DEVICE AND METHOD FOR CLOSING SYRINGE BODY

Description

[0001] The present invention relates to a device for manually inserting a piston plug made of elastomer, which forms part of a piston, into a syringe cylinder,

[0002] A method and device for inserting a piston stopper into a syringe cylinder are known from US 2006 / 168916 A1. In the method and device described in US 2006 / 168916 A1, a vacuum is used to insert the stopper into a syringe.

[0003] The insertion of a stopper into a syringe is also the subject of US 5,519,984 A, as well as KR 101 617 853 B1.

[0004] US 1990301 A describes a device for sealing bottles, e.g., using corks.

[0005] The methods used to date for sealing syringes with plunger stoppers are either very complex (requiring the use of filling machines) or not sterile or representative (manipulating the plunger stopper during insertion to prevent overpressure). In the early stages of development or during the life cycle management of a liquid drug or medical device intended for syringe administration, there are generally two reasons why sealing syringes with plunger stoppers outside of routine large-scale production is necessary: It is necessary to investigate and analyze the material compatibility regarding the interaction between the solution and the packaging over an extended period (ideally corresponding to the desired shelf life of the drug) and, if necessary, to adjust the formulation or packaging. It is essential that the manufacturing process closely resembles later industrial production using a filling machine. Even minor deviations can significantly influence the analytical results to such an extent that a reliable statement about compatibility is no longer possible. This can lead to considerable problems in later phases of drug development (reduced shelf life) or even necessitate the complete redesign of the formulation / packaging, resulting in a significant expenditure of time and money. Toxicological studies and in vivo tests are often required in the early stages of drug development.For these tests, the intended sterile medicinal products must actually exhibit sterility. Since this cannot be guaranteed by manipulating the piston stoppers during conventional manual stopper insertion, this manufacturing method cannot be used. Filling on a filling machine is equally problematic, as GMP regulations prohibit the introduction of substances with unknown toxicological properties into the premises (to avoid cross-contamination, and cleaning validation is not possible). Furthermore, the available batch size is often insufficient for automated stopper insertion on a filling machine (dead volumes).

[0006] Therefore, there was a need to provide a device or method that would enable the filling of syringes mentioned above, even in very small batches.

[0007] In a first aspect of the present invention, this problem is solved by a device for manually inserting an elastomeric piston plug, forming part of a piston, into a syringe cylinder, comprising: a receptacle configured to hold the syringe cylinder; a tubular insertion tube configured to receive the piston plug within it; a holding device configured to hold the insertion tube relative to the receptacle; and a displacement device configured to displace the piston plug relative to the insertion tube; wherein the holding device comprises an actuating section configured to be manually actuated in order to displace the insertion tube relative to the piston plug.

[0008] The device according to the invention makes it possible to process a series of filled syringes (and other syringe-like cylindrical tubes such as e.g.

[0009] The device according to the invention allows for the production of cartridges, dual-chamber cartridges, and dual-chamber syringes starting from a quantity of 1. Additionally, each syringe can be filled aseptically and reliably for various applications using the device according to the invention. This leads to a significant reduction in costs and time for the applications described so far.

[0010] In particular, the device according to the invention allows the filling sequence of fully automated filling systems to be replicated, so that a later switch from small-batch to actual series production of pharmaceuticals is possible without major modifications. Components of a filling machine can also be directly taken for the device according to the invention in order to achieve absolutely identical conditions for the properties of the manufactured syringe. For example, the plunger tube and the plunger (see below) are suitable for this purpose.

[0011] The device according to the invention allows a piston plug to be inserted without creating overpressure in the syringe cylinder, which could, for example, unintentionally expel product. Therefore, in connection with the present invention, the term "pressure-free" plug insertion is also used.

[0012] The piston plugs can therefore be positioned with absolute precision, ensuring that the desired and required "headspace" and uniformity can be achieved across an entire batch.

[0013] For the purpose of gassing during the filling process, protective gases or other gases can be connected. In general, the device according to the invention can be used and operated in an aseptic environment (from laboratory to isolator) throughout the entire development chain (formulation development, stability studies, toxicity studies, clinical studies, packaging changes, and life cycle management).

[0014] Advantageously, at least all components that come into contact with parts of the syringe to be filled and / or the medicinal product, in particular all components of the device according to the invention, are autoclavable.

