UNIT DOSE CONTAINER

CONTENANT POUR DOSE UNIQUE DE PRODUIT

English Abstract

A liquid containing thermoplastic unit dose container (1) which comprises
a body portion (2), a neck portion (3) and an outlet opening {7) at the end of
neck portion (3) which is sealed by a non re-sealable cap (4). The outside wall of
the neck portion (3) comprises a thread engagement portion (8) which is located
at or proximate the outermost edge of the neck portion (3) so that after removalof cap (4) thread engagement portion (8) is adapted to engage within an inwardlyfacing screw thread channel (14) at the end of a syringe. This enables sealing
connection of the container (1) to the syringe so that liquid within container (1)
may be directly transferred from the container (1) to the syringe.

French Abstract

Flacon à dosage unitaire en thermoplastique (1) contenant un liquide. Ce flacon comprend un corps (2), un collet (3) et une ouverture (7) à l'extrémité du collet (3) obturée par un bouchon non réutilisable (4). La paroi extérieure du collet (3) comprend une partie filetée (8) qui est placée sur le bord extrême du collet (3) ou à sa proximité de façon qu'après l'enlèvement du bouchon (4), la partie filetée (8) s'adapte pour coopérer avec un canal (14) à filetage tourné vers l'intérieur à l'extrémité de la seringue. Cet agencement forme une connexion étanche entre le flacon (1) et la seringue, permettant au liquide contenu dans le flacon (1) d'être transféré directement du flacon (1) à la seringue.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A liquid drug-containing thermoplastic unit dose container for
engaging and transferring liquid to a syringe of a standard size appropriate for
administering the particular drug, the syringe being of the type which has a central
projecting cone, an outer peripheral wall surrounding the cone, and a bottom wall
together defining an annular channel, wherein the outer peripheral wall contains
an inwardly facing screw thread for engaging a needle fitting; wherein said
container comprises:
a body portion containing said dose;
an outlet comprising a hollow neck portion sized to receive the cone
of a mating syringe and to extend up into the annular channel, the neck portion
having an outwardly facing surface, an internal surface and an outermost rim; and
a removable, non-resealable cap secured to said rim for sealing the
outlet; wherein the outwardly facing surface of the neck portion comprises a thread
engagement portion for engaging the inwardly facing screw thread of the mating
syringe, such that the cap may be removed and the syringe screwed onto the
container neck portion, and wherein the neck portion includes means for providing
a seal between the container and the syringe cone, when the syringe is screwed
onto the container, so that liquid may be directly transferred from the container to
the syringe.

2. A container as defined in claim 1, wherein a portion of the internal
surface of the neck portion has a diameter smaller than at least part of the outside

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surface of the cone and is deformable, and is positioned to contact the cone when
the syringe is screwed onto the neck portion, thereby constituting the means for
providing a seal between the container and syringe cone.

3. A container as defined in claim 2, wherein the neck is in the shape of
an inverted truncated cone, decreasing from a maximum diameter at the rim to a
minimum diameter portion, and wherein the neck is sized and shaped so as to
contact the syringe cone only at the minimum diameter portion.

4. A container as defined in claim 3, wherein the neck includes a
second truncated cone, having a minimum diameter portion facing and joining the
minimum diameter portion of the inverted truncated cone, and wherein the neck is
shaped so as to contact the syringe cone only at the minimum diameter portion
joining the two cones.

5. A container as defined in claim 3, wherein the minimum diameter
portion is cylindrical, having a constant diameter.


6. A container as defined in claim 1, for use with a syringe in which the
outer peripheral wall has an inwardly facing surface, wherein the thread
engagement portion comprises a shoulder on the outwardly facing surface of the
neck, adjacent the rim, and has a diameter greater than the inwardly facing
surface of the outer peripheral wall and is deformable, thereby constituting the
means for providing a seal between the container and syringe cone.

-13-


7. A container as defined in claim 1, wherein the neck is sized and
shaped so that the neck rim contacts the syringe bottom wall, when the syringe is
screwed completely onto the container neck, and comprises the means for
providing a seal between the container and syringe cone.

