Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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The present application relates to additive transfer
units for storing a fixed volume of a liquid medicament and for
transferring the medicament into an evacuated container.
Bottles of parenteral solution are typically shipped to
the administering institution, such as a hospital, in bulk
quantity. For efficiency in production, transfer and storage of
such bottles, the chemical composition of the parenteral solution
is uniform, bottle to bottle, and is not subject to degradation
or contamination solely on account of the age of the solution.
However, the chemical composition of the solution administered to
the end user, such as a patient, must be tailored according to
the individual needs of the user. For example, a patient to be
administered a standard intravenous solution, such as distilled
water with five percent (5~) glucose, may require a quantity of
vitamins, minerals, serums, such as sodium pentothal, or other
drugs to be added to the parenteral solution for concurrent
intravenous administration.
Medicinal additives have a tendency to degrade over a
period of time and, therefore, are preferably added to the
intravenous solution just prior to administration to a patient.
The additives are typically packaged in five milliliter glass
vials provided with a closure having a removable top portion and
a hollow spike having both ends sharpened. After removal of the
top portion and upon the application of force against the rubber
diaphragm of the parenteral solution container, one end of the
spike penetrates the container while the other end of the spike
substantially simultaneously penetrates a puncturable seal
provided on the vial. A vacuum maintained in the parenteral
solution container pulls the additive solution therein through
the hollow passageway provided in the spike.
The assembly of the closure system for the vials of
the prior art is complex. Initially, all of the closure
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components are usually preassembled before the closure is mounted
onto the container. In such preassembly, a double-edged, hollow
spike, provided with an outwardly projecting rim, auxiliary core
slides and the like, is inserted into a rubber stopper until the
rim locks into a groove provided in the stopper. The rubber
stopper is closed at the end opposite the exposed spike. A first
ferrule, designed to hold the stopper onto the vial, is placed
over the exposed spike and against a ledge provided on the rubber
stopper. A removable overcap is placed over the exposed spike
and fits tightly against the rubber stopper. A second metal
ferrule, which is removable and is designed to hold the overcap
onto the vial, is placed over the overcap and over the first
ferrule. The preassembled closure is placed over the mouth of a
vial and both ferrules are simultaneously constricted under the
bead at the mouth of the vial in one rolling operation.
After the closure and vial are assembled, the
assembly must be sterilized. The most common method of ster-
ilization is by exposing the parts to a pressurized steam atmos-
phere at a temperature of about 250F (120C). The cavity
surrounding the spike in the closure of the prior art is air
tight. In order to insure that steam will be present in such
cavity during heating and pressurization, it is necessary to
assemble the closure parts in a w0t condition. Manual wet
assembly is a complicated process. The assembly of such closure
systems typically adds significantly to the overall cost of the
additive vial.
The vials of the prior art are typically provided with
an overcap which is removable by a multiple step process. For
example, it is common to have a tear-off ring provided on the top
of the vial which must be pulled to sever the ring and thereby
render the ring removable. Thereafter, the ring is pulled or
unwrapped from the vial to free the removable overcap. The
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overcap may then be lifted from the vial in order to gain access
to the spike.
Upon removal of the overcap from the vials of the prior
art, the spike or needle is exposed. Such exposure may cause
contamination from the atmosphere.
A significant technical weakness of the vials of the
prior art is that during penetration of the spike of the vial
into the parenteral solution container, air may be drawn into the
parenteral solution. Such air is drawn by the vacuum maintained
in the parenteral solution container at locations around the
spike, which are characterized by uneven spike penetration.
Accordingly, an improved additive vial is desired which
is characterized by relatively simple, yet efficient, construc-
tion, assembly and operation. In particular, such improved
additive vial should consist of relatively few parts, will have a
compact construction and should prevent leakage and minimize
contamination during transfer of its contents to an evacuated
parenteral solution container.
