WO2021260086A1 - Device for a medication transfer system, and medication transfer system - Google Patents

Abstract

The invention relates to a device (100, 2003, 300, 400) for a medication transfer system for the removal and/or supply of fluid substances, more particularly drugs, from and/or into a substance container, said device comprising a fluid volume chamber (11, 41), which forms a fluid volume (15) together with a plunger (12, 42) guided in the fluid volume chamber (11, 41), wherein the fluid volume (15) is variable by means of the plunger (12, 42), and comprising a pressure equalization volume (25) separated from the fluid volume (15) and formed by a pressure equalization volume chamber (21, 41) together with a plunger (22, 42) guided therein, wherein the pressure equalization volume (25) is variable by means of the plunger (22, 42), and wherein, for fluidic connection to the substance container, at least one fluid line (14) is provided for the fluid volume (15) and at least one pressure equalization line (24) is provided for the pressure equalization volume (25). The at least one pressure equalization line (24) runs here through the pressure equalization volume chamber (21, 41).

Description

Device for a drug transfer system and drug transfer system

The invention relates to a device for a drug transfer system and to a drug transfer system comprising such a device.

Many substances that are administered as injections or in a comparable delivery form, such as CMR drugs, which are used, for example, in cancer therapy and whose therapeutic application is primarily aimed at damaging growth-intensive tumor cells, show a considerable potential risk outside of the actual therapeutic application. Due to their mechanism of action, such substances are in part self-carcinogenic, which is why contact with people who are not in therapy should be avoided. For CMR drugs, therefore, more and more closed ones are used in the manufacture of ready-to-use preparations

Drug transfer system, so-called "Closed System Transfer Devices" or CSTDs are used. An important component of such drug transfer systems are pressure equalization mechanisms that prevent toxic elements, for example in the form of aerosols and gases, from escaping when liquids are injected into and removed from a substance container (vial).

A well-known pressure equalization mechanism is based on the use of filter systems in which toxic air components are separated from the outflowing air. In a specific embodiment, the pressure equalization takes place via a hydrophobic air filter membrane and another series-connected filter made of activated carbon fabric. Such a system is therefore in an exchange of air with its surroundings and can only be regarded as closed with a sufficiently proven filter effect with regard to avoiding the escape of toxic elements will. Corresponding evidence is provided in a complex series of tests. In the absence of transparency about the resilience of the test series, the user also has a certain residual uncertainty about the safe functioning of the filter systems.

Alternatively, for pressure equalization from the external environment, screened pressure equalization systems, so-called "barrier systems", are used, which collect toxic air components in a mostly flexible equalization container. A bladder mounted on the side of a vial adapter, into which toxic air constituents can flow, is used, inter alia, as a compensation container, whereby the bladder can expand like a balloon. However, such systems carry the risk that they will be damaged during use or during their disposal, for example by sharp-edged objects, and that the toxic components contained therein will be released in an uncontrolled manner. Furthermore, there is often the disadvantage that the flexible compensation containers have collapsed in the delivery state and therefore liquid medicaments cannot be removed directly from the rigid medicament containers. In such systems it is necessary to first fill the expansion tank with an air-filled syringe via the vial, ie first inject air into the vial in order to be able to remove liquid afterwards. If the air is sucked into the syringe in a non-sterile or non-antiseptic work area, there is a risk that bacteria or germs will be carried into the medication container via the air and the medication will be contaminated. This can be countered by the additional provision of a ventilation valve in combination with a bacteria-retaining air filter, which, however, involves a corresponding effort. Another disadvantage with the use of compensation containers is the risk that drugs can get into the compensation container when liquid is splashed back into the substance container. Once trapped there, under normal circumstances it is hardly possible to draw it back up with the syringe. In the case of very expensive drugs in particular, this unintended residual volume is a considerable disadvantage in use. An alternative is a pressure equalization integrated into the syringe, with a pressure equalization line being passed through the syringe plunger. However, this arrangement influences the internal friction in the syringe and places high demands on the tightness of the pressure equalization line bushing. In addition to the resulting manufacturing requirements, there is additional effort due to specific validation measures.

