamber further including an internal wall having a clo~ed end and an open en~ and segregating the gas-trappiny and rQservoir compar~ments except ~or an open ~low path between the c~mpartments adjac~nt the open end, ~h~ compressible chamber containing a ~iquid, irst compo~ent, the apparatus further including a container containing a second component, at least one o~ the compressi~le chamber and the c~ntainer ~l~o containin5 a z~
-6e-gas, the apparatus also including ~ ~electi-~ely sper.ed pathway between the container and the gas-trapping compartment, the steps comprising:
(a) opening the pathway between th~ csmpres~iDle chamber and the container;
~b) transferring some of the liquid ~irst component into the co~tainer through the pathway ~fter some gas is in the container, said liquid transfer including, (i) manipulating the chamber until the liquid first component i~ adjacent the chamber access means, (ii) comprassing the chamber, thereby urging 60me liquid from the chamber into contact with the second component in the containPr, and (iii) stopping said compression before the container i~ filled with liquid;
(c) e~changing some of the liquid in the container with ~ome of the liquid in the chamber by, (i) manipulating the chamber until liquid in the gas-trapping compartment is adjacent the chamber access means and the chamber access means : i5 above the gas-trapping compartment, (ii) compressing the chamber, thereby uxging 60me li~uid from the chamber in~o the container, and (iii) stopping Raid compression, thereby urging some liquid from the container into the chamber; and (d) emptying the liquid in the container into the chamber, said liquid emptying step i~cluding, (i) manipulating the chamber such that at least some of the gas in the reservoir compartment enters the sa -trapping compartment through ~he flow path, ~6f-(ii~ manipulating the chamber until the gas ~n the gas-trapping compartment is adjac~nt the chamber access means and the chamber access mea~s i8 ~bove t-ne gas-trapping compartment, (iii) compressing the chamber, thereby urging at least some of the gas from the gas-trapping compart-ment into the container, thus pressurizing the gas, above the liquid in th~ container, and (iv) stopping said compression of tne chamber, the pressurized gas in the container expelling the liquid in the ~ontainer through the pathway into the chamber.

~,h Description of the Drawin2~
Fig. 1 is a perspective Yiew o the closed Oystem.
Fig. 2 i~ a perspective view of the compres~ible chamber een in Fig. 19 Fig. 3A is a fragmentary view taken along the line 3A-3A of Fig. 2.
Fig. 3B is an enlarged fragmentary view in partial cross-section of the retaining tube and frangible cannula~
Fig. 4 is a partially schematic side elevational view of the closed system during manufacture rotated ninety degrees for ease of illustration on the page.
Fig. 5 is a front elevational view in partial cross-section of the system illustrated in Fig. 1, during manufacture.
t~ Fig. 6 is a fragmentary, cross-sectional view of the sterile coupling used in the closed system illustrated in Fig. 1.
Fig. 7 is a fragmentary view of the closed system in partial cross-section, illustrating the establishment of a sterile pathway.
Fig. 8 is the view illustrated in Fig. 7 and further illustrating the open frangible cannula.
Fig. 9 i8 a partially cut-away, front elevational view illustrating liquid transfer .
Fig. lO is a partially cut-away, front elevational view illustrating liquid exchange.
Figs. 11, 12A and 12B are front elevational views of the container illustrating the step of emptying the liquid from the container into the chamber.
3o Fig. 13 illustrates an alternate embodiment of the sterile coupling.
Fig. 14 i~ a front elevational view of another alternate embodiment of the sterile coupling.

-8- ~

Figs. 15 and 16 are fragmentary views in partial cross-section of the sterile coupling of Fig. 14, before and after establishment of a sterile pathway, respec-tively.

-9~

Detailed Description of the Preferred Embodiments Referring to Figs. 1 through 3, there i8 seen in Pig.
1 a closed system 20. A compressible chamber 22 is pro-vided which may be made from flexible plastic Oheets 24, 26 sealed together to form an e~ternal Oeal 28 about the compressible chamber 22. The plastic sheets 24, 26 may be made of, for example, polyvinyl chloride material and th~
external seal 28 may be, for example, a heat seal or a radio-frequency (RF) seal. The compressible chamber 22 includes a reservoir compartment 30 and a selectively gas-trapping compartment 32. The reservoir and gas-trapping compartments 30, 32 are partially defined by an internal wall 34 ha~ing a closed end 36 a~d an open end 38. The internal wall 34 may also be formed by heat seal-ing or RF sealing the two fle~ible plasti~ ~heets together. The internal wall 34 may be an exten~ion of the external seal 28. The open end 38 of the internal wall 34 may be a wider, rounded seal 40 for increased strength.
The internal wall 34 ~egregates the gas-trapping and ~o reservoir compartments 32, 30 along the length of the internal wall 34 and at the clofied end 36. The internal wall 34 defines an open flow path 42 around the open end 38, between the gas-trapping and reservoir compartments 32, 30.
The e~ternal seal 28 and internal wall 34 ~ogether define a generally "J"-shaped configuration for the compressible chamber 22 in the preferred embodiment. The reservoir compartment 30 corresponds to the long leg of the J-~haped configur~ion and the gas-trapping compart-ment 32 corresponds ~o the short leg of the J shaped con-figuration. The internal wall 34 separates the long and short legs.
Means 44 to access the compressible chamber 22 i8 Iocated adjacent the gas-tEapping compartment 32. In the -lo~ Z~

