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EP3795132B1 - Équipement pour fabriquer une préparation médicale - Google Patents

Équipement pour fabriquer une préparation médicale Download PDF

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Publication number
EP3795132B1
EP3795132B1 EP20199834.1A EP20199834A EP3795132B1 EP 3795132 B1 EP3795132 B1 EP 3795132B1 EP 20199834 A EP20199834 A EP 20199834A EP 3795132 B1 EP3795132 B1 EP 3795132B1
Authority
EP
European Patent Office
Prior art keywords
valve
pump
target container
directional control
control valve
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.)
Active
Application number
EP20199834.1A
Other languages
German (de)
English (en)
Other versions
EP3795132A2 (fr
EP3795132A3 (fr
EP3795132C0 (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 EP3795132B1 publication Critical patent/EP3795132B1/fr
Publication of EP3795132C0 publication Critical patent/EP3795132C0/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 a system 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.
  • Plants for producing a medical preparation 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, if necessary also together with a medicinal product.
  • TPN Total Parenteral Nutrition
  • the scales used in conventional systems cannot produce very accurate weighing results. This is not only due to the tolerance of the load cell used, but also because, for example, a scale to which a target container is attached is subject to changing tensile forces of the connecting hose, which affects the measurement result.
  • EP1148936 discloses a system having the technical features of the preamble of claim 1.
  • 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 plant for producing a medical preparation according to claim 1.
  • 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 comprises 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 removed from a source container using the pump.
  • the user can program patient-specific recipes 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 dosing steps.
  • the system is modular and comprises at least one scale module and/or one screen module, as well as a main module with the pump.
  • a scale module is a device with a scale, which can preferably be installed next to the main module.
  • the scale module comprises at least one load cell and a holder for a target container.
  • the scale module can also comprise 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 in addition to or as an alternative to the scale module.
  • a modular component in the form of a screen is therefore provided, via which the system can be operated, preferably via touch control.
  • the display 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 also comprises electronic control and regulation components, in particular a computer, with which the pump and the valves are controlled.
  • the main module preferably comprises the valve unit.
  • the valve unit is intended to provide a valve unit as a disposable component which is replaced after a predetermined period of use and/or after a predetermined volume has passed through.
  • valve unit preferably comprises hoses and connections for connecting the source containers, as well as a further connection for connecting the target container to the valve unit, which can also be designed as a hose.
  • connection hose for the target container is inserted into a peristaltic pump.
  • the transferred liquids only come into contact with the valve unit, which is designed as a disposable component, and not with other components of the system.
  • the modular design enables a compact design of the system, while at the same time the components are so light 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 ensures a defined, i.e. always the same, distance when the scale module is placed next to the main module.
  • the system comprises a frame on which the scale module and the main module are arranged in a defined position relative to each other.
  • the frame is designed in particular as a base frame on which the scale module and the main module can be placed.
  • the frame preferably comprises a receptacle for the main module and a receptacle for the weighing module, wherein the receptacles for the main module and the receptacles for the weighing module can have form-locking elements into which form-locking elements of the weighing module and the main module engage.
  • the frame has recesses, in particular holes, into which feet of the main module and the scale module can be inserted.
  • the frame has recesses, in particular holes, into which 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 is not in the way in the front area of the system.
  • the frame ensures that the main module and the scale module assume a defined position relative to one another. In particular, a constant distance between the connection of a target container and a connection on the system side is ensured.
  • This defined distance reduces fluctuating forces caused by the connection hose of the target container, which influence the weighing result.
  • the usually lighter scale module is protected against unintentional displacement due to its connection to the main module, which is preferably heavier than the scale module.
  • the weighing module comprises a weighing pan which at least partially spans a gap 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 upwards towards the main module.
  • a target container which is designed as an infusion bag, can be suspended 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 located approximately at the height of a system-side connection for the target container, which also reduces the introduction of forces onto the scale through the connection hose.
  • the screen module preferably comprises a touchscreen that can be pivoted on a hinge.
  • the screen module is not firmly connected to another component of the system, in particular to the frame, but can be freely positioned by the user of the system.
  • a screen with a base which can be positioned on the right and left side of the system so that the system can be easily adapted to be operated by right-handed and left-handed persons.
  • 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.
  • the system preferably the screen module, comprises a reader for an electronic memory, in particular a memory chip.