This invention may be summarized as providing an
improved additive transfer unit for transferring liquid medica-
ment into an evacuated container. Such transfer unit or vial
comprises a liquid medicament storage container having a neck
terminating at a generally flat-rimmed bead defining a mouth
opening in the container. Closing the mouth of the container is
a rigid disc, having a hollow, generally cylindrical piercing
member extending axially outwardly from a central location of the
disc and terminating in a needle point. An elastic sealing means
is provided around and contiguous an outer portion of the con-
tainer rim. The sealing means also overlies an outer peripheral
portion of the exterior surface of the disc. A penetrable tip
provides a seal over the needle point of the piercing member, and
a removable, outwardly projecting cylindrical portion of a metal
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closure extends over and around the tip covering the needle
point. The metal closure also includes an annular rim at least
partially overlying an outer peripheral portion of the disc and
the sealing means, and a depending skirt extending downwardly
from the annular rim with its lower portion turned inwardly under
and against the container bead to constrict the sealing means and
the disc toward the rim, effectuating a seal about the rim of the
container.
The disc includes a generally cylindrical hub spaced
radially outwardly of the piercing member and abutting against
the elastic sealing means to stabilize the sealing means against
the metal closure.
In a preferred embodiment, a circular portion of the
annular rim on the metal closure is indented into the sealing
means toward the disc around the circumference of the annular
rim, thereby maintaining a seal about the rim of the container.
In a particularly preferred embodiment, the protective
tip over the needle point on the piercing member is impervious to
liquids but deflects radially outwardly of the piercing member in
response to a positive pressure differential of at least about 20
pounds per square inch in the interior of the container. Gas
thereby passes from the interior of the container, through a
passageway in the piercing member to the exterior of the con-
tainer.
A principal advantage of the present invention is the
provision of an additive transfer unit having a container sealed
by a rigid disc and an elastic sealing means, cooperating with
one another to provide a seal over the rim of the container.
A further advantage of the present invention is to
provide an improved additive transfer unit wherein the interior
and exterior surfaces of a needle may be steam sterilized after
assembly without the necessity of adding water to the assembled
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components of the unit.
Among other advantages of the present invention is the
provision of a new and improved compact additive transfer unit
having relatively few parts so that the unit is easily assembled
at low cost.
An additional advantage of the present invention is
the provision of an improved additive transfer unit which maxi-
mizes sterility during transfer of a medicament into a bottle of
parenteral solution by preventing air from being drawn into the
bottle around the needle during transfer.
The above and other objects and advantages of the
present invention will be more thoroughly understood and appre-
ciated with reference to the following description of a preferred
embodiment, read in conjunction with the drawings.
Figure 1 is a front elevational view of an additive
transfer unit of the present invention.
Figure 2 is a fragmentary cross-sectional view taken
along the lines 2-2 of Figure 1.
Figure 3 is an enlarged, fragmentary cross-sectional
view of an upper portion of a second embodiment of a transfer
unit of the invention.
Figure 4 is a cross-sectional view of a needle of the
additive transfer unit shown in Figure 2.
Figure 5 is a top elevational view of the needle shown
in Figure 3.
Figure 6 is a cross-sectional view of an additive
transfer unit of the present invention showing a needle inserted
through a stopper of a bottle of parenteral solution.
~ eferring to the drawings, Figures 1 and 2 illustrate a
preferred additive transfer unit or vial of the invention. The
unit shown in Figures 1 and 2 includes a liquid storage container
10 for holding a medicament 12 to be transferred. The storage
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container 10 has a neck or neck portion 14 which terminates in a
bead 16. The bead 16 is preferably provided with a generally
planar rim 18, and the inside dimension of the rim defines the
circumference of a mouth opening 20 in the container 10.
The li~uid storage container 10 is preferably con-
structed of glass for sterility purposes, but it may also be
constructed of plastic, metal or any other material that will
support the closure system 22 described below. It will be
understood that the container 10 may also be constructed of a
flexible material which may aid in manual transfer of its con-
tents by compression of its sidewalls in instances where the
receiving container is not sufficiently evacuated to receive such
contents without external aid. Typically, transfer units are
sized to hold enough liquid medicament to efficiently transfer
five milliliters. It will be understood that units of any size
are comprehended by the present invention, and that the con-
tainers 10 are typically overfilled to compensate for product
remaining after the desired amount has been transferred. Also, a
relatively large head space of air is required to be maintained
in the filled container 10 to insure that adequate air is avail-
able to force the contents of the container 10 into an evacuated
parenteral solution container.
