Apparatus and Methods
FIELD OF THE INVENTION
This invention relates to medical devices for labelling a syringe filled from an ampoule,
to safer devices for filling a syringe from an ampoule, and to associated methods.
BACKGROUND TO THE INVENTION
An estimated 180,000 patients die in the US each year as a result of adverse medical
events and medication error is a leading contributing factor. In an analysis of
medication errors reported to the United States Pharmacopoeia (USP) voluntary
Medication Errors Reporting Program for a one-year period between 1996 and 1997,
the USP found that 33% of the reports cited labelling or packaging as having
contributed to the medication error (USP 1998). In nearly 30% of the fatalities
reported, labelling or packaging was cited as a contributing factor to the medication
error that led to the fatality (USP 1998). A survey of 687 Canadian anaesthesiologists
identified 1038 drug-related events; the misidentification of a syringe or "syringe swap"
was the most common cause of error.
It can be easy to mistake one drug for another, even though careful thought is given to
packaging design. There is a particular problem with intravenous drugs, as they are
often supplied in small ampoules and their labels can be difficult to read and must be
transferred into another correctly-labelled device (typically a syringe) before they are
administered. Misidentification of drug syringes or ampoules is an important cause of
medication errors during anaesthesia. An Australian Incident Monitoring Study reported
that 144 out of 2000 anaesthetic incidents involved situations in which the wrong drug
was given or almost given. The risk of actual administration of a wrongly selected drug
was higher if the drug was in a syringe (93%) rather than an ampoule (58%).
Colour coding syringe labels can help to decrease the incidents of drug errors but
mislabelling remains a significant problem. Other problems associated with the use of
ampoules include cut fingers, lack of sterility, and glass powder in the injected drug,
which can be deposited in patients' lungs if they enter the circulation.
One of the inventors has carried out research into these problems and background
information can be found in: "Variability in the concentrations of intravenous drug
infusions prepared in a critical care unit", Daniel Wheeler et al., Intensive Care Med,
DOI 10.1 007/sO0 134-008-1 113-9, Springer-Verlag 2008; and in the review article
"Medication errors in anaesthesia and critical care", S. J. Wheeler and D. W. Wheeler,
Anaesthesia, 2005, 60, pages 257-273. The inventor's research into drug
administration errors and problems with patient safety has informed the aspects and
embodiments of the invention described later.
One previous approach to addressing these problems is to couple a bar code reader to
an anaesthetic machine, but this device reads the sticker rather than the labelled
contents and it still relies upon the sticker being applied to the syringe correctly. A
simple device to help break the top off an ampoule is also known from US6,099,51 0,
but this is of little help in addressing the above problems.
SUMMARY OF THE INVENTION
According to a first aspect of the invention there is therefore provided a device for
attaching to an ampoule to label a syringe filled from the ampoule, the device
comprising: an ampoule-mounting portion for mounting the device to said ampoule;
a syringe-fitting portion to enable the device to be fitted onto said syringe; and a label
holder to hold a label for contents of said ampoule; wherein one of said syringe and
said ampoule is detachable from said device; and wherein said label is configured such
that in conjunction with a filling operation of said syringe and detachment of said one of
said syringe and said ampoule from said device said syringe is able to be labelled by
said label.
In use embodiments of the device may be shipped permanently fitted to a filled
ampoule, with the (empty) syringe being fitted immediately prior to use.
In some embodiments the label is detachable from the device for attachment to the
syringe in conjunction with (before, during or after) the filling operation; the label holder
may then simply be a part of the device to which the label is initially attached.
Preferably in such an approach the detachable label is positioned such that the label
must be at least partially removed for an effective filling operation.
Thus, for example, in one approach (our code name Marshall) the device is one-piece
moulded and configured to fit over and preferable snap onto a snap-top (neck) of the
ampoule. The label is attached across the syringe fitting so that the syringe cannot be
inserted into its female mating portion (luer) without removing a label. In use the fitted
syringe provides a lever which may be employed to snap off the top of the ampoule.
Thus in this approach the label is detachable and must be removed in order to be able
to insert the syringe; the user is thus encouraged to place the removed label directly
onto the syringe. Leverage from the syringe is then used to snap the top off the
ampoule, and then the syringe, with the device attached, is placed over the open top of
the ampoule to aspirate the contents.
In another approach (our code name Hartke) again the label is detachable and must be
removed in order to operate the device. However in this instance the label is applied
across a side of the snap-top of the ampoule so that the ampoule top cannot be
snapped off without removing the label. In an example of this approach the ampoule
mounting portion (ampoule holder) holds the ampoule in a cradle along its length. A
hinged portion is located above the ampoule in the cradle so that it can be hinged down
to bear onto the snap-top, past the label, which must therefore be removed to operate
the device. In preferred embodiments the hinged portion comprises the syringe fitting
portion, again to provide leverage, and may comprise a projection at the end of an arm.
In embodiments the projection may comprise a female mating portion (luer) for the
syringe. Thus the device may be configured such that once the snap-top has been
broken off rotation (of the luer component) about the hinge may be continued so that
the projection moves into the now open top of the ampoule for aspiration of the
contents. A cavity may be provided in the cradle substantially opposite the hinge to
receive the snapped off top, which is then retained within the cavity by the syringe.
Thus, in use, the ampoule and syringe may begin by being arranged alongside one
another with the syringe inserted into the luer of the hinged mating portion, and the
hinged mating portion may then be rotated so that the syringe moves through 180° to
align with the then opened ampoule.
In a still further embodiment (our code name Fender) the ampoule-mounting portion
contains the ampoule sufficiently for a space above the top of the ampoule to be
substantially airtight except for an air bleed hole. An optional (air-tight) opening may be
provided to enable the label of the ampoule to be read, depending whether the
container is transparent. The label is provided over the air bleed hole so that this label
needs to be removed in order for the contents of the ampoule to be aspirated. To
enable the top to be snapped off a push-button arrangement may be provided in the
closed-top ampoule-mounting portion, in order to allow a user to apply pressure to the
snap-top of the ampoule. The syringe fitting portion provides a substantially airtight fit
to the syringe. Then, in use, the label must be removed from the air bleed hole (and
attached to the syringe) to provide a route for air to enter the ampoule after the top has
been snapped off when the contents are being aspirated (there being substantially no
other air path into the ampoule).