  • This memory is primarily used to easily identify the user of the system.
  • an RFID reader is provided in the screen module.
  • the user carries an RFID chip, for example on a card, and can use it to wirelessly log into the system in order to enable the system to be operated via the touchscreen.
  • the main module comprises a receptacle for a scanner.
  • the scanner enables barcodes to be read, 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 locations in order to adapt the system to different users, in particular right-handed and left-handed people.
  • the holder for the scanner is held magnetically to an upper housing front of the main module.
  • the holder for the scanner can comprise a magnet and can thus be easily removed.
  • the system comprises a pump, in particular a peristaltic 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, wherein the pump is arranged tilted relative to a vertical plane.
  • a vertical plane is understood to be the plane which, when the system is in its installed state, is spanned by vertically positioned outer edges of a system housing.
  • the position of the pump in particular the peristaltic pump, is defined by a plane that is perpendicular to the axis of rotation of a pump wheel of the peristaltic pump.
  • the plane described by the rotation of the pump wheel is not vertically aligned, but tilted at an angle.
  • the pump is tilted relative to the vertical plane at an angle of 10° to 80°, preferably 15° to 50°, particularly preferably 20° to 40°.
  • the pump is arranged at an angle on the front housing of the system.
  • the bend angle of the inserted hose towards the top of the system's housing is reduced compared to a non-tilted pump mounted on the front of the housing.
  • the tilting allows for a more compact design of the system.
  • an upper section of the housing front is angled. This means that not only the pump is angled but an entire section of the upper housing front on which the pump is mounted.
  • This angled section creates space for an angled screen, allowing for a more compact design.
  • the scanner or the holder for the scanner is preferably arranged in the angled section of the housing front, which also makes it easier for the user to reach the scanner.
  • the system comprises at least one pump, in particular a peristaltic pump, with which liquids can be transferred from a plurality of source containers into a target container.
  • the system preferably comprises at least two, preferably three, cascaded valve nodes, each of which has connections for the source containers.
  • valve units for this type of system are preferably designed as disposable components.
  • a valve unit has a plurality of valves that can be opened and closed via an actuator in order to control the dosage from different source containers.
  • Drivers for the actuators are provided on the system side.
  • the valve unit can be placed on the system and the valves can be opened and closed via the drivers, which are operated by a computer on the system side.
  • valve units with a large number of valves are usually used, even if the system is then only operated by the user with a few source containers.
  • the invention provides that at least two valve nodes are arranged in a cascade, i.e. 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 has 4 to 20 connections for each source container.
  • a valve unit with cascaded valve nodes preferably comprises 2 to 4 valve nodes.
  • the cascaded valve units are attached to a receptacle on a housing, in particular snapped on, and connected by means of hoses. This makes it possible to easily provide valve units with a different number of valve nodes.
  • system can easily be offered by the manufacturer 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, which has a correspondingly larger number of connections for source containers.
  • the user can also temporarily use different valve units with a different number of valve nodes, depending on how many source containers are in use.
  • the invention further preferably relates to a valve unit for a system as described above, which comprises at least two valve nodes which are connected to a hose.
  • This hose carries fluid from an external valve node via an internal valve node to a connection for a target container.
  • the system comprises at least one pump, in particular a peristaltic 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 control valve is in particular a three-way valve which has an inlet from which the liquid can be directed, for example, into one or the other chamber of the target container.
  • the directional control valve is designed as a one-way component, so it is replaced regularly.
  • the directional control valve is connected to the target container.
  • the directional control valve can be inseparably connected to the target container and, after the filling process has been completed, is removed from the system together with the target container.
  • the directional control valve is actuated by a driver on the system side.
  • this driver can be arranged on both 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 is inseparably connected to the valve unit.
  • the directional control valve is designed as a separate disposable component which has connections for the target container and a further connection for connecting to the valve unit present on the system.
  • the directional control valve can also be used to connect another target container parallel to the target container, in particular a target container which serves as a so-called "waste bag” and is therefore 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 system has at least one valve node, which can in particular be part of a valve unit.
  • the valve assembly can be snapped onto a holder.
  • the receptacle is designed in particular as a plate which comprises drivers for actuating elements of the valve node, which can in particular protrude from the plate.
  • an edge, in particular a peripheral edge of the receptacle forms a positive locking element for the snap-on valve node.