8. A container as defined in claim 1, wherein the body, in a region
adjacent the neck, is hexagonal and includes a pair of opposed yokes for
strengthening such region.

9. In combination a syringe and a liquid drug-containing thermoplastic
unit dose container for engaging and transferring liquid to the syringe, wherein the
syringe comprises a central projecting cone, an outer peripheral wall surrounding
the cone, and a bottom wall together defining an annular channel, wherein the
outer peripheral wall contains an inwardly facing screw thread for engaging a
needle fitting; and wherein said container comprises:
a body portion containing said dose;
an outlet comprising a hollow neck portion sized to receive the cone
of the syringe and to extend up into the annular channel, the neck portion having
an outwardly facing surface, an internal surface, and an outermost rim; and
a removable, non-resealable cap secured to said rim for sealing the
outlet; wherein the outwardly facing surface of the neck portion comprises a thread
engagement portion for engaging the inwardly facing screw thread of the mating
syringe, such that the cap may be removed and the syringe screwed onto the
container neck portion, and wherein the neck portion includes means for providing

-14-


a seal between the container and the syringe cone, when the syringe is screwed
onto the container, so that liquid may be directly transferred from the container to
the syringe.

10. The combination defined in claim 9, wherein a portion of the internal
surface of the neck portion has a diameter smaller than at least part of the outside
surface of the cone and is deformable, and is positioned to contact the cone when
the syringe is screwed onto the neck portion, thereby constituting the means for
providing a seal between the container and syringe cone.


11. The combination defined in claim 10, wherein the neck is in the
shape of an inverted truncated cone, decreasing to a minimum diameter portion,
and wherein the neck is shaped so as to contact the syringe cone only at the
minimum diameter portion.

12. The combination defined in claim 11, wherein the neck includes a
second truncated cone, having a minimum diameter portion facing and joining the
minimum diameter portion of the inverted truncated cone, and wherein the neck is
shaped so as to contact the syringe cone only at the minimum diameter portion
joining the two cones.

13. The combination defined in claim 11, wherein the minimum diameter
portion is cylindrical, having a constant diameter.


-15-


14. The combination defined in claim 11, wherein the cone of the syringe
has an outlet end and tapers in diameter toward the outlet end, such that when
the syringe is screwed onto the container neck, and the cone moves further into
the neck, the seal formed at the minimum diameter region increases.

15. The combination defined in claim 11, wherein the outer periphery
wall of the syringe has an inwardly facing surface, wherein the thread engagement
portion comprises a shoulder on the outwardly facing surface of the neck, adjacent
the rim, and has a diameter greater than the inwardly facing surface of the outer
peripheral wall and is deformable, thereby constituting a means for providing an
additional seal between the container and syringe.

16. The combination defined in claim 15, wherein the neck is sized and
shaped so that the neck rim contacts the syringe bottom wall, when the syringe is
screwed completely onto the container neck, and comprises a means for creating
an additional seal between the container and syringe cone.

17. The combination defined in claim 9, wherein the outer peripheral wall
of the syringe has an inwardly facing surface, wherein the thread engagement
portion comprises a shoulder on the outwardly facing surface of the neck, adjacent
the rim, and has a diameter greater than the inwardly facing surface of the outer
peripheral wall and is deformable, thereby constituting the means for providing a
seal between the container and syringe cone.

-16-


18. The combination defined in claim 9, wherein the body, in a region
adjacent the neck, is hexagonal and includes a pair of opposed yokes for
strengthening such region.

19. The combination defined in claim 9, wherein the neck is sized and
shaped so that the neck rim contacts the syringe bottom wall, when the syringe is
screwed completely onto the container neck, and comprises the means for
providing a seal between the container and syringe cone.