In view of the disadvantages associated with the prior art, the object of the present invention is to provide a device for a drug transfer system and a drug transfer system with such a device, by means of which pressure equalization is realized in a simple and reliable manner.

The object according to the invention is achieved by a device for a drug transfer system according to claim 1 and a drug transfer system according to claim 14. Further advantageous refinements of the invention emerge from the subclaims.

According to the invention, the device for a drug transfer system for removing and / or supplying fluid substances, in particular drugs, from and / or into a substance container, comprises a fluid volume wall which, together with a piston guided in the fluid volume wall, forms a fluid volume, the fluid volume being above the Piston is changeable, a pressure equalization volume separated from the fluid volume, formed by a pressure equalization volume wall together with a piston guided therein, the pressure equalization volume being changeable via the piston, with at least one fluid line for the fluid volume and at least one pressure equalization line for the fluid connection with the Substance container is provided, and wherein the at least one pressure equalization line runs through the pressure equalization volume wall.

The pressure equalization line and / or the fluid line can be designed for direct engagement in the substance container or can be connected indirectly to the substance container via an adapter or coupling element. the Pressure equalization line can run through the pressure equalization volume wall in the sense of an inlet or outlet provided in the pressure equalization volume wall, to which the pressure equalization line is connected, or in the sense of a pressure equalization line protruding through the pressure equalization volume wall into the pressure equalization volume. The course is preferably designed to be rigid, ie there is no relative movement between the pressure equalization line and the pressure equalization volume wall. The term pressure equalization volume wall or the fluid volume wall is related to the boundary surfaces of the respective volume within which a piston is moved. In other words, the walls generally form a cylinder for receiving a piston. In the simplest case, the pressure equalization line takes place through connection to an opening on a lateral section and / or on a - preferably lower end face - end section, for example through connection to an outlet side of a pressure equalization piston.

The technical solution according to the invention is simple and yet at the same time reliable in order to avoid any leakage of the toxic substance and possibly gaseous constituents of the content.

Due to the course of the pressure equalization line according to the invention, an influencing of the handling by friction is avoided, for example, compared to a guidance of the pressure equalization line through the syringe plunger and thus through the fluid volume. At the same time, the associated tightness requirements are unnecessary.

In a first embodiment, the fluid volume and the pressure equalization volume are formed by separate cylinders arranged next to one another with a respective piston.

The cylinder that forms the pressure equalization volume together with the corresponding piston, also pressure equalization cylinder, comprises a lateral pressure equalization volume wall section enclosing the pressure equalization volume in the direction of the piston guide and an end face for this forming pressure compensation volume wall section. From the pressure equalization volume wall forming the end face, the pressure equalization volume line extends preferably at least in an initial section in the axial direction of the piston guide. Likewise, the cylinder that forms the fluid volume together with the corresponding piston, also fluid cylinder, a lateral fluid volume wall section enclosing the fluid volume in the direction of the piston guide and a fluid volume wall section forming an end face for this. From the fluid volume wall forming the end face, the fluid line extends preferably at least in an initial section in the axial direction of the piston guide. Analogously to the terms pressure compensation cylinder and fluid cylinder, the respective pistons can also be referred to as pressure compensation piston and fluid piston. The pressure compensation cylinder and / or the fluid cylinder can be open on a side facing away from their end face or closed or at least sealed for further sealing, provided, for example, redundancy for sealing is to be created by the piston. In addition, the term “cylinder” is generally directed to a piston receptacle and is not to be understood in the geometric sense, although a cylindrical shape of the cylinder can often be preferred as an advantageous embodiment.

The pistons can each be moved in a targeted manner by an actuator, for example a piston rod, as can be provided in particular for the fluid piston for removing and / or supplying fluid substances. Alternatively, however, the pistons can also be designed in such a way that they move through the respective pressure conditions without an actuator. The movement principles can be applied independently of one another for each piston, e.g. the fluid piston, as already mentioned, has an actuator, while the pressure compensation piston can be moved passively by changing the pressure conditions.