Typical additive solutions include sodium bicarbonate,
antibiotics, anticoagulants and a variety of vitamins and min-
erals.
Referring again to Figures 1 and 2, a disc 24 of rigid
material, such as plastic, closes the mouth 20 of the container
10. A peripheral portion 26 of the disc 24 overlies at least a
portion and preferably one-third of the rim 18 of the container
10. A portion of the inner surface 28 of the disc 24 may also
fit into the mouth of the container 10. In a preferred embodi-
ment, the disc 24 is in contact with the inner circumferential
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portion of the rim 18 of the container 10.
A generally cylindrical, rigid, piercing member or
shaft 30 extends from a central location of the disc 24 in a
direction axially outwardly of the mouth 20 of the container 10,
terminating in a needle point 31. The piercing member 30 must be
sufficiently rigid to withstand insertion through a sealing
member, such as a rubber seal closing the mouth of an intravenous
bottle or the like, without bending or breaking. Plastic has
been found to be the preferred material for the piercing member
30 and the disc 24. Though not required, it has also been found
that the disc 24 and piercing member 30 should be cast integrally
as a one-piece construction.
In the transfer unit of the present invention, an
aperture 32 extends from the needle point 31 generally through a
longitudinal axis of the piercing member 30 and continues through
the disc 24 along such axis to define a passageway from the
interior to the exterior of the container 10.
A portion of an elastic sealing member 34 is provided
around and contiguous an outside diameter of the disc 24 to
assist in providing an air-tight seal for the unit. A portion of
the sealing member 34 preferably overlies at least an outer
peripheral portion of the rim 18 of the container 10. Further,
the sealing member 34 preferably overlies an outer peripheral
portion 26 of the disc 24 along an exterior surface 36 of the
disc 24. It should be understood that the disc 24 has an exte-
rior surface 36 and an interior surface 28 with respect to the
container 10.
The needle point 31 of the piercing member 30 is
covered with a protective tip 40. The tip 40 is preferably
elastic and, in the embodiment illustrated in Figure 2, is fit
tightly over all of the slots 64 provided in the needle point 31
in order to isolate the passageway 32 therethrough and to provide
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an hermetic seal for the container 10 under normal conditions.
The protective tip 40 must be readily penetrable by the needle
point 31.
In a preferred embodiment, as illustrated in Figure 2,
the protective tip 40 should be so flexible that a bottom portion
41 of the tip 40 would deflect in a direction radially outwardly
of the slots 64 in the needle point 31 in response to a positive
pressure differential of approximately 20 to 30 pounds per square
inch (137.9 to 206.8 kilopascals) inside the container 10. This
feature permits dry assembly of the transfer unit, yet assures
steam sterilization of a cavity 80 surrounding the piercing
member 30. By heating the assembled unit, a portion of the
solution vaporizes and creates a pressure inside the container 10
greater than the pressure in the cavity 80. When such pressure
differential reaches at least about 20 pounds per square inch,
the pressurized vapor in the container 10 vents into the cavity
80 through a small passageway 43, shown in Figure 3, created
under the protective tip 40. During such venting, a small
quantity of vapor will pass into the cavity adequate to effec-
tuate steam sterilization of the cavity 80. Such embodimenteliminates the necessity of wet assembly of the closure parts.
A preferred construction for the protective tip 40 is
illustrated in Figure 3. Preferably the upper portion 45 of the
tip 40 has a generally planar top surface 47 and is preferably
provided with an upwardly projecting peripheral ring-shaped
projection 51. As explained below, such ring-type construction
insures that a seal is maintained around the needle 30 as the
;; container contents are being transferred into a parenteral
solution container. The needle point 31 of the piercing member
30 may have any construction. A preferred needle construction is
shown in Figures 4 and 5. The preferred needle point 31 is
generally pyramid shaped having four equally spaced sharp corners.