20. A method of providing a liquid drug dose to a syringe, comprising the
steps of:
providing a syringe having a central projecting cone, an outer
peripheral wall surrounding the cone, and a bottom wall together defining an
annular channel, wherein the outer peripheral wall contains an inwardly facing
screw thread for engaging a needle fitting;
providing a liquid drug-containing thermoplastic unit dose container
comprising a body portion containing said dose; an outlet comprising a hollow
neck portion sized to receive the cone of the syringe and to extend up into the
annular channel, the neck portion having an outwardly facing surface, an internal
surface, and an outermost rim; and a removable, non-resealable cap secured to
said rim for sealing the outlet; wherein the outwardly facing surface of the neck
portion comprises a thread engagement portion for engaging the inwardly facing
screw thread of the mating syringe, and wherein the neck portion includes means
for providing a seal between the container and the syringe cone, when the syringe

-17-

is screwed onto the container;
removing the cap from the container to expose the container rim;
screwing the syringe onto the container neck so as to form a seal
between the container and syringe cone, and transferring liquid from the container
to the syringe.

21. A liquid containing thermoplastic unit dose container which comprises
a body portion, a neck portion, an outlet opening provided at the end of the neck
portion and sealed by a non resealable cap, the neck portion being in the shape of
an outwardly widening truncated cone having an engagement portion being
provided at the edge of said outwardly truncated cone, said engagement portion
being adapted to engage with the end of a syringe, thus enabling sealing
connection of the container to the said syringe, so that liquid within the container
may be directly transferred from the container to the syringe, characterised in that
said engagement portion is formed as a thread engagement portion being adapted
to be inserted in an inwardly facing screw thread channel at the end of a syringe,
whereby said portion is slightly deformed thereby providing a sealing connection
between the thread engagement portion of the container and the peripheral wall of
the syringe, and in that the top of said body portion has a hexagonal cross
section.

22. A container according to claim 21, characterised in that two yokes
are provided substantially 180° to each other on either side of the body of the
container.

-18-


23. A container according to claim 21 or 22, characterised in that the
thread engagement portion comprises a shoulder shaped to fit within the inwardly
facing screw thread channel at the end of a Luer Lock syringe.

24. A container according to claim 23, characterised in that the thread
engagement portion is formed such that it is adapted to be screw threadingly
engaged within a Luer Lock fitting of a syringe.

25. A container according to claim 24, characterised in that the outlet
opening is formed to be adapted to a cone provided within the screw thread
channel of the Luer Lock syringe.

26. A container according to any one of claims 21 to 25 characterised in
that the non releasable cap is attached to the outlet opening along a weakened
section of the container.

27. A container according to any one of claims 21 to 26 characterised in
that the walls of the body portion of the container are flexible.

-19-

Description

WO91/08729 - 1 - PCT/AU90/00551
2~S9610
-- ,. ..
UNIT DOSE CONTAINER

This invention relates to a thermoplastic container
suitable for use in holding and transferring injectable
solutions to a syringe.
There are many different forms of syringe which are
presently available for use by the medical professions. The
most appropriate syringe design for any one situation depends
largely on the particular circumstances of use, the nature of
the solution being injected and the location of the intended
injection.
One particular design difference between various
syringes is the manner in which the open end is shaped to
accommodate a hypodermic needle. The two most popular forms
of needle fitting are the friction fit fitting (such as the
luer slip fitting) and the combination of screw thread and
friction engagement fitting (such as the luer lock fitting).
Screw thread engagement fittings of interest in the context
of the present invention are female fittings having an
internal thread such as in the case of the luer lock fitting
and all references to screw thread engagement fittings on
syringes hereafter are references to female fittings. A
screw thread engagement fitting is the fitting of preference
where the circumstances of use indicate that there is some
prospect of the needle becoming disengaged with the syringe
body (e.g. epidural injectionsJ. This invention is
particularly concerned with contAiners suitable for
transferring injectable solutions to syringes having a screw
thread engagement fitting.