By designing separate cylinders, these can be exchanged independently of one another. In addition, there are further degrees of freedom in the application-specific design. Furthermore, the pressure compensation cylinder and the fluid cylinder can be designed to be identical. One of the cylinders, in particular the cylinder that forms the fluid volume together with the piston, preferably has an angle of attack that deviates from a parallel arrangement with respect to the other cylinder.

Particularly in connection with a piston rod as an example of an actuator, this facilitates the removal and / or supply of a fluid substance, since the distance between the cylinder ends facing away from the end faces can be increased via the angle of attack. Since the actuator is often operated in the area of these cylinder ends, handling is improved by the spacing.

In particular, the device comprises a connecting element with which at least the fluid line and / or the pressure equalization line can be connected in a detachable manner.

At the connection point for the fluid line and / or the pressure equalization line, the connecting element has a channel via which the respective line is continued in order to enable the fluid exchange. The channel comprises a channel inlet for connection to the fluid line and / or pressure equalization line and a channel outlet. The connecting element can then be connected to or introduced into the substance container via the channel outlet, or it can be connected to the drug transfer system in some other way.

If the connecting element is detachably connected to both the fluid line and the pressure equalization line, the fluid channel and the pressure equalization channel in the connecting element are preferably guided parallel, in particular coaxially, to one another, at least in the area of the channel outlets. This results in a space-saving arrangement which can advantageously be used as a cannula for introduction into a substance container. In the case of a coaxial arrangement, it is advantageous if the pressure equalization channel surrounds the fluid channel, since the opening of the fluid channel should extend beyond the opening of the pressure equalization channel, so that in this case an application-oriented tip can be formed over the arrangement of the openings, which is shown in one Substance container is insertable. Regardless of the optional formation of a tip, the opening of the pressure equalization channel is also not covered from the outside by the fluid channel.

The detachable connection supports the exchange of individual cylinders without the connection to the substance container having to be detached. In one embodiment, it can be provided that at least one of the cylinders cannot be released without being destroyed in order to prevent recycling of the at least one cylinder.

In addition, the connecting element can have a mechanism for automatically closing the respective cylinder access when a cylinder is removed in order to prevent toxic substances from escaping.

In a second embodiment, the fluid volume wall with a piston guided therein lies at least partially within the pressure equalization volume wall with a piston guided therein, or vice versa.

The term "partial" refers in particular to an overlap of the lateral wall sections in the axial direction of the cylinder, which does not have to be complete with different lengths of the cylinder, for example if the inner wall is longer than the outer wall. The axial direction corresponds to a direction of the piston guide. This results in a nested arrangement of the fluid cylinder and the pressure compensation cylinder.

The fluid volume is thus at least partially surrounded by the pressure equalization volume, separated by the fluid volume wall, or the pressure equalization volume is at least partially surrounded by the fluid volume, separated by the pressure equalization volume wall. In the case of a cylindrical configuration of the fluid volume wall and the pressure equalization volume wall, the respective inner volume is, for example, at least partially surrounded by the respective outer volume. In particular, the inner wall and the outer wall are arranged coaxially in the axial direction, so that a uniform gap dimension is formed circumferentially.

The configuration of the piston surface perpendicular to the axial direction corresponds to the surface of the respective volume in this cross section, as can also be used for all other embodiments. Taking up the example of the cylindrical configuration of the fluid volume wall and the pressure compensation volume wall, with the fluid volume being surrounded by the pressure compensation volume as an example, the fluid piston has a round piston surface perpendicular to the axial direction, while the pressure compensation piston is designed as an annular surface in the same direction.

The fluid volume wall and the

Pressure compensation volume wall with their respective pistons from separate cylinders, so that these can be replaced independently of one another.

In contrast to an integral design or a design in which the outer wall of the inner volume is used as the inner wall of the outer volume, this not only increases the flexibility with regard to an exchange per se, but also with regard to the design of the respective cylinder, such as their capacity or the material used.

