EP0808148A1

EP0808148A1 - Transfer device

Info

Publication number: EP0808148A1
Application number: EP96904064A
Authority: EP
Inventors: Reinhold WOLKENSTÖRFER; Peter Iwatschenko
Original assignee: Pharmacia and Upjohn AB
Current assignee: Fresenius Kabi AB; Pfizer Health AB
Priority date: 1995-02-10
Filing date: 1996-02-12
Publication date: 1997-11-26
Anticipated expiration: 2016-02-12
Also published as: ATE172869T1; DK0808148T3; DE59600779D1; DE19504413A1; WO1996024323A1; EP0808148B1

Abstract

A transfer device for contamination-free transfer of liquids between two containers, each of which has a closure, comprises an alignment device with two adapters, each of which is set on the closure of a container, and a transfer part which has a transfer duct and is detachably mounted in the alignment device. Such a transfer device is improved by making the transfer part separable from the container into which the liquid is transferred. It is economical to produce and safe and easy to handle and allows a reliably contamination free transfer of liquids.

Description

Transfer device

The invention relates to a transfer device for the contamination-free transfer of liquids between two containers, each having a closure, with an alignment device which has two receptacles for placement on the closure, one of each container, and a transfer part, which has a transfer has channel.

In hospital operation, it is often necessary to produce infusion solutions from two components which cannot be mixed with one another over a longer period of time without impairing their use value. The components may therefore only be mixed shortly before the infusion into the human body. For mixing a first component stored in a first container with a second component stored in a second container, it is known to design the size and filling quantity of the second container such that there is sufficient space to add the first component. The free space in the second container is under negative pressure. So-called transfer devices are known for transferring liquid from the first container into the second container. These devices have two hollow piercing mandrels for piercing one closure of each of the containers and a continuous transfer channel. If the two containers are connected by the transfer device, the pressure gradient between the external air pressure and the negative pressure of the second container pushes the liquid out of the suitably ventilated first container through the transfer channel into the second container, in which both liquids mix and are available for use.

A transfer device of the type mentioned, in which the alignment device and the transfer part from each other are independent components, is described in German utility model G 89 09 304. The alignment device disclosed there has two receptacles which can be formed by free-standing arms or can be designed in the form of a bowl. To mix the liquids, a first piercing mandrel of the transfer part is first pierced through the closure of the first container, and one of the receptacles of the alignment device is placed on the second container. Then the two containers are aligned axially to one another, and the first container with the transfer part is inserted into the still free receptacle of the alignment device until a second piercing mandrel of the transfer part pierces the closure of the second container so that the liquid of the can pass through the transfer channel into the second container.

With such a transfer device, however, the problem arises that the handling of the four individual parts, namely the two independent components of the transfer device and the two containers, is cumbersome for a user without the help of a second person. The transfer process is also cumbersome and prone to errors because it consists of many individual steps which have to be carried out in the correct order. There is also the danger that liquid will escape from the first container or that the liquid in the first container will be contaminated if the first container with the plugged-on transfer part piercing the closure of the container into the still free receptacle of the alignment ¬ device is introduced.

US-A-3,826,260 describes a syringe with one component of a medicament and a container with another component of the medicament. The syringe and the container are connected to one another by a connecting device, in which a hollow needle, which is sharp on both sides, is arranged and does not penetrate the closures of the syringe or the container. In use, the syringe and container are compressed, thereby pushing one end of the needle through the closure into the syringe and pushes the other end through the closure into the container. It is not intended to separate the needle from the syringe. The needle containing the transfer channel also serves as an injection needle for the medicament mixed in the syringe.

DE-A-41 22 476 describes a transfer device.

Accordingly, the object of the invention is to provide a transfer device which is simple and safe to use and inexpensive to manufacture and which enables reliable, contamination-free transfer of the liquid.

To achieve this object, the invention proposes to design a transfer device of the type mentioned at the beginning such that the transfer part can be detachably fastened in the alignment device and that the transfer part can be separated from the container into which the transfer takes place.

During use, the transfer device according to the invention constitutes a structural unit. It is therefore more convenient to use than the two individual parts of the known transfer device. The steps preparing the actual transfer process can be carried out more quickly, which not only reduces the workload, but also the risk of contamination of the medical liquids, because the critical phase between the removal of protective covers from the container closures and the piercing spikes and the piercing of the container closures takes less time.