  • the valve assembly has locking means for locking onto the holder.
  • the housing of the valve manifold comprises a web on the underside which, when latched on, engages under the edge of the receptacle.
  • a spring-loaded handle On the side of the housing opposite the web, there is preferably a spring-loaded handle, which also has a web that, when locked in place, grips under the edge of the holder. Using the spring-loaded handle, the web can be pulled out over the spring-loaded tab under the edge to remove the valve assembly and the valve assembly can be removed.
  • valve assembly can also be removed from one side using a handle that is only available on one side.
  • the system can transfer liquids from a number of source containers to a target container.
  • the system comprises at least two pumps.
  • the pumps are designed as peristaltic pumps.
  • the smaller pump delivers a smaller quantity in one full revolution of the impeller, in particular a quantity that is less than half as large as the quantity that the larger pump delivers in one revolution of the impeller.
  • the quantity is understood to be 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, whereby switching back and forth between the pumps can be carried out, preferably via a directional control 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 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 to be inserted into the smaller pump, and a second section with a larger diameter which is designed to be inserted into the larger hose pump.
  • This system also includes a peristaltic pump with which liquids can be transferred from a plurality of source containers to a target container.
  • the system comprises a combined flow/bubble sensor.
  • the flow/bubble sensor is designed as an ultrasonic sensor and detects both when bubbles are transported through the hose and the flow velocity of the medium transported in the hose.
  • the bubble sensor can be used to prevent incorrect fillings, for example after a source container has been completely emptied or if air is drawn in before the combined flow/bubble sensor.
  • the flow sensor can be used to control the amount of liquid pumped by the pump(s).
  • the flow sensor it is possible to use the flow sensor to detect occlusions even when dosing micro quantities.
  • the hose can relax and the micro-quantity apparently taken from the source container is sucked in from the other source container.
  • the combined flow/bubble sensor is therefore preferably arranged, with respect to the flow direction, behind a valve unit and in front of a pump.
  • the tubes connecting the source containers to the valve unit are usually of significantly smaller diameter, so that the dead volume present through these tubes is lower, which in turn means that the risk of apparent flow despite occlusion due to contracting tubes is lower.
  • the combined sensor can be used to check for bubbles and to check the flow rate at a single central location, especially close to the valve unit.
  • the system preferably comprises a device for wirelessly transmitting a user ID.
  • This can in particular be the reader based on RFID technology described above.
  • 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 the ease of use and the safety of using the system.
  • Fig.1 shows in a perspective view a plant 1 for the production of a medical preparation in the form of parenteral nutrition preparation.
  • System 1 is modular and includes a main module 2.
  • the main module 2 comprises a pump 9, which is designed as a peristaltic pump.
  • the main module 2 further comprises a scanner 12 with which recipe data or barcodes on target containers 5 and/or source containers 6 can be read.
  • valve nodes 10a to 10c are arranged on the top of the main module, which together form a valve unit.
  • the valve nodes 10a to 10c are connected in a cascade, which is explained in more 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 mounted on a base frame 11, which ensures a constant position of scale module 3 and main module 2 in relation to each other.
  • the gap 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 upwards relative to a horizontal plane in the direction of the main module 2. This also moves the connection of the target container 6 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 source containers 5 are arranged are also visible.
  • the source containers 5 are connected to the valve nodes 10a to 10c via hoses 37. Furthermore, the valve nodes 10a to 10c are arranged in a cascade 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 into the target container 6 under computer control by means of the peristaltic pump 9 via the valve unit 60 consisting of the valve node 10a to 10c.
  • one of the valves 63 is opened so that the pump 9 pumps liquid from a source container 5 into the target container in a dosing step.
  • the next valve 63 is then opened. Liquids are taken from the various source containers 5 until the filling process is completed.
  • valve 63 is used during each individual dosing step (see e.g. Fig.9 ), which leads to a source container 5, is opened. Liquid is therefore only ever taken from one source container 5.
  • each preparation contains a so-called universal liquid, also referred to as "Universal Ingredient” (UI).
  • UI Universal Ingredient
  • This liquid may come into direct contact with any other ingredient without undesirable side effects and is used in a relatively large quantity in each preparation, in particular to top up the preparation to the desired total quantity.
  • the universal liquid is usually isotonic water.
