Needle protection device

A device (2) for bringing a first vessel member (6, 26) in fluid communication with a needle member (4), which device (2) includes an adaptor (20) having a housing (14) with a holding arrangement (16, 18) configured to secure the needle (4) to the housing (14), where the housing (14) has at least a first opening (38, 40) sealed by a seal (10, 12); a cutting device (32, 34) configured to perforate the seal (10, 12). The cutting device (32, 34) is configured to perforate the seal (10, 12) and thereby break the seal (10, 12) by bringing the seal (10, 12) into contact with the cutting device (32, 34) by moving the adaptor (20) towards the vessel member (6, 26) in a manner in which the needle member (4) is not brought into contact with the seal (10, 12).

FIELD OF INVENTION

The present invention generally relates to a device for bringing a first vessel member in fluid communication with a needle member. The invention more particularly relates to a device for bringing a first vessel member in fluid communication with a sterile needle member kept in a sealed adaptor. The adaptor is preferably sealed in a manner so that the seal(s) keeps the needle sterile during storage.

PRIOR ART

It is known to use devices e.g. for reconstituting liquid for medical use. This is traditionally done by bringing together a first liquid (e.g. a diluent for reconstitution of lyophilizes medicinal drug) in a cartridge and another substance (e.g. a drug in solid form of a lyophilized medicinal drug).

Such reconstitution device is known from the US patent U.S. Pat. No. 7,077,835 that discloses a device that is configured to bring a cartridge in fluid communication with a vial by using a needle assembly having a lower and an upper sterile double-ended needle chamber both being closed by an axially slidably bung. In use the needle penetrates the bungs and hereby the needle may be damaged. The needle may bend, break or be infected with impurities and hereby no longer be suitable of being used as a reconstitution device.

Thus, there is a need for a device which reduces or even eliminates the above mentioned disadvantages of the prior art.

It is an object of the present invention to provide a device for bringing a first vessel member in fluid communication with a sterile needle member kept in a sealed adaptor, in a manner in which damaged of the needle can be prevented.

SUMMARY OF THE INVENTION

The object of the present invention can be achieved by a device having the features as defined in claim1. Preferred embodiments are defined in the dependent sub claims and explained in the following description and illustrated in the accompanying drawings.

The device according to the invention is a device for bringing a first vessel member in fluid communication with a needle member, which device comprises:an adaptor having a housing comprising a holding arrangement configured to secure the needle to the housing, where the housing has at least a first opening sealed by a seal;cutting means configured to perforate the seal.

The cutting means are configured to perforate the seal and hereby break the seal by bringing the seal into contact with the cutting means by moving the adaptor towards the vessel member in a manner in which the needle member is not brought into contact with the seal.

Hereby it is achieved that the seal can be broken without bringing the needle member into contact with the seal. In this way damaged and contamination of the needle member can be prevented.

By the term needle member is meant a hollow needle or a hollow spike having a through-going bore with a first opening and a second opening. The needle may have at least one grinded end and thus have a bevel. The needle may be a hypodermic needle by way of example.

It is preferred that the adaptor contains a sterile needle and that the adaptor is sealed in a manner so that the seal(s) keeps the needle sterile during storage. The first vessel member may in principle be any type of vessel e.g. a vial or a cartridge by way of example.

The adaptor may be any type of assembly capable of containing the needle in a way in which the needle can be positioned and maintained in a desired position and manner.

The adaptor may by way of example have a cylindrical geometry and have a needle member extending basically along the longitudinal axis of the adaptor.

The adaptor comprises a housing comprising a holding arrangement configured to secure the needle to the housing. The housing may have any suitable geometry and the holding arrangement may be constructed in any desired way.

The seal may be any suitable seal, however, it is preferred that the seal is made in material with a small tensile strain at break—e.g. aluminium. As it will apparent from the following description, it is important that the seal will break rather than deflect, when stressed.

The cutting means may be any type of cutting means capable of perforating the seal in a desired way. The cutting means may comprise one, two or more cutting members of either equal type or of different type.

