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EP2320851B1 - Procédé et dispositif pour le transfert d'une substance entre des systèmes fermés - Google Patents

Procédé et dispositif pour le transfert d'une substance entre des systèmes fermés Download PDF

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Publication number
EP2320851B1
EP2320851B1 EP09776032.6A EP09776032A EP2320851B1 EP 2320851 B1 EP2320851 B1 EP 2320851B1 EP 09776032 A EP09776032 A EP 09776032A EP 2320851 B1 EP2320851 B1 EP 2320851B1
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EP
European Patent Office
Prior art keywords
substance
closed
ampoule
closed system
sterile
Prior art date
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Active
Application number
EP09776032.6A
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German (de)
English (en)
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EP2320851A1 (fr
Inventor
Walter Pobitschka
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Individual
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Individual
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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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/22—Arrangements for transferring or mixing fluids, e.g. from vial to syringe with means for metering the amount of fluid
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • the present invention relates to a method for transferring a substance between closed systems, wherein the closed systems, namely at least one donor system and at least one target system, are at least simply sterile connected prior to transfer, whereby the substance passes into the target system, wherein after the transfer Substance, the target system and the donor system are sterile separated from each other and the pressure differences occurring during the transfer of the substance are compensated.
  • the present invention relates to a closed system for the transfer of a substance between the closed system and at least one other closed system, wherein the systems are sterile and mutually sterile separable from each other and having means for transfer of the substance.
  • sterile connection techniques such as the "sterile docking" and the "sterile Welding” are known, with which thermoplastic plastic tubes of two closed systems are connected to each other sterile and sterile again separated can.
  • the "DOCKING” is about the creation of cuts under the influence of temperature and the direct fusion of both ends of two plastic hoses.
  • the "WELDING” is about the separation of the connection, whereby a compression under temperature to form a homogeneous cross-sectional area and cutting, so that two closed cut surfaces arise.
  • the sterile connection can also be produced in a known manner independently of the aforementioned connection techniques such as “sterile docking" and "sterile welding” by mounting and welding plastic containers and hoses under clean room conditions and sterilization measures.
  • a concrete use case for matter or a substance to be introduced into the closed system refers to stem cells obtained by apheresis treatment of patient blood. Before a patient suffering from cancer undergoes chemotherapy, stem cells are taken from him. Only then does the patient receive chemotherapy. Since stem cells are broken down in this chemotherapy, the patient is later given the stem cells removed.
  • the apheresis treatment proceeds in such a way that blood is taken from the patient and transferred to a closed system. Centrifugal forces act in the closed system, breaking down the blood into constituents. Cell populations are separated that contain stem cells in order to secure them first. The remaining blood is returned directly to the patient.
  • the separated cell populations are provided according to their intended use with additives such as, for example, the patient's own plasma and foreign plasma.
  • This substance which is a cell suspension, must be preserved in order to be able to supply it later to the patient.
  • Preservation can only take place using the chemical compound dimethylsulfoxide, called in other DMSO, in a freezer bag for cryopreservation.
  • the chemical compound DMSO is used to concentrate the cell fluid in the preparation, there to differences between different to balance osmotic pressures. This protects the stem cell substance from cell destruction / bursting.
  • the freezing bag consists, for example, of ethylene vinyl acetate, a plastic which is also abbreviated to the abbreviation EVA.
  • the addition of the chemical compound DMSO poses the weak point in maintaining the closed system. Even adding DMSO through a filter such as DE 101 24 487 A1 It is not known that contaminants such as viruses or toxic gases can enter the closed system. Due to its aggressiveness towards plastics, DMSO can not be placed in bag systems by the manufacturer and subjected to a sterilizing pretreatment. A storage of the chemical compound DMSO is in any case longer term in chemically inert vessels, for example. Boroslicate glass, make with solvent-resistant closure.
  • the system deals with a bag system for the cryopreservation of body fluids DE 101 51 343 A1 ,
  • a bag system for the cryopreservation of body fluids DE 101 51 343 A1 .
  • the transfer takes place via a sterile connection, which was realized before the transfer in the production of the closed system.
  • a sterile separation takes place with disposal of the emptied donor systems filled in advance in a sterile manner.
  • this bag system is disadvantageous in terms of the transfer that no exact volume dosage is possible and that air bubbles can not be defined defined within the substance to be forwarded, but depends on the skill of the person handling the flexible bag. Air pockets in the substance can not be excluded and can adversely affect effects and results of later applications, for example, mixing operations.
  • the present invention seeks to provide a method and an apparatus, wherein a contamination-free transmission of a substance without gas inclusions between closed systems is made possible.
  • the method of the type in question is characterized in that the pressure differences within the closed system, which consists during the transfer of substance from sterile connected donor and Nehmersystemen and is sterile flow-connected with a pressure compensation device, are compensated, wherein displaced air or displaced inert gas without Contact with the ambient air in the pressure compensation device is collected and is available in connection with substance removal operations while avoiding vacuum.
  • a closed system of the type in question is characterized in that the system comprises a container that the container at least one Connection for sterile connection with at least one sterile connectable connection of the other system, that the container comprises a pressure compensation device to compensate for the pressure differences during the transfer within the interconnected, sterile, closed systems, which is fluidly connected to the container that the substance from the system , in particular under the action of the gravitational force, in the other closed system is transferable, wherein in the container of the system, a receptacle in the form of a bottle or ampoule is contained, within which the substance be the closure means in the operative position to the ground, wherein the means for transferring the substance comprises a short cannula for transferring the substance, in particular a liquid, and a long cannula for air or inert gas supply and wherein the cannulas in the operating position,
  • a closed system of the type in question is characterized in that the system comprises a container, that the container at least one connection to the sterile Connection with at least one sterile connectable connection of the other system, that the container comprises a pressure compensation device to compensate for the pressure differences during the transfer within the interconnected sterile, closed systems, which is fluidly connected to the container that in the container of the closed system as a means for Transmission of the substance is arranged a calibrated syringe with an ampoule flask and an ampoule body and that at least part of the wall of the container is designed so flexible that the syringe is at least partially from the outside via the flexible wall, in particular via a bellows actuated.
