EP3795132A2 - System for producing a medical preparation - Google Patents

Abstract

The invention relates to an installation for the production of a medical preparation, in particular for the production of a parenteral nutritional preparation. The system comprises a pump with which liquids can be transferred from a plurality of source containers into a target container. The system has a modular structure and comprises a weighing module and a main module with the pump. According to a further aspect of the invention, the pump is arranged tilted relative to a vertical plane. According to a further aspect of the invention, the system comprises cascaded valve nodes.

Description

Field of the invention

The invention relates to an installation for producing a medical preparation. In particular, the invention relates to a system with which, for example, infusion bags and / or syringes for parenteral nutrition are filled.

Background of the invention

Systems for the production of a medical preparation, in particular for the production of a preparation for parenteral nutrition, are used, for example, in pharmacies or clinics to fill a patient-specific preparation, in particular a mixture of various basic nutrients, trace elements and vitamins, possibly also together with a drug.

Such systems are also referred to as TPN compounders (TPN = Total Parenteral Nutrition). Systems known from practice and available on the market, such as the MultiComp® system from Fresenius, include a computer-controlled pump unit with which the components of the composition are transferred from various source containers to a target container located on a scale.

The demands on the safety and user-friendliness of such systems are high. Known systems often have the disadvantage that they are large and heavy and so cannot be transported by a single person.

Furthermore, the scales that are used in conventional systems cannot achieve very accurate weighing results. This is not only due to the tolerance of the load cell used, but also to the fact that, for example, a scale to which a target container is attached is exposed to changing tensile forces of the connection hose, which affects the measurement result.

Object of the invention

In contrast, the invention is based on the object of providing a system for producing a medical preparation, in particular a system for producing a parenteral nutritional preparation, which can be set up and / or operated comfortably and safely.

Summary of the invention

The object of the invention is already achieved by a system for producing a medical preparation and by a valve unit for a system for producing a medical preparation according to one of the independent claims.

Preferred embodiments and developments of the invention can be found in the subject matter of the respective dependent claims, the description and the drawings.

The invention relates, on the one hand, to a system for producing a medical preparation, which is designed in particular for producing a parenteral nutritional preparation.

The system includes a pump, in particular a hose pump. According to the invention, the hose pump can be a roller pump in one embodiment. The pump can be used to transfer liquid from a plurality of source containers into a target container. For this purpose, the system preferably comprises a valve unit with which the connection to a source container can be opened so that liquid can be withdrawn from a source container with the pump.

This is preferably done computer-controlled. The user can program in patient-specific formulations or select them from a database. The system is then started by the user and a filling process for a target container, in particular an infusion bag or a syringe, is carried out by pumping liquids from various source containers into the target container in a plurality of metering steps.

According to the invention, the system has a modular structure and comprises at least one scale module and / or a screen module, as well as a main module with the pump.

A scale module is understood to mean a device with a scale, which can preferably be set up next to the main module.

The weighing module comprises at least one load cell and a receptacle for a target container. The scale module can also include electronic control and regulation components of the scale. The scale module is preferably connected to the main module and / or an external control device via an electrical cable, in particular via an electronic interface.

In addition to or as an alternative to the scale module, the system includes a screen module.

A modular component in the form of a screen is therefore provided, via which the system can be operated, preferably by touch control.

The screen module is preferably connected to the main module via an electrical cable and / or an electronic interface.

The main module comprises at least the pump for transferring the liquids. The main module preferably also includes electronic control and regulation components, in particular a computer with which the pump and the valves are controlled.

The main module further preferably comprises the valve unit. In particular, provision is made to provide a valve unit as a disposable component, which is exchanged after a predetermined period of use and / or after a predetermined volume has flowed through.

For this purpose, the valve unit preferably comprises hoses along with connections for connecting the source container, as well as a further connection for connecting the target container to the valve unit, which connection can also be designed as a hose.

The connection hose for the target container is preferably placed in a hose pump. On the way from the source container to the target container, the transferred liquids only come into contact with the valve unit, which is designed as a disposable component, but not with other components of the system.

The modular structure enables a compact design of the system in which the components are so light at the same time that they can preferably be carried by one person.

The scale module and / or screen module can preferably be separated from the main module without tools.

In particular, the scale module and / or screen module are separate units that can be lifted and moved independently.

Preferably, however, a positioning means is provided at least for the scale module which, when the scale module is set down next to the main module, ensures a defined, that is to say always the same, distance.

In particular, the system comprises a frame on which the scale module and main module are arranged in a defined position relative to one another.

The frame is designed in particular as a sub-frame on which the weighing module and the main module can be placed.

The frame preferably comprises a receptacle for the main module and a receptacle for the scale module, wherein the receptacles for the main module and the receptacles for the scale module can have form-fit elements, in which form-fit elements of the scale module and the main module engage.

In particular, it is provided that the frame has recesses, in particular bores, into which the feet of the main module and the scale module can be inserted. In a preferred embodiment of the invention, only the rear feet of the main module and the scale module are inserted into the frame. This means that the frame in the front area of the system is not in the way.

The frame ensures that the main module and the weighing module assume a defined position with respect to one another. In particular, a constant distance between the connection of a target container and a connection on the system side is ensured.

Due to this defined distance, fluctuating forces acting due to the connection hose of the target container, which influence the weighing result, are reduced.

Furthermore, because of the connection to the main module, which is preferably heavier than the scale module, the generally lighter scale module is secured against unintentional displacement.

In one embodiment of the invention, the weighing module comprises a weighing pan which at least partially spans an intermediate space between the main module and the weighing module.

A connection of an inserted target container can thus be placed closer to the main module. By moving the valve unit and the target container connection closer together, the hose length and thus the dead volume can be reduced.

In a preferred embodiment of the invention, the weighing pan is inclined obliquely upwards in the direction of the main module.

A target container, which is designed as an infusion bag, can be hung in such a weighing pan on form-fitting elements, for example on pins, and thus has a defined position relative to the weighing pan and also relative to the other components of the system.

Furthermore, the connection of the target container can be approximately level with a system-side connection for the target container, which also reduces the introduction of forces on the scales through the connection hose.

The screen module preferably comprises a touch screen that can be pivoted on a hinge.

The screen module is preferably not permanently connected to another component of the system, in particular to the frame, but can be freely positioned by the user of the system.