It may be an advantage that the device comprises a collar provided with protruding cutting edges and less protruding pressing edges, where the collar is configured to be mounted on or be integrated into a vessel member.

Hereby it is achieved that the cutting means can perforate the seal and hereby break the seal when the seal is brought into contact with the cutting means due to a translation of the adaptor towards the vessel member. At the same time the less protruding pressing edges can assist the process of breaking the seal in a controlled manner.

It may be an advantage that the device comprises a collar provided with protruding cutting edges and less protruding pressing edges, where the collar is configured to be mounted on or be integrated into a vessel member, where the needle member is a hollow needle or a hollow spike having at least one through-going bore having a first opening and a second opening, where the adaptor contains a sterile needle member and where the adaptor is sealed in a manner so that the seal(s) keeps the needle member sterile during storage.

It may be beneficial that the cutting means are mechanically attached to or integrated into the outside of the housing of the adaptor, where the needle member is a hollow needle or a hollow spike having at least one through-going bore having a first opening and a second opening, where the adaptor contains a sterile needle member and where the adaptor is sealed in a manner so that the seal(s) keeps the needle member sterile during storage.

It may be an advantage that the cutting means are mechanically attached to or integrated into the outside of the housing of the adaptor.

Hereby a simple and useful device can be provided. It is, by way of example possible to provide a device that merely comprises an adaptor.

In one embodiment according to the invention the cutting means are provided at the end portion of a number of flexible leg members extending from the outside of the adaptor towards the central portion of the opening of the adaptor.

It may be an advantage that the flexible legs are configured to be brought into contact with the seal when a vessel member is being pressed against the legs. Hereby a first vessel member can be brought in fluid communication with a sterile needle member kept in a sealed adaptor without damaging or contaminating the needle member.

It may be advantageous that the device comprises an adaptor having:a first opening sealed by a first seal anda second opening sealed by a second seal.

Hereby the device may be used to provide fluid communication with a sterile needle member and two vessel members so that fluid communication can be provided between the two vessel members.

The first opening and the second opening may have basically same size and geometry; however, it is also possible that the first opening and the second opening have different size and geometry.

In a preferred embodiment according to the invention the device is configured to move the cutting means essentially along the longitudinal axis of the adaptor and hereby break the seal.

Hereby a safe, effective and easy cutting process can be carried out. The motion of the cutting means may be caused by manual action or by using an actuator of any suitable type.

It may be an advantage that the cutting means are configured to cut/break the seal approximately at the midline of the seal.

Hereby access to the needle through the central portion of the seal can be provided. In this way a centrally arranged needle can be inserted into a vessel member without bringing the needle member into contact with the seal.

In a preferred embodiment according to the invention the opening and the seal sealing the opening has a basically circular shape.

Advantageously the cutting means are configured to cut/break the seal in a manner in which only the central portion of the seal is broken.

Hereby a centrally arranged needle member can be inserted to a vessel member without bringing the needle member into contact with the seal and without risking that the peripheral portions of the seal is brought into contact with the needle member.

It may be an advantage that the needle member is arranged in the adaptor in such a way that the distance between the apex of the needle member and an end point at the periphery of the seal is more than 5%, preferably more than 10% larger than the distance between the midpoint of the seal and the end point of the seal.

Hereby it is achieved the seal is prevented from coming into contact with the needle member so that the needle member can be kept sterile both during storage of the adaptor and when the needle member is inserted into the vessel member.

It may be beneficial that the seal is circular shaped and that the needle member is arranged in the adaptor in such a way that the distance between the apex of the needle member and an end point at the periphery of the seal is more than 5%, preferably more than 10% larger than the distance between the midpoint of the seal and the end point of the seal.

Advantageously the distance between the seal and the apex of the needle member is more than 5%, preferably more than 10% of the width of the seal.

By such arrangement it is achieved that the seal is prevented from being brought into contact with the needle member. Hereby the needle member can be kept sterile both during storage of the adaptor and when the needle member is inserted into the vessel member.

It is preferred that the device is configured to maintain the apex of the needle member in a position relative to the housing of the adaptor so that a non-zero distance is kept between the apex of the needle member and the seal both when the seal is unbroken and when the seal is broken.

