EP2446875B1 - Mixing device and method for reconstructing or mixing a medicinal liquid - Google Patents

Description

The invention relates to a mixing device for reconstructing or mixing a medical fluid composed of at least two components according to the preamble of claim 1 and to a method for reconstructing or mixing a medical fluid composed of at least two components.

Such a mixing device has a first connection for connecting a first container containing a first component, and a second connection for connecting a second component containing a second container. Via the terminals, the mixing or reconstructing components contained in the first and second containers may be supplied to each other, wherein closing means are provided for selectively closing or opening at least one of the terminals via which this feeding of the components can be controlled.

The medicinal liquid to be mixed or reconstructed via the mixing device can be a liquid-form medicament or another liquid, for example a dietary supplement. For example, the medical fluid may consist of at least two in advance components which are separately present in liquid form, ie are mixed, or the medicinal liquid is for example more of a component which is present in a lyophilized (freeze-dried) form as a powder by adding a further component which is present as a solvent in liquid form and for dissolving it lyophilized component is prepared. The latter is called reconstructing.

Medicines are nowadays typically provided in a hospital environment in so-called vials, in which the medicaments are stored in a sterile manner. A vial is hereby closed via a sterile closure cap, which is typically pierced by a cannula for administration to withdraw the drug present in the vial and administer it to a patient. Because of the steps required from taking the drug from the vial to administering the drug to a patient, there is a fundamental risk of contamination of the drug, which can be dangerous to a patient and, in the worst case, even lead to death of the patient.

In addition, if the drug is in lyophilized or concentrated form prior to administration, it is necessary to add a reconstructing or diluting solution to the drug to obtain a drug solution that can be administered to the patient. The requisite mixing or reconstruction steps further increase the risk of contamination.

From the WO 2009/038887 A1 For example, a mixing device for reconstructing or mixing a medical fluid is known in which a container in the form of a vial is connected via a connection arrangement to another container in the form of a flexible bag. In the vial, a drug component may be provided as a liquid, gel, or powder (in, for example, lyophilized form) which may be merged via the portarial only with a solution in the further container for mixing or reconstituting a medicinal fluid in the form of a medicament. Via a removal device, the medical liquid produced can be removed from the further container in the form of the flexible bag in order to be administered to a patient.

The mixing device of WO 2009/038887 A1 1 is relatively complicated in structure and also limited to the merging of two components. If a made of two components medical solution, for example, a Saline solution for administration to a patient may be added, this is with the device of WO 2009/038887 A1 not readily possible and requires further mixing operations.

The documents EP 1 997 471 A1 . WO 2008/081424 A2 and US 5,911,252 A each show a mixing device for reconstructing or mixing a medical fluid composed of two components.

The object of the present invention is to provide a mixing device and a method for reconstructing or mixing a medical fluid composed of at least two components with which the reconstructing or mixing operation of the two components for producing the medical fluid within a closed, sterile system using a simply constructed, easy to use and inexpensive to produce mixing device can be performed.

This object is achieved by an article having the features of claims 1 and 8.

Thus, in a mixing device, a third port is provided for connecting a conveying means for conveying at least one of the first and second components and a fourth port for connecting a third container for receiving a medical fluid reconstituted or mixed from the first component and the second component.

The present invention is based on the idea of providing a mixing device in which a plurality of different containers with different components of a medical fluid to be produced can be connected to a plurality of different ports. At a first connection of the mixing device in this case is a first container with a first component of the medical liquid to be produced, to a second connection a second container with a second component of the medical fluid to be produced and to a third connection a third container for receiving the completely reconstructed or mixed connected to medical fluid. For controlling the reconstruction or mixing operation, closure means are provided, over which one or more of the connections are selectively opened or closed For example, in order to supply the components contained in the first container and the second container for reconstructing or mixing the medical liquid to one another. In order to initiate the reconstruction or mixing process in this case and drive, a conveying means is also provided, which serves to promote the first and / or the second component of the first and / or the second container to supply the components to each other and the to deliver medical liquid prepared in this way to the third container.

In the third container, for example, a further solution, for example a saline solution, may be arranged in advance, to which the medicinal liquid produced from the components is added in order to be administered to a patient together with the solution.

The first port and the second port of the mixing device may each be connected to a line of the mixing device, which connects the third port and the fourth port in the manner of a (rigid) pipe or (flexible) hose. The connection of the first terminal and the second terminal to the line can be made in each case at a connection point, which is designed in the manner of a T-piece.

The Verschlussmlttel be in this case advantageously designed as a multi-way valves, wherein a first multi-way valve at the junction between the first port and the conduit and a second multiway valve is disposed at the junction between the second port and the conduit.

• in einer ersten Stellung die zugeordnete Verbindungsstelle verschlossen ist,
• in einer zweiten Stellung die zugeordnete Verbindungsstelle für einen Durchfluss von dem jeweils zugeordneten ersten oder zweiten Anschluss über die Leitung hin zu dem dritten Anschluss geöffnet ist und
• in einer dritten Stellung die zugeordnete Verbindungsstelle für einen Durchfluss durch die Leitung zwischen dem dritten und dem vierten Anschluss geöffnet ist.