In particular, the fluid line runs at least partially through the pressure equalization line or vice versa.

Comparable to the statements on the channels of the connecting element, a space-saving arrangement results from the guidance that takes place in one another. In addition, if the fluid line and the pressure equalization line are arranged at the front, the fluid exchange and pressure equalization can be implemented in a simple manner. The fluid line is at least partially ring-shaped from the pressure equalization line surround, the term "ring-shaped" not being limited to a circular configuration and / or a constant gap size.

Likewise comparable to the statements on the arrangement of the openings of the fluid channel and the pressure equalization channel of the connecting element, the fluid line preferably runs partially through the pressure equalization line. A preferred arrangement of the fluid volume wall within the pressure equalization volume wall results accordingly. This arrangement also has the advantage that the fluid volume is additionally shielded from the environment by the pressure equalization volume. Even if the escape of toxic components from the pressure equalization volume is undesirable, the risk of danger emanating from the fluid volume is nevertheless greater.

In particular, the outer line and / or a section of the outer cylinder forms a gas- and / or liquid-tight barrier when the inner line is removed.

If it is intended to remove the inner cylinder or at least the associated line, the space previously occupied by the inner line should be closed. This can be done with an elastic inner ring or similar, which expands inward after removing the inner line. Alternatively or in addition, a gas- and / or liquid-tight barrier can be achieved by means of a spring element that is pushed outwards by the inner cylinder or the inner line and / or held in an open state and moves back into a closed position when the line is removed .

In a third embodiment, the fluid volume and the pressure equalization volume are arranged one behind the other, preferably with respect to one end for the removal and / or supply of fluid substances, initially the fluid volume with the pressure equalization volume lying behind it. The pressure equalization volume and the fluid volume do not have to lie directly one behind the other, but can also be separated from one another, for example, by an intervening ventilation chamber.

By arranging the volumes one behind the other, not only can a slim design be implemented, but the fluid volume wall and the pressure equalization volume wall can also be formed from one wall. If the respective cylinders are to be exchanged, it goes without saying that the walls can also be designed separately.

In a further development, the device comprises a piston that can be moved through both volumes, so that both volumes can be changed via the piston movement.

If the fluid volume is reduced, for example via the piston, the pressure equalization volume increases accordingly. The opposite change in the volume can take place in the same way or through gear ratios or motion reducers in a predetermined ratio. For this purpose, a piston with at least two piston elements coupled to one another is suitable, with one piston element covering a movement path that is different from the other piston element. Regardless of possible different movement paths, the use of at least two piston elements coupled to one another is also possible if the volumes are not arranged directly one behind the other. In combination with different movement distances, for example, a venting chamber can be arranged between the two piston elements.

In a further development, the piston for changing the fluid volume is formed via a cylinder comprising the pressure compensation volume, the cylinder having a venting chamber.

In contrast to the previous development, the pressure equalization volume is not changed via the piston that changes the fluid volume. Thus, the Pressure equalization via a pressure equalization piston in connection with a ventilation chamber in order to decouple the movement of the pressure equalization piston from a counter pressure. As an alternative to a ventilation chamber, a chamber with a compressible medium can also be provided which does not prevent movement of the pressure compensation piston for pressure compensation.

The pressure equalization line is preferably designed as a flexible and / or adjustable line, preferably as a telescopic line.

The term "flexible" is not limited to an elastic design of the pressure compensation line, but generally includes a line design that allows a change in the shape of the line, such as a change in length or a change in the course of the line, for example a curve compared to a previously straight course.

The flexible and / or adjustable pressure equalization line has the advantage, on the one hand, that its length can be adjusted specifically for the application without having to produce a length that is tailored to the application. In cases in which the pressure equalization line is moved with a piston movement, as happens in the embodiment in which the pressure equalization cylinder forms the fluid piston, the flexible design allows length compensation between two firmly connected points of the pressure equalization line that are moved towards one another. A design as a telescopic line offers the advantage that the pressure equalization line continues to run straight in this section and thus does not form any interfering contours.

