EP2727574A1 - Préparation de solutions d'infusion - Google Patents

Préparation de solutions d'infusion Download PDF

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Publication number
EP2727574A1
EP2727574A1 EP12190973.3A EP12190973A EP2727574A1 EP 2727574 A1 EP2727574 A1 EP 2727574A1 EP 12190973 A EP12190973 A EP 12190973A EP 2727574 A1 EP2727574 A1 EP 2727574A1
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EP
European Patent Office
Prior art keywords
substance concentrate
water
infusion
substance
situ
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.)
Withdrawn
Application number
EP12190973.3A
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German (de)
English (en)
Inventor
Torsten Baumann
Nils Breuer
Thomas Schmidt
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to EP12190973.3A priority Critical patent/EP2727574A1/fr
Publication of EP2727574A1 publication Critical patent/EP2727574A1/fr
Withdrawn legal-status Critical Current

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    • 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

Definitions

  • the invention relates to a device for the in situ provision of administrable, preferably pure, infusion solutions for the treatment of humans or animals. Furthermore, the invention relates to a use of such a device and to a use of at least one substance concentrate container.
  • the patients are supplied or treated with infusion solutions.
  • the aqueous infusion solutions are provided in already administerable form in bags or bottles with a low concentration, for example, with salts in water or saline solutions, the manufactured on an industrial scale, finished infusion solutions from the containers, such as bags or bottles gravity driven into the patient be infused.
  • the object of the invention is to provide as needed for the treatment of patients infusion solutions, the logistical effort is to be significantly reduced.
  • a device for in-situ delivery of administerable, preferably pure, infusion solutions for the treatment of humans or animals with a water sterilization device by means of drinking water to sterile water is prepared or processed, with a receiving device for receiving at least one A substance concentrate container, wherein the substance concentrate container is filled or filled with a water-soluble substance concentrate for the infusion solution, and with a mixing unit for mixing and / or providing an infusible solution for administration from the sterile water dispensed from the water sterilization device and a portion of that in the Receiving device arranged and arranged substance concentrate container dispensed substance concentrate and with a discharge line for in-situ infusion of the infusion solution.
  • the invention is based on the idea that is provided by a mobile and / or stationary device as needed in the presence of the patient adapted to this patient infusion solution for a direct infusion, wherein the preparation of the infusion solution through the device directly on site on the patient, ie in-situ.
  • the device Since, for example, in hospitals or medical practices, water is generally available in the form of drinking water, the device is or is connected to a drinking water connection in the patient's treatment room, whereby the water provided by the drinking water connection becomes sterile Water is treated so that the treated sterile water, a portion or an amount of a substrate concentrate is added from a substance concentrate container and mixed with this. This will provide a prompt infusion solution for a direct low concentration infusion for immediate patient care.
  • the substance concentrate container is provided as a packaging for a substance concentrate, wherein for producing the ready-to-administer infusion solution for in-situ infusion of a patient, a substance concentrate amount is metered mixed with a predetermined amount of sterile water.
  • a mixing unit is provided which comprises, for example, a mixing container or a container for mixing and / or a mixing tube.
  • the prepared, sterile water it is likewise possible for the prepared, sterile water to be passed through the substance concentrate container for the provision of the infusion solution for immediate use, so that a portion of the substance concentrate in the container is flushed out.
  • the advantage of the invention is that sterile substance concentrate containers are used, each with a substance concentrate, whereby a high storage requirement compared to finished bags and / or bottles is reduced with infusion solutions. In addition, the disposal of unneeded infusion solutions is minimized, since possibly only the substance concentrates and possibly their packaging are to be disposed of.
  • a further advantage of the invention is that infusion solutions are produced individually for a patient and administered immediately after their preparation for the treatment of the patient. This will be right at the place of use or treatment provided by patients the infusion solution.
  • the device is characterized in that the water sterilization device at least one, preferably operated with reverse osmosis, UV light and / or other sterilization process, sterile filter, e.g. Reverse osmosis filter, for the treatment of drinking water to sterile water and / or a connection for connecting the water sterilization device to a drinking water supply, in particular a drinking water connection has.
  • sterile filter e.g. Reverse osmosis filter
  • Such sterile filters are also known under the name "sterile filter”.
  • a further embodiment of the device is characterized in that a substance concentrate metering device is provided, such that portions of the substance concentrate metered from the substance concentrate container can be fed to the sterile water.
  • a substance concentrate metering device is provided, such that portions of the substance concentrate metered from the substance concentrate container can be fed to the sterile water.
  • a plurality of receiving devices are provided for receiving a plurality of substance concentrate containers. Characterized in that at the same time a plurality of substance concentrate containers are received in the device, various substances from the corresponding substance concentrate containers of a solution or the sterile water can be supplied and mixed with this for producing the demand-based infusion solution, whereby, for example, salts from a concentrate container and from a another concentrate container electrolytes for the preparation of the infusion solution are delivered.
  • corresponding substance concentrate dosing means are also provided for a plurality of substance concentrate containers in order to add and mix in a metered manner from the plurality of absorbed substance concentrate containers corresponding concentrates to the sterile water.
  • a control device or a control device for the water sterilization device is provided, whereby the water sterilization device is regulated by means of the control device or the water sterilization device is controlled by the control device.
  • the device is characterized in that a control device or a control device for the substance concentrate metering device is provided, whereby for mixing at least part or an amount of a substance concentrate this is mixed with a predetermined amount of sterile water.
  • a mixing device for the dispensed substance concentrate amount and the dispensed sterile amount of water can be provided within the scope of the invention.
  • a device for measuring the concentration of dissolved substance in the infusion solution, wherein in particular the measuring device with the control device for controlling the water sterilization device and / or with the control device for controlling the at least one substance concentrate metering device for the substance concentrate contained in the substance concentrate container is connected.
  • a measuring device for measuring the concentration of dissolved substance in the infusion solution
  • this makes an exact amount of concentrate in the sterile Water dissolved substance, for example, by weighing or by a Infusiomaten achieved.
  • Another measuring device is provided for example by a weighing device.
  • a pump device in particular a peristaltic pump, is provided for the immediate administration of the infusion solution, wherein in particular the pump device is provided with the mixing unit for the provided (in situ) infusion solution is connected.