In these and other arrangements the device has a portion configured for snapping off a
snap-top of the ampoule. In the above described Fender device this comprises a push
button region of the ampoule housing; in the Hartke device this comprises a hinged
portion of the device, in particular the hinged syringe-fitting portion; in the Marshalltype
device this comprises a (snap) cap for the snap-top of the ampoule.
In a still further approach (our code name Ampeg) this comprises a collar, in particular
sized to fit the snap-top of an ampoule (ampoules are of standard, albeit different,
sizes). In embodiments of this latter arrangement, the syringe fitting portion clips to the
syringe and the ampoule-mounting portion clips to the ampoule in embodiments by a
collar around the neck of the snap-top. In embodiments the collar is hingedly attached
to the syringe-fitting portion (and may be folded back onto the syringe fitting portion
after use). This enables the syringe-fitting portion to be articulated with respect to the
ampoule-mounting portion (collar) to snap the top off the ampoule, which may then be
removed from the device and filled in the normal way. In this approach the device
remains attached to the syringe, along with the label it bears. In such an approach
preferably the device is shipped together with the syringe and ampoule so that the
label, which is attached to the device, remains on the syringe after aspiration of the
drug from the ampoule.
Thus, broadly speaking, in some preferred embodiments the syringe-fitting portion is
mounted to allow motion of the syringe-fitting portion relative to the device, more
particularly relative to the ampoule-mounting portion. This motion applies a force to
snap off the snap-top of the ampoule. In this way the syringe, when attached, may be
used as a lever to snap off the snap-top of the ampoule. In some preferred
embodiments a hinging motion or rotation about an axis is employed. The skilled
person will, however, appreciate that other forms of motion may alternatively be
employed - for example a rotation about a longitudinal axis (a screw-type motion) may
be employed to apply force to the snap-top to open the ampoule.
In embodiments the label holder comprises a detachable item which is not released
from the device until the snap-top of the ampoule has been removed, for example by
configuring the device such that the label holder is released by snapping off the snaptop.
This reduces the risk of the syringe being inadvertently labelled without aspirating
the contents of the ampoule and then later the same syringe being used to aspirate the
contents of a different ampoule.
The label holder comprises a part of the device bearing a label. It may, for example,
have an adhesive label attached to it or a label (label information) may be moulded into
this component/part of the device.
Although the above described embodiments have various different advantages
including, for example, low cost, in some particularly preferred embodiments the device
is configured for automatically labelling the syringe. Thus in such an arrangement the
label holder is detachable from the device and configured such that, when the syringe
is engaged with the syringe-fitting portion of the device and then removed from the
syringe-fitting portion, the label holder attaches to the syringe and is detached from the
device to thereby automatically label the syringe. The skilled person will appreciate that
there are many ways in which the label holder could be configured in such a manner
including, for example, connection to the syringe by adhesive, by a ratchet, by a one
way lock mechanism, by a compression fitting and/or by the use of teeth or barbs,
which may be arranged to provide a one-way slide fit of the label holder to the syringe.
One preferred approach, which is inexpensive, is to employ a label holder with a collar
which fits around and grips the syringe, in particular a split collar of slightly smaller
internal diameter than the syringe. This can provide a push/friction fit over the syringe,
gripping the syringe when the syringe is removed. In embodiments, however, a
combination of the above described approaches may be employed. For example, in a
moulded version of the device barbs may be preferable.
Where the label holder comprises a collar for the syringe, this may be of clear plastic,
so that gradations on the syringe are visible through the collar, and so that air bubbles
can be more easily expelled. This is particularly advantageous with smaller syringes,
for example, less than 5ml, where for small doses a 1-2 ml volume would be behind the
collar. Alternatively the collar may be arranged so that it can be pulled all the way to the
distal end of the syringe (syringes have a flange at the distal end which would inhibit
removal of the collar).
In embodiments the collar and/or device is tinted or coloured, for example by using
coloured plastic, to match a colour of the label on the ampoule (there is an international
colouring standard for drugs of different types).
Thus in embodiments the label holder comprises a collar, in particular designed to grip
onto the outside diameter of the syringe. Then, in use, as the syringe is pushed into
the device the collar clasps the syringe and may, at the same time, let go of the device
to facilitate detachment. In other embodiments, for example to facilitate manufacture,
the label holder may be attached to the device (more particularly the ampoulemounting
portion) by thin, breakable plastic strands, similar to a tamper-evident ring on
a bottle top. In such a case optionally a plurality of plastic or metal barbs may be
provided, for example disposed circumferentially around the collar, to fasten the label
holder onto the syringe. Then in embodiments it may only be possible to remove the
label ring from the syringe destructively.
The label may comprise a conventional paper, plastic or cloth label and/or a barcode
and/or an RFID (radio frequency identification) tag. Depending upon the diameter of
the syringe there may be limited space for a label. In this case it can be advantageous
if the label holder has a label-carrying portion, which is able to fold out longitudinally
(i.e. parallel to the axis of the collar). In embodiments this portion is attached
circumferentially to the collar. Initially it is folded down to lie alongside the ampoule, but
after the label holder has attached to the syringe this can be hinged through
approximately 180° to lie along the length of the syringe. This longitudinal piece may be
attached to the curved circumference of the collar by a so-called living hinge, a butterfly
hinge or bow-tie hinge which employs an over-centre stretch so that it has a bistable
bias either up or down along the axis of the collar (in a similar manner to a plastic bottle
flip-top). Use of a label of this type also has the advantage that the collar can be of low
height so that it obscures little of the longitudinal length (gradations) of the syringe.
Preferred embodiments of the device also provide a cavity to hold the snap-top after
this has been snapped off, to retain the broken glass within the device for safety.
Depending upon the regulatory environment this may allow the device to be disposed
of as conventional waste rather than as special "sharps" waste, which is expensive.
Thus in embodiments, after use the snap-top is substantially entirely within the cavity.
Embodiments of the device may therefore also include one or more interlocks, for
example plastic snap-lock features, to constrain the device to one-time use.
We now describe another aspect of the invention which facilitates sharp-free filling of a
syringe from an ampoule. The skilled person will appreciate that features of the various
aspects and embodiments of the invention that we describe may be, and in
embodiments are, combined.
Thus in another aspect the invention provides a device for attaching to an ampoule to
facilitate filling a syringe from the ampoule, the device comprising: an ampoulemounting
portion for mounting the device to a filled ampoule; and a syringe-fitting
portion to enable the device to be fitted onto said syringe; wherein the device has two
configurations, a first, syringe-attaching configuration for attaching said syringe to the
device and a second, syringe-filling configuration for filling said syringe with liquid from
said filled ampoule; wherein the device is reconfigurable between said first
configuration and said second configuration; and wherein said reconfiguration between
said first configuration and said second configuration applies a force to snap-off a
snap-top of said ampoule.