In particular, provision is made to provide a screen with a base which can be positioned on a right and a left side of the system so that the system can be easily adapted to the operation for right-handed and left-handed users.

In a preferred embodiment, the base comprises at least one recess into which a receptacle of the frame or a foot of the main module can engage.

The base is fork-like or fork-shaped so that it can be pushed under the main module.

On the one hand, this enables a compact design and, on the other hand, the screen module can be pushed under the main module on a right and left side, the respective front foot of the main module or a receptacle for the main module engaging in the recess between the two forks of the screen module .

In one embodiment of the invention, the system, preferably the screen module, comprises a reader for an electronic memory, in particular a memory chip.

This memory is preferably used for simple identification of the user of the system.

In particular, an RFID reader is provided in the screen module. The user carries an RFID chip with him, for example on a card, and can use it to log into the system wirelessly in order to enable the system for operation via the touchscreen.

In one embodiment of the invention, the main module comprises a receptacle for a scanner. The scanner enables barcodes to be read in, for example barcodes from source and / or target containers. These barcodes can be used to control the system.

According to a preferred embodiment of the invention, the holder for the scanner can also be positioned at different points in order to adapt the system to different users, in particular right-handed and left-handed users.

For this purpose, in a preferred embodiment of the invention, the receptacle for the scanner is held magnetically on an upper housing front of the main module. In particular, the receptacle for the scanner can comprise a magnet and can thus be easily removed.

The invention further relates to a plant for producing a medical preparation, in particular a plant with one or more of the features described above and / or below.

The system comprises a pump, in particular a hose pump, with which liquids can be transferred from a plurality of source containers into a target container.

According to the invention, the pump is arranged on a housing front, the pump being arranged tilted relative to a vertical plane.

A vertical plane is understood to mean the plane which is spanned by vertically standing outer edges of a housing of the system in the erected state of the system.

The position of the pump, in particular the hose pump, is defined by a plane that is perpendicular to the axis of rotation of a pump wheel of the hose pump.

According to the invention, the plane described by the rotation of the pump wheel is not aligned vertically, but tilted at an angle.

In particular, it is provided that the pump is tilted at an angle of 10 ° to 80 °, preferably 15 ° to 50 °, particularly preferably 20 ° to 40 °, with respect to the vertical plane.

The pump is thus arranged at an angle on a front housing front of the system.

This enables better access to the pump and, in particular, easier cleaning after removing the pump wheel.

At the same time, compared to a non-tilted pump attached to the front of the housing, the kink angle of the inserted hose towards the top of the housing of the system is reduced.

Compared to a pump that is placed flat on the top of the housing, the tilting in turn enables a compact design of the system. An upper section of the housing front is preferably angled. So it is not only the pump that is inclined, but an entire section of an upper housing front on which the pump is attached.

This inclined section creates space for an inclined screen and thus enables a more compact design.

Furthermore, the scanner or the receptacle for the scanner is preferably also arranged in the angled section of the housing front, which also makes it easier for the user to reach the scanner.

The invention also relates to a system for producing a medical preparation, in particular a system with one or more of the features described above and / or below. The system comprises at least one pump, in particular a hose pump, with which liquids can be transferred from a plurality of source containers into a target container.

According to the invention, the system comprises at least two, preferably three, cascaded valve nodes, which each have connections for the source container.

As described at the outset, the valve units for the generic system are preferably designed as one-way components.

A valve unit has a plurality of valves which can be opened and closed via an actuating element in order to control the dosage from different source containers. On the system side, drivers are provided for the actuating elements. The valve unit can be placed on the system and the valves can be opened and closed via the computer-controlled drivers on the system side.

Depending on what medical preparations are being made and / or the quantities in which the medical preparations are being made, a different number of source containers is required from which liquids are taken.

Among other things, this has the disadvantage that valve units with a large number of valves are usually used, even if the system is then operated by the user with only a few source containers.

At the same time, if the manufacturer provides systems with a different number of connections to the source container, it would be necessary to offer different valve units.

The invention provides that at least two valve nodes are cascaded, that is to say connected in series. The outlets of the individual valves open into a central channel. By using a different number of valve nodes, a valve unit with a different number of connections can be provided in a simple manner.

A valve node preferably has 4 to 20 connections for one source container in each case. A valve unit with cascaded valve nodes preferably comprises 2 to 4 valve nodes.

The cascaded valve units are preferably attached to a receptacle on a housing, in particular snapped on, and connected by means of hoses.

This makes it possible to provide valve units with a different number of valve nodes in a simple manner.

Furthermore, the manufacturer can easily offer the system in different versions, for example as a system for a valve unit with only one valve node or as a system with several valve nodes that has a correspondingly larger number of connections for source containers.

Depending on how many source containers are in use, the user can also temporarily use different valve units with a different number of valve nodes.

The invention further relates to a valve unit for a system described above which comprises at least two valve nodes which are connected to a hose.

Via this hose, liquid is conducted from an external valve node via an internal valve node to a connection for a target container.

The invention further relates to a plant for producing a medical preparation, in particular a plant with one or more of the features described above and / or below.

The system comprises at least one pump, in particular a hose pump, with which liquids can be transferred from a plurality of source containers into a target container.

According to the invention, the system comprises a directional control valve arranged downstream of the pump in the flow direction, via which a target container with at least two chambers or at least two different target containers can be filled.

It is therefore particularly provided that a directional control valve is arranged between the valve unit and the target container.

The directional valve is in particular a three-way valve which has an inlet from which the liquid can be directed into one or the other chamber of the target container, for example.

The directional control valve is preferably designed as a one-way component, so it is also regularly replaced.

In a first embodiment, the directional control valve is connected to the target container. The directional control valve can preferably be inseparably connected to the target container and is removed from the system together with the target container after the filling process has been completed.

According to one embodiment of the invention, the directional control valve is actuated via a driver on the system side. Depending on the embodiment, this driver can be arranged both on the main module described above and on the scale module.

In another embodiment of the invention, the directional control valve is operated manually.

In a further embodiment, the directional control valve is part of the valve unit, in particular inseparably connected to the valve unit.

In a further embodiment, the directional valve is designed as a separate one-way component, which has connections for the target container and a further connection in order to be connected to the valve unit present on the system side.

In addition to filling a target container with two chambers, the directional control valve can also be used to connect a further target container parallel to the target container, in particular a target container that serves as a so-called "waste bag", which is discarded after use.