preferred embodiment the acce~s means includes a needle 46 which may be of standard construction, mounted in a plastic needle hub 48. The chamber acce58 mea~s 44 further includes a plastic, flexible sleeve 50 such as may be made with polyvinyl chloride material. The leeYe ;0 may be bonded at its first end 56 to the needle hub 48, by conventional means such as solvent bonding . The chamber access means 44 further includes a membrane 52 bonded to and closing the sleeve 50 a~ the second end 58 of the sleeve. The membrane ~2 includes annular ribs 54. The membrane 52 may also be a plastic material.
The first end 56 of the sleeve 50 is ~ecured into the hollow end 60 of a frangible cannula 62. Such frangible ~annulas are known and may be constructed as shown for example, in U.S. Patent Nos. 4,181,140, 4,340,439 and 4,294,247, all assigned to the assignee of the present invention. Referring to Figs. 3A and 3B, it is seen that the frangible cannula 62 may be housed in a hollsw re~aining member 64 which includes one or more openings 66 in the sidewall 68 of the retaining member 64, the openings 66 being located near the top of the short leg of ~he J-shaped compressible chamber 22. The frangible cannula 62 includes a breakaway portion 72 which may have fins 73 and which may be 6electively broken away from the hollow end 60 at the frangible portion 70.
As ~een best in Figs. 1 and 3B, the external seal 28 i~ made around the sidewall 68 of the retaining member 64. If RF ~ealing i~ ~tilized, t~e sidewall 68 of the retaining memb~r 64 will simultaneously seal to the plastic ~heets 24, 26 and to the hollow end 60 of the frangible cannula 62 upon application of the RF source.
The compressible chamber 22 contains a first component 74 which may be a sterile liquid diluent such as water, dextrose solution or aaline solution. Other diluent~ are of course possible.
The closed system 20 preferably includes hanging means such as a defined opening 98 through the flexible plastic sheets 24, 26. The compressible chamber 22 preferably includes a selectively opened port 100 which may be con-nected to an administration 6et (not 6hown) for deliv~ry to the venous system of a patient.
Referring to FigsO 1 and 6, a junction 76 enclosea the end portion 78 of the chambçr access means 44. In the preferred embodiment the junction 76 i8 made from an inj~ction moldable plastic material. The junction 76 connects the chamber access means 44 with a container 80.
The container 80 contains a second component ~2 ~uch a~ a powdered or liquid drug. In the preferred embodiment, the container 80 is a ylass dxug vial of stan~ard construc-tion, which allows for the incorporation of drugs into the closed system 20 from other 60urces in such standard vials without necessitating retooling for a new drug container.
When the container 80 is a drug vial of such ~andard construction, it typically includes a rubber atopper 84 and a metal band 86 about the mouth 88 of the container 80, the metal band 86 retaining the rubber stopper 84 in the container 80. The rubber stopper 84 and metal band 86 together form means 90 to access ~he container 80. As will be described below, neither the chamber access means 44 nor the container access means 90 are limited to the 6pecific construction described herein, but rather can include a wide range of configuration The container 80 may be loosely retained by a flap 92 extending from the 1e~ible plastic sheet 24 and heat sealed at its distal end 94 to the other flexible plastic aheet 26. A plastic pouch 96 i~ placed about the con-tainer 80. The plastic pouch 9~ may be of a polyolefin ~2¢3~629~

material against which t'ne container 80 may easily sli~e.
The polyolefin material has a lower coefficient of 'ri--tion than, for example, polyvinyl chloride, from whicn ~he flexible plastic sheets 24, 26 may be made.
The closed system 20 is manufactured by bringing together the compressible chamber 22 and tho container 80 after the contents of each has been separately sterilized. For example, after the apparatus 102 seen in Fig. 2 is filled with the first component 74 it may be placed in a closed pouch (not shown) of a plastic material such as polypropylene. The apparatus 102 may then be sub-jected to autoclaving to sterilize the interior of the compressible chamber 22 and the first component 74. The apparatus 102 is then taken out of the pouch and placed on a preferably horizontal surface 103 at a work station with the flexible plastic sheet 24 and the flap 92 face up, as illustrated in Fig. 4. Fig. 4 has been rotated ninety degrees for ease of illustration on the page. The pouch-ing of the apparatus 102 before autoclaving is helpful in promoting a clean environment for the apparatus but is not claved without pouching. After this step, the apparatus can be taXen direct~y to the work station.
The flap 92 is folded away from the chamber access means 44. The container 80 is then placed on the horizontal surface 103. The end portion 104 of the container access means 90 is biased into abutting relation with the end portion 78 of the chamber access means 4~
The end portions 78, 104 may be biased by any appropriate biasing means, such as, for example, a spring mechanis~
; 30 lOG.
As seen in Fig. 5, a mold 110 is then placed about the end portions 78, 104 of the chamber access means 44 and container access means 90, respectively. Molten material 112 is then injected through the supply line 114 lnto ~ne mold interior 120, about the end portions 7~, 104. It is anticipated that the molten material 112 will be a plastic, and preferably a thermoplastic; however, it is conceivable that other molten materials meeting the requirements described below will also work. In the pre-ferrea embodiment, the molten material is a plastic sol~
under the trademark Kraton by Shell oil Company. It is believed that Kraton is a blocX copoly~er of polystyrene and a rubbery polyolefin material. Another plastic r~hich may be acceptable is Delrin , sold by E. I. DuPont de Nemours & Co. The plastic should be puncturable but resistant to coring during puncture. The pressure of the injected molten material 112 overcomes the bias between the end portions 78, 104 and separates the end portions into spaced relation as seen in Fig. 6.
In order to be in a molten state, the molten material su~h as molten plastic will be quite hot. It has been found that during injection molding the molten material sterilizes the end portions 78, 104 of both access means 44, 90 by heat trans~er from the injection molded molten material 112. When Kraton is used, a temperature of 500F. or more should be maintained so as to sterilize the end portions 78, 1040 Generally, a higher temperature for the molten material 112 will improve the sterilizing ability of the heat transfer during injection molding.
It has been found that spraying water on the end por-tions 78, 104 before injection of the heated molten material 112 may improve the sterilizing ability of the heat transfer, although this is not believed necessary in the preferred embodiment.
The molten material 112 is then cooled into a unitary junction 76 ~/hich encloses the end portions 78, 104 and also maintains the end portions in sterile, spaced rela-~r~2~