  • displaced air is advantageously not discharged into the ambient air, but collected in a pressure compensation device and is there in connection with substance removal operations available so that no vacuum is created.
  • the closed systems according to the invention can be used as disposables at the site of the preparation, for example in the blood bank or in the transplantation laboratory. Standardized industrially manufactured disposable articles according to the invention enrich the sterile work enormously and expand the application possibilities of substances.
  • One of the two alternative closed systems includes a donor system with an ampoule or bottle whose opening faces the floor.
  • the other of the two alternative closed systems involves a syringe.
  • the pressure equalization could take place wherever volume changes of the substance occur. As a rule, this could occur both with the encoder system and with the target system. In an application in which the donor system only from a sterile jacketed ampoule with sterile konnektierbarem transfer means, the pressure equalization could also be completely relocated to the target system and the resulting negative pressure in the donor system can be accepted, since the empty ampoule is disposed of after sterile separation from the target system.
  • Essential to the invention is the realization of a volume-accurate transfer of the substance, which is achieved in that the substance is transferred dosed.
  • semiquantitative dosing or dosing by means of calibrated dosing devices is included.
  • the substance could be actively transferred from the encoder system to the target system or actively removed from the encoder system.
  • calibrated syringes or carpules could be used with regard to a desired dosage.
  • the substance could enter the target system under the influence of gravitational force.
  • a dosage could be done here via a calibrated drip chamber.
  • Transmission means such as syringes, carpules, drip chambers, in turn, could form closed systems or be components of closed systems.
  • the encoder system could be connected sterile with several other target systems.
  • the multiple connection of the encoder system with one or more target systems could be successive or simultaneously possible. This allows a partial transfer of substance.
  • the target system becomes the donor system when the absorbed substance is passed on to another target system. Either this could happen after a first sterile connection and disconnection, or the device is designed to change function by opening and closing metering gates.
  • a Dosierabsperrung initially opened for receiving substance between the donor and target system is closed after filling the target system. If substance is then transferred from the filled target system to another target system by opening a further dosing shutoff, the filled target system now has a donor function.
  • the substance could preferably be introduced under clean-room conditions into the donor system in a sterile manner, which is then closed under sterile conditions to form the blister pack.
  • a container could be factory-filled and sealed under clean-room conditions, then reach the laboratory doctor, who makes a sterile connection to a target system and thus can transfer the prepared substance.
  • a differently stored, but equally simple embodiment provides to manufacture a container without substance at the factory, the means for transferring the substance - here for removal - from an example. Laboratory existing encoder system or supplied contains.
  • the closed system could be a donor system, a target system or even a system with donor and receiver function and have a container for the substance.
  • the container separates the environment from the interior of the closed system in which the substance could already be contained.
  • the pressure compensation device could be materially connected to the container and be present as a rubber bag. The connection of the pressure compensation device could be welded into the container, so that the closure of the system is not interrupted. Alternatively, the pressure compensation device could also be an integral part of the container via a special shaping process.
  • the means for transferring the substance could comprise at least one port for sterile connection to at least one port of another closed system.
  • the connection could be formed as a thermoplastic plastic tube.
  • the connection could also be connected to the container of the system in a cohesively sterile manner.
  • the connection or the plastic tube could have a length which allows a multiple sterile connecting and disconnecting.
  • multiple connections or plastic tubing could be provided for multiple connection to another closed system or to several other closed systems.
  • the closed system container could include a baseplate.
  • This base plate could consist of a rigid plastic and, for example, accommodate holding devices and / or connection points that affect the connection. So that the objects contained in the container are visible, the container could at least be transparent in the flexible areas of the wall. The transparency allows, for example, the metered substance removal or filling and - in a specific embodiment - the placement or mounting of the transfer means within the container. Otherwise, at least the view of the existing amount of substance is released by the transparency.
  • the container could also have a cover plate. Between the cover and the base plate, the flexible wall, in particular the bellows, or a sheath could extend.
  • a stabilizing element could be arranged, which contributes to the attachment of a container arranged within the receptacle for the substance during transport.
  • the holding devices could be assigned to the base plate and / or the cover plate and also exercise the function as a spacer or stabilizer on the holding function.
  • a particularly handling-friendly variant of the at least partially flexible container is that the flexible wall is designed in the form of a bellows.
  • This bellows could be strongly deformed in all directions due to the extremely tear-resistant and thin material, which could also be stretchable beyond. This deformation is reversible. Due to the low material thickness, objects located inside the container can be grasped, connected or positioned or otherwise manipulated. Because of the gripping movement, it is particularly important that the wall comprises at least two opposite flexible areas. With regard to the manufacture of the container, the bellows could be welded or glued sealingly on the base plate and on the cover plate.
  • a further embodiment of the closed system already provides a factory sterile connection of closed systems.
  • the donor system could be connected sterile with a closed donor and target system in the sense of a metering device and form an overall system. It is understood that an overall system may also include more than two closed systems. It is possible after emptying the donor system to separate this sterile and dispose of it, or to use elsewhere for partial quantities. The successive separation can be done with any system with encoder function, as long as the previous encoder system is completely or as required emptied.