By using this waste bag it is possible, among other things, to exchange individual source containers while the target container is connected.

The invention further relates to a system, in particular a system with one or more of the features described above and / or below, the system comprising at least one pump, in particular a hose pump, with which liquids can be transferred from a plurality of source containers to a target container.

The system has at least one valve node, which can in particular be part of a valve unit.

The valve node can be snapped onto a receptacle.

The receptacle is designed, in particular, as a plate which comprises drivers for actuating elements of the valve node; these can in particular protrude from the plate.

According to the invention, an edge, in particular a circumferential edge of the receptacle, forms a form-locking element for the snap-on valve node.

There is therefore not a separate form-fit element for the valve node, but the edge of a receptacle, in particular the protruding edge of a plate, is used to serve as a form-fit element for the valve node.

In this way, the system is easier and easier to clean in the area of the receptacle for the valve manifold.

The valve node has latching means for latching onto the receptacle.

In a preferred embodiment of the invention, the housing of the valve node comprises a web on the underside which, in the locked state, engages under the edge of the receptacle.

On the side of the housing opposite the web, a resilient handle is preferably arranged, which also
has a web which engages under the edge of the receptacle in the locked state.

Using the resilient handle, the web for removing the valve node can be pulled out via the resilient tab under the edge and the valve node can be removed.

The valve manifold can also be removed from one side using a handle that is only present on one side.

The invention further relates to a plant for producing a medical preparation, in particular a plant with one or more of the features described above and / or below.

With the system, liquids can be transferred from a plurality of source containers into a target container.

According to the invention, the system comprises at least two pumps.

In particular, it is provided that there is a pump with a larger delivery rate and a pump with a smaller delivery rate, the smaller pump for conveying micro-quantities, that is to say quantities of liquid, in particular in the ml range is designed, whereas the main components are dosed with the other pump with a higher delivery rate.

The pumps are preferably designed as hose pumps.

The smaller pump delivers a smaller amount with one full revolution of an impeller, in particular an amount which is less than half as large as the amount that the larger pump delivers during one revolution of the impeller. The amount is understood to mean the volume of the liquid in question.

More precise dosing is possible using a smaller pump for dosing micro-quantities.

In particular, a pump is used as a smaller pump, into which a hose with a smaller diameter is also inserted.

In one embodiment of the invention, the pumps are connected in series.

In another embodiment of the invention, pumps are connected in parallel, it being possible to switch back and forth between the pumps, preferably via a directional valve.

In a further embodiment of the invention, each pump comprises a separate inlet to the target container. This embodiment of the invention is intended, for example, for filling a target container with two chambers. Each of the pumps can be connected to different source containers via a respective valve unit.

In the valve unit provided for this embodiment of the invention, the valve unit can in particular be connected to a hose which leads in the direction of the target container and which has a first section which is designed for insertion into the smaller pump and a second section with a larger diameter , which is designed to be inserted into the larger peristaltic pump.

The invention further relates to a plant for producing a medical preparation, in particular a plant with one or more of the features described above and / or below.

This system also comprises a peristaltic pump with which liquids can be transferred from a plurality of source containers into a target container.

According to the invention, the system comprises a combined flow / bubble sensor.

The flow / bubble sensor is designed in particular as an ultrasonic sensor and detects both when bubbles are transported through the hose and the flow speed of the medium conveyed in the hose.

In particular, incorrect fillings can be avoided via the bubble sensor, for example after a swell container has been completely emptied or if air is drawn in front of the combined flow / bubble sensor.

The flow sensor can be used to control the amount of liquid being pumped by the pump or pumps.

In particular, it is possible to use the flow sensor to detect occlusions even when dosing microns.

When dosing micro-quantities, there is the problem that in the event of an occlusion, for example the connection of the source container, liquid is nevertheless transferred into the target container, since the tubes, in particular the connecting tube of the target container, contract and thus enable a small amount of liquid to be conveyed .

If the source container from which the micro-quantity was apparently dosed is now closed via the valve unit and another valve is opened, for example to dose a main component, the hose can relax and the micro-quantity apparently removed from the source container is sucked in from the other source container .

It has been found, however, that in the event of an occlusion, the flow rate, in particular the flow rate between the valve unit and the peristaltic pump, drops significantly, which can be detected by the combined flow / bubble sensor. The combined flow / bubble sensor is therefore preferably arranged behind a valve unit and in front of a pump, based on the direction of flow.

The tube length between the combined flow / bubble sensor and the valve unit is small.

The hoses with which the source containers are connected to the valve unit usually have a significantly smaller diameter, so that the dead volume present through these hoses is smaller, which in turn leads to the risk of an apparently existing flow despite occlusion due to contraction Tubing is lower.

The use of a combined flow / bubble sensor enables a more compact design of the system compared to a system in which two separate sensors are available.

Furthermore, the combined sensor can be used to check for bubbles and to check the flow rate at a single central point, in particular close to the valve unit.

The invention further relates to a system for producing a medical preparation with a pump with which liquids can be transferred from a plurality of source containers into a target container.

In particular, it is a system with one or more of the features described above and / or below.

According to the invention, the system comprises a device for wireless transmission of a user ID. This can in particular be the above-described reader based on RFID technology.

The device for wireless transmission of a user identification is integrated in particular in a screen module of the system.

The possibility of wireless transmission of a user ID increases both ease of use and security when using the system.