WO91/08729 - 2 - PCT/AU90/00551
~69~1D

Background Art
In the past, the general practice of surgeons or other
medical practioners using hypodermic syringes has been to
transfer an injection solution to a syringe from a glass vial
using a broad channelled needle attached to the syringe
body. Following transfer, this broad channelled needle has
been removed from the syringe and replaced with a narrower
channelled hypodermic needle suitable for injecting the
solution into the patient. It will be appreciated that this
past practice has necessitated the use of a number of
separate components. Furthermore, as solution transfer for
injecting into humans requires scrupulous sterilizing of
components, this previous practice has required separate
sterilizing measures to be taken at each step.
To avoid the problems of such transfer, it has been
previously proposed to provide ampoules or vials holding a
single dose. These single dose vials have been adapted to
fit like cartridges into a syringe body onto which can be
fitted a hypodermic needle. Such unit dose vials are
normally manufactured from glass and sealed with a rubber
membrane and the vial is punctured by attaching to the
syringe body a double sided needle.
An alternative arrangement is disclosed in Australian
patent 556,483 where a unit dose container is described made
from a thermoplastic material which is adapted to be opened
and co-operatively engaged directly onto a needle fitting on
a syringe to which it is desired to transfer injection
fluid. Whilst this patent describes a satisfactory
arrangement for use with a standard friction fit needle


2 0 6 9 6 ~ O
fitting such as a Luer slip fitting, it does not deal with the problems associated with
syringes utilizing screw thread engagement systems such as the Luer Lock
system.
It is an object of the present invention to provide a container suitable
for use with a syringe having a screw thread engagement fitting to facilitate more
secure, easier and more convenient transfer of an injection solution to a syringe
which has a screw thread engagement fitting than has hitherto been possible.
Description of the Invention
According to the present invention there is provided a liquid drug-

10 containing thermoplastic unit dose container for engaging and transferring liquid toa syringe of a standard size appropriate for administering the particular drug, the
syringe being of the type which has a central projecting cone, an outer peripheral
wall surrounding the cone, and a bottom wall together defining an annular channel,
wherein the outer peripheral wall contains an inwardly facing screw thread for
engaging a needle fitting; wherein said container comprises: a body portion
containing said dose; an outlet comprising a hollow neck portion sized to receive
the cone of a mating syringe and to extend up into the annular channel, the neck
portion having an outwardly facing surface, an internal surface and an outermost
rim; and a removable, non-resealable cap secured to said rim for sealing the
20 outlet; wherein the outwardly facing surface of the neck portion comprises a thread
engagement portion for engaging the inwardly facing screw thread of the mating
syringe, such that the cap may be removed and the syringe screwed onto the
container neck portion, and wherein the neck portion includes means for providing
a seal between the container and the syringe cone, when the syringe is screwed



- 3 -
23940-737
A

~ 2 ~ ~ 9 6 1 0 1
onto the container, so that liquid may be directly transferred from the container to
the syringe.
The invention also provides a liquid containing thermoplastic unit
dose container which comprises a body portion, a neck portion, an outlet opening
provided at the end of the neck portion and sealed by a non resealable cap, the
neck portion being in the shape of an outwardly widening truncated cone having
an engagement portion being provided at the edge of said outwardly truncated
cone, said engagement portion being adapted to engage with the end of a syringe,
thus enabling sealing connection of the container to the said syringe, so that liquid
10 within the container may be directly transferred from the container to the syringe,
characterised in that said engagement portion is formed as a thread engagement
portion being adapted to be inserted in an inwardly facing screw thread channel at
the end of a syringe, whereby said portion is slightly deformed thereby providing a
sealing connection between the thread engagement portion of the container and
the peripheral wall of the syringe, and in that the top of said body portion has a
hexagonal cross section.
The invention further provides in combination a syringe and a liquid
drug-containing thermoplastic unit dose container for engaging and transferring
liquid to the syringe, wherein the syringe comprises a central projecting cone, an
20 outer peripheral wall surrounding the cone, and a bottom wall together defining an
annular channel, wherein the outer peripheral wall contains an inwardly facing
screw thread for engaging a needle fitting; and wherein said container comprises:
a body portion containing said dose; an outlet comprising a hollow neck portion
sized to receive the cone of the syringe and to extend up into the annular channel,