It may be an advantage that the needle member extends parallel to the direction of which the adaptor is configured to be moved in order to break the seal.

Hereby the needle member can be inserted into the vessel member in an effective, safe and reliable way.

It may be an advantage that the needle member has a longitudinal axis extending parallel to both the longitudinal axis of the adaptor and the longitudinal axis of the vessel member during breakage of the seal.

Hereby the needle member can be inserted into the vessel member in an appropriate and desirable way so that fluid communication between the vessel member and the needle member can be achieved.

In a preferred embodiment of the device according to the invention the device comprises means for preventing movement of the adaptor towards the vessel member and hereby causing unintended breakage of the seal.

This feature is particular desirable when the device is kept in a storing state in which no fluid communication between the vessel member and the needle member is wanted or in a situation in which only fluid communication between one of two vessel members and the needle member is desirable.

The means for preventing movement of the adaptor towards the vessel member may be mechanical means such as lock members, protrusions configured to engage in on or more corresponding indentations or any other suitable means.

It may be an advantage that the device comprises an adaptor having:a first end with an opening, configured to be connected to a first vessel member anda second end with an opening, configured to be connected to a second vessel member,

where the device is configured to be operated in a first state, in which the adaptor can be moved towards the first vessel member without moving the adaptor relative to the second vessel member, where the device further is configured to be operated in a second state following the first state, in which the adaptor can be moved towards the second vessel member without moving the adaptor relative to the first vessel.

Hereby the device can be used to carry out a predefined sequence, e.g. by bringing the needle member into contact with the first vessel member (e.g. comprising a lyophilized medicinal drug) e.g. in the first state of operation in a secure way, where the needle member will not be unintendedly brought into contact with the second vessel member (e.g. comprising a diluent for reconstituting the lyophilizes medicinal drug). When the needle member is brought into contact with the first vessel member, the second state of operation can be initiated in order to bring the other free end of the needle member into contact with the second vessel member.

Since it is of essential importance that the diluent is not spoiled/wasted accidently, it is of great value to have a device that is configured to be operated in a first state, in which the adaptor can be moved towards the first vessel member without moving the adaptor relative to the second vessel member and where the device further is configured to be operated in a second state following the first state, in which the adaptor can be moved towards the second vessel member without moving the adaptor relative to the first vessel.

It may be an advantage that the cutting means comprises two cutting edges that are configured to be arranged essentially symmetrically about the needle member when the cutting means are brought into contact with the seal.

Hereby it is possible to provide a centrally arranged opening in the seal in the area surrounding the needle member. In this way the needle member can be kept sterile.

It may be an advantage that the cutting edges are basically equal.

It may be beneficial that the adaptor comprises a housing having basically parallel walls.

The walls of the adaptor may have other forms e.g. a conical geometry by way of example.

The adaptor may comprise a housing having basically parallel walls and a base member extending essentially perpendicular to the walls of the housing.

It may be an advantage that the device comprises means for reconstituting a lyophilized medicinal drug powder contained in a first vessel member with a fluid diluent contained in a second vessel member by connecting and mixing the two substances through an adapter and where the device provides means for delivering the diluent in a controlled slow manner, in order to avoid foaming during reconstitution with the lyophilized medicinal drug powder by requiring a rotational user activation of the plunger rod actuator.

Hereby foaming can be avoided during discharge and/or filling of a vessel member.

It is preferred that a smooth, slow and controlled movement of the adaptor relative to the vessel member can be established by using the device so that a steady discharge and/or filling of a vessel member without foaming can be carried out.

It may be an advantage that the device comprises a top chassis and a button member rotably mounted in the device and being restricted from being translated/slided along the longitudinal axis of the top chassis, where the device further comprises a rod actuator slidably mounted in the device and being restricted from being rotated relative to the top chassis.

Hereby a controlled translation of the rod actuator can be provided by rotating the button member so that a controlled and steady discharge and/or filling of a vessel member without foaming can be carried out

In a preferred embodiment according to the invention the device comprises a rod actuator provided with one or more protrusions configured to be guided in a track inside a button member in such a manner that the track is configured to pull the rod actuator in a first direction when the button member is rotated.