The multi-way taps are used to selectively close or open the first and / or the second port to promote the first component via the first port from the first container and / or the second component via the second port from the second container and the components for mixing or reconstructing each other. Each multi-way valve can take several positions, where

• in a first position, the associated connection point is closed,
• in a second position, the associated connection point for a flow is opened from the respectively assigned first or second connection via the line to the third connection, and
• in a third position, the associated connection point is open for flow through the conduit between the third and fourth ports.

By means of the closure means forming multi-way valves thus the reconstruction or mixing process is controlled, wherein using the conveyor, which may for example be designed as a medical syringe and is connected to the third port of the mixing device, in a suitable position of each multiway cock the first component via the first port from the first container and / or the second component via the second port from the first second container can be sucked or pushed back into a container to supply the two components for the purpose of reconstruction or mixing each other and to obtain the medical fluid.

The multi-way valves can be designed in particular as three-way valves with three different positions.

A concrete procedure of a method for reconstructing or mixing a medical fluid using such a mixing device described here will be explained later.

The first container and the second container are advantageously each configured as a vial and connected via a thorn-end cap to the first port or the second port of the mixing device to mix the components of the medical fluid contained therein or the one, for example, in lyophilized Reconstruct form present component using the other, for example, a suitable solvent-forming component.

In order to secure the connection of the first container to the first terminal and / or the second container to the second terminal in each case via a connection cap, a retaining ring is additionally provided which, when the container is connected, to the connection cap for securing the connection between the container and the connection cap is set. This can be achieved, for example, in that the connection cap engages around an associated container arranged thereon with suitable latching elements and thereby holds positively and the securing ring is pushed over these latching elements of the connection cap in order to prevent the latching elements from disengaging from the associated one Container can reach.

The retaining ring can be part of the connection cap. The circlip is in this case not loose and separated from the connection cap before, but is already mounted in a parking position in which he is not yet secured to the locking elements of the connection cap on the connection cap to then pushed from this parking position in its safety position to be, in which he surrounds the locking elements of the connection cap locking.

The connection cap can be firmly and non-detachably connected to the first connection or the second connection, and the delivery device can also be permanently and non-detachably connected to the associated third connection. In this way, the connection cap and the conveyor are already preassembled and part of the mixing device, which can be delivered with attached connection cap and attached conveyor (for example in the form of a medical tip).

The third container, which is designed to receive the medical fluid mixed or reconstituted from the first component and the second component, can advantageously be designed as a flexible bag, wherein a flexible fluid, for example a saline solution or the like, may already be contained in this flexible bag can be fed to which the medicinal liquid produced from the two components of the first and second container.

Advantageously, the mixing device is configured, with connected containers and with attached funding (for example in the form of a medical syringe) form a closed, against contamination from the outside, sterile system. This is based on the idea of using the mixing device to carry out the reconstruction or mixing of the medical liquid to be produced in a system that no longer needs to be accessed after the connection of the individual containers and after the connection of the conveyor in a risk of contamination-related manner. The reconstructing or mixing by bringing together the components of the medicinal liquid contained in the individual containers is thus controlled from the outside; however, the components conveyed in the mixing device do not come into contact with the external environment and flow completely within the closed system of the mixing device. At the end of the reconstructing or blending operation, the manufactured medicinal liquid is contained in the third container and can be withdrawn from this third container for administration to a patient via a suitable retrieval device.

The reconstitution or mixing of the medicinal liquid can be carried out using the mixing device, for example in the context of a hospital or other medical care facility, in a pharmacy in which the containers and the conveying means are connected to the mixing device and the mixing device for mixing or Reconstructing the medical fluid is actuated. With the reconstituted or mixed medical fluid, the system, so the mixing device with it connected containers and attached conveyor, then delivered and brought to the place where the medical fluid is to be administered to a patient.

Alternatively, it is also possible, although already in a pharmacy to connect the container and the funding to the mixing device and so to create the closed system, however, perform the actual reconstruction or mixing process only at the point of administration to a patient, the system so initially not to deliver unreconstructed or mixed components.

In order to facilitate the delivery of the closed system formed from the mixing device and the connected containers and the connected conveyor and to prevent misuse due to improper handling during transport, securing elements are provided on one or more of the closure means in the form of multiway taps be attached to the respective closure means and lock an actuation of the closure means. If the medical liquid has already been prepared prior to delivery and has already been conveyed into the third container, it can be prevented by such a securing element that a closure means, for example in the form of a multi-way stopcock, is operated during transport in such a way that the medicinal liquid produced therefrom is made from this third container can flow out again. If the medical fluid is to be prepared by reconstruction or mixing only after delivery to the place of administration of the drug, then one or more securing elements on the closure means, for example in the form of the multi-way valves, may prevent it from being in contact due to improper handling during transport can come between the components contained in the containers.

The securing element can, for example, embrace an associated multi-way valve in a form-fitting manner, so as to prevent the multi-way valve from being rotated from its currently set position (for example the closed position). To then, for example, for the purpose of reconstructing or mixing to operate the respective multi-way stopcock, the fuse element can be removed, for example, be broken off in a destructive manner, so that the multi-way valve can be actuated.