[0015] Furthermore, it can be advantageous if at least the intake and / or the filling tube are designed in such a way that they can be replaced by a counterpart for a syringe of a different format. In this way, for example, it is possible to fill syringes of approximately 1 ml, 3 ml, or 10 ml sizes.

[0016] In the device according to the invention, for example, a pre-filled syringe cylinder can first be arranged in the receptacle. The syringe cylinder is then moved relative to the filling tube such that the end of the filling tube associated with the drug assumes a predetermined distance from the drug. A piston plug can then be moved through the filling tube, whereby gas located in the filling tube between the piston plug and the drug can be expelled when the piston plug is moved within the filling tube and can escape from the syringe cylinder between the filling tube and the syringe cylinder without causing overpressure to build up in the syringe cylinder. If the piston plug is located at the end of the filling tube adjacent to the drug, an operator of the device according to the invention actuates the actuating section, thereby moving the filling tube relative to the piston plug and away from the drug.The piston plug expands in such a way that it interacts with the syringe cylinder in a sealing manner. The finished syringe can now be removed from the device according to the invention.

[0017] In a further development of the present invention, the actuating section of the holding device can comprise a rocker mechanism configured to transmit a manual actuating force acting in a first direction, applied at a first end of the rocker mechanism, into a lever force acting in a second direction at a second end of the rocker mechanism, which is arranged opposite the first end, wherein the first direction can be substantially opposite to the second direction. Such a device can make it possible to convert a small actuating force on one side into a comparatively larger displacement force on the other side, thus simplifying the actuating of the actuating section.

[0018] The rocker mechanism can be designed as an elongated, plate-like element. This can represent a particularly simple and cost-effective design for the rocker mechanism.

[0019] Furthermore, the plate-like element can have a first end designed to be actuated with a finger, and a second end arranged essentially opposite the first end, which at least partially encloses the setting tube. The plate-like element can therefore be arranged on the device according to the invention, in particular, such that it is easily accessible to a user so that the user can act on the first end of the plate-like element with their finger.

[0020] Advantageously, the device can further comprise at least one support element to which the holding device and / or the relocation device are connected.

[0021] The device can also further comprise a base plate, which can advantageously be connected to the at least one support element. The at least one support element and the base plate can thus together form a frame on which the parts of the device according to the invention described above can be mounted.

[0022] In particular, the mounting can be attached to the base plate. This ensures that the mounting is supported against the base plate and that, for example, horizontal play of the mounting relative to the base plate can be reduced or even avoided.

[0023] The holder can be adjusted relative to the holding device and / or the displacement device, advantageously via at least one screw connection. This allows the syringe cylinder to be repositioned within the device. Furthermore, the device according to the invention can thus be adapted to filling syringes with different fill levels or different syringe formats.

[0024] Advantageously, the holding device and / or the repositioning device and / or the receiver can be adjustable relative to each other, advantageously via at least one screw connection each. In this way, maximum flexibility can be achieved when manufacturing the syringes and / or when adapting the device according to the invention to different syringe formats and / or fill levels.

[0025] The insertion tube can further be designed to be displaceable relative to the receptacle such that, at a predetermined position along its displacement path, it projects at least partially into the interior of a syringe cylinder mounted on the receptacle. Thus, the insertion tube, with a piston stopper located therein, can be moved into the syringe cylinder until it is near a drug located within the syringe cylinder.

[0026] In particular, the setting tube can have a collar extending radially outwards at one end. The setting tube can thus be inserted into a corresponding holder, for example from above, and held in place by the collar and gravity. This can enable easy replacement of the setting tube on the device according to the invention.

[0027] Furthermore, the receptacle designed to hold the syringe cylinder can comprise at least two parts.

[0028] The device may comprise a first centering receptacle designed to hold a second centering receptacle, and the second centering receptacle designed to hold the syringe cylinder, wherein the second centering receptacle is at least partially immersed in the first centering receptacle.

[0029] The first centering fixture can have a depth stop designed to limit the displacement of the second centering fixture. In other words, the displacement of the second centering fixture can be defined by the first centering fixture.

[0030] The second centering receptacle can have a holder for a syringe cylinder at its end, which is essentially opposite to that of the first centering receptacle. This holder is advantageously designed to be hollow or clamp-like. A syringe cylinder can then be inserted into this holder of the second centering receptacle either from above or snapped into place laterally, for example, in a horizontal direction, if the holder is designed as an elastic clamp. The medication can already be in the syringe cylinder at this point or can be added only after the cylinder has been adjusted in the holder of the second centering receptacle.

