WO2010128328A2 - Pre-filled syringe system - Google Patents

Abstract

The syringe assembly (10) is pre-packaged and may be shipped and distributed within a single package. For example, the syringe assembly (10) may be provided in a blister pack. This blister pack contains the syringe (12), the chassis (14) and the vial (16) including the single drug dose. The chassis (14) is secured to the syringe (12) and the chassis (14) secures the vial (16) in a protected position. Once removed from the packaging, the user may manually move the vial (16) to a second secured position in the chassis (14) where the needle (18) of the syringe (12) punctures a diaphragm (22) of the vial (16) such that a tip (20) of the needle (18) is just positioned in the internal chamber of the vial (16). A plunger (30) of the syringe (12) can then be operated in order for the single drug dose to be transferred to the syringe (12). Once transferred, the vial (16) and chassis (14) can be discarded in order for the syringe (12) to be operated in the conventional manner and to deliver a set drug dose to a patient.

Description

Pre-Filled Syringe System

Field of the Invention

The present invention relates to a pre-filled syringe system and to a method of providing a pre-filled syringe.

Background to the Invention Pre-filled syringes are supplied with the liquid drug solution already in the syringe eliminating the need to fill the syringe by extracting the liquid drug from a vial and overfilling the vial. User steps are greatly reduced.

Unfortunately they suffer from a number of drawbacks. For stability reasons the syringe is usually glass with its attendant cost and manufacturing tolerance problems. The liquid drug is sealed by the plunger piston and needle cap both of which are not ideal for long shelf life storage due to possible evaporation of the drug and contamination from outside.

The piston needs to be lubricated for good slideability and the lubricant may interact with the drug while in storage. Additionally they are susceptible to gas bubble expansion and stopper movement during airfreight and general closure integrity.

Additionally filling lines for pre filled syringes are expensive relative to tried and tested Vial lines.

The present invention is an attempt to overcome some or all the above problems. It is intended as an alternative to conventional pre filled syringes.

Many safety syringes are available on the market. Some as described for instance in patents US5279580 and US4507117 have means that allow the plunger to engage with the needle at the end of the injection stroke. After engagement the needle can be retracted into the body of the syringe and stored out of harms way.

In the above type of device the needle is supplied attached to the syringe or may be attached by the user. In both cases the needle is attached to the syringe externally and for this reason needs a needle sheathe. A drawback of such systems is that before injecting a patient the syringe needs to be filled by inserting the needle into a vial and retracting the plunger to fill the syringe cavity. Before inserting the needle into the vial the plunger cannot be fully pressed into the body without attaching itself to the needle and deactivating the system and making it unusable. For this reason there is a gap between the plunger and body end which when filling with drug by retracting the plunger causes an air bubble to form which needs to be expelled before use.

Also it is quite common for users to push the plunger in before filling with drug to pressurise the vial deactivating the system before use and because the needle and vial are not ideally matched it is difficult to extract all the drug from the vial and for this reason the vial needs to be overfilled with drug.

These systems can only be used one. Once used they need to be disposed of as the needle becomes trapped within the body.

An alternative to vials are the pre-filled syringes. They have advantages but also some disadvantages in that the drug is stored in the syringe with implications for drug interaction with the syringe materials and evaporation from the syringe during shelf life. Glass is usually used for the body with cost and safety implications.

The current invention is an improved hand syringe and vial combination that requires little or no overfilling of the vial. It is safe to use, has the same shelf life as conventional vials, the needle is retracted after use inside the syringe and in a safe position and the whole system may be discarded after use in a safe manner avoiding needle injuries.

Sometimes the drug must be kept in a lyophilized form. In pre-filled syringes a dual- chambered system is needed one holding the powder the other the diluents. These are complex and expensive systems due to the fact that the powder must be kept completely dry in storage. In the present invention the powder and the liquid diluents can be kept completely separate.

It is an aim of the present invention to overcome at least one problem associated with the prior art whether referred to herein or otherwise. Summary of the Invention

According to a first aspect of the present invention there is provided a syringe assembly comprising a syringe, a chassis and a vial wherein the chassis engages the syringe and is retained thereto, the syringe comprising a syringe body and a needle, the chassis further comprising first vial securement means to secure the vial at a first position relative to the syringe and second vial securement means to secure the vial at a second position relative to the syringe and in which, in the first position the needle of the syringe does not penetrate the vial and in the second position the needle of the syringe penetrates the vial.

Preferably the syringe body comprises a cylindrical body extending in a longitudinal direction.

Preferably the chassis engages the syringe and inhibits relative movement of the syringe in a first longitudinal direction and in a second longitudinal direction.

Preferably the chassis engages the syringe through friction and/or an interference fit in order to inhibit relative movement of the syringe in a first longitudinal direction and in a second longitudinal direction.

Preferably the chassis comprises a retaining element to retain the syringe to the chassis. The retaining element may be removable to allow removal of the syringe from the chassis.

The chassis may be integral with the syringe. In particular, the chassis may be integral with the syringe body.

Preferably the first vial securement means of the chassis inhibits relative movement of the vial in a first longitudinal direction and in a second longitudinal direction. Preferably the first vial securement means of the chassis inhibits relative movement of the vial towards the syringe and away from the syringe.

Preferably the second vial securement means of the chassis inhibits relative movement of the vial in a first longitudinal direction and in a second longitudinal direction. Preferably the second vial securement means of the chassis inhibits relative movement of the vial towards the syringe and away from the syringe

Preferably the first vial securement means prevents inadvertent penetration of the vial by the needle.

Preferably the first vial securement means prevents inadvertent detachment of the vial from the chassis.

Preferably the first vial securement means comprises a first securement member which prevents relative movement of the vial in a first longitudinal direction (towards the syringe).

The first vial securement means may comprise a plurality of first securement members. The or each first securement member may comprise a resilient member.

Preferably the or each first securement member abuts a first end of the vial.

Preferably the or each first securement member are bias towards an inner position which prevents or inhibits movement of the vial and wherein the or each first securement member may be flexed outwards in order to enable the vial to move.

Preferably the first vial securement means is arranged, in use, to signal when the vial reaches the first position. Preferably the first securement means is arranged, in use, to provide an audible signal when the vial reaches the first position.

Preferably the first vial securement means comprises a second securement member which prevents relative movement of the vial in a second longitudinal direction (away from the syringe).

The first vial securement means may comprise a plurality of second securement members. The or each second securement member may comprise a resilient member.

Preferably the or each second securement member abuts a second end of the vial.

Preferably the or each second securement member are bias towards an inner position which prevents or inhibits movement of the vial and wherein the or each second securement member may be flexed outwards in order to enable the vial to move.

Preferably the second vial securement means is arranged, in use, to signal when the vial reaches the second position. Preferably the second vial securement means is arrange, in use, to provide an audible signal when the vial reaches the second position.

Preferably the second vial securement means prevents inadvertent extraction of the needle from the vial.

Preferably the second vial securement means limits the penetration distance of the needle in the vial. Preferably the second vial securement means prevents inadvertent over penetration of the vial by the needle. Preferably the second vial securement means controls the penetration distance of the vial by the needle.

Preferably the second vial securement means comprises a limiter which prevents relative movement of the vial in a first longitudinal direction (towards the syringe).

The limiter may comprise an abutment surface. Preferably the chassis provides an abutment surface.

The limiter may comprise a plurality of limiters. The or each limiter may comprise an abutment surface.

Preferably the or each limiter is arranged, in use, to abut a first end of the vial.

