A Pharmaceutical Component-Mixing Delivery Assembly
Field of the Invention
The present invention relates to a novel syringe suitable for mixing a pair of
components.
More particularly, the invention relates to a novel syringe suitable for mixing a two
component system, such as a solid medicament and a liquid, liquid/ liquid
components, viscous/non-viscous components, etc. The present invention also relates
to methods related thereto.
Background to the Invention
Many medicaments are unsuitable for the long term storage as a liquid solution
because they may be unstable when mixed into a solution and thus have a shorter
shelf-life than other forms. Such medicaments may be reconstituted with a diluent or
carrier, usually a liquid, prior to administration. Thus, liquid or solid medicaments
may be stored in a sealed vial prior to reconstitution. Increasingly, prefilled syringes
capable of separate storage of at least two different components are being used. Such
syringes usually comprise a medicinal component stored in a first chamber and a
dissolving or dispersing agent in a second chamber. The components are kept apart
until use.
Dual chamber syringes have been developed which can suitably be used with
powdered medicaments and a suitable liquid. Such dual chambers may be used for
the administration of "biopharmaceuticals", such as recombinant proteins; and the
like.
One example of a commercially successful dual chamber syringe is the Vetter Lyo-
Ject® dual chamber syringe, which is known to be used with recombinant antihaemophilic
factor. The recombinant anti-haemophilic factor is lyophilised in situ in
the syringe. The Vetter syringe is described in US Patent No. 6,419,656 and
comprises a tubular body extending along an axis; a plunger axially slidable in the
body and a free piston slidable in the body forward of the plunger. The plunger
subdivides the body into a front compartment, forward of the plunger, and a rear
compartment between the plunger and the piston. The body is also provided with a
bypass passage forward of the piston. In use, a lyophilised medicament is located in
the front compartment and a liquid is located in the rear compartment. When the
plunger is depressed and the second compartment is drawn alongside the bypass
chamber, the liquid is able to flow into the first compartment and solubilise the
medicament or form a suspension of the medicament.
However, one disadvantage of dual chamber syringes, such as the Vetter Lyo-Ject®
syringe, is that it is expensive to manufacture. Also producing a lyophilised powdered
medicament in situ in the syringe is difficult and does not lend itself to rapid and large
scale manufacturing techniques.
Other dual chamber syringes are known. For example, US Patent No. 5,281,198
describes a syringe assembly suitable for multiple pharmaceutical components, such
as a lyophilized medicament component and a diluent component contained within
first and second cartridges fitted with a movable piston. The second cartridge is
forced into the interior of the first cartridge causing a spike or needle assembly to
couple the two cartridges and causing the contents of the first cartridge to be driven
into the second cartridge, thereby mixing them. A ratchet plunger is used to drive a
second piston, the distance that the ratchet plunger moves determining the dose
administered.
However, one disadvantage with such devices is that small particles may be generated
when the spike or needle assembly penetrates or pierces a septum dividing a first and
second cartridge. Furthermore, the user may experience considerable resistance or
friction in pushing the plunger to pierce the septum. It is also important that the
sterility of the syringe is maintained until the device is ready to be used.
Summary of the Invention
We have now found a device that overcomes or mitigates the problems associated
with the prior art devices. More particularly, we have found a novel dual syringe
assembly which avoids the need to pierce a septum. Furthermore, the novel device of
the present invention can suitably utilise conventional standard syringe components,
avoiding the need for a bypass chamber to be built into the body of a syringe.
Thus, according to a first aspect of the present invention there is provided a
pharmaceutical component-mixing delivery assembly comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component.
In a particular embodiment the non-invasive valve component, e.g. comprising a
piston, is provided with a terminal rib, that is, a circumferential rib located at the end
of the non-invasive valve component nearest to the open end of the second cartridge.
The inclusion of a terminal rib is advantageous in that, inter alia, it allows the sterility
of the delivery assembly to be maintained when the device is primed before injection.
Furthermore, the non-invasive valve component, e.g. a piston, may be generally
elongated. The region of the second cartridge that contains the second pharmaceutical
component will generally comprise an aseptic mixing chamber, whilst the inner wall
of the second cartridge outside of the mixing chamber and beyond the terminal rib of
the piston, will generally be non-aseptic. In use, as the plunger of the delivery
assembly is depressed and the piston moves towards the inlet end of the second
cartridge, the mixing chamber essentially expands longitudinally. Thus, the length of
the piston is desirably chosen so that as the piston moves, the mixing chamber never
comes into contact with the non-aseptic walls of the second cartridge and the sterility
of the mixing chamber is maintained at all times. Therefore, the length of the piston
will be dictated by how far back along the second cartridge it has to move, which will
in turn be dictated by the volume required for the mixing chamber.
In a particular aspect of the invention the non-invasive valve component may
comprise a ball valve, a flow through stopper component or a T-shaped stopper
component.
The pharmaceutical component-mixing delivery assembly will generally comprise a
syringe assembly. Thus, the pharmaceutical component-mixing delivery assembly
hereinbefore described may include a needle, e.g. a hypodermic needle, attached to
the outlet end of the second cartridge.
One of the first and second pharmaceutical components may comprise a solid
therapeutically active agent and the other is a liquid capable of solubilising or forming
a suspension with the solid therapeutically active agent. In a particular aspect of the
invention the first pharmaceutical component comprises a liquid and the second
pharmaceutical component comprises a solid therapeutically active agent. However,
it will be understood by the person skilled in the art that the first and second
pharmaceutical components may comprise liquid/ liquid components, viscous/nonviscous
components, etc.
The use of a non-invasive valve as hereinbefore described is advantageous in that,
inter alia, conventional syringe bodies and/or plungers may be utilised, significantly
reducing the expense of the syringe assembly as a whole It also avoids, for example,
the need for an elastomeric septum.