The reconfiguration of the device between the first, syringe-attaching configuration and
the second syringe-filling configuration may be achieved in a number of different ways.
For example it may be achieved by a relative twist between the two portions of the
device, using a long-pitch thread, or it may be achieved using a sliding or translational
motion between the portions of the device, or some combination of these. However in a
particularly preferred embodiment the syringe-fitting portion of the device is hingedly
attached to the ampoule mounting portion and these are initially at an (oblique) angle to
one another (in the first configuration) - this can be seen, for example, in Figure 1
described later. They are then brought into longitudinal alignment with one another to
align the syringe to the ampoule for filling. This hinging or rotation action, in
embodiments, brings a forcing portion of the device, for example a face or projection of
the syringe filling portion of the device, to bear upon the snap-top of the ampoule,
thereby snapping off the snap-top in moving from the syringe-attaching configuration to
the syringe-filling configuration.
In some particularly preferred embodiments the connection or linkage between the
syringe-fitting portion and the ampoule-mounting portion of the device allows both
rotation and translation of one portion with respect to the other. More particularly in
preferred embodiments the syringe filling portion is constrained to first predominantly
rotate with respect to the ampoule-mounting portion, to snap the top off, and then to
predominantly translate towards the ampoule mounting portion, so that a nozzle of the
syringe fitting portion then moves into the open-top of the ampoule. (The ampoule and
syringe combination is generally inverted when filling so that the ampoule is above the
syringe, and the surface tension of the liquid, usually water-based, inhibits the liquid
from flowing out around the nozzle).
There are different ways to achieve this rotation-translation motion depending, for
example, on whether the device is intended for one-time use or multi-use. In the
former case a relatively inexpensive plastic linkage is desirable; in the latter case a
more robust linkage, which may incorporate metal parts, is desirable (and in the latter
case the device should be sterilisable).
In the former case the hinged attachment may comprise a so-called four bar linkage,
which can be arranged so that the connected portions first move generally to rotate
with respect to one another, and then generally to translate with respect to one
another. Such an arrangement may be one-piece plastic moulded, for example
incorporating living hinges.
In a more robust embodiment the hinged attachment may comprise a sliding hinge, for
example a rod able to translate along a slot. In this case the rotation-translation
movement may be imposed by a camming surface between the syringe-fitting portion
and the (ampoule-mounting portion of the) device, for example a camming surface
provided on the main body moulding.
In embodiments the nozzle of the syringe-fitting portion may be moved such that it
finishes 1-2 mm inside the ampoule. A rotation lock may be provided to inhibit rotation
back once the syringe and ampoule are longitudinally aligned and/or one or more
safety lock(s) may be provided to inhibit motion of the syringe-fitting portion away from
the ampoule-mounting portion once the ampoule top has been snapped off (to safely
trap the sharp top and/or to inhibit labelling the syringe without filling the syringe). This
may be achieved by a simple plastic latch or ratchet.
In a single use device the device is preferably mounted to the ampoule during the
ampoule production process, and labelled during the same process.
In embodiments the ampoule-fitting portion may be fabricated from a plastic material
such as polyethylene, polycarbonate or polypropylene. However because these
materials do not provide a good friction grip to an ampoule, preferably the ampoulefitting
portion is configured to hold an ampoule at both ends or, in embodiments, to
enclose or encapsulate the ampoule. Within its holder the ampoule is oriented such
that the scored edge of the snap-off top faces the part of the device which bears onto
the top. In embodiments the ampoule holder and body of the device is formed as a
single plastic component, for example as a clam shell-type component which is
snapped together to hold/contain the ampoule inside.
The syringe-fitting portion comprises a female portion to mate with a proximal end of
the syringe, typically by means of a nozzle with a slightly tapered bore, optionally
threaded. In embodiments a standard luer fitting is employed. To accommodate the offcentre
needles used in larger syringes the luer fitting may also be offset. The syringe
fitting portion may comprise a second plastic component.
In a related aspect the invention provides a device for labelling a medical syringe, the
device having an ampoule mounting portion for mounting the device to a filled
ampoule, a detachable label holder to hold a label for the contents of said ampoule,
and a syringe-fitting portion to enable the device to be fitted onto said syringe, and
wherein said label holder is configured to engage said syringe on or after fitting of said
syringe into said device such that on withdrawal of said syringe from said device after
filling said detachable label-holder is detached from said device and attached to said
syringe.
In a further related aspect the invention provides a device for enabling filling of syringe
from an ampoule, the device comprising: an ampoule-mounting portion for mounting
the device to a filled ampoule; a syringe-fitting portion to enable the device to be fitted
onto said syringe; and a cavity for holding a snapped-off top of said ampoule; wherein
said syringe fitting portion is hingedly attached to said ampoule mounting portion;
wherein the device has two configurations, a first, syringe-attaching configuration in
which an axis of the syringe fitting portion is at an oblique angle to an axis of said
ampoule-mounting portion and a second syringe-filling configuration in which the
syringe fitting portion and the ampoule-mounting portion are aligned to enable the
syringe to be filled from the ampoule; wherein the device is reconfigurable between
said first configuration and said second configuration and said configuration; and
wherein, in going from said first to second configuration, the ampoule top is snapped
off and the top is captured in the cavity.
Preferably the cavity is located substantially behind or underneath a hinging junction
between said syringe-fitting portion and said ampoule-mounting portion.
In a further related aspect the invention provides a one-piece moulded device for
attaching to an ampoule to facilitate filling a syringe from the ampoule, the device
comprising: an ampoule-mounting portion for mounting the device to a filled ampoule;
and a syringe-fitting portion to enable the device to be fitted onto said syringe; and
wherein said ampoule-mounting portion comprises a cap for a snap-top of the
ampoule; wherein said syringe-fitting portion comprises a female luer fitting for the
syringe; wherein an opening of said cap to receive said ampoule faces in a generally
opposite direction to an opening of said female luer fitting to receive said syringe such
that, in use, said syringe and said ampoule are generally antiparallel; and wherein, in
use, said syringe is usable as a lever to snap off said snap-top of said ampoule.
In embodiments a label is provided over the opening of the female luer fitting, as
previously described.
