U.S. patent number 3,788,369 [Application Number 05/149,321] was granted by the patent office on 1974-01-29 for apparatus for transferring liquid between a container and a flexible bag.
This patent grant is currently assigned to The Upjohn Company. Invention is credited to Fred M. Killinger.
United States Patent |
3,788,369 |
Killinger |
January 29, 1974 |
APPARATUS FOR TRANSFERRING LIQUID BETWEEN A CONTAINER AND A
FLEXIBLE BAG
Abstract
A resiliently flexible bag has a chamber with inlet and outlet
passageways, the outlet passageway being connectible to a tube and
the inlet passageway having perforable closure means. The chamber
is normally filled with a liquid, such as a saline solution. A
cannula is mounted upon a container for insertion through the
closure member and communication between the chamber in the bag and
the interior of the container. If the container holds a liquid,
intermittent, manual compressing and releasing of the flexible bag
causes the liquid within the bag to move into the container or the
liquid in the container to move into the bag, depending upon their
relative vertical positions. A special cannula and container
therefor are provided to furnish filtered air to the bag prior to
connection thereof with the container if such air is needed.
Inventors: |
Killinger; Fred M. (Portage,
MI) |
Assignee: |
The Upjohn Company (Kalamazoo,
MI)
|
Family
ID: |
22529750 |
Appl.
No.: |
05/149,321 |
Filed: |
June 2, 1971 |
Current U.S.
Class: |
141/114; 141/330;
604/408; 141/383; 604/414 |
Current CPC
Class: |
A61J
1/2089 (20130101); A61J 1/1475 (20130101); A61J
1/201 (20150501); A61J 1/2082 (20150501); A61J
1/10 (20130101); A61J 1/2017 (20150501); A61J
1/2075 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); A61J 1/05 (20060101); B65b
003/16 () |
Field of
Search: |
;141/329,382,330,383,311,384,313,317,10,18,17,68,19,21,23,24,114
;128/272 ;222/212,215 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Bell, Jr; Houston S.
Assistant Examiner: Schmidt; Frederick R.
Attorney, Agent or Firm: Woodhams, Blanchard & Flynn
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. An apparatus for transferring and mixing liquids,
comprising:
resiliently flexible bag means having a liquid holding chamber and
a pair of integral outlet means connected to one end of the
chamber;
closure means on said outlet means;
a liquid within said chamber substantially, but not entirely,
filling said chamber and said outlet means so that some air space
exists within said bag means;
rigid vial means having a transfer needle attached thereto and
adapted to communicate with the interior of said vial means, said
vial means being totally closed and at least partially filled with
a medicament adapted to be mixed with said liquid, said vial means
having a perforable closure structure at one end thereof; and
said vial means having a sleevelike support member fixedly secured
thereto and projecting outwardly from said one end of said vial
means in substantial alignment with the perforable closure
structure, and said needle being sharpened at both ends and being
at least partially disposed and slidably supported by said
sleevelike support member, one end of said needle being positioned
directly adjacent the perforable closure structure and being
insertable therethrough to communicate with the interior of said
vial means, the other end of said needle thereafter being
insertable through the closure means associated with one of the
outlet means of said bag means for permitting communication between
said chamber and said vial means; and
an actuator sleeve disposed in surrounding relationship to said
needle and having one end thereof fixedly connected to a center
portion of said needle, the other end of said actuator sleeve being
disposed in surrounding relationship to said sleeve-like support
member, and detent means coacting between said support member and
said sleeve for normally maintaining said sleeve and said needle in
a first position wherein the one end thereof is positioned closely
adjacent the perforable closure structure, said sleeve being
manually slidable from said first position toward said closure
structure for causing said one end of said needle to penetrate said
closure structure;
said bag means being manually collapsible for pumping liquid
between said rigid vial means and said bag means through said
outlet means and said needle, the flow of liquid being in a
downward direction, by alternately compressing and releasing said
bag means.
2. An apparatus according to claim 1, wherein said closure means
associated with one of said outlet means includes a self-closing
seal means adapted to be penetrated by the other end of said needle
for permitting communication between said bag means and said vial
means, said self-closing seal means being capable of automatically
closing and sealing to prevent leakage therethrough when the needle
is withdrawn therefrom so as to again close off said chamber.