In one aspect of the invention the non-invasive valve component may comprise a ball
valve. Such a ball valve component may comprise one or more balls located within
the outlet of the first cartridge, such that the ball(s) acts to seal the first cartridge. The
ball valve component includes a substantially hollow apertured piston suitable for
receiving the ball from the first cartridge.
More specifically, the ball valve component may comprise a substantially hollow
apertured piston with a first end adjacent the outlet end of the first cartridge and a
second end adjacent the inlet end of the second cartridge. The hollow apertured
piston will comprise side walls which generally form a seal against the inner walls of
the second cartridge.
The first end of the piston may comprise means for locating the outlet end of the first
cartridge. For example, such means may comprise a substantially circumferential
ridge. The second end of the piston may comprise one or more apertures which, when
in use, are dimensioned to allow fluid to flow.
A single ball or a plurality, e.g. two or three balls, may be located within the outlet of
the first cartridge, such that the ball(s) acts to seal the first cartridge.
In use, when the plunger is depressed within the first cartridge the fluid pressure will
force the ball valve to open allowing fluid to flow from the first cartridge to the
second cartridge enabling mixing to occur.
In another aspect of the invention the non-invasive valve component may comprise a
ball valve as hereinbefore described. However, the second end of the piston may
comprise a separate plug component which is provided with one or more apertures
which, when in use, are dimensioned to allow fluid to flow. In addition, the plug
component may be provided with means for displacing the ball from the outlet of the
first cartridge allowing fluid to flow from the first cartridge to the second cartridge
enabling mixing to occur. Thus, in accordance with this aspect of the invention there
is provided a pharmaceutical component-mixing delivery assembly as hereinbefore
described wherein the ball valve component includes a plug component which is
provided with one or more apertures and which is provided with means for displacing
the ball from the outlet of the first cartridge. One example of such displacement
means is a plug provided with a protruding spigot.
In another aspect of the invention the non-invasive valve component may comprise a
flow through stopper component. The flow through stopper component may comprise
a stopper which is provided with conduit means. Said conduit means may comprise
an internal conduit within the stopper or alternatively, may comprise an external
conduit, that is, a conduit between the walls of the piston and the stopper.
One example of a flow through stopper component with an internal conduit is a Tvalve.
Such a T-valve component may comprise a substantially hollow apertured
piston with a first end adjacent the outlet end of the first cartridge and a second end
adjacent the inlet end of the second cartridge. The hollow apertured piston will
comprise side walls which generally form a seal against the inner walls of the second
cartridge as hereinbefore described.
The first end of the piston may comprise means for locating the outlet end of the first
cartridge. For example, such means may comprise a substantially circumferential
ridge. The piston also houses a stopper which has a flow through capability and
which seals the outlet end of the first cartridge. Said stopper may comprise an
internal conduit which is substantially coaxial with the longitudinal axis of the first
cartridge, but which is provided with one or more branches which seal against the side
walls of the piston.
In use, when the plunger is depressed within the first cartridge the fluid pressure will
displace the flow through stopper such that the one or more branches of the conduit
are no longer sealed against the side walls of the piston allowing fluid to flow from
the first cartridge to the second cartridge enabling mixing to occur. Optionally, a
second stopper may be provided adjacent the inlet of the second cartridge. The
second stopper may also be provided with one or more branched conduits, which act
in a substantially similar manner to the first.
In any of the embodiments described herein the side walls of the non-invasive valve
component may be provided with one or more external ribs to improve the seal
formed between the non-invasive valve component and the second cartridge. Thus,
for example, when the non-invasive valve component comprises a piston, the piston
may be ribbed, i.e. is provided with one or more external ribs, to improve the seal
formed between the piston and the inner walls of the second cartridge. Preferably the
piston is provided with one or more circumferential ribs. It is especially preferred for
the piston to be provided with a plurality of circumferential ribs, e.g. 2, 3 or 4 ribs.
An alternative example of a flow through stopper component with an external conduit
is an "annular valve". Although an "annular valve" possesses a similar functionality
to the aforementioned T-valve, the "annular valve" stopper itself does not comprise an
internal conduit.
Adjacent the first cartridge the internal walls of the piston are configured to form a
snug fit with the stopper. In this first position, the stopper seals the first cartridge.
The piston also provides a second position wherein the stopper forms a loose fit, such
a conduit external to the stopper is formed between the stopper and the piston, such
that fluid may pass through the conduit, between the walls of the piston and the
stopper.
Thus, according to this aspect of the invention there is provided a pharmaceutical
component-mixing delivery assembly as hereinbefore described wherein the "annular
valve" comprises a piston configured to form a snug fit with a stopper which seals the
first cartridge; and
wherein the piston provides a second position wherein the stopper forms a loose fit,
such that fluid may pass between the walls of the piston and the stopper.
The use of a T-valve is advantageous, inter alia, in that:
It provides guidance for the piston in the hollow stopper (the plug cannot tilt)
Aids assembly - physical stop
Prevents the piston being accidently drawn back into the syringe
Ribs provide enhanced sealing in the neck of the of the cartridge
The larger diameter part is held by the hollow stopper which provides
additional retention of the piston
According to a further aspect of the present invention there is provided a method of
operating a pharmaceutical component-mixing delivery assembly holding first and
second pharmaceutical components; said delivery assembly comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component;
said method comprising pressing the plunger axially into the first cartridge to an
intermediate position thus pressurizing the first cartridge and opening the non
invasive valve component, causing the first pharmaceutical component to flow
through the valve and into the second cartridge to mix with the second pharmaceutical
component.
According to a yet further aspect of the present invention there is provided a method
of administering a therapeutically active agent to a patient which comprises operating
a pharmaceutical component-mixing delivery assembly holding first and second
pharmaceutical components; said delivery assembly comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component;
said method comprising the steps of:
(i) pressing the plunger axially into the first cartridge to an intermediate
position thus pressurizing the first cartridge and opening the a non-invasive valve
component, causing the first pharmaceutical component to flow through the valve and
into the second cartridge to mix with the second pharmaceutical component;
(ii) after the first and second pharmaceutical components have mixed,
administering the mixed pharmaceutical components to a patient.