[0031] Furthermore, the holding device designed to retain the setting tube can at least partially enclose the setting tube. Partial enclosure can, in particular, be such that the setting tube is only held in a way that allows it to move along its longitudinal axis.

[0032] The holding device can be designed in a hollow cylindrical shape with a bore, preferably concentric to the central axis of the holding device, for receiving the setting tube.

[0033] In a further development of the present invention, the displacement device for moving the piston plug relative to the setting tube can comprise a plunger guide configured to align a plunger relative to the setting tube, and the plunger configured to move the piston plug relative to the setting tube. The plunger can, for example, be designed as a rod which is displaceable, particularly parallel, and advantageously coaxially, to a longitudinal center axis of the syringe cylinder.

[0034] The displacement device may also include a plunger guide receptacle designed to hold the plunger guide. For example, the plunger guide may be designed as a sliding bushing.

[0035] Furthermore, the plunger guide or the plunger guide receptacle can be connected to the at least one support element, wherein the plunger guide can advantageously be adjusted directly or indirectly, preferably via at least one screw connection. Here, too, adjustability of the plunger guide can allow the device according to the invention to be adapted to different syringe formats.

[0036] Advantageously, the plunger can have a cylindrical section at the end facing the holding device, the outer diameter of which is smaller than the clear inner diameter of the setting tube. This allows the plunger to penetrate the setting tube and move the piston plug through it. A diameter of this plunger section that is only slightly smaller than the inner diameter of the setting tube can prevent the piston plug from tilting unintentionally within the setting tube.

[0037] The plunger can further comprise, at the end opposite the holding device, a head that advantageously extends radially outwards and is advantageously designed to be operated manually, preferably with a finger, to displace the piston plug relative to the setting tube. The plunger head can, on the one hand, provide a sufficiently large actuating surface to allow an operator to displace the plunger by hand. On the other hand, the plunger head can also serve as a weight to assist the operator in applying the force necessary to displace the piston plug through the setting tube.

[0038] In particular, the plunger can also advantageously include an adjustable depth stop designed to define the end of the piston plug's displacement travel within the insertion tube via the displacement device. This allows an operator, after successfully adjusting the depth stop and maintaining a consistent syringe size / fill level, to move the plunger to the limit without having to pay attention to the plunger's position relative to the syringe cylinder. Once the plunger has reached its maximum displacement travel, the operator can actuate the actuating section, for example, the rocker mechanism, thereby releasing the piston plug as described above.

[0039] Furthermore, the device can include a locking device designed to prevent unintentional displacement of the piston plug relative to the set tube. The locking device is advantageously pivotably connected to the at least one support element, preferably via at least one screw connection. Thus, the screw connection can prevent the locking device from pivoting in a locked state and allow it to pivot in a unlocked state. The locking device can also be equipped with an elastic element, such as a spring, so that the locking device automatically moves from a release state, in which displacement of the plunger is permitted, to a locking state, in which displacement of the plunger is restricted.

[0040] In an advantageous embodiment of the device, it may include: a base plate; a support element connected to the base plate; a receptacle advantageously attached to the base plate comprising a first centering receptacle designed to hold a second centering receptacle and advantageously having a depth stop, and the second centering receptacle designed to hold the syringe cylinder; a tubular setting tube designed to receive the piston plug inside it;a holding device advantageously attached to the support element, which is configured to hold the setting tube relative to the receptacle and which advantageously at least partially encloses the setting tube, wherein the holding device comprises a rocker device designed as an elongated plate-like element, which is configured to displace the setting tube relative to the piston plug, wherein the rocker device advantageously has a first end which is configured to be actuated with a finger and a second end which is arranged substantially opposite the first end and which at least partially encloses the setting tube, and a displacement device comprising a plunger guide which is configured to align a plunger relative to the setting tube, wherein the plunger guide is advantageously adjustable directly or indirectly;the plunger, which is configured to displace the piston plug relative to the setting tube and which advantageously has a depth stop, and a plunger guide receptacle, advantageously attached to the support element and configured to hold the plunger guide; and optionally a locking device, which is configured to prevent unintentional displacement of the piston plug relative to the setting tube, the locking device being advantageously pivotably connected to the at least one support element. With regard to this particular embodiment of the present invention, reference is made to the descriptions given for the corresponding individual features.