The mixing device has been previously described with reference to a medical fluid to be prepared which is composed of two components and made up of this is reconstructed or mixed. It is also conceivable to provide two or even more components for producing a medical fluid which are to be supplied to one another for the purpose of reconstruction or mixing. For this purpose, further connections for connecting one or more further containers to be mixed or reconstructed components of a medical fluid can be connected to the mixing device, which in turn are each connected to the line of the mixing device via a T-shaped junction and each of which a multi-way cock is assigned to control the conveyance of the component from the respective container or in the respective container and drive.

• einen ersten Anschluss zum Anschließen eines eine erste Komponente enthaltenden, ersten Containers,
• einen zweiten Anschluss zum Anschließen eines Fördermittels zum Fördern der ersten Komponente,
• einen dritten Anschluss zum Anschließen eines zweiten Containers zum Aufnehmen der ersten Komponente und
• Verschlussmittel zum wahlweisen Verschieden oder Öffnen zumindest eines der Anschlüsse,

wobei mit dem ersten Anschluss eine einen Dorn aufweisende Anschlusskappe zum Anschließen einer den ersten Container ausbildenden Viole und mit dem zweiten Anschluss ein Fördermittel unlösbar verbunden sind.A particularly simply constructed mixing device for reconstructing or mixing a medical fluid composed of at least two components

• a first port for connecting a first container containing a first component,
• a second port for connecting a conveying means for conveying the first component,
• a third terminal for connecting a second container for receiving the first component and
• Closure means for selectively differentiating or opening at least one of the connections,

wherein with the first connection, a mandrel-having connection cap for connecting a Viole forming the first container and a conveying means are permanently connected to the second connection.

There is thus provided a mixing device with three connections, in which two terminals each have a container and to a further connection a conveying means e.g. are connected in the form of a medical syringe. The conveyor is firmly and permanently connected to the associated port. In addition, an adapter in the form of a connection cap with a mandrel for connecting a container in the form of a vial is fixedly and permanently connected to the first connection.

This mixing device is particularly simple in construction, but also allows only a mixture of a maximum of two components for producing a medical fluid, wherein the second component is contained in the second container and the first component from the first container is added via the conveyor. The fact that the connection cap and the conveyor firmly to each associated connections are connected, a closed system can be provided, which in particular can not be opened by disassembly of the conveyor or a connection cap and thereby optionally made available for contamination.

• wird an einen ersten Anschluss einer Mischvorrichtung ein eine erste Komponente enthaltender, erster Container angeschlossen,
• wird an einen zweiten Anschluss der Mischvorrichtung ein eine zweite Komponente enthaltender, zweiter Container angeschlossen und
• werden Verschlussrriittel der Mischvorrichtung zum wahlweisen Verschließen oder Öffnen zumindest eines der Anschlüsse betätigt.

The object is further achieved by a method for reconstructing or mixing a medical fluid composed of at least two components. In this process

• a first container containing a first component is connected to a first connection of a mixing device,
• is connected to a second terminal of the mixing device containing a second component, second container and
• closing means of the mixing device are actuated to selectively close or open at least one of the connections.

• an einen dritten Anschluss der Mischvorrichtung ein Fördermittel zum Fördern einer von erster und zweiter Komponente angeschlossen wird und
• an einen vierten Anschluss der Mischvorrichtung ein dritter Container zum Aufnehmen einer aus der ersten Komponente und der zweiten Komponente rekonstruierten oder gemischten medizinischen Flüssigkeit angeschlossen wird.

It is envisaged that

• to a third port of the mixing device, a conveyor for conveying one of the first and second components is connected and
• a third container for receiving a medical fluid reconstituted or mixed from the first component and the second component is connected to a fourth port of the mixing device.

This method, which is advantageously carried out using the mixing device described above, serves to mix or reconstruct a medical fluid from at least two components in the context of a closed, sterile system, by means of which impurities can be avoided as far as possible during the reconstruction or mixing.

For example, the first component contained in the first container can be formed by a solution and the second component contained in the second container can be formed by a drug component in a lyophilized, ie freeze-dried form. These components are supplied to each other in the context of the method for the purpose of the reconstruction of the medical fluid, wherein the second, present in lyophilized form drug component is converted by supplying the first, a liquid solution representing component in a liquid form.

Of course, the components may in principle also be present in other forms, for example in the form of a liquid, a gel or a powder.

In a specific method for mixing or reconstructing the medicinal liquid, in a first step, by actuating the closure means (for example in the form of multi-way taps) and the conveying means (for example in the form of a medical syringe) of the mixing device, the first component from the first container in the subsidy sucked. For this purpose, for example, the multi-way valve assigned to the first connection is brought into such a position (second position, see above) that the component present in liquid form in the first container can flow from the container into the conveying means. If the conveyor is designed as a medical syringe, for this purpose, the syringe is raised (by actuation of a suitable piston), so as to suck the component from the first container into the syringe.