According to a particular aspect of the method of the invention the non-invasive valve
component is provided with a terminal rib to improve the seal formed between the
non-invasive valve component and the second cartridge.
The pharmaceutical component-mixing delivery assembly will generally comprise a
syringe assembly. Thus, the method of administering a therapeutically active agent to
a patient will generally comprises an additional step of attaching a needle, e.g. a
hypodermic needle, to the outlet end of the second cartridge, followed by
administering the mixed pharmaceutical components to a patient.
In the aforementioned methods preferably one of the first and second pharmaceutical
components comprises a solid therapeutically active agent and the other is a liquid
capable of solubilising or forming a suspension with the solid therapeutically active
agent. In a particular aspect of the invention the first pharmaceutical component
comprises a liquid and the second pharmaceutical component comprises a solid
therapeutically active agent. Alternatively, the first and second pharmaceutical
components may comprise liquid/ liquid components, viscous/non-viscous
components, etc.
In another embodiment of the present invention resistance or friction may be
minimised for the user by providing a plunger with an external screw thread. In this
particular embodiment the plunger is desirably threaded along a predetermined
portion of its length. It is within the scope of the present invention for the plunger to
be threaded along the whole of its length, however, it is preferred that the plunger is
only partially threaded, i.e. threaded along only a portion of its length. Thus, the user
may screw the plunger to bring the contents of the first and second cartridges into
contact, since this is generally where the user experiences most resistance. However,
the remainder of the shaft of the plunger may desirably be unthreaded so that a
conventional push action may be used for administration of the medicament solution
to a patient.
The use of a threaded, or partially threaded, plunger as hereinbefore described may
also be advantageous in that it may be used to provide a sealed system, improving
sterility of the delivery device. Thus, a frangible seal may be provided around the
shaft of the plunger, for example, within the body of the first cartridge, such that
twisting of the plunger by the user can cause the frangible seal to break.
The use of a threaded plunger may suitably be used with any of the aforementioned
syringe embodiments hereinbefore described. However, it will be understood by the
person skilled in the art that such a threaded plunger arrangement is novel per se and
may therefore be suitably applied to a conventionally known invasive valve
component, such as a needle piercing an elastomeric septum. Desirably, the
pharmaceutical component-mixing delivery assembly according to this aspect of the
invention will generally comprise a sealed unit, e.g. an outer casing which house the
first and second cartridges.
A particular advantage of the use of a threaded plunger is that a seal may be placed
around the end of the first cartridge by, i.e. between the first cartridge and the outer
casing.
Thus, according to this further aspect of the present invention there is provided a
pharmaceutical component-mixing delivery assembly comprising:
an outer casing is provided which houses a first and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with an at least partially threaded plunger the end of which
protrudes from the outer casing, said first cartridge containing a first pharmaceutical
component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component;
wherein the first and second cartridges are separated by a valve component;
and
a frangible seal is provided between the outer casing and the first cartridge.
In use, when the at least partially threaded plunger is twisted the frangible seal is
broken; then as the at least partially threaded plunger and the cartridge are pushed
towards the second cartridge the first cartridge disengages from the seal. The use of a
frangible seal enables the device to remain sterile during storage, whilst the
disengagement of the frangible seal from the first cartridge reduces friction and
lowers force required to complete the administration of the therapeutically active
agent.
According to this aspect of the invention the valve component may comprise a non
invasive valve as hereinbefore described or a conventionally known valve, such as a
needle valve or a bypass valve.
In a further aspect of the invention there is provided a method of administering a
therapeutically active agent to a patient which comprises operating a pharmaceutical
component-mixing delivery assembly holding first and second pharmaceutical
components; said delivery assembly comprising:
an outer casing is provided which houses a first and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with an at least partially threaded plunger the end of which
protrudes from the outer casing, said first cartridge containing a first pharmaceutical
component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component;
wherein the first and second cartridges are separated by a valve component;
and
a frangible seal is provided between the outer casing and the first cartridge.
The method of operation according to this aspect of the invention will generally
comprise first turning the at least partially threaded plunger causing the frangible seal
to break and disengage from the first cartridge and subsequently pressing the plunger
to administer the mixed pharmaceutical components to a patient.
The term "non-invasive valve" will be understood by the person skilled in the art.
However, for the avoidance of doubt, the term should be construed so as not to
include a component wherein, for example, a needle is utilised to pierce a septum and
the like. Furthermore, the term "non-invasive valve component" should be construed
as meaning that the valve is made up entirely of the component, i.e. it does not utilise
the wall of the syringe or cartridge (which is distinct from, for example, the Vetter
syringe described in US Patent No. 6,419,656).
According to a yet further aspect of the invention there is provided a kit suitable for
mixing and delivery of pharmaceutical components, said kit comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that when placed together
they are movable relative to one another such that the first cartridge is slidable within
the second cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein when the first and second cartridges are placed together they are
separated by a non-invasive valve component.
There is also provided a kit suitable for mixing and delivery of pharmaceutical
components, said kit comprising:
an outer casing which houses a first and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with an at least partially threaded plunger the end of which
protrudes from the outer casing, said first cartridge containing a first pharmaceutical
component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component;
wherein the first and second cartridges are separated by a valve component;
and
a frangible seal is provided between the outer casing and the first cartridge.
The invention further provides the use of a pharmaceutical component-mixing
delivery assembly comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component;
for the mixing and delivery of a first and second pharmaceutical component.
According to this aspect of the invention the non-invasive valve component is
provided with a terminal rib to improve the seal formed between the non-invasive
valve component and the second cartridge.