Hereby a rotation of the button member can cause a steady and controlled translation of the rod actuator so that a controlled and steady discharge and/or filling of a vessel member without foaming can be carried out.

It may be an advantage that the device comprises:a base having a base chassis having an open end and a lower end, which base chassis is configured to receive and contain a vessel member at its lower end;an adaptor containing a sterile needle member and having a first opening being sealed by a first seal and a second opening being sealed by a second seal;a hand operable handle configured to engage with the base while sandwiching an adaptor between the handle and the base, where the handle comprises a top chassis configured to receive and be mechanically connected to a button grip, where the handle is configured to receive and contain a syringe being sandwiched between the button grip and the top chassis, where the button comprises a rod actuator translatable mounted in the handle in a manner in which it is restricted from being rotated relative to the top chassis, where the button member rotably mounted in the handle in a manner in which it is restricted from being translated relative to the top chassis so that rotation of the button grip cause translation of the rod actuator which hereby activates syringe.

Hereby an automated, easy, safe and controlled filing sequence and empting sequence may be carried out by using the device. Such device is user friendly, reliable and easy to use.

It may be an advantage that the base chassis and the top chassis are cylindrical and configured to receive and contain a vial and/or a having a cylindrical geometry.

DETAILED DESCRIPTION OF THE INVENTION

Referring now in detail to the drawings for the purpose of illustrating preferred embodiments of the present invention, a schematically view of a device2of the present invention is illustrated inFIG. 1.

FIG. 1is a schematic side view of a device2according to the invention. The device2comprises an adaptor20having a cylindrical housing14and a circular disc-shaped base member attached to the inside of the housing14. The adaptor20comprises a sterile needle4attached to a cylindrical holding member18centrally arranged and attached to an aperture in the base member16. The needle4extends along the longitudinal axis Y of the housing14.

The adaptor20is provided with a first opening38sealed by a first seal10and a second opening40sealed by a second seal12.

InFIG. 1a) the adaptor20is arranged above a vessel member6formed as a vial6having a longitudinal axis X and being sealed by a septum8provided with protruding cutting edges32.

The longitudinal axis X of the vial6extends parallel to the longitudinal axis Y of the housing14of the adaptor20.

InFIG. 1b) the adaptor20has been pushed against the vial6. The seal10has been broken without bringing the needle in contact with the seal10and the needle has penetrated the septum8of the vial6. Thus, the needle4has been brought into fluid communication with the vial6without bringing the needle4into contact with the seal10. Accordingly, to the needle4is kept sterile and is being protected from damage and contamination during the breakage of the seal10.

FIG. 2illustrates another schematic cross-sectional view of a device similar to the one shown inFIG. 1. The device2comprise the same features as illustrated inFIG. 1, however, an additional cartridge26sealed with a septum24and being provided with a plunger22is provided above the adaptor20. The septum24of the cartridge26is provided with cutting edges32configured to break the seal12of the adaptor20.

InFIG. 2a) the cartridge26is arrange above the adaptor20which is arranged slightly above the vial6. Thus, the first seal10and the second seal12are kept undamaged.

InFIG. 2b) the adaptor20has been pushed against the vial6and the cutting edges32provided at the septum8of the vial6have penetrated and hereby caused a breakage of the first seal10of the adaptor20. The needle4has been inserted into the vial6through the septum8. Accordingly, fluid communication has been established between the needle4and the vial6. The cartridge26on the other hand is remained in the same distance above the adaptor20.

InFIG. 2c) the cartridge26has been pushed against the seal12of the adaptor20. The cutting edges32′ provided at the septum24of the cartridge26have penetrated the seal12of the adaptor20. Accordingly, an aperture has been created in the seal12so that the needle4has been given access to the septum24of the cartridge26. The needle4has penetrated the septum24of the cartridge26and hereby fluid communication has been established between the needle4and the cartridge26.