  • Gravity-operated closed systems without dosing function are usually pure encoder systems.
  • the substance is transferred from the donor system under the influence of the gravitational force into the other closed system.
  • the donor system could have a container in which the substance is contained and whose connection points in the operating position to the ground.
  • the container itself could form the receptacle for the substance and, for example, be present as a collapsible flexible bag.
  • This embodiment enables cost-effective production and storage of substances, such as preparation solutions, at the point of use while maintaining the integrity of the systems.
  • connection could on the one hand open into the container, in particular protrude minimally into the substance and be provided there with a resealable closure.
  • connection could emerge from the container and be welded with its free end sterile to another system or already.
  • the reclosability of the end of the connection projecting into the substance makes possible the partial removal of substances, such as, for example, preparation solutions, of course taking into account the sterile connection and disconnection.
  • substances such as, for example, preparation solutions
  • the formation of the closure is a snap closure of sealing material, which is equipped with a mounting bridge and can be actuated via the flexible wall of the container.
  • the attachment bridge serves for the captivity of the closure.
  • the closure ensures that the substance is not introduced into the connection before the sterile connection has taken place and is possibly contaminated.
  • the material of the bagged container is soft but strong enough not to be damaged during manipulation of the closure
  • the container could also include in its bag form a base plate, through which the terminal is passed sealed.
  • the pressure compensation device could be arranged so that it opens into the filled with air or inert gas region of the container, which always points upwards in the operating position.
  • a variant of the first exemplary embodiment which is suitable for the volume-accurate transfer consists in that the donor system present as a bag is already connected in a sterile manner to a donor / target system in the form of a calibrated drip chamber and forms an overall system with it.
  • the metering device is included in the overall system as a separate closed system, which is also gravity driven.
  • the donor system could be assigned a Dosierabsperrung.
  • an overall system which, in addition to the encoder system and the metering device with combined encoder and target function, also contains further closed target systems. In any case, however, a factory sterile connection between the systems also applies as a process step which precedes the transfer of substance in time.
  • the container may have a volume between 30 ml to 1000 ml in larger pack sizes.
  • minibags reach a volume of between 10 ml and 30 ml.
  • a particular, second embodiment of the closed system is that it is designed as a gravity-driven metering device.
  • at least two ports could be provided for the system, which include an inlet and an outlet pointing in the operating position to the ground.
  • a container of the system could be provided a calibrated drip chamber, in which the substance is at least temporarily included.
  • the substance is supplied via the inlet from a donor system and discharged via the outlet to a target system.
  • the inlet and / or the outlet could be associated with a Dosierabsperrung.
  • the inlet and outlet are sealed to the drip chamber.
  • the drip chamber by a base plate, a cover plate and a transparent plastic jacket between deck and base plate are used.
  • the connection of the pressure compensation device in particular via the cover plate, could open in a sealed manner into the drip chamber.
  • the calibrated drip chamber with the two sterile connectors connectable forms in the second embodiment, a closed system in terms of a gravity-driven metering device, which is both donor and target system. It is advisable that the donor system for the above-described gravity-operated metering device also releases the substance under the influence of gravitational force after the sterile connection of the connections in the calibrated drip chamber.
  • the metering shut-off at the inlet could be used to regulate the amount of substance coming out of the donor system.
  • a third embodiment of the closed system which is also based on the principle of gravity, provides to arrange a receptacle in the container of the donor system in the form of a bottle or ampoule, within which the substance is located and whose closure has in the operating position to the ground.
  • the receptacle could be attached to a cover plate of the container. On the outside of the cover plate, an eyelet could be provided so that the container can be hung like a drip. In one of the cover plate opposite base plate of the connection could be welded.
  • the means for transferring the substance may comprise a short cannula for discharging the substance, in particular a liquid, and a long cannula for supplying air or inert gas.
  • the cannulas could pierce the closure of the receptacle and protrude into the receptacle.
  • the short cannula could be fluidly connected to the sterile connection in the operating position.
  • a connecting piece connected to the short cannula in the form of a plastic tube could project into a larger plastic tube of the connection with respect to the cross-section.
  • the connector is welded to the base plate of the container and the plastic tube connected to the short cannula passes through a sealed one Passage opening in the base plate.
  • the long cannula opens into the bellows-equipped container to which the pressure compensation device is connected. At rest, the bellows is extended and takes up the two cannulas. The cannulas are prevented by a holding device from puncturing the closure of the receptacle.
  • the holding device can be supported on the base plate.
  • the holding device could be in the form of a flexible slotted sleeve according to a preferred structural embodiment, which is particularly easy to handle.
  • the cannulas are not used, they are arranged in the holding device, which protects the flexible wall of the container, the bellows, before piercing.
  • the sleeve is resting in the resting state on the one hand against the base plate of the container, on the other hand against the shoulders of the recording. In the operating position, the sleeve is manipulated from the outside via the bellows, now lies around the ampoule body and the cannulas pierce the closure. The bellows of the container is thereby moved together.
  • the volume of the recording could be predetermined, so that the amount removed can be estimated.
  • the arrangement of a Dosierabsperrung at the connection improves the volume and time accurate dosage of the set for the other closed system amount.
  • the container comprises a calibrated drip chamber.
  • This drip chamber could be welded directly to the base plate of the container and with appropriate sealing and sterility of all connections and connectors be part of the encoder system.
  • Both cannulas - both the long and the short cannula - are fluidly connected to the drip chamber via connecting pieces.