[0041] In a second aspect, the present invention relates to a method for manually inserting a liquid-tight piston plug made of elastomer, which forms part of a piston, into a syringe cylinder, comprising the steps of: (i) Inserting the piston plug into a tubular setting tube; (ii) Inserting the syringe cylinder into a receptacle provided for this purpose; (iii) Moving the piston plug within the setting tube to a predetermined position; and (iv) Moving the setting tube relative to the piston plug by manually actuating an actuating section of a moving device.

[0042] It should be noted at this point that all advantages, features and effects mentioned in relation to the device according to the invention are also applicable to the method according to the invention and vice versa.

[0043] The inventive method also allows for the production of small series of syringes filled with a medicinal product (and other syringe-like cylindrical tubes such as cartridges, double-chamber cartridges and double-chamber syringes) from a quantity of 1 while simultaneously adhering to series production conditions.

[0044] The piston plug can be positioned in the predetermined position within the syringe cylinder. This means the piston plug can be positioned in the predetermined position either within the settling tube or within the syringe cylinder.

[0045] Once the piston plug has reached its predetermined position within the settling tube and syringe barrel, the settling tube can be moved relative to the piston plug to a further position, causing the piston plug to fully extend from the settling tube and expand to make contact with an inner surface of the syringe barrel. In this way, the piston plug and the syringe barrel create a seal.

[0046] The method according to the invention can further comprise the step of filling the syringe cylinder and optionally closing a syringe head before the syringe cylinder is inserted into the receptacle. This step of filling the syringe cylinder with a drug can be carried out in a section of the device according to the invention specifically designed for this purpose or in a section separate from the device according to the invention. Filling can be carried out, for example, by means of a pipette or semi-automatic filling, advantageously in a sterile environment, such as in an isolator. According to the invention, it is possible to integrate all the necessary equipment for filling syringe cylinders on the one hand and for stoppering on the other into an isolator. This allows both filling and stoppering to be carried out under sterile conditions.

[0047] Furthermore, the method can include the step of arranging the setting tube in a holding device before the piston plug is inserted into the setting tube. In this way, different setting tubes can be interchangeably connected to the holding device.

[0048] The method can further include the step of repositioning the holder with the syringe cylinder into a predetermined position before the piston plug is repositioned within the setting tube, wherein the end of the setting tube facing the syringe cylinder is at least partially located within the syringe cylinder in the predetermined position. In such an embodiment of the method according to the invention, the holding device with the setting tube can remain fixed, for example, relative to a frame to which the holding device is connected, whereas the syringe cylinder can be repositioned into the predetermined position via the setting tube.

[0049] The predetermined position of the holder with the syringe cylinder can be achieved by aligning the holder with a depth stop integrated into the holder. This prevents the syringe cylinder from shifting beyond the predetermined position relative to the insertion tube, thus preventing the insertion tube from coming into contact with the drug.

[0050] Before repositioning the piston stopper within the plunger tube, the syringe cylinder mount and the plunger tube can be adjusted so that they are essentially coaxial. This allows the plunger tube and syringe cylinder to be moved relative to each other without them touching, which could, for example, contaminate the inner wall of the syringe cylinder.

[0051] Furthermore, the displacement of the piston plug within the setting tube can be effected by a displacement device designed to displace the piston plug relative to the setting tube. The displacement direction of the displacement device can be essentially parallel or coaxial to a longitudinal center axis of the setting tube and / or the syringe cylinder.

[0052] In particular, the displacement of the piston plug within the setting tube can be effected by exerting, advantageously manually, a pressure force on a plunger that forms part of the displacement device and is configured to displace the piston plug relative to the setting tube. As already described with reference to the device according to the invention, the plunger can displace the piston plug through the setting tube in such a way that the piston plug maintains a desired orientation relative to the setting tube, i.e., unwanted tilting of the piston plug can be prevented.

[0053] The predetermined position of the piston plug can advantageously be achieved by arranging a depth stop on the plunger against a plunger guide. Here, too, a depth stop can prevent the piston plug from being displaced beyond the predetermined position.

[0054] Advantageously, the displacement of the plunger tube relative to the piston stopper can be effected by manually applying an actuating force in a first direction, advantageously with a finger, to a first end of a rocker mechanism. This transmits a lever force acting in a second direction to the plunger tube at a second end of the rocker mechanism, which is arranged essentially opposite to the first end and which advantageously at least partially encloses the plunger tube. The first and second directions can be essentially opposite. This allows the plunger tube to be displaced from its holding device in such a way that it moves away from the syringe cylinder, thereby releasing the piston stopper so that it expands and comes into contact with the syringe cylinder.At the latest after the finished syringe has been removed, the setting tube can be moved back to its original position in its holding device, for example due to gravity or due to a new piston plug being inserted into the setting tube.