  • the screen module 4 which has a touchscreen for operating the system 1, is freely movable relative to the base frame 11 and thus relative to the remaining system components.
  • the screen module 4 can be moved to the left.
  • the scanner 12 can be mounted further to the right.
  • Fig. 2 shows a perspective view of the base frame 11.
  • the base frame 11 has a holder 13 for the scale module 3.
  • the holder 13 comprises holes 14 into which feet 28b of the scale module 3 can be inserted.
  • the base frame 11 also has a holder 15 for the main module 2.
  • the holder 15 protrudes like a fork from the rest of the base frame 11.
  • the holder 15 for the main module 2 also comprises holes 16 into which two feet 42b of the main module 2 can be inserted.
  • scale module 3 and main module 2 When installed, scale module 3 and main module 2 are firmly positioned in relation to each other in the horizontal plane.
  • the distance between scale module 3 and main module 2 is determined by section 17 of base frame 11.
  • the base frame 11 has, behind the holder 15 for the main module 2, holders 18 for the rods 8 to which the source 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 medicinal preparation are supplied can be hung on a rack remote from the system by means of hooks (not shown).
  • Fig.3 shows a perspective view of the underside of the base frame 11.
  • the base frame 11 has a plurality of feet 19, which can be designed, for example, as inserted or glued-on elastomer elements.
  • recesses 20 are provided on the underside of the base frame 11 to improve ventilation under the main module 2.
  • Fig.4 shows a perspective view of the base frame 11, into which the rods 8 are now inserted, which serve to attach the source containers 5.
  • the rods 8 consist of a lower part 8a and an upper part 8b and are telescopically extendable.
  • holders 21 for the source containers 5 can be attached to the rods 8, which are preferably designed to be height-adjustable. This ensures flexible adaptation to different types and sizes of source containers 5.
  • the modular concept means that the base frame 11 is fixed in the erected state by the heavier main module 2, which simultaneously means that the rods 8 connected to the base frame 11 are secured against tipping over.
  • Fig.5 shows a perspective view of the scale module 3.
  • the scale module 3 comprises a housing 26 in which the load cell (not shown) and possibly other electronic components for control and regulation are arranged.
  • the weighing pan 7 is designed in the shape of a slide or trough. In this view, a target container 6 is suspended in the pins 27 of the weighing pan 7. This ensures a defined positioning of the target container 6 on the weighing pan 7.
  • the weighing pan 7 is mounted on the scale 22 in which the load cell is arranged.
  • the weighing pan 7 also 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 system-side connection 39 of the valve unit 60.
  • Fig.6 is another 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 holes 14 of the base frame 11.
  • an electrical connection 40 with which the scale 22 is connected to the main module 2.
  • a plug connection is 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 top 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 with hoses 61 not shown here (see also e.g. Fig. 19 ).
  • the connections 29b and 29c as well as the connections 29d and 29e are connected.
  • connection 29a is connected to a hose 36 which leads to the target container 6 (see also e.g. Fig. 19 ).
  • Port 29f is closed.
  • Fig.8 is another detailed view, in which Fig.7 the valve nodes 10a to 10c are removed.
  • valve nodes 10a to 10c can be snapped onto the system-side mounts 30a to 30c.
  • Each of these receptacles 30a to 30c comprises drivers 31, which in this embodiment are designed like a screwdriver, and which serve to move the actuating members 35a to 35f, with which the valves 63 of the valve unit 60 can be actuated (see also e.g. Figs. 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 containers 5.
  • Each of the connections 32a to 32l is connected to a hose 37 which leads to a source container 5 (see also e.g. Fig. 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.
  • a central channel 62 extends between the connections 29a and 29b.
  • valves 63 are designed as 3-way valves. Consequently, there are only half as many actuating elements 35a-35f as there are connections 32a-32l.
  • valves 63 which are designed as 3/3-way valves with a closed center position.
  • connection 32e or 32f can be opened via the actuating element 35a.
  • the individual valve nodes 10a to 10c are preferably designed identically.
  • the actuating elements 35a to 35c are in the closed middle position, whereas the actuating elements 35d to 35f are in the open position and have opened an inlet.
  • Fig. 11 shows a valve node 10a with hoses 36, 37.
  • the hoses 37 are used to connect the source containers 5, and the hose 36 is led through the pump 9 and is used to connect the target container 6.
