Patent Application
20240024200
The present invention generally relates to reconstitution of a drug solution or pharmaceutical solution for medical or pharmaceutical applications by combining a first liquid component and a second solid or liquid component by means of negative pressure, and relates more specifically to an apparatus for combining a first liquid component stored in a container and a second solid or liquid component stored in a medical vial by means of negative pressure. The present invention also relates to a system and packaging unit including such an apparatus, which stores or packages a vial and a container for the afore-mentioned purposes.
Certain drugs are preferably provided in powder or dry form (such as a lyophilized form), and require liquid reconstitution prior to administration to a patient. Lyophilized drugs, for example, typically are supplied in a freeze-dried form that must be mixed with a diluent to reconstitute the substance into a form that is suitable for injection.
Drugs may also be provided as multi-component systems which require mixing prior to administration. For example, a multi-component system may include one or more liquid (e.g., flowable) components and/or dry (e.g., powdered or granular) components which must be mixed prior to administration.
There are a number of devices and methods for drug reconstitution, where a lyophilized drug is stored and supplied in a standard vial under negative pressure.
According to a first approach, a user uses a first syringe to inject the diluent from a diluent vial into the vial containing the dry drug. Next the user withdraws the reconstituted drug from the vial using a second syringe. The second syringe is used to inject the reconstituted drug into a patient. The use of syringe with injection needles bears the risk of inadvertent injuries of users or patients.
A second approach avoids the use of syringes with injection needles by means of specially designed vial adapters that have a piercing mandrel for piercing or puncturing a vial stopper. For enabling an efficient needleless or needle-free coupling of a syringe with a vial, US 2017/0143586 A1 discloses an example for such a vial adapter comprising an outer thread for a Luer lock thread of a syringe for threading the syringe tip onto the vial adapter.
In medical applications, it is usually desirable to prevent the patient from being exposed to the fluid which is being injected to or extracted from the patient, and it is desirable to insulate nurses and doctors from exposure to the liquid which may contain the patient's blood or waste products.
Often the male component of the syringe used to inject or withdraw the fluid, retains some of the fluid on the tip thereof, thus providing a risk to nurses and doctors of being exposed to the fluid. Wiping off this fluid prior to disconnecting the syringe is highly desirable. For enabling a safe and efficient wiping off of fluid in such applications, U.S. Pat. No. 6,651,956 B2 discloses a valve which includes a stem having a slit at an end thereof. The valve stem is located in a valve body and is deformable. When the tip of a syringe is engaged with the slit in the stem, the stem shifts in the valve body, a top portion thereof folds inward and the slit seals against the instrument and allows liquid to flow through the stem, to or from the instrument. When the tip of the syringe is removed again, the surface of the valve stem will not be contaminated with liquid.
Integrating such a valve stem into a vial adapter of the kind discussed above is also known from the prior art.
U.S. Pat. No. 6,558,365 B2 discloses a third approach, which uses two vial adapters, namely a first adapter being connected to a container containing the powder component and a second adapter that can be removably interconnected with the first adapter and can also be readily connected to a container containing a fluid such as a diluent so as to permit aseptic intermixing of the diluent with the powder.
FR 2293916 A1 discloses an apparatus for combining a first liquid component stored in a container and a second solid or liquid component stored in a vial, for drug reconstitution by liquid transfer. The accommodation member is a cylindrical oblong sleeve formed of plastic material, which is open at its two ends. A partition wall is arranged transversely inside the sleeve, so as to delimit two contiguous chambers intended to receive the vials. The separation wall has a slot in radial direction for insertion of a double perforating needle from a side of the sleeve for installation, and the slot ends in a slightly wider part in which the double perforating needle is intended to come to rest. After insertion of the two vials into the open ends of the sleeve, the vials are pushed towards the separation wall until the vial stoppers are pierced by the double perforating needle. The accommodation member is not formed as a tray having a planar upper surface.
US 20160296420 A1, U.S. Pat. No. 5,445,631 A1 and JP 405049672A disclose similar sleeve-shaped transfer adaptors. WO 00/25846 A2 discloses a device for axial alignment of a syringe and a vial and guiding the axial sliding movement of the syringe towards the vial for self-administering of drugs.
