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Патент USA US3050073

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Aug- 21, 1962
|_. F. GOYKE
Filed May 29, 1957
‘ trite n
Patented Aug. 21, 1962
advantages of my invention can be seen as this speci?ca
tion proceeds.
This invention will be explained in conjunction with
the accompanying drawing, in -which—
Filed May 29, 1957, Ser. No. 662,361
teral solution container in communication with an addi
tive vial; and FIG. 2 is an elevational view, partially
in section, similar to FIG. 1 but showing the structure
of FIG. 1 in a different operative condition.
Leonard F. Goyke, Chicago, 111., assignor to Baxter Lab
oratories, 1116., Morton Grove, 111., a corporation of
3 Claims. (Cl. 128—272)
This invention relates to parenteral solution equipment
FIGURE 1 is a cross-sectional view of a bulk paren
and the use thereof, and more particularly to equipment
In the illustration given, the numeral 10 (in both
useful in supplementing bulk parenteral solutions.
The bulk parenteral solutions to which this invention
?gures) denotes generally a parenteral solution con
tainer. Container 10 includes a glass bottle 11 provided
is directed, are usually considered to be solutions in ex
with an annular groove or recess 12 adjacent the bottom
cess of 250 cc. Most usually, these solutions are pro
thereof. Mounted on bottle 11 within recess 12 is band
vided in sizes of 250 cc., 500 cc., and 1000 cc. Depend 15 13. Attached to lugs or ears 13a of band 13 is bail 14
ing upon the quantity of the solution and the require
ments of the patient, the administration of these solu
tions may vary over a period from about one hour to
(seen only in FIG. 2). Bail 14 and band 13 cooperate
to provide a convenient means for suspending bottle 11
in a mouth-downward fashion, such as is shown in FIG.
as much as eight hours. The administration is usually
1, and which is the position employed during dispensing
achieved by a length of tubing communicated at one end 20 of liquid from parenteral solution container 10.
with a parenteral solution bottle mounted mouth-down
Bottle 11 is provided with a mouth 15 into which is
wardly and at the other end with a needle inserted under
inserted stopper 16. Conventionally, stopper 16 is con
the skin of an intended recipient. Suitable ?ow-regu
structed of a resilient material such as rubber or rubber
lating means are associated with the administration set,
‘substitutes. Stopper 16 is provided with an annular
usually a drip-meter and clamp for the tubing so as to 25 ?ange portion 17 which overlies the top lip of bottle 11.
permit dropwise administration of the parenteral solu
Stopper 16 is maintained in place in the neck 15 of bottle
11 by a clamping ring 18 which is anchored to an ‘an
Although parenteral solutions are often thought of in
nular bead 11a provided in the external wall of bottle
terms as a source of intravenous feeding, they are by
11. Overlying stopper 16 is a frangible diaphragm 19.
no means limited to providing nutriment. They have 30 Extending through stopper 16 are passages 20 and 21.
been found useful in maintaining the recipient against
Mounted within passage 20 and extending inwardly of
shock, such as attends the loss of blood during surgery.
bottle 11, is an air tube 22.
They have been used to maintain the salt level of the
When the solution 23 contained within bottle 11 is in
tended to be dispensed without supplementation, the con
blood in this connection. They have also been used as
carriers for anesthetics and other associated medicines. 35 nector portion of an administration set is inserted into
The wide use of parenteral solutions permits them to
passage 21, the act of insertion causing rupture of dia
phragm 19 if it has not already been removed. Suitable
act as carriers for a wide variety of medicines. It is to
puncture of diaphragm 19 is also required in the portion
be appreciated, however, that because of their bulk, a
overlying passage 20. When bottle 11 is disposed in the
wide variety of parenteral solutions cannot be conveniently
condition shown in FIG. 1, parenteral solution 23 ?ows
stored, even in hospitals of considerable size. Thus, it
out of passage 21 and the space vacated by solution 23 is
is not uncommon for parenteral solutions of a basic
replaced by air entering through passage 20 and air tube
nature, such as glucose or saline, to be supplemented by
a particular medicine just prior to- the administration of
The foregoing parenteral solution container structure
the bulk parenteral solution. I have noted reports that
and operation is considered conventional, and is set forth
show that in as many as one in every four administra
in detail only for the sake of clearness of understanding
tions, the basic solution has been supplemented by one
of this invention. In this connection, it is to be noted
type of medicine or another. This is particularly the
that in some instances integral diaphragms are provided
case in the use of certain preparations such as vitamins
in stopper 19 to close passages 20 and 21.
that are unstable as water solutions.
In both FIGURES, the numeral 24 designates generally
Because of the increasing frequency with which basic
an additive vial structure which embodies teachings of
parenteral solutions are being supplemented, a problem
this invention. Vial 24, like bottle 11, can be conveniently
has arisen in the performance of this supplementation in
constructed of glass. Vial 24 is equipped with a top clo
a quick, ef?cient, and aseptic manner.