[0055] This involves moving the setting tube relative to the piston plug by means of (i) Holding the piston plug in the predetermined position within the syringe cylinder by exerting a holding force on the piston plug, advantageously via a fixable plunger which forms part of the displacement device and which is configured to displace the piston plug relative to the plunger tube and which advantageously bears against a plunger guide with a depth stop arranged thereon, and (ii) exerting a compressive force, advantageously with a finger, on a first end of an elongated plate-like element, whereby a lever force is transmitted at a second end, which is arranged opposite to the first end and at least partially encloses the plunger tube, to the plunger tube, the direction of which is substantially opposite to the compressive force. This is achieved so that the piston stopper fully extends from the setting tube and expands to such an extent that it comes into contact with an inner surface of the syringe barrel. As mentioned above, this allows a piston stopper in a syringe barrel to be brought close to the fill level of a drug contained within the syringe barrel without creating overpressure in the syringe barrel, which could, for example, expel drug from the syringe barrel.

[0056] In an advantageous embodiment of the method according to the invention, the method may comprise the following steps: (i) Inserting the piston stopper into a tubular setting tube; (ii) Inserting an advantageously filled syringe cylinder into a receptacle provided for this purpose, comprising a first centering receptacle configured to hold a second centering receptacle, and the second centering receptacle configured to hold the syringe cylinder; (iii) Positioning the second centering receptacle with the syringe cylinder into a predetermined position within the first centering receptacle, the predetermined position advantageously being achieved by positioning the second centering receptacle against a depth stop provided in the first centering receptacle; (iv) Positioning the setting tube with the piston stopper in a holding device; (v) Optionally adjusting the receptacle with the syringe cylinder and the setting tube so that they are substantially coaxial with each other;(vi) Releasing a safety device designed to prevent unintentional displacement of the piston plug relative to the setting tube; (vii) Displacing the piston plug within the setting tube by exerting, advantageously manually, a pressure force on a plunger designed to displace the piston plug relative to the setting tube, wherein the piston plug, located at the end of the piston plug opposite the plunger, is displaced into a predetermined position by means of the pressure force exerted on the plunger, wherein the predetermined position of the piston plug is advantageously achieved by arranging a depth stop on the plunger against a plunger guide;and (viii) repositioning the setting tube relative to the piston plug by holding the piston plug in the predetermined position within the syringe cylinder by exerting a holding force on the piston plug via the plunger, which advantageously bears against the plunger guide with the depth stop; and ; Applying a pressure force, advantageously with a finger, to a first end of an elongated plate-like element, whereby a lever force is transferred to the setting tube at a second end, which is arranged opposite to the first end and at least partially encloses the setting tube, the direction of which is essentially opposite to the pressure force, wherein the piston plug fully exits the setting tube and expands in such a way that it comes into contact with an inner surface of the syringe cylinder.

[0057] With reference to the above description of the inventive method and the inventive device with regard to the individual features of this embodiment, this embodiment can represent a particularly simple implementation for producing small series of syringes filled with medicinal products, even of different syringe formats, while adhering to series production conditions.

[0058] The present invention will now be described in greater detail with reference to an exemplary embodiment and the accompanying drawings. It illustrates: Figure 1 shows a perspective view of an embodiment of a device according to the invention.

[0059] In Figure 1One embodiment of the device according to the invention is generally designated by reference numeral 10. The device 10 comprises a base plate 12 as a base plate on which the device 10 rests. A support element 14 is connected to the base plate 12, which here is designed as a square tube and is welded to a cover 16 at its end opposite the base plate 12.

[0060] The base plate 12 also includes a syringe holder 18 in the Figure 1In the illustrated embodiment, the syringe holder 18 is connected to the base plate 12 via two screws 20. The connection of the syringe holder 18 to the base plate 12 allows the syringe holder 18 to be moved along an axis X towards or away from the support element 14. The syringe holder 18 comprises a first centering receptacle 22, which is configured to receive a second centering receptacle 24. The second centering receptacle 24, in turn, is configured to receive a syringe cylinder (not shown). The second centering receptacle 24 is movable within the first centering receptacle 22 along an axis Y. A screw 26, connected to the second centering receptacle 24 and engaging with the first centering receptacle 22, forms a depth stop 26 and allows the two centering receptacles 22 and 24 to be adjusted relative to each other in a desired position.