tion, as ~een in Fig. ~. In addition to establishing ~nd maintaining a sterile spaced relation ~etween the acce~s means 44, 90 the above-described ~.ethod provides an arrangement whereby a piercing element such as, for example, the needle 46 may be urgPd through the junction 76 to selectively establish a ~terile pathway 118 betwee~
the compressible chamber 22 and container 80 through both access means 44, 90, as ~een, for example, in Figs. 7 and 8.
It is believed that the above-described method for establishing and maintaining ~he sterile spaced rela~ion between the access mean6 may be accomplished without bias-ing the end portions 78, 104. Alternatively, the end por-tions may be held or maintained in a predetermined spaced relation. The molten material may then be injected ~bou~
at least the end portions 78, 104 sf both access means 44, 90. In this alternative method, the injection molding of the molten material does not itself separate the end por-tions 78, 104, but the step does sterilize the end por-~ions.
It is believed that ince, in the preferred embodi-ment, the injection molding of molten material occurs only about the container access means 90 of the container 80, only a minimum amo~nt of heat transfer occurs between the molten material 112 and the second component 82 ~uch as a powdered drug in the container 80, thus maintaining the efficacy of the drug. When a glass vial i5 used as the container 80, the glass serves as a good insulator against heat transfer between the molten material 112 and the 3o ~econd component 82 inside the vial. The rubber stopper 84 also i8 a good insulator.
It may be seen that the above-described method for establishing and maintaining a sterile spaced relation between the access means 44, 90 is not limited to access means of ~he apecifically described chamber 22 and con-tainer 80. Indead, any two receptacles may be used in place of the chamber 22 and the container 80.
As stated, the container 80 in the preferred -mbodi-ment i8 a glass vial having a rubber 6topper 84 in themouth 88 of the vial. Because of the use of a glass con-struction and a rubber stopper 84, the con~ainer 80 can not be subiected to etrong stresses. For this reason, ~he injection molding step described above to form the junc-tion 76 must be made from a low pressure supply into themold interior 120. The molten material 112 is injected at a pressure of less than 10 PSI and preferably at a pres-~ure of about 5 PSI. This low pressure injection molding makes impossible an otherwise useful, known technique for determining when the mold interior 120 is full. For example, completion of an injection cycle i often deter-mined by monitoring the back pressure in the supply line.
When the bacX pressure of the molten material rises to a certain level it is known that the mold interior is full and injection of further plastic is then ~topped. Under the low injection molding pressure requirements, however, it i8 difficult to determine a ignificant rise in back pressure of the molten material 112. If the back pressure is allowed to rise, the pressure might either blow the rubber stopper 84 into the container 80 or breaX the con-tainer 80.
Other means of determining injection cycle completion include measuring the quantity of molten material injected into the mold interior through the supply line. Such measurement means can be expensive and it i~ often diffi-cult to per~orm precise measuring.
Solving the problem of determining completion of an injection cycle i6 solved by providing an open channel 122 in the mold 110, as ~een in ~ig. 50 Preferably, the open l~V~