It can be seen that the cutting edges32of the vial6penetrates the first seal10of the adaptor20by moving the adaptor20along its longitudinal axis Y towards the vial6and thus along the longitudinal axis Y of the vial6. In the same manner the cutting edges32′ of the cartridge26penetrate the first seal10of the adaptor20by moving the adaptor20along its longitudinal axis Y towards the vial6and thus along the longitudinal axis Y of the vial6. In the same manner the cutting edges32′ of the cartridge26penetrates the second seal12of the adaptor20by moving the cartridge26along its longitudinal axis X towards the adaptor20and thus along the longitudinal axis Y of the adaptor20.

FIG. 3a) illustrates a perspective view of a vial6according to the invention. The vial6comprises a basically cylindrical collar30mechanically attached to the top portion of the vial6. On the upper surface28of the collar30two protruding cutting edges32and two less protruding pressing edges34are provided.

FIG. 3b) illustrates a close-up perspective view of the collar30shown inFIG. 3a). It can be seen that the collar30comprises a circular centrally arranged aperture36configures to receive a needle4of an adaptor20.

InFIG. 3c) an adaptor20is being brought into contact with the vial6. It can be seen that the cutting edges32touches the outer surface of the seal10of the adaptor20while there is a non-zero distance between the seal10and the pressing edges34.

FIG. 3d) illustrates the seal10seen from the outside of the adaptor20while the two cutting edges32are brought into contact with the seal10.

InFIG. 3e) the cutting edges has are penetrating the seal10while the pressing edges34are brought into contact with the seal10.

InFIG. 3f) the seal10begins to break along the central portion of the midline126of the seal10. The force F exerted by the pressing edges34towards the seal10is indicated.

FIG. 3g) illustrates a cross-sectional view of an adaptor20according to one embodiment of the invention. It can be seen that the seal10is arranged in a non-zero distance d3from the apex p of the needle4so that the seal10is not being brought into contact with the needle4.

The distance d1between the end point e (at the periphery of the seal10) and the break point b (corresponding to the midpoint of the seal10) is smaller than the distance d2between the end point e (at the periphery of the seal10) and the apex p of the needle4. Moreover it can be seen that the width D of the seal10corresponds to two times the distance d1between the end point e and the break point b.

It is preferred that needle4is arranged in the adaptor20in such a way that the distance d2between the apex p of the needle4and an end point e at the periphery of the seal10is more than 5%, preferably more than 10% larger than the distance d1between the midpoint b of the seal10and the end point e of the seal.

In this way the seal10is prevented from coming into contact with the needle4. Accordingly, the needle4can be kept sterile both during storage of the adaptor20and furthermore damage of the needle4during insertion of the needle4into a vessel member6can be avoided.

It is preferred that the distance d3between the seal10and the apex p of the needle4is larger than 5%, preferably larger than 10% of the width D of the seal10.

FIG. 4a),FIG. 4b) andFIG. 4c) illustrates a cross-sectional view of a device2according to the invention. The device2comprises an adaptor20corresponding to the one shown inFIG. 1-3.

InFIG. 4a) the collar30of the vial6is being pressed against the seal10of the adaptor20. It can be seen that an aperture has been created in the seal10so that the needle4can be inserted into the vial6.

InFIG. 4b) the needle4has been inserted into the vial6. It can be seen that the needle4has penetrated the septum8of the vial6.

InFIG. 4c) the needle4has been brought into fluid communication with a vial6and with a cartridge26. The first seal10has been broken by the cutting edges32of the collar30of the vial. Moreover, the second seal12has been broken by the cutting edges (not shown) of the collar30′ of the cartridge26.

FIG. 4d) illustrates an alternative embodiment of a device2according to the invention. The device2comprises an adaptor20having two arms124. Cutting edges32are provided at the distal end of the arms124and the arms124are mechanically attached to the outside of the housing of the adaptor20at their proximate end. A vial6is arranged below the adaptor20. When the vial6is pressed against the arms124of the adaptor20the cutting edges32will penetrate the seal10of the adaptor20and hereby break the seal10so that the sterile needle4has free access to the vial6without being touched by the seal10.