The maximum pressure equalization volume is preferably adapted to a withdrawal and / or supply amount of the fluid substance, in particular greater than the fluid volume.

In all of the embodiments, an application-oriented design of the pressure compensation volume can thus be carried out. This can be used in particular to use the pressure equalization volume when removing and / or supplying multiple doses for the total amount of cans, without one Replace the pressure compensation cylinder or have to provide several pressure compensation cylinders. Accordingly, it is advantageous to provide a pressure equalization volume that is larger than the individual fluid volume when, in the context of multiple doses, individual fluid volumes per dose or at least individual fluid volumes that are smaller than the total amount of the multiple doses are used. Ultimately, a buffer can also be created through a pressure equalization volume that is larger than the fluid volume.

The present invention is also directed to a drug transfer system that comprises a device for a drug transfer system, as described above, and a substance container, the drug transfer system being gas- and / or liquid-tight.

The drug transfer system is thus a closed system in which, when the aforementioned device is connected to the substance container, contamination of the environment with toxic components is avoided due to the gas and / or liquid tightness. The described advantages of using the device according to the invention can be transferred to the drug transfer system.

In particular, the substance container-side outlet of the fluid line for withdrawing and / or supplying a fluid substance from and / or into the substance container and the substance-container-side outlet of the pressure equalization line for pressure equalization are arranged in the substance container.

The respective outlets are thus in direct connection with the substance container contents, so that intermediate elements can be dispensed with. To attach the device to the substance container, a detachable coupling element can be provided which connects the device to the substance ratio in such a way that the lines are securely held in the substance container. Features and expediencies of the invention are also described below on the basis of exemplary embodiments with reference to the drawings.

It shows

1 shows a cross-sectional view of an example of a first embodiment with two cylinders arranged next to one another and a connecting element in a sectional plane parallel to the axial direction of the piston guides;

2 shows a cross-sectional view of an example of a second embodiment with a fluid volume wall with a piston guided therein, which is located within the pressure equalization volume wall with a piston guided therein, in a sectional plane parallel to the axial direction of the piston guides;

3 shows a cross-sectional view of an example of a third embodiment, in which the fluid volume and the pressure equalization volume are arranged one behind the other and both volumes can be changed via a common movable piston, in a sectional plane parallel to the axial direction of the piston guide;

4 shows a cross-sectional view of an example of a fourth embodiment, in which the fluid volume and the pressure compensation volume are arranged one behind the other and the piston for changing the fluid volume is formed via a cylinder comprising the pressure compensation volume, the cylinder having a venting chamber, in a sectional plane parallel to the axial direction the piston guides.

Figure 1 shows a device 100 for a drug transfer system for removing and / or supplying fluid substances from and / or into a substance container, in which a fluid cylinder 10 and a pressure compensation cylinder 20 are arranged side by side and with a connecting element 30 for introduction into a not shown here Substance container are connected. The fluid cylinder 10 comprises a fluid volume wall 11 which, together with a fluid piston 12 guided in the fluid volume wall 11, forms a fluid volume 15, as well as a fluid line 14. The fluid volume 15 is generated by the movement of the fluid piston 12, here via a fluid piston rod 13 as an example of an actuator, changeable. When the fluid volume 15 is reduced, i.e. when the fluid piston 12 moves in the direction of the fluid line 14, a fluid is supplied to a substance container, while an increase in the fluid volume 15, i.e. a movement of the fluid piston 12 against the fluid line 14, results in a removal of a fluid a substance container is used. The fluid volume wall 11 has a lateral fluid volume wall section 111 enclosing the fluid volume 15 in the direction of the fluid piston guide and a fluid volume wall section 112 forming an end face for this. The fluid cylinder 10 has an angle of attack that deviates from a parallel arrangement with respect to the pressure compensation cylinder 20. This makes handling easier, since more space is available for moving the fluid piston rod 13. In a modified arrangement, the pressure compensation cylinder 20 can also be adjusted accordingly instead of the fluid cylinder 10, or both cylinders can have an angle of attack or both cylinders 10 and 20 can be arranged in parallel.