channel 122 is a formed groove in the side of one of two mold halves which compr-se the mold 110. The open channel 122 extends between the mold interior 120 and the e~t~rior of the mold 110. The open c'nannel 122 is preferably placed away from the supply line 114, although it is believed that this is not necessary. The open channel i~
relatively narrow compared with the mold interior 120 and in the preferred embodimen is within the ran~e of about 0.030 in. to about 0.060 in. wide, when the molten material is Kraton. After molten material 112 has filled the mold interior 120, it enters the open channel 122.
The presence of the molten material 112 in the open channel 122 is then sensed, whereupon the low pressure supply of the molten material ceases.
It i8 believed that by placing the mold-interior end of the open channel 122 away from the supply line 114 and most importantly by ma~ing the open channel 122 narrow, the open channel 122 becomes the path of greatest resistance to the molten material 112 and i6 ~herefore filled with molten material 112 only after the mold interior 120 is filled. The object is to make the open channel 122 the path of greatest resistance but to prevent clogging of the channel and allow molten mat rial to enter the channel 122. Thus, when the molten material is more viscous, the channel 122 will need to be wider so as to permit material 112 to enter the open channel and to prevent clogging of ~he channel 122, yet still narrow enough to be the path of greatest resistance to the molten material 112.
If the injection molding process is performed manually, the presPnce of the molten material in the channel 122 may be sensed visually, whereupon the operator ceases the application of pressure to the material ~upply. In an au~omated procedure, the sensing of the molten material in the channel 122 could be mad~ b~
various means including, for example, a microswitch (no.
shown) connected to the inside of the open channel 122 or at the exterior end 123 of the open channel 122. The microswitcn can be connected to and control the low pressure supply.
Wh~n the molten material 112 c0015 and becomes the junction 76, a ~terile coupling 124 i6 formed which enables the ~elective establishment of the sterile pathway 118 between two separate receptacles, such as the con-tainer 80 and the compressible chamber 22. In the closed y tem 20 the ~terile coupling 124 includes the chamber access mean 44, the container access means 90 and the molded junction 76 affixed about at least the end portions 78, 104 of the access means ~4, 90, re~pectively, whereby the junction maintains the end portions in sterile ~paced relation. The sterile coupling 124 fur~her includes the piercing element ~uch as the needle 46 which is capable of piercing the junction 76 between the end portion 78, 104 ~o as to ~electively bring the access means into pathway communication and establish a sterile pathway 118 between the container 80 and the compressible chamber 22 through the access means 44, 90. In the preferred embodiment, the needle is housed within and is a part of the chamber access means 44. The needle ~6 forms the conduit between the container 80 and the chamber 22 when the sterile path-way 118 is formed. However, it is not necessary for the piercing element to be a needle 46 and it is not necessary for the piercing element to al~o be the conduit. Other 3 pi~rcing element and conduit configurations may be used in the sterile coupling 124. Indeed, the s~erile coupling 124 is not limi~ed to use in the above-described closed system 20. For example, the cterile coup~ing 12~ can include first means to access one receptacle and second means to access another receptacle, whereby the junctisr.
76 is permanently affixed about at least the end portions of both the first and second access means. The piercing element should be capable of piercing the preferaDly plastic junction from the end portion of the corresponding access means through the junction at least to the end por-tion of the other of the first and second access means in a manner to establish a sterile pathway through both access means, between the receptacles.
Upon formation of the s~erile coupling 124 in the closed system 20, the loose fitting, open ended plastic pouch 96 i8 placed about the container 80, as seen for example in Fig. 1. The flap 92 is then brought down over the c~n~ainer 80 and heat sealed at its distal end 94 to the flexible plas~ic sheet 26. The plastic ~heet 26, flap 92 and pouch 96 confine the container 80 but allow for axial movement of the container. As stated above, the plastic sheet 26 and flap 94 may be made of polyvinyl chloride material. Such material has a very high coerficient of friction thereby hindering axial movement of the container 80 relative to the compressible chamber 22. The plastic pouch 96 i6 provided merely to reduce the coefficient of friction and ease axial movement of the container. The plastic pouch 96 may be a polyolefin such as polypropylene, for example.
The closed system 20 provides for the separa~e storage of two components and the selective mi~ing of those components under 6terile conditions. The fir~t component 74 in the compressible chamber 22 and the second chamber 82 in the container 80 are mixed by first forming the sterile pathway 118 within the junction 76 of the sterile coupling 124, as illustrated in Figs. 7 and 8. In the preferrea embodiment the ~terile pathway 118 is made by urging the piercing element, in this case the needle 4~, through the membrane 52 and the end portion 78 cf the chamber acce s means 44. After piercing the m~mbrane 52, the needle 46 pierces the junction 76 and then the rubber stopper 84 of the container 80, the rubber stopper 84 being part of the container access means 90. Th2 interior of the needle 46 is then in communication with the interior of the container 80 housing the second component 82. The piercing element i~ urged ~oward ~he container 80 by ~imply grasping the container 80 and the chamber access means 44 and pushing ~hem toward each other. The closed system 20 allows ~or axial movement of the container 80.
When the container 80 and needle 46 are urged together as seen in Fig~ 7, the ~leeve 50 collapses becau~e of its flexible construction. The sleeve 50 and membrane 52 ~erve to hold the chamber ~ccess means 44 within the junc-tion. The annular ribæ 54 about the membrane 52 aid in retaining the membrane 52 within the junction 76. If the junction 76 were molded directly about the needle 46 it might be possible to withdraw the needle 46 from the junc-tion 76. While it i6 believed that such a configurationof the invention will work, the chamber access means 44 including the sleeve 50 and membrane 52, is preferred.
The frangible cannula 62 fiegregates the liquid fir6t component 74 f.rom the chamber access means 44, preventing the collection of liquid within ~he sleeve 50 before the frangible cannula 62 is opened. In addition, the frangible cannula 62 provid~s further assurance that there will be no contamination of the fir t component 74 stored in the compressible chamber 22. To comple~ely open the sterile pathway 118 between the interior~ of the chamber 22 and container 80, the frangible cannula 62 must be opened. This is done by manipulating the cannula 62 from e~terior of the compres~ible chamber 22. The break-away portion 72 i8 bent relative to the hollow end 60, fractur-ing the cannula 62 at frangible portion 70. If de~ired, the break-away portion 72 may thereafter be urged away from the hollow end 60 down the retainins member 64. The frangible cannula 62 may be designed ~o as to include fins 73 on the break-away portion 72 which frictionally engage the retaining member 64. The break-away portion 72 is thus trapped in the retaining member 64 and does not float loosely within the chamber 22.
After the sterile pathway 118 i~ formed and after the frangible cannula 62 is opened, fluid flow b~tween the container 80 and chamb~r 22 i5 made through the needle 46 and ~round the fins 73 of the frangible cannula ~2 as well as through the defi~ed opening 66 in the retaining member 64. Once the sterile pathway 118 is establiæhed, the gas-trapping nd reservoir compartmentR 32, 30, respec-tively, may be ~electively positioned to facilitate the proper mixing of the first and Recond components 74, 82.
The mixing procedure is best seen with reference to Figs. 9 through 12. The method includes the step~ of transferring some of the liquid first component 74 into the container 80 after at leas some air 128 is in the container 80, exchanging some of the liquid in the con-tainer with some of the liquid in the chamber 22 and finally, emptying ~he liquid in the container 80 into the chamber 22.
In the illustrated embodiment the liquid, first component 74 is stored in the compressible chamber 22 210ng with at least a small amount of air 128 or other gas. The first component 74 may be packaged without any air 128 in the compressible chamber if there i9 some air 128 stored in the container 80. Powdered drugs are often stored in drug vials under partial vacuums, however, and thus additional air i8 required for the working of the inventio~. ThuR, air 128 i~ ~tored in ~he chamber 22.