The key advantages of the dual cartridge pharmaceutical component-mixing delivery
assembly of the present invention can be summarised as follows:
• Minimal air present in the reconstitution process
• Use of many standard components
• Diluent, Powder cartridges separate (processing in parallel, separate lines)
• Barrier properties
• Visible reconstitution
• Low waste/deadspace
• Minimal number of components in contact with the powder and diluent
• Less Air - removes priming step and enables auto-injection
• Minimal Stability/Drug interaction issues -
• Lower cost
• Plastic/glass combinations can be used
• Customisable for different pharmaceuticals
• Bulk lyophilisation of the solid component will be possible
• Reduced formulation burden
• Use of many conventional components
• Bulk testing before filling would be possible
• Multiple powders can be filled
The invention will now be illustrated by way of example only and with reference to
the accompanying figures in which:
Figures 1 (a) to (d) are cross-sectional views of a pharmaceutical component-mixing
delivery assembly comprising a ball valve component;
Figures 2 (a) to (d) are cross-sectional views of a pharmaceutical component-mixing
delivery assembly comprising a ball valve component provided with ball
displacement means;
Figures 3 (a) to (e) are cross-sectional views of a pharmaceutical component-mixing
delivery assembly comprising a T-valve component;
Figures 4 (a) to (e) are cross-sectional views of a pharmaceutical component-mixing
delivery assembly comprising an "annular valve" component;
Figures 5 (a) to (d) are cross-sectional views of a sealed pharmaceutical componentmixing
delivery assembly comprising a partially threaded plunger and "needle valve"
component;
Figures 6 (a) to (d) are cross-sectional views of a pharmaceutical component-mixing
delivery assembly comprising a spigot plug component;
Figures 7 (a) and 7 (b) are cutaway perspective views of a pharmaceutical componentmixing
delivery assembly comprising a spigot plug component of Figure 6; and
Figure 7 (c) is a perspective view of the delivery assembly of Figure 6;
Figures 8 (a) to (d) are cross-sectional views of a pharmaceutical component-mixing
delivery assembly comprising a hollow plug component;
Figures 9 (a) and 9 (b) are cutaway perspective views of a pharmaceutical componentmixing
delivery assembly comprising a hollow plug component of Figure 8; Figure 9
(c) is a perspective view of the delivery assembly of Figure 8;
Figures 10 (a) and (b) are cross-sectional views of a pharmaceutical componentmixing
delivery assembly comprising a ribbed non-invasive valve component;
Figures 11 (a) and 11 (b) are cutaway perspective views of a pharmaceutical
component-mixing delivery assembly comprising ribbed non-invasive valve
component of Figure 10; and
Figure 11 (c) is a perspective view of the delivery assembly of Figure 10.
Referring to Figures 1 (a) to (d) a pharmaceutical component-mixing delivery
assembly (1) comprises a first cartridge (2) and a second cartridge (3), the first
cartridge (2) being dimensioned so that it is slidable within the second cartridge (3)
from a pre-mixed position to a post-mixed position. The first cartridge (2) comprises
a body (4) provided with an outlet end (5) and a plunger (6). The first cartridge (2)
contains a first pharmaceutical component (7). The second cartridge (3) comprises a
body (8) provided with an inlet end (17) and an outlet end (10). The second cartridge
(3) contains a second pharmaceutical component ( 11). A non-invasive valve
component (12) separates the first and second cartridges (2) and (3).
The non-invasive valve component (12) comprises a ball valve (13) which consists of
a hollow piston (14) with a first end (15) adjacent the outlet end (5) of the first
cartridge (2) and a second end (16) adjacent the inlet end (17) of the second cartridge
(3). The hollow piston (14) comprises a side wall (18) which generally forms a seal
against the inner surface (19) of the body (8) of the second cartridge (3).
The first end (15) of the hollow piston (14) is provided with a circumferential recess
(20) suitable for locating the outlet end (5) of the first cartridge (2). In the
embodiment shown the outlet end (5) of the first cartridge (2) is provided with a
circumferential shoulder (21) adapted to fit into the circumferential recess (20) of the
first end (15) of the hollow piston (14). The second end (16) of the hollow piston (14)
is provided with a pair of apertures (22) and (23). The outlet end (5) of the first
cartridge (2) is provided with an orifice (24) within which sits a ball (25) which acts
to seal the first cartridge (2).
In use, when the plunger (6) is depressed within the first cartridge (2) the increase in
pressure will force the ball (25) out of the orifice (24), which causes the valve
component (12) to open allowing the first pharmaceutical component (7), usually a
fluid to flow from the first cartridge (2) through orifice (24), around ball (25), through
apertures (22) and (23) and into the second cartridge (3) where it mixes with the
second pharmaceutical component ( 11).
Referring to Figures 2 (a) to (d) a pharmaceutical component-mixing delivery
assembly (1) comprises a first cartridge (2) and a second cartridge (3) as hereinbefore
described with reference to Figures 1 (a) to (d). The non-invasive valve component
(12) comprises a ball valve (13) which consists of a hollow piston (14) with a first end
(15) adjacent the outlet end (5) of the first cartridge (2) and a second end (16) adjacent
the inlet end (17) of the second cartridge (3) as hereinbefore described.
However, the second end (16) of the hollow piston (14) comprises a separate plug
component (16a) which is provided with a pair of apertures (22) and (23). In addition,
the plug component (16a) is provided with a substantially central spigot (16b) which
protrudes from plug component (16a) towards the outlet end (5) of the first cartridge
(2) .
In use, when the plunger (6) is depressed within the first cartridge (2) the first
cartridge (2) slides towards the plug component (16a). When the spigot (16b) comes
into contact with the ball (25), the ball (25) is displaced from orifice (24), which
causes the valve component (12) to open allowing the first pharmaceutical component
(7), usually a fluid to flow from the first cartridge (2) through orifice (24), around ball
(25), through apertures (22) and (23) and into the second cartridge (3) where it mixes
with the second pharmaceutical component ( 11).