In a second step, by actuating the closure means and the conveying means of the mixing device, the first component is conveyed from the conveying means into the second container in order to mix or reconstruct the second component contained in the second container with the first component and to obtain the medical fluid , In this way, the first component of the second component sucked from the first container into the conveyor is fed into the second container, whereby, for example by shaking the second container, a suitable mixture of the components or a reconstruction of the second component contained in the second container by means of the first Component can be done.

In a third step, the mixed or reconstituted medicinal liquid from the second container is in turn sucked into the conveying means, for example by raising the medical syringe, and then in a fourth step, after actuation of the closing means for a flow from the conveying means to the third container ( third position of the closure means, see above), to transfer the mixed or reconstituted medicinal liquid from the delivery means into the third container. The closure means are then closed to close the conduit and ports (first position of the obturating means, see above) so that the mixed or reconstituted medicinal liquid is contained in the third container and can not flow out of the third container via the conduit.

As already mentioned above with regard to the mixing device, one or more securing elements are provided for locking the closure means. The one or more securing elements can be attached to the respective associated closure means either before mixing or reconstructing the medical fluid or after mixing or reconstructing the medical fluid, in order to block actuation of the closure means.

In the first instance, the closed system assembly comprising unmixed components formed by the mixing device and associated containers and attached conveyor may be delivered to remove the one or more securing elements and the components for mixing only at the point of administration of the medical fluid or reconstructing each other.

In the second case, the system is delivered with already mixed or reconstituted medical fluid, in which case the one or more securing elements serve to cause the already mixed or reconstructed medical fluid to rise from the third container as a result of improper handling of the mixing device to prevent transport.

The mixing device described above and the method described above can be used in a variety of ways in the medical field. For example, so-called cytostatic drugs can be mixed or reconstructed using the mixing device and provided for administration. It is also conceivable, however, to use the mixing device for mixing or reconstructing completely other medicaments or liquids, for example also dietary supplements such as vitamin solutions or the like, which in the present case should also be subsumed under the term medical fluid.

Fig. 1

eine Übersichtsdarstellung einer Mischvorrichtung mit daran anzuschließenden Bauteilen;

Fig. 2

eine Detailansicht der Mischvorrichtung;

Fig. 3

eine Ansicht der Mischvorrichtung mit daran angeschlossenen Containern und daran angeschlossenem Fördermittel;

Fig. 4

eine Ansicht der Mischvorrichtung zu Beginn eines Mischvorgangs;

Fig. 5

eine Ansicht der Mischvorrichtung beim Einsaugen einer in einem ersten Container enthaltenen ersten Komponente einer medizinischen Flüssigkeit in ein Fördermittel in Form einer Spritze;

Fig. 6

eine Ansicht der Mischvorrichtung mit in das Fördermittel eingesogener erster Komponente;

Fig. 7

eine Ansicht der Mischvorrichtung beim Fördern der ersten Komponente aus dem Fördermittel in einen zweiten Container zum Zusammenführen der ersten Komponente mit einer in dem zweiten Container enthaltenen zweiten Komponente;

Fig. 8

eine Ansicht der Mischvorrichtung mit in dem zweiten Container zusammengeführter erster und zweiter Komponente;

Fig. 9

eine Ansicht der Mischvorrichtung beim Einsaugen der durch Zusammenführen der Komponenten hergestellten medizinischen Flüssigkeit aus dem zweiten Container in das Fördermittel;

Fig. 10

eine Ansicht der Mischvorrichtung mit teilsweise in das Fördermittel eingesogener medizinischer Flüssigkeit;

Fig. 11

eine Ansicht der Mischvorrichtung beim Zuführen der hergestellten medizinischen Flüssigkeit in einen an die Mischvorrichtung angeschlossenen dritten Container in Form eines flexiblen Beutels;

Fig. 12

eine Ansicht der Mischvorrichtung mit in den dritten Container geförderter medizinischer Flüssigkeit;

Fig. 13

eine Detailansicht der Mischvorrichtung mit einem daran angesetzten Sicherungselement zum Sperren eines Verschlussmittels und

Fig. 14

eine Ansicht der Mischvorrichtung gemäß Fig. 13 aus anderer Perspektive.

The idea underlying the invention will be explained in more detail with reference to the embodiments illustrated in the figures. Show it:

Fig. 1

an overview of a mixing device with it to be connected components;

Fig. 2

a detailed view of the mixing device;

Fig. 3

a view of the mixing device with attached containers and attached funding;

Fig. 4

a view of the mixing device at the beginning of a mixing process;

Fig. 5

a view of the mixing device when sucking a first component of a medical fluid contained in a first container in a conveying means in the form of a syringe;

Fig. 6

a view of the mixing device with sucked into the conveyor first component;

Fig. 7

a view of the mixing device when conveying the first component from the conveying means in a second container for merging the first component with a second component contained in the second container;

Fig. 8

a view of the mixing device with merged in the second container first and second components;

Fig. 9

a view of the mixing device when sucking the medical fluid produced by combining the components of the second container in the conveying means;

Fig. 10

a view of the mixing device with partially absorbed in the conveyor medical fluid;

Fig. 11

a view of the mixing device in supplying the prepared medical liquid in a third container connected to the mixing device in the form of a flexible bag;

Fig. 12

a view of the mixing device with conveyed in the third container medical fluid;

Fig. 13

a detailed view of the mixing device with a fuse element attached thereto for locking a closure means and

Fig. 14

a view of the mixing device according to Fig. 13 from a different perspective.