Preferably the second vial securement means comprises a third securement member which prevents relative movement of the vial in a second longitudinal direction (away from the syringe).

The third securement means may comprise a plurality of third securement members. The or each third securement member may comprise a resilient member.

Preferably the or each third securement member abuts a second end of the vial.

Preferably the or each third securement member are bias towards an inner position which prevents or inhibits movement of the vial and wherein the or each third securement member may be flexed outwards in order to enable the vial to move.

Preferably the assembly comprises plunger retaining means. Preferably the plunger retaining means is arranged, in use, to retain the plunger in an extended position prior to use. Preferably the plunger retaining means prevents inadvertent movement of the plunger into the syringe body.

Preferably the plunger retaining means is actuated to enable the plunger to be moved relative to the syringe body.

Preferably the chassis comprises the plunger retaining means.

The plunger retaining means may be provided on a packaging or as part of a packaging.

Preferably the needle is arranged, in use, to be retracted into the syringe body after the syringe has been used and the drug has been injected.

Preferably the needle is arranged, in use, to be retracted into the syringe body after the plunger has been depressed in order to expel the drug.

The plunger may comprise needle engagement means. The needle may comprise a needle mount. The needle engagement means may be arranged, in use, to engage a needle mount in order for subsequent movement of the plunger out of the syringe body to cause movement of the needle into the syringe body.

The needle engagement means may selectively engage and disengage the needle mount.

The needle engagement means may require actuation in order to engage the needle mount. The needle engagement means may require a supplementary movement in order to engage the needle mount. Preferably once the needle engagement means has engaged the needle mount the needle engagement means can be actuated to release the needle mount and may release the needle mount in an operative position.

The actuation may comprise rotating the plunger relative to the needle. The needle engagement means may comprise a screw thread engagement.

The needle engagement means may comprise a push fit or interference fit.

The needle engagement means may comprise a bayonet fitting.

The syringe may comprise an end cap. Preferably the end cap comprises the needle mount. The needle mount may be secured to the end cap. The needle mount may be integral with the end cap.

Preferably the end cap is removably secured to the syringe body.

The end cap may be connected to the syringe body by a screw thread.

The end cap may be connected to the syringe body by a bayonet fitting.

The end cap may be connected to the syringe body by a push fit or an interference fit.

The needle engagement means may comprise first engagement means provided on an inner end of the plunger and cooperating second engagement means provided on the end cap.

The syringe assemble may comprise automatic needle extractor means which is arranged, once activated, to withdraw the needle into the syringe body.

The automatic needle extractor means may comprise movement means in order to withdraw and move the needle into the syringe body. The movement means may comprise a spring.

Preferably the needle extractor means is arranged to be activated once a predetermined volume of a liquid has be expelled from the syringe body through the needle.

Preferably the needle extractor means is arranged to be activated once the plunger has been depressed by a predetermined amount. Preferably the needle extractor is arranged to be activated whilst the needle is located in the tissue being injected.

The syringe may comprise an inner needle and an outer needle. Preferably the outer needle provides a protecting sheath for the inner needle. Preferably the outer needle prevents damage to the inner needle when the needle is inserted into the vial. The outer needle may be arranged, in use, to be retained by the vial and preferably by a diaphragm or closure member of the vial. The diaphragm or closure member of the vial may be arranged to grip the outer needle and then to retain the outer needle by separating the outer needle from the syringe body.

Preferably the vial comprises a diaphragm or closure member for closing the vial and retaining the liquid in the vial. The vial may comprise a resilient material.

The vial may comprise an inner shaped surface to prevent retention of the liquid in the vial. Preferably the inner shaped surface of the vial directs the liquid in the vial towards the tip of the needle, in use.

The inner shaped surface may comprise a downwardly directed conical surface.

The inner shaped surface may comprise a concave surface.

The syringe assembly may comprise an outer protective packaging. The outer protective packaging may prevent movement of the vial from the first position to the second position. The outer protective packaging may prevent the application of a force to a base of the vial. The outer protective packaging may comprise a blister pack. Preferably the outer protective packaging is removable.

The outer protective packaging containing the syringe assembly may be treatable in order to sterilise the syringe assembly.

The chassis may provide an enclosure within which to house the needle. The enclosure may comprise a sealed enclosure. The enclosure may comprise a sterile enclosure. According to a second aspect of the present invention there is provided a chassis for a syringe assembly wherein the chassis is arranged, in use, to engage a syringe and to retain the syringe thereto, the chassis further comprising first vial securement means which is arranged, in use, to secure a vial at a first position relative to the syringe and the chassis further comprising second vial securement means which is arranged, in use, to secure the vial at a second position relative to the syringe and in which, in the first position a needle of the syringe does not penetrate the vial and in the second position the needle of the syringe penetrates the vial.

According to a first aspect of the present invention there is provided a method of providing a single measured dose of a fluid in a syringe comprising retaining a syringe within a chassis, the method further comprising providing a vial including a fluid within the chassis, the method comprising securing the vial in a first position within the chassis at which a needle of the syringe does not penetrate the vial and moving the vial from the first position to a second position within the chassis at which the needle of the syringe penetrates the vial and the vial is secured by the chassis at the second position.

Brief Description of the Drawings

The present invention will now be described by way of example only, with reference to the drawings that follow, in which:

Figure 1 is a preferred embodiment of a syringe assembly.

Figure 2 is a preferred embodiment of a syringe assembly with the vial in an activated position.

Figure 3 is a preferred embodiment of a syringe assembly during removal of the syringe from the chassis.

Figure 4 is a preferred embodiment of a chassis of a syringe assembly.

Figure 5 is a preferred embodiment of a syringe for use in a syringe assembly.

Figure 6 is a second embodiment of a chassis and vial for use in a syringe assembly. Figure 7 is a third embodiment of a chassis of a syringe assembly.

Figure 8 is a forth embodiment of a chassis of a syringe assembly.

Figure 9 is a fifth embodiment of a chassis of a syringe assembly.

Figure 10 is a sixth embodiment of a chassis of a syringe assembly.

Figure 1 1 is a seventh embodiment of a chassis of a syringe assembly.

Figure 12 is an eighth embodiment of a chassis of a syringe assembly.

Figure 13 is a perspective view of a preferred embodiment of a vial gasket.

Figure 14 is a cross section of a preferred embodiment of a vial gasket which has been penetrated by a needle of a syringe.

Figure 15 is a perspective view of a second embodiment of a vial gasket.

Figure 16 is a cross-section of a third embodiment of a vial gasket.

Figure 17 is a cross-section of a fourth embodiment of a vial gasket.

Figure 18 is an exploded view of a preferred embodiment of a syringe of a syringe assembly.

Figure 19 is a partial view of a preferred embodiment of a part of a plunger of a syringe of a syringe assembly.

Figure 20 is an exploded view of a part of a second embodiment of a plunger of a syringe of a syringe assembly.

Figure 21 is a cross section of a part of a plunger and syringe of a syringe assembly. Figure 22 is a perspective cut away view of a part of a plunger and a syringe of a syringe assembly.

Figure 23 is a perspective cut away view of a part of a second embodiment of an end cap and a syringe of a syringe assembly.

Figure 24 is a perspective cut away view of a part of a third embodiment of an end cap and a syringe of a syringe assembly.

Figure 25 is a perspective cut away view of a part of a fourth embodiment of an end cap and a syringe of a syringe assembly.