The transfer part can be fastened in the alignment device in such a way that it assumes the position most suitable for the transfer process when the receptacles of the alignment device are placed on the container closures. An incorrect placement of the transfer part on the containers is thus avoided.

The transfer part is protected by the alignment device from being touched by a careless user. This will Both the risk of contamination of the transfer part and the risk of the user injuring himself with the pointed spikes of the transfer part are reduced.

According to the invention, the transfer part is detachably fastened in the alignment device. Compared to a one-piece delivery device, this saves material and costs, because the alignment device, which does not come into contact with the medical fluids, has only low requirements regarding sterility. The alignment device can therefore be manufactured and stored under less critical conditions, and its packaging requires less effort. An alignment device can be used several times in the clinic. In contrast, much higher sterility requirements are placed on the transfer part. For example, it can be designed as a disposable part made of plastic. In the case of a transfer device according to the invention, only the transfer part consisting of relatively little material then needs to be thrown away, but not the entire transfer device. Even if the transfer part is intended for multiple use, only this, and not the entire device, needs to be sterilized. Overall, the design of the transfer part and alignment device according to the invention reduces the manufacturing, packaging, storage, cleaning and disposal costs. Of course, the transfer part and the alignment device can also be supplied in a preassembled form, so that they can be used immediately after removal from the packaging.

In order to ensure good ventilation of the first container during and possibly before the start of the transfer process, a first piercing mandrel of the transfer part preferably contains both a section of the transfer channel and a section of a ventilation channel. If the first piercing mandrel has a tip, an outlet of the ventilation channel and, further away from the tip, an inlet of the transfer channel, it is avoided that air bubbles flowing out of the ventilation channel get into the transfer channel, where could be compensated for by the negative pressure in the second container even before all of the liquid has been transferred from the first container. This is avoided even more effectively if the outlet of the ventilation channel and the inlet of the transfer channel are separated by an axial wall during the first piercing mandrel.

The two piercing mandrels and the inlet and outlet openings arranged thereon are preferably designed such that when a container closure is pierced, no pieces are punched out of the plastic or rubber material of the closure. This risk would exist, for example, in the case of cylindrical, tubular piercing mandrels. In a preferred embodiment, on the other hand, the piercing pins are not cylindrical, but are cone-shaped and tapered, the tip being arranged approximately on the central axis of the piercing pin.

The transfer part can have an air filter as the inlet of the ventilation duct in order to prevent contamination of the liquids by the inflowing air. A glass fiber filter system with a very low filter resistance is preferably used. Instead of the filter or additionally, the transfer part can also have an automatic valve, preferably a lip valve, so that the ambient air can flow in, but leakage of the liquid is reliably prevented. This is particularly advantageous for collapsible containers, for example bags. If both a filter and an automatic valve are provided, the latter is preferably arranged between the outlet of the ventilation channel on the spike and the filter, so that even if the transfer process is interrupted, no liquid reaches the filter and the latter glued. Alternatively or additionally, a manually operable valve, for example a flap, can be provided so that the start and the speed of the overflow of liquid can be controlled by opening and closing this flap. Means for releasably fastening the transfer part in the aligning device are preferably provided in the transfer device, which ensure an exchange-free arrangement of the transfer part and aligning device. This further increases the user-friendliness of the transfer device and its security against incorrect use.

In order to determine the mutual alignment of the transfer device and the containers even more precisely, in particular with regard to the safe penetration of the piercing pins through the container closures, at least one of the receptacles, preferably both receptacles, is equipped with latching devices which engage with the closure one of the containers can be brought.

At least one of the receptacles is preferably set up to receive the closure of one of the containers in a latching position in which the piercing mandrel associated with this receptacle projects into the closure of the container but does not penetrate it. In this latching position, the inlet or outlet arranged at the tip of the piercing mandrel can be sealed airtight by the container closure surrounding it. This seal prevents unfiltered ambient air from entering the container on the other piercing mandrel (possibly under vacuum) through the transfer duct. This prevents contamination of the medical fluids and / or premature leakage.