The pressure compensation cylinder 20 is constructed analogously to the fluid cylinder 10 and accordingly comprises a pressure compensation volume wall 21 which, together with a pressure compensation piston 22 guided in the pressure compensation volume wall 21, forms a pressure compensation volume 25, as well as a pressure compensation line 24. The pressure compensation volume 25 can be changed by the movement of the pressure compensation piston 22. The pressure equalization volume wall 21 has a lateral pressure equalization volume wall section 211 enclosing the pressure equalization volume 25 in the direction of the pressure equalization piston guide and a pressure equalization volume wall section 212 forming an end face for this.

The connecting element 30 comprises a fluid channel 31 with a fluid channel inlet 311 for connection to the fluid line 14 and a fluid channel outlet 312 for introduction into a substance container. It also includes Connecting element 30 has a pressure equalization channel 32 with a pressure equalization channel inlet 321 for connection to the pressure equalization line 24 and a pressure equalization channel outlet 322 for introduction into a substance container. The fluid channel 31 and the pressure equalization channel 32 are arranged in such a way that they run parallel to one another at least in the region of the channel outlets 312 and 322. Specifically, the pressure equalization channel 32 runs coaxially around the fluid channel 31 in this area. Due to the conical shape of the connecting element 30 on the outlet side, the pressure equalization channel outlet 322 is above the fluid channel outlet 312 in the figure in the direction of gravity below a gas space, in their respective active regions.

To connect the fluid cylinder 10 and the pressure compensation cylinder 20 to the connecting element 30, the connecting element 30 has respective projections on which the cylinders 10 and 20 can be placed. The connection can be designed, for example, as a Luer lock or snap connection.

The mode of operation of the device 100 is described by way of example for a case in which the outlet side of the connecting element 30, that is to say the area of the fluid channel outlet 312 and the pressure equalization channel outlet 322, was introduced into a substance container. The fluid channel outlet 312 is immersed in a fluid substance of the substance container, while the pressure equalization channel 322 is in fluid connection with a gas space formed above the substance. To remove the fluid substance from the substance container, the fluid piston 13 of the fluid cylinder 10 is moved over the fluid piston rod 13 in a direction opposite the frontal fluid volume wall section 112, i.e. obliquely upward in FIG. 1. The fluid volume 15 is thereby increased and the fluid substance is drawn into the fluid volume 15 by the negative pressure that occurs. By removing the fluid substance, the gas space in the substance container increases, which in turn creates a negative pressure in it, which acts on the pressure compensation volume 25 via the pressure compensation channel 32 and the pressure compensation line 24. The negative pressure transmitted to the pressure compensation volume 25 causes the pressure compensation piston 22 to move in FIG Direction of the pressure line 24, whereby the pressure compensation then takes place. When fluid is fed into the substance container via the fluid cylinder 10, the pistons move in the opposite way to the withdrawal. The fluid piston 12 is therefore moved in the direction of the fluid line 14, the fluid volume 15 being reduced. The overpressure generated therein by the increase in fluid in the substance container is compensated for by a movement of the pressure compensation piston 22 against the pressure compensation line 24 in order to increase the pressure compensation volume 25.

In principle, this passive piston movement of the pressure compensation piston 22 does not require a pressure compensation piston rod 23. However, this can be used to support a movement process or to actively intervene in it. In addition, the presence of such a piston rod can also be due to a structurally identical design of the fluid cylinder 10 and the pressure compensation cylinder 20.

Even if the structure of the device 200 shown in FIG. 2 differs from the device 100, the mode of operation described above can be used in the same way. The device 200 ultimately comprises, apart from the connecting element described in relation to FIG. For this purpose, the pressure compensation piston 22 is designed in the form of a ring. The pressure equalization line 24 here also surrounds the fluid line 14 in an annular manner. The example shown in Figure 2 does not include a pressure compensation piston rod for the pressure compensation piston 22. When fluid is supplied via the fluid cylinder 10, the pressure compensation piston rod then moved against the pressure compensation line 14 would hinder the operation of the fluid piston rod 13 due to the interfering contour it forms. In principle, however, the use of an actuator for the pressure compensation piston 22 is possible.