  • the hoses 36 and 37 are connected to the connections 29a to 29f and 32a to 32l of the respective valve node 10a to 10c in such a way that they cannot be removed without causing damage.
  • the valve unit 60 which consists of the valve nodes 10a to 10c and hoses 36, 37, is thus designed as a disposable component.
  • Fig. 12 shows a detailed view of the end of the hoses 37 for connecting the source containers 6.
  • connections 38 can be seen, which in this embodiment are designed as a Luer-Lock connection 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 includes 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 spring-loaded.
  • 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 recordings 30a to 30c.
  • a combined flow/bubble sensor 46 and a hose holder 47 are arranged on the top of the housing 41.
  • the hose 36 connected to the valve node 10a is first inserted into the housing of the combined flow/bubble sensor 46, then passed through the hose pump 9 and finally through the hose holder 47.
  • the main module 2 has an electrical connection 44 for the screen module 4 on one side and an electrical connection 43 for the scale module 3 on the other side.
  • the holder 59 for the scanner 12 includes a magnet and can be easily removed. For example, it can be placed on the form-locking element 45 in order to convert the system 1 to operation by a left-handed person.
  • Fig. 15 shows another 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 scale module 3.
  • housing 41 has a bevelled upper housing front 53.
  • the vertical plane is spanned by the vertically running straight lines 52 shown here, which are arranged at the corners of the housing 41.
  • the pump wheel 50 or its top side, which can be seen here, and thus the entire pump 9, is tilted by the angle ⁇ relative to this vertical plane.
  • the angle ⁇ is preferably between 20° and 40°; in this exemplary embodiment, the angle ⁇ is approximately 30°.
  • This design makes the pump 9 easily accessible in order to insert the hose 39 and/or to clean the pump after removing the pump wheel 50.
  • the screen of the screen module 4 can be pivoted 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 touchscreen 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 includes connectors 57 for connection to the main module 2.
  • Fig. 18 is another perspective view of the display module 4.
  • the base 54 has a recess 58.
  • the base 54 is thus formed in a fork-like manner.
  • 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 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 each other by a hose 61.
  • connection 29f is closed and the opposite connection 29a is connected to the hose 36 which is led through the pump 9 and which is connected to the target container 6.
  • All connections 32a-32l of each valve unit 10a-10c are thus 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 arranged in a cascade.
  • valve unit 60 can be used which, as shown here, has three valve nodes 10a-10c or only two or one valve node (not shown).
  • Fig. 20 is a detailed representation of the already shown figures Fig. 14 to Fig. 16 recognizable receptacle 30a for a valve node 10a.
  • the receptacle 30a comprises a base 65 and is plate-shaped above the base, with a peripheral edge 64 protruding.
  • the circumferential edge 64 serves as a form-locking element for the corresponding valve node 10a.
  • the drivers 31 for the actuating elements 35a - 35f of the valve node 10a protrude from the plate-shaped receptacle 30a.
  • the drivers 31 can also be recessed into the receptacle 30a (not shown).
  • 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 On the side opposite the web 68, a handle 66 is arranged, which is designed to be spring-loaded and also has a web 67 which, in the latched state, grips 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 as a single piece with the housing 33.
  • the housing 33 can be designed as a plastic injection-molded part.
  • 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 back towards the housing and the valve node 10a is locked via the web 68 and the web 67.
  • valve hub 10a can be easily removed from one side 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 hose 36 connecting 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 scale module 3.
  • the combined flow/bubble sensor 46 is thus arranged close to the valve unit 60.
  • the combined flow/bubble sensor 46 has a cover 71, which in this embodiment can be opened to one side so that the hose 36 can then be inserted.
  • the hose 46 is a sensor in which the evaluation electronics are integrated, which therefore outputs a measured value for the flow rate and another measured value for the presence or absence of bubbles in the hose 46.
  • the sensor can thus be connected to the evaluation electronics of system 1 via an interface.
  • an error message can be generated via the display unit 4.
  • Fig. 23 is a schematic principle sketch of an alternative embodiment of a system 1a, in which two possible modifications to the previously described system are to be described.
  • the system 1a has a plurality of source 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 during each 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 capacity than the pump 9b and is used to dose the main components of the medicinal preparation.