There is a continuous need for a reconstitution device with a safer and more accurate activation system which ensures that the needle mechanism used for injection a reconstituted drug solution will not be prematurely exposed or connected as it could lead to contamination of the drug and/or containers, loss of drug or safety risks.
There is also a need for a more user-friendly reconstitution device, which reduces the possibility of user error during the reconstitution process. A further need exists for an arrangement which would allow the device to be provided as a pre-assembled kit in which the vial and diluent container come pre-attached to reduce user handling steps; as a kit in which only the vial is attached; and/or as a separate system in which the vial and the diluent container are attached by a user just prior to use.
It is an object of the present invention to provide safe and reliable solutions for enabling reconstitution of a drug solution or pharmaceutical solution for medical or pharmaceutical applications by combining a first liquid component and a second solid or liquid component by means of negative pressure
According to the present invention there is provided an apparatus for combining a first liquid component stored in a container and a second solid or liquid component stored in a vial by means of negative pressure, comprising tray having a vial cavity for accommodating at least a portion of the vial and a container cavity for accommodating at least a portion of the container, and a transfer needle having a first needle tip, a second needle tip opposite to the first needle tip and a lumen, for establishing a fluid communication between the vial and the container via the lumen of the transfer needle in a transfer position, in which the first needle tip is engaged with the vial and the second needle tip is engaged with the container. According to the present invention the transfer needle is fixedly held or fixed at the tray at an intermediate needle holding portion provided between the vial cavity and the container cavity, wherein the vial cavity is configured for guiding a movement of the vial along an axial direction from an intermediate position, in which the first needle tip is not engaged with the vial, towards the transfer position, and wherein the container cavity is configured for guiding a movement of the container along the axial direction from an intermediate position, in which the second needle tip is not engaged with the container, towards the transfer position.
The tray thus can be used as a jig, gauge or caliber to define the positional relationship between the vial and container in the intermediate or storage position and to guide them during their displacement from the respective intermediate position to the transfer position. From the intermediate position the transfer position can be accomplished by a simple axial displacement of the vial and diluent container, i.e., a displacement which is mainly in axial direction. In the transfer position, the two opposite needle ends of the transfer needle are engaged with the vial and diluent container, respectively, namely the rubber stopper of the vial and a bottom of the diluent container is each pierced by a needle end of the transfer needle, for enabling the transfer of liquid out of the diluent container and into the vial, e.g. for reconstitution of a liquid drug solution in the vial by mixing the second solid or liquid component stored in the vial with the diluent transferred from the container into the vial by the negative pressure prevailing inside the vial via the transfer needle.
The intermediate position may be identical with a storage position in which the vial and diluent container are stored in the tray over an extended period of time. According to further embodiments, however, the storage position is different to the intermediate position, and it is also conceived that the tray is not used for long-time storage of the vial and diluent container, but that the tray is used only for positioning the vial and diluent container relative to each other short time before effecting the axial displacement of the vial and diluent container from the intermediate position to the transfer position.
In the intermediate position the vial and diluent container may be positioned in axial alignment with each other, which shall mean that the axial center lines of the vial and diluent container, which are each generally of cylindrical shape, generally coincide. Of course, minor deviations from a perfect axial alignment between the vial and diluent container may exist in the intermediate position, and most important is that the axial displacement of the vial and diluent container is guided in such a manner that the transfer needle ends start piercing or puncturing the vial stopper and container bottom, respectively, at its center and that the needle ends of the transfer needle remain centered during the further displacement of the vial and diluent container from the intermediate position to the transfer position. The main purpose of the tray is thus to enable a sufficient centering effect so that the transfer needle ends will pierce or puncture the vial stopper and container bottom at a central position for establishing a fluid communication.
‘Maintaining the axial alignment of the vial and diluent container’ during the transfer from the intermediate position to the transfer position, of course, shall allow a certain lateral displacement of the vial and diluent container, as long as the i.e., tray enables a sufficient centering effect so that the vial stopper and bottom of the diluent container will be pierced or punctured at a central position thereof.