  • the pump device can also serve to build up a pressure in order to prevent a further sterile filter which may optionally be arranged in a delivery line from becoming clogged.
  • an input device to be provided for input of production process-related data, in particular control parameters or control parameters, and / or a display device for display of, in particular process-related, data.
  • a central programming unit or a central control unit corresponding parameters for the manufacturing process of an in-situ infusion solution by means of the device are specified, so that, for example, the flow rate of the sterile water or the release rate of a substance concentrate amount and the concentration the solute is given in the infusion solution.
  • the display device for example a display, the corresponding parameters or data are displayed to a user or user.
  • an embodiment of the device according to the invention is characterized in that the device is designed as a compact device or a structural unit, e.g. Module or the like, is formed, in particular, the device is designed as a kind of trolley or as a trolley, wherein the compact device or the assembly is particularly stationary, fully mobile or portable.
  • a mobile device it is possible to transport or move the device, for example in a hospital, from patient room to another patient room, wherein the infusion tubes are exchanged for reasons of sterility, for example during a user change or change of use.
  • the device is disconnected from a drinking water connection and correspondingly reconnected, for example in another room, to a water connection present there. Due to the manageable, compact size of the device, the device can be moved in configuration as a trolley in a simple way from one user space to another user space.
  • the trolley has corresponding rolling means or rollers.
  • the device comprises a, in particular fully mobile, water reservoir, so that even temporarily can be dispensed with a fixed water connection.
  • the object is achieved by using a device for the in-situ production or in-situ production of administrable, preferably pure, infusion solutions for the treatment of humans or animals, wherein the device is designed as described above and wherein at least one Substance concentrate container with one in the substance concentrate container concentrated substance or substance concentrate is used for the in situ provision of infusion solutions.
  • the substance concentrate container provided as packaging for the substance concentrate is designed as a capsule or as a pad or as a cartridge or as a bag, resulting in simple handling of the substance concentrate container.
  • the substance concentrate container is inserted when inserted into the designated receiving device for receiving a substance concentrate container or disposed therein, so that for the production of an in-situ infusion solution small metered amounts of the substance concentrate are discharged in the substance concentrate container.
  • a further solution of the object is achieved by using at least one substance concentrate container with a substance concentrate located in the substance concentrate container and intended for the infusion solution for in-situ delivery of infusible solutions for in situ infusion of humans or animals for one or in combination with one above-described device for the in situ provision of administerable infusion solutions, wherein in particular the substance concentrate container is designed as a capsule or as a pad or as a cartridge or as a bag.
  • the substance concentrate in a substance concentrate container has concentrated electrolytes and / or half-electrolytes and / or nutrients and / or vitamins and / or nutritional supplements and / or ingredients for an enteral or parenteral nutrition and / or medicaments, in particular for chemotherapy.
  • Fig. 1 schematically the basic structure of a mobile device 10 for in-situ provision or production of infusion solutions for direct administration or immediate infusion of patients is shown.
  • the device 10 is designed as a mobile cart or as a mobile trolley.
  • the device 10 has a housing or (driving) frame, wherein a processing unit 12 for the production of sterile water is arranged in the housing.
  • a processing unit 12 for the production of sterile water is arranged in the housing.
  • the chassis can be omitted.
  • the treatment unit 12 is formed, for example, with a sterile filter or a reverse osmosis filter, wherein by means of the treatment unit 12 drinking water is treated to sterile water.
  • the processing unit 12 has an input side Terminal 14, so that the treatment unit 12 is connected by means of a connected to the terminal 14 hose 16 with an external water connection 18, for example, a treatment room or is.
  • tap water or drinking water is supplied to the processing unit 12.
  • tap water is processed to sterile water by osmotic methods (reverse osmosis) or by a sterile filter or comparable measures.
  • This sterile water thus forms the basis substance of the infusion solutions to be produced.
  • an output-side discharge line 20 the treated sterile water is dispensed for infusion solutions to be produced from the treatment unit 12.
  • the device 10 with receptacles 22 for receiving sterile cartridges 30, 32 is formed so that in the receptacles 22 cartridges 30, 32 are arranged.
  • the cartridges 30, 32 are filled with different highly concentrated substances for the infusion solution.
  • a controllable or controllable metering unit 40, 42 is provided for each cartridge.
  • the dosing units 40, 42 are activated, predetermined metered amounts of substance concentrates are provided from the cartridges 30, 32 for the preparation of the in-situ infusion solutions.
  • the substance concentrate quantities discharged from the cartridges 30, 32 are fed via a discharge line 24 to the sterile water supplied from the discharge line 20 and mixed with one another, so that via a common delivery line 26 formed Mixing unit, the sterile water and the delivered substance concentrate amounts are mixed together.
  • the mixture ie the prepared in situ infusion solution, is carried away by means of a peristaltic pump 28 via an infusion tube 50 and, for example, infused into a patient.
  • measuring devices for concentrating the substance dissolved in the infusion solution present in the container 28 can be provided in a development of the device 10 in order to set a desired concentration of the substance in the infusion solution.
  • the highly concentrated substance concentrates in the cartridges 30, 32 can be present in liquid form or as dry substance.
  • the exact metered supply of a substance concentrate amount is achieved in one embodiment of the device by a weighing unit, suitable sensor technology or metering technique or by a Infusiomaten.
  • the infusion solution is further tested by a measuring device with regard to the correct concentration ratios of the substances in the infusion solution provided, with a double test in particular being carried out for this purpose.
  • a further sterile filter 36 is provided to avoid a risk of infection of the patient before the infusion solution to a patient.
  • a peristaltic pump system is furthermore provided, which is used in particular as a disposable tube system in a patient-related manner and is exchanged during a user change. Others too Pump systems and infusion systems can be used in the context of the present invention.
  • an input unit 52 is provided in the device in order to make appropriate parameters or programs for the production of infusion solutions for the operation of the device 10.
  • a display 54 is provided for controlling the set production parameters or the set infusion program.
  • the sterility of the device 10 is achieved, for example, by inserting and processing the cartridges 30, 32 in a sterile manner. Alternatively, the sterility can also be achieved by a further sterile filter. Further, the device 10 may include a sterilizing port 56 so that a solution or water may be supplied to the device 10 via the sterilizing port 56 to sterilize the entire water-carrying units, by means of a heater the solution or water for sterilizing the device e.g. be heated to a temperature of at least 95 ° C or higher in the device 10. Furthermore, chemical processes can also be used for sterilization, for example the addition of acetic acid to the water-conducting units of the device 10.