Fig. 1 shows in an overview view of a mixing device 1, which is used for reconstructing or mixing a medical liquid from different, optionally present in different form components.

The components of the medical fluid are in an initial state in two containers 4, 5 in the form of violas to be supplied to each other and thereby mixed or reconstructed and fed in a mixed or reconstructed state a third container 3 in the form of a flexible bag, in turn for example, may contain a saline solution. The medical fluid is then optionally taken together with the saline from the third container 3 and administered to a patient.

The mixing device 1 is designed as a plastic part, is manually handled in a lighter, more intuitive manner and has a handle 10, via which a user can grasp the mixing device 1.

The mixing device 1 has a pipe 16 in the manner of a pipe and a total of five connected to the line 16 connections 11, 12, 13, 14, 15, to which a first container 5, a second container 4, a conveyor 2 in the form of a medical Syringe and the third container 3 can be connected. Fig. 3 shows the mixing device 1 with connected containers 3, 4, 5 and connected conveyor. 2

The containers 4, 5, which contain the components of the medical fluid to be mixed or reconstructed and are each closed by a closure cap 41, 51, are connected to the connections 12, 13 of the mixing device 1. In this case, the first container 5, which contains, for example, a solution present in liquid form, to a first terminal 12 and the second container 4, for example, contains a present in powder form, lyophilized drug component, connected to a second terminal 13 of the mixing device 1.

For connection to the respective connection 12, 13, a connection cap 6 with an inner mandrel is respectively provided which engages positively with locking elements 61 the closure cap 41, 51 of the associated container 4, 5 and holds the container 4, 5 via the latching elements 61. The connection cap 6 is attached to one of the connections 12, 13 and thus provides the connection of the container 4, 5 with the respective terminal 12, 13 forth, wherein the connection between the terminal cap 6 and the terminal 12, 13 is advantageously designed as a Luer lock.

In order to secure the connection between the terminal cap 6 and the respective associated container 4, 5, as in Fig. 2 shown, a locking ring 7 is provided, which is pushed at the plugged onto the container 4, 5 connection cap 6 via the connection cap 6, so that the locking elements 61 in the radial direction do not dodge outward and thus can get out of farm with the container 4, 5. By means of the securing ring 7, the connection of the connection cap 6 with the associated container 4, 5 is secured, so that the container 4, 5 is positively held on the connection cap 6 and not readily, at least not without removing the securing ring 7, of the connection cap. 6 can be removed.

The conveying means 2 in the form of the syringe is connected to a third connection 11 of the mixing device 1, as in FIG Fig. 2 and 3 shown. The conveying means 2 in the form of the syringe has a hollow cylinder body 20 and a piston 22 which is movable in the cylinder body 20 and can be connected to the connection 11 of the mixing device 1 via a connection 21. The connections 11, 21 of the mixing device 1 or of the conveying means 2 can likewise form a luer lock for securely connecting the conveying means 2 to the mixing device 1.

The syringe realizing the conveying means 2 is advantageously designed so that the piston 22 is not completely in a pulling direction Z (see Fig. 5 ) can be pulled out of the cylinder body 20 and removed from the cylinder body 20. For this purpose, for example, on the terminal 21 remote from the end of the cylinder body 20 plugged clip can be used, which cooperates with the piston 22 so that the displacement of the piston 22 in the cylinder body 20 is limited and the piston 22 in particular not fully extended from the cylinder body 20 can be. In this way, it is prevented that the conveying means 2 can be opened by pulling out the piston 22 and thus possibly impurities can get into the mixing device 1.

The third container 3 is connected via a connection 31 to a fourth connection 15 of the mixing device 1. For this purpose, the container 3 designed as a flexible bag is brought into engagement with its connection 31 with the fourth connection 15 of the mixing device 1, the connection 31 being designed as a connection (port) without a mandrel.

The third container 3 in the form of the flexible bag has a further connection 32, via which a liquid can be removed from the container 3 by means of a suitable removal device, for example an infusion set.

In the in Fig. 3 illustrated state in which the containers 3, 4, 5 and the conveyor 2 are connected in the form of the medical syringe to the mixing device 1, the arrangement consisting of the mixing device 1, the containers 3, 4, 5 and the conveyor 2 is a closed System in which the containers 3, 4, 5 and the conveyor 2 via line 16 with line sections 161, 162, 163, 164 and the terminals 11, 12, 13, 14, 15 are in fluid communication with each other. The terminals 12, 13, 14 open at junctions 120, 130, 140 in the manner of T-pieces in the line 16, wherein at each connection point 120, 130, 140, a closure means in the form of a multiway tap 121, 131, 141 is provided to control a fluid exchange via the ports 11, 12, 13, 14, 15 between the containers 3, 4, 5 and the conveyor 2.