Preferably the tray member has a planar upper surface, wherein the vial cavity and the container cavity is each open toward the planar upper surface of the tray member. Thus, both cavities can be easily sealed, e.g. by adhesive bonding of a packaging foil on the planar upper surface of the tray member, if required. The planar upper surface of the tray member preferably encircles both cavities, i.e. the vial cavity and the container cavity, so that both cavities can be sealed sterile against the environment, if required, and the tray can be used for long-time storage of the vial and container.
The cavities of the tray member are preferably sufficiently deep so that the vial and diluent container each does not protrude beyond an upper surface of the tray, when the vial adapter and diluent container is accommodated inside the vial cavity and container cavity, respectively, so that e.g., a packaging foil may be bonded to the upper surface of the tray to provide a packaging unit. Both cavities generally may be of cylindrical shape, and preferably correspond to the outer profile of the vial and diluent container, respectively. Preferably, the container cavity is large enough to fully accommodate the diluent container in the intermediate position, whereas a portion of the vial may extend beyond a front end of the vial cavity in the intermediate position, e.g., being exposed in an intermediate cavity between the vial cavity and needle packaging, for enabling access to the vial body with the fingers of a user or grippers of a robot to drive the axial displacement of the vial.
According to a further embodiment, the vial cavity or the vial cavity and the container cavity may each comprise retaining members, which are configured to position the vial and the diluent container, respectively, in the intermediate position and in parallel with the axial direction of the cavities. The retaining members may each be formed simply by a bottom of the vial cavity and container cavity itself. The bottoms of the cavities then may serve for establishing an axial alignment between the vial and diluent container in the intermediate position and maintaining this axial alignment during the transfer from the intermediate position to the transfer position. During the transfer from the intermediate position to the transfer position, the bottoms of the cavities will then also be used for guiding the axial displacement of the vial and diluent container. Preferably, the bottom of at least the vial cavity is curved corresponding to the outer profile of the vial.
According to a further embodiment, the retaining members may comprise pairs of protrusions formed on opposite side-walls of the vial cavity and container cavity, respectively, which are configured for contacting side-surfaces of the vial and container, respectively, for positioning the vial and the container in the respective cavity. The retaining members may be configured for preventing a displacement of the vial and diluent container in a direction perpendicular to the axial direction. Of course, the retaining members may also serve for guiding the axial displacement of the vial and diluent container, respectively, from the intermediate position to the transfer position.
According to a further embodiment, the retaining members may comprise pairs of protrusions formed on opposite side-walls of the vial cavity and container cavity, respectively, which are configured for contacting side-surfaces of the vial and diluent container, respectively, for positioning the vial and diluent container. By contacting side-surfaces of the vial and diluent container, respectively, the protrusions may control and keep constant the level of the vial and diluent container, respectively, in the cavities of the tray during the transfer from the intermediate position to the transfer position, and in additional may serve for guiding the axial movement of the vial and container, respectively, along the axial direction. The retaining members, particularly the protrusions, may retain the vial and vial adapter in the vial cavity and vial adapter cavity, respectively, in a positive-fit manner. Such a positive fit may be sufficient to also fix the axial positions of the vial and container, respectively, in the intermediate position. When the vial and container is moved in axial direction for the transfer from the intermediate position to the transfer position, a certain friction between the retaining members and the vial/container may be caused. However, such friction is low enough to enable a sliding movement of the vial/container from the intermediate position to the transfer position without exerting high axial forces.
According to a further embodiment, a height of contact regions of the protrusions with the side-surfaces of the vial and diluent container, respectively, above a bottom of the vial cavity and container cavity, respectively, may be larger than the height of a center line of the vial and diluent container above the bottom of the vial cavity and container cavity. The protrusions may thus serve to delimit the level of the vial and diluent container, respectively, in a direction perpendicular to their axial direction, for preventing a significant lateral displacement of the vial and diluent container, respectively, in the direction perpendicular to their axial direction during the transfer from the intermediate position to the transfer position, to thereby maintain the alignment of the vial and diluent container and ensure a proper piercing of the vial stopper and container bottom, as outlined above.
According to a further embodiment, the opposite side-walls on which the protrusions are formed may each be upright and planar side-walls. Thus, the vial and diluent container can each be accommodated in cylindrical volumes formed between the bottom of the respective cavity and associated protrusion. Preferably, the upright and planar side-walls are a little flexible so that the protrusions can move a little outward when the vial and diluent container are inserted from above into the respective cavity. And preferably, the upright and planar side-walls will then flex back to their home position once the vial and diluent container has been inserted from above into the respective cavity, to secure the level of the vial and diluent container, respectively.