Liquid transfer from the chamber 22 into the container 80 i8 accomplished by manipulating the c~amber 22 until the liquid first mixing component 74 i~ adjacent the chamber acc2ss means 44, as seen in Fiy. 9. The chamber 22, being made of flexible plastic sheets 24, 26, may be manually compresRed, there~y urging some li~uid from the chamber 22 into contact with the second mixing component 82 in the container 80. The liquid i8 transferred most easily if the closed system 29 i8 maintained horizontally with the gas-trapping compartment 32 and the container 80 beneath the reservoir compartment 30, such as i8 shown in Fig. 9. It i8 important to stop compression of the chamber 22 before the container 80 is totally filled with liquid. If the container 80 is packa~ed with a vacuum, it would otherwise be possible to fill ~he cont iner totally with liquid.
After 80me of the first component 74 is in the con-tainer 80, the container 80 is agitated by ~haking the clo~ed Rystem 20. This mixes the fir~t component 74 with the ~econd component 82. In those in~tances where the second component 82 iR a powder, ayitation of the con-tainer i6 most useful in ini~iating a mi~ing between the components. Thi5 i8 especially true where the powder has "caked" into a single piece, which provides for only small surface area contact between the components. Agitation helps to break up the second component 82 into smaller particles.
After the step of liquid transfer, ~ome of the liquid in the container 80 is exchanged with some of the liquid in the chamber 22, ac best seen in ~ig~ lO. First, the chamber is manipulated until liquid, as opposed to air 128, i8 in the gas-trapping compartment 32 of the chamber 22 adjacent the chamber access means 44 and until the cha~ber acce~s meanæ 44 i8 abo~e the gas-trapping compart-ment 32. The J-shaped configuration of the compressiDle chamber 22 allows for liquid in the chamber 22 to be adjacent the chamber access means 44 while ~till holding the closed system 20 in the upright position shown in Fig.
10. Any air 128 in the chamber 22 can b2 stored entirely in the reservoir compartment 30. This is accomplished by manipulating the position of the closed system 20 so that air 128 in the gas-trapping compartment 32 flows through the open flow path 42.
The chamber may ~hen be manually compressed, which urges ~ome of the liquid in ~he gas-trapping compartment 32 of the chamber 22 into the container 80. During the compression step, air in the container 80 which is above the liquid in the container 80 is pressurized.
1~ Compression of ~he chamber is then stopped. When compression ceases the pressurized air in the container forces some of the liquid from the container into the chamber 22. The liquid first component 74 now has some of the second component 82 mixed therewith.
Were it not for the unique shape of the compressible chamber 22, the liquid exchange step would be performed by first turning the system 20 upside down 80 that the chamber access m~ans 44 would be below the gas-trapping compartment and then pressing the chamber. Then, while ~till exerting pressure on the chamber to compress it, the closed system would have to be rotated approximately 180 until the air in the container 80 is positioned above the liquid in ~he container. Only then could compression of the chamber 22 be stopped, which would then urge liquid from the container 80 into the chamber 22.
The liquid exchange step of the mixing method tran~fer some of the second component 82 into the chamber 22 and places additional amount of the liquid first component 74, having a lower concentration of the second 2~

component 82 therein, into contact with any amount of second CompOneDt remaining in the container 80. By plac-ing the less highly concentrated mixture into contact witn the remaining portion of the ~econd component 82, thorough 5 mixture of the two components 74, 82 is facilitated. The liquid exchange step may be repeated several times if necessary, or if desired to ensure thorough mixing. After each liquid exchange step is completed, the closed system 20 may be agitated to facilitate mixing. Repetition of the liquid exchange step i6 most useful when the second component is, for example, a powdered drug.
After a homogenous mixture between the first and second components has been created, or after all powder has been disolved, the liquid in the container is emptied into the chamber, leaviny virtually none of either the first or second components 74, 82 in the container 80.
The liquid emptying 6tep is best illustrated in Figs. ll, 12A and 12B. First, the chamber 22 i6 manipulated until at least some of the air 128 in the reservoir compartment 30 enters the gas-trapping compartment 32 through the open flow path 42 between the gas-trapping and reservoir compartments 32, 30. This is done by rotating the closed system 20 approximately 90 from the position of Fig. lO, shown by phamtom line in Fig. ll, to the substantially horizontal position illustrated by solid line in ~ig. ll.
In order to insure than air l28 flows around the internal wall 34, through the open flow path 42 and into ~he gas-trapping compartment 32, it is desirable to rotate the closed eystem 20 until the port tube end 130 i6 ~omewhat higher than the hanging end 132. This i~ depicted schematically by the lines l34 in Fig. 11.
~ ext, the chamber i6 manipulated until the air 128 in the ga~-trapping compartment 32 i~ adjacent the chamber access means 44. This arrangement is shown in Fig. 12A, in which the closed system 20 has been ro~ated approxi-mately 90 counterclockwise. The internal wall 34, in addition to defining and partially segrPgating the gas-trapping and reservoir compartments 32, 30, also enables this above-described selective entrapment of at least a portion of the air 128 in t'ne ga--trapping compartment 32 adjacent the chamber access means 44. ~ne next step in emptying the liquid from the container is to compress the chamber as seen in Fig. 12A. This compression urges at least ~ome of the air in the gas-trapping compartment 32 into the container 80, thereby pressurizing the air 128 above the liquid in the container 80. Comprecsion of the chamber is then stopped and, as illustrated in Fig. 12B the now pressurized air in the container 80 expels the liquid in the container through ~he 6terile pathway 118 into the chambex 22.
Mixing is now complete. A homogenous mixture is in the compressible chamber 22. The container 80 is virtually empty. The closed 6ystem 20 may now be used as a supply container to deliver the mixture in the chamber 22 directly to a patient. A spike of an administration set may be inserted into the port 100 to accomplish this fluid delivery.
The uniquely designed compressible chamber 22 of the invention may also be utilized without the sterile coupl-ing 124 previously described. The compressible chamber having a selectively gas-trapping compartment and a reservoir ompartment with an open flow path ~herebetween, may, in combination with, or for future attachment to a container, comprise an apparatus for separately storing and ~electively mixing components or for mixing a li~uid first component ~tored therein wi~h a ~econd component ~tored in the future connected container. When the apparatus includes the compres~ible chamber and the con-tainer, the closed system 20 i8 such an appar~tus, but 'he container and chamber may be connected by an~ selectively opened pathway between the chamber and container and i~
not limited to use of the junction 76. For example, the container 80 and cham~er 22 may have a selectively opened pathway which is a conduit h~ving a frangible cannula therein. The selectively opened pathway may have a configuration different from those described above. At least one of the container and the compressible chamber also contains a gas. The apparatus i6 useful for mixing two components even when sterile conditions are not necessitated.
When ~he apparatus does not include the container, the apparatus 102 may be as shown in Fig. 2, for example. The apparatus 102 includes means to access the gas-trapping compartment so that this access means 44 can be sele~tiYely connected to a ~eparate container to form a selectively opened pathway between the container and chamber.
~igs. 14 through 16 illustrate an alternate mbodiment of the 6terile coupling described above. In this embodi-ment, there is provided a closed device 136 including a compressible primary chamber 138 and a compressible auxiliary chamber 140. The chambers 138, 140 may be made from flexible pl~stic sheets of, for example, polyvinyl chloride. Area 141 has no function other than to provide a uniform appearance to the device 136. A port 100' pro-vides for selective communication between the primary chamber 138 and the exterior of the device 136.
Tubes 142, 144 extend from and communicate with the interiors of primary and auxiliary chambers 138, 140, respectively. Distal ends 146, 148 of the tubes 144,-142, respectively, are closed by a cap portion 150 which may be made o~ a needle pierceable plastic or rubber material.
The first end 56' of a flexible ~leeve 50' is attached to the cap portion 150. The second end 58' of the sleevs ;0' i~ attached to and clo6ed by a pierceable membrane 52'.
Housed within the slee~e 50' are two double pointed needles 152, 154. Together, tubes 142, 144, cap portion - ~ 150, sleeve 50', membrane 52' and double pointed needles 152, 154 form first means to access a receptacle, the receptacle in this instance including both primary and auxiliary chambers 138, 140, A junction 76' such as described above is affixed about the end portion 78' of the first access mean , which includes the membrane 52', the l~eve 50', the cap portion 150, the needles 152, 154 and the tubes 142, 144. The junction 76' is also affixed about the rubber ~topper 84' of a container 80'. In this embodiment, the rubber stopper 84' is part of the second access means to access a second reseptacle, in this case the container 80'.
A liquid first component 74' i~ ~tored in the primary chamber 138. A second component 82' is ~tored in the con-tainer 80'. The auxiliary chamber 140 remains empty until mixing is desired, at which time the container 80' is urged toward the first access means. Both of the double pointed needles 152, 154 puncture the junction 76', the stopper 84' and the cap portion lS0. An open fluid pas~age i~ then established as seen in Pig. 16. The fluid passage extends from the primary chamber 138 throu~h the tube 142, and the double pointed needle 152 into the con-tainer 80'. ~he ~luid passage c~tinues from the con-tainer 80', through the double pointed needle 154 and the tube 144, into the auxiliary chamber 140.
Mixing is accomplished by ~irst compressins the primary chamber 138 ~o urge liquid therein into the con-tainer 80'and rom the container into the auxiliary chamber 140. ~ext, the auxiliary chamber 140 i8 compre~sed, reversing the fluid flow, thr~ugh the con-tainer ~0' to the primary chamber 138. This cycle is ,S~t -27~