  • the short cannula within the container could be associated with a Dosierabsperrung which is actuated via the bellows of the container. From the calibrated drip chamber, the port could exit for connection to another system, which expediently faces the ground in the operating position.
  • the long cannula could also open directly into the pressure compensation device.
  • a pressure compensation device is provided, which ensures the pressure equalization in the container and in the receptacle of the encoder system and in the calibrated drip chamber of the target and encoder system - in short, in all components of the closed overall system.
  • a fourth embodiment deals with a closed system with a closed system using a calibrated syringe with an ampoule flask and an ampoule body as means for active metered transfer of the substance.
  • the application of force can be done manually by the user.
  • the syringe can also be incorporated into a known per se electromotive pumping system, in which the dosage can be programmed time and volume precision.
  • the syringe could be filled within a container from a recording containing the substance out
  • the ampoule body of the syringe could already be filled with substance or finally filled by pulling the syringe with substance from another donor system.
  • the ampule body of the syringe forms a generally temporary receptacle for the substance, since the transfer takes place via the syringe.
  • the syringe could be actuated from the outside.
  • the system comprising the syringe could have a superimposed donor and target function when filling with substance and dispensing substance in the same system.
  • the syringe could be arranged within the container and be actuated via an at least partially flexible wall of the container, in particular via the bellows, from the outside.
  • a cannula could also be included, which can also be handled via the bellows.
  • the syringe would be assembled with the cannula. Thereafter, the puncture plug of the recording would be pierced and the syringe wound up, that is filled with substance within the system. Thereafter, the cannula would be removed and the drawn syringe connected to a connector in the form of a tubular fitting to the target-oriented port. Finally, the vial plunger would be pushed into the vial body so that the substance flows into the port and into the sterile connected target system.
  • the connector could also be in the form of an inner conduit.
  • the inner line could protrude at rest through a passage opening of the container in the connection and be rolled up spirally within the container.
  • the inner pipe initially projects only so far into the plastic tube that it can be connected to the connection of the other closed system without obstruction.
  • the inner conduit could have a smaller cross-section than the port or the other closed system leading plastic hose of the terminal and made of a rigid, flexible material with a lubricious surface. As a material would, for example, polypropylene into consideration.
  • the free end of the inner conduit projecting into the container could be connected to the syringe to be put into operation.
  • This embodiment with inner conduit allows accurate placement of the free end of the inner conduit in the other system and can serve both to deliver the substance and to remove the substance.
  • the feed of the inner line could be realized by the sterile connected connection to a specific sampling point in the other closed system.
  • the extracted substance could affect blood or umbilical specimens to be provided to the laboratory. In the laboratory, the status of the preparation must be determined and compatibility for the patient.
  • the sample is removed from the other system via the syringe on the inner tube and into a receptacle in the first sterile system introduced - here on the suction and ejection movements of the syringe through a cannula and the puncture plug of a preferably evacuated ampoule through.
  • the separation from the sampling system can be made.
  • the connection between the syringe and cannula is first prepared, hereby taken the substance, then removed the cannula and the syringe connected to the inner line, the free end already positioned in the target system has been. With the piston movement, the substance is transported through the inner pipe to the destination. After the transfer, the internal line is withdrawn via the connected plastic tubes of both systems in the first system and the systems are separated sterile.
  • the ampoule body of a syringe could simultaneously form the receptacle for the substance.
  • the ampoule body could be mounted in a holding device on the base plate and have a connection in the form of a plastic tube, which passes through the base plate in a sealed manner and serves for sterile connection to another system.
  • the vial body could already be filled in advance with the substance.
  • a further modification of the fourth embodiment of the syringe-related closed system provides for associating with the ampoule body a cannula with a cannula closure which can be opened and closed via the flexible wall of the container.
  • a faster emptying and filling of the pressure compensation device according to the variable gas volume in the container is achieved if the container comprises two chambers with two connecting pieces for preferably a pressure compensation device or two smaller separate pressure compensation devices.
  • the first chamber could contain the ampoule flask and the second chamber could contain the ampoule body with the cannula and the closure.
  • the connection is welded in a base plate, here the second chamber of the container could, at the end remote from the first chamber for the ampoule piston, form the connection for the sterile connection to the connection of another closed system itself.
  • the other closed system here the donor system, could be in the form of an ampoule containing the substance in the embodiment in question here.
  • This ampoule could in turn have a plastic casing with a connection for the sterile connection of the connection of the container or the second chamber, in short, the connection of the first closed system.
  • the jacketed ampule with sterile connectable port forms a closed system by itself and could be made of borosilicate glass with aggressive materials and be equipped with an elastomeric piercing plug.
  • the cannula of the syringe of the closed system is moved through the connected ports to the ampoule, the ampoule flask is forced into the ampoule body, and air or inert gas is injected into the ampoule after piercing the elastomeric plug.
  • the ampoule contents is under pressure and it is a fine dosage when removing the substance possible.
  • the ampoule flask is now pulled out of the ampoule body while sucking the substance and the two systems are separated sterile.
  • the now filled closed system is available as a donor system for renewed sterile connection with a target system.
  • the ampoule flask and the ampoule body could be flow-connected.
  • the ampoule plunger could have a sterile connectable connection to another closed donor system.
  • a Dosierabsperrung could be provided.
  • the connection could be in the form of a plastic tube that extends into the ampoule flask. Facing away from the ampoule flask, the ampoule body could have a connection which can be connected in a sterile manner into a closed target system, which is likewise provided with a metering shut-off device.
  • the connection of the ampoule body is closed, which opens the ampoule flask and moves the latter out of the ampoule body.
  • the substance flows from the donor system into the target system, which in this situation is represented by the syringe.