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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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP12190973.3A 2012-11-01 2012-11-01 Préparation de solutions d'infusion Withdrawn EP2727574A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP12190973.3A EP2727574A1 (fr) 2012-11-01 2012-11-01 Préparation de solutions d'infusion

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP12190973.3A EP2727574A1 (fr) 2012-11-01 2012-11-01 Préparation de solutions d'infusion

Publications (1)

Publication Number Publication Date
EP2727574A1 true EP2727574A1 (fr) 2014-05-07

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EP12190973.3A Withdrawn EP2727574A1 (fr) 2012-11-01 2012-11-01 Préparation de solutions d'infusion

Country Status (1)

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EP (1) EP2727574A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0152051A2 (fr) * 1984-02-10 1985-08-21 Millipore Corporation Procédé et installation pour produire des solutions aqueuses et de l'eau stériles
WO1986000797A1 (fr) * 1984-07-25 1986-02-13 Green Cross Corporation Dispositif de melange de solutions de perfusion
EP0443324A1 (fr) * 1990-02-19 1991-08-28 Gambro Ab Système pour la peparation d'un fluide concentré
WO1992005814A1 (fr) * 1990-09-28 1992-04-16 Baxter International Inc. Procede et appareil de preparation de solutions a partir de concentres
US5511594A (en) * 1992-06-23 1996-04-30 Brennan; Eric L. Modular pharmacy system and pharmacy process
WO1996025214A1 (fr) * 1995-02-13 1996-08-22 Aksys, Ltd. Systeme modulaire pour dialyse a domicile

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0152051A2 (fr) * 1984-02-10 1985-08-21 Millipore Corporation Procédé et installation pour produire des solutions aqueuses et de l'eau stériles
WO1986000797A1 (fr) * 1984-07-25 1986-02-13 Green Cross Corporation Dispositif de melange de solutions de perfusion
EP0443324A1 (fr) * 1990-02-19 1991-08-28 Gambro Ab Système pour la peparation d'un fluide concentré
WO1992005814A1 (fr) * 1990-09-28 1992-04-16 Baxter International Inc. Procede et appareil de preparation de solutions a partir de concentres
US5511594A (en) * 1992-06-23 1996-04-30 Brennan; Eric L. Modular pharmacy system and pharmacy process
WO1996025214A1 (fr) * 1995-02-13 1996-08-22 Aksys, Ltd. Systeme modulaire pour dialyse a domicile

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