In a further aspect the invention provides a method of automatically labelling a syringe,
the method comprising: attaching a label to a device on an ampoule of liquid; fitting a
syringe to the ampoule/device; filling the syringe with liquid from the ampoule;
withdrawing the syringe from the ampoule with the label attached to the syringe.
In a still further aspect the invention provides a method of labelling a medical syringe,
the method comprising: providing an ampoule; providing a device to couple said
syringe to said ampoule, wherein said device is configured to enable loading of said
syringe with contents of said ampoule without removal of said syringe from said device;
engaging said syringe with said device such that a label holder attached to said device
attached to said ampoule engages with said syringe; filling said syringe with said
contents of said ampoule; and withdrawing said filled syringe from said device such
that said label holder engaged with said syringe is carried by said syringe to label said
syringe.
Improved aspiration
Tests of the above described arrangements have revealed that on occasion when the
device is used to suck drug out from the inverted ampoule air comes into the ampoule
to replace the withdrawn drug as largish bubbles. If the needle is not in the centre of
the ampoule neck the air typically comes up the widest available passage and before
the bubble breaks away from the edge of the ampoule to float to the top of the liquid
(which is the base of the ampoule because the ampoule is upside down) it passes
alongside the top of the filling needle. Thus as aspiration of the drug continues a
portion of the air bubble that has just been drawn into the ampoule neck may be
aspirated into the syringe. Depending upon the conditions up to 30% air may be
aspirated.
Experiments have determined that two design features can ameliorate this problem:
arranging the device so that the aspiration tip is off-centre in the neck opening when
the contents of the ampoule are aspirated; and arranging for the suction at the
aspiration tip to be asymmetrical, in embodiments by providing the aspiration tip with a
nozzle having an opening on one side, and preferably closed at the tip end. Either of
these features may be employed independently of the other, but preferably they are
used in conjunction. Thus in embodiments the device holds the aspiration tip off-centre
in such a way that the opening on the aspiration tip is on the side farthest from the
most likely air ingress path; experiments with such an arrangement have demonstrated
aspiration of substantially 100% liquid.
In one embodiment the aspiration tip has a longitudinal chamber or conduit closed at
the end of the tip, and the nozzle is formed by providing an opening in a lateral side of
the longitudinal chamber or conduit, in embodiments adjacent the end of the tip. The
end of the aspiration tip may be slanted so that the side or face of the tip bearing the
opening of the nozzle is longer than an opposite side or face of the tip without such an
opening.
The above described arrangements are also useful outside the context of a syringe
labelling device because typically a little air is aspirated when filling a syringe from an
ampoule using a filling needle, albeit this is later tapped out.
Thus in a further aspect the invention provides a filling needle for filling a syringe from
an ampoule, the filling needle comprising: a female luer for fitting the needle to the
syringe; and an aspiration tip for aspirating the contents of the ampoule; and wherein
said aspiration tip comprises a nozzle with an opening on one side.
Preferably, as previously described, the nozzle is closed at the end of the filling needle.
The female luer may comprise, for example, a push fit or a luer lock connector.
The invention further provides a method of filling a syringe from an ampoule using such
a filling needle, in which the ampoule is held in a generally inverted position and the
filling needle is held off-centre with the side opening facing towards the closer side of
the ampoule neck.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other aspects of the invention will now be further described, by way of
example only, with reference to the accompanying figures in which:
Figures 1a to 1c show, respectively, an automatic syringe-labelling device according to
an embodiment of the invention, and the device before and after insertion of a syringe
for automatic labelling of the syringe;
Figures 2a to 2d show a sequence of steps illustrating use of the device of Figure 1 for
filling and labelling a syringe from an ampoule;
Figure 3 shows a vertical cross-section view through the device of Figure 1, and details
of an example label holder of the device;
Figures 4a and 4b show, respectively, a perspective and cross-sectional view of the
device in use to break the top off an ampoule;
Figures 5a to 5c show, respectively, a perspective view, an enlarged perspective view,
and a vertical cross-section view through the device after breaking the top off an
ampoule and prior to insertion of the nozzle of the female mounting portion of the
syringe into the open top of the ampoule for aspiration of the contents;
Figures 6a and 6b show, respectively, a 3D perspective view and a cross-section view
of the device after the nozzle of the female mating portion for the syringe has been
inserted into the open top of the ampoule;
Figure 7 illustrates aspiration of the contents and subsequent removal of the syringe
bearing the label holder;
Figure 8 shows a device (Marshall) for snapping off the top of an ampoule and labelling
a syringe;
Figure 9 shows the device of Figure 8 in use;
Figure 10 shows another device (Hartke) for snapping off the top of an ampoule and
labelling a syringe;
Figure 11 shows the device of Figure 10 in use;
Figure 12 shows a further example of a device (Fender) for snapping off the top of an
ampoule and labelling a syringe, illustrating use of the device;
Figure 13 shows a still further example of a device (Ampeg) for snapping off the top of
an ampoule and labelling a syringe;
Figure 14 shows the device of Figure 13 in use;
Figures 15a to 15c show a preferred example of an aspiration tip for use in
embodiments of the invention illustrating, respectively, a nozzle with an opening on one
side, the nozzle inserted into the neck of an ampoule, and a vertical cross-sectional
view showing a longitudinal chamber within the aspiration tip terminating with a closed
end and a nozzle with a side opening; and
Figure 16 shows a syringe labelling device having an integral syringe cap.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Broadly, according to one aspect of the invention we will describe a device for
attaching to an ampoule to place a label referring to the contents of the ampoule to a
syringe to be filled with the contents.
Referring to Figure 1a this shows an embodiment 100 of a device for breaking the
snap-top 152 of an ampoule 150 and for automatically labelling a syringe 160 after it is
filled from the ampoule. The device comprises an ampoule mounting portion 102
including an ampoule holder 104 which, in the illustrated embodiment, contains the
ampoule, optionally in clear plastic or with an opening to facilitate reading a label of the
ampoule. The device also has a syringe-fitting portion 110 comprising a syringe
housing 112 including a female luer fitting 114 having an aspiration tip or nozzle 116 for
aspirating the contents of the ampoule. As illustrated the ampoule-mounting portion
102 of the device comprises a main body of the device and this is formed of two parts
(front and rear) which attach or clamp around the ampoule 150 (in embodiments these
may comprise a clamshell-type plastic moulding).