It is a general object of this invention to provide equip— 55 sure 25 which, in the illustration given, is shown secured
to vial 24 in a manner similar to the securement of stop
ment and the use thereof that solves the foregoing prob
per v'16 to bottle 11. In the illustration given, vial stopper
lem. Another object is to provide equipment to ac
25 is provided with an annular ?ange 25a which overlies
complish supplementation of a bulk parenteral solution
the top lip ‘of vial 24. Stopper 25 is maintained in place
with a minimum of manipulation, whereby aseptic trans
by a clamping ring 26 which is anchored to vial 24 under
fer is substantially achieved. Still another object is to 60 an annular bead 24a.
provide a novel method of supplementing a bulk paren
Extending through stopper 25 are a pair of passages 27
teral solution. Yet another object is to provide a method
and 28. Passages 27 and 28 are spaced apart a distance
for transferring a supplementing medicament from a
separate source to a bulk parenteral solution container
only under the influence of gravity. A still further object 65
is to provide a method of supplementing a bulk parenteral
approximately the same as the separation of passages 20
and 21 in stopper 16.
Mounted in passageway 27 is connector ?tting 27a.
Fitting 27a extends outwardly of vial 24 and is shown in
serted into passage 21 of stopper 16 of parenteral solution
solution in which the supplemental medication is intro
container 10.
duced through the air tube of a bulk parenteral solution
Mounted in passageway 28 is puncture ?tting 29‘, which
bottle. A still further object is to provide a novel closure
structure for an additive vial which achieves the pur 70 is shown inserted into passage 20‘ of stopper 16. Prefer
ably, ?tting 29 is of a length suf?cient to extend into air
poses and objects set forth above. Other objects and
tube 22 when ?tting 27a is inserted into passage 21 and
in communication with parenteral solution 23.
Fitting 29 is provided with a tight ?tting annular sleeve
30 which terminates a distance spaced from the end of
Ward. This has been found particularly convenient when
vial 24 contains a solid medicament, since a solid medica
ment does not have a tendency to flow out of vial 24.
After insertion of ?ttings 21 and 20, liquid solution 23
from container 10 ?ows into vial 24, diluting or dissolv
sleeve 30 is constructed of a resilient material such as
ing the medicament contained in vial 24 and effectively
rubber, in which case it can act as a seal in cooperation
making it possible to transfer all of the medicament into
with stopper 16 or diaphragm 19, as the case may be.
container 10. Thereafter, inversion of the coupled con
It is believed that a brief description of the use of vial
tainer and vial to the condition shown in FIG. 2 e?ectu
24 in the environment set forth will be helpful in under 10 ates transfer of the supplemental medication.
puncture ?tting 29. Optimum operation is achieved when
standing this invention.
While, in the foregoing speci?cation, my invention has
When it is desired to supplement a parenteral solution
been set forth in considerable detail to facilitate under
standing thereof, it is to be understood that variations
therein will be apparent to those skilled in the art and
23 such as is contained within parenteral solution con
that no unnecessary limitations are to be inferred from
tainer 10 with a liquid medicine, it is only necessary to
the foregoing detailed description, given, as it is, for pur~
communicate the suplemental medicine-containing vial
poses of illustration.
I claim:
1. In combination, a parenteral solution container
tainer 10 is positioned upwardly. Not shown associated 20 equipped with a resilient stopper, said stopper having a
with additive vial 24 is a suitable protector or cap struc
pair of passages therein adapted to communicate the in
ture for ?ttings 27a and v29 to protect them from contami
terior of said container with the exterior of said stopper,
nation. When additive vial 24 is coupled or communi
an air tube mounted in one of said passages and extend
cated to container 10 as shown in FIG. 2, the liquid 31 in
ing only inwardly of said container and to a point adja
vial 24 ?ows downwardly through ?tting 29 into air tube 25 cent the bottom of said container, a vial containing a sup
22 and eventually into the body of solution 23. Mean
plemental medicament for the container solution, a clo
while, air moves from container 10 upward through ?tting
sure secured to said vial, said closure being equipped with
with the parenteral solution container as shown in FIG.
2. In FIG. 2, the mouth of bulk parenteral solution con
27a into Vial 24 to replace the liquid which is dispensed
therefrom under the in?uence of gravity. During the
transfer of liquid medicine 31 from vial 24 into container
10, vial 24 and container 10 provide a closed system, i.e.,
a pair of spaced apart spouts of equal length extending
only outwardly of the portion of said closure connected
to said vial, said spouts having passages extending there—
through, both of said spouts being of generally circular
a system in which no contact with unsterile outside air is
cross-section and one spout being of smaller outer diam
eter than the other, the smaller outer diameter spout
being received in the air tube-equipped passage of said
permitted. As seen in FIG. 2, ?tting 27a is pressed-?tted
into passage 21 of stopper 16 so as to effectively seal air
from entering container 10 through passage 21. The abut
ment of sleeve 30 against the top surface of stopper 16
likewise prevents entry of unsterile air into parenteral
solution container 10.