The fact that the mixing device 1 with connected containers 3, 4, 5 and connected conveyor 2 provides a closed system that is without direct flow connection to the outside, so that a fluid or any impurities from the outside can not get into the system, the possibility becomes created to bring the components in the containers 3, 4, 5 to each other, to mix with each other or to reconstruct from each other without the mixing or reconstruction process there is a risk of contamination of the medical liquid produced.

How out Fig. 3 can be seen, a terminal 14 is provided, which is free in the illustrated embodiment, that is connected to the no container. A further container with another component of a medical fluid can be connected to this further port 14 in order, for example, if desired, to mix or reconstruct a medical fluid of three components that are originally present in three different containers. (If there is also a component in the third container 3 -for example a saline solution-a medical fluid mixed or reconstructed from four components would be obtained in this case, which is present in the third container 3 after mixing or reconstruction and removed therefrom can be.)

The closure means in the form of multi-way valves 121, 131, 141 of the mixing device 1 can each occupy several different positions, by means of which a fluid exchange between the containers can be controlled and the flow through the line is adjusted.

In a first position, the respective multi-way valve 121, 131, 141 closes the associated connection point 120, 130, 140 between the respectively assigned connection 12, 13, 14 and the line 16 such that neither a flow through the connection 12, 13 , 14 is still a flow through the conduit 16 at this connection point 120, 130, 140 is possible. A fluid exchange via the respective connection point 120, 130, 140 is thus not possible.

In the in Fig. 2 state shown are the multi-way valves 121st 131, 141 respectively in this first position.

In a second position of the multi-way valve 121, 131, 141 is opened so that a flow from the respective associated port 12, 13, 14 via the line 16 to the conveyor 2 is possible. The respectively assigned connection 12, 13, 14 is thus opened on one side such that a fluid exchange with the line section 161, 162, 163 adjoining the connection point 120, 130, 140 in the direction of the conveying means 2 is possible via the connection 12, 13, 14 ,

Fig. 4 shows, for example, the multi-way valve 121 in this second position, in which via the port 12, a fluid exchange with the line section 161 (see Fig. 2 ) possible, so that the first component located in the first component 5 can flow towards the conveyor 2.

In a third position, in turn, the respectively assigned connection point 120, 130, 140 is open for a passage through the line 16, but not towards the respective associated connection 12, 13, 14. Thus, a fluid exchange between the connections 120, 130 , 140 subsequent line sections 161, 162, 163, 164 take place, but not a fluid exchange with the respectively associated connection 12, 13, 14.

Fig. 7 shows, for example, the multi-way valve 121 in this third position.

Show a process for mixing or reconstructing a medical fluid using the mixing device 1 4 to 12 , This is assumed by the in Fig. 3 illustrated state in which the containers 3, 4, 5 and the conveyor 2 are connected in the form of the medical syringe to the mixing device 1 and thus a closed system has been formed. The merging of the located in the Containem 4. 5 components for the purpose of mixing or reconstructing a medical fluid is now carried out by actuation of the closure means in the form of multi-way valves 121, 131, 141 and the conveyor 2, wherein by operating the multi-way faucets 121st , 131, 141 controls the mixing or reconstruction process and is driven by actuating the conveying means 2.

In a first step, presented in Fig. 4 and 5 , the multi-way valve 121 associated with the first port 12 is brought into its second position, so that a fluid exchange between the first container 5 and the conveying means 2 via the first port 12 and the line section 161 of the mixing device 1 is possible. As in Fig. 5 shown, is located in this second position multi-way stopcock 121 of the piston 22 of the conveyor 2 in a pulling direction Z, so that a present in the first container 5, for example in the form of a solution liquid is sucked into the conveyor 2.

Now, first, the multi-way valve 121 of the first port 12 is closed ( Fig. 6 ) and then brought into its third position, so that although the first port 12 is closed, but a flow through the conduit 16 in the region of the first connection point 120 is possible ( Fig. 7 ). At the same time, as in Fig. 7 shown, the multi-way valve 131, which is assigned to the second terminal 13, brought into its second position, so that by pressing the piston 22 of the conveyor 2 in a printing direction P located in the conveyor 2, taken from the first container 5 first Component in the flow direction F according to Fig. 7 can be promoted via the line sections 161, 162 and the second terminal 13 in the second container 4.

Fig. 8 shows the arrangement with inserted piston 22 and in the second container 4 funded first component. After completion of the operation of the conveyor 2, ie with inserted piston 22, the second port 13 associated multi-way valve 131 is closed and shaken the second container 4, for example, present in powder form, lyophilized second component of the second container 4 by means of to reconstruct a suitable solution-providing first component of the first container 5. (Of course, the components of the container 4, 5 in other forms, for example, each as Liquid, present and mixed by merging in the second container 4.)

After shaking the multi-way valve 131 associated with the second port 13 is again brought into its second position and thus for a flow in the in Fig. 9 illustrated flow direction F towards the conveyor 2 open. By renewed extraction of the piston 22, the medical liquid contained in the second container 4 and composed of the components of the first container 5 and of the second container 4 is sucked into the conveying means 2.