Brief description of the drawings

• Fig. 1 zeigt eine perspektivische Ansicht eines Ausführungsbeispiels einer erfindungsgemäßen Anlage zur Herstellung einer medizinischen Zubereitung.
• Fig. 2 und Fig. 3 sind perspektivische Ansichten eines Untergestells, wie es Teil der in Fig. 1 dargestellte Anlage ist.
• Fig. 4 zeigt eine perspektivische Ansicht des Untergestells, welches zusammen mit Stangen, die Halterungen für Quellbehälter aufweisen, ein Gestell ausbildet.
• Fig. 5 und Fig. 6 sind perspektivische Ansichten des in Fig. 1 bereits dargestellten Waagemoduls.
• Fig. 7 ist eine Detailansicht auf die Ventilknoten.
• Fig. 8 ist eine Detailansicht des Hauptmoduls mit abgenommenen Ventilknoten.
• Fig. 9 und Fig. 10 sind perspektivische Detailansichten eines Ventilknotens.
• Fig. 11 ist eine perspektivische Ansicht des Ventilknotens mit Anschlussschläuchen.
• Fig. 12 zeigt die Schläuche zum Anschluss der Quellbehälter und Fig. 13 zeigt den Schlauch zum Anschluss des Zielbehälters.
• Fig. 14 bis Fig. 16 sind perspektivische Ansichten des Hauptmoduls.
• Fig. 17 und Fig. 18 sind perspektivische Ansichten des Bildschirmmoduls.
• Fig. 19 ist eine perspektivische Ansicht einer Ventileinheit, bestehend aus drei Ventilknoten.
• Fig. 20 ist eine Detailansicht einer Aufnahme für einen Ventilknoten.
• Fig. 21 ist eine weitere perspektivische Ansicht auf die Unterseite des Ventilknotens.
• Fig. 22 ist eine Detailansicht des Hauptmoduls der Anlage.
• Fig. 23 zeigt schematisch das Grundprinzip einer alternativen Ausführungsform einer Anlage zur Herstellung einer medizinischen Zubereitung, welche im Unterschied zu der vorher dargestellten Ausführungsform zwei Pumpen, sowie ein Wegeventil zur Befüllung eines Zielbehälters mit zwei Kammern umfasst.
• Fig. 24 bis Fig. 27 zeigen weitere Ausführungsbeispiele des schematischen Grundprinzips einer Anlage zur Herstellung einer medizinischen Zubereitung mit zwei Pumpen.
• Fig. 28 zeigt das schematische Grundprinzip einer Anlage, bei welcher über ein Wegeventil parallel zum Zielbehälter ein waste bag angeschlossen ist.

The subject matter of the invention is intended below, with reference to the drawings FIGS. 1 to 28 are explained in more detail.

• Fig. 1 shows a perspective view of an embodiment of a system according to the invention for producing a medical preparation.
• FIGS. 2 and 3 are perspective views of an underframe as part of the FIG Fig. 1 shown system is.
• Fig. 4 shows a perspective view of the underframe which, together with rods that have holders for source containers, forms a frame.
• FIGS. 5 and 6 are perspective views of the in Fig. 1 scale module already shown.
• Fig. 7 is a detailed view of the valve manifold.
• Fig. 8 is a detailed view of the main module with the valve nodes removed.
• Figures 9 and 10 are perspective detailed views of a valve node.
• Fig. 11 Fig. 3 is a perspective view of the valve hub with connecting tubes.
• Fig. 12 shows the hoses for connecting the source containers and Fig. 13 shows the hose for connecting the target container.
• FIGS. 14 to 16 are perspective views of the main module.
• Fig. 17 and Fig. 18 are perspective views of the display module.
• Fig. 19 is a perspective view of a valve unit consisting of three valve nodes.
• Fig. 20 is a detailed view of a receptacle for a valve node.
• Fig. 21 Figure 3 is another perspective view of the underside of the valve node.
• Fig. 22 is a detailed view of the main module of the plant.
• Fig. 23 shows schematically the basic principle of an alternative embodiment of a system for producing a medical preparation, which, in contrast to the embodiment shown above, comprises two pumps and a directional valve for filling a target container with two chambers.
• FIGS. 24 to 27 show further exemplary embodiments of the basic schematic principle of a system for producing a medical preparation with two pumps.
• Fig. 28 shows the schematic basic principle of a system in which a waste bag is connected via a directional valve parallel to the target container.

With the drawings Figures 23 to 28 are the possible deviations of the system compared to the in FIGS. 1 to 22 shown system.

Detailed description of the drawings

Fig. 1 shows a perspective view of an installation 1 for producing a medical preparation in the form of a parenteral nutritional preparation.

The system 1 has a modular structure and comprises a main module 2.

The main module 2 comprises a pump 9, which is designed as a hose pump.

The main module 2 further comprises a scanner 12, with which recipe data or barcodes can be read in on target containers 5 and / or source containers 6. On the top of the main module, three valve nodes 10a to 10c are arranged, which together form a valve unit. The valve nodes 10a to 10c are connected in a cascaded manner, which will be explained in detail below.

In addition to the main module 2, the system 1 includes a scale module 3 and a screen module 4.

The weighing module 3 comprises a weighing pan 7 into which a target container 6 is placed.

Scale module 3 and main module 2 are placed on an underframe 11, which ensures a constant position of scale module 3 and main module 2 with respect to one another.

The space between the weighing module 3 and the main module 2 is partially spanned by the weighing pan 7, so that the connection of the target container 6 is close to the top of the housing of the main module 2.

Furthermore, the weighing pan 7 is inclined obliquely upwards in relation to a horizontal plane in the direction of the main module 2. As a result, the connection of the target container 6 also moves close to the top of the main module 2, which reduces the length of a hose 36 for connecting the target container 6 to the valve node 10a.

The hoses 36, 37 are not shown in this view.

Rods 8 on which a plurality of swelling containers 5 are arranged can also be seen.

To operate the system, the source containers 5 are connected to the valve nodes 10a to 10c via hoses 37. Furthermore, the valve nodes 10a to 10c are cascaded so that only the valve node 10a is directly connected to the target container 6.

The hose 36 used to connect the target container is passed through the hose pump 9.

Via the valve unit 60 consisting of the valve node 10a to 10c, the desired preparation can be transferred to the target container 6 in a computer-controlled manner by means of the hose pump 9.

During a filling process, one of the valves 63 is opened, so that liquid is pumped from a source container 5 into the target container with the pump 9 in a dosing step. The next valve 63 is then opened. Liquids are withdrawn from the various source containers 5 until the filling process has ended.

Preferably, there is always only a single valve 63 during each individual metering step (see e.g. Fig. 9 ), which leads to a source container 5, is opened. So it is only ever taken from one source container 5 liquid.

In addition to the main components of the medical preparation and the micro-quantities which are located in the source containers 5, there is a so-called universal liquid, also referred to as "Universal Ingredient" (UI), for each preparation. This liquid is allowed to come into direct contact with any other ingredient without undesirable side effects and is used in each preparation in a relatively large amount, in particular to make up the preparation to the desired total amount. The universal liquid is mostly isotonic water.

It is envisaged that when the system 1 is put into operation for the production of the medical preparation, a first target container is used which is then discarded, a so-called "waste bag". This waste bag is opened by means of the valve unit 60 (see, for example, Fig. 19 ) and the hoses 37 leading to all the source containers 5 are vented by removing an amount of liquid required for this in each case.