According to a further embodiment, the vial cavity may comprise at least two pairs of protrusions formed on opposite side-walls of the vial cavity, and at least one pair of protrusions may still be in contact with side-surfaces of the vial in the transfer position, when the first end of the transfer needle pierces the rubber stopper of the vial. The at least one pair of protrusions may then be used for guiding the axial displacement of the vial toward the transfer position and maintaining the centering effect even at the final stage of the transfer from the intermediate position to the transfer position.
According to a further embodiment, a bottom of the vial cavity may be curved with a radius of curvature corresponding to an outer radius of a vial body of the vial and the profile of a bottom of the container cavity may correspond to an outer profile of the diluent container, so that the bottoms of the cavities can be used directly as retaining members, as outlined above.
According to a further embodiment, the vial cavity may further comprise axial position limiting members configured for delimiting an axial movement of the vial inside the vial cavity in a storage position or in the intermediate position. The axial position of the vial can thus be defined precisely and in a simple manner, in order to ensure that the vial will be spaced apart from the first end of the transfer needle in the intermediate position. These axial position limiting members may be formed as protrusions on the bottom and/or side-walls of the vial cavity. Preferably, the axial position limiting members may be formed integrally with the bottom and/or side-walls of the vial cavity.
According to a further embodiment, the axial position limiting members are more flexible than the retaining members of the vial cavity. When the vial slides over the axial position limiting members during the transfer from the intermediate position to the transfer position, the axial position limiting members will thus not cause a significant displacement of the vial in a direction perpendicular to the axial direction of the vial.
According to a further embodiment, the vial cavity and the container cavity may each comprise a stop surface for delimiting an axial displacement of the vial and of the container by abutment with a front end of the vial and a bottom of the container, respectively. Thereby, the transfer position of the vial and diluent container can be precisely defined by abutment of the front end of the vial and bottom of the diluent container, respectively, with a bottom of the associated cavity of the tray.
According to a further embodiment, the vial cavity may further comprise a portion that is sufficiently wide to enable access to a vial body of the vial by means of fingers of a user or by means of grippers or the like of a robot in the intermediate position, for driving the axial displacement of the vial, and/or for removal of the vial from the tray member by means of fingers of a user or grippers of a robot.
According to a further embodiment, the tray member may further comprise a rear end cavity, where a bottom of the vial is sufficiently exposed to enable access to the bottom for a finger of a user or a manipulation member of a robot for driving the axial displacement of the vial from the intermediate position to the transfer position.
According to a further embodiment, the tray may comprise a tray member that is made of plastic material, in particular by vacuum thermoforming or pressure thermo-forming of a plastic sheet or by means of plastic injection molding. Or the tray member may be made of paper or cardboard with a thin film of plastic or bioplastic arranged on inner surfaces of the vial adapter cavity and vial cavity. Or the tray member is simply made of paper or cardboard without a thin film of plastic or bioplastic arranged on inner surfaces of the vial adapter cavity and vial cavity. Preferably, the retaining members are formed integrally with the tray member.
According to a further embodiment, the tray may comprise a first tray member having a vial cavity configured for long-time storage of the vial, preferably under sterile conditions, and a second tray member comprising the container cavity configured for long-time storage of the diluent container, preferably under sterile conditions.
The two tray members may be connected with each other to form the tray of the medical apparatus for drug reconstitution, so that both tray members may be stored or delivered separately, and connected with each other only shortly before performing a process for reconstitution of the drug solution.
According to a further embodiment, the tray may comprise a first tray member comprising the vial cavity and having a planar upper surface and a second tray member comprising the container cavity and having a planar upper surface, wherein a film hinge is provided between the first tray member and the second tray member so that the first tray member and the second tray member can be pivoted relative to each other via the film hinge. The drug reconstitution tray may thus be stored and/or delivered in a rather compact configuration, in which the first tray member is pivoted onto the second tray member, so that both tray members are generally stacked one above the other and the total length of the drug reconstitution tray is much shorter, by up to 50%, as compared to the total length in the transfer position. Such a collapsed drug reconstitution tray may then also be wrapped easily by a plastic foil, or packaged in a simple plastic pouch for storage or delivery. Preferably, both the vial and the container is accommodated in the respective cavity of the first and second tray member. The tray would then be unfolded only for the purpose of drug reconstitution from this compact configuration to an extended or open configuration, in which the planar upper surface of the second tray member is substantially aligned or flush with the planar upper surface of the first tray member and the vial cavity and the container cavity is each aligned along the axial direction.