repeated until the first and second components 74', ~2~
re mi~ed. The port 100' may then be opened and the mix-ture delivered. The us~ o~ the primary and auxiliary chamber 138, 140 and the container 80' to estaDlish flow pattern i8 as discloged in ~he u.s Pa~ent Mo.

4,484,920 of Kaufman, et al., entitled "Container For Mixing a Liquid and a Solid", and assigned to the assignee of the present invention.

The above-described closed device 136 provides a sterile pathway utilizing the s~erile coupling, without the J-shaped configuration chamber.
Yet another embodime~t of the sterile coupling is seen in Fig. 13. ~ere, the junction 76'' is affixed a~out a 1~ rubber stopper 84'' serving a-~ ~n acces~ means to a con-tainer 80'' or other receptacls. The junction 76'' connects the container 80'' to a~other receptacle, a first component storage u~it 156~ The access means to ~he ~torage u~it 156 includes a ~lexible balloon 158 attached at one end to an inlet port 160 of the storage unit and at the other end to the junctio~ 76''. The storage unit access means further includes a ~eedle hou~ing 162 having a double pointed needle 164 and two ~insle pointed needles 166, 168 mounted therein. The needle housing 162 further includes check valve5 170, 172 providing one-way fluid communication between the balloon interior l59 and the 6ingle pointed neeales 166, 168, resp~ctively. The junc-tion 76'' provides a sterlle coupling between the rubber stopper 84'' and the storage unit access means.
Commu~ication between the s~orage unit 156 and con-tainer 80'' i~ established by ~ringing the two receptacles toward each other, thereby compressing the balloon 158 as illustrated, forcinq the needle housing 162 toward both the junction 76'' and the inlet port 160. The needles 164, 166 puncture the rubber stopper 84''. The neeales 16~, 168 puncture the inlet port 160. Fluid may then be transferred from the storage unit 156 through the single pointed needle 168 and into the balloon interior 1;9 through the check ~alve 172. The fluid may continue fro~
the balloon interior 159 through the check valve 170 and the needle 166 into the container 80''. Fluid is free to flow from the container 80'' into the storage unit 156 through the double poin~ed needle 164. The balloon 1~8 10~nd the check valves 170, 172 provide for mixture of the first and second components 74'' and 82'' within the balloon 158. The balloon 158 may be repeatedly squeezed to effect a pumping action, thereby mixing the first and second components 74'' and 82 ''0 15While several embodiments and features have been described in detail herein and fihown in the accompanying drawings, it will be evident that various further modifi-cations are possible without departing from the scope of the invention.