The screen module 4, which has a touch screen for operating the system 1, is freely movable with respect to the subframe 11 and thus with respect to the remaining system components.

In this view, it is on the right-hand side of Appendix 1.

If the system is operated by a left-handed person, the screen module 4 can be shifted to the left.

At the same time, the scanner 12 can then be attached further to the right.

Fig. 2 shows a perspective view of the underframe 11.

The subframe 11 has a receptacle 13 for the weighing module 3.

The receptacle 13 comprises bores 14 into which feet 28b of the scale module 3 can be inserted.

The subframe 11 also has a receptacle 15 for the main module 2. The receptacle 15 protrudes from the rest of the underframe 11 like a fork.

The receptacle 15 for the main module 2 also includes bores 16 into which two feet 42b of the main module 2 can be inserted.

In the erected state, the balance module 3 and the main module 2 are firmly positioned in relation to one another in the horizontal plane.

The distance between the scale module 3 and the main module 2 is determined by the section 17 of the subframe 11.

Behind the receptacle 15 for the main module 2, the underframe 11 has receptacles 18 for the rods 8, to which the swelling containers 5 can be attached.

Preferably, source containers 5 for smaller quantities are attached to these rods 8, while, for example, bags from which the main components of the medical preparation are supplied can be hung on a rack remotely by means of hooks (not shown).

Fig. 3 FIG. 11 shows a perspective view of the underside of the underframe 11.

It can be seen that the underframe 11 has a plurality of feet 19, which can be designed, for example, as inserted or glued-on elastomer elements.

Between the feet 19, recesses 20 are made on the underside of the subframe 11, which are used for better ventilation under the main module 2.

Fig. 4 shows a perspective view of the underframe 11, in which the rods 8 are now inserted, which are used to attach the source container 5.

The rods 8 consist of a lower part 8a and an upper part 8b and can be pulled out telescopically.

Furthermore, holders 21 for the swelling containers 5 can be attached to the rods 8, which holders are preferably designed to be vertically displaceable. In this way, flexible adaptation to different types and sizes of source containers 5 is ensured.

At the same time, due to the modular concept, the subframe 11 is fixed in the erected state by the heavier main module 2, which means that at the same time the rods 8 connected to the subframe 11 are secured against tipping over.

Fig. 5 shows a perspective view of the weighing module 3. The weighing module 3 comprises a housing 26 in which the weighing cell (not shown) and, if necessary, further electronic components for control and regulation are arranged.

The weighing pan 7 is designed in the shape of a slide or a trough. In this view, a target container 6 is suspended in the pins 27 of the weighing pan 7. In this way, a defined positioning of the target container 6 on the weighing pan 7 is ensured.

The weighing pan 7 is mounted on the balance 22 in which the weighing cell is arranged.

The weighing pan 7 further comprises a hose holder 25, into which the connecting hose 24 of the target container 6 can be inserted. The connection 23 of the target container 6 is connected to a connection 39 of the valve unit 60 on the system side.

Fig. 6 FIG. 3 is a further perspective view of the scale module 3. It can be seen that the housing 26 has cylindrical or conical feet 28a, 28b on the underside.

The feet 28b are inserted into the bores 14 of the underframe 11.

An electrical connection 40, with which the balance 22 is connected to the main module 2, can also be seen. A plug connection is preferably provided for the connection.

Fig. 7 shows a detailed view of the already in Fig. 1 shown main module 2.

It can be seen that three valve nodes 10a to 10c are arranged on the upper side of the housing of the main module 2.

The valve nodes 10a to 10c each have two connections 29a to 29f.

In order to combine the valve nodes 10a to 10c to form a cascaded valve unit 60, they are connected to hoses 61 (not shown here) (see also, for example, FIG Fig. 19 ). The connections 29b and 29c and the connections 29d and 29e are therefore connected.

The connection 29a, on the other hand, is connected to a hose 36 which leads to the target container 6 (see also, for example, FIG Fig. 19 ). The connection 29f is closed.

Fig. 8 is a further detailed view in which opposite Fig. 7 the valve nodes 10a to 10c are removed.

The valve nodes 10a to 10c can be snapped onto the system-side receptacles 30a to 30c.

Each of these receptacles 30a to 30c comprises drivers 31, which in this exemplary embodiment are designed like screwdrivers and which are used to move the actuating members 35a to 35f with which the valves 63 of the valve unit 60 can be actuated (see also, for example, FIG Figures 9 and 10 ).

Fig. 9 is a perspective detailed view of a valve node 10a without connecting hoses.

The valve node 10c comprises the connections 32a to 32l for connecting the source container 5. Each of the connections 32a to 32l is connected to a hose 37 which leads to a source container 5 (see also, for example, FIG Figures 11 and 12 ).

The connections 32a to 32l are an integral part of the housing 31 of the valve node 10c.

The connection 29f is closed with a plug 34.

Fig. 10 shows a perspective view of the underside of the valve node 10a.

The connections 29a and 29b can be clearly seen in this view.

It can also be seen that a central channel 62 extends between the connections 29a and 29b.

When the valve 63 is open, the liquid flows from the respective connection 32a to 32l into this central channel 62.

In this exemplary embodiment, the valves 63 are designed as 3-way valves. As a result, there are only half as many actuators 35a-35f as connections 32a-32l.

Specifically, these are valves 63 which are designed as 3/3-way valves with a closed central position.

The connection 32e or 32f, for example, can be opened via the actuating member 35a.

The individual valve nodes 10a to 10c are preferably designed identically.

In this illustration, the actuators 35a to 35c are in the closed central position, whereas the actuators 35d to 35f are in the open position and have an inlet open.

It goes without saying that, as a rule, only one valve 63 is open when the system 1 is in operation.

Fig. 11 shows a valve node 10a with tubes 36, 37.

The hoses 37 are used to connect the source container 5, and the hose 36 is passed through the pump 9 and is used to connect the target container 6.

In this view, only the beginning of the tubes 36, 37 on the valve node side can be seen.

The hoses 36 and 37 are preferably connected to the connections 29a to 29f or 32a to 32l of the respective valve node 10a to 10c in such a way that they cannot be removed without being destroyed.