According to a further embodiment, the film hinge may be a bistable plastic film hinge, which is pretensioned into the afore-mentioned extended or open configuration, in which the drug reconstitution tray is unfolded. This may help to automatically maintain the alignment of the vial cavity and container cavity with each other, without the need that an operator needs to push down one (or both) of the tray portions on a supporting plate or base. This eases the reconstitution of a drug solution by means of the apparatus significantly, because the operator may better concentrate on a proper displacement of the vial and container to establish the fluid transfer via the transfer needle.
According to a further embodiment, a central portion of the transfer needle is accommodated in a needle packaging that is fixedly held or fixed at the tray at the intermediate needle holding portion. Moreover, the needle tips may be covered by cap members so that the transfer needle can be packaged under sterile conditions, in particular also against the residual inner volume of the tray itself. In the afore-mentioned unfolded or aligned position of the drug reconstitution tray, when the cavities of the two tray members are aligned with each other, the needle tips will then protrude into the vial cavity and container cavity, respectively. The end caps may be configured for removal from the needle packaging or for being opened for access to the needle tips for fluid transfer.
According to a further embodiment, the needle packaging may be held at the tray at the intermediate needle holding portion in a positive-fit manner, by friction or adhesive bonding.
According to a further aspect of the present invention there is provided a system for combining a first liquid component stored in a container and a second solid or liquid component stored in a vial by means of negative pressure, comprising the apparatus as outlined above, wherein the vial is accommodated in the vial cavity of the tray at an intermediate position, in which the first needle tip is not engaged with the vial, towards the transfer position, and the container is accommodated in the container cavity at an intermediate position, in which the second needle tip is not engaged with the container, towards the transfer position.
According to a further aspect of the present invention there is provided a packaging unit for packaging a vial storing a second solid or liquid component together with a container storing a first liquid component, comprising a system as outlined in the previous paragraph, and a packaging foil, wherein the tray or at least the vial cavity is sealed against the environment by the packaging foil. The packaging unit may be used for sterile packaging the vial and diluent container.
According to a further embodiment, the tray may comprise a planar upper surface and the packaging foil may be adhesively bonded to the upper surface of the tray.
The invention will now be described by way of example and with reference to the accompanying drawings, from which further features, advantages and problems to be solved will be-come apparent. In the drawings:
In the drawings, the same reference numerals designate identical or substantially equivalent elements or groups of elements.
The vial 7 can be made of glass or plastic material and is used to store a solid or liquid component under negative pressure. Preferably, the vial stores a lyophilized powder under negative pressure, which needs to be mixed with a diluent to reconstitute the substance into a form that is suitable for injection. The diluent container 125 can be made of any material suited to store a diluent required for reconstitution of the drug solution and may also be embodied as a pouch made of a flexible foil. Preferably, the diluent container 125 is of cylindrical or parallelepiped shape and is accommodated in a container cavity 12 of corresponding profile formed in the tray member 10, more specifically in the tray member container portion 10′. In particular, such a diluent container 125 may be made of plastic material with rigid or semi-rigid side-walls.