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It will be understood that three, five or six corners may also be
provided by similar or equivalent design. In the pyramid-shaped
needle 30 shown in Figures 4 and 5, the point 31 is located
centrally of the shaft 30. The passageway 32, therefore, extends
through a longitudinal axis of the piercing member 30 to a
location near the point 31 and a plurality of slots 64, pref-
erably two oppositely disposed slots 64, are provided in the
sharpened walls defining point 31 to provide gaseous communica-
tion with the exterior of the container 10.
The tip 40 covering the needle point 31 should extend
completely over the slots 64, as illustrated in Figures 2 and 3.
Upon penetration of the needle 30 into the elastic tip 40 and
into a penetrable seal on a parenteral solution bottle, the four
sharp corners create a high tear stress along their respective
edges causing the penetrable material to tear substantially
uniformly. Thus, rather than having one large, non-uniform tear,
four small, controlled tears result in forming a substantially
even X-shape in the target area of the penetrable material.
A metal closure 22, preferably constructed of aluminum,
is provided over the disc 24, the piercing member 30 and the
sealing member 34 to hold the parts in place and to protect the
piercing member 30. The closure 22 has an outwardly projecting
cylindrical portion 42 extending over and around the piercing
member 30. This outwardly projecting cylindrical portion 42 is
manually removable and also serves as a tamper-proof seal. At
the base of the cylindrical portion 42 is an annular rim 44
overlying an outer peripheral portion of the disc 24 and the
sealing member 34. A depending skirt 46 extends downwardly from
the annular rim 44 of the closure. A lower portion 46a of the
skirt 46 is turned inwardly under and against the container bead
16 around the periphery of the container mouth 20. Such inward
deformation of the closure skirt 46 constricts the elastic
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sealing member 34 and the disc 24 toward the rim 18 of the
container 10. Inward deformation of the closure skirt 46 under
the bead 16 in combination with a seal 49 at the base of the top
portion 42 effectuates an hermetic seal about the rim 18 of the
container 10.
Referring now to Figures 2 and 4, the disc 24 includes
a generally cylindrical hub 50 extending axially outwardly from
the upper portion thereof. The hub is spaced radially outwardly
a short distance from the piercing member 30 and includes a
radially outwardly facing outer surface portion 51 abutting
against an inner peripheral portion of the elastic sealing means
34. Such abutment between the hub 50 and sealing means 34
stabilizes the sealing means 34 and cylindrical portion 42 in
sealing relationship with one another.
In a preferred embodiment, a circular portion 48 of
the annular rim 44, which overlies the outer peripheral portion
26 of the disc 24 and the sealing member 34, is indented toward
the sealing member 34 and disc 24, thereby providing a seal 49
beginning at the indentation 48 and extending outwardly and
downwardly along the annular rim 44 and closure skirt 46 to the
rim 18 of the container. Such seal is maintained around the
circumference of the rim 44. This indenting action also assists
in constricting the elastic sealing member 34 and the disc 24
toward the rim 18 of the container 10, and thereby assists in
maintaining the hermetic seal. Tests have shown that the seal
about the rim 18 is maintained without leakage at pressures in
excess of 60 pounds per square inch (413.7 kilopascals). Such
excessive pressures should never be experienced in routine
practice. One mode for rendering the outwardly projecting
cylindrical portion 42 removable is to provide a circular score
or scoreline 55 around the circumference of the rim 44 of the
closure 22. Such score 55 is preferably provided through at
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least 50~ of the metal thickness to permit manual removal of the
cylindrical portion 42. Even though the score 55 penetrates
through the metal of the indentation 48, an air-tight seal is
still maintained between the cylindrical portion 42 and sealing
means 34. The hub 50 stabilizes the sealing means 34 against the
cylindrical portion 42 after the indentation 48 and score 55 are
formed, thereby preventing passage of air until the cylindrical
portion 42 is removed.