  • Dosierabsperrung ampoule piston side is closed and opened the ampule body side.
  • the ampoule flask is retracted into the ampoule body, thus transferring the substance to the target system.
  • the syringe is the donor system.
  • a further advantageous application possibility arises when the ampoule body becomes the mixing container or the target system from both directions.
  • the space-saving design of the container which consists of a combination of wrapping in the area of the ampoule body and a bellows in the region of the ampoule envelope.
  • the closed system with the syringe is better clamped in a known syringe pump, since the container is reduced to a minimum.
  • the feeding of the substance is ensured by the alternation of suction and ejection continuously.
  • the active connection of the syringe with a syringe pump allows the transfer of the substance automatically at preset times is feasible.
  • a development of the above-described variant of the fourth embodiment is that an overall system is formed with a donor system according to the second embodiment.
  • the encoder system has a receptacle in the form of an operating state with the opening facing the bottom ampoule.
  • the syringe is this target system.
  • the syringe is then the donor system.
  • the entire system could already be factory-made and the donor and combined donor / target system could be sterile connected via a connector that extends to the top of the ampoule flask.
  • An overall system could also be formed by connecting two donor systems with a syringe and extracting substance from the donor system via the ampoule plunger by means of the syringe, and extracting substance from the other donor system via the ampoule body.
  • the syringe could then the Mix and the new substance could be transferred to another target system after sterile separation and reconnection.
  • the syringe in the closed system surrounding container could be clamped together with the container in a conventional syringe pump.
  • the transfer of the substance can be advantageously realized automatically at preset times.
  • a further variant of the fourth embodiment provides the syringe again as a mixing vessel.
  • a reusable closure sucked in substances.
  • this branch is closed and the branch opened, which concerns the aspiration of DMSO.
  • DMSO donor systems can be coupled and contained within sterile containers Brechampullen.
  • the DMSO branch is closed and opened a third branch, is discharged through the possibly sucked native air into the container containing the syringe.
  • the third - the pressure equalization device corresponding - branch is closed and opened a fourth branch of the reusable closure, to which at least one freezing bag or even several, connected in series and separately closable Einfrier milk is sterile connected or are.
  • the mixture is then ejected into the freezing bag by means of an ampoule flask.
  • the container in this variant is a foil wrapper which is dimensioned to have sufficient free volume for native gas / native air.
  • the generously dimensioned film wrapping is here with respect to the mixing syringe and with respect to the DMSO Brechampullen whose future openings facing down, provided.
  • the Pressure compensation device is not designed as a welded bag, but it is achieved via the dimensions of the container and the arrangement of the substance outlet or via a branch opening in the container, the pressure equalization, without affecting the substance.
  • the substance could be contained in a carpal or in its Karpullenanalysis, which is preferably calibrated.
  • the Karpulle includes a Karpullen redesign displaceable Karpullenkolben.
  • a pressure compensation device is provided per chamber.
  • a cannula could be provided, which points with its tip to the body of the carcass, or its piercing plug and protrudes with its opposite end into the port.
  • the connection could also be present here as a sterile connectable plastic tube which is to be connected to the connection of another system, a target system, sterile.
  • the second chamber could consist of a cylindrical portion and a bellows, wherein within a cylindrical portion of the Karpullen endeavor is included and a part of the Karpullenkolbens and wherein contained within the bellows, the rest of the Karpullenkolbens.
  • this chamber and a delivery tube of the first chamber could be movable relative to one another and preferably fixable to one another in a predetermined position. The transfer of the substance takes place after establishing the flow connection to the connection in that the Karpullenkolben shifts a sliding plug within the Karpullen emotionss.
  • the Karpulle according to the fifth embodiment allows the portionwise and volume accurate delivery of the substance from the Karpullenanalysis the first closed system in another closed system.
  • the closed system according to the fifth embodiment could be particularly useful as a disposable article.
  • the donor system is suitably closed after filling to prevent leakage of the substance within the container.
  • a closure is provided which is easy to open, possibly also closable.
  • the closure could preferably in Present form of a piercing.
  • the piercing plug could be made of elastomer and preferably Teflon-coated.
  • substance images of borosilicate glass could be used, which are suitable for aggressive substances that attack plastic.
  • An aggressive substance could be, for example, dimethylsulfoxide (DMSO), which is to be transferred into another system containing the stem cells of a patient for their preservation.
  • DMSO dimethylsulfoxide
  • This embodiment is particularly important in terms of the storage stability of the substance DMSO of two years in the inclusion of borosilicate glass.
  • a connection made of PVC is contacted only briefly during the transfer of the DMSO, so that dissolution processes are not set in motion.
  • the DMSO enters the other closed system, which, for example, is in the form of a freezer bag with a stem cell preparation.
  • the recording may also contain another substance which, for example, is incompatible with another component. Closed systems, which are pure target systems, could be hose and bag systems.
  • connection of a donor-function system could be sterile-connectable to another closed system which contains an internal duct.
  • the inner conduit could be manipulated via the bellows of the container and allows accurate positioning in another target system.
  • the cross-section of the inner line is below that of the connections of the encoder and the target system.
  • a sterile package prior to connection to the other closed system.
  • a blister pack is created.
  • the package could have a smooth surface with no backsplashes or depressions to facilitate the disinfection and introduction into the clean room.
  • the disinfection could be carried out by means of 70% ethanol, so that the conditions for introducing the packaging into clean room areas are met. An additional evacuation of the packaging is possible.
  • the pyrogen-free packaging could be made and it could be gamma-sterilized.