Claims (18)

WHAT IS CLAIMED IS:
1. Apparatus for separately storing and selectively mixing two components, comprising:
(a) a compressible chamber containing a liquid, first component and including (i) a selectively gas-trapping compartment, (ii) a reservoir compartment, and (iii) an open flow path between said gas-trapping and reservoir compartments;
(b) a container containing a second component, at least one of said container and said compressible chamber also containing a gas:
(c) a selectively opened pathway between said con-tainer and said gas-trapping compartment of said compressible chamber:
(d) whereupon after said pathway is opened, said gas-trapping and reservoir compartments may be selectively positioned relative to each other to facilitate proper mixing of the first and second mixing components.
2. The apparatus as in Claim 1, wherein said second component is a particulate solid.
3. Apparatus as in Claim 1, wherein said second component is a liquid.
4. Apparatus for mixing a liquid, first component stored therein with a second component stored in a con-tainer, comprising:
(a) a compressible chamber containing said liquid first component and a gas and including (i) a selectively gas-trapping compartment, (ii) a reservoir compartment, and (iii) an open flow path between said gas-trapping and reservoir compartments;
(b) means to access said gas-trapping compartment of said compressible chamber such that said compressible chamber access means may be connected to the container to form a selectively opened pathway between the container and said compressible chamber;
(c) whereupon after said pathway is opened, said gas-trapping and reservoir compartments may be selectively positioned relative to each other to facilitate the proper mixing of said first component and the second component.
5. The apparatus as in Claim 1, further including an internal wall in said compressible chamber, said internal wall having a closed end and an open end, defining said gas-trapping and reservoir compartments, segregating said gas-trapping and reservoir compartments along the length of said internal wall and at said closed end, and defining said open flow path between said gas-trapping and reservoir compartments, whereupon after opening said pathway said internal wall enables selective entrapment of at least a portion of said gas in said gas trapping compartment adjacent said open pathway, upon the selective movement of said gas-trapping and reservoir compartments.
6. The apparatus as in Claim 5, wherein said compressible chamber is defined by two flexible, plastic sheets sealed together to form an external seal about said compressible chamber.
7. The apparatus as in Claim 6, wherein said external seal of aid flexible, plastic sheets and said internal wall together define a generally "J" configura-tion for said compressible chamber, said reservoir compartment corresponding to the long leg of the "J" con-figuration, said gas-trapping compartment corresponding to the short leg of the "J" configuration and said internal wall separating the long and short legs of the "J" con-figuration, and further wherein said pathway communicates with a top of said gas-trapping compartment, said top corresponding to the top of the "J" configuration.
8. The apparatus as in Claims 1 or 4, wherein said compressible chamber is defined by two flexible plastic sheets sealed together to form an external seal about said compressible chamber.
9. a method for separately storing and selectively mixing two components in an apparatus, the apparatus including a compressible chamber having a selectively gas-trapping compartment and a reservoir compartment in open communication with the gas-trapping compartment, the compressible chamber further including an internal wall ] having a closed end and on open end and segregating the gas-trapping and reservoir compartments adjacent the open end, the compressible chamber containing a livid, first component, the apparatus further including a container containing a second component, at least one of the compressible chamber and the container also containing a gas, the apparatus also including a selectively opened pathway between the container and the gas-trapping compartment, the steps comprising:
(a) opening the pathway between the compressible chamber and the container;
(b) transferring some of the liquid first component into the container through the pathway after some gas is in the container;

(c) exchanging some of the liquid in the container with some of the liquid in the chamber by (i) manipulating the chamber until liquid in the gas-trapping compartment is adjacent the chamber access means and the chamber access means is above the gas-trapping compartment, (ii) compressing the chamber, thereby urging some liquid from the chamber into the container, and (iii) stopping said compression, thereby urging some liquid from the container into the chamber: and (d) emptying the liquid in the container into the chamber.
A method for selectively mixing a liquid first component in an apparatus with a second component in a container, the apparatus including a compressible chamber having a selectively gas-trapping compartment and a reservoir compartment, The compressible chamber further including an internal wall, having a closed end and an open end and segregating the gas-trapping and reservoir compartments except for an open flow path between the compartments adjacent the open end, the apparatus further including means to access the gas-trapping compartment of the compressible chamber such that the access means may be connected to the container to form a selectively opened pathway between the container and the apparatus, the steps comprising (a) connecting the chamber access means to the con-tainer;
(b) opening the pathway between the compressible chamber and the container;

