A composite medicament container including a vial to contain a dry powdered medicament, an outlet opening in the vial, a Lyo-stopper closing and sealing the outlet opening, and a flexible liquid container to contain a diluent for the dry medicament. The liquid container has a discharge port having an ellipsoidal shape. There is a closure plug in the discharge port. The closure plug has an ellipsoidal configuration and a size to mate with the interior of the discharge port and be secured therein. The configurations and sizes of the discharge port and said closure plug co-act to provide an enlarged, closely contacting extensive scaling area. The vial opening has a circular external configuration so that the vial outlet opening and the liquid container closure plug are mateable. Also included is a composite interengaging and sealing means which is operatively attaching and sealing the containers in mated relationship for intermixing the materials therein.

GENERAL TECHNICAL FIELD 
The invention relates broadly to dispensing containers for medicaments and 
more particularly to a multicompartment, wet/dry bag with lypholization 
vials. Initially a dry medicament is in one separately sealed compartment 
consisting of a glass vial, and a diluent or fluid mixture therefor is in 
a second separately sealed compartment, consisting preferably of a 
flexible plastic material. 
Such multicompartmented containers are broadly known in the art. Many 
different types of construction have been utilized, but heretofore some 
difficulties have been encountered in effecting seals of the individual 
containers or compartments, and in general, storage difficulties have been 
encountered by breakdowns in the respective sealing means and/or 
vaporization or transmission of liquids and fluids which tend to destroy 
or, in any event, lessen the effectiveness of the medicament to be 
dispensed, and especially as used in connection with I.V. administration 
of the medicament. 
The prior art encountered difficulties in structures permitting separately 
fillable compartments or separate containers, which were thereafter 
interconnected for permitting administration of a mixed medicament 
consisting of a dry medicament and a fluid or liquid diluent therefor. The 
prior art also encountered difficulties in selective storage of dry 
medicaments in a container, including a sealed medicament compartment, and 
a flexible plastic container having a diluent for mixing with the 
medicament in a sterile, non-contaminated condition for I.V. dispensing, 
or hypodermic removal, which constitute the main field and use of 
structures similar to the present invention. 
The present invention is, therefore, directed to structures of 
multicomponent containers which tend to lend to overcome difficulties in 
prior art structures and to provide a highly efficiency, wet/dry bag in 
combination with medicament lypholization vials, the bags being 
constructed of plastic materials and the lypholization vials being of 
glass. Particular emphasis is directed to the interjoining of the two 
compartments or containers. The dry medicament powder is contained 
normally in standard glass vials to allow lypholization via standard, 
in-place lypholization lines. As will be described in more detail 
hereinafter, the present invention is directed to a glass vial of, for 
example, a 30 ml capacity, of powder, and the vial is attached to a 
flexible plastic diluent container by means of an efficient sealing 
concept including an aluminum seal which can be secured by rolling about 
the juncture point and interconnection between the two members. A seal is 
also effected by use of an elastomeric gasket between the glass vial and a 
plastic port in the plastic diluent container. Movable plug structures 
close the flexible plastic container and also a stopper of highly 
resistant material being utilized both in the ports of the glass vial and 
the plastic diluent container. The stopper or seal unit consists of two 
plugs, one closeably and sealingly closing the members and the two 
compartments or containers when interconnected can be activated by 
movement of both stoppers such as by pushing both stoppers into the glass 
vial by selectively operable push rod means attached to or in contact with 
a lower one of the stoppers. 
The flexible container is of a design or contour devised for increased 
efficiency of connection of an outlet port with the flexible body of the 
liquid container and a connection with the glass vial discharge neck. The 
different materials have sometimes presented difficulties of sealing 
juncture. 
While a single embodiment incorporating the inventive aspects will be 
disclosed and described hereinafter and shown in the accompanying 
drawings, manifestly, minor detail changes will be apparent to those 
skilled in the art and without departing from the scope of the invention. 
BACKGROUND OF THE INVENTION 
Multicomponent containers adapted for initially holding in separate 
compartments, two or more substances or materials such as medicaments, one 
being dry, and the other a liquid diluent or carrier solution for such dry 
components, have been known and used. A specific example of such a 
compound container of this general nature is disclosed in U.S. Pat. No. 
4,550,825, assigned to a common assignee with the present application. 