In a preferred embodiment, at least one of the receptacles is set up to receive the closure of one of the containers in two different latching positions. This can be a first latching position in which the piercing mandrel assigned to this receptacle penetrates the closure of the container but does not penetrate it, and a second latching position in which the piercing mandrel penetrates the container closure. A relatively large force is preferably required to move the container closure from the first into the second locking position. tion because this can be the step that immediately initiates the actual transfer operation.

The transfer device is preferably designed in such a way that the transfer device can be placed on the container in a manner that is not interchangeable. This is essential for the transfer process, since only the first container may be ventilated. In order to achieve this security against being mixed up, the receptacles of the alignment device and / or the piercing pins of the transfer part and / or protective caps for the piercing pins can have a coding. This coding can be a mechanical one, for example by lugs that engage in suitably arranged recesses. However, the coding is preferably carried out by color, in particular by the color of the protective caps, because the protective caps are separate components from the preferably one-piece transfer part, which could be produced in two different colors without additional effort. The containers can then have a corresponding color coding.

It is practical if, when the containers are separated after the transfer process has ended, the transfer part is also simultaneously pulled out of the alignment device. For this purpose, the releasable fastening of the transfer part in the alignment device and the shape, size and surface structure of the piercing mandrels are preferably designed in such a way that the force required to release the attachment of the transfer part in the alignment device is greater than that for inserting the second piercing mandrel into the closure of one of the The force required by the container is smaller than the force required to pull the first piercing mandrel out of the closure of the other of the containers. In this embodiment, the connection between the transfer part and the alignment device is not released when the transfer device is placed on the container to be filled, but when the containers are pulled apart, the first piercing mandrel of the transfer part remains in the closure of the corresponding container. If the alignment device is either held by hand or grips the closure of the other container tightly enough, the transfer part and the alignment device are separated from one another at the same time.

The transfer part and the alignment device preferably consist essentially of plastic. In particular, metal parts are preferably dispensed with. This avoids mixed waste with metal and plastic components, which can only be disposed of with great effort.

The transfer device is preferably designed in such a way that the entire transfer process can be carried out in a constant vertical position of the transfer device without liquid leaking prematurely or being contaminated. This enables a particularly reliable, safe and convenient transfer operation. In this context, the term "transfer process" refers not only to the actual overflow of liquid, but rather to the entire process, from placing the transfer device on the bottle to be filled to separating the filled bottle from the transfer device.

An embodiment of the invention will now be described in detail with reference to the drawings. They represent:

1 shows a longitudinal section through an alignment device with an inserted transfer part in a side view,

2 is a side view of the device of FIG. 1,

3 shows the side view of the transfer part,

4 shows the side view of an embodiment variant of the transfer part,

5 shows a longitudinal section through a transfer device plugged onto a container in a representation rotated counterclockwise by 90 °, and Fig. 6 and Fig. 7 shows a longitudinal section through one on two

Transfer device attached to the container, rotated 90 ° counterclockwise.

1 and FIG. 2 show a transfer device, the main components of which are an alignment device 10 and a transfer part 40.

The alignment device 10 is approximately dumbbell-shaped and consists of transparent plastic. It has a first receptacle 20 for placement on a closure 92 of a first container 90 and a second receptacle 30 for placement on a closure 102 of a second container 100. The first and the second receptacles 20 and 30 are connected to one another by a drum-shaped connecting section 12 which is set up to receive a transfer part 40 and to hold it in a releasable clamp seat. For this purpose, the connecting section 12 has a narrow guide 14 with a rectangular cross section and a wide guide 16, the latter being provided with a light bead 18 or punctiform elevations running around the inside.

The first receptacle 20 has an essentially cylindrical wall 22 with two axially incisions radially opposite one another. The ends of the axial incisions facing the connecting section 12 are widened in a T-shape. In addition, in the first receptacle 20 a latching device 24 designed as a bead and a stop 26 formed by a region of the wide guide 16 of the connecting section 12 are provided.

The second receptacle 30 has a likewise cylindrical wall 32 with a first latching device 34 and a second latching device 36, which are each designed as a bead running around the inside of the wall 32, and a stop 38 connected to the narrow guide 14 of the connecting section 12. The second latching device 36 is arranged close to an edge 37 of the second receptacle 30 facing away from the connecting section 12, and the first latching device 34 is arranged between the stop 38 and the second latching device 36, but not in the middle, but closer to the stop 38. The wall 32 of the second receptacle 30 has two radially opposite axial incisions, which are at their The ends facing the connecting section 12 are each widened in a T-shape and run towards the edge 37 in each case in a recessed area of the wall 32, which at the edge 37 occupies approximately an arc of an initial section of 90 °.