Referring to Figures 3 (a) to (e), a pharmaceutical component-mixing delivery
assembly (1) comprises a first cartridge (2) and a second cartridge (3), the first
cartridge (2) being dimensioned so that it is slidable within the second cartridge (3)
from a pre-mixed position to a post-mixed position. The first cartridge (2) comprises
a body (4) provided with an outlet end (5) and a plunger (6). The first cartridge (2)
contains a first pharmaceutical component (7). The second cartridge (3) comprises a
body (8) provided with an inlet end (17) and an outlet end (10). The second cartridge
(3) contains a second pharmaceutical component ( 11). A non-invasive valve
component (12) separates the first and second cartridges (2) and (3).
The non-invasive valve component (12) comprises a T-valve component (26). The Tvalve
component (26) consists of a pair of hollow pistons (27) and (28). A first
hollow piston (27) is adjacent the outlet end (5) of the first cartridge (2) and a second
hollow piston (28) is adjacent the inlet end (17) of the second cartridge (3). Each of
the hollow pistons (27) and (28) comprises a side wall (29) and (30) respectively
which generally forms a seal against the inner surface (19) of the body (8) of the
second cartridge (3).
The first hollow piston (27) is provided with a circumferential recess (31) suitable for
locating the outlet end (5) of the first cartridge (2). In the embodiment shown the
outlet end (5) of the first cartridge (2) is provided with a circumferential shoulder (21)
adapted to fit into the circumferential recess (31) of the first hollow piston (27). The
first hollow piston (27) is fitted with a stopper component (32) with an internal
conduit (33) which is substantially coaxial with the longitudinal axis of the first
cartridge (2). The internal conduit (33) is provided with a branch (34) which seals
against the side wall (29) of the hollow piston (27).
The second hollow piston (28) is fitted with a second stopper component (35) with an
internal conduit (36) which is substantially coaxial with the longitudinal axis of the
first cartridge (2). The internal conduit (36) is provided with a branch (37) which
seals against the side wall (30) of the hollow piston (28).
In use, when the plunger (6) is depressed within the first cartridge (2) the increase in
pressure will force the stopper component (32) to protrude out of the first hollow
piston (27). This movement causes the branched conduit (34) to be exposed and lose
its seals against the side wall (29) of the hollow piston (27) allowing the first
pharmaceutical component (7), usually a fluid, to flow from the first cartridge (2)
through internal conduit (33) and branched conduit (34) into the second hollow piston
(28). Continued depression of the plunger (6) causes the second stopper component
(35) to protrude out of the second hollow piston (28). This movement causes the
branched conduit (37) to be exposed and lose its seal against the side wall (30) of the
second hollow piston (28) allowing the first pharmaceutical component (7) to flow
from the first cartridge (2) and first hollow piston (27) through internal conduit (36)
and branched conduit (37) into the second cartridge (3) where it mixes with the
second pharmaceutical component ( 11).
Referring to Figures 4 (a) to (e), a pharmaceutical component-mixing delivery
assembly (1) comprises first and second cartridges (2) and (3) as hereinbefore
described.
An annular valve component (38) comprises a round stopper component (39) with a
conduit external to the stopper. This is hereinafter referred to an "annular valve".
The "annular valve" component (38) consists of a pair of hollow pistons (40) and
(41). A first hollow piston (40) is adjacent the outlet end (5) of the first cartridge (2)
and a second hollow piston (41) is adjacent the inlet end (17) of the second cartridge
(3). Each of the hollow pistons (40) and (41) comprises a side wall (42) and (43)
respectively which generally forms a seal against the inner surface (19) of the body
(8) of the second cartridge (3).
The first hollow piston (40) is provided with a circumferential recess (44) suitable for
locating the outlet end (5) of the first cartridge (2) The first hollow piston (40) is
fitted with a first stopper component (45) with a circumferential shoulder (46) adapted
to fit into the outlet end (5) of the first cartridge (2) and seal it.
The first hollow piston (40) comprises a star shaped orifice (47) whilst the first
stopper component (45) is substantially circular in cross section.
Similarly, the second hollow piston (41) comprises a star shaped orifice (48) and is
fitted with a second stopper component (49). The second stopper component (49) is
substantially circular in cross section. However, the inner surface (43a) of the side
wall (43) is provided with ridges (not shown) which enable the second stopper
component (49) to form a seal.
It will be understood by the person skilled in the art that the shape of the orifices (47)
and (48) and/or the first and second stopper components (45) and (49) may suitably be
varied provided that the stopper (45) and (49) does not form a sealing fit within the
orifice (47) and (48).
In use, when the plunger (6) is depressed within the first cartridge (2) the increase in
pressure will force the first stopper component (45) out of the first cartridge (2). This
movement allows the first pharmaceutical component (7), usually a fluid, to flow
from the first cartridge (2) between the stopper component (45) and the side wall (42)
of the piston (40) and through first orifice (47) into the second hollow piston (41).
Continued depression of the plunger (6) causes the second stopper component (49) to
move axially within the second hollow piston (41) away from the ridges (not shown).
This movement causes the second stopper component (49) to lose its seal against the
side wall (43) of the second hollow piston (41) allowing the first pharmaceutical
component (7) to flow from the first cartridge (2) and first hollow piston (40) past the
second stopper component (49) and through orifice (48) into the second cartridge (3)
where it mixes with the second pharmaceutical component ( 11).
Referring to Figures 5 (a) to (d) a pharmaceutical component-mixing delivery
assembly (1) comprises a first cartridge (2) and a second cartridge (3), the first
cartridge (2) being dimensioned so that it is slidable within the second cartridge (3)
from a pre-mixed position to a post-mixed position. An outer casing (63) is provided
which houses the first and second cartridges (2 and 3). The first cartridge (2)
comprises a body (4) provided with a sealed outlet end (50). The outer casing (63)
comprises a sealed plunger end (51) and the plunger (6) protrudes through the sealed
plunger end (51) of the outer casing (63). The first cartridge (2) contains a first
pharmaceutical component (7). The second cartridge (3) comprises a body (8)
provided with an inlet end (9) and an outlet end (10). The second cartridge (3)
contains a second pharmaceutical component ( 11).