- 3a -
23940-737
A

~ ~ ~ 9 ~ ~ ~
._
the neck portion having an outwardly facing surface, an internal surface, and an
outermost rim; and a removable, non-resealable cap secured to said rim for
sealing the outlet; wherein the outwardly facing surface of the neck portion
comprises a thread engagement portion for engaging the inwardly facing screw
thread of the mating syringe, such that the cap may be removed and the syringe
screwed onto the container neck portion, and wherein the neck portion includes
means for providing a seal between the container and the syringe cone, when the
syringe is screwed onto the container, so that liquid may be directly transferred
from the container to the syringe.
The invention also provides a method of providing a liquid drug dose
to a syringe, comprising the steps of: providing a syringe having a central
projecting cone, an outer peripheral wall surrounding the cone, and a bottom wall
together defining an annular channel, wherein the outer peripheral wall contains
an inwardly facing screw thread for engaging a needle fitting; providing a liquid
drug-containing thermoplastic unit dose container comprising a body portion
containing said dose; an outlet comprising a hollow neck portion sized to receive
the cone of the syringe and to extend up into the annular channel, the neck
portion having an outwardly facing surface, an internal surface, and an outermost
rim; and a removable, non-resealable cap secured to said rim for sealing the
20 outlet; wherein the outwardly facing surface of the neck portion comprises a thread
engagement portion for engaging the inwardly facing screw thread of the mating
syringe, and wherein the neck portion includes means for providing a seal
between the container and the syringe cone, when the syringe is screwed onto the
. container; removing the cap from the container to expose the container rim;



- 3b -
23940-737

2~ ~Q ~ ~ ~
,_
screwing the syringe onto the container neck so as to form a seal between the
container and syringe cone, and transferring liquid from the container to the
syrlnge.
The cap is preferably attached to the outlet opening along a
weakened section so that it may be readily detached by a rocking or twisting
action. The thread engagement portion on the outside wall of the container neck
preferably has a cross sectional diameter




- 3c -
23940-737
~.

WO91/08729 _ 4 _ PCT/AU90/00551
~0f~610
~greater than the distance between the top of the thread on
opposite sides of the syringe fitting and is adapted to
engage in the screw thread channel of the syringe to
facilitate connection.
The diameter of the non engagement portion is equal to
or preferably smaller than the distance between the top of
the thread on opposite sides of the syringe fitting so that
it effectively clears the thread when the neck is drawn onto
the screw thread of the syringe by the engagement of the
thread engagement portion in the thread channel.
The thread engagement portion can be of any shape that
will engage within the screw thread channel of the syringe
fitting. Most preferably, the thread engagement portion of
the neck is located at the edge of the outlet opening and
comprises a shoulder shaped to fit within the screw thread
channel of the syringe fitting. One example of a particular
embodiment of the invention is a container having a
cylindrical neck portion (being the non engagement portion)
with a peripheral shoulder at the edge of the outlet opening
forming the engagement portion. In other words, it is
possible to form the container with parallel sides. If the
screw thread fitting comprises a central cone such as in the
luer lock fitting, it is preferred that these sides be sized
to seal against the luer cone. Alternatively, the container
may have an inverted truncated cone neck portion with the
leading edge thereof being formed to engage with the thread
on a syringe fitting (the thread engagement portion) and the
trailing section of the truncated cone forming the non
engagement portion of the neck.