An integral transfer part 40 injection-molded from plastic has a first piercing mandrel 50, a second piercing mandrel 70, a central part 44 connecting the mandrels 50 and 70 and a continuous transfer channel 42 running through the mandrels 50 and 70 and the central part 44. The middle part 44 can be detachably fastened in the connecting section 12, an end section 46 located at the first piercing mandrel 50 being received by the wide guide 16 and an end section 48 located at the second piercing mandrel 70 being received by the narrow guide 14. The central part 44 is approximately rectangular in cross section. It is held securely in the alignment device 10 by engagement of the thickened end section 46 with the bead 18.

The two piercing pins 50 and 70 described in more detail below are covered by protective caps 80 and 82.

The transfer part 40 is shown in more detail in FIGS. 3 and 4, FIG. 4 showing an embodiment variant with a slightly modified filter 66. The first piercing mandrel 50 is traversed by a section 56 of the transfer channel 42, which opens into an opening forming an inlet 58. Furthermore, the first piercing mandrel 50 is traversed by a section 62 of a ventilation channel 60 which opens into an opening forming an outlet 64. The outlet 64 is closer to a tip 54 of the first piercing mandrel 50 than the inlet 58, with the outlet 64 and the inlet 58 being radially opposite. Starting from the tip 54, the first piercing mandrel 50 has a wall 52 which runs parallel to the axis of the first piercing mandrel 50 and forms approximately its diameter in cross section. The wall 52 extends from the tip 54 to just before the inlet 58, where it merges into an inclined, flat end surface 59. Starting from the tip 54, the first piercing mandrel 50 initially has a semicircular cross section, the straight side of which is delimited by the wall 52 and the diameter of which widens progressively until a substantially constant area in a region between the outlet 64 and the inlet 58 Cross section is maintained. In an adjoining area around the inlet 58, the cross section of the first piercing mandrel 50 increasingly approaches a full circle, in that the straight side, which initially forms the diameter of a semicircle, shifts outward in parallel. This displacement corresponds to the incline of the end face 59 arranged around the inlet 58. With the end of this end face 59 up to the beginning of the middle part 44, the cross section of the first piercing mandrel 50 is essentially circular with a slightly increasing diameter, the transfer duct 42 and the ventilation duct 60 are radially opposite.

The ventilation duct 60 has an inlet provided with an air filter 66, which is arranged in the region of the thickened end section 46 in the middle part 44.

Starting from the inlet 58 in the first piercing mandrel 50, the transfer duct 42 runs through the middle part 44 and then the second piercing mandrel 70 to an outlet 78 located near a tip 74 of the second piercing mandrel 70.

The second piercing mandrel 70 which is traversed by a section 76 of the transfer duct 42 has essentially a circular outer and inner cross section. The second piercing mandrel 70 runs out into the tip 74 at a section 72 that is fluted in the side view. 5 shows the second container 100, here a bottle, with its closure 102 in the second receptacle 30 of the alignment device 10 in a first latching position. A front area 106 of the closure 102 bears against the first latching device 34 and a rear edge 108 of the latch 102 against the second latching device 36. The second piercing mandrel 70 penetrates into a pierceable area made of rubber 104 of the closure 102, but does not penetrate it. As a result, the outlet 78 of the piercing mandrel 70 is closed in a gas-tight and liquid-tight manner.

6, the first container 90, here also a bottle, is latched with its closure 92 in the first receptacle 20 of the aligning device 10. A front area 96 of the closure 92 lies against the stop 26 of the first receptacle 20, and a rear edge 98 of the closure 92 against the latching device 2. The first piercing mandrel 50 penetrates a pierceable area 94 of the closure 92 made of rubber.

7, the closure 102 of the second container 100 is accommodated in the second receptacle 30 of the alignment device 10 in a second latching position. The front area 106 of the closure 102 lies against the stop 38 of the second receptacle 30, and the first latching device 34 rests under tension on a side surface 109 of the closure 102. The second piercing mandrel 70 penetrates the pierceable area of the closure 102.