The tray member vial portion 10 and the tray member container portion 10′ are preferably each formed as a tray having a planar upper surface that can be sealed by adhesive bonding of a packaging foil, if required. The tray member vial portion 10 and the tray member container portion 10′ are preferably formed integrally to a single tray 1 as shown in
The tray member vial portion 10 comprises a vial cavity 11 that is open towards an upper surface of the tray member 10, will be described hereinafter in more detail and defines an axial direction AD. The vial cavity 11 is configured for accommodating a vial 7 and primarily serves as a jig, gauge or caliber for guiding an axial displacement of the vial 7 in the vial cavity 11 along the axial direction AD from an intermediate position, in which the first end 131a of the dual-ended transfer needle 131 does not pierce a rubber stopper of the vial 7, towards a transfer position, in which the first end 131a of the dual-ended transfer needle 131 pierces the rubber stopper of the vial 7 for fluid transfer. Of course, the vial cavity 13 may also be used for positioning the vial 7 in this intermediate position and preventing or at least reducing an axial displacement of the vial 7 from this intermediate position, in particular for reliably preventing the first end 131a of the dual-ended transfer needle 131 piercing the rubber stopper of the vial 7. Of course, the vial cavity 13 may also be used for storage of the vial 7 in the intermediate position over an extended period of time. For this purpose, the vial cavity 13 may also be sealed against the environment by a packaging foil, as outlined below in more detail.
Correspondingly, the tray member container portion 10′ comprises a container cavity 12 that is open towards the upper surface of the tray member 10′, will be described hereinafter in more detail and defines an axial direction AD that is in parallel with the axial direction AD of the tray member vial portion 10 in the tray 1 shown in
As shown in
As shown in
The general shape of a vial to be accommodated in the vial cavity 11 of a tray member vial portion 10 of the tray 1 is shown in
More details of the tray member vial portion 10 are shown in
As shown in
As will become apparent to the skilled person, the bottom 17 and upper side-walls 18 of the vial cavity 11 may also embrace the vial body 70 by a little more than 180 degrees and thus serve directly as retaining members to position the vial 7 in the intermediate position and in parallel with the axial direction AD. For insertion of the vial 7 into the vial cavity 11 it would thus be necessary to flex the tray 1 a little about the central axis of the vial cavity 11 to open the vial cavity 11 a little bit more.
The vial body 70 may be clamped a little by the bottom 17 and upper side-walls 18 of the vial cavity 11 to define the position of the vial 7 in axial direction. As shown in
The vial body 70 may be accommodated in the vial cavity 11 in the intermediate position with a certain play in axial direction, but the vial body 70 may also be accommodated in the vial cavity 11 in the intermediate position without play in axial direction. The movement limiting protrusions 35a, 35b and 35c may be formed integrally with the bottom or side-walls of the vial cavity 11, and are preferably formed in the bottom 17 of the vial cavity 11, as shown in
As shown in
As shown in
As will become apparent to the skilled person, the bottom 120 and upper side-walls 121 of the container cavity 12 may also embrace the container 125 by a little more than 180 degrees and thus serve directly as retaining members to position the container 125 in the intermediate position and in parallel with the axial direction AD. For insertion of the container 125 into the container cavity 12 it would thus be necessary to flex the tray 1 a little about the central axis of the container cavity 12 to open the container cavity 12 a little bit more.
As shown in
The diluent container 125 may be accommodated in the container cavity 12 in the intermediate position with a certain play in axial direction, but the diluent container 125 may also be accommodated in the container cavity 12 in the intermediate position without play in axial direction. The movement limiting protrusion 128 may be formed integrally with the bottom 120 or side-walls 121 of the container cavity 12. The movement limiting protrusion 128 and the container retaining protrusions 129 may be formed as convex bulges protruding a little into the container cavity 12.
The tray 1 is preferably made of plastic material, in particular by vacuum thermoforming or pressure thermo-forming of a thin plastic sheet or by means of plastic injection molding, and preferably all of the retaining and movement limiting members 35a, 35b, 35c, 36a, 36b, 128 and 129 are formed integrally with the tray 1. Any other materials may be used as well, however. In particular, the tray 1 may also be made of paper or cardboard. A thin film of plastic or bioplastic may be arranged on inner surfaces of the diluent container cavity 12 and vial cavity 11 to enable even the storage of the diluent container and vial in the cavities 11, 12 under sterile conditions. DE 102011122211 A1 discloses an example of such a compound packaging material including a substrate made of paper or cardboard that is coated by a thin film of plastic or bioplastic, and the whole contents of DE 102011122211 A1 is hereby incorporated by reference. Preferably, the tray 1 may be a little flexible, so that it can be flexed a little about the middle axis of the cavities 11, 12, e.g., to ease insertion of the vial 7 and diluent container 125 into the cavities 11, 12, as outlined above.