In a preferred embodiment, the exterior surface 36 of
the disc 24 is provided with a recess 66 about the piercing
member 30. As shown in Figures 2 and 4, the recess 66 is pref-
erably ring shaped and is centrally provided substantially
concentric with the piercing member 30. The recess 66 provides
room within which the elastic tip 40 may be compressed as the
piercing member 30 is inserted into the stopper of an intravenous
container or the like. Providing such recess 66 insures that the
piercing member may be inserted into a bottle of parenteral
solution at a maximum depth with minimum interference from
displacement of the elastic tip 40 as it slides downwardly of the
piercing shaft 30 during insertion.
Additive vials of the prior art typically had to be
manually assembled wet under clean conditions in a sterile
environment. Moisture trapped between the parts would vaporize
and thereby sterilize the vial cavities when an entire package
was pasteurized. Such expensive steps are eliminated by the
present invention.
The cavity 80 between the outside of the needle and the
inside of the cylindrical portion 42 of the closure 22 may be
sterilized by steam vapor. In utilizing the transfer unit of the
present invention, such steam vapor is able to vent from under
the elastic tip 40. Such venting is possible because the vapor
pressure inside the container 10 at temperatures experienced
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during the retort cycle is greater than pressure in the cavity 80
outside the piercing member 30. Such simplification in steri-
lizing methods has a unique, economical advantage over wet
assembly used in vials of the prior art.
In operation of the transfer unit of the present
invention, the outwardly projecting cylindrical portion 42 is
manually removed. Removal of the cylindrical portion 42 may be
readily accomplished by pushing laterally against the cylindrical
portion 42 with the thumb or forefinger or both, causing the
closure to fracture adjacent the annular rim 44. A subsequent
pulling or twisting action against the cylindrical portion 42
completely separates that portion 42 from the unit.
After the cylindrical portion 42 has been removed, the
elastic tip 40 protects from at~ospheric contamination the
contents of the unit. The elastic tip 40 provides protection by
covering the needle point 31 and thereby seals off the passageway
through the piercing member 30.
To transfer a liquid medicament 12 from the transfer
unit to a bottle of intravenous solution or the like, the unit is
inverted and the covered point 31 of the piercing member 30 is
directed against a penetrable portion of the receiving container.
As shown in Figure 6, the unit is pushed against a penetrable
rubber stopper 70 provided over the mouth of the bottle 72 of
parenteral solution 74. As the inverted vial is moved toward the
stopper 70, the outer peripheral ring 51 on the upper portion 45
of the elastic sealing member 40 contacts the outside surface of
the rubber stopper 70. As the unit is moved further, the point
31 of the piercing member 30 penetrates the elastic sealing
member 40. The ring 51 seals against the receiving container and
assists in preventing air from entering the receiving container
from around the needle 31 during insertion. The unit is pushed
into the stopper 70 until the annular rim 44 of the closure 22
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approaches the exterior surface of the stopper 70 insuring that
the passageway extends into the interior of the bottle 72 of
solution 74. During insertion of the piercing member 30 through
the stopper 70, the elastic sealing member 40 is displaced along
the shaft 30 and eventually is compressed into the recess 66
provided in the disc 24 so as not to interfere with penetration
of the needle point 31.
Typically, a vacuum exists in the bottle 72 sufficient
to create a pressure differential between the containers. Such
pressure differential causes the more positive pressure gas in
the vial to respond in an attempt to overcome the vacuum and
thereby force the liquid medicament 12 in the vial through the
passageway 32. As mentioned above, however, flexible sidewalls
may be provided that are manually compressible to assist in such
transfer.
The stopper 70 is typically constructed of suitable
resilient material that automatically reseals the interior of the
bottle 72 from the atmosphere as the piercing member 30 is
retracted therefrom. After the additive transfer unit has been
used, it is typically discarded.
Various modifications may be made in the invention
without departing from the spirit thereof or the scope of the
claims, and, therefore, the exact form shown is to be taken as
illustrative only and not in a limiting sense, and it is desired
that only such limitations shall be placed thereon as are imposed
by the prior art or are specifically set forth in the appended
claims.
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