3. An apparatus for transferring and mixing a liquid and a
medicament, comprising:
flexible bag means having a liquid holding chamber therein, and a
liquid within said chamber substantially, but not entirely, filling
said chamber so that some air space exists within said bag
means;
said bag means including first and second tubular portions fixedly
secured thereto and projecting outwardly from one side thereof,
said tubular portions communicating with said chamber for
permitting liquid to be supplied to or removed therefrom;
one of said tubular portions comprising an outlet spout adapted to
be connected to an intravenous tube, and means associated with the
free end of said outlet spout for normally maintaining same in a
closed condition;
said other tubular portion comprising an inlet spout, and closure
means associated with said inlet spout adjacent the free end
thereof for normally sealingly closing same, said closure means
including a sealing member fixedly and sealingly engaged with said
inlet spout adjacent the free end thereof and extending across the
passageway defined within the interior of said spout for closing
same, said sealing member being constructed of a resilient material
permitting penetration thereof by a needle so as to allow
communication with said chamber while the resilient material of
said sealing member automatically expands to close and seal the
aperture formed by the needle after the needle has been withdrawn
from the sealing member;
rigid vial means having a compartment therein which is at least
partially filled with a medicament adapted to be mixed with a
liquid, said vial means having a transfer needle mounted thereon
and adapted for communication with said compartment, the needle
being provided with a pointed end thereon remote from said
compartment and being insertable through the sealing member on said
inlet spout for providing communication between said compartment
and said chamber;
said vial means including a perforable resilient closure member at
one end thereof for totally closing and sealing said compartment,
said needle being pointed at the other end thereof, said other end
being normally disposed adjacent said perforable closure member for
penetrating same so as to permit said needle to communicate with
said compartment, and means mounted on said vial means adjacent
said one end thereof and disposed exteriorly of said perforable
closure member for slidably supporting said needle while
effectively preventing tilting of said needle so as to facilitate
penetration of said perforable closure member by said other end of
said needle; and
said bag means being manually collapsible for pumping liquid
between said vial means and said bag means through said inlet spout
and said needle, the flow of liquid between said compartment and
said chamber being caused by alternately compressing and releasing
said bag means.
4. An apparatus according to claim 3, wherein said inlet and outlet
spouts are disposed adjacent and in substantially parallel
relationship to one another and extend outwardly from one end of
said bag means, and said bag means being provided with means
associated with the other end thereof for permitting said bag means
to be suspended from a suitable holding device.
Description
BACKGROUND OF THE INVENTION
This invention relates in general to an apparatus for transferring
a liquid between a container and a flexible bag and/or mixing
liquids and, more particularly, to types thereof adapted for
placing additives in an infusion bag.
It is commonplace to feed or treat a medical patient by injecting
nutrients and/or medicaments in liquid form into a vein. It has
also been commonplace to use resiliently flexible containers, such
as plastic bags, to hold the liquid, such as a saline solution,
dextrose or glucose, to be injected into the vein of the patient.
Furthermore, it is well known in practice to add medicaments to the
liquid being injected into the patient's vein, thereby avoiding the
inconvenience and discomfort of independent injections of these
additives. However, it has been found necessary to package the
additives in airtight glass vials for a number of reasons. In the
first place, Federal regulations require the use of glass
containers for the storage of parenterals. These containers must be
air-tight for certain medicaments because of their relatively rapid
deterioration in the presence of ambient air. Also, the containers
must be capable of sterilization at temperatures which would damage
some plastics. Furthermore, certain of these additives will, over a
period of time, react with certain types of plastic containers,
whereas, they will not react with glass containers.
Glass syringes can be used as storage containers for some
additives, but not others because of air leakage, risk of
contamination and the short shelf life of certain medicaments after
they have been mixed with a diluent. Also, glass syringes are
expensive, difficult to fill and inconvenient to store.
The most convenient method for moving additives from a glass vial
to the flexible bag containing the liquid carrier is by means of a
cannula or transfer needle which is mounted or mountable upon the
additive vial. Usually the cannula must be moved relative to the
additive vial in order to effect communication between the cannula
and the interior of the vial. Otherwise, the airtight condition
within the container would be disturbed prior to use of the
additive therein.
Where the additive is a liquid, it has in the past been transferred
from the vial to the bag either by relying upon gravity, which
produces an exasperatingly slow flow, or by using a syringe to
remove the liquid from the vial and then injecting it into the bag.
However, where the additive is a dry material, it has heretofore
been necessary to first put the dry material into solution within
the vial and thereafter transfer the solution from the vial to the
flexible bag either by the process of gravity flow or by using a
syringe. Obviously, these procedures have produced inefficiency and
have risked the chance of producing unsterile conditions in both
the mixing and administration of the additives involved.