(c) transferring some of the liquid first component into the container through the pathway after some gas is in the container;
(d) exchanging some of the liquid in the container with some of the liquid in the chamber by (i) manipulating the chamber until liquid in the gas-trapping compartment is adjacent the chamber access means and the chamber access means is above the gas-trapping compartment, (ii) compressing the chamber, thereby urging some liquid from the chamber into the container, and (iii) stopping said compression, thereby urging some liquid from the container into the chamber; and (e) emptying the liquid in the container into the chamber.
11. The method as in Claim 9, wherein said liquid transfer includes steps comprising:
(a) manipulating the chamber until the liquid first component is adjacent the chamber access means;
(b) compressing the chamber, thereby urging some liquid from the chamber into contact with the second component in the container; and (c) stopping said compression before the container is filler with liquid.
12. The method as in Claim 10, wherein said liquid transfer includes steps comprising:
(a) manipulating the chamber until the liquid first component is adjacent the chamber access means;
(b) compressing the chamber, thereby urging some liquid from the chamber into contact with the second component in the container; and (c) stopping said compression before the container is filled with liquid.
13. The method as is Claims 9, 10 or 11, wherein said liquid emptying step includes further steps, compris-ing:
(a) manipulating the chamber such that at least some of the gas in the reservoir compartment enters the gas-trapping compartment through the flow path;
(b) manipulating the chamber until the gas in the gas-trapping compartment is adjacent the selectively opened pathway and the selectively opened pathway is above the gas-trapping compartment;
(c) compressing the chamber, thereby urging at least some of the gas from the gas trapping compartment into the container, thus pressurizing the gas, above the liquid in the container; and (d) stopping said compression of the chamber, the pressurized gas in the container expelling the liquid in the container through the pathway into the chamber.
14. A method for separately storing and selectively mixing two components in an apparatus, the apparatus including a compressible chamber having a selectively gas-trapping compartment and a reservoir compartment in open communication with the gas-trapping compartment, the compressible chamber further including an internal wall having a closed end and an open end and segregating the gas trapping and reservoir compartments except for an open flow path between the compartments adjacent the open end, the compressible chamber containing a liquid, first component, the apparatus further including a container containing a second component, at least one of the compressible chamber and the container also containing a gas, the apparatus also including a selectively opened pathway between the container and the gas-trapping compartment, the steps comprising:
(a) opening the pathway between the compressible chamber and the container:
(b) transferring some of the liquid first component into the container through the pathway after some gas is in the container, said liquid than for including, (i) manipulating the chamber until the liquid first component is adjacent the chamber access means, (ii) compressing the chamber, thereby urging some liquid from the chamber into contact with the second component in the container, and (iii) stopping said compression before the container is filled with liquid;
(c) exchanging some of the liquid in the container with some of the liquid in the chamber by, (i) manipulating the chamber until liquid in the gas-trapping compartment is adjacent the chamber access means and the chamber access means is above the gas-trapping compartment, (ii) compressing the chamber, thereby urging some liquid from the chamber into the container, and (iii) stopping said compression, thereby urging some liquid from the container into the chamber; and (d) emptying the liquid in the container into the chamber, said liquid emptying step including, (i) manipulating the chamber such that at least some of the gas in the reservoir compartment enters the gas-trapping compartment through the flow path, (ii) manipulating the chamber until the gas in the gas-trapping compartment is adjacent the chamber access means and the chamber access means is above the gas-trapping compartment, (iii) compressing the chamber, thereby urging at least some of the gas from the gas-trapping compart-ment into the container, thus pressurizing the gas, above the liquid in the container, and (iv) stopping said compression of the chamber, the pressurized gas in the container expelling the liquid in the container through the pathway into the chamber.
15. The apparatus as in Claim 4, further including an internal wall in said compressible chamber, said internal wall having a closed end and an open end, defining said gas-trapping and reservoir compartments, segregating said gas-trapping and reservoir compartments along the length of said internal wall and at said closed end, and defining said open flow path between said gas-trapping and reservoir compartments, whereupon after opening said pathway said internal wall enables selective entrap-ment of at least a portion of said gas in said gas-trapping compartment adjacent said open pathway, upon the selective movement of said gas-trapping and reservoir compartments.
16. The apparatus as in claim 15, wherein said compressible chamber is defined by two flexible, plastic sheets sealed together to form an external seal about said compressible chamber.
17. The apparatus as in Claim 16, wherein said external seal of said flexible, plastic sheets and said internal wall together define a generally "J" configuration for said compressible chamber, said reservoir compartment corresponding to the long leg of the "J" configuration, said gas-trapping compartment corresponding to the short leg of the "J" configuration and said internal wall separating the long and short legs of the "J" con-figuration, and further wherein said pathway com-municates with a top of said gas-trapping compart-ment, said top corresponding to the top of the "J"
configuration.
18. The method as in Claim 12, wherein said liquid emptying step includes further steps, com-prising:
(a) manipulating the chamber such that at least some of the gas in the reservoir compartment enters the gas-trapping compartment through the flow path, (b) manipulating the chamber until the gas in the gas-trapping compartment is adjacent the selectively opened pathway and the selectively opened pathway is above the gas-trapping compart-ment;
(c) compressing the chamber, thereby urging at least some of the gas from the gas-trapping compartment into the container, thus pressurizing the gas, above the liquid in the container; and (d) stopping said compression of the chamber, the pressurized gas in the container expelling the liquid in the container through the pathway into the chamber.
CA 424721 1982-04-06 1983-03-29 Mixing apparatus Expired CA1208624A (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US06365943 US4411662A (en) 1982-04-06 1982-04-06 Sterile coupling
US06365945 US4458733A (en) 1982-04-06 1982-04-06 Mixing apparatus
US365,945 1989-06-13

Publications (1)

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CA1208624A true CA1208624A (en) 1986-07-29

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CA 424722 Expired CA1198089A (en) 1982-04-06 1983-03-29 Sterile coupling
CA 424721 Expired CA1208624A (en) 1982-04-06 1983-03-29 Mixing apparatus

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Application Number Title Priority Date Filing Date
CA 424722 Expired CA1198089A (en) 1982-04-06 1983-03-29 Sterile coupling

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JP (1) JPS59500602A (en)
CA (2) CA1198089A (en)
DE (1) DE3375453D1 (en)
DK (1) DK556583D0 (en)
EP (2) EP0091311B1 (en)
ES (2) ES8502942A1 (en)
WO (2) WO1983003585A1 (en)

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WO1983003540A1 (en) 1983-10-27 application
US4432755A (en) 1984-02-21 grant
ES521283A0 (en) 1984-08-16 application
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CA1198089A (en) 1985-12-17 grant
EP0091311B1 (en) 1988-01-27 grant
DE3375453D1 (en) 1988-03-03 grant
ES521284D0 (en) grant
CA1198089A1 (en) grant
EP0091312A3 (en) 1984-09-12 application
ES8502942A1 (en) 1985-05-01 application
JPS59500602A (en) 1984-04-12 application
US4458733A (en) 1984-07-10 grant
EP0091312A2 (en) 1983-10-12 application
WO1983003585A1 (en) 1983-10-27 application
ES8406876A1 (en) 1984-11-16 application
CA1208624A1 (en) grant
DK556583A (en) 1983-12-02 application
EP0091311A3 (en) 1984-12-12 application
US4411662A (en) 1983-10-25 grant
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ES521284A0 (en) 1985-02-01 application
EP0091311A2 (en) 1983-10-12 application

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