Note: Descriptions are shown in the official language in which they were submitted.
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EASY LINKING DEVICE WITH
RETRACTABLE PROTECTOR
FIELD OF THE INVENTION
The present invention relates to a transfer system and more particularly,
relates to an
assembly for transferring one or more components of a pharmaceutical
composition between
containers.
BACKGROUND OF THE INVENTION
Typically, a syringe is filled manually by aspirating a liquid pharmaceutical
component from a pharmaceutical vial which traditionally has a penetrable
closure. The
syringe has a needle that penetrates the penetrable closure following which
the syringe is
typically filled by drawing air into the body of the syringe, aligning the
needle with the vial's
penetrable closure and inserting the needle through the penetrable closure
into the vial.
Subsequently, the vial is inverted and air is forced from the body of the
syringe into the vial.
The plunger is then withdrawn to draw out the desired volume of the
pharmaceutical
component into the syringe and the needle is removed from the vial.
Many pharmaceutical preparations must be distributed and sold as two or more
separate components - typically a solid component and a liquid component. They
are
mixed just prior to administration. In some instances, the two or more
components may each
be liquid and require mixing prior to administration to the patient.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an assembly for
transferring the
contents of a first container to a second container.
In a large number of cases, the transfer device of the present invention
provides for
the easy linking of a vial and a syringe whereby the components may be mixed
to form a
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composition in the syringe ready for patient injection.
The contents of the vial may be any suitable pharmaceutical component though
in
many instances, it will be a dry pharmaceutical component such as a
lyophilized product.
However, as previously mentioned, it could also be a liquid component.
The syringe will normally contain a liquid component which is frequently a
diluent for
the active pharmaceutical ingredient in the vial. The syringe may be any
conventional
syringe readily available from different manufacturers. Typically, the syringe
will contain a
piston and have a vac stop or finger flange attached to one end thereof. A
plunger rod will
be attachable to the piston of the syringe.
One problem with known transfer devices is that access to the needle or
plastic spike
within the transfer device should be minimized to prevent accidental pricks.
Once such
transfer device is shown in International Application PCT/CA2010/001399, the
teachings of
which are incorporated herein by reference. In the transfer device, a cap is
provided to
permit access to the syringe side of the device and the luer connection cannot
be accessed
until the cap is removed. However, the cap can only be removed when the device
is coupled
to the vial.
On some occasions, it is deemed desirable to re-use the transfer device. With
the
aforementioned transfer device, this was not possible as the vial remains
secured to the
transfer device and both are disposed of as a unit.
BRIEF DESCRIPTION OF THE DRAWINGS
Having thus generally described the invention, reference will be made to the
accompanying drawings illustrating an embodiment thereof, in which:
Figure 1 is a side elevational view of a transfer device according to the
present
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invention;
Figure 2 is a side elevational view, partially in section, of a vial
containing a
medicant;
Figure 3 is a side elevational view of a syringe and plunger rod;
Figure 4 is a cross sectional view of the transfer device prior to its use;
Figure 5A is a side elevational view of the device being placed on a vial;
Figure 5B is a side elevational view thereof;
Figure 6A is a side elevational view showing displacement of the cap;
Figure 6B is a cross sectional view illustrating the cap being ejected;
Figure 7 is a view, partially in cross section, of a syringe being attached to
the transfer
device;
Figure 8 is a view similar to Figure 7A illustrating the mixing of components;
Figure 9 is a view, partially in section, illustrating the aspiration of the
mixture into
the syringe;
Figure 10 is an exploded view, partially in cutaway, of the components of the
transfer
device;
Figure 11 is a cross sectional view illustrating placement of the transfer
device on the
top of a vial, this view being rotated 90 from the view of Figure 5B;
Figure 12 is a cross sectional view similar to Figure 11 illustrating the
piercing of the
septum of the vial and commencement of the removal of the cap;
Figure 13 is a cross sectional view similar to Figures 11 and 12 illustrating
removal of
the cap.
Figure 14 illustrates a further embodiment wherein the piercing member is a
spike;
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Figure 15 illustrates a variation thereof wherein the spike has a vent formed
therein;
Figure 16 illustrates a modified inner body member;
Figure 17 is a cross sectional view thereof;
Figures 18A to 18J illustrate sequential operation of a transfer device
according to an
embodiment of the present invention; and
Figures 19A to 19H illustrate the operation of a further embodiment of a
transfer
device.
DETAILED DESCRIPTION OF THE INVENTION
Referring to the drawings in greater detail and by reference characters
thereto, there is
illustrated a transfer system which is generally designated by reference
numeral 10 and
which is suitable for use with a vial generally designated by reference
numeral 12.
Vial 12 has a body 14 with a neck sealed by a septum 16 over which there is a
cap 18.
A medicant 20 is provided in body 14 and would typically comprise a dry
ingredient
although a fluid may also be utilized.
Transfer system 10 includes an outer housing 24 having finger grip depressions
25 on
opposed sides. An inner body 26 is connected to outer housing 24 by means of a
lower
horizontal wall 30 which extends between housing 24 and inner body 26. Lower
horizontal
wall 30 is not continuous, but rather is arranged so that there are a pair of
opposed openings
or channels 29 which extend through lower horizontal wall 30. Inner body 26 is
also
provided with a luer connector 28 at an upper portion thereof.