The valve unit 60, which consists of the valve nodes 10a to 10c together with hoses 36, 37, is designed as a disposable component.

Fig. 12 shows a detailed view of the end of the tubes 37 for connecting the source container 6.

The connections 38 can be seen, which in this exemplary embodiment are designed as Luer lock connections with a connected spike.

Fig. 13 FIG. 13 is a reduced perspective view of the hose 36 for connecting the target container 8.

This is connected to the connection 29a of the valve node 10a and comprises a connection 39 for the target container 6.

The connection 39 can also be designed as a Luer lock connection.

Fig. 14 shows a perspective view of the main module 2.

The main module 2 comprises the pump 9, which is designed as a hose pump and has the removable pump wheel 50. The pump wheel 50 is preferably designed to be sprung.

When the hose 36 is inserted, the pump 9 has a suction side 48 and a pressure side 49, which are determined by the direction of rotation of the pump wheel 50.

On the top of the housing 41 there are three receptacles 30a to 30c for the valve nodes 10a to 10c.

Depending on the configuration required by the customer, the system 1 can also comprise only one (e.g. 10a) or two valve nodes (e.g. 10a and 10b).

The state shown here shows the full occupancy with three receptacles 30a to 30c.

A combined flow / bubble sensor 46 and a hose holder 47 are arranged on the upper side of the housing 41.

The hose 36 connected to the valve node 10a is first placed in the housing of the combined flow / bubble sensor 46, then passed through the hose pump 9 and then through the hose holder 47.

The front feet 42a of the main module 2, which are not inserted into the subframe 11, can also be seen.

It can also be seen that the main module 2 has an electrical connection 44 for the screen module 4 on one side and an electrical connection 43 for the weighing module 3 on the other side.

The receptacle 59 for the scanner 12 comprises a magnet and can easily be removed. For example, it can be placed on the form-fit element 45 in order to switch the system 1 over to being operated by a left-hander.

Fig. 15 shows a further perspective view of the main module 2.

It can be seen that there is a recessed grip 51 on the side of the electrical connection 44.

As in Fig. 16 which can also be seen in a perspective view of the main module 2, a recessed grip 51 is also provided on the other side, namely on the side of the electrical connection 43 for the weighing module 3.

In this view one can see one of the rear feet 42b, which are inserted into the receptacles 15 of the underframe 11.

It can also be seen that the housing 41 has a beveled upper housing front 53.

Due to the beveled housing front 53, the peristaltic pump 9 and thus the pump wheel 50 are also tilted relative to the vertical.

The vertical plane is spanned by the vertical straight lines 52 drawn in here, which are arranged at the corners of the housing 41.

The pump wheel 50 or its upper side facing this, and thus the entire pump 9, is tilted by the angle α with respect to this vertical plane. The angle α is preferably between 20 ° and 40 °, in this exemplary embodiment the angle α is approximately 30 °.

This configuration makes the pump 9 easily accessible in order to insert the hose 39 and / or to clean the pump after the pump wheel 50 has been removed.

A particularly compact design of the main module 2 is also made possible.

The screen of the screen module 4 can be swiveled into the area created by the inclination of the upper housing front 53.

Fig. 17 shows a perspective view of the screen module 4.

The screen module 4 comprises a touch screen 56 which is connected to the base 54 via a hinge 55.

The touchscreen 56 can be pivoted via the hinge 55.

At the rear, the touchscreen 56 comprises connections 57 for connection to the main module 2.

Fig. 18 FIG. 4 is another perspective view of the screen module 4.

In this view it can be clearly seen that the base 54 has a recess 58. The base 54 is designed like a fork.

Due to the recess 58, the base 54 can also be pushed under the main module 2 in the area of the feet 42a of the main module 2.

Fig. 19 is a perspective view of a valve unit 60, which in this exemplary embodiment consists of the three valve nodes 10a to 10c.

The valve nodes 10a and 10b as well as 10b and 10c are each connected to one another with a hose 61.

The connection 29f that is not required is closed and the opposite connection 29a is connected to the hose 36 which is passed through the pump 9 and which is connected to the target container 6.

All connections 32a-32l of each valve unit 10a-10c are located on a, preferably single, central channel which is formed from the respective channel 62 of the respective valve node 10a to 10c and the hoses 61 and 36.

The valve nodes 10a to 10c are cascaded in this way.

Depending on how many source containers 5 are to be connected, a valve unit 60 can be used which, as shown here, has three valve nodes 10a-10c or also only two or one valve node (not shown).

Fig. 20 is a detailed representation of the already in the figures FIGS. 14 to 16 to be recognized receptacle 30a for a valve node 10a.

The receptacle 30a comprises a base 65 and is plate-shaped above the base, with a circumferential edge 64 protruding.

The circumferential edge 64 serves as a form-fit element for the corresponding valve node 10a.

It can be seen that the drivers 31 for the actuating members 35a-35f of the valve node 10a protrude from the plate-shaped receptacle 30a. Alternatively, the drivers 31 can also be countersunk into the receptacle 30a (not shown).

The underside of the valve node 10a is shown in FIG Fig. 21 to see.

It can be seen that the housing 33 of the valve node 10a has a web 68 on a rear side which can be pushed under the edge 64 of the receptacle 30a.

On the side opposite the web 68, a handle 66 is arranged, which is designed to be resilient and also has a web 67 which, in the locked state, engages under the edge 64 of the receptacle 30a.

The handle 66 with the web 67 is preferably designed as a resilient plastic component, which in particular can also be designed in one piece with the housing 33. For example, the housing 33 can be designed as a plastic injection-molded part.

When the valve node 10a is snapped on, the handle 66, together with the web 67, can initially spring away from the rest of the housing 33, so that the web 67 slides past the edge 64 of the receptacle 30a. In this state, the opposite web 68 is pushed under the edge 64 on the opposite side.

The handle 66 then springs again in the direction of the housing and the valve node 10a is latched via the web 68 and the web 67.

The valve node 10a can easily be removed from one side in order to replace the valve unit 60 by the user pulling on the handle 66.

Fig. 22 is a detailed representation of the Fig. 14 , in which the combined flow / bubble sensor 46 can be seen.

The receptacle 30a for the valve node 10a can also be seen.

Once the valve unit 60 is installed, the hose 36, which connects the valve node 10a to the target container 6, is first passed through the combined flow / bubble sensor 46, then through the pump 9 and then through the hose holder 47.