  • a particular advantage of the closed system is that in itself inexpensive recordings, such as ampoules, bottles, syringes, carpules and connections, which are otherwise used in open systems, can be applied to fully enclosed systems. This is possible because the arrangement of the low-cost donor systems in a corresponding container or a plastic coating a closed system can be produced, which can interact with other closed systems.
  • low cost donor systems can be used in the closed system of the invention and made available to medical and scientific work. Basically, preserving each substance for complex preparation steps within one shot within a closed system is desirable.
  • the Fig. 1 to 14 show a closed system for the transfer of a substance between closed systems G, G / Z, Z, G + G / Z where the systems G, G / Z, Z, G + G / Z are sterile with each other and sterile separable from each other and means have to transfer the substance.
  • a pressure compensation device 1 which is flow-connected in a sterile manner to at least one system G, G / Z, Z, G + G / Z.
  • the pressure compensation device 1 is integrally connected to the system G, G / Z, Z, G + G / Z, namely, welded.
  • the means for transferring the substance comprise at least one connector 2 for sterile connection with at least one further system G, G / Z, Z, G + G / Z.
  • the connections 2 are formed here as thermoplastic plastic hoses.
  • a container 3 is provided to form the system G, G / Z, Z and the terminal 2 is welded to the container 3 of the system G, G / Z, Z sterile.
  • the container 3 has a base plate 4 and / or a cover plate 5 and / or at least one holding device 6.
  • Fig. 1, 2 . 4 to 14 it is shown that at least part of the wall of the container 3 is formed so flexible that the means for transferring the substance are at least partially actuated from the outside via the flexible wall.
  • the 4 to 14 show that the flexible wall is in the form of a bellows 7.
  • the first, structurally very simple embodiment of the closed system according to the Fig. 1 and 2 is based on the principle of gravity, in order to transfer the substance from the closed donor system G to the other closed system Z or G / Z.
  • the container 3 is present as a collapsible, flexible bag with a volume of 30 ml, which is already filled with the substance and whose connection 2 points in the operating position to the ground.
  • the terminal 2 protrudes slightly sealed with one end through the base plate 4 in the container 3, into the substance and is there provided with a resealable snap closure 8.
  • the snap closure 8 is made of sealing material, is equipped with a mounting bracket 9 and actuated via the flexible wall of the container 3.
  • the port 2 has a Dosierabsperrung 13. at Fig. 1 Connection 2 is available for sterile connection with the closed target system Z.
  • the closed system according to the in Fig. 2 shown variant of the first embodiment forms an overall system G + G / Z, the closed and factory over the connector 15 sterile interconnected systems G and G / Z combined.
  • the system G / Z of the overall system G + G / Z essentially corresponds to that in Fig. 3B described closed Systzem according to the second embodiment.
  • 14 denotes a cross connector, which is symbolic of the sterile system connection between the terminal 2 of the overall system G + G / Z with the terminal 2 of the target system Z.
  • FIGS. 3A to 3E In the second embodiment according to the FIGS. 3A to 3E is provided as a container 3, a calibrated drip chamber 12 for receiving the substance, which is composed essentially of a base plate 4 and a cover plate 5 and a plastic jacket extending therebetween.
  • the FIGS. 3A and 3B show a variant with two ports 2, which include an inlet 10 and an operative position pointing to the ground outlet 11. The inlet 10 and the outlet 11 project through the base plate 4 and the cover plate 5 of the drip chamber 12 and are tightly welded therein.
  • the pressure compensation device 1 is sealed with the cover plate 5 of the drip chamber 12 connected and protrudes into it. Both ports 2 each have a Dosierabsperrung 13 assigned.
  • the closed system according to FIGS. 3A to 3E represents a closed donor and target system G / Z in the sense of a gravity-driven metering device, which can be combined with various donor systems G and target systems Z and thus enables a sterile and volume-accurate transfer of the substance.
  • the closed system should be removed from a sterilized blister pack 16 prior to use.
  • the components of the closed system are arranged prior to sterile connection with another closed system G, G / Z, Z within a sterilized blister pack 16, which are exemplified in the Fig. 3A . 11A , and 6 is shown.
  • the blister pack 16 is pyrogen-free and gamma sterilized.
  • the blister pack 16 is disinfected with 70% ethanol.
  • FIG. 3C shown variant shows a sterile connected to a donor system G inlet 10 and four outlets 11, which are connected via two terminals 2 with the target systems Z sterile. Two of the outlets 11 are still without function.
  • An outlet-side connection 2 is assigned a metering shut-off 13.
  • a further variant of the closed system with four inlets 10 is shown, which are connected in a sterile manner via the connections 2 with four sensor systems G and wherein in each case a metering shut-off 13 are provided.
  • a mixture of four substances can be produced in the dropping chamber 12.
  • the connection 2 is sterile connected to the target system Z and has a Dosierabsperrung 13.
  • Fig. 4 to 7 is the third embodiment of the closed system shown in different variants, which is also based on the gravitational force principle.
  • a receptacle 17 in the form of a bottle or ampoule contain, within which the substance is located and the closure has in the operating position to the ground. Also, the only port 2 has in the operating position down.
  • the recording 17 is located in the Fig. 4 and 7 as ampoule, in FIGS. 5 and 6 as a bottle in front.
  • a puncture plug 20 is provided in each case.
  • the pressure compensation device 1 protrudes through the base plate 4 in the container 3 and is sterile and tightly connected.
  • the receptacle 17 is attached to the cover plate 5 of the container 1.
  • an eyelet 21 is arranged, which serves for suspending the closed system.
  • a short cannula 18 is provided for air supply.
  • the short cannula 18 is fluidly connected to the port 2.