The plunger (6) is provided with a threaded surface (52) such that the threaded surface
(52) is present along a predetermined portion of the length of the plunger (6). The
sealed plunger end (51) of the outer casing (63) is provided with a stopper (53) which
includes an orifice (54) through which the plunger (6) passes and a frangible seal (64).
The inner surface (55) of the orifice (54) is provided with a threaded surface (56)
which corresponds to and engages with the threaded surface (52) of the plunger (6).
A plug component (57) separates the first and second cartridges (2) and (3). Said plug
component (57) comprises a first seal (58) provided with a hollow needle (59) which
extends either side of the first seal (58). A second seal (60) comprises a septum (61)
provided with a guide channel (62) which, in use, is adapted to receive the needle (59)
extending from the first seal (58).
In use, when the plunger (6) is turned within the orifice (54) of the stopper (53) in the
outer casing (63) the frangible seal (64) is broken and the plunger (6) and the first
cartridge (2) are pushed towards the second cartridge (3), causing the first cartridge
(2) to disengage from the frangible seal (64). Continued turning of the plunger causes
the first cartridge (2) to slide towards the plug component (57) until the needle (59)
pierces the sealed outlet end (50) of the first cartridge (2). Continued turning of the
plunger (6) causes the needle (59) to pierce the septum (61) allowing the first
pharmaceutical component (7), usually a fluid, to flow from the first cartridge (2)
through the needle (59) and into the second cartridge (3) where it mixes with the
second pharmaceutical component ( 11). Once the first and second pharmaceutical
components (7) and ( 11) are mixed and the threaded portion (52) of the plunger (6)
has passed through the orifice (54), the plunger (6) may be pushed in a conventional
manner to administer the medicament solution to a patient.
Referring to Figures 6 and 7 a pharmaceutical component-mixing delivery assembly
(1) comprises a first cartridge (2) and a second cartridge (3), the first cartridge (2)
being dimensioned so that it is slidable within the second cartridge (3) from a premixed
position to a post-mixed position. The first cartridge (2) comprises a body (4)
provided with an outlet end (5) and a plunger (6). The first cartridge (2) contains a
first pharmaceutical component (7). The second cartridge (3) comprises a body (8)
provided with an inlet end (17) and an outlet end (10). The second cartridge (3)
contains a second pharmaceutical component ( 11). A non-invasive valve component
(12) separates the first and second cartridges (2) and (3).
The non-invasive valve component (12) comprises a spigot plug component (63)
housed in a piston component (64). The piston component (64) is anchored to the
first cartridge (2) by a lip (70). The spigot plug component (63) consists of a Tshaped
component (65) with a first end (66) of narrower diameter forming a plug in
the outlet end (5) of the first cartridge (2) and a second end (67) of wider diameter
adjacent the inlet end (17) of the second cartridge (3). The dimensions of the second
end (67) are such that it forms an "annular valve" component (68) with the side wall
(69) of piston component (64).
In use, when the plunger (6) is depressed within the first cartridge (2) the increase in
pressure will force the spigot plug component (63) away from outlet end (5) of the
first cartridge (2), which creates a conduit (71) between T-shaped component (65) and
the side wall (69) of piston component (64) through which the first pharmaceutical
component (7), usually a fluid, can flow into the second cartridge (3) where it mixes
with the second pharmaceutical component ( 11).
Referring to Figures 8 and 9 a pharmaceutical component-mixing delivery assembly
(1) comprises a first cartridge (2) and a second cartridge (3), the first cartridge (2)
being dimensioned so that it is slidable within the second cartridge (3) from a premixed
position to a post-mixed position. The first cartridge (2) comprises a body (4)
provided with an outlet end (5) and a plunger (6). The first cartridge (2) contains a
first pharmaceutical component (7). The second cartridge (3) comprises a body (8)
provided with an inlet end (17) and an outlet end (10). The second cartridge (3)
contains a second pharmaceutical component ( 11). A non-invasive valve component
(12) separates the first and second cartridges (2) and (3).
The non-invasive valve component (12) comprises a hollow plug component (72)
housed in a piston component (73). The piston component (73) is anchored to the
first cartridge (2) by a lip (74). The hollow plug component (72) consists of a stopper
(75) provided with a T-shaped conduit (76) such that the inlet end (77) of the conduit
is coaxial with the first and second cartridges (2 and 3) and the outlet end (78) of the
conduit is perpendicular to the inlet end (77) of the conduit, i.e. diametrical to the
stopper (75). The piston component (73) is also T-shaped such that the outlet end
(79) of the piston component is of greater diameter than the inlet end (80) of the
piston component (73). Thus, the outlet end (78) of the conduit is capable of forming
an "annular valve" component (81) with the side wall (82) of piston component (73).
In use, when the plunger (6) is depressed within the first cartridge (2) the increase in
pressure will force the hollow plug component (72) away from outlet end (5) of the
first cartridge (2), which opens the T-shaped conduit (76). Thus, the first
pharmaceutical component (7), usually a fluid, can flow through the inlet end (77) of
the conduit to the outlet end (78) of the conduit and between the side of the hollow
plug component (72) and the side wall (82) of piston component (73) into the second
cartridge (3) where it mixes with the second pharmaceutical component ( 11).
Referring to Figures 10 and 11 a pharmaceutical component-mixing delivery
assembly (1) comprises a first cartridge (2) and a second cartridge (3), the first
cartridge (2) being dimensioned so that it is slidable within the second cartridge (3)
from a pre-mixed position to a post-mixed position. The first cartridge (2) comprises
a body (4) provided with an outlet end (5) and a plunger (6). The first cartridge (2)
contains a first pharmaceutical component (7). The second cartridge (3) comprises a
body (8) provided with an inlet end (17) and an outlet end (10). The second cartridge
(3) contains a second pharmaceutical component ( 11). A non-invasive valve
component (12) separates the first and second cartridges (2) and (3).