Figures 3 and 4 each show an example of a serial structure of a device for drug transfer, in each of which the pressure equalization volume 25 in the axial direction of the piston guide with respect to a The end for the removal and / or supply of fluid substances is arranged behind the fluid volume 15.

In FIG. 3, the device 300 comprises a cylinder 40 with a wall 41 which, together with the cylinder piston 42, forms both the fluid volume 15 and the pressure equalization volume 25. In other words, the cylinder piston 42 replaces the fluid piston 12 and the pressure compensation piston 22. If the piston 42 is now moved in the axial direction of the piston guide, one volume increases compared to the other volume according to the movement distance of the piston 42 Wall in 41 in the area of pressure equalization volume 25 in an end section facing away from the end for removing and / or supplying fluid substances, in the illustration in FIG. 3 an upper end. The pressure equalization line 24 then extends in the axial direction along the wall 41 in order to then again enclose the fluid line 14 in an annular manner in the region of the end for the removal and / or supply of fluid substances.

In an alternative embodiment of the serial arrangement of the fluid volume and the pressure compensation volume, as shown in FIG. 4, the pressure compensation cylinder 20 forms the fluid piston 12. In this sense, the pressure compensation cylinder 20 can also be understood as a fluid piston rod, at whose end facing the fluid volume the fluid piston 12 is arranged. The pressure compensation cylinder 20 also has a pressure compensation piston 22, since otherwise there would initially be no change in the pressure compensation volume with the movement of the pressure compensation cylinder 20. The pressure compensation piston 22 is arranged in such a way that a ventilation chamber 55 is formed between the pressure compensation volume 25 and the fluid volume 15 and has a ventilation opening 56. The vent opening 56 can include a filter to provide a further safeguard against contamination of the surroundings.

The pressure equalization line 24 is guided in a manner comparable to the guide shown in FIG. 3, but has a telescopic structure in order to compensate for the change in distance between the outlet and inlet points of the pressure equalization line 24 when the pressure equalization cylinder 20 moves. When a fluid substance is withdrawn from a substance container via the device 400 according to FIG. 4, the pressure compensation cylinder 20 is moved in the axial direction against the end of the device 400 for withdrawal and / or supply. This increases the distance between the outlet and inlet point of the pressure equalization line 24. The increase in distance is compensated for via the pressure equalization line in that the

Pressure equalization line section 241 and the pressure equalization line section 241 overlap in such a way and are movable relative to one another in the overlapping area, so that they can be pulled apart without the pressure output line

24 is thereby interrupted. In the same way, the pressure equalization line sections 241 and 242 can be pushed into one another when the distance is reduced.

By moving the pressure cylinder 20 to remove a fluid substance, the fluid volume 15 is enlarged and the fluid substance is drawn into the fluid volume 15. The resulting negative pressure in the substance container is transmitted via the pressure equalization line 24 to the pressure equalization volume 25, whereby the pressure equalization piston 22 is moved in a direction facing away from the fluid volume 15 to counteract the negative pressure by reducing the pressure equalization volume

25 to counter. In order to counteract an obstruction of the movement of the pressure compensation piston 22 by a counter pressure, the venting chamber 55 with the venting chamber 56 is provided. Otherwise, a cylinder section would develop between the pressure compensation piston 22 and the fluid piston 12, which, if this cylinder section is enlarged, would also develop a negative pressure which would influence the movement of the pressure compensation piston 22. Reversed kinematics of the movable elements result when a fluid substance is fed into a substance container with correspondingly reversed pressure conditions.