  • special holding devices 6 are provided for the needles 18, 19 are in the in the Fig. 4 and 7 shown variants of the third embodiment of the base plate 4 special holding devices 6 are provided.
  • Fig. 4 shown variant of the third embodiment realizes a semiquantitative substance transfer and is particularly simple and inexpensive to produce.
  • the volume the receptacle 17, namely the ampoule, is predeterminiert and it can be estimated - also about the predetermined immersion depth of the short cannula 18 into the ampoule, which amount was removed. In the total quantity removal, the exact volume is present over the total volume of the receptacle 17 and the immersion depth of the short cannula 18.
  • the long cannula 19 opens into the container 3, so that the pressure compensation via the opening into the container 3 pressure equalization device 1 can be done.
  • the bellows 7 is at rest in the extended state, is supported by a stabilizer, not shown here and contains the two spaced from the piercing plug 20 needles 18, 19 which are fixed to the base plate 4 and to the holding device 6.
  • the short cannula 18 protrudes with its from the receptacle 17 facing away connector 15 in the form of a PVC tube into the terminal 2 inside.
  • the Fig. 4 shown operating position can be seen that no stabilizer is present and that the bellows 7 is compressed, wherein the displaced air escapes into the pressure compensation device 1.
  • FIGS. 5 and 6 A somewhat more complex variant of the third embodiment is in the FIGS. 5 and 6 shown.
  • the cover plate 5 of a calibrated drip chamber 12 is integrated into the base plate 4 of the container 3, namely, welded, and belongs to the encoder system G. From the drip chamber 12 go outlet 11 and port 2 from.
  • the two cannulas 18, 19 project into the drip chamber 12 via connecting pieces 15 and inlets 10.
  • a third, free inlet 10 is provided, which connects the drip chamber 12 with the container 3, so that the pressure compensation device 1 of the container 3 is also responsible for the pressure equalization in the drip chamber 12.
  • the connecting piece 15 of the short cannula 18 has a Dosierabsperrung 13, which is adjustable via the bellows 7. At port 2 a Dosierabsperrung 13 is also provided.
  • Fig. 6 shows the device according to Fig. 5 within a blister pack 16 comprising a stabilizer 22 with guards 23 for the two cannulas 18, 19.
  • the stabilizer 22 is fixed within the blister pack 16 to the holding device 6, which in Fig. 5 is shown.
  • the connecting pieces 15 of the two cannulas 18, 19 are fixed at their cannula-side end in a holding plate 24.
  • the holding plate 24 is removed with the needles 18, 19 via the bellows 7 from the stabilizer 22 and the guards 23 and the puncture plug 20 of the receptacle 17 is pierced until the holding plate 24 abuts against this.
  • FIG. 7A and 7B show in the Figs. 7A and 7B a receptacle 17 in the form of an ampoule, similar to in Fig. 4 , but with differences.
  • an overall system G + G / Z consisting of a donor system G and a combined donor / target system G / Z as in Fig. 3B shown exists.
  • the sterile connection between the donor system G and combined donor / target system G / Z factory made by a connector 15 which is equipped with a Dosierabsperrung 13.
  • the connecting piece 15 of the short cannula 18 opens into a calibrated drip chamber 12.
  • the long cannula 19 opens via its connecting piece 15 into the pressure compensation device 1.
  • the pressure compensation device 1 is connected via two further connecting pieces 15 with the container 3 and the drip chamber 12 in conjunction and thus provides everywhere for pressure equalization in the overall system G + G / Z. From the overall system G + G / Z, in particular from the drip chamber 12, protrudes a port 2, which is connected to the terminal 2 of a target system Z sterile.
  • the holding device 6 is formed in the form of a slotted sleeve, which in the rest position at Fig. 7A against the shoulder of the ampoule supports and thus the distance between the cannulas 18, 19 secures the puncture plug 20.
  • the holding device 6 In the operating position according to Fig. 7B the holding device 6 is pushed over the ampoule, wherein the cannulas 18, 19 pierce the puncture plug 20.
  • the container 3 is as in Fig. 4 a combination of wrapping and bellows 7.
  • the latter extends in the rest position in the region of the holding device 6 while the receptacle 17 is quasi encased.
  • FIGS. 8 to 13 show a fourth embodiment of the closed system, wherein the means for transfer of the substance comprise a calibrated syringe with an ampoule piston 25 and an ampoule body 26.
  • the syringe is disposed within the container 3 and via whose, extending between the cover plate 5 and the base plate 4 bellows 7 operable from the outside.
  • the container 3 is formed by a bellows 7 in the region of the ampoule piston 25 which is sealed to the ampoule body 26.
  • the end remote from the ampoule body 26 of the ampoule piston 25 is glued to the base plate 4 of the container 3.
  • the ampoule body 26 temporarily takes up the substance in all variants of the fourth embodiment.
  • the 8A, 8B show the arrangement of the syringe and a receptacle 17 in the form of a filled with substance ampoule with push-through plug 20 within the container 3 with the aid of matching holding devices 6, which are integrally formed on the base plate 4.
  • the receptacle 17 has a piercing plug 20 and consists here of borosilicate glass.
  • DMSO dimethyl sulfoxide
  • the piercing plug 20 is made of elastomer and is Teflon-treated in terms of chemical resistance.
  • the holding devices 6 hold according to the two in the 8A, 8B and 9 variants shown, the receptacle 17, a protective device 23 for the cannula 28 of the syringe, the connector 15 and the ampoule body 26 with the ampoule piston 25th
  • a stabilizer 22 is provided which has the task of keeping the receptacle contained in the container 3 17 and the syringe needle 28 - ie components that could be solved - during transport in position.