Accordingly, a primary object of this invention has been the
provision of an apparatus for quickly mixing an additive with a
liquid for intraveneous injection wherein the additive is contained
in a relatively rigid glass vial and, sometimes, in a dry form.
A further object of this invention has been the provision of a
method for transferring liquid between a resiliently flexible bag
and a relatively rigid glass vial interconnected by a transfer
needle wherein the vial, under some circumstances, contains a dry
material which must be dissolved, said method being adapted to use
some of the liquid within the flexible bag as the diluent after
which the method moves the solution from the vial into the flexible
bag.
A further object of the invention is the provision of a method and
apparatus, as aforesaid, whereby sterile air can be added to the
contents of the flexible bag prior to communication thereof with
the interior of the additive vial in order to facilitate the
transfer of liquid therebetween.
Other objects and purposes of this invention will become apparent
to persons familiar with this type of equipment upon reading the
following descriptive material and examining the accompanying
drawings, in which:
FIG. 1 is a broken front elevational view of a liquid transfer
apparatus embodying the invention.
FIG. 2 is a broken side elevational view of said apparatus.
FIG. 3 is a broken front elevational view of said apparatus showing
the bag in a compressed condition.
FIG. 4 is a broken front elevational view illustrating the
apparatus after the compressed bag is released.
FIG. 5 is a broken fragment of the front elevational view of said
apparatus in the inverted position.
FIG. 6 is a sectional view taken along the line VI--VI in FIG.
1.
FIG. 7 is a broken fragment of a front elevational view of said
apparatus illustrating a modified additive container.
FIG. 8 is a side elevational view of a transfer needle
container.
FIG. 9 is a sectional view taken along the line IX--IX in FIG.
8.
FIG. 10 is an enlarged broken fragment of FIG. 9 showing a modified
transfer needle and container.
For convenience in description, the terms "upper," "lower" and
words of similar import shall have reference to the apparatus of
the invention as appearing in FIGS. 1 and 2. The terms "inner,"
"outer" and derivatives thereof shall have reference to the
geometric center of said apparatus and the component parts
thereof.
SUMMARY OF THE INVENTION
The objects and purposes of the invention, including those set
forth above, have been met by providing a resiliently flexible and
liquid-tight bag having inlet and outlet spouts at the lower end
thereof. The outlet spout is connectibe to a tube for the purpose
of conducting liquid from the bag into a vein of a patient. The
inlet spout has a closure means which can be penetrated by a
transfer needle mounted upon a rigid glass vial holding a
medicament which must be added to the liquid contents of the bag.
The method concerns the movement of liquid from the rigid glass
container into the flexible bag by alternately squeezing and
releasing the bag in a pumping action, while holding the vial above
the bag.
The method also pertains to a situation where a dry material is
disposed within the vial and some of the liquid within the bag is
moved by said pumping action into the vial to dissolve the dry
material. The solution is then transferred from the vial into the
bag by the pumping action. A transfer needle and container therefor
including air filter means are used in the method for providing
additional sterile air in the flexible bag if necessary.
DETAILED DESCRIPTION
The liquid transfer apparatus 10, one preferred embodiment of which
is illustrated in FIG. 1, includes a resiliently flexible bag or
receptacle 11 which, in this particular instance, is fabricated
from two sheets 12 and 13 of plastic material, which sheets are
firmly secured to each other along corresponding edges thereof to
form a chamber 14 and flange 16 which extends completely around the
bag. Cylindrical inlet and outlet spouts 17 and 18, respectively,
are integral with the front and rear sheets 12 and 13 and
communicate with the chamber at the lower end thereof. The outlet
spout 18 is initially covered with a cap 19, and the bag is filled
with a liquid 22 such a saline solution, glucose or the like. The
cap 19 can be removed and replaced by a tube 23 (FIG. 4) for the
purpose of transferring the liquid 22 from the bag 11 into the vein
of a patient in a conventional manner.
The inlet spout 17 (FIG. 1) is closed by a membrane 24 (FIG. 6)
spaced upwardly from the lower end thereof and by a removable
closure member 26 which covers the lower end of the spout 17. Both
the membrane 24 and the lower wall 27 of the closure member 26 are
penetrable by a cannula or transfer needle 28 mounted upon the vial
29.
The bag 11 may be fabricated from a variety of plastic materials,
such as polyethylene, polypropylene or polyvinyl-chloride, and the
flange 16 thereon is provided with a plurality of openings 32 near
the upper and lower ends thereof for suspending the apparatus 10 or
the bag 11 by means of hooks 33, FIGS. 1 and 2.