Figure 26 is a perspective cut away view of a part of a fifth embodiment of an end cap and a syringe of a syringe assembly.

Figure 27 is a perspective cut away view of a part of a sixth embodiment of an end cap and a syringe of a syringe assembly.

Figure 28 is a cross section of an alternative embodiment of a syringe assembly.

Figure 29 is a cross section of an alternative embodiment of the present invention.

Figure 30 is a cross section of a second alternative embodiment of the present invention.

Figure 31 is a cross section of a third alternative embodiment of the present invention.

Figure 32 is a cross section of a forth alternative embodiment of the present invention.

Figure 33 is a cross section of a fifth alternative embodiment of the present invention.

Figure 34 is a cross section of a fifth alternative embodiment of the present invention.

Figure 35 is a cross section of an alternative embodiment of the present invention at step 1 and step 2. Figure 36 is a cross section of an alternative embodiment of the present invention at step 3.

Figure 37 is a cross section of an alternative embodiment of the present invention following a step 4.

Figure 38 is a cross section of an alternative embodiment of the present invention at step 5.

Figure 39 is a cross section of an alternative embodiment of the present invention at step 6.

Figure 40 is a cross section of an alternative embodiment of the present invention at step 7.

Figure 41 is a cross section of an alternative embodiment of the present invention at step 8.

Figure 42 is a cross section of an alternative embodiment of the present invention at step 9.

Figure 43 is a cross section of an alternative embodiment of the present invention including a lyophilized drug.

Figure 44 is a cross section of a further embodiment of the present invention.

Figure 45 is a cross section of a further embodiment of the present invention with the vial in an activated state.

Figure 46 is a cross section of a further embodiment of the present invention with the plunger withdrawn.

Figure 47 is a cross section of a further embodiment of the present invention in a used configuration. Figure 48 is a cross section of a conventional syringe without a needle.

Figure 49 is a cross section of a conventional syringe without a needle.

Figure 50 is another embodiment of the present invention prior to use.

Figure 51 is a cross section of another embodiment of the present invention with the plunger withdrawn.

Figure 52 is a cross section of another embodiment of the present invention with the plunger depressed.

Figure 53 is a cross section of another embodiment of the present invention in a used configuration.

Figure 54 is a cross section of yet another embodiment of the present invention.

Figure 55 is a partial cross section of a part of the syringe with the needle withdrawn.

Figure 56 is a cross section of a part of a syringe with the needle withdrawn and deflected.

Description of the Preferred Embodiments

The present invention provides a syringe assembly 10 comprising a syringe 12 and a chassis 14. The chassis 14 is arranged to be secured to the syringe 12. The chassis 14 also comprises securement means in order to secure a vial 16 in fixed positions relative to the syringe. Accordingly, the chassis 14 provides p re-determined separation distances at which the vial 16 can be held relative to the syringe 12. The vial 16 comprises a liquid pharmaceutical product which is to be injected into a patient. In particular, the vial 16 contains a single measured dose of a drug.

The syringe assembly 10 is pre-packaged and may be shipped and distributed within a single package. For example, the syringe assembly 10 may be provided in a blister pack.

This blister pack contains the syringe 12, the chassis 14 and the vial 16 including the single drug dose. The chassis 14 is secured to the syringe 12 and the chassis 14 secures the vial 16 in a protected position. Once removed from the packaging, the user may manually move the vial 16 to a second secured position in the chassis 14 where the needle 18 of the syringe 12 punctures a diaphragm 22 of the vial 16 such that a tip 20 of the needle 18 is just positioned in the internal chamber of the vial 16. A plunger 30 of the syringe 12 can then be operated in order for the single drug dose to be transferred to the syringe 12. Once transferred, the vial 16 and chassis 14 can be discarded in order for the syringe 12 to be operated in the conventional manner and to deliver a set drug dose to a patient.

The present invention thereby provides a simple single package containing a single drug dose and delivery device which is quick and easy to administer. The present invention and preferred embodiments will now be described in more detail.

As shown in Figure 1 , a preferred embodiment of a syringe assembly 10 comprises a syringe 12, a chassis 14 and a vial 16. All three components are secured together and are provided and distributed as a single item/product. In particular, the syringe assembly 10 may be contained within a semi-ridged plastic blister pack which can keep the contents clean and sterile.

The vial 16 contains a single dose of a liquid drug which is to be administered to a patient. The vial 16 comprises a rigid container 24 having a diaphragm 22 or cover that can be punctured and penetrated by a needle 18 of the syringe 12. Such penetration enables the syringe 12 to extract the liquid in a conventional manner.

The syringe 12 comprises a tubular body 32 defining an inner chamber, a plunger 30 and a hollow needle 18. As in conventional syringes, the plunger 30 is withdrawn and depressed in order to control the flow of fluid through the hollow needle 18. The syringe 12 includes a needle mount comprising an end cap 70 which is secured to the tubular syringe body 32 and mounts the needle 18 to the syringe 12.

The chassis 14 is a securement device which retains the vial 16 in a spaced relationship with the syringe 12. In particular, initially the chassis 14 secures the vial 16 at a distance whereby the needle 18 of the syringe 12 is spaced from the vial 16. The vial 16 can then be moved to a second position in the chassis 14 wherein the needle 18 punctures the diaphragm 22 of the vial 16 and the tip 20 of the needle 18 just locates within the inner chamber of the vial 16 such that the syringe 12 can extract the liquid from the vial 16.

The chassis 14 comprises a plastic material and may be formed by an injection moulding method. The chassis 14 comprises a framework which provides the various components (e.g. the first and second vial securement means, plunger restrictor and syringe retainer) in the correct locations relative to the syringe 12. The chassis 14 has two legs 80, 81 which extend for the length of the chassis 14. The legs 80, 81 are secured together by reinforcement members. The frame of the chassis 14 comprises planar elements in order to increase the rigidity of the chassis 14 and provide the necessary strength. As previously described, particular components may be provided on flexible members or parts of the chassis 14 to enable the syringe 12 and vial 16 to be moved within the frame.

The chassis 14 may have planar outer surfaces or at least edges forming a base in order for the assembly 10 to be safely placed on a surface without rolling. In addition, the corners and or edges of the chassis 14 are rounded to prevent any sharp edges or corners being present.

The chassis 14 may be arranged to provide an enclosure in which the needle 18 is housed and contained. Such an enclosure may be used to retain the needle 18 in a protective atmosphere and may retain and house the needle 18 in a sterile atmosphere. In such an assembly 10, the chassis 14 would secure around the periphery of the vial 16 and would be sealed thereto, for example by an elastomeric O-ring. Similarly, the chassis 14 would secure around the periphery of the syringe body 32 and would be sealed thereto, for example by an elastomeric O-ring.

In some circumstances the complete assembly 10 can be sterilised whilst all the components are sealed in the blister pack. However, in other circumstances the drug may not be treatable with such sterilisation methods and, therefore, the use of a sterile enclosure for the needle 18 may be used.

Accordingly, the outer protective packaging containing the syringe assembly 10 may be treatable in order to sterilise the syringe assembly 10 if the drug is not adversely effected by such treatment. However, if the drug would be effected by such treatment then the chassis 14 may provide an enclosure within which to house the needle 18. The enclosure may comprise a sealed, sterile enclosure. The operational steps of the present invention will now be described.