[0061] Along direction Y, above the second centering receptacle 24, a holding device 28 is screwed to the support element 14 such that the holding device 28 can be displaced along axis X relative to the support element 14 when the screw connection is loosened. The holding device 28 has a central through-bore into which a setting tube 30 is inserted. At the end of the tube section opposite the second centering receptacle 24, the setting tube 30 comprises a collar 32, which extends radially outward from the tube section of the setting tube 30. The collar 32 defines, firstly, a predetermined position of the setting tube 30 relative to the holding device 28. Secondly, an actuating section 34 engages with the collar 32, which at least partially surrounds the setting tube 30 between the collar 32 and the holding device 28.

[0062] The actuating section 34 is designed here as a plate-like rocker mechanism, which is supported on the holding device 28 via an adjusting screw 36, by means of which a preload or an inclination of the actuating section 34 relative to the holding device 28 or the setting tube 30 can be set, so that actuation of the actuating section 34 at its end 38 opposite the setting tube 30, for example by a finger pressure of a user, in the Y-direction in Figure 1 downwards, lifting of the setting tube 30 in the Y-direction in Figure 1 upwards.

[0063] In the Y direction in Figure 1Above the holding device 28, a plunger guide receptacle 40 is connected to the support element 14. This receptacle is also displaceable and adjustable relative to the support element 14 along the X-axis. A plunger guide 42 is connected to the plunger guide receptacle 40, in which a plunger 44 is displaceably arranged along the Y-direction. The section of the plunger 44 facing the setting tube 30 has an outer diameter that is smaller than the inner diameter of the setting tube 30, so that the plunger 44 can immerse itself in the setting tube 30. At a predetermined, in particular adjustable, position of the plunger 44, a depth stop 46 is connected to it. This depth stop can come into contact with the plunger guide 42 in such a way that displacement of the plunger in the Y-direction beyond a position defined by the depth stop 46 is prevented.

[0064] At its end opposite the setting tube 30, the plunger 44 has a pressure head 48, which serves as a gripping surface for an operator. Figure 1 It can be seen that a safety device 50 engages with the printhead 48, which prevents displacement of the plunger 44, in particular from the position in Figure 1 The position shown, downwards along the Y-direction, is prevented. The in Figure 1 The illustrated embodiment of the locking device 50 is designed to be pivoted about the axis Y in order to release a displacement of the plunger 44.

[0065] The inventive method, in one possible embodiment, will now be briefly described again with reference to the inventive device 10. First, a piston stopper is inserted into the setting tube 30, for example using tweezers. Then, a syringe cylinder filled with a drug is inserted into the second centering receptacle 24. The second centering receptacle 24 is then rotated in the Y direction. Figure 1The plunger 30 is moved upwards until further movement is limited by the depth stop 26. In this position, the screw 26 is tightened, thus fixing the relative position of the second centering receptacle 24 to the first centering receptacle 22. In this state, the plunger 30 is immersed in the syringe cylinder. Next, the locking device 50 is pivoted to the side, allowing the plunger 44 to be moved downwards in the Y-direction until the depth stop 46 abuts the plunger guide 42. While an operator maintains pressure on the printhead 48, the operator pushes on the first end 38 of the actuating section 34 downwards in the Y-direction, at least partially moving the plunger 30 upwards out of the syringe cylinder.In this process, the piston plug, which continues to be held in its position relative to the syringe cylinder by the plunger 44, is released so that it can expand in order to engage with the syringe cylinder in a sealing manner.

[0066] Subsequently, the plunger 44 and the second centering receptacle 24 are moved back to their starting positions and the syringe cylinder fitted with the piston plug can be removed from the device 10.