The invention is not restricted to the embodiments described. In principle, details given for various embodiments can also be transferred to other embodiments, provided that they are not mutually exclusive. For example, the pressure compensation piston 22 of the device 400 can also be actively moved via a pressure compensation piston rod. With regard to the device 400, another pressure equalization mechanism can also be provided for the cylinder section between the pressure equalization piston 22 and the fluid piston 12 instead of a venting chamber 55, such as the use of reversibly compressible media.

Claims

Expectations: 1. Device (100, 2003, 300, 400) for a drug transfer system for removing and / or supplying fluid substances, in particular drugs, from and / or into a substance container, comprising a fluid volume wall (11, 41) which, together with a the piston (12, 42) guided in the fluid volume wall (11, 41) forms a fluid volume (15), the fluid volume (15) being variable via the piston (12, 42); a pressure equalization volume (25) separated from the fluid volume (15) and formed by a pressure equalization volume wall (21, 41) together with a piston (22, 42) guided therein, the pressure equalization volume (25) being variable via the piston (22, 42) ; wherein at least one fluid line (14) is provided for the fluid volume (15) and at least one pressure equalization line (24) is provided for the pressure equalization volume (25) for fluid connection with the substance container; and wherein the at least one pressure equalization line (24) runs through the pressure equalization volume wall (21, 41). 2. Device (100) according to claim 1, wherein the fluid volume (15) and the pressure equalization volume (25) are formed by separate cylinders (10, 20) arranged next to one another with a respective piston (12, 22). 3. Device (100) according to claim 2, wherein one of the cylinders (10, 20), in particular the cylinder (10) which forms the fluid volume (15) together with the piston (12), has one to the other cylinder (10, 20) has a different angle of attack from a parallel arrangement. 4. Device (100) according to one of claims 2 or 3, wherein the device (100) comprises a connecting element (30) with which at least the fluid line (14) and / or the pressure equalization line (24) is or are releasably connectable. 5. The device (200) according to claim 1, wherein the fluid volume wall (11) with a piston (12) guided therein at least partially within the Pressure compensation volume wall (21) with a piston (22) guided therein or vice versa. 6. Device (200) according to claim 5, wherein the fluid volume wall (11) and the pressure compensation volume wall (11) with their respective pistons (12, 22) separate Form cylinders (10, 20) so that they can be exchanged independently of one another. 7. Device (200) according to claim 5 or 6, wherein the fluid line (14) runs at least partially through the pressure equalization line (24) or vice versa. 8. The device (200) according to claim 7, wherein the outer line (14, 24) and / or a portion of the outer cylinder (10, 20) when removing the inner line (14, 24) a gas- and / or liquid-tight barrier trains. 9. The device (300, 400) according to claim 1, wherein the fluid volume (15) and the pressure compensation volume (25) are arranged one behind the other, preferably with respect to one end for the removal and / or supply of fluid substances, initially the fluid volume (15) with a pressure equalization volume behind it (25). 10. The device (300) according to claim 9, wherein the device comprises a piston (42) movable through both volumes (15, 25), so that both volumes (15, 25) can be changed via the piston movement. 11. The device (400) according to claim 9, wherein the piston (12) for changing the fluid volume (15) is formed via a cylinder (20) comprising the pressure compensation volume (25), the cylinder (20) having a venting chamber (55) . 12. Device (300, 400) according to one of claims 9 to 11, wherein the pressure compensation line (24) is designed as a flexible and / or adjustable line, preferably as a telescopic line. 13. Device (100, 200, 300, 400) according to one of the preceding claims, wherein the maximum pressure compensation volume (25) is adapted to a withdrawal and / or supply amount of the fluid substance, in particular is greater than the fluid volume (15). 14. A drug transfer system comprising: a device (100, 200, 300, 400) for a drug transfer system according to one of claims 1 to 13 and a substance container, the drug transfer system being gas- and / or liquid-tight. 15. Medicament transfer system according to claim 14, wherein the substance container-side outlet of the fluid line (14) for removing and / or supplying a fluid substance from and / or into the substance container and the substance-container-side outlet of the pressure equalization line (24) for pressure equalization are arranged in the substance container.