The syringe assembly 10 is provided in an initial configuration whereby the vial 16 is secured by first vial securement means of the chassis 14. In this position, the tip 20 of the needle 18 is spaced from the diaphragm 22 of the vial 16. The chassis 14 comprises a resilient material and includes the vial securement means at or towards a first end. The vial securement means comprises first vial securement means to secure the vial 16 at a first (initial) position and second vial securement means to secure the vial 16 at a second (activated) position.

As shown in Figure 1 and Figure 4, the first vial securement means comprises a first securement member 40 which prevents movement of the vial 16 towards the syringe 12. The first securement member 40 comprises an inwardly extending shoulder 40 which restricts or inhibits the front outer periphery of the vial 16 passing therethrough. The first securement member(s) 40, 41 effectively provides a restricted passageway through which the vial 16 cannot normally pass in a direction towards the syringe 12. This passageway is formed by the first securement member 40 or a plurality of first securement members 40, 41 and the or each first securement member 40, 41 can be deflected outwardly to increase the cross sectional area of the passageway to enable the vial 16 or at least a part of it to pass therethrough. The shoulder 40, 41 comprises, or is mounted on, a flexible member which can be deflected outwardly in order for the vial 16 to move towards the syringe 12. In use, a user pushes on the base 26 of the vial 16 and the force on the vial 16 causes the shoulder(s) 40, 41 to deflect outwardly such that the vial 16 may move towards the second activated position. In the first (initial) position the bias of the chassis 14 causes the shoulder(s) 40, 41 to be urged towards the vial 16 and to effectively grip the vial 16.

The first vial securement means comprises a second securement member 42 which prevents movement of the vial 16 away from the syringe 12. The second securement member 42 comprises an inwardly projecting shoulder 42 which abuts the base 26 of the vial 16 and prevents the vial 16 moving from the first position away from the syringe 12.

This prevents the vial 16 from becoming inadvertently separated from the chassis 14 and syringe 12. The second securement member(s) 42, 43 effectively provides a restricted passageway through which the vial 16 cannot normally pass in a direction away from the syringe 12. This passageway is formed by the second securement member 42 or a plurality of second securement members 42, 43 and the or each second securement member(s) 42, 43 can be deflected outwardly to increase the cross sectional area of the passageway to enable the vial 16 or at least a part of it to pass therethrough. The shoulder(s) 42, 43 comprises or is mounted on a flexible member which can be deflected outwardly in order for the vial 16 to be inserted into the chassis 16. In the first (initial) position, the bias of the chassis 14 causes the shoulder(s) 42, 43 to be urged inwardly blocking the movement of the vial 16 through the passageway.

In addition, the first vial securement means secures the vial 16 in a concealed, shrouded and/or countersunk position. This shrouded and protected position prevents the vial 16 from being inadvertently pushed over the first securement member(s) 40, 41 towards the syringe 12 which would inadvertently activate the syringe assembly 10. Furthermore, since the syringe assembly 10 is provided in a semi-rigid blister pack, this combination means that it is impossible to activate the syringe assembly 10 until the packaging is removed.

The shoulder(s) 42, 43 of the second securement member 42, 43 is angled or tapered to aid insertion of the vial 16 in the chassis 14. The shoulder 42, 43 of the second securement member 42, 43 can be flexed or deflected outwardly in order for the vial 16 to be removed from the chassis 14, if required.

Accordingly, the vial 16 is retained between retaining shoulders 40, 41 , 42, 43 in the first position and requires a definite and intended action to move the vial 16 to the second activated position. In use, a user moves the vial 16 by using a finger which deflects the shoulder(s) 40, 41 of the first securement member such that the needle 18 of the syringe 12 punctures the diaphragm 22 and the tip 20 of the needle 18 penetrates the inner chamber of the vial 16. At a position where the tip 20 is just located within the inner chamber, the second vial securement means operates to retain and fix the vial 16 in that position. Accordingly, as the user pushes on the base 26 of the vial 16, the vial 16 is forced between the first securement member(s) 40, 41 and the tip 20 of the needle 18 abuts the diaphragm 22 of the vial 16. Further movement of the vial 16 forces the tip 20 of the needle 18 through the diaphragm 22 until the tip 20 just locates in the vial 16. At this position, the chassis 14 is designed such that the top of the diaphragm 22 abuts an abutment surface 48 to prevent any further movement of the vial 16 and retains this specific position of the vial 16 relative to the syringe 12.

As shown in Figure 2 and Figure 4, the second vial securement means comprises an abutment surface 48 to limit the movement of the vial 16 towards the syringe 12. In particular, the abutment surface 48 is arranged to abut the top of the vial 16 at a position that is predetermined to coincide with the tip 20 of the needle 18 just entering the inner volume of the vial 16. The abutment surface 48 provides an opening through which the needle 18 of the syringe 12 extends.

The second vial securement means also comprises a third securement member 50 which is arranged to prevent the vial 16 from being moved from the activated position to the original initial position. In particular, the third securement member 50 securely retains the vial 16 in position as the needle 18 of the syringe 12 is pushed through the diaphragm 22 of the vial 16.

The third securement member 50 comprises an inwardly projecting shoulder 50 which abuts and engages a groove provide between the diaphragm 22 or top of the vial 16 and the body 24 of the vial 16. The third securement member(s) 50, 51 effectively provides a restricted passageway through which the vial 16 cannot normally pass. This passageway is formed by the third securement member 50 or a plurality of third securement members 50, 51. If it is required to remove the vial 16 from the chassis following use then the or each third securement member 50, 51 can be deflected outwardly to increase the cross sectional area of the passageway to enable the vial 16 or at least a part of it to pass therethrough. The shoulder 50, 51 comprises or is mounted on a flexible member which can be deflected outwardly in order for the vial 16 to pass through the relevant part of the chassis 14.

In the preferred embodiment, the first securement member 40, 41 and the third securement member 50, 51 are combined such that the shoulders or engaging portions for both components are provided on opposing surfaces of a single element. In particular, a single flexible arm has a first surface 40, 41 angled in a first direction to prevent movement of the vial 16 from the initial position in a first direction to the activated position and a second surface 50, 51 angled in a second direction to prevent movement of the vial 16 from the activated position in a second direction to the initial position. The syringe assembly 10 is provided with the plunger 30 of the syringe 12 in an extended, withdrawn position, as shown in Figure 1. The chassis 14 surrounds the syringe 12 and retains the syringe 12 therein. The chassis 14 also comprises plunger securement means which retains the plunger 12 in an outer position and prevents the plunger 12 from being depressed. The plunger securement means comprises a tab 44 including an engagement element 45 which abuts the outer end 36 of the plunger 30 and retains the plunger 30 in an extended position. The tab 44 is removable, as shown in Figure 2. In particular, the tab 44 can be broken off from the main body of the chassis. Once the tab 44 is removed, the plunger 30 can then be depressed in order to expel the air in the inner chamber of the syringe 12. This movement can be performed once the syringe assembly 10 has been activated such that the expulsion of the air pressurises the contents of the vial 16. Once the tab 44 is removed, the syringe assembly 10 is then ready to be activated.

The syringe assembly 10 is activated by moving the vial 16 from the initial position over the first securement member(s) 40, 41 to the activated position where the vial 16 is held in position between the abutment surface 48 and the third securement member(s) 50, 51. The plunger 30 can then be depressed in order to pressurise the contents of the vial 16.

The syringe assembly 10 is held with the vial 16 located above the syringe 12 such that the liquid in the vial 16 is located towards the diaphragm 22. The plunger 30 is then withdrawn in a conventional manner such that the liquid is transferred into the syringe 12. At this stage the syringe 12 is primed and ready for use.

