EP3795132A2 - Équipement pour fabriquer une préparation médicale - Google Patents

Équipement pour fabriquer une préparation médicale Download PDF

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Publication number
EP3795132A2
EP3795132A2 EP20199834.1A EP20199834A EP3795132A2 EP 3795132 A2 EP3795132 A2 EP 3795132A2 EP 20199834 A EP20199834 A EP 20199834A EP 3795132 A2 EP3795132 A2 EP 3795132A2
Authority
EP
European Patent Office
Prior art keywords
pump
module
valve
target container
receptacle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP20199834.1A
Other languages
German (de)
English (en)
Other versions
EP3795132C0 (fr
EP3795132A3 (fr
EP3795132B1 (fr
Inventor
Michael Hock
Henrik SCHAAKE
Ulla Schöbel
Holger Lenkeit
Marcel Borgward
Martin Biehl
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to EP24195306.6A priority Critical patent/EP4438024A3/fr
Publication of EP3795132A2 publication Critical patent/EP3795132A2/fr
Publication of EP3795132A3 publication Critical patent/EP3795132A3/fr
Application granted granted Critical
Publication of EP3795132C0 publication Critical patent/EP3795132C0/fr
Publication of EP3795132B1 publication Critical patent/EP3795132B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/74—Device provided with specific sensor or indicating means for weight
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like

Definitions

  • the invention relates to an installation for producing a medical preparation.
  • the invention relates to a system with which, for example, infusion bags and / or syringes for parenteral nutrition are filled.
  • 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.
  • TPN Total Parenteral Nutrition
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • connection hose for the target container is preferably placed in a hose pump.
  • 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.
  • the scale module and / or screen module are separate units that can be lifted and moved independently.
  • 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.
  • 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.
  • the frame has recesses, in particular bores, into which the feet of the main module and the scale module can be inserted.
  • the frame has recesses, in particular bores, into which the feet of the main module and the scale module can be inserted.
  • 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.
  • the generally lighter scale module is secured against unintentional displacement.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • the receptacle for the scanner is held magnetically on an upper housing front of the main module.
  • 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.
  • 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.
  • the plane described by the rotation of the pump wheel is not aligned vertically, but tilted at an angle.
  • 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.
  • the kink angle of the inserted hose towards the top of the housing of the system is reduced.
  • 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.
  • 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.
  • the system comprises at least two, preferably three, cascaded valve nodes, which each have connections for the source container.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the directional control valve is actuated via a driver on the system side.
  • this driver can be arranged both on the main module described above and on the scale module.
  • the directional control valve is operated manually.
  • the directional control valve is part of the valve unit, in particular inseparably connected to the valve unit.
  • 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.
  • 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.
  • waste bag 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.
  • an edge in particular a circumferential edge of the receptacle, forms a form-locking element for the snap-on valve node.
  • 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.
  • the housing of the valve node comprises a web on the underside which, in the locked state, engages under the edge of the receptacle.
  • a resilient handle is preferably arranged, which also has a web which engages under the edge of the receptacle in the locked state.
  • 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.
  • 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.
  • liquids can be transferred from a plurality of source containers into a target container.
  • the system comprises at least two pumps.
  • 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.
  • a pump is used as a smaller pump, into which a hose with a smaller diameter is also inserted.
  • the pumps are connected in series.
  • pumps are connected in parallel, it being possible to switch back and forth between the pumps, preferably via a directional valve.
  • 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.
  • valve unit 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.
  • 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.
  • 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.
  • the flow sensor it is possible to use the flow sensor to detect occlusions even when dosing microns.
  • the hose can relax and the micro-quantity apparently removed from the source container is sucked in from the other source container .
  • 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 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.
  • the system comprises a device for wireless transmission of a user ID.
  • 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.
  • Figures 23 to 28 are the possible deviations of the system compared to the in FIGS. 1 to 22 shown system.
  • 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.
  • a scanner 12 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.
  • 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.
  • the weighing pan 7 is inclined obliquely upwards in relation to a horizontal plane in the direction of the main module 2.
  • 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.
  • 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.
  • the desired preparation can be transferred to the target container 6 in a computer-controlled manner by means of the hose pump 9.
  • valves 63 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.
  • valve 63 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.
  • UI Universal Ingredient
  • 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.
  • 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.
  • the screen module 4 can be shifted to the left.
  • 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.
  • 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.
  • the underframe 11 has receptacles 18 for the rods 8, to which the swelling containers 5 can be attached.
  • 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. 11 shows a perspective view of the underside of the underframe 11.
  • the underframe 11 has a plurality of feet 19, which can be designed, for example, as inserted or glued-on elastomer elements.
  • 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.
  • 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.
  • 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. 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.
  • valve nodes 10a to 10c are arranged on the upper side of the housing of the main module 2.
  • valve nodes 10a to 10c each have two connections 29a to 29f.
  • valve nodes 10a to 10c 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.
  • connection 29a 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.
  • 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 ).
  • connections 32a to 32l are an integral part of the housing 31 of the valve node 10c.
  • connection 29f is closed with a plug 34.
  • Fig. 10 shows a perspective view of the underside of the valve node 10a.
  • connections 29a and 29b can be clearly seen in this view.
  • a central channel 62 extends between the connections 29a and 29b.
  • valves 63 are designed as 3-way valves. As a result, there are only half as many actuators 35a-35f as connections 32a-32l.
  • valves 63 which are designed as 3/3-way valves with a closed central position.
  • 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.
  • 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.
  • 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.
  • 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.
  • connections 38 can be seen, which in this exemplary embodiment are designed as Luer lock connections with a connected spike.
  • FIG. 13 is a reduced perspective view of the hose 36 for connecting the target container 8.
  • connection 29a of the valve node 10a This is connected to the connection 29a of the valve node 10a and comprises a connection 39 for the target container 6.
  • 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.
  • the pump 9 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.
  • 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.
  • 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.
  • 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.
  • housing 41 has a beveled upper 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 ⁇ with respect to this vertical plane.
  • the angle ⁇ is preferably between 20 ° and 40 °, in this exemplary embodiment the angle ⁇ 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.
  • the touchscreen 56 comprises connections 57 for connection to the main module 2.
  • FIG. 4 is another perspective view of the screen module 4.
  • the base 54 has a recess 58.
  • the base 54 is designed like a fork.
  • 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.
  • valve nodes 10a and 10b as well as 10b and 10c are each connected to one another with a hose 61.
  • 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.
  • valve nodes 10a to 10c are cascaded in this way.
  • 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.
  • the drivers 31 for the actuating members 35a-35f of the valve node 10a protrude from the plate-shaped receptacle 30a.
  • the drivers 31 can also be countersunk into the receptacle 30a (not shown).
  • valve node 10a The underside of the valve node 10a is shown in FIG Fig. 21 to see.
  • 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.
  • 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.
  • the housing 33 can be designed as a plastic injection-molded part.
  • the handle 66 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the installation 1 a has a plurality of swelling containers 5.
  • 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.
  • 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.
  • system 1a can be designed in the same way as the system 1 described above.
  • the system comprises a directional control valve 70 which is arranged in front of the target container 6a.
  • 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.
  • the directional valve 70 is actuated by a driver present on the system side.
  • 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.
  • the pumps 9a and 9b are not connected in series.
  • 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.
  • the pump 9b has a smaller delivery rate than the pump 9a and is used for metering micro-quantities.
  • Fig. 25 is another exemplary embodiment of a system 1c with two pumps 9a, 9b.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • the target container 6a can also be designed as a container with only one chamber.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Nutrition Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
EP20199834.1A 2016-03-15 2017-03-15 Équipement pour fabriquer une préparation médicale Active EP3795132B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24195306.6A EP4438024A3 (fr) 2016-03-15 2017-03-15 Installation de production d'une préparation médicale