More preferably, the transfer needle 131 is received in the needle packaging 130 under sterile conditions against the residual volume of the cavities 11, 12 of the tray 1.
As shown in
As shown in
In the state shown in
A system for combining a first liquid component stored in a container and a second solid or liquid component stored in a vial by means of negative pressure according to the present invention comprises the tray 1 with the transfer needle 131 fixedly held or fixed at the tray 1 at an intermediate needle holding portion 13 between the vial cavity 11 and the container cavity 12, as shown in
From the intermediate position shown in
Starting with the packaging unit 9 shown in
As a next step, by pushing the pusher 123, the container 125 is pushed in the direction of the needle packaging 130 until the second needle end 131b engages the container 125 and pierces the bottom 127 or a side-wall of the container 125. For this purpose, the end cap member 133b (cf.
As a next step, the vial 7 is pushed towards the first needle end 131a. To provide access to the first needle end 131a, the end cap member 133a (cf.
Finally, the metal cap at the front end of the vial 7, which retains the rubber stopper, will abut against the front wall 19 of the vial cavity 11, and the first needle end 131a engages the vial 7 by piercing the rubber stopper. This transfer position of the vial 7 may be fixed by friction or positive-fit. As an example, the front retaining protrusions 36b may fix the transfer position of the vial 7 shown in
In the transfer position of
As a next step, the vial 7 is withdrawn from the front wall 19 of the vial cavity 11, to stop engagement with the first needle end 131a. The axial displacement of the vial 7 in the opposite direction is again guided by the bottom and lateral side-walls of the vial cavity 11, and may be guided additionally by the retaining members 36a, 36b of the vial cavity 11. For driving the axial displacement of the vial 7 in the opposite direction, a user's finger or a pusher member of a robot may push against the bottom 71 of the vial 7 via the rear end cavity 14 of the tray 1 and/or fingers of a user or grippers of a robot may clamp the vial body 70 of the vial 7 via the widened lateral cavity 15, as outlined above. Finally, the vial 7 reaches again the intermediate position shown in
As a next step, the vial 7 is removed from the vial cavity 11, as shown in
As will become apparent to the skilled person from the above description, the tray 1 is used as a jig, gauge or caliber to define the positional relationship between the vial and vial adapter in the intermediate position and to keep them in axial alignment during the axial displacement from the intermediate position to the transfer position. From the intermediate position the transfer position can be accomplished by a simple axial displacement of the vial and diluent container, i.e., a displacement only in axial direction. In the transfer position, the vial and container are in engagement with the ends of the transfer needle for enabling the transfer of the liquid diluent out of the container and into the vial via the lumen 131′ of the transfer needle 131, e.g., for reconstitution of a liquid drug solution in the vial.
Of course, the tray 1 may also be used for long-time storage of the diluent container and vial, in particular under sterile conditions. For this purpose, a sterile packaging foil 8 may be adhesively bonded to the upper surface of the tray 1, as shown in
With reference to
In such a tray, a needle packaging as shown in
Preferably, the film hinge 140 is a bistable plastic film hinge, which is pretensioned into the extended or open configuration of
The stages of a process for transferring a diluent stored in a diluent container 125 into a vial 7, for reconstituting a drug solution in the vial 7 using the drug reconstitution tray according to the second embodiment are summarized in
As will become apparent to the skilled person when studying the above description, a tray according to the present invention may be used for the storage/positioning/guiding of any kind of vial and diluent container. As a preferred example, the vial may store a lyophilized drug component under negative pressure. Of course, the vial may also store other drug components, such as dry powders required for drug reconstitution.
As will become apparent to the skilled person, also the diluent container 125 may be vial made of glass or plastic material, having a pierceable member, such as a rubber stopper, that seals the diluent container 125 and will be pierced by the second end 131b of the transfer needle 131 in the afore-mentioned transfer position.
While the preferred embodiments of the present invention have been described so as to enable one skilled in the art to practice the device of the present invention, it is to be understood that variations and modifications may be employed without departing from the concept and intent of the present invention as defined in the appended claims. Accordingly, the preceding description is intended to be exemplary and should not be used to limit the scope of the invention. The scope of the invention should be determined only by reference to the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202121033506 | Jul 2021 | IN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IN2022/050669 | 7/25/2022 | WO |