Other examples of multicompartment medicament dispensers are, for example, 
disclosed in U.S. Pat. No. 4,410,321, issued Oct. 18, 1983. Numerous other 
examples are found in the prior art but many included one or more 
drawbacks in manufacture processing, effective long-life sealing of the 
individual containers or compartments, and a composite or compound unit 
being effectable by manufacture of the individual components in separate 
manufacturing or process lines, such containers being separately fillable 
with dry medicaments and diluents therefor and the individual containers 
being separately, if desired, stored and in some instances being 
effectively conjoined one with another for use or utilization by 
dispensers of the medicaments in I.V. systems or the like, such 
interconnected and sealed separate containers, when actively interjoined 
for storage, shipment, and use, being highly efficient and overcoming 
drawbacks in prior non-constructions. 
In effecting or manufacture of a structure incorporating the present 
inventive concepts, a vial of glass is filled with a desired amount of 
powdered medicament and individually sealed, and a flexible container of 
plaastic material is filled selectively with a diluent and individually 
sealed in a sterile manner as is the powder container. The two containers 
are actively interconnected by seal means including an aluminum seal 
consisting of a pliable aluminum strip which is rolled over the juncture 
of the two separate and separely sealed containers. 
The so-joined separate containers also preferably include hanger means 
operatively attached to the glass powder medicament container, and which 
can include labeling means for identification purposes and such labels can 
be removably mounted if desired. The seal between the two containers 
having the rolled aluminum seal is further enhanced or effected by 
incorporation therebetween of an elastomeric material gasket between glass 
and plastic material ports. A movable plug closes the flexible container 
and a so-called Lyo-stopper closes the port in the glass vial. 
Means are included for effecting intercommunication of the liquid with the 
powdered medicament by pushing or moving both stoppers into the glass vial 
by means such as a push rod attached to or in contact with the stopper in 
the plastic diluent container. 
Another of the problems heretofore existing in the interconnection of glass 
containers with plastic material containers resided in or was related to 
the use of adequate vapor barrier means in the two different material 
containers. The present invention utilizes for such vapor barriers, and 
sterile closure means, two plugs instead of a single one such as in some 
of the prior art structures and which were pierced or forced out of a port 
to effect intermixture. The two separate closure plugs constituting 
separate vapor barriers overcomes a problem of sealing capability over 
extended periods of time. 
The present invention significantly is of a design to effect a good sealing 
of a plastic bag to a glass container, both the glass bottle or container 
with its own separate stopper is joined to a plastic neck on the plastic 
flexible diluent container bag, and the structure and materials are such 
that the two can be joined together by heat and/or sonic means and the 
like. Each of the containers is individually sealed and the two initially 
sealed containers are joined together by composite sealing means with 
aluminum flexible material spun over the juncture point therebetween, 
resulting in a compound unit of exceptional effectiveness, long lasting 
sealing, and both components of which can be produced in separate 
production lines, separately stored and thereafter effectively 
interconnected or joined and activated in an I.V. system with good and 
high effectivity, and in the absence of contamination or effective 
actuation of the medicament material as intermixed for use in such 
dispensing or introduction methods or systems. 
Very broadly, in the preferred embodiment hereinafter described in detail, 
and as shown in the drawings, the basic concept of the invention is 
disclosed. A separate glass dry medicament or drug container is formed in 
a usual manner, and a plastic material diluent holding bag which is 
resilient is composed of two layers or sides of plastic material heatedly 
or otherwise appropriately interconnected. A resilient closure plug is 
fitted into the interior of the outlet port of the glass vial, and a port 
is formed in the plastic diluent structure by an elliptical or 
ellipsoidal-shaped plastic inert, which is inserted into the opened port 
of the flexible bag and appropriately sealed therein. The overall 
structure overcomes the problems encountered in joinder of glass with 
plastic materials by utilization of the elliptical portion of the plug in 
the diluent container bag. The use of the plastic ellipsoidal-shaped 
insert in the bag discharge port of a plastic material facilitates 
adherence of the plug and interconnection with the glass container through 
the aformentioned sealing means. Adhesion or affixing can utilize suitable 
adhesives, heat sealing and/or other known methods. 
Broadly speaking, therefore, the present invention incorporates two 
separate material containing structures which are individually producible 
along separate production lines and each has a suitable closure plug, and 
means such as a push rod plunger actuator is incorporated in the plastic 
bag which, upon being displaced, will also displace the individual seals 
or plug members of the two containers for movement into the glass vial, 
and the diluents and dry medicament are thereafter permitted to intermix 
with no fragmentation or contamination. 
Other objects and advantages of the present invention will become readily 
apparent from the following detailed description, wherein there is shown 
and described a preferred embodiment of the invention, simply by way of 
illustration of a preferred and presently contemplated mode for carrying 
out the invention. As will be realized, the invention is susceptible to 
minor modifications in various, obvious respects, all without departing 
from the invention. The drawings and description are to be regarded merely 
as illustrative in nature and not as restrictive.