The hose holder 47 ensures a defined position of the hose, which reduces the risk of fluctuating forces being introduced to the target containers 5 located on the weighing module 3.

The combined flow / bubble sensor 46 is thus arranged close to the valve unit 60 at the same time.

The combined flow / bubble sensor 46 has a cover 71 which, in this embodiment, can be opened to one side so that the tube 36 is then inserted.

It is preferably a sensor in which the evaluation electronics are integrated, which therefore outputs a measured value for the flow rate and a further measured value for the presence or absence of bubbles in the hose 46. The sensor can be connected to the evaluation electronics of the system 1 via an interface.
If the combined flow / bubble sensor 46 detects a flow rate which is not plausible with the pumping power in the respective dosing step, an error message can be generated via the screen unit 4.

This can be defined, for example, via a threshold value. For example, a flow rate can be defined as the threshold value that is 20 percent below the calculated flow rate, which would have to be present in the respective metering step due to the control of the pump 9.

Fig. 23 is a schematic principle sketch of an alternative embodiment of a plant 1a, in which two possible modifications are to be described compared to the plant described above.

It is shown schematically that the installation 1 a has a plurality of swelling containers 5. In this exemplary embodiment, the source container 5a comprises water or universal liquid for flushing the valve unit 60.

The valve unit 60 can be used to control from which source container 5 liquid is withdrawn in the respective dosing step.

In contrast to the previously illustrated embodiment, the system 1a comprises two pumps, namely a larger pump 9a and a smaller pump 9b.

The pump 9a has a greater delivery rate than the pump 9b and is used to meter the main components of the medical preparation.

The two pumps 9a and 9b can in particular be hose pumps, with a hose being inserted into the pump 9a which has a larger diameter than the hose which is inserted into the pump 9b.

The hose 36, which connects the valve unit 60 to the target container 6a, thus preferably comprises two sections with different diameters.

Micro-quantities can be dosed with greater accuracy via the smaller pump 9b.

Otherwise, the system 1a can be designed in the same way as the system 1 described above.

As a further modification to the system 1 shown above, the system comprises a directional control valve 70 which is arranged in front of the target container 6a.

It goes without saying that this modification compared to the system 1 can also be present on its own, that is to say without the two pumps 9a and 9b, or the system 1a can only include the two pumps 9a and 9b and no directional control valve 70.

The target container 6a comprises the chambers 69a and 69b.

The chambers 69a and 69b can be filled with a medical preparation of different composition via the directional valve 70 controlled by the system 1a.

The directional control valve 70 is preferably part of a one-way component.

In one embodiment, the directional valve 70 is actuated by a driver present on the system side.

In an alternative embodiment of the invention, the directional valve 70 is operated manually, that is, the user connects the target container 6a, first starts a filling process, for example for the chamber 69a, then switches the directional valve 70 so that liquid can flow into the chamber 69b , and starts another filling process for chamber 69b.

Fig. 24 is a further embodiment of a system 1b with two pumps 9a, 9b.

In contrast to the previously illustrated embodiment, the pumps 9a and 9b are not connected in series.

Rather, the connection to the target container 6 branches after the valve unit, viewed in the direction of flow. Via a directional control valve 72, either fluid can be fed via the pump 9a or via the pump 9b.

In this exemplary embodiment, the pump 9b has a smaller delivery rate than the pump 9a and is used for metering micro-quantities.

Behind the pumps 9a, 9b, the connection to the target container 6 is brought together again. This can, as shown in this embodiment, about a directional control valve 73 take place in order to prevent a backflow of liquid in the direction of the pump which is not currently working.

Fig. 25 is another exemplary embodiment of a system 1c with two pumps 9a, 9b.

In this exemplary embodiment, two valve units 60a, 60b are provided. A part of the source container 5 is connected to the target container 6 via the valve unit 60a. Liquids from these source containers are conveyed into the target container 6 via the pump 9a, whereas liquids from the source containers 5, which are connected to the target container via the valve unit 60b, are conveyed into the target container 6 via the pump 9b.

The pump 9b and the separate valve unit 60b are used for metering micro-quantities.

Both valve units 60a, 60b are each connected to a source container 5a, which comprises universal liquid, in order, among other things, to be able to flush the valve units.

Fig. 26 is an embodiment of a system 1d with two pumps 9a, 9b. In this exemplary embodiment, a target container 6a is filled with two chambers 69a, 69b.

The chamber 69b is connected to a plurality of source containers 5, 5a via the pump 9a and the valve unit 60.

Liquid is only transferred into chamber 69b via the pump 9a. The metering from the various source containers takes place by activating the valve unit 60.

The other chamber 69a of the target container 6a is connected to the source container 5c via the pump 9b. Only the second chamber 69a is therefore filled with liquid from the source container 5c via the pump 9b.

It is provided in particular that the source container 5c comprises a lipid-containing component for the medical preparation.

Fig. 27 shows a further embodiment of an installation 1e for producing a medical preparation.

In contrast to the in Fig. 26 In the illustrated embodiment, the pump 9b is also connected to source containers 5 via a further valve unit 60b.

The chamber 69a can therefore be filled via the pump 9b, the metering from the various source containers 5 being controlled via the valve unit 60b.
The chamber 69b is filled accordingly via the pump 9a, the metering being controlled via the valve unit 60a.

A swelling container 5a with universal liquid is connected to each of the two valve units for flushing.

Fig. 28 shows a further embodiment of an installation 1f for the production of a medical preparation.

In this exemplary embodiment, a directional valve 74 is provided after the valve unit 60, viewed in the direction of flow, via which liquid can be transferred from a plurality of source containers 5, 5a both into the two chambers 69a, 69b of a target container 6a and into a waste bag 75 .

Via the waste bag connected at the same time as the target container 6a, the inlets to individual source containers 5 can thus be rinsed at any time, for example in order to replace an individual source container 5 when it is empty. It is not necessary to flush the entire system when a source container 5 is exchanged. Rather, a source container 5 can also be exchanged while the target container 6a is connected.

The directional valve 74 is preferably designed as at least a 4-way valve.

In an embodiment not shown here, the target container 6a can also be designed as a container with only one chamber.

Furthermore, the embodiment of an installation 1f for the production of a medical preparation shown here can also comprise two pumps, in particular as before, with reference to FIG Figures 23 to 27 , was shown.