In order to carry out the transfer process, the transfer part 40 is first removed from a sterile packaging and inserted into the alignment device 10, in which it engages. It is also possible to use a transfer device which has been preassembled by the manufacturer and in which the transfer part 40 has already been inserted into the alignment device 10. The cover cap 82 is removed from the second piercing mandrel 70, and likewise a protective cover from the pierceable area 104 of the closure 102 of the second container 100. device placed in the first locking position shown in FIG. 5 on the second container 100. The second container 100 stands upright, for example on a table top, and the transfer device is arranged vertically on the closure 102 of the second container 100, so that the central axes of the transfer device and the second container 100 coincide. To reach the first latching position, a certain force has to be applied in order to push apart regions of the wall 32 which are separated by the T-shaped incisions, so that an edge located between the front region 106 and the side surface 109 of the closure 102 of the second container 100 and the side surface 109 can pass the second latching device 36 of the second receptacle 30. The second piercing mandrel 70 is now in a position in which it penetrates the pierceable area 104 of the closure 102, but does not penetrate it. Due to the fact that the rubber material of the pierceable area 104 bears against the outlet 78 of the second piercing mandrel 70, the outlet 78 is securely closed in the first latching position. The second container 100 also remains tightly closed, so that the negative pressure existing in it is maintained. The releasable fastening of the transfer part 40 in the alignment device 10 is designed such that the transfer part 40 remains securely fixed even when the second piercing mandrel 70 is inserted into the closure 102 of the second container 100.

The next steps are to remove the cover cap 80 from the first piercing mandrel 50 and a protective cover from the pierceable area 94 of the closure 92 of the first container 90. Without changing the spatial position of the transfer device or the second container 102, the closure 92 of the first container 90 is inserted into the in FIG. 6 shown locking position brought in the first receptacle 20, the first piercing mandrel 50 piercing the closure 92. The container 90, which is originally under vacuum, is ventilated via the ventilation channel 60 provided with the filter 66 as soon as the outlet 64 has penetrated the closure 92 of the first container 90. The outlet 78 of the Transfer channel 42 is closed by the pierceable area of the closure 102, so that unfiltered ambient air cannot enter the first container 90 through the transfer channel 42, nor can liquid escape from the first container 90. The unit from the two containers 90 and 100 is still upright.

The closure 102 of the second container 100 is now brought into its second latching position in the second receptacle 30, as shown in FIG. 7. For this purpose, a greater force must be applied than is required to lock the closure 102 into the first locking position and to lock the closure 92 into its (only) locking position, because the areas of the wall 32 separated by the T-shaped incisions must be be pushed further apart so that the edge between the front area 106 and the side surface 109 of the closure 102 of the second container 100 can pass the first latching device 34 of the second receptacle 30. In its second latching position, the closure 102 of the container 100 is held on the side surface 109 by the first latching device 34, which is under tension; so it does not engage in the strict sense. Nevertheless, this position is referred to as the (second) rest position.

When the position shown in FIG. 7 is reached, the liquid is drawn from the first container 90 into the second container 100 by the negative pressure in the second container 100. The liquid flows in the direction of the arrow shown in FIG. 7 through the inlet 58, the transfer duct 42 and the outlet 78 into the second container 100, where it mixes with the liquid already contained therein. The vacuum created by the removal of liquid in the first container 90 is compensated for by filtered ambient air which flows through the filter 66, the ventilation duct 60 and the outlet 64 into the first container 90.

As soon as the overflow of the liquid has ended, that is to say the first container 90 has been emptied, one is possibly still in the residual vacuum located in the second container 100 through the transfer duct 40, the ventilation duct 60 and the filter 66, which is designed as a glass fiber filter system with a very low filter resistance, reduced to a negligibly small remainder. The now filled second container 100 is separated from the transfer device. The pierceable area 104 of the closure 102 closes again after the second piercing mandrel 70 has been pulled out. Since there is only a negligibly low negative pressure in the second container 100 due to the low filter resistance of the filter 66, penetration occurs airtight during the time that the pierceable area 104 of the closure 102 needs after the second piercing mandrel 70 has been pulled out to close, practically no unfiltered (and thus possibly non-sterile) ambient air through the closure 102 into the second container 100. The now mixed liquid is kept in the second container 100 until it is soon used.