The embodiment shown inFIG. 4d) is simple and easy to use. Arms124similar to the ones shown may also be provided at the other end of the adaptor20so that these arms (not shown) can penetrate the other seal12of the adaptor20so that the needle4can be inserted into another vessel member (not shown).

The arms124are preferably flexible so that the cutting edges32may be moved relative to the housing of the adaptor20. The arms124may be hinged to the outside of the housing of the adaptor20. The arms124may also be integrated into the adaptor20. The arms124may be mechanically connected to the outside of the housing of the adaptor20by other suitable means.

FIG. 5illustrates schematic perspective views of a device2according to the invention. The device2comprises an adaptor20and means for performing a predefined sequence. A cartridge26provided with a collar30′ is being moved towards the adaptor20while a vial6provided with a collar30is arranged below the adaptor20. The device2comprises an interface42comprising a plate member54and two members each having two beams44extending along the length of the adaptor20are attached to a collar member30″ surrounding the cartridge26.

A space58is provided between the beams44. The device2comprises a rib56that is configured to be contained in the space58so that the beam44can be axially fixed relative to the rib56.

Each of the beams44are provided with end members having an angled surface46, a side surface48and a front surface50. It can be seen that the collar30′ is provided with cutting edges32as well as pressing edges34.

FIG. 6illustrates several perspective views of a device according to the invention. A cartridge26is connected to an interface42like the one shown inFIG. 5. It can be seen that the adaptor20is sealed by a first seal10and a second seal12and that motion of the cartridge26towards the adaptor20will cause breakage of the seal12.

During the steps shown inFIG. 6a) andFIG. 6b) the beams44are guided within two rail members52. When the beams44are guided within two rail members52the beams44cannot be moved away from each other and deflect (like shown inFIG. 6c). Therefore, the cartridge26cannot be slided towards the adaptor20when the beams44are guided within two rail members52. InFIG. 6a) andFIG. 6b) the cartridge26will push against the adaptor20and herby move the adaptor towards the vial6so that the seal10of the adaptor20will break like shown inFIG. 1-4.

On the other hand, when the collar30of the vial6has been fully inserted into the adaptor20, a further press of the cartridge26towards the adaptor20will result in a situation like the one illustrated inFIG. 6c). InFIG. 6c) the beams44are no longer guided within the two rail members52(like shown inFIG. 6and inFIG. 6b). Therefore, further motion of the cartridge26towards adaptor20will cause the rib to enter the space between the beams44so that the beams44will be moved away from each other. When the cartridge26is moved further towards the vial6the rib56will be fully contained within the space between the beams44like illustrated inFIG. 6d).

FIG. 6e) illustrates a perspective close-up view of the beams44being guided with in two rail members52.

FIG. 7illustrates a sequence where the device according to the invention is being used. InFIG. 7a) a cartridge26is brought into fluid communication with the needle4of the adaptor20. The adaptor20has further been brought into fluid communication with a vial6. The plunger rod60is pressed into the cartridge26and a first substance64is being filled into the vial6. A second substance62is already filled into the vial6. The first substance64may be a diluent for reconstitution of lyophilizes medicinal drug and the another substance62is a drug in solid form of a lyophilized medicinal.

InFIG. 7b) the first substance64and the second substance64are mixed into a third substance66.

InFIG. 7c) the arrangement is turned upside down.

InFIG. 7d) the mixed substance66has been sucked out of the vial6.

InFIG. 7e) the adaptor20and the vial6have been removed and the cartridge26is filled with the mixed substance66and is ready for being used to injection of the mixed substance66.

FIG. 8illustrates cross-sectional views of various embodiments of a needle member4according to the invention.

FIG. 8a) illustrates a needle4that is integrated into the adaptor20(e.g. by a plastic moulding process).

FIG. 8b) illustrates a needle member4having two needle members4′,4″ arranged in the same level and pointing towards the same plane. The two needle members4′,4″ are connected by a through-going bore/channel. This needle member4may be used to bring the needle member4into fluid contact with two vessel members (not shown) that can be inserted into the adaptor20from the same side. The first needle member4′ is arranged in a first chamber seal by a first seal10, while the second needle member4″ is arranged in a second chamber seal by a second seal12.