WO91/08729 - 5 - PCT/AU90/00551
. i ~ 2~6s~la
The container of the present invention is particularly
useful for use with syringes having screw thread engagement
fittings such as the "luer lock" fitting. The luer lock
fitting comprises a central male cone, an outer peripheral
wall and a bottom wall. The outside wall of the cone, the
bottom wall and the inside of the peripheral wall together
define an annular channel. On the inside of the peripheral
wall there is provided a screw thread.
When used in conjunction with a syringe having a
fitting like that of the luer lock, it is necessary that the
outlet opening of the ContA i ~er be large enough to
accommodate the central male cone on the syringe.
Thus according to one embodiment of the invention, the
diameter of the neck portion is equal to or slightly smaller
than the corresponding outside diameter of the cone on the
syringe fitting at at least one portion of the contA i ner
neck. As the container of the invention is of a
thermoplastic material, it is capable of slight deformation
and the diameter of the neck portion in at least one position
is most preferably slightly smaller than the outside diameter
of the syringe so to sealingly abut against the cone at that
point or points.
Where sealing engagement is facilitated in this manner,
it is not necessary that the engagement portion of the
contA i ner neck also provide a seal with the fitting although
this is desirable. It is however very important that sealing
engagement occur either between the engagement portion of the
neck and the peripheral wall of the fitting or alternatively
between a portion of the inside of the container neck and the


WO91/08729 - 6 - PCT/AU90/00551
~O~C9610
central male cone. If there is no sealing connection, it is
possible for the intrusion of unsterile air into the
container and this may lead to contAmin~tion of the container
contents of the syringe.
Sealing between the container and the syringe fitting
is also enh~nced if the engagement portion of the neck is
slightly greater in cross sectional diameter than the
internal diameter of the annular channel. This means that
upon engagement of the container with the syringe, the
engagement portion slightly deforms and sealingly abuts
against the inside of the peripheral wall.
The body of the container may be of any shape.
However, it is preferred that the top of the body be formed
hexagonally. The hexagonal form makes it easier to connect
the syringe to the container as it strengthens the container
in such a way that it can stand radial and axial strains
better. The hexagonal upper part of the body is then further
strengthened by one yoke on each side. The yokes also reduce
the risk of the containers being punctured when they are
being produced.
In use, the transfer of injection solution held within
a container made in accordance with the invention is effected
in the following way.
First, the non resealable container cap is removed by a
rocking or twisting action and separates from the container
along the weakened portion adjacent the outlet opening. The
container is held in an upright position and the syringe into
which it is intended to transfer the solution is placed so
that the screw thread engagement fitting aligns with the


WO91/08729 - 7 - PCT/AU90/00551
2 ~
outlet opening. The plunger in the syringe should be fully
inserted. The container is then sealingly engaged with the
syringe fitting by rotating the syringe and container with
respect to each other until the container has completely
engaged with the screw thread on the syringe. When so
connected, the contents of the container may be conveniently
withdrawn into the syringe by the rearward action of the
plunger in the syringe body and if necessary, assistance in
this fluid transfer may be given by partial deformation of
the outside walls of the container.
The invention is further described below with reference
to preferred embodiments of the invention shown in the
accompanying drawings wherein:
Figure l illustrates a front view of a unit dose
container made in accordance with the invention sealed by a
non resealable cap;
Figure 2 illustrates the top part of the unit dose
cont~iner of figure l with the cap removed from the outlet
opening;
Figure 3 illustrates the top portion of an alternative
embodiment of the invention.
Figure 4 illustrates the unit dose container of figure
2 with a syringe connected to the outlet opening thereof; and
Figure 5 is an exploded view of the connection between
the outlet opening and the syringe fitting as illustrated in
figure 4.
In figure l there is shown a container l of
thermoplastic material which can be readily deformed.
Suitable materials for the manufacture of such containers are


WO9l/08729 - 8 - PCT/AU90/00551
2069610
well known in the art but include polyethylene and
polypropylene. The container 1 comprises a body portion 2
and a neck portion 3. At the end of the neck portion, there
is provided a non resealable cap 4 connected to the end of
neck 3 along weakened line S. Neck portion 3 is in the form
of an outwardly widening truncated cone and this feature is
easier to identify in figure 2.
In figure 3 there is shown an alternative embodiment of
the invention wherein the top of the body is formed
hexagonally and the body is strengthened by one yoke on each
side.
The non resealable cap 4 may be removed from neck
portion 3 by a rocking or twisting action and separates from
the neck portion 3 along weakened line 5. After removal of
the non resealable cap, there is revealed an outlet opening 7
at the end of neck portion 3 through which, liquid contained
in container 1 may pass.
Neck portion 3 comprises a thread engagement portion
being the shoulder 8 located about the peripheral edge of
outlet 7. The neck portion also comprises a non engagement
portion 9 of reduced cross sectional diameter. Figures 4 and
5 show the connection of such a cont~iner to a syringe so to
facilitate transfer of the liquid contained in the container
to the syringe. These figures illustrate a syringe having a
luer lock needle fitting 10. This fitting has a central male
cone 11, an outer peripheral wall 12 and a bottom wall 13.
These walls form the boundary of an annular channel 14. A
screw thread 15 is provided on the inside wall of peripheral
wall 12. The central luer cone 11 is provided with a