After the desired amount of medical fluid has been removed from the second container 4, the multi-way valve 131 associated with the second port 13 is closed, shown in FIG Fig. 10 to then bring all multi-way valves 121, 131, 141 each in their third position and thus a flow in the flow direction F according to Fig. 11 to allow through the line 16 from the conveyor 2 towards the third container 3.

By inserting the piston 22 in the printing direction P according to Fig. 11 Then, the fluid contained in the conveyor 2 in the form of the mixed or reconstructed medical fluid is conveyed through the conduit 16 into the third container 3, whereupon the multi-way valves 121, 131, 141, as in Fig. 12 are shown again in their first, closed position to prevent further fluid exchange.

In the in Fig. 12 Thus, the mixed or reconstructed medical fluid is thus in the third container 3, wherein in the third container 3 may have previously been contained a further liquid, such as saline, which from the components of the first container 5 and the second Containers 4 mixed or reconstituted medicinal liquid has been added to administer the resulting solution to a patient. This solution can be supplied via the further connection 32 and a suitable removal device, for example an infusion set, then to a patient.

An advantage of the provided mixing device 1 and the method for mixing or reconstructing a medical fluid performed therewith is that the mixing or reconstruction process can be carried out completely within a closed system, without the components to be brought into contact with the external environment to step. The control and execution of the mixing or the reconstruction process is carried out from the outside by actuation of the multi-way valves 121, 131, 141 and by operating the conveyor 2, but without thereby accessing the fluid to be delivered itself. The risk of contamination of the mixed or reconstructed liquid is thus significantly reduced.

The mixing device and its components may be formed, for example, as plastic molded parts. The result is a simple mechanism and a simple, manual handling by a user with simple, cost manufacturability of the mixing device.

The mixing device 1 can be designed as a disposable part and delivered together with attached thereto containers 3, 4, 5 and conveyor 2 and disposed of after use.

The mixing or reconstruction process can be carried out, for example, in a pharmacy of a hospital or another medical care facility. For this purpose, in the pharmacy, the containers 3, 4, 5 and the conveyor 2 are attached to the mixing device 1 to produce the desired medical liquid by carrying out the above-described steps from the components of the container 4, 5 and in the container 3 to fördem. The medical liquid can then be delivered in the container 3 with mixing device 1 attached thereto and connected containers 4, 5 and connected conveyor 2, for example, to be transported to a patient at the place of administration. The closed system is thus not opened for transport. Only at the point of administration, the medicinal liquid is removed for example via a suitable infusion set.

In order to prevent the delivery and the transport that improper handling and unintentional operation of the multi-way valves 121, 131, 141 liquid can pass from the container 3, a fuse element 8 after the in Fig. 13 , and 14 be provided, which is attached to at least one of the multi-way valves 121, 131, 141, to prevent accidental operation of at least one of the multi-way valves 121, 131, 141.

At the in Fig. 13 and 14 illustrated embodiment, the securing element 8 is attached in a positive manner with a positive connection portion 81 to the multi-way valve 131, so as to lock its operation. The securing element 8 surrounds Here, with its form-fitting portion 81, the multi-way valve 131 and a relative to the multi-way valve 131 fixed portion of the mixing device 1, so that the multi-way valve 131 can not be moved from its currently set (closed) position.

Instead of mixing or reconstructing the components from the containers 4, 5 already at the location of a pharmacy prior to delivery, it is also conceivable to place the containers 3, 4, 5 and the conveying means 2 already at the pharmacy, to the mixing device But do not yet perform the mixing or reconstruction process, but to deliver the created closed system with unmixed or unreconstructed components, to mix or reconstruct the components 4, 5 only at the point of administration to the patient.

In order to prevent in this case that by improper handling by operating the multi-way valves 121, 131, 141 of the mixing or reconstruction process already initiated or an unwanted fluid exchange between the containers 3, 4, 5 takes place, also securing elements 8 of Fig. 13 and 14 shown used to block actuation of at least one of the multi-way valves 121, 131, 141. To initiate the mixing or reconstruction process, the one or more fuse elements 8 are then removed by the fuse elements 8 are removed, for example, by destroying the respective form-fitting portion 81 of the respectively associated multi-way valve 121, 131, 141.

The idea underlying the invention is not limited to the embodiments described above, but can also be realized in completely different types of embodiments. For example, the mixing device may also have a different number of ports for mixing a larger number of components. It is also conceivable to design the closure means not as multi-way taps, but by other types of taps or closures.

The use of a mixing device of the type described herein is possible for the mixing or reconstruction of different medical fluids, for example medicaments, nutritional supplements or the like, using components which are separated in a starting state and in different forms, for example in the form of a liquid, a gel or of a powder. The mixing device is not limited to specific types of drugs, but variously replaceable for the manufacture of medicaments and other liquids for any therapeutic and non-therapeutic purposes.