The vial 29 (FIG. 1) is comprised of a glass bottle 34 (FIG. 6)
with a perforable rubber seal or stopper 36, which may be made from
natural or synthetic materials, inserted in or extending across the
open upper end of the neck 37 on said bottle 34. The seal 36 is
held in position by a metal collar 38 which is spun on or otherwise
secured to the neck 37. The collar 38 has an upper wall 39 with a
central opening 42 through which a cylindrical stem 43 extends.
Said stem 43 has an integral outwardly projecting and annular
flange 44 that is clamped between the wall 39 and the seal 36 (FIG.
6). These two parts can also be made in one piece.
The needle 28 may be of the substantially conventional transfer
type having points at both ends and being rigidly engaged
approximately midway between the ends thereof by a substantially
cylindrical hub 46. A sleeve 47 is firmly secured at one end upon
the hub 46 and extends downwardly therefrom concentrically with the
needle 28. The lower end of the sleeve 47 has an outwardly
extending, annular flange 48 which is spaced upwardly from the
lower end of the needle. The sleeve 47 is slideably but snugly
supported upon the stem 43 when the lower end of the needle 28 is
disposed within the stem 43 but spaced upwardly from seal 36. When
it is desired to effect communication between the needle 28 and the
interior 49 of the bottle 34, said bottle and the sleeve 47 are
relatively moved from their FIG. 1 positions to their FIG. 3
positions wherein the lower end of the needle 28 pierces the seal
36 and extends into the interior 49.
In this particular embodiment of the invention, the vial 29
contains a dry material, such as a freeze-dried medicament, which
must be mixed with a diluent. The liquid solution is then added to
the liquid in the chamber 14 for injection into the vein of the
patient. However, it will be apparent that the apparatus and method
of the invention can and will be used where the material within the
vial 29 is initially a liquid.
FIG. 7 illustrates an alternate apparatus 60 including a bag 11 and
vial 61 which are interconnectible by a transfer needle 62 having a
hub 63. The vial 61, which may be similar to the vial disclosed in
U.S. Pat. No. 3,464,414, has two compartments 68 and 72 separated
by a constriction 66 in which a plug 67 is removably disposed. The
plug 67 is forced out of the constriction and into the lower
compartment 68 by pressure applied to the stopper 69 as it is moved
from a raised position into its lowered position appearing in FIG.
7.
Normally, a dry material, such as a freeze-dried medicament, is
disposed within the lower compartment 68 and, after the plug 67 is
placed in the constriction 66, a diluent is placed in the upper
compartment 72. Thereafter, the stopper 69 and collar 73 are
mounted on the bottle 64.
The bag 11 may be closed, after it is initially filled with a
liquid, so that there is insufficient air therein to be removed and
replaced by the liquid solution 74 in vial 61. It will be noted
that, in the alternate apparatus 60, no liquid is required from the
bag to be mixed with the liquid in the vial 61. Accordingly, it may
be desirable to increase the amount of air in the bag 11 in order
to facilitate the pumping action by which such air is moved into
the vial 61 in order to displace the liquid 74 therefrom.
Nevertheless, it is also desirable that the air which is placed in
the bag 11 should be sterile. This result is achieved by means of
the structure disclosed in FIGS. 8 and 9 or the structure disclosed
in FIG. 10.
Specifically, the transfer needle 62 (FIG. 9) is placed in a two
part cylindrical container 76 having upper and lower cup-shaped
parts 77 and 78, respectively, the open ends of which are
telescopically engaged. The upper wall 79 of the upper cup 77 is
comprised of a filter 82 through which ambient air can pass, but
which blocks contaminants in said air. Thus, after removing the
lower cup 78, the lower end 83 of the needle 62 (FIG. 9) is
inserted through the closure member 26, as shown in FIG. 7, so that
ambient air can pass through the filter 82 into the chamber 84
within the upper part 77 thence through the needle 62 and into the
bag 11. Ordinarily, the bag 11 will be in its FIG. 5 position
during this operation so that no liquid will escape from the
bag.
After the desired amount of air has been released into the bag 11,
the upper part 77 (FIG. 9) of the container 76 is removed from the
needle and its upper end is inserted into and through the stopper
69 (FIG. 7) of the vial 61, for example. The transfer of liquid
from the vial 61 into the bag 11 can then proceed as discussed
above with respect to vial 29.