Claims

1. Device (10) for manually inserting an elastomer plunger plug, which forms part of a plunger, into a syringe cylinder, comprising: a receptacle (18) designed to hold the syringe cylinder, wherein the receptacle (18) comprises a first centering receptacle (22) designed to receive a second centering receptacle (24), and the second centering receptacle (24) is displaceable in the first centering receptacle (22) along an axis y; a tubular setting tube (30) adapted to receive the plunger plug therein; a holding device (28) adapted to hold the setting tube (30) relative to the receptacle (18); and a displacement device (40, 42, 44, 46, 48) adapted to displace the plunger plug relative to the setting tube (30), wherein the displacement device comprises a plunger guide (42) adapted to align a plunger (44) relative to the setting tube (30), and the plunger (44) adapted to displace the plunger plug relative to the setting tube (30), wherein the plunger (44) has a cylindrical section at the end facing the holding device (28) whose outer diameter is smaller than an inside diameter of the setting tube (30), and wherein the plunger (44) comprises a depth stop (46) and an outwardly extending button (48) adapted to be manually actuated to displace the plunger plug relative to the setting tube (30).

2. Device (10) according to claim 1, characterized in that the actuating section (34) of the holding device (28) comprises a rocker device (34), advantageously designed as an elongated plate-like element, which is arranged to convert a manual operating force acting in a first direction, which has been applied to a first end of the rocker device (34), into a lever force acting in a second direction at a second end of the rocker device (34), which is arranged opposite the first end, wherein the first direction is substantially opposite to the second direction.

3. Device (10) according to one of the preceding claims, characterized in that the holding device (28) and / or the displacement device (40, 42, 44, 46, 48) and / or the receptacle (18) are adjustable relative to each other, advantageously via at least one screw connection (26) in each case, and / or characterized in that the setting tube (30) is further designed to be displaceable relative to the receptacle (18) in such a way that, in a predetermined position of its displacement path, it protrudes at least partially into an interior space of an syringe cylinder arranged on the receptacle (18), and / or characterized in that the setting tube (30) has a collar (32) extending radially outward at one end, and / or characterized in that the receptacle (18) designed to hold the syringe cylinder comprises at least two parts.

4. Device (10) according to one of the preceding claims, characterized in that the holding device (28) designed to hold the setting tube (30) surrounds the setting tube (30) at least partially, wherein the holding device (28) is advantageously designed to be hollow cylindrical with a bore preferably concentric to the central axis of the holding device (28) for receiving (18) the setting tube (30).

5. Device according to one of the preceding claims, characterized in that the button (48) is actuated with a finger and / or the button (48) is arranged at the end opposite the holding device.

6. Device according to one of the preceding claims, characterized in that the plunger (44) comprises an adjustable depth stop which is designed to determine the end of the displacement path of the plunger plug in the setting tube by means of the displacement device.

7. Device according to one of the preceding claims, characterized in that the displacement device comprises a plunger guide which is designed to align a plunger (44) relative to the setting tube.

8. Device according to claim 7, characterized in that the plunger is designed to displace the plunger plug relative to the setting tube.

9. Device according to one of the preceding claims, characterized in that the displacement device further comprises a plunger guide receptacle designed to hold the plunger guide.

10. Device according to one of the preceding claims, characterized in that the plunger has a cylindrical section at the end facing the holding device, the outer diameter of which is smaller than the inside diameter of the setting tube.

11. Device (10) according to one of the preceding claims, comprising: a base plate (12); a support element (14) connected to the base plate (12); a receptacle (18) advantageously mounted on the base plate (12) comprising a first centering receptacle (22) adapted to hold a second centering receptacle (24) and advantageously having a depth stop (26), and the second centering receptacle (24), which is designed to hold the syringe cylinder; a tubular setting tube (30), which is designed to accommodate the plunger plug inside it; a holding device (28) advantageously attached to the support element (14), which is designed to hold the setting tube (30) relative to the receptacle (18) and which advantageously at least partially encloses the setting tube (30), wherein the holding device (28) comprises a rocker device (34) designed as an elongated plate-like element, which is designed to displace the setting tube (30) relative to the plunger plug, wherein the rocker device (34) advantageously has a first end (38) that is designed to be actuated by a finger and a second end that is arranged substantially opposite the first end (38) and which at least partially encloses the setting tube (30), and a displacement device (40, 42, 44, 46, 48) comprising a plunger guide (42) adapted to align a plunger (44) relative to the setting tube (30), wherein the plunger guide (42) is advantageously directly or indirectly adjustable; the plunger (44) which is adapted to displace the plunger plug relative to the setting tube (30) and advantageously comprises a depth stop (46), and a plunger guide receptacle (40) advantageously attached to the support element (14), which is designed to hold the plunger guide (42); and, optionally, a locking device (50) designed to prevent unintentional displacement of the plunger plug relative to the setting tube (30), wherein the locking device (50) is advantageously pivotably connected to the at least one support element (14).