As shown in Figure 3, the syringe 12 is then removed from the chassis 14. In order to do this, a retaining element 46 is first removed from the chassis 14. The retaining element 46 includes a lug 47 which engages with a part 48 of the syringe 12 and retains the syringe

12 within the chassis 14. The retaining element 46 can be manually snapped or removed from the chassis 14 and this then enables the syringe 12 to be easily extracted from the chassis 14. In particular, the user can grasp the syringe 12 and pull it out of the chassis 14. The syringe 12 is then ready for use as a conventional syringe.

Alternative embodiments of the invention are shown in Figure 6 to Figure 9 and Figure 10 to Figure 12 and it will be seen that each of these assemblies 10 provides first vial securement means and second vial securement means. In Figure 6, the retaining element 46 is shortened and the first securement member(s) 40, 41 comprise a greater abutment surface to restrict the movement of the vial 16 from the initial position to the activated position. In particular, the first securement member(s) 40, 41 comprise a generally arcuate or semi-circular profile which thereby also provides the third securement member(s) 50, 51.

In Figure 7, the retaining element 46 is provided on the main body of the chassis 14 and is not located on a removable portion . I n this embodiment, greater force and/or manipulation may be required to release the syringe from the chassis 14. In addition, the plunger 30 is retained by a tab 44 which is located between the two main legs 80, 81 of the chassis 14 rather than being located on a single leg 80, 81 of the chassis 14. This may increase the rigidity of the syringe assembly 10.

In Figure 8, again the tab 44 locates between the two legs 80, 81 of the chassis 14. In addition, the syringe 12 is not retained by a tab but is solely retained by an interference fit which grips the syringe body 32.

In Figure 9, the chassis 14 includes a leg link 83 to reinforce the rigidity between the two legs 80, 81 of the chassis 14.

The embodiment shown in Figure 10, Figure 1 1 and Figure 12 comprise a chassis 14 in an essentially tubular form. In Figure 1 0, the tab 44 can be broken off to enable movement of the plunger 30 and the syringe 12 is retained by the retaining element 46. In addition, the chassis 14 includes first vial securement means and second vial securement means.

In Figure 1 1 , the tab 44 is in the form of a removable sleeve 84. In Figure 12, the syringe 12 is secured in the chassis 14 by an interference fit and the pressure is relieved by squeezing two wings 85, 86 together which thereby allows the easy removal of the syringe 12 from the chassis 14.

As shown in Figure 5, the syringe 12 also incorporates a needle retraction system whereby the needle 18 can be retracted into the body 32 of the syringe 12 after use. The inner end 38 of the plunger 14 includes needle engagement means. At the completion of the inwards movement of the plunger 14, the engagement means are arranged to engage with a part of the needle assembly such that retraction of the plunger 14 pulls the needle 18 inside the syringe body 32. This thereby makes the syringe 12 safer for disposal.

In the preferred embodiment, as shown in Figure 5, Figure 18, Figure 19, Figure 21 and Figure 22 the needle engagement means includes a screw thread 60 provided on the inner end 38 of the plunger 30 and the needle 18 is provided on a needle cap 71 which is secured to an end cap 70. In a further preferred embodiment the end cap 70 and the needle cap 71 may be combined and may be integral. In the present embodiment, the end cap 70 is secured to the needle cap 71 by any suitable method, for example an adhesive. The end cap 70 includes a reciprocal screw thread 72. In this embodiment, the end cap 70 is secured to a needle cap 71 to which the needle is secured 18. In the preferred embodiment, the end cap 70 comprises an annular projection 75 which is arranged to locate through an aperture 76 in the end of the syringe body 32 and secures the end cap 70 to the syringe body 32. The annular projection 75 may comprise a resilient/deformable material. The needle mount including the end cap 70 (and the needle cap 71 ) includes an O-ring seal 77 (or may comprise a number of O-ring seals 77) in order to provide the integrity of the assembly. Similarly, the inner end 38 of the plunger 30 includes an O-ring seal 77. At the end of the injection movement, the plunger 30 is rotated (for example, by a half turn) relative to the syringe body 32 and needle assembly. This rotational movement engages the end cap 70 with the plunger 30 and enables the plunger 30 to withdraw the end cap 70 (and the needle cap 71 ) and hence the needle 18. Accordingly, the retraction of the plunger 30 forces the annular projection 75 inwardly through the aperture 76 on the end of the syringe body 32.

In another embodiment, the inner end 38 of the plunger 30 may be secured to the end cap 70 by a push fit/snap fit/interference fit. In particular, as shown in Figure 20, the inner end of the plunger 30 includes an annular projection 78 which is arranged, in use, to be engaged and retained in an inner annular groove 79 defined in the end cap 70. Accordingly, at the end of the inward movement, the annular projection 78 is forced to locate within the annular groove 79 and to thereby retain the end cap 70 to the plunger 30. Following this engagement, the plunger can withdraw the end cap 70 and the needle 18.

The present invention incorporates several suitable end cap engagement means whereby the end cap 70 is secured to the body 32 of the syringe 12, as shown in Figure 23 to Figure 27. For example, as shown in Figure 23, the end cap 70 may include an outer peripheral annular shoulder 90 which is arranged to be engaged over an inner peripheral annular shoulder 91 defined within the syringe body 32. At the end of the inwards plunger 30 movement, the inner end 38 of the plunger 30 is connected to the end cap by the twist grip or push fit previously described and then the plunger 30 can be used to force the outer peripheral shoulder 90 over the inner annular peripheral shoulder 91 of the syringe body 32 in order for the needle 18 to be retraced.

In Figure 24, the end cap 70 is connected to the syringe body 32 by a bayonet type fitting. The syringe body 32 has inner projecting male lugs 92 which can be engaged in female slots 93 on the end cap 70. Again, once the inner end 38 of the plunger 30 is secured to the end cap 70 the plunger 30 can rotate the end cap 70 to disengage the lugs 92 from the slots 93 and enable the needle 18 to be retracted. Figure 25 shows a similar version incorporating a bayonet fitting between the end cap 70 and the syringe body 32.

In Figure 26, the end cap 70 is provided with an outer screw thread 94 which is engaged within a cooperating screw thread 95 defined on the inner surface of the syringe body 32. This screw thread 94, 95 may be a short screw thread requiring a portion of a single turn, for example a quarter of a turn (90 degrees) to be engaged/disengaged. Again, once the inner end 38 of the plunger 30 has been engaged with the end cap 70, for example through a push fit or screw fit, the plunger 30 can be rotated in order to unscrew the end cap 70 from engagement with the syringe body 32. Figure 27 shows an alternative embodiment of this screw thread securement in which a plurality of turns are required to engage/disengage the end cap 70 with the syringe body 32.

The diaphragm (gasket) 22 of the vial 16 includes an inner profiled or contoured surface 23 as shown in Figure 13 and Figure 14. In the preferred embodiment, the inner surface 23 of the diaphragm 22 provides an inwardly tapered or inverted conical surface which directs the liquid in the vial 16 towards the tip 20 of the needle 18. This guiding surface ensures that substantially the entire single dose is transferred to the syringe 12 without the user having to carefully manipulate the assembly. Figure 15 to Figure 17 show alternative embodiments of the diaphragm 22 with different shaped internal surfaces 23 for guiding the liquid. The combination of the guiding surface 23 and the predetermined needle entrance distance set by the second vial securement means ensures that substantially all of the single dose is easily transferred from the vial 16 to the syringe 12. The syringe assemble may comprise automatic needle extractor means (not shown) which is arranged, once activated, to withdraw the needle into the syringe body. The automatic needle extractor means comprises movement means in order to withdraw and move the needle into the syringe body. In particular, a spring is arranged to be activated in order to withdraw the needle from the tissue and into the syringe body. The needle extractor means comprises a trigger which once actuated, for example by abutment of a part of the plunger, activated the release of the energy is stored in the spring which is translated into inwards movement of the end cap or at least the needle mount.