FIG. 8c) andFIG. 8d) illustrates adaptors20having needle members connected to a valve being in fluid communication with a pipe70.

FIG. 8f) illustrates a needle member4having a first bore72and a second bore72′.

FIG. 8g) illustrates a needle member4provided with a bore72and a vent74, whileFIG. 8h) illustrates a similar adaptor with a filter76arranged in the vent74.FIG. 9illustrates a device2according to the invention. The device2comprises a handle80having a button90, with a button grip92and a rod actuator94. The device moreover comprises a top chassis86to which the handle80is configured to be attached. The top chassis86is configured to receive and contain a syringe84and a lock member88. The device2comprises an adaptor20configured to be sandwiched between the top chassis86and a base chassis82having a base78. The base chassis82is configured to receive and contain a vial6at the lower end of its inside.

The button grip92is rotably mounted to the rod actuator94. Rotation of the button grip92causes translation of the rod actuator94that hereby pushes against and thus activates the syringe84.

FIG. 10illustrates several other views of a device according the invention.FIG. 10a) illustrates a cross sectional view of a device in an assembled state.

InFIG. 10b) the upper part108of the device has been lifted up.

FIGS. 10c) and10d) illustrates how the plunger rod60of the syringe can be reversed while the lower part106of the device is separated from the upper part104of the device.

FIG. 10e) illustrates a view in which the syringe84has been removed from the lower part106of the device.

FIG. 10f) illustrates a perspective view of the rod actuator94(also shown inFIG. 9). It can be seen that the rod actuator94comprises a flexible arm110provided with a plunger114at its end portion.

FIG. 10g) andFIG. 10h) illustrates cross-sectional views of the device. The rod actuator94is provided with two flexible arms110each provided with a plunger114at their distal end. As the button grip92rotates, the wedges112will get into contact with the plungers114on the flexible arms110on the rod actuator94. The wedges112are configured to move the plungers114in direction of the hooks116and hereby open them. This action will unlock the top chassis86from the base chassis82.

FIG. 11illustrates schematically views of the device. Note that the adaptor has been removed for illustrating purposes.

The device as shown inFIG. 11a) is locked. A protrusion96on the lock member88sits on a rib98in the base chassis82. By twisting the handle80a certain angle, the protrusion96turns away from the rib98and is hereafter free to translate downwards.

When the handle80has been pushed in direction of the base chassis82, a number of snap locks102on the lock member88locks against a stop surface100in the base chassis82. This lock member88will allow the user of the device to retract the plunger rod60without pulling the cartridge26away from the vial6on a later stage in the sequence.

InFIGS. 12a),12b) and12c) the button grip92is mounted in a way so it is configured to rotate without being able to translate/slide relative to the top chassis86. On the other hand the rod actuator94is mounted in way in which it is configured to translate but not to rotate relative to the top chassis86.

The rod actuator94is provided with a number of protrusions96that are guided in a track118inside the button grip92. When turning the button grip92, the tracks118will pull the rod actuator94downwards.

The rod actuator94will accordingly push and hereby cause movement of the plunger rod60and the plunger22downwards in the cartridge26. Hereby the medium (e.g. a diluent for reconstitution of lyophilizes medicinal drug) in the cartridge26will flow through the needle4into the vial6.

FIGS. 12d) and12e) illustrates that the top chassis86is axially locked to the base chassis82by means of a hook116. The hook116, however, allows rotation between the top chassis86and the base chassis82.

InFIGS. 12f) and12g) the button grip92is provided with a helical track120. At the end of the helical track120there is a flat portion122. Once the rod actuator94reaches the end of the helical portion, the plunger22has reached full stroke in the cartridge26.

The flat portion122of the helical track120is used to unlock the top chassis86from the base chassis82. The button grip92is provided with a wedge112configured to be used to open the hook116in the base chassis82.

The parts of the device according to the invention may be produced in all suitable materials and by using all suitable manufacturing techniques.

LIST OF REFERENCE NUMERALS