The non-invasive valve component (12) comprises an elongated piston (83). The
piston (83) is provided with a plurality of external circumferential ribs (84) which
form a seal between the side wall (85) of the piston (83) and the inner wall (86) of the
second cartridge (3). The piston is also provided with terminal rib (87), comprising a
circumferential rib located at the end (88) of the piston (83) nearest to the inlet end
(17) of the second cartridge (3).
The region of the second cartridge (3) that contains the second pharmaceutical
component ( 11) will generally comprise an aseptic mixing chamber (89). The length
of the piston (83) will be dictated by how far back along the second cartridge (3) it has
to move, which will in turn be dictated by the volume required for the mixing
chamber (89). In use, as the plunger (6) is depressed and the piston (83) moves
towards the inlet end (17) of the second cartridge (3), the mixing chamber (89) does
not come into contact with the non-aseptic inner wall (86) of the inlet end (17) of the
second cartridge (3) and the sterility of the mixing chamber (89) is maintained at all
times.

Claims
1. A pharmaceutical component-mixing delivery assembly comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component.
2 . A pharmaceutical component-mixing delivery assembly according to any one
of the preceding claims wherein the non-invasive valve component is provided with a
terminal rib to improve the seal formed between the non-invasive valve component
and the second cartridge.
3 . A pharmaceutical component-mixing delivery assembly according to claims 1
or 2 wherein the non-invasive valve component comprises a ball valve, a flow through
stopper component or a T-shaped stopper component.
4 . A pharmaceutical component-mixing delivery assembly according to any one
of the preceding claims wherein the assembly comprises a syringe assembly.
5 . A pharmaceutical component-mixing delivery assembly according to claim 4
wherein a hypodermic needle is attached to the outlet end of the second cartridge.
6 . A pharmaceutical component-mixing delivery assembly according to any one
of the preceding claims wherein one of the first and second pharmaceutical
components comprises a solid therapeutically active agent and the other is a liquid
capable of solubilising the solid therapeutically active agent.
7 . A pharmaceutical component-mixing delivery assembly according to claim 6
wherein the first pharmaceutical component comprises a liquid and the second
pharmaceutical component comprises a solid therapeutically active agent.
8 . A pharmaceutical component-mixing delivery assembly according to any one
of claims 1 to 5 wherein the first pharmaceutical component comprises a liquid and
the second pharmaceutical component comprises a liquid.
9 . A pharmaceutical component-mixing delivery assembly according to any one
of claims 1 to 4 wherein the first pharmaceutical component comprises a non-viscous
liquid and the second pharmaceutical component comprises a viscous liquid.
10. A pharmaceutical component-mixing delivery assembly according to any one
of the preceding claims wherein the non-invasive valve component is generally
elongated.
11. A pharmaceutical component-mixing delivery assembly according to claim 10
wherein the length of non-invasive valve component is chosen so that as the valve
moves, the mixing chamber of the second cartridge never comes into contact with the
non-aseptic walls of the second cartridge.
12. A pharmaceutical component-mixing delivery assembly according to any one
of the preceding claims wherein the non-invasive valve component comprises a ball
valve.
13. A pharmaceutical component-mixing delivery assembly according to claim 12
wherein the ball valve component comprises one or more balls located within the
outlet of the first cartridge, such that the ball(s) acts to seal the first cartridge.
14. A pharmaceutical component-mixing delivery assembly according to claim 13
wherein the ball valve component includes a substantially hollow apertured piston
suitable for receiving the ball from the first cartridge.
15. A pharmaceutical component-mixing delivery assembly according to any one
of claims 12 to 14 wherein the ball valve component comprises a single ball.
16. A pharmaceutical component-mixing delivery assembly according to any one
of claims 12 to 14 wherein the ball valve component comprises a plurality of balls.
17. A pharmaceutical component-mixing delivery assembly according to any one
of claims 12 to 16 wherein the ball valve component includes a plug component
which is provided with one or more apertures and which is provided with means for
displacing the ball from the outlet of the first cartridge.
18. A pharmaceutical component-mixing delivery assembly according to claim 17
wherein the displacement means comprises a protruding spigot.
19. A pharmaceutical component-mixing delivery assembly according to any one
of claims 1 to 11 wherein the non-invasive valve component comprises a flow through
stopper component.
20. A pharmaceutical component-mixing delivery assembly according to claim 19
wherein the flow through stopper component is provided with conduit means.
21. A pharmaceutical component-mixing delivery assembly according to claim 20
wherein the conduit means is an internal conduit within the stopper.
22. A pharmaceutical component-mixing delivery assembly according to claims
20 or 2 1 wherein the conduit means is an external conduit, that is, a conduit between
the walls of the piston and the stopper.
23. A pharmaceutical component-mixing delivery assembly according to any one
of claims 1 to 11 wherein the flow through stopper component is an "annular valve".
24. A pharmaceutical component-mixing delivery assembly according to claim 23
wherein the "annular valve" comprises a piston configured to form a snug fit with a
stopper which seals the first cartridge; and
wherein the piston provides a second position wherein the stopper forms a loose fit,
such that fluid may pass between the walls of the piston and the stopper.
25. A pharmaceutical component-mixing delivery assembly according to claims
23 wherein the flow through stopper component comprises a hollow plug component.
26. A pharmaceutical component-mixing delivery assembly according to claim 25
wherein the plug component is T-shaped such that the outlet end of the plug
component is of greater diameter than the inlet end of the piston component.
27. A pharmaceutical component-mixing delivery assembly according to any one
of claims 1 to 11 wherein the stopper component comprises a spigot plug component.