To separate the containers 90 and 100, the user grips the alignment device 10 with one hand and the second container 100 with the other hand and pulls them apart in the direction of their common axis. As a result, the alignment device 10 is separated from the second container 100. The user then pulls the alignment device 10 off the first container 90. The releasable attachment of the transfer part 40 in the aligning device 10 is designed such that the transfer part 40 is pulled out of the aligning device 10 by the force exerted by the closure 92 of the first container 90 on the first piercing mandrel 50. The transfer part 40 therefore remains stuck in the closure 92 and can be disposed of together with the first container 90 or separately therefrom. The alignment device 10 can be reused for further transfer operations after appropriate cleaning and / or disinfection. Since the alignment device 10 does not come into direct contact with the medical fluids, it does not need to be sterilized.

Claims

claims

1. Transfer device for contamination-free transfer of liquids between two containers (90, 100), each having a closure (92, 102) with

- An alignment device (10) which has two receptacles (20, 30) for placement on the closure (92, 102) each one of the containers (90, 100), and

- A transfer part (40) having a transfer channel (42), wherein

- The transfer part (40) in the alignment device (10) can be detachably fastened, characterized in that the transfer part (40) can be separated from the container (100) into which the transfer takes place.

2. Transfer device according to claim 1, characterized in that a first piercing mandrel (50) of the transfer part (40) contains both a section (56) of the transfer channel (42) and a section (62) of a ventilation channel (60).

3. Transfer device according to claim 2, characterized in that the first piercing mandrel (50) has a tip (54), an outlet (64) of the ventilation channel (60) and, further away from the tip (54), an inlet (58) of the Transfer cable (42).

4. Transfer device according to claim 2 or 3, characterized in that the first piercing mandrel (50) has an axial wall (52) between the outlet (64) of the ventilation channel (60) and the inlet (58) of the transfer channel (42).

5. Transfer device according to one of claims 2 to 4, characterized in that the transfer part (40) has an air filter (66) and / or a valve as the inlet of the ventilation channel (60).

6. Transfer device according to one of claims 1 to 5, characterized in that means for releasably attaching the transfer part (40) in the aligning device (10) are provided which provide a non-interchangeable arrangement of transfer part (40) and aligning device (10 ) to ensure.

7. Transfer device according to one of claims 1 to 6, characterized in that at least one of the receptacles (20, 30) is equipped with latching devices (24, 34, 36) which engage one of the containers in engagement with the closure (92, 102) (90, 100) can be brought.

8. Transfer device according to claim 7, characterized in that at least one of the receptacles (30) is set up to receive the closure (102) of one of the containers (100) in a detent position in which the receptacle (30) assigned to this receptacle (70) projects into the closure (102) of this container (100), but does not penetrate it.

9. transfer device according to claim 8, characterized in that the second piercing mandrel (70) assigned receptacle (30) is set up to receive the closure (102) of one of the containers (100) in a latching position in which one at the second piercing mandrel (70) arranged outlet (78) of the transfer duct (42) is sealed by the closure (102) of this container (100).

10. Transfer device according to one of claims 7 to 9, characterized in that at least one of the receptacles (30) is set up to receive the closure (102) of one of the containers (100) in two different latching positions.

11. Transfer device according to one of claims 1 to 10, characterized in that the receptacles (20, 30) of the aligning device (10) and / or the piercing pins (50, 70) of the transfer part (40) and / or protective caps (80, 82) for the piercing mandrels (50, 70) have a coding, in particular by means of color, which ensures that the transfer device is placed on the containers (90, 100) in a manner that is not interchangeable.

12. Transfer device according to one of claims 1 to 11, characterized in that the force required for releasing the fastening of the transfer part (40) in the alignment device (10) is greater than that for inserting the second piercing mandrel (70) into the closure (102) one of the containers (100) requires force, but less than the force required to pull the first piercing mandrel (50) out of the closure (92) of the other of the containers (90).

13. Transfer device according to one of claims 1 to 12, characterized in that the transfer part (40) and the alignment device (10) consist essentially of plastic hen.

14. Transfer device according to one of claims 1 to 13, characterized in that the entire transfer process can be carried out in a constant vertical position of the transfer device.