The needle extractor means is arranged to be activated once a predetermined volume of a liquid has be expelled from the syringe body through the needle. In particular, the needle extractor means is arranged to be activated once the plunger has been depressed by a predetermined amount. The needle extractor is arranged to be activated whilst the needle is located in the tissue being injected.

Furthermore, the syringe may comprise an inner needle and an outer needle. The outer needle provides a protecting sheath for the inner needle and such an outer needle prevents damage to the inner needle when the needle is inserted into the vial. The outer needle may be arranged, in use, to be retained by the vial and preferably by the diaphragm or closure member of the vial. The diaphragm or closure member of the vial is arranged to grip the outer needle and then to retain the outer needle by separating the outer needle from the syringe body.

The present invention provides a ready to use pre-filled syringe system comprising a syringe and a vial containing liquid. The syringe and the vial are both held in a chassis in such a way that its use is very easy and safe for the user. The syringe may hold desiccated or freeze-dried or lyophilized drug in which case the vial holds the liquid solution.

The syringe is preferably a safety syringe in which the needle can be retracted after use for safe disposal. The present invention relates to a system comprising a chassis for holding, (i) a syringe comprising a body with an open end and a necked end and a plunger with handle at one end of the chassis and (ii) a vial containing an injectable liquid and a stopper at the other end of the chassis where the syringe may be released from the body by a mechanical arrangement. The necked end of the syringe body may have a needle attached so that the vial may be pushed by the user towards the needle causing the needle to perforate the vial stopper. The travel of the vial is preferably limited by a stop so that the needle only perforates the vial stopper by a prescribed distance so that when the syringe plunger is retracted all or near all of the liquid in the vial is removed from the vial.

The vial stopper may be shaped in a conical or other fashion to help empty the vial.

More preferably the needle is attached to a second plunger or is sideably mounted within the syringe body so that it may be retracted into the body when attached by some means to the plunger piston at the end of the injection stroke so as to hide the needle within the body for safety reasons.

The second plunger is prevented from moving when the needle is forced into the vial.

The plunger is attached to the second plunger by twisting by means of a screw thread or other means. The second plunger may be released from the syringe body also by twisting the plunger within the body of the syringe. Alternatively it may be released when the syringe is released from the chassis by some mechanism.

The syringe body has a stopper to prevent the plunger piston being retracted more than necessary. The plunger may be supplied in a retracted position with the correct amount of air trapped within ready to be injected into the vial prior to extracting the liquid from the vial into the syringe.

The system is used as follows:

Step 1 - Remove device from packaging which may be a laminated pouch or similar to minimize evaporation or hu midity ingress into the system and to prevent any contamination.

Step 2 - Pull syringe plunger back until it stops (unless the plunger is supplied already retracted). Step 3 - Push the vial towards the syringe until it stops. This will force the needle to perforate the vial stopper and enter the vial up to a predetermined distance so as to facility the complete extraction of all the liquid in the vial.

Step 4 - Holding the system vertically downwards with the vial below the syringe, depress the plunger until it comes to a stop filling the vial with air and pressurizing the contents.

Step 5 - Rotate system by 180 degrees with the vial above the syringe and extract the contents from the vial. The specially shaped vial stopper with cavity will ensure that all or nearly all the liquid is transferred to the syringe (if syringe contains lyophilized drug then shake the content to fully dissolve).

Step 6 - Remove the syringe from the chassis exposing the needle and dispose of chassis and empty vial.

Step 7 - Push the plunger until a liquid drop appears on the needle tip.

Step 8 - Inject the patient.

Step 9 - At the end of the injection stroke remove needle from patient and twist the plunger in the syringe body. This will release the needle and mount and lock the needle mount to the plunger piston.

Step 10 - Retract the needle into the Syringe by making it safe by pulling the plunger.

Step 1 1 - Dispose of used parts.

Figure 28, Figure 29 and Figure 29a shows the device components before use and Figures 30 to 33 show alternative embodiments of the invention. Figures 34 to 42 show one embodiment of the device during usage and indicate the various user steps. Figure 43 shows the device with a lyophilized drug in the syringe body.

Figure 28 shows an embodiment of the invention before use. The complete device may be supplied in a hermetically sealed package or other type of package. A chassis or holder 41 1 has a vial 412 attached. The vial 412 has a stopper 415 with a conical cavity 416 on the inner side. The vial 412 holds liquid drug 413 and has a gas head space 414.

The chassis 411 is attached to a syringe body 421 via an attachment 420. The syringe body 421 has a piston 424 with connecting rod 426 and handle 427. A slidable mount 422 holds a hypodermic needle 423. Stops 430 prevent the piston 424 being removed from body 421. Connectors 428a and 428b form a connection between the piston 424 and the mount 422 when the handle 427 is twisted. The stops 431 limit the linear travel possible by vial 412 within the chassis 411.

In Figure 29b two alternatives to the conical portion 416 in stopper 415 are shown and, in particular, the stopper may include a semi circular cavity 416a or the stopper may include a cylindrical cavity 416b.

In Figure 30 the device is shown with a dust cap or shield to protect the device and especially the needle from contamination. Alternatively the syringe 421 and vial 412 are held by holder 450 by an air tight and hermetically sealed fit without an attachment 420 as shown in Figure 28. The assembly includes seals 490, 491 (e.g. O-ring seals) comprising an elastomer. In particular, a first seal 490 locates between the chassis 41 1 and the vial

412 and a second seal locates between the chassis 41 1 and the syringe body 421. In this case chassis 450 has no openings to keep all surfaces within sterile.

In some circumstance the arrangement of keeping the needle in a sterile enclosed atmosphere may be critical. For example, with some drugs it may be possible to sterilise the complete package once all the components are sealed in the blister pack. However, some drugs may be sensitive (e.g. bio-pharmaceuticals) and this method of sterilisation of the components may not be possible. Accordingly, in such circumstances the necessary surfaces can be sterilised and the needle 423 will then be contained and enclosed in the sealed enclosure created by the chassis 41 1 between the syringe body 421 and the vial 412.

In Figure 31 the holder 452 extends over the vial 412 to protect it from being moved before use.

In Figure 32 the vial 412 and the connecting rod 426 are locked by lock inserts 455, 456 to prevent accidental movement before use. In Figure 33 the rod 426 is locked in position by an alternative lock arm or extension 460, 461.

In Figure 34 a lock arm 460, 461 is shown removed as additional step 1a which would be prior to steps 1 to 9 as described below in Figures 35 to 42. In these Figures the embodiment shown in Figure 28 is used with the associated steps 1 to 9.

Figure 35 shows the two first steps. In step 1 the vial 412 is pressed towards syringe 421 until it reaches the stops 431. At this position, the needle has perforated the vial stopper 415 and travelled as far as the conical portion 41 6. I n step 2, the device is turned vertically so that the vial is at the bottom of the system.