28. A pharmaceutical component-mixing delivery assembly according to any one
of the preceding claims wherein the plunger is provided with an external screw thread.
29. A pharmaceutical component-mixing delivery assembly comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by an invasive valve component
and the plunger is provided with an external screw thread.
30. A pharmaceutical component-mixing delivery assembly according to claim 29
wherein the invasive valve component comprises an elastomeric septum and the
assembly is provided with a needle suitable for piercing the septum.
31. A pharmaceutical component-mixing delivery assembly according to any one
of the preceding claims wherein the plunger is threaded along a predetermined portion
of its length such that the plunger may be screwed to bring the contents of the first and
second cartridges into contact; and
a conventional push action may be used for administration of the medicament solution
to a patient.
32. A pharmaceutical component-mixing delivery assembly comprising:
an outer casing which houses a first and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with an at least partially threaded plunger the end of which
protrudes from the outer casing, said first cartridge containing a first pharmaceutical
component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component;
wherein the first and second cartridges are separated by a valve component;
and
a frangible seal is provided between the outer casing and the first cartridge.
33. A pharmaceutical component-mixing delivery assembly according to claim 3
wherein the valve component comprises a non-invasive valve.
34. A pharmaceutical component-mixing delivery assembly according to claim 33
wherein the non-invasive valve component is provided with a terminal rib to improve
the seal formed between the non-invasive valve component and the second cartridge.
35. A pharmaceutical component-mixing delivery assembly according to claim 32
wherein the valve component may comprise a needle valve.
36. A pharmaceutical component-mixing delivery assembly according to claim 32
wherein the valve component may comprise a bypass valve.
37. A method of operating a pharmaceutical component-mixing delivery assembly
holding first and second pharmaceutical components; said delivery assembly
comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component;
said method comprising pressing the plunger axially into the first cartridge to an
intermediate position thus pressurizing the first cartridge and opening the non
invasive valve component, causing the first pharmaceutical component to flow
through the valve and into the second cartridge to mix with the second pharmaceutical
component.
38. A method of administering a therapeutically active agent to a patient which
comprises operating a pharmaceutical component-mixing delivery assembly holding
first and second pharmaceutical components; said delivery assembly comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component;
said method comprising the steps of:
(i) pressing the plunger axially into the first cartridge to an intermediate
position thus pressurizing the first cartridge and opening the a non-invasive valve
component, causing the first pharmaceutical component to flow through the valve and
into the second cartridge to mix with the second pharmaceutical component;
(ii) after the first and second pharmaceutical components have mixed,
administering the mixed pharmaceutical components to a patient.
39. A method according to any one of claims 37 or 38 wherein the non-invasive
valve component is provided with a terminal rib to improve the seal formed between
the non-invasive valve component and the second cartridge.
40. A method according to claims 37 to 39 wherein the delivery device is a
syringe.
41. A method according to claim 40 which includes an additional step of attaching
a needle, e.g. a hypodermic needle, to the outlet end of the second cartridge, followed
by administering the mixed pharmaceutical components to a patient.
42. A method according to claim 4 1 one of the first and second pharmaceutical
components comprises a solid therapeutically active agent and the other is a liquid
capable of solubilising the solid therapeutically active agent.
43. A method according to claim 42 one of the first pharmaceutical component
comprises a liquid and the second pharmaceutical component comprises a solid
therapeutically active agent.
44. A method according to any one of claims 37 to 43 wherein the non-invasive
valve component is generally elongated.
45. A method according to claim 44 wherein the length of non-invasive valve
component is chosen so that as the valve moves, the mixing chamber of the second
cartridge never comes into contact with the non-aseptic walls of the second cartridge.
46. A method of administering a therapeutically active agent to a patient which
comprises operating a pharmaceutical component-mixing delivery assembly holding
first and second pharmaceutical components; said delivery assembly comprising:
an outer casing which houses a first and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with an at least partially threaded plunger the end of which
protrudes from the outer casing, said first cartridge containing a first pharmaceutical
component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component;
wherein the first and second cartridges are separated by a valve component;
and
a frangible seal is provided between the outer casing and the first cartridge.
47. A method according to claim 46 wherein the valve component is provided
with a terminal rib to improve the seal formed between the valve component and the
second cartridge.
48. A kit suitable for mixing and delivery of pharmaceutical components, said kit
comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that when placed together
they are movable relative to one another such that the first cartridge is slidable within
the second cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein when the first and second cartridges are placed together they are
separated by a non-invasive valve component.
49. A kit suitable for mixing and delivery of pharmaceutical components, said kit
comprising:
an outer casing which houses a first and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with an at least partially threaded plunger the end of which
protrudes from the outer casing, said first cartridge containing a first pharmaceutical
component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component;
wherein the first and second cartridges are separated by a valve component;
and
a frangible seal is provided between the outer casing and the first cartridge.
50. A kit according to any one of claims 48 or 49 wherein the valve component is
provided with a terminal rib to improve the seal formed between the valve component
and the second cartridge.
51. The use of a pharmaceutical component-mixing delivery assembly
comprising:
a first cartridge and a second cartridge;
the first and second cartridges being dimensioned so that they are movable
relative to one another such that the first cartridge is slidable within the second
cartridge from a pre-mixed position to a post-mixed position;
the first cartridge comprising a body provided with an outlet end, the first
cartridge being fitted with plunger and containing a first pharmaceutical component;
the second cartridge comprising a body provided with an inlet end and an
outlet end, the second cartridge containing a second pharmaceutical component; and
wherein the first and second cartridges are separated by a non-invasive valve
component;
for the mixing and delivery of a first and second pharmaceutical component.
52. The use according to claim 5 1 wherein the non-invasive valve component is
provided with a terminal rib to improve the seal formed between the non-invasive
valve component and the second cartridge.
53. A pharmaceutical component-mixing delivery assembly, method, kit or use as
hereinbefore described with reference to the accompanying figures.