When it is desired to supplement parenteral solution 23
stopper, the larger outer diameter spout being received in
the other passage of said stopper, the smaller diameter
spout being equipped with resilient means in sealing en—
vgagement with said stopper.
2. In combination, a parenteral solution container
with a solid medicament, the arrangement shown in FIG. 40 equipped with a resilient stopper, said stopper having a
1 is ?rst employed. In FIG. 1, as in the arrangement just
described with respect to FIG. 2, vial 24 and container 10
are communicated by virtue of having ?ttings 27a and 29
pair of passages therein adapted to communicate the in
inserted into passageways 21 and 20, respectively. The
ing only inwardly of said container and to a point adja
coupled or communicated vial 24 and container 10 are dis
posed in the position shown in FIG. 1, wherein container
10 is uppermost and positioned in a mouth-downward
condition. When such is the case, solution 23 flows out
terior of said container with the exterior of said- stopper,
an air tube mounted in one of said passages and extend
cent the bottom of said container, a vial containing a sup
plemental medicament for the container solution, a clo
sure secured to said vial, said closure being equipped with
a pair of spaced apart, outwardly extending tubular spouts
disposed in generally parallel relation, one of said spouts
27a into vial 24 to come in contact with the solid medica< 50 being of larger outer diameter than the other, the larger
ment container in vial 24. In FIG. 1, particles 32 of solid
outer diameter spout being in sealing engagement with
of container 10 through passage 21 and through ?tting
medicament contained within vial 24 are shown in a state
prior to solution or dispersion within solution 23. Mean
while, air from vial 24 is forced upwardly through ?tting
29 into air tube 22 and therefrom as shown by the arrows
the Walls of the passage of said stopper other than the
passage equipped with said air tube, the smaller diameter
spout being mounted in the air tube-equipped passage of
said stopper, and sealing means about said smaller diam
eter spout interposed between said spout and said stopper.
3. In combination with a parenteral solution container
closed with a resilient stopper having a liquid outlet pas
in FIG. 1 to replace the liquid solution withdrawn from
container 10. After a short period, all air is forced from
vial 24 and any solid medicament therein is dispersed or
dissolved in solution 23 entering vial 24. Thereafter, in
version of the coupled vial and bottle to the condition 60 sage and an air inlet passage equipped with an air tube,
a device for coupling engagement with said container
shown in FIG. 2 results in flow of liquid 31 from vial 24
a medicament-containing vial and a closure
as described above, the air entering vial 24- through ?tting
for said vial, said closure having a pair of parallel, spaced
27a and being shown in the form of bubbles 33.
apart, outwardly extending, tubular, puncturing spouts
From the foregoing, it is seen that the structure and
method of this invention permits the supplementation of
bulk parenteral solutions with a minimum of manipula
tion. All that is required is coupling of a medicament
containing vial to a parenteral solution bottle. This is
achieved by thrusting ?ttings 27a and 29 into passage
ways 21 and 20, respectively, when container 10 is posi
tioned mouth-downwardly, as seen in FIG. 1. Flow of
having passages extending therethrough, said spouts being
of unequal outside diameter, the outside diameter of the
larger of said spouts being about equal in size to the inside
diameter of said outlet passage and the outside diameter
of the smaller of said spouts being less than the inside
diameter of said air tube, said smaller spout being
equipped with an annular resilient sleeve extending along
the length therefo but, terminating a spaced distance from
the tip of said spout so that when said device is in cou
liquid out of container 10 is prevented by virtue of dia
phragm 19 closing passages 20 and 21. Alternatively, it
pling engagement with said parenteral solution container,
is possible to couple vial 24 to container 10 when the
latter is positioned as shown in FIG. 2, i.e., mouth-up 75 the spout of smaller outside diameter extends into said
air tube and the resilient annular sleeve cooperates with
said stopper to provide a contamination preventing seal.
Norman _____________ __ Sept. 30, 1952
Adams et a1 __________ -._ Sept. 21, 1954
Ryan _______________ .._ Mar. 22, 1955
References Cited in the ?le of this patent
Ban- _________________ __ Dec. 9, 1958
Shaw ---------------- -- May 5, 1959
France ______________ __ May 28, 1956
France ______________ .._ Apr. 16, 1950
Gillrnan _____________ __ Feb. 17, 1925
Mlllford et a1 --------- __ May 28, 1940
Rausch ______________ __ Jan. 1, 1952
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