  • Both pumps 9a and 9b can in particular be peristaltic pumps, wherein a hose is inserted into the pump 9a which has a larger diameter than the hose inserted into the pump 9b.
  • the hose 36 which connects the valve unit 60 to the target container 6a, preferably comprises two sections with different diameters.
  • the smaller pump 9b allows micro quantities to be dosed with greater precision.
  • Annex 1a can be designed in the same way as Annex 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 system 1 can also be present alone, i.e. without the two pumps 9a and 9b, or that system 1a can only comprise 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 control valve 70 controlled by the system 1a.
  • the directional control valve 70 is preferably part of a one-way component.
  • the directional control valve 70 is actuated by a driver present on the system side.
  • the directional control valve 70 is operated manually, i.e. the user connects the target container 6a, first starts a filling process, for example for the chamber 69a, then switches the directional control valve 70 so that liquid can flow into the chamber 69b, and starts another filling process for the chamber 69b.
  • Fig. 24 is another embodiment of a system 1b with two pumps 9a, 9b. In contrast to the previously shown embodiment, the pumps 9a and 9b are not connected in series.
  • connection to the target container 6 branches off after the valve unit, as seen in the direction of flow. Via a directional valve 72, fluid can be fed either via the pump 9a or via the pump 9b.
  • the pump 9b has a smaller delivery capacity than the pump 9a and is used for dosing micro quantities.
  • connection to the target container 6 is reconnected. This can, as shown in this embodiment, be done via a directional control valve 73 to prevent fluid from flowing back towards the pump that is not currently operating.
  • Fig. 25 is another example of a system 1c with two pumps 9a, 9b.
  • valve units 60a, 60b are provided.
  • a portion of the source containers 5 is connected to the target container 6 via the valve unit 60a. Liquids from these source containers are pumped 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 pumped into the target container 6 via the pump 9b.
  • the pump 9b and the separate valve unit 60b are used for dosing micro quantities.
  • Both valve units 60a, 60b are each connected to a source container 5a, which contains universal liquid in order to be able to flush the valve units, among other things.
  • Fig. 26 is an embodiment of a system 1d with two pumps 9a, 9b.
  • a target container 6a with two chambers 69a, 69b is filled.
  • the chamber 69b is connected to a plurality of source containers 5, 5a via the pump 9a and the valve unit 60.
  • Liquid is transferred only to chamber 69b via pump 9a. Dosing from the various source containers is carried out by controlling the valve unit 60.
  • the other chamber 69a of the target container 6a is connected to the source container 5c via the pump 9b. Thus, only the second chamber 69a is 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 a plant 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, whereby the dosage from the various source containers 5 is controlled via the valve unit 60b.
  • the chamber 69b is filled accordingly via the pump 9a, whereby the dosage is controlled via the valve unit 60a.
  • a source container 5a with universal liquid is connected to each of the valve units for flushing.
  • Fig. 28 shows a further embodiment of a plant 1f for producing a medical preparation.
  • a directional control valve 74 is provided after the valve unit 60, as seen 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 waste bag which is connected at the same time as the target container 6a, can be used to flush the inlets to individual source containers 5 at any time, for example 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 replaced. Rather, a source container 5 can also be replaced while the target container 6a is connected.
  • the directional control 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.
  • a system 1f for producing a medical preparation shown here can also comprise two pumps, in particular as previously described with reference to Fig. 23 to 27 , was presented.
  • the invention makes it possible to provide a compact system for producing a medical preparation which is simple and safe to operate.

Landscapes

  • 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)

Claims (15)

  1. Équipement (1) de fabrication d'une préparation médicale, en particulier de fabrication d'une préparation d'alimentation parentérale, comprenant au moins une pompe (9), en particulier une pompe péristaltique, avec laquelle des liquides peuvent être transférés d'une pluralité de récipients sources (5) vers un récipient cible (6), dans lequel l'équipement (1) comprend à cet effet une unité de soupape (10a à 10c, 60), avec laquelle le raccordement à un récipient source (5) peut être ouvert, de sorte que le liquide puisse être retiré d'un récipient source (5) avec la pompe (9), caractérisé en ce que l'équipement (1) présente un distributeur (70) agencé dans le sens d'écoulement après la pompe (9), par l'intermédiaire duquel un récipient cible (6a) comportant au moins deux chambres (69a, 69b) peut être rempli et/ou deux récipients cibles différents peuvent être remplis.