12. Method for manually inserting an elastomeric plunger plug, which forms part of a plunger, into a syringe cylinder in a liquid-tight manner, comprising the steps of: (i) inserting the plunger plug into a tubular setting tube (30); (ii) inserting the syringe cylinder into a second centering receptacle (24) of a receptacle (18) designed for this purpose; (iii) displacing the plunger plug within the setting tube (30) to a predetermined position by means of a displacement device; and (iv) displacing the setting tube (30) relative to the plunger plug by manually actuating an actuating section (34) of a displacement device (40, 42, 44, 46, 48) such that the setting tube (30) moves away from the syringe cylinder, wherein the setting tube releases the plunger plug so that it expands and comes into contact with the syringe cylinder.

13. Method according to claim 12, characterized in that the displacement of the plunger plug within the setting tube (30) is effected by a displacement device (40, 42, 44, 46, 48) which is designed to displace the plunger plug relative to the setting tube (30).

14. Method according to claim 12 or 13, characterized in that the displacement of the setting tube (30) relative to the plunger plug is effected by manually exerting an actuating force acting in a first direction, advantageously with a finger, on a first end (38) of a rocker device (34), whereby at a second end of the rocker device (34) which is arranged substantially opposite the first end (38) and which advantageously at least partially encloses the setting tube (30), a lever force acting in a second direction is transmitted to the setting tube (30), wherein the first direction is substantially opposite to the second direction, whereby the displacement of the setting tube relative to the plunger is made by means of (i) holding the plunger plug in the predetermined position within the syringe cylinder by exerting a holding force on the plunger plug, advantageously via a fixable plunger (44) which forms part of the displacement device (40, 42, 44, 46, 48) and which is adapted to displace the plunger plug relative to the setting tube (30) and which advantageously abuts against a plunger guide (42) with a depth stop (46) arranged thereon, and (ii) exerting a pressure force, advantageously with a finger, to a first end (38) of an elongated plate-like element (34), thereby exerting a lever force on the setting tube (30) at a second end which is arranged opposite the first end (38) and at least partially encloses the setting tube (30), the direction of which is substantially opposite to that of the pressure force, causing the plunger plug to emerge completely from the setting tube (30) and expand so that it comes into contact with an inner surface of the syringe cylinder.

15. Method according to one of claims 12-14, characterized in that the method comprises the following steps of: (i) inserting the plunger plug into a tubular setting tube (30); (ii) inserting a syringe cylinder, preferably filled, into a receptacle (18) designed for this purpose, comprising a first centering receptacle (22) designed to hold a second centering receptacle (24), and the second centering receptacle (24) designed to hold the syringe cylinder; (iii) moving the second centering receptacle (24) with the syringe cylinder into a predetermined position within the first centering receptacle (22), wherein the predetermined position is advantageously reached by arranging the second centering receptacle (24) at a depth stop (26) mounted in the first centering receptacle (22); (iv) arranging the setting tube (30) with the plunger plug in a holding device (28); (v) optionally, adjusting the receptacle (18) with the syringe cylinder and the setting tube (30) so that they are aligned substantially coaxially with each other; (vi) releasing a locking device (50) which is designed to prevent unintentional displacement of the plunger plug relative to the setting tube (30); (vii) displacing the plunger plug within the setting tube (30) by exerting, preferably manually, a pressure force on a plunger (44) that is designed to displace the plunger plug relative to the setting tube (30), wherein the plunger plug, which is arranged at the end of the plunger plug opposite the plunger (44), is displaced into a predetermined position by means of the pressure force exerted on the plunger (44) to a predetermined position, wherein the predetermined position of the plunger plug is advantageously achieved by arranging a depth stop (46) arranged on the plunger (44) on a plunger guide (42); and (viii) displacing the setting tube (30) relative to the plunger plug by holding the plunger plug in the predetermined position within the syringe cylinder by exerting a holding force on the plunger plug via the plunger (44), which is advantageously in contact with the depth stop (46) on the plunger guide (42); and exerting a pressure force, advantageously with a finger, to a first end (38) of an elongated plate-like element (34), thereby transmitting a lever force to the setting tube (30) at a second end opposite the first end (38) and at least partially enclosing the setting tube (30) whose direction is substantially opposite to that of the pressure force, wherein the plunger plug emerges completely from the setting tube (30) and expands so that it comes into contact with an inner surface of the syringe cylinder.