As illustrated, initially the syringe is at an oblique angle to the ampoule, and hence a
longitudinal axis of the syringe fitting portion is at an oblique angle to a longitudinal axis
of the ampoule-mounting portion. (The angle may be considered obtuse or acute,
depending upon from where it is measured, although potentially in embodiments the
syringe could either start straight or at 180° to the ampoule axis). The mechanism of
the device is configured to constrain the syringe fitting portion (syringe) to first
predominantly rotate with respect to the ampoule-mounting portion (ampoule) and then
predominantly to translate towards the ampoule.
The illustrated embodiment is particularly suitable for multiple use, having a relatively
robust mechanism. In the illustrated example this mechanism comprises a pivot 120 in
a slot 122, optionally reinforced, to allow the syringe-fitting portion both to rotate and to
translate with respect to the ampoule-mounting portion of the device. A surface 124 of
the ampoule-mounting portion provides a cam surface and a portional plate 126 of the
syringe fitting portion that acts as a cam follower moving over this surface. The cam
surface has a curved portion at one end (a distal end with respect to the ampoule)
followed by a substantially straight or flat portion so that the syringe-fitting portion must
be rotated before it can be translated towards the ampoule.
The rotational motion brings a forcing portion or projection of the syringe-fitting part of
the device to bear on the snap-top or cap 152 of the ampoule, to break this off and then
the translational motion inserts the aspiration tip or nozzle 116 of the syringe-fitting part
of the device into the then open ampoule top. The ampoule top is contained within a
cavity (not shown) of the main body 102 of the device and, in embodiments, the
syringe-fitting portion 110 is provided with a cover plate 128 for increased safety, to
further inhibit broken glass from escaping from the device, and to inhibit user access to
the sharp top of the opened ampoule.
The syringe-fitting portion 110 is provided with a detachable label holder 130, in the
illustrated example in the form of a collar with a gap 132 in the circumference of the
collar. The collar is provided with a plurality of clips 134 disposed circumferentially
around the base of the collar, and these grip a flange at the top of the syringe-fitting
portion 110. The diameter of the collar may be selected such that the clips 134 are
biased inwards to grip the flange 136, for example by making a diameter of the collar
slightly smaller than defined by the syringe-fitting portion 110. The diameter of the
collar is chosen to be slightly smaller than that of the syringe so that when the syringe
160 is inserted into the syringe-fitting portion 110 the collar 130 expands and clips 134
release the flange 136, so that when the syringe is withdrawn from the device the label
holder 130 remains attached to the syringe and is detached from device 100.
Figures 1b and 1c illustrate a moulded embodiment of a device similar to that of Figure
1a, in use. In these and subsequent figures like elements to those previously described
are indicated by like reference numerals.
Referring now to Figures 2a to 2d, these illustrate stages in the use of the device 100.
Thus Figure 2a illustrates insertion of the syringe 160 into the syringe-fitting portion
110; Figure 2b illustrates rotation of the syringe and syringe-fitting portion to align the
syringe 160 with the ampoule 150 (and the syringe-fitting portion with the ampoulemounting
portion), thereby snapping off the snap top 152 of the ampoule (although not
apparent, in Figure 2b the ampoule top is snapped off). Then the syringe and syringefitting
portion are pushed towards the ampoule-mounting portion so that the pivot 120
slides along slot 122, to insert the aspiration tip or nozzle 116 of the syringe-fitting
portion into the ampoule, before drawing up the contents of the ampoule into the
syringe (figure 2c). Then, in Figure 2d, the syringe 160 is removed from the device
with the label holder 130 attached to the syringe. Initially the label holder is at the base
of the syringe; in embodiments the label holder is provided with a set of internal teeth
or barbs so that the label holder moves easily only in one direction along the syringe
body, so that it cannot easily be removed after filling the syringe. Optionally the label
holder 130 may be pushed up towards the flange 162 of the syringe so that it does not
obscure gradations on the syringe and/or the label holder may be formed of clear
plastic.
Figure 3 illustrates the label holder 130 and its attachment to the device 100 in an
example embodiment, in more detail. Thus figure 3 shows a set of metal barbs 138
which engage the outer plastic body of the syringe 160. When the syringe is inserted,
the metal barbs lock the label ring to the syringe.
Figure 4 illustrates the process of snapping the top off the ampoule in more detail. As
can be seen the projection 114 of the syringe fitting portion bears against the top 152 of
the ampoule and when the top is broken off it is received by a cavity 140 within the
ampoule-mounting portion. As can be seen the length of the syringe provides a lever
which helps a user to snap the top off the ampoule. In some preferred embodiments a
snap lock 142 is provided to lock the syringe in its vertical position once the top of the
ampoule has been snapped off. This is illustrated in more detail in Figures 5a and 5b,
which show the ampoule top 152 locked into cavity 140 by mating male and female
snap features 142 on the syringe-fitting portion and ampoule-mounting portion (main
body) of the device. Figure 5c shows in more detail how the ampoule top is securely
retained in cavity 140 by the nozzle and female luer of the syringe-fitting portion of the
device.
Figures 6a and 6b illustrate insertion of the syringe, more particularly the female luer
fitting (luer receiving portion) of the syringe-mounting portion 110 into the ampoule so
that the aspirating nozzle/tip 116 is 1-2mm below the open end of the nozzle. In some
preferred embodiments when the syringe slides down into the top of the ampoule,
positioning it for aspiration, a second lock 144 locks the syringe fitting portion into its
aspirating position. Again, in embodiments, the lock 144 may comprise a mating pair
of snap features on the syringe-fitting portion 110 and ampoule-mounting portion 102
respectively, for example a plastic ratchet.
Figure 7 illustrates filling of the syringe with the contents of the ampoule, normally done
in an inverted position as illustrated (surface tension inhibits the liquid contents of the
ampoule from spilling out during this process). Then the syringe 160 is removed from
the device, bearing the label holder 130. At this stage the device 100 encloses the
emptied ampoule and sharp elements and, depending upon local regulations, may then
be disposed of in normal rather than special "sharps" waste.
Thus the device aids a clinician in the transfer of liquid medication from a glass
ampoule to a syringe. The safety features mean that it is difficult to incorrectly label a
syringe without deliberate intent to do so.
It is envisaged that the device will be shipped with a filled ampoule already in place.
This places the responsibility for getting the correct drug/label combination on the drug
company. The fitting of the device can be seen as the final stage in the packaging
process. (The syringe is unlikely to be shipped together with the device).