Under some circumstances, there may be insufficient room in the bag
to add additional air. In such case the upper part 77 may be
removed from the needle 62 and some of the liquid within the bag 11
urged out through the needle by squeezing the bag. Then, before
releasing the pressure on the bag, the upper part 77 is returned to
the needle so that the air, thereafter drawn into the bag to
replace the discharged liquid, is filtered and sterile.
In another version of the invention, the transfer needle 62 is
replaced by a transfer needle 90 (FIG. 10) in which the hub 91
thereof also comprises the filter element. That is, the hub 91 is
provided with a plurality of small lengthwise bores 92 which act as
filter passageways through which air can pass, but which block
contaminants. Thus, after the lower part 93 of the container 94 is
removed from the upper part 96 thereof, ambient air can pass
upwardly through the bores 92 into the chamber 97 and thence
downwardly through the needle 90 and into the bag 11.
OPERATION
The operation of the apparatus 10, as well as the manner in which
the method is carried out by means of the disclosed apparatus, will
be apparent to persons skilled in this art from the aforegoing
description. However, for convenience, they are specifically
discussed hereinafter.
In operation, where the additive in the vial 29 is initially in
liquid form and there is sufficient air space in the bag 11 for
such liquid, the needle 28 (FIG. 6) is inserted into and through
the lower wall 27 of the closure member 26 with the bag 11 in its
inverted position of FIG. 5. The bag is then manually squeezed and
released intermittently with a pumping action whereby air is first
forced upwardly into the vial 29 and liquid is thereafter urged
downwardly into the bag until all of the liquid in the vial 29 has
been transferred into the bag 11.
If there is insufficient air in the bag 11, the transfer needle 62
or the transfer needle 90, with its corresponding container upper
part 77 and 96, respectively, is utilized to increase the amount of
sterile air. Where a vial 29 is to be used, which has its own
needle, the transfer needle 62 or 90 is then removed from the
closure member 26 and the needle 28 is inserted through said
closure member in its place.
Where the vial is furnished with a non-liquid additive which must
be dissolved in the liquid contained in the bag, then the needle 28
is urged downwardly relative to the bottle 34 until the needle
penetrates the seal 36 and communicates with the interior 49 of the
bottle 34. The needle 28 of the vial 29 containing the dry material
is then inserted upwardly, as shown in FIG. 1, through the lower
wall 27 of the closure member 26 and through the membrane 24 so
that it is in communication with the chamber 14. These penetrations
by the needle 28 can be reversed, if desired. The bag 11 is then
squeezed or compressed, as appearing in FIG. 3, so that some of the
liquid therein moves downwardly through the needle 28 into the
bottle 34. When the pressure on the bag is released, the air
compressed within the bottle 34 bubbles up through the liquid in
the bag 11, as appearing in FIG. 4. The bottle 34, containing the
dry material plus some of the liquid from the bag 11, is now
agitated, as by shaking, until the dry material is dissolved in the
portion of the liquid which has been forced into the bottle 34
through the needle 28.
After the solution in the glass bottle 34 is completed, the
apparatus 10 is inverted, as appearing in FIG. 5, and the alternate
compression and release of the bag 11 is repeated until all of the
liquid has been forced out of the bottle 34 and down through the
needle 28 into the bag 11. This is accomplished by virtue of the
fact that the air at the upper end of the bag is forced upwardly
into the bottle 34 during the compression of the bag and the
pressure of the air in the bottle is elevated somewhat. Thus, when
the bag is released, the compressed air forces the liquid down
through the needle into the bag.
The closure member 26 and the membrane 24 are designed so that they
will automatically close, after the needle 28 is removed, and
provide a leak proof seal to prevent accidental discharge of the
liquid through the inlet spout under normal operating conditions.
That is, the force of gravity will not be sufficient to produce a
leak of the liquid 22 through the inlet spout 17.
The vial 61 (FIG. 7) requires some preparation before use in that
the dry material must be mixed with the diluent to produce the
liquid 74. This procedure is well known. Thereafter, the transfer
needle 62 or the transfer needle 90 is caused to penetrate the
closure member 26 and the membrane 24 and the operation of the vial
61 with the bag 11 will be substantially the same as discussed
above with respect to a vial 29 containing a liquid additive. The
apparatus disclosed herein is capable of performing the method
claimed hereinafter. However, it will be readily recognized that
other specific types of apparatus can be utilized to carry out the
claimed method.
Accordingly, although particular preferred embodiments of the
invention have been disclosed above in detail for illustrative
purposes, it will be recognized that variations or modifications of
the disclosed structures, including the rearrangement of parts, lie
within the scope of the present invention.
* * * * *