The invention makes it possible to provide a compact system for producing a medical preparation which can be operated easily and safely.

Reference list

• 1, 1a-e system
• 2 main module
• 3 scale module
• 4 screen module
• 5, 5a, 5c source container
• 6, 6a target container
• 7 weighing pan
• 8 rod
• 8a lower part
• 8b upper part
• 9, 9a, 9b pump, hose pump
• 10a-10c valve manifold
• 11 base
• 12 scanners
• 13 holder (for scales)
• 14 bore
• 15 holder (for main module)
• 16 bore
• 17 section
• 18 holder (for rod)
• 19 feet
• 20 recess (for source container)
• 21 holder (for source container)
• 22 scales
• 23 connection
• 24 hose
• 25 hose holders
• 26 housing
• 27 pin
• 28a, b feet (scales)
• 28a-f connector
• 30a-30c holder (for valve manifold)
• 31 carriers
• 32a-32l connection (source container)
• 33 housing
• 34 stopper
• 35a-35f actuator
• 36 hose
• 37 hose
• 38 Connection
• 39 Connection
• 40 electrical connection
• 41 housing
• 42a, 42b feet
• 43 Connection (balance)
• 44 Connection (screen)
• 45 form-fit element
• 46 combined flow-bubble sensor
• 47 hose holder
• 48 running side
• 49 Print side
• 50 impeller
• 51 Recessed grip
• 52 line
• 53 upper housing front
• 54 base
• 55 hinge
• 56 touchscreen
• 57 Connection
• 58 recess
• 59 Recording (scanner)
• 60 valve unit
• 61 hose
• 62 channel
• 63 valve
• 64 margin
• 65 base
• 66 handle
• 67 bridge
• 68 bridge
• 69a, 69b chamber
• 70 directional control valve
• 71 flap
• 72 directional control valve
• 73 directional control valve
• 74 directional control valve
• 75 waste bag

Claims (15)

Plant (1) for producing a medical preparation, in particular for producing a parenteral nutritional preparation, comprising at least one pump (9) with which liquids can be transferred from a plurality of source containers (5) into a target container (6), the plant (1 ) is modular and comprises at least one scale module (3) and / or a screen module (4) and a main module (2) with the pump (9). System (1) according to the preceding claim, characterized in that the system comprises a frame, in particular an underframe (11), on which the weighing module (3) and the main module (2) are arranged in a defined position relative to one another. System (1) according to one of the preceding claims, characterized in that the frame has a receptacle (15) for the main module (2) and a receptacle (13) for the weighing module (3), the receptacle (15) for the main module (2) and / or the receptacle (13) for the scale module (3) have form-fit elements, in particular bores (14, 16), in which form-fit elements of the scale module (3) and / or the main module, in particular feet (28b, 42b), intervention. System (1) according to one of the preceding claims, characterized in that the screen module (4) comprises a touchscreen (56) pivotable on a hinge and / or the weighing module (3) comprises a weighing pan (7) which has a space between the main module (2) and scale module (3) at least partially spanned. System (1) according to one of the preceding claims, characterized in that the screen module (4) comprises a base (54), the base (54) having a recess (58) into which a receptacle (15) for the main module ( 2) or a foot (42a) of the main module (2) can grip, so that the base (54) is designed to be partially slidable under the main module (2). System (1) according to one of the preceding claims, characterized in that the main module (2) has a receptacle (59) for a scanner (12), in particular wherein the receptacle (59) is magnetically attached to an upper housing front (53) of the main module ( 2) is held. System (1) for producing a medical preparation, in particular system (1) according to one of the preceding claims, comprising at least one pump (9), in particular a hose pump, with which liquids are transferred from a plurality of source containers (5) to a target container (6) are transferable, the pump (9) being arranged on a housing front (53), the pump (9) being arranged tilted relative to a vertical plane. System (1) according to the preceding claim, characterized in that the pump (9) relative to the vertical plane at an angle (α) of 10 ° to 80 °, preferably from 15 ° to 50 °, particularly preferably from 20 ° to 40 ° ° is tilted, and / or that an upper section of the housing front (53) is angled. System (1) for producing a medical preparation, in particular system (1) according to one of the preceding claims, comprising at least one pump (9), in particular a hose pump, with which liquids are transferred from a plurality of source containers (5) to a target container (6) are transferable, the system (1) having at least two cascaded valve nodes (10a-10c), each of which has connections (32a-32l) for the source container (5), the valve nodes (10a-10c) preferably each on a receptacle ( 30a-30c) are attached to a housing (41) of the system and are connected by means of hoses (61). Valve unit (60) for a system (1) according to the preceding claim, comprising at least two valve nodes (10a-10c) which are connected to a hose (61) Plant (1) for producing a medical preparation, in particular plant (1) according to one of the preceding claims, comprising at least one pump (9), in particular a hose pump, with which liquids are transferred from a plurality of source containers (5) to a target container (6) are transferable, the system (1) being arranged downstream of the pump in the direction of flow Directional valve (70), via which a target container (6a) with at least two chambers (69a, 69b) and / or two different target containers can be filled. System (1) for producing a medical preparation, in particular system (1) according to one of the preceding claims, comprising at least one pump (9), in particular a hose pump, with which liquids are transferred from a plurality of source containers (5) to a target container (6) are transferable, the system having at least one valve node (10a-10c) which can be snapped onto a receptacle (30a-30c), preferably designed as a plate, with a preferably circumferential edge (64) of the receptacle (30a-30c) as a form-fit element for the valve node (10a-10c) is formed. System (1) for producing a medical preparation, in particular system (1) according to one of the preceding claims, with which liquids can be transferred from a plurality of source containers (5) into a target container (6), the system (1) having at least two pumps (9a, 9b). Plant (1) for producing a medical preparation, in particular plant (1) according to one of the preceding claims, comprising a pump (9), in particular a hose pump, with which liquids can be transferred from a plurality of source containers (5) into a target container (6) The system (1) has at least one combined flow / bubble sensor (46), which is preferably arranged behind a valve unit (60) and in front of the pump (9), based on the direction of flow. Plant (1) for producing a medical preparation, in particular for producing a parenteral nutritional preparation, comprising at least one pump (9) with which liquids can be transferred from a plurality of source containers (5) into a target container (6), the plant (1 ), in particular a screen module (4) of the system, comprises a device for wireless transmission of a user ID.

Images