In embodiments the device is made entirely from injection moulded plastic, with the
possible addition of some thin metal components to help the label ring grip onto the
outer surface of the syringe. The device described above is a machined prototype: the
general functionality of a production device may be similar to this, but made from fewer
components and specifically designed to prevent multiple use.
Suitable materials for manufacture include polypropylene (PP), high-density
polyethylene (HDPE) and polycarbonate (PC). The benefit of PC is its optical clarity
which aids vision of the ampoule itself (to see if air bubbles remain, for example) and
gradations on the syringe that is to be used. It is also possible to tint PC such that a
colour is imparted to correspond to the drug whilst maintaining a good degree of optical
clarity.
The mechanism in the machined prototype may be modified for moulding. In the
machined embodiment, the Cam Follower slides over the Cam Surface, providing the
desired rotation-followed-by-sliding motion. However it may be preferable to use pivots
and links rather than a sliding mechanism, and 'living hinges' may be used to simplify
assembly and reduce the number of parts. (Broadly, a living hinge is a hinge made
from a locally thinned piece of plastic between two thicker, more solid sections of the
same component).
Use of the device is as follows, in an example procedure:
• unpack the device. This may comprise removing it from a standard Tyvek
(RTM) pouch as is used to pack a syringe, or a rip-off strip may be provided that
is directly attached to the device.
· unpack a suitable syringe. Note that different versions of the device may each
be dedicated to a single syringe size to ensure that no half-doses are given.
• orient the syringe such that the male luer fitting on the end lines up with the
female luer fitting in the syringe housing (syringe fitting portion of the device).
• press the syringe into the device. The luer fitting should be made and the
devices should be well locked together. At this point, the label ring will have
gripped onto the syringe.
• lift the syringe upwards to straighten the device. This will break the Ampoule
Cap off the Ampoule and an audible 'crack' can be heard. This is followed by a
'click' as the Syringe Housing locks into this position to prevent re-use.
• press the syringe down towards the ampoule. In the final device, another click
will be heard as the mechanism locks into a final position, thus preventing any
re-use or the glass ampoule cap from falling out. The aspiration tip will now be
inside the neck of the ampoule and in embodiments the cover plate
substantially completely covers the sharp parts of the ampoule and the brokenoff
cap.
• invert the device and aspirate the medication in the usual way.
• when the drug has been transferred to the syringe, the syringe can be removed:
The label holder (label ring) comes away with the syringe, ensuring that the
label and drug correspond to one another.
In embodiments the device allows drugs to be supplied in glass ampoules, hence
extending shelf life. In some preferred examples of the device the drug is drawn
through the aspiration tip 116 and through a filter (not shown in the drawings). In
embodiments the drug may be drawn up into the syringe through a 0.2mhi filter, to
provide sterility and for the absence of microscopic glass shards. Afterwards, a part of
the device may be applied to the tip of the syringe as a sterile bung. During the
process, a label is applied to the syringe stating drug name, class and dose. This
removes the labelling step, which is prone to error. Preferably the label is large enough
to allow large print and use of colour and visual cues to reduce errors caused by
selecting the wrong drug.
Referring now to Figure 8, this shows a further example of a syringe labelling device
1000 comprising a once-piece moulded plastic item in which the ampoule-mounting
portion 102 provides a cap for the snap-top of the ampoule, and in which a label 1002
is attached over the female luer of the syringe-fitting portion 110 so that this must be
removed before the syringe can be filled. Figure 9 illustrates steps in the use of the
device: removing the label, fitting a syringe, using a syringe as a lever to break the top
off the ampoule, and then inserting the nozzle 116 of the syringe-fitting portion into the
ampoule and filling the syringe (in an inverted position).
Figure 10 illustrates a second example of a device 1010 for snapping the top off an
ampoule and labelling a syringe. In this example a label 1012 is placed across the
snap-top of the ampoule when the ampoule is mounted in the device, so that this label
must be removed before the top can be snapped off the ampoule. The syringe-fitting
portion 110 is hinged to the device, for use as illustrated in figure 11: the tip of the
syringe is inserted into the syringe-fitting portion when the syringe and ampoule are
parallel to one another and then the syringe is used as a lever so that the forcing
portion 114 of the device snaps off the snap-top of the ampoule, to contain this within
cavity 140, allowing the syringe and ampoule to be aligned (anti parallel) for the syringe
to be filled.
Figure 12 illustrates a further example of a device 1020 for breaking the top off an
ampoule and enforcing labelling of a syringe filled with the contents of the ampoule. In
this example a push button 1022 transmits a force to the ampoule top for snapping the
top off. The push button 1022 is coupled to the ampoule mounting portion 102 by a set
of bellows 1024 and the ampoule-mounting portion comprises a moulded housing
which provides a substantially air-tight enclosure for the top of the ampoule. A
detachable label 1026 covers an air bleed hole 1028 into the space above the top of
the ampoule and thus this label must be removed in order to permit the syringe to be
easily filled with the contents of the ampoule. The cross sectional views of Figure 12
also show a particle filter 1029 between an inlet to the syringe and the ampoule
opening, for example a mechanical 0.2 mhi filter. In some preferred implementations of
the previously described devices such a filter is also present, to filter glass particles
from the aspirated drug.
Figure 13 illustrates a further example of a device 1030 for snapping off the top of an
ampoule and labelling a syringe. In the example at Figure 13 it is anticipated that the
syringe, ampoule and device 1030 will be shipped together, as illustrated. The
ampoule is held around the neck of the ampoule by a collar 1032 which, preferably,
can be folded to lie flat against the device 1030. A label 1034 is attached to the device
(permanently) and remains on the device, which remains attached to the syringe after
filling with the contents of the ampoule, as illustrated in Figure 14. The ampoule top
may be snapped off manually, this being facilitated by the ampoule being held by the
device 1030. Once the ampoule top has been removed the ampoule is detached from
the device and the syringe, which remains attached to the labelled device, is filled with
the contents of the ampoule.
Referring now to Figure 15, this shows an example of an aspiration tip 1500 of the
syringe fitting portion of the device, the tip comprising a nozzle 1502 having an opening
1504 on one side leading into an internal chamber or conduit 1506 to the female luer
for mounting the syringe. As can be seen in Figure 15c, in use the aspiration tip is offcentre
within the neck of the ampoule. A filling needle for filling a syringe without using
the labelling device may simply comprise a short metal shaft, for example 10-30 mm
long, with a blunt, closed end and an opening towards a tip on one side to provide fluid
communication with a longitudinal internal conduit, leading to a female luer at the other
end of the needle. Thus, broadly speaking, such a needle may comprise a "stripped
down" version of the syringe fitting portion illustrated in Figure 15c.