WO9l/08729 _ 9 _ PCT/AU90/00551
2~69~l a
transfer channel 16 which is open at its outer most end 17.
In figure 3, the engagement portion has a less sharply
defined edge. This shoulder is adapted to engage with the
screw thread fitting of the syringe but may require continued
application of force during connection with the screw thread
to ensure engagement. The neck is strengthened by yokes 6
and the top of the package is hexagonally formed.
The container 1 is adapted to engage with the luer lock
fitting 10 as follows. After the non resealable cap 4 is
removed from container 1, it is held in an upright position
and the syringe fitting 10 is located adjacent to the outlet
opening 7 of container 1 whereby central luer cone 11 is
inserted into the outlet opening 7. By relative rotation of
the container with respect to the syringe fitting, thread
engagement shoulder 8 on neck 3 is caused to engage with
thread 15. To assist in initial engagement, the syringe
fitting may be pushed slightly down into the outlet opening
7. Once the thread ~I takes", shoulder 8 fits behind the
thread 15 and abuts against the underside 17 of the thread
and the inside of peripheral wall 12. The non engagement
portion 9 of neck 3 is of narrower cross section so that it
does not interfere with the thread 15 but can move freely
into channel 14 whilst the container is screwed onto the
syringe fitting.
The internal diameter of neck 3 at point 19 is slightly
smaller than the outside cross sectional diamter of cone 11.
As can be seen in figure 5, this ensures sealing engagement
between the components at the area generally designated by
the numeral 20. The extent of the sealing at 20 improves as


' -

WO91/08729 - 10 - PCT/AU90/00~1
2~6s~ln

the container is screwed onto the luer lock fitting as in a
standard luer cone, the side wall of the cone is slightly
inclined with the base of the cone being of slightly
increased diameter than the top of the cone.
Accordingly, as container 1 is screwed onto the screw
thread fitting 10, that portion of the neck indicated at
position 19 is forced outwardly to increase the internal
diameter of the neck at this position. This causes stresses
in the neck resulting in closer and tighter abuttment of
portion 19 against the outside wall of cone 11 as the
container is screwed onto the needle fitting.
In figure 5, there is also shown in hatch lines the
position of the container once fully screwed onto the needle
fitting. In this position, the top of the outlet opening 7
abuts against the base 13 of the needle fitting to further
ensure sealing engagement of the cont~iner onto the needle
fitting.
Once the container has been fully secured onto the
needle fitting, transfer of the injectable solution in the
container is easily effected by the rearward action of the
plunger in the syringe body. Nost preferably, the cont~iner
side walls are flexible enough so that the container can
partially collapse in the drawing out of the injection
solution. Transfer of the solution can be assisted by
squeezing the outside walls 21 of the container.
The container of the present invention can be filled
with a solution of any drug which is suitable for injection
but is particularly advantageous for use with aqueous
solutions of autoclavable local anaesthetics such as


WO91/08729 - 11 - PCT/AU90/00551
~ 20~9~
lidocaine, prilocaine, mepivocaine, bupivocaine, etidocaine
or other drugs which are used under conditions where the
demands for easy handling and sterility are especially high. ~
Finally, it is to be understood that various
alterations, modifications and/or additions may be introduced
into constructions and parts previously described without
departing from the spirit or ambit of the invention as
defined in the following claims.

Representative Drawing