In Figure 36, the device has been turned vertically with the gas headspace 414 above the liquid 413 in the vial 412. This prevents bubble formation when the air is pushed into the vial but in some cases it is not strictly needed. The needle 423 has just pierced the stopper and its sharp end is within conical portion 416. In step 3 the handle 427 is pushed in, transferring the air 435 in the syringe 421 into the vial 412 pressurizing it to aid the extraction of the liquid later.

In Figure 37, during step 4 the system is rotated by 360 degrees so that the vial 412 is now on top of the syringe 421.

In Figure 38, the drug 413 is extracted from the vial 412 and transferred to the syringe 421. Due to the shape of the conical portion 416 and the stops 430 the exact amount of drug is extracted from the vial 412 with little remaining in vial 412.

In Figure 39, during step 6 the user removes and discards the chassis 41 1 and vial 412 assembly thereby exposing the needle 423 for the first time by releasing chassis 41 1 from attachment 420. In Figure 40, the liquid 413 is injected into the patient 436 by depressing handle 427 forcing the piston forwards ejecting the liquid 413 via the needle 423.

In Figure 41 , the handle 427 is rotated locking the piston 424 to the needle mount 422 by means of connectors 428. In Figure 42, the handle 427 is pulled until it reaches the stops 430 retracting the needle 423 and enclosing it in the syringe 421 for safe disposal. In other embodiments, further rotation of the handle 427 may release the mount 422 from the syringe body 421 if the mount 421 is not simply held by friction forces to prevent it moving backwards into the syringe when the needle perforated the vial stopper 415.

In other embodiments, the needle may move sideways as shown in Figure 42 to prevent reuse.

Figure 43 shows an embodiment of the present invention with a lyophilized drug 439 within the syringe body. In use the system is used in the same way as described above but after transferring the liquid 413 to the syringe the mixture needs to be shaken to fully dissolve. In addition, there will be more air to be pushed out prior to injecting.

The present invention, as shown in Figure 44 to Figure 47 comprises a syringe body with one open end and one necked end and a seal tight plunger with a handle inserted through the open end. The assembly also includes a second plunger with a needle holder located within the syringe body with a needle attached located inside the body. A vial holder is connected via a twist connection such as a bayonet fitting or such like to the injecting end or necked end of the syringe.

The plunger has a male bayonet fitting or such like at the sealing end while the second plunger has a female bayonet or such fitting at the opposition end to the needle holder or needle.

A vial with stopper may be connected by the user by clipping on or such like to the other end of the vial holder or may be supplied already connected to the syringe via a holder.

After connecting the vial, if not supplied already connected, the user pushes the plunger in by the handle forcing both plungers to move in unison towards the necked end of the body until the second plunger can move no more and is sealingly placed against the necked end with the needle inserted into the vial via the vial stopper. Preferably the needle length and vial holder length are matched so that the needle only just enters the liquid. The user then withdraws the first plunger with the syringe and vial upright filling the syringe body with drug. Because of the close match of needle and holder length no drug is left in the vial and little if any overfill is needed. The body may have a stop to prevent the plunger being pulled back too far. The stop position on the body may be matched in length to the needle and holder to eliminate or nearly eliminate any air entering the syringe from the vial.

The user then removes the vial and holder by twisting or such like, expels any air bubbles from the syringe if needed and then injects the patient until the first plunger is in contact with the second again.

To make the device safe the user then rotates the handle in a clockwise direction until reaching a stop and pulls the handle back withdrawing the needle making the device safe again. The syringe and needle within can then be disposed of in a safe manner with the needle retracted and made safe.

The device may come supplied with a lyophilized drug or powdered drug and a diluent stored respectively in the vial and syringe barrel itself or vice versa. If the liquid is stored in the syringe then a second solid stopper is provided to seal the top of the needle to minimise evaporation during storage. This is fully perforated by the needle just before the needle enters the vial stopper. The liquid is then injected into the vial where the drug is reconstituted before being sucked back into the syringe prior to injecting the patient.

The handle may be snapped off after use to prevent re-use. The plungers may be of one or two part moulding types. The body may be made of plastic or glass or other material. The plungers may be made of plastic and/or rubber like material or glass and rubber like material. The body may have graduations. The rotating locking positions may be indicated on the handle and body.

The needle may be located in such a manner on the needle holder that it moves sideways once fully retracted so as to prevent further use.

The body may have a stop to prevent the used pulling the plungers out of the body.

In Figure 44, a body 201 has a plunger 202 with handle a 203, 204 which has a male bayonet type fitting 215, 216 attached. A second plunger 212 has a female bayonet fitting 213, 214 within and has a needle holder or neck 211 with a needle 220 attached. The device is in the unused state. A vial 250 with a drug 251 and a vial holder 252 are attached to the neck 211 by a bayonet or screw like fitting not shown in detail.

In Figure 45 the invention is shown with a plunger 202 with a male bayonet type fitting 215, 216 connected to plunger 212 with bayonet fitting 213, 214 with a needle 220 inside a vial 250 ready to extract a drug 251 from within by retracting plunger 202 by pulling a handle 204. The bayonet fitting 213, 214, 215, 216 are not engaged as the handle 204 has not been rotated.

In Figure 46 the syringe body 201 is full of a drug 219. The vial 250 is still attached. To inject the patient, the vial 250 is first removed with the vial holder 252 by twisting or snapping or by any other suitable means.

In Figure 47 the injection has taken place, the bayonet fitting 213, 214, 215 and 216 has been engaged by twisting handle 204 and plunger 202 pulled back with plunger 212 attached and needle 220 is in a safe position ready for disposal.

The present invention also provides an improved hand syringe which gives the user the option of reusing the syringe and needle or just the syringe but at the same time always making the syringe safe by protecting the needle after use even in between usage if so desired. Additionally the needle may be supplied with the syringe in a completely safe manner without the need to remove a needle sheath which in itself can cause injuries to the user.

The present invention comprises a syringe body with one open end and necked end and a seal tight plunger with handle is inserted through the open end. A second plunger with needle holder is located within the syringe body either with a needle attached or not and either located at the necked end or somewhere inside the body.

The plunger has a male bayonet fitting or such like at the sealing end while the second plunger has a female bayonet fitting at the opposite end to the needle holder or needle. In another embodiment the device comes with the second plunger at the necked end of the body. The plunger is in contact with the second plunger and ready for use. The user then attaches a needle with sheath to the needle holder. Alternatively the device is supplied with a needle attached to the needle holder and second plunger with a protective sheath. The user then removes the sheath and insets the needle into a drug container and withdraws the first plunger filing the body with drug. The user then injects the patient until the first plunger is in contact with the second.

To make the device safe the user then rotates the handle in a clockwise direction until reaching a stop and pulls the handle back withdrawing the needle making the device safe. The device can then be disposed of in a safe manner with the needle retracted and made safe.

In another embodiment the needle is supplied with the syringe and is located in the body with the sharp end not protruding out and hence safe to handle. To operate the user pushes the plunger in by the handle forcing both plungers to move in unison towards the necked end of the body until the second plunger can move no more and is sealingly placed against the necked end. The user then inserts the needle into a drug container and withdraws the first plunger filing the body with drug. The user then injects the patient until the first plunger is in contact with the second again.

To make the device safe the user then rotates the handle in a clockwise direction until reaching a stop and pulls the handle back withdrawing the needle making the device safe again. By rotating the handle anti clockwise until it reaches a stop the device is ready to use again if so desired. Otherwise it can be disposed of in a safe manner with the needle retracted and made safe.