Figure 16 illustrates an example of a cap 1600 which may be moulded with the label
part of the device. Once filled the syringe is withdrawn from the device and the cap
allows for short-term storage of the syringe without contaminating the tip.
No doubt many other effective alternatives will occur to the skilled person. It will be
understood that the invention is not limited to the described embodiments and
encompasses modifications apparent to those skilled in the art lying within the spirit
and scope of the claims appended hereto.

CLAIMS:
1. A device for attaching to an ampoule to label a syringe filled from the ampoule,
the device comprising:
an ampoule-mounting portion for mounting the device to said ampoule;
a syringe-fitting portion to enable the device to be fitted onto said syringe; and
a label holder to hold a label for contents of said ampoule;
wherein one of said syringe and said ampoule is detachable from said device;
and
wherein said label holder is configured such that in conjunction with a filling
operation of said syringe and detachment of said one of said syringe and said ampoule
from said device said syringe is able to be labelled by said label.
2. A device as claimed in clam 1 wherein said label is detachable from said device
for attachment to said syringe in conjunction with said filling operation.
3. A device as claimed in claim 2 wherein said detachable label is positioned such
that said label must be at least partially removed for an effective said filling operation.
4. A device as claimed in claims 1, 2 or 3 having a portion configured for snapping
off a snap-top of said ampoule.
5. A device as claimed in claim 4 wherein said portion configured for snapping off
said snap-top comprises a cap or collar for said snap-top.
6. A device as claimed in claim 4 or 5 wherein said syringe-fitting portion of said
device is mounted to allow motion of said syringe-fitting portion relative to said device
such that said motion applies a force to said snap-top to perform said snapping off.
7. A device as claimed in claim 4, 5 or 6 configured such that said label holder is
released to enable attachment of said label to said syringe by said snapping off of said
snap-top.
8. A device as claimed in any preceding claim for automatically labelling said
syringe, wherein said label holder is detachable from said device and configured such
that, when said syringe is engaged with said syringe-fitting portion and then removed
from said syringe-fitting portion, said label holder attaches to said syringe and is
detached from said device to automatically label said syringe.
9. A device as claimed in claim 8 wherein said label holder comprises a collar for
said syringe.
10. A device as claimed in claim 9 wherein said label holder further comprises a
fold-out longitudinal label portion attached to said collar, for folding out to lie parallel to
an axis of said collar and along a longitudinal length of said syringe.
11. A device as claimed in claim 9 or 10 wherein said collar comprises clear plastic.
12. A device as claimed in any preceding claim wherein a colour of said label
holder or of said device substantially matches a colour of said label.
13. A device as claimed in any preceding claim further comprising a cavity to hold
said snap-top after said snapping off.
14. A device as claimed in any preceding claim wherein the device has two
configurations, a first, syringe-attaching configuration for attaching said syringe to the
device and a second, syringe-filling configuration for filling said syringe with liquid from
said filled ampoule;
wherein the device is reconfigurable between said first configuration and said
second configuration; and
wherein said reconfiguration between said first configuration and said second
configuration applies a force to snap-off a snap-top of said ampoule.
15. A device as claimed in claim 14 wherein said syringe-fitting portion of said
device is hingedly attached to said ampoule-mounting portion of said device;
wherein in said first configuration said syringe-fitting portion holds said syringe
at an angle to said ampoule such that said syringe and said ampoule are out of
longitudinal alignment with one another;
wherein in said second configuration said syringe-fitting portion holds said
syringe in longitudinal alignment with said ampoule to enable said syringe to be filled
from said ampoule; and
wherein hinging said syringe-fitting portion of said device with respect to said
ampoule-mounting portion of said device to bring said syringe into longitudinal
alignment with said ampoule brings a forcing portion of said device to bear on a snaptop
of said ampoule to snap off said snap-top.
16. A device as claimed in claim 15 wherein said hinged attachment between said
syringe-fitting portion of said device and said ampoule-mounting portion of said device
is configured to allow both relative rotation and relative translation between said
portions of said device such that said syringe-fitting portion is constrained to first
predominantly rotate with respect to said ampoule-mounting portion and then to
predominantly translate towards said ampoule-mounting portion, to said bring said
forcing portion of said device to bear on said snap-top to snap off said snap-top, and
then to move a nozzle of said syringe-filling portion towards an open top of said
ampoule.
17. A device as claimed in claims 14 or 15 further comprising a safety lock to inhibit
motion of said syringe-fitting portion once said snap-top has been snapped off.
18. A device for attaching to an ampoule to facilitate filling a syringe from the
ampoule, the device comprising:
an ampoule-mounting portion for mounting the device to a filled ampoule; and
a syringe-fitting portion to enable the device to be fitted onto said syringe;
wherein the device has two configurations, a first, syringe-attaching
configuration for attaching said syringe to the device and a second, syringe-filling
configuration for filling said syringe with liquid from said filled ampoule;
wherein the device is reconfigurable between said first configuration and said
second configuration and said configuration; and
wherein said reconfiguration between said first configuration and said second
configuration applies a force to snap-off a snap-top of said ampoule.
19. A device as claimed in claim 18 further comprising a cavity to capture and hold
a snapped-off top of said ampoule.
20. A device as claimed in claim 18 or 19 wherein said syringe-fitting portion of said
device is hingedly attached to said ampoule-mounting portion of said device;
wherein in said first configuration said syringe-fitting portion holds said syringe
at an angle to said ampoule such that said syringe and said ampoule are out of
longitudinal alignment with one another;
wherein in said second configuration said syringe-fitting portion holds said
syringe in longitudinal alignment with said ampoule to enable said syringe to be filled
from said ampoule; and
wherein hinging said syringe-fitting portion of said device with respect to said
ampoule-mounting portion of said device to bring said syringe into longitudinal
alignment with said ampoule brings a forcing portion of said device to bear on a snaptop
of said ampoule to snap off said snap-top.
2 1. A device as claimed in claim 20 wherein said hinged attachment between said
syringe-fitting portion of said device and said ampoule-mounting portion of said device
is configured to allow both relative rotation and relative translation between said
portions of said device such that said syringe-fitting portion is constrained to first
predominantly rotate with respect to said ampoule-mounting portion and then to
predominantly translate towards said ampoule-mounting portion, to said bring said
forcing portion of said device to bear on said snap-top to snap off said snap-top, and
then to move a nozzle of said syringe-filling portion towards an open top of said
ampoule.