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16160331 2016-03-15
PCT/EP2017/056099 WO2017158009A1 (fr) 2016-03-15 2017-03-15 Installation pour élaborer une préparation médicinale
EP17710550.9A EP3429545B1 (fr) 2016-03-15 2017-03-15 Installation pour élaborer une préparation médicinale

Related Parent Applications (2)

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EP17710550.9A Division EP3429545B1 (fr) 2016-03-15 2017-03-15 Installation pour élaborer une préparation médicinale
PCT/EP2017/056099 Previously-Filed-Application WO2017158009A1 (fr) 2016-03-15 2017-03-15 Installation pour élaborer une préparation médicinale

Related Child Applications (1)

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EP24195306.6A Division EP4438024A3 (fr) 2016-03-15 2017-03-15 Installation de production d'une préparation médicale

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EP3795132A2 true EP3795132A2 (fr) 2021-03-24
EP3795132A3 EP3795132A3 (fr) 2021-07-21
EP3795132C0 EP3795132C0 (fr) 2024-08-21
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EP24195306.6A Pending EP4438024A3 (fr) 2016-03-15 2017-03-15 Installation de production d'une préparation médicale
EP20199834.1A Active EP3795132B1 (fr) 2016-03-15 2017-03-15 Équipement pour fabriquer une préparation médicale

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EP24195306.6A Pending EP4438024A3 (fr) 2016-03-15 2017-03-15 Installation de production d'une préparation médicale

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US (4) US11000451B2 (fr)
EP (3) EP3429545B1 (fr)
ES (2) ES2992953T3 (fr)
PL (1) PL3795132T3 (fr)
WO (1) WO2017158009A1 (fr)

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Publication number Publication date
US20250281359A1 (en) 2025-09-11
PL3795132T3 (pl) 2024-11-25
WO2017158009A1 (fr) 2017-09-21
US20190083360A1 (en) 2019-03-21
US12201587B2 (en) 2025-01-21
US11000451B2 (en) 2021-05-11
EP4438024A3 (fr) 2025-01-08
US20210369568A1 (en) 2021-12-02
EP3795132C0 (fr) 2024-08-21
US20240180782A1 (en) 2024-06-06
EP3795132A3 (fr) 2021-07-21
EP3429545A1 (fr) 2019-01-23
EP3795132B1 (fr) 2024-08-21
EP4438024A2 (fr) 2024-10-02
ES2992953T3 (en) 2024-12-20
ES2833926T3 (es) 2021-06-16
US11793723B2 (en) 2023-10-24
EP3429545B1 (fr) 2020-10-28

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