  2. Équipement (1) selon la revendication précédente 1, caractérisé en ce que le distributeur (70) est agencé entre l'unité de soupape (10a à 10c, 60) et le récipient cible (6a).
  3. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70) est conçu comme une soupape au moins à trois voies qui présente une entrée à partir de laquelle les liquides peuvent être dirigés dans au moins l'une ou l'autre chambre (69a, 69b) du récipient cible (6a) ou dans les deux récipients cibles différents.
  4. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70) est conçu comme un composant à usage unique.
  5. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70) est raccordé au récipient cible (6a), de préférence de manière indissociable.
  6. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70) peut être actionné par l'intermédiaire d'un entraîneur côté équipement, dans lequel l'entraîneur peut être agencé sur un module principal (2) de l'équipement (1) ou sur un module de pesée (3) de l'équipement (1).
  7. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70) peut être actionné manuellement.
  8. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70) fait partie de l'unité de soupape (10a à 10c, 60) et est en particulier raccordé de manière indissociable à l'unité de soupape (10a à 10c, 60).
  9. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70) est conçu comme un composant séparé à usage unique qui présente des raccords pour le récipient cible (6a) et un autre raccord pour être raccordé à l'unité de soupape (10a à 10c, 60) présente côté équipement.
  10. Équipement (1) selon l'une des revendications précédentes, caractérisé en ce que le distributeur (70), en plus d'un remplissage d'un récipient cible (6a), peut être utilisé pour raccorder, en parallèle au récipient cible (6a), un autre récipient cible (75) qui sert de « sac à déchets ».
  11. Équipement (1) de fabrication d'une préparation médicale selon l'une des revendications précédentes, caractérisé en ce que l'équipement (1) est construit de manière modulaire et comprend au moins un module de pesée (3) et/ou un module d'écran (4) ainsi qu'un module principal (2) avec la pompe (9).
  12. Équipement (1) de fabrication d'une préparation médicale selon l'une des revendications précédentes, caractérisé en ce que l'unité de soupape (10a à 10c, 60) peut être encliquetée sur un logement (30a à 30c), qui est de préférence conçu comme une plaque, dans lequel un bord (64) de préférence périphérique du logement (30a à 30c) est conçu comme un élément de liaison par complémentarité de forme pour l'unité de soupape (10a à 10c, 60).
  13. Équipement (1) de fabrication d'une préparation médicale selon l'une des revendications précédentes, caractérisé en ce que l'équipement (1) présente au moins deux pompes (9a, 9b).
  14. Équipement (1) de fabrication d'une préparation médicale selon l'une des revendications précédentes, caractérisé en ce que l'équipement (1) présente au moins un capteur combiné de débit/bulle (46), qui est agencé de préférence derrière l'unité de soupape (10a à 10c, 60) et devant la pompe (9), par rapport au sens d'écoulement.
  15. Utilisation d'un distributeur (70) pour le rinçage des entrées des récipients sources (5) individuels dans un équipement (1) de fabrication d'une préparation médicale selon l'une des revendications précédentes, dans laquelle, parallèlement au récipient cible (6), un « sac à déchets » (75) est raccordé en tant qu'autre récipient cible dans lequel le liquide peut être transféré.
EP20199834.1A 2016-03-15 2017-03-15 Équipement pour fabriquer une préparation médicale Active EP3795132B1 (fr)

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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

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EP (3) EP3429545B1 (fr)
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US20190083360A1 (en) 2019-03-21
PL3795132T3 (pl) 2024-11-25
US12201587B2 (en) 2025-01-21
EP4438024A2 (fr) 2024-10-02
US20240180782A1 (en) 2024-06-06
EP3795132A2 (fr) 2021-03-24
EP3795132A3 (fr) 2021-07-21
US20250281359A1 (en) 2025-09-11
US11000451B2 (en) 2021-05-11
US20210369568A1 (en) 2021-12-02
ES2833926T3 (es) 2021-06-16
WO2017158009A1 (fr) 2017-09-21
ES2992953T3 (en) 2024-12-20
US11793723B2 (en) 2023-10-24
EP3429545B1 (fr) 2020-10-28
EP4438024A3 (fr) 2025-01-08
EP3429545A1 (fr) 2019-01-23
EP3795132C0 (fr) 2024-08-21

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