LIST OF REFERENCE NUMBERS

1

mixing device

10

grip

11,12,13,14,15

connection

120,130,140

junction

1 2i, 1 31, 1 41

Closure means (multi-way stopcock)

16

management

161, 162, 163, 164

line section

2

Conveyor (syringe)

20

cylinder body

21

connection

22

piston

3

Flexible bag

31.32

connection

4.5

viol

41.51

cap

6

connection cap

61

locking elements

7

circlip

8th

fuse element

81

Form-fitting section

F

flow

P

print direction

Z

tensile direction

Claims (12)

1. Mixing device (1) for reconstructing or mixing a medical liquid composed of at least two components, with

   - a first connector (12) for connection of a first container (5) containing a first component,

   - a second connector (13) for connection of a second container (4) containing a second component,

   - closure means (121, 131, 141) for selectively closing or opening at least one of the connectors (12, 13),

   - a third connector (11) for connection of a delivery means (2) for delivering at least one of first and second components, and

   - a fourth connector (15) for connection of a third container (3) for receiving a medical liquid that is reconstructed or mixed from the first component and the second component, characterized in that the mixing device (1) comprises a securing element (8), which can be fitted on at least one of the closure means (121, 131, 141), for blocking an actuation of the closure means (121, 131, 141).
2. Mixing device (1) according to Claim 1, characterized in that the first connector (12) and the second connector (13) are each connected to a line (16) of the mixing device (1), which line (16) connects the third connector (11) and the fourth connector (15) to each other, wherein the connection of the first connector (12) and of the second connector (13) to the line (16) is formed in each case by a connecting site (120, 130, 140) in the shape of a T-piece.
3. Mixing device (1) according to Claim 2, characterized in that the closure means are designed as multi-way cocks (121, 131, 141), wherein a first multi-way cock (121) is arranged at the connecting site (120) between the first connector (12) and the line (16), and a second multi-way cock (121) is arranged at the connecting site (130) between the second connector (13) and the line (16).
4. Mixing device (1) according to Claim 3, characterized in that each multi-way cock (121, 131, 141) has several positions, wherein

   - in a first position, the associated connecting site (120, 130, 140) is closed,

   - in a second position, the associated connecting site (120, 130, 140) is opened to allow a flow (F) through the line (16) from the respectively associated first or second connector (12, 13, 14) to the third connector (11), and

   - in a third position, the associated connecting site (120, 130, 140) is opened to allow a flow (F) through the line (16) between the third and fourth connectors (11, 15).
5. Mixing device (1) according to one of the preceding claims, characterized in that the first container (5) and the second container (4) are each designed as vials and can be connected to the first connector (12) or the second connector (13) via a connector cap (6) with a spike.
6. Mixing device (1) according to Claim 5, characterized by a securing ring (7) which, when the container (4, 5) is connected, can be fitted onto the connector cap (6) for securing the connection between the container (4, 5) and the connector cap (6), in order to secure the connection of the connector cap (6) to the container (4, 5).
7. Mixing device (1) according to one of the preceding claims, characterized in that the delivery means (2) is formed by a medical syringe.
8. Mixing device (1) according to one of the preceding claims, characterized in that the mixing device (1) forms a closed system when the containers (3, 4, 5) are connected and the delivery means (2) is connected.
9. Mixing device (1) according to one of the preceding claims, characterized by a further connector (14) for connection of a further container (4, 5) containing a further component of the medical liquid to be mixed or reconstructed.
10. Method for reconstructing or mixing a medical liquid composed of at least two components, in which method

    - a first container (5), containing a first component, is connected to a first connector (12) of a mixing device (1),

    - a second container (4), containing a second component, is connected to a second connector (13) of the mixing device (1), and

    - closure means (121, 131, 141) of the mixing device (1) for selectively closing or opening at least one of the connectors (12, 13) are actuated,

    - a delivery means (2) for delivering one of first and second components is connected to a third connector (11) of the mixing device (1), and

    - a third container (3) for receiving a medical liquid that is reconstructed or mixed from the first component and the second component is connected to a fourth connector (15) of the mixing device (1),
    characterized in that at least one of the closure means (121, 131, 141) is blocked against actuation by means of a securing element being fitted either before the mixing or reconstruction of the medical liquid or after the mixing or reconstruction of the medical liquid, so as to supply the mixing device (1), with containers (3, 4, 5) arranged thereon and with delivery means (2) arranged thereon, to a user of the medical liquid.
11. Method according to Claim 10, characterized in that the first component, contained in the first container (5), is a solution, and the second component, contained in the second container (4), is a medicament component in lyophilized form.
12. Method according to Claim 10 or 11, characterized in that the medical liquid is mixed or reconstructed as follows:

    - in a first step, by actuation of the closure means (121, 131, 141) and of the delivery means (2) of the mixing device (1), the first component is sucked out of the first container (5) into the delivery means (2),

    - in a second step, by actuation of the closure means (121, 131, 141) and of the delivery means (2) of the mixing device (1), the first component is delivered from the delivery means (2) into the second container (4), such that the second component, contained in the second container (4), is mixed or reconstructed with the first component, and the medical liquid is obtained,

    - in a third step, the mixed or reconstructed medical liquid is sucked out of the second container (4) into the delivery means (2), and

    - in a fourth step, the mixed or reconstructed medical liquid is delivered from the delivery means (2) into the third container.

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