The handle may be snapped off after use for extra safety. The plungers may be of one or two part mouldings. The body may be made of plastic or glass or other material. The plungers may be made of plastic and/or rubber like material or glass and rubber like material. The body may have graduations. The rotating locking positions may be indicated on the handle and body.

The needle may be located in such a manner on the needle holder that it moves sideways once fully retracted so as to prevent further use. The device may be pre-filled with drug. The device can have any liquid capacity from O.i cc to lOOOcc. Any needle type and fitting can be used.

The body may have a stop to prevent the user pulling the plungers out of the body.

In Figure 48 a conventional two part moulding syringe is shown. A body 101 has a plunger 102 within attached to a handle 103 and 104. At the far end the body 101 is necked and shaped to receive a needle.

In Figure 49 a conventional three part moulding syringe is shown. A body 101 has a plunger 102 within with a softer material seal 106 attached and is attached to a handle 103 and 104. At the far end the body 101 is necked and shaped to receive a needle.

In Figure 50 a first embodiment of the invention is shown based on a two part moulding syringe. A plunger 102 has a male bayonet type fitting 115 and 1 16 attached. A second plunger 1 12 has a female bayonet fitting 1 13 and 1 14 within and has a needle holder or neck 11 1. The device is in the unused state.

In Figure 51 the invention is shown with plunger 102 with a male bayonet type fitting 1 15 and 116 in the retracted position with the body 101 full of drug 1 19. The second plunger 1 12 with female bayonet fitting 1 13 and 114 within the needle holder or neck 1 11 with the needle 120 attached is in the ready to inject position.

In Figure 52 a first embodiment of the invention is shown with device after injection. Male bayonet 1 15 and 116 is inserted into female bayonet fitting 1 13 and 114 and has been twisted to create a fixing connection between plunger 102 and plunger 1 12. In this state the user can pull handle 104 and retract the needle 120 into body 101.

In Figure 53 the device is shown in the safe position after the user has pulled the plunger back. Needle 120 is inside body 101 and safely stored for device disposal. In this state the handle 104 may be snapped off to prevent further use.

In Figure 54 a second embodiment is shown before use. The second plunger 112 and needle 120 are inside body 101 before use. To use the user pushes handle 104 inwards until plunger 112 can travel no longer and needle 120 is ready for use and in the state shown in Figure 50. The steps shown in Figures 51 to 53 are then followed in the same way.

At the position shown in Figure 53 the handle may be rotated anticlockwise to return the device to position shown in Figure 54 for further use if required.

In Figures 55 and 56 a needle use prevention system is shown. In Figure 55 the needle 131 is shown before use in the equivalent position as shown in Figure 54. The needle 131 can be pushed to its ready to use position because of the slope of body 132. In Figure 56 the needle has be de-activated and is in the equivalent position as shown in Figure 53 but the needle 131 bent sideways to prevent re usage.

Claims

1. A syringe assembly comprising a syringe, a chassis and a vial wherein the chassis engages the syringe and is retained thereto, the syringe comprising a syringe body and a needle, the chassis further comprising first vial securement means to secure the vial at a first position relative to the syringe and second vial securement means to secure the vial at a second position relative to the syringe and in which, in the first position the needle of the syringe does not penetrate the vial and in the second position the needle of the syringe penetrates the vial.

2. A syringe assembly according to Claim 1 in which the chassis engages the syringe and inhibits relative movement of the syringe in a first longitudinal direction and in a second longitudinal direction.

3. A syringe assembly according to Claim 1 or Claim 2 in which the chassis comprises a retaining element to retain the syringe to the chassis.

4. A syringe assembly according to Claim 3 in which the retaining element is removable to allow removal of the syringe from the chassis.

5. A syringe assembly according to any preceding claim in which the first vial securement means of the chassis inhibits relative movement of the vial towards the syringe and away from the syringe.

6. A syringe assembly according to any preceding claim in which the second vial securement means of the chassis inhibits relative movement of the vial towards the syringe and away from the syringe

7. A syringe assembly according to any preceding claim in which the first vial securement means prevents inadvertent penetration of the vial by the needle.

8. A syringe assembly according to any preceding claim in which the first vial securement means prevents inadvertent detachment of the vial from the chassis.

9. A syringe assembly according to any preceding claim in which the second vial securement means prevents inadvertent extraction of the needle from the vial.

10. A syringe assembly according to any preceding claim in which the second vial securement means limits the penetration distance of the needle in the vial.

1 1. A syringe assembly according to any preceding claim in which the assembly comprises plunger retaining means which is arranged, in use, to retain the plunger in an extended position prior to use.

12. A syringe assembly according to Claim 1 1 in which the plunger retaining means prevents inadvertent movement of the plunger into the syringe body.

13. A syringe assembly according to any preceding claim in which the needle is arranged, in use, to be retracted into the syringe body after the syringe has been used and the drug has been injected.

14. A syringe assembly according to any preceding claim in which the plunger comprises needle engagement means.

15. A syringe assembly according to Claim 14 in which the needle engagement means is arranged, in use, to engage a needle mount in order for subsequent movement of the plunger out of the syringe body to cause movement of the needle into the syringe body.

16. A syringe assembly according to Claim 14 or Claim 1 5 in which the needle engagement means selectively engages and disengages a needle mount.

17. A syringe assembly according to any one of Claim 14 to Claim 16 in which the needle engagement means requires actuation in order to engage the needle mount.

18. A syringe assembly according to any preceding claim in which the syringe comprises an end cap and in which the end cap is removably secured to the syringe body.

19. A syringe assembly according to any preceding claim in which the vial comprises a diaphragm for closing the vial and retaining the liquid in the vial and wherein the vial comprises an inner shaped surface to prevent retention of the liquid in the vial.

20. A syringe assembly according to Claim 19 in which the inner shaped surface of the vial directs the liquid in the vial towards the tip of the needle, in use.

21. A syringe assembly according to any preceding claim in which the syringe assembly comprises an outer protective packaging.

22. A syringe assembly according to any preceding claim in which the outer protective packaging prevents movement of the vial from the first position to the second position.

23. A syringe assembly according to Claim 22 in which the outer protective packaging prevents the application of a force to a base of the vial.

24. A syringe assembly according to any preceding claim in which the syringe assembly is treatable in order to sterilise the syringe assembly.

25. A syringe assembly according to Claim 24 in which the syringe assembly is treatable whilst it is contained and sealed within an outer protective packaging.

26. A syringe assembly according to any preceding claim in which the chassis provides an enclosure within which to house the needle.

27. A syringe assembly according to Claim 26 in which the enclosure comprises a sealed enclosure.

28. A syringe assembly according to Claim 26 or Claim 27 in which the enclosure comprises a sterile enclosure.

29. A syringe assembly wherein the chassis is arranged, in use, to engage a syringe and to retain the syringe thereto, the chassis further comprising first vial securement means which is arranged, in use, to secure a vial at a first position relative to the syringe and the chassis further comprising second vial securement means which is arranged, in use, to secure the vial at a second position relative to the syringe and in which, in the first position a needle of the syringe does not penetrate the vial and in the second position the needle of the syringe penetrates the vial.

30. A method of providing a single measured dose of a fluid in a syringe comprising retaining a syringe within a chassis, the method further comprising providing a vial including a fluid within the chassis, the method comprising securing the vial in a first position within the chassis at which a needle of the syringe does not penetrate the vial and moving the vial from the first position to a second position within the chassis at which the needle of the syringe penetrates the vial and the vial is secured by the chassis at the second position.