22. A device as claimed in claim 20 or 2 1 wherein said hinged attachment
comprises a sliding hinge.
23. A device as claimed in claim 20 or 2 1 wherein said hinged attachment
comprises a 4-bar linkage.
24. A device as claimed in claim 20, 2 1, 22 or 23 further comprising a rotation lock
to inhibit rotation back once said syringe-fitting portion and said ampoule-mounting
portion are longitudinally aligned.
25. A device as claimed in any one of claims 20 to 24 when dependent on claim 19
wherein said forcing portion of said device which bears on said snap-top is arranged to
push said snapped off top into said cavity.
26. A device as claimed in any one of claims 18 to 25 further comprising a safety
lock to inhibit motion of said syringe-fitting portion away from said ampoule-mounting
portion once said snap-top has been snapped off.
27. A device as claimed in any one of claims 18 to 26 further comprising a
detachable label holder to hold a label for the contents of said ampoule, and wherein
said label holder is configured to engage said syringe on or after fitting of said syringe
into said device, such that on withdrawal of said syringe from said device after filling
said detachable label-holder is detached from said device and attached to said
syringe.
28. A device for labelling a medical syringe, the device having an ampoule
mounting portion for mounting the device to a filled ampoule, a detachable label holder
to hold a label for the contents of said ampoule, and a syringe-fitting portion to enable
the device to be fitted onto said syringe, and wherein said label holder is configured to
engage said syringe on or after fitting of said syringe into said device such that on
withdrawal of said syringe from said device after filling said detachable label-holder is
detached from said device and attached to said syringe.
29. A device for enabling filling of syringe from an ampoule, the device comprising:
an ampoule-mounting portion for mounting the device to a filled ampoule;
a syringe-fitting portion to enable the device to be fitted onto said syringe; and
a cavity for holding a snapped-off top of said ampoule;
wherein said syringe fitting portion is hingedly attached to said ampoule
mounting portion;
wherein the device has two configurations, a first, syringe-attaching
configuration in which an axis of the syringe fitting portion is at an oblique angle to an
axis of said ampoule-mounting portion and a second syringe-filling configuration in
which the syringe fitting portion and the ampoule-mounting portion are aligned to
enable the syringe to be filled from the ampoule;
wherein the device is reconfigurable between said first configuration and said
second configuration and said configuration; and
wherein, in going from said first to second configuration, the ampoule top is
snapped off and the top is captured in the cavity.
30. A device as claimed in claim 29 wherein said cavity is located substantially
behind a hinging junction between said syringe-fitting portion and said ampoulemounting
portion.
3 1. A device as claimed in any preceding claim wherein said ampoule-fitting portion
is configured to hold said ampoule at both a neck and a base end of said ampoule.
32. A one-piece moulded device for attaching to an ampoule to facilitate filling a
syringe from the ampoule, the device comprising:
an ampoule-mounting portion for mounting the device to a filled ampoule; and
a syringe-fitting portion to enable the device to be fitted onto said syringe; and
wherein said ampoule-mounting portion comprises a cap for a snap-top of the
ampoule;
wherein said syringe-fitting portion comprises a female luer fitting for the
syringe;
wherein an opening of said cap to receive said ampoule faces in a generally
opposite direction to an opening of said female luer fitting to receive said syringe such
that, in use, said syringe and said ampoule are generally antiparallel; and
wherein, in use, said syringe is usable as a lever to snap off said snap-top of
said ampoule.
33. A device as claimed in any preceding claim wherein said syringe-fitting portion
has an aspiration tip, and wherein said aspiration tip comprises a nozzle with an
opening on one side.
34. A device as claimed in claim 33 wherein said nozzle is closed at the end.
35. A device as claimed in claim 33 or 34 configured to hold said aspiration tip offcentre
in a neck opening of said ampoule when aspirating the contents of said
ampoule.
36. A device as claimed in claim 35 when dependent on claim 33 or 34 wherein the
device is configured to hold said aspiration tip such that a space between said nozzle
and a first portion of said neck is smaller than a space between said nozzle and a
second portion of said neck, and wherein said opening of said nozzle is arranged to
face said first portion of said neck.
37. A device as claimed in any preceding claim wherein said syringe-fitting portion
incorporates a mechanical particle filter in a fluid passage between a nozzle of said
syringe-fitting portion to receive a fluid from said ampoule and a fluid connection to said
syringe.
38. A device as claimed in any preceding claim in combination with said ampoule.
39. A device as claimed in any preceding claim in combination with said syringe.
40. A filling needle for filling a syringe from an ampoule, the filling needle
comprising:
a female luer for fitting the needle to the syringe; and
an aspiration tip for aspirating the contents of the ampoule; and
wherein said aspiration tip comprises a nozzle with an opening on one side.
4 1. A filling needle as claimed in claim 40 wherein said nozzle is closed at an end
of said filling needle.
42. A method of automatically labelling a syringe, the method comprising:
attaching a label to a device on an ampoule of liquid;
fitting a syringe to said device;
filling the syringe with liquid from the ampoule;
withdrawing the syringe from the ampoule with the label attached to the syringe.
43. A method as claimed in claim 4 1 wherein said device comprises a label holder
holding said label, and wherein, after said withdrawing, said label holder is attached to
said syringe.
44. A method of labelling a medical syringe, the method comprising:
providing an ampoule;
providing a device to couple said syringe to said ampoule, wherein said device
is configured to enable loading of said syringe with contents of said ampoule without
removal of said syringe from said device;
engaging said syringe with said device such that a label holder attached to said
device attached to said ampoule engages with said syringe;
filling said syringe with said contents of said ampoule; and
withdrawing said filled syringe from said device such that said label holder
engaged with said syringe is carried by said syringe to label said syringe.
45. A method as described in claim 42, 43 or 44 comprising providing said ampoule
in conjunction with said device.
46. A method of filling a syringe from an ampoule using the filling needle of claim 40
or 4 1, the method comprising removing a top of said ampoule to leave an open neck;
and aspirating the contents of said ampoule with the ampoule in an inverted position
using a syringe fitted with said filling needle, wherein said aspirating comprises holding
said filling needle off-centre in said open neck such that said filling needle is displaced
towards one side of said open neck, and arranging said opening of said nozzle such
that it faces towards said one side of said open neck.