As hereinbefore mentioned, the diluent container is provided with a 
discharge fitting 46. This discharge fitting 46 has one terminal end of an 
ellipsoidal configuration, and consists of a plastic material. Appropriate 
seal means such as an adhesive 48 serves to integrate this fitting in the 
discharge end of container 34. Obviously, the materials used are such that 
a good and effective juncture or joining of the members is incorporated. 
The fitting 46 includes a central bore 50 as shown more clearly in FIGS. 4 
and 5 and terminates in an enlarged upper discharge opening 52. A plunger 
rod 54, of plastic material or the like, and of general X-shaped 
configuration is inserted and extends through the central bore and 
includes an upper and having the configuration of a maltese cross of 
larger diametrical dimensions than the diameter of the bore 50. The ends 
of the maltese cross rest on a ledge or shoulder 58 formed at the juncture 
between the two bores. This serves to maintain the plunger rod in the 
appropriate position. 
The enlarged upper bore portion or discharge opening 52 has inserted 
therein a rubber closure and sealing plug 60, which is hemispherical in 
shape, and consists of a suitable resilient rubber material not subject to 
rapid deterioration by materials such as in the medicament containers. It 
will be seen from FIG. 4 that this closure and sealing plug 60 tightly 
fits within the discharge opening 52 but has contact mainly at the outer 
extended periphery 62. The small area of interengagement is to permit a 
displacement of this plug or closure member from the discharge opening as 
desired and which will be explained hereinafter. A hemispherical recess 64 
likewise serves to facilitate flexure of the sealing plug to facilitate 
placement and sealing engagement thereof within the discharge port. It is 
noted that the upper edge 66 serves as a contact ring with the outer end 
of the Lyo-stopper 16 engaged in the discharge port of the glass vial 10. 
This contact serves to effect an opening of the two containers upon 
actuation of the pusher or plunger rod 54 in the direction indicated by an 
arrow 68 in FIG. 6. An appropriate pressure can be applied to the lower 
end 70 of plunger rod 54 from the exterior due to the flexibility of the 
plastic container for the diluent. 
The resultant action is diagrammatically shown in FIG. 6. When the rod 54 
is pressed down in the direction of arrow 68 it will displace the 
Lyo-stopper 16 out of the neck of the glass vial into the interior of the 
vial and this is accomplished by contact between the plunger rod end 56 
with the end of the rubber plug 60 which in turn is in pushing engagement 
with the top of the Lyo-stopper 16. The arrows 72, 74 indicate the action 
following pushing of the rod in this manner. The resulting action opens 
the discharge part from the plastic bag constituting the liquid or diluent 
container 34, and a passageway indicated by arrows 76 are diluent flow 
indicators showing the liquid diluent discharged into the glass vial for 
intermixing. In the usual manner, a kneading or shaking of the combined 
structure will appropriately intermix the liquid and dry medicament 
material. The combination can then be appropriately suspended from or by 
the loop 30 for I.V. dispension. 
It is noted that the fitting or closure 46 is elliptical in configuration 
and has a circular or cylindrical portion 78 extending thereabove and 
incorporating an enlarged circular flange 80 thereon. This enlarged flange 
80 can serve as a retainer or manipulator in a final sealing 
interengagement between the various members. To this end, a stepped 
cylindrical collar 82 of thin aluminum material is rolled over and around 
the intermated or intermeshed edges of the discharge openings of the two 
containers into a sealing arrangement and interengagement as indicated at 
84 in FIGS. 4 and 6. The rolling of this sealing strip is known in the art 
per se. 
Attention is directed to FIGS. 4 and 5 for another portion of the sealing 
arrangement. The upper end or flange 86 of the fitting member 46 has a 
recessed circular groove 88 therein in which is placed an O-ring 90 of 
elastimeric material and this, at its top surface, interengages with the 
top surface of and around the discharge opening of the glass container. 
When the aluminum strip is appropriately rolled about this interengagement 
of portions of the two containers, there is effected a tight and effective 
sealing interengagement which will effectively prevent vapor or 
vaporization transfer or emmission from and into or between the 
interengaged containers. 
It is also noted that the lower terminal end of the flexible container 34, 
has a pierceable fitting 100 centrally located and sealably bonded to the 
flexible container, for the interconnection of an I.V. line or the 
addition of an additional medicament, the lower end of fitting 100 is 
protected from contamination by cap 102. 
While a single embodiment has been shown and described, it is obvious that 
minor changes can be made without departing from the spirit and scope of 
the invention as defined in the appended claims.