Extending downwardly from lower horizontal wall 30 are a pair of legs 32 each
of
which has a lower tapered end 34. A latch 36 is also provided on legs 32 for
reasons which
will be come apparent hereinbelow. Formed on an inner face of each latch 36 is
a recess 37.
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Transfer system 10 also includes a plurality of ribs 38 on the inner side of
housing 24
which define channels 29.
A pusher element 44 has a base 46 and a pair of upwardly extending legs 48. A
lower
portion of upwardly extending legs 48 has an inwardly extending element 50
which
preferably terminates in a cruciform configuration 51.
Transfer system 10 also includes a cover 54 which has a top wall 56 and a pair
of
downwardly extending side walls 58. A pair of slots 60 separate side walls 58
to provide a
desired flexibility. On the outside of each side wall 58 there is provided a
rib 62. Top
wall 56 of cover 54 includes a slight overhang 64.
Transfer system 10 further includes a needle 66 having a piercing tip 68
retained in
inner body 26. Needle 66 may be replaced by a spike.
In operation, transfer system 10 is placed on top of vial 12 as shown in
Figures 5A
and 11 with a finger or thumb engaging depression 25. Transfer system 10 is
then moved
downwardly as shown in Figures 6B, 12 and 13. In moving upwardly, the lower
tapered
ends 34 of legs 32 engage the cap 18 of vial 12 and force the legs outwardly.
This allows
release of base 46 of pusher element 44. Continued movement will cause latches
36 to
engage the neck of vial 12. This upward movement causes a piercing of septum
16 by
piercing tip 68 of needle 66 to thereby reduce any vacuum therein. The upward
movement
also results in elements 50 of pusher member 44 moving upwardly to engage the
bottom
edge of side walls 58 of cover 54 to move the same upwardly. This then permits
the removal
of cover 54 and access to the contents 20 of vial 12.
The transfer system is preferably utilized with a syringe such as shown in
Figures 3
and 4. The syringe includes a syringe body 74 having a plunger 76 mounted
therein. A
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plunger rod 78 is designed to be screwthreadedly engageable with plunger 76.
Preferably,
syringe body 74 includes a back stop 80 to permit proper gripping by the hand
of the user.
At its front end, syringe body 74 includes a female luer connection 82.
Typically, syringe
body 74 is filled with a diluent 84 (Figure 7) although any desired fluid may
be utilized.
As shown in Figure 7, plunger rod 78 is connected to plunger 76 and the
diluent 84 is
then forced into vial body 14 as shown in Figure 8. The medicant and diluent
may then be
mixed and the assembly inverted as shown in Figure 9. The mixture 86 is then
aspirated
back into syringe body 74. The mixture 86 is then ready for injection when a
needle
assembly is attached to luer connection 82.
As shown in Figures 14 and 15, the device may include a spike 90 to replace
the
needle 66. Spike 90 may include a venting channel 92 formed therein to permit
pressure
equalization upon piercing of the vial. As shown in Figures 16 and 17, various
numbers of
legs may be employed; in Figures 16 three legs 94 are illustrated.
The embodiment illustrated in Figures 18A to 18J is similar to the previously
described embodiment and similar reference numerals will be employed. The
primary
difference in this embodiment is that a pair of latches 100 extend downwardly
from pushing
member 44. Each latch 100 has a straight portion 102 and a hooked latch
portion 104.
As may be seen in the drawings, latches 100 engage under the neck of vial 14.
As
seen in Figures 181 and 18J, when it is desired to withdraw vial 12, the
engagement of
latches 102 with vial 12 will cause pusher element 44 to be pulled downwardly
to a position
wherein piercing tip 68 is again protected by pusher member 44. The latches
cannot move
outwardly to release the vial until pusher element 44 is in the desired
position.
A further embodiment of a transfer device 120 is illustrated in Figures 19A to
19H.
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The transfer device 120 is similar to that of Figure 18; however, no cover is
provided.
Transfer device 120 includes a housing 122 which has a pair of apertures 124
formed
therein on opposite sides. As in the previously described embodiment, there is
provided a
spike 126. Interiorly of housing 122 there are provided a pair of flanges 128
each having a
recess 130 formed therein.
Moveable member 132 acts to protect the user from accidental pricks. Moveable
member 132 has a base 138 with a first set of legs 134 extending therefrom,
each leg 134
having a button 136 formed thereon. Button 136 is designed to engage within
aperture 124.
There are also provided a pair of diametrically opposed latches 142 for
engaging the
neck of the vial.
As shown in Figures 19C to 19H, when housing 122 is engaged with the vial,
pressure
is exerted on base 138 and moveable member 132 to cause the same to move
upwardly
whereby buttons 136 engage in apertures 124.
When it is desired to remove the vial, buttons 136 may be depressed and
housing 122
moved upwardly with respect to the vial. In so doing, base 138 moves
downwardly where it
again engages in recesses 130.
It will be understood that the above described embodiment is for purposes of
illustration only and that changes and modifications may be made thereto
without departing
from the spirit and scope of the invention.
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