  • the connection 2 and the pressure compensation device 1 are in each case via a passage opening not shown in detail with the container 3 in connection, wherein at the passage opening a sealing connection - here a welded joint - is made.
  • the syringe shown is already provided by the manufacturer with a substance in the ampoule body 26 and has at its ampoule body 26, a cock 30 for opening and closing.
  • This closed system is delivered in the mounted state and represents a donor system G.
  • a single holding device 6 is provided on the base plate 4 of the container 3.
  • the free end of the ampule body 26 forms the connection 2, which passes through the base plate 4 sealed.
  • This is a disposable item that is disposed of after emptying.
  • the in the Figs. 11A to 11G shown variant of the fourth embodiment of the closed system also shows a syringe, which is already assembled on the ampoule body 26 with a cannula 28 and a cannula closure 31 has.
  • a specially trained container 3 with two chambers 32, 33 provided, which are connected via two connecting pieces 15 with the pressure compensation device 1.
  • the first chamber 32 contains the ampoule plunger 25 of the syringe and the second chamber 33 contains the ampoule body 26 with the cannula 28 and the cannula closure 31.
  • the end face of the ampoule plunger 25 is fixedly connected to the base plate 4 of the first chamber 32.
  • the second chamber 33 of the container 3 forms at the end facing away from the first chamber 32, the connection 2 for sterile Konnekttechnik with the connection of another closed system G, Z from.
  • the ampoule piston 25 is fluidly connected to the ampoule body 26.
  • the ampoule piston 25 is connected via a connector 2 sterile with a donor system G.
  • This connection 2 extends in the manner of an inner tube into the ampoule plunger 25 and opens centrally at the free end of the ampoule plunger 25 into the ampoule body 26.
  • the ampoule plunger-side connection 2 is equipped with a Dosierabsperrung 13. From the ampoule body 26, a port 2 is formed, which is connected in a sterile manner with a closed system Z and a Dosierabsperrung 13 includes.
  • the connection 2 on the ampoule body 26 is closed, which opens on the ampoule plunger 25 and the latter moves out of the ampoule body 26.
  • the substance from donor system G flows into the ampoule body 26.
  • the specially designed syringe here is a combination of donor and target system G / Z.
  • the target function comes into play when forwarding to the target system Z, the donor function.
  • the target system Z For forwarding the sucked from system G in the system G / Z substance in the target system Z Dosierabsperrung 13 ampulenkenkben school closed and ampoule body side opened.
  • the ampoule piston 25 is retracted into the ampoule body 26 and thus the substance is transferred to the system Z.
  • Fig. 12D the outgoing from the ampoule body 26 terminal 2 is connected to a closed system Z with an inner line 27 sterile.
  • the inner pipe 27 is manipulated via the bellows 7 of the container 3 and led to a next closed system G / Z, in order then to place the substance accurately there.
  • An overall system G + G / Z consisting of a closed encoder system G with the features of the encoder system according to Fig. 7A, 7B and a closed system G / Z with those in the FIGS. 12A to 12D features shown, comprising the donor and the objective function, is in the Figs. 13A to 13D shown.
  • each system G and G / Z within the overall system G + G / Z has its own pressure compensation device 1 with connectors 15.
  • system G is the pressure compensation device 1 with the container 3 and the long cannula 19 fluidly connected.
  • the pressure compensation device 1 is also fluidly connected to the local container 3.
  • Fig. 13A shows the rest position, in which the cannulas 18, 19 are still fixed in the holding device 6.
  • Fig. 13B If the puncture plug is already punctured, the bellows 7 of the container 3 of the donor system G is folded and the pressure compensation device 1 filled with displaced air.
  • the metering lock 13 is opened at the connector 15 and the ampule piston 25 of the syringe is raised, wherein the pressure compensation device 1 now contains less air and the volume of the bellows 7 is increased.
  • the substance of the donor system G flows according to the arrows.
  • Fig. 13D the suction process is finished.
  • the ampoule piston 25 transfers the substance according to the arrows drawn from the ampoule body 26 into the port 2 and finally to the target system Z. In this transfer, the Dosierabsperrung 13 ampulenkenkoben endeavor closed and ampoule body side open.
  • a fifth embodiment of the closed system according to Fig. 14 deals with a calibrated cartridge as a means for transferring the substance with a Karpullenkolben 34 and a Karpullenanalysis 35, in which the substance is contained.
  • the Karpullenanalysis 35 is closed with a piercing plug 20.
  • the transparent container 3 containing the cartridge comprises two chambers 32, 33. Each chamber 32, 33 is fluidly connected to a respective pressure compensation device 1.
  • the first chamber 32 comprises a cannula 36, which points with its tip to the puncture stopper 20 of the Karpullen emotionss 35 and protrudes with its opposite end formed as a connector 15 in the terminal 2.
  • the Karpullenkolben 34 is disposed in the second chamber 33, which includes a bellows 7 and a cylindrical portion in the form of a stable sleeve 38.
  • the end of the Karpullenkolbens 34 is glued to the cover plate 5, on which the bellows 7 is arranged.
  • the bellows 7 then goes into the stable sleeve 38, which also receives the Karpullenanalysis 35.
  • a radially inwardly facing annular shoulder 40 is provided, against which the Karpullen stresses 35 is supported.
  • the sleeve 38 also has a radially inwardly facing annular shoulder 41, which counteracts an axial movement of the Karpullenkolbens 35. While the annular shoulder 40 is already formed on the sleeve 38, the annular shoulder 41 is formed by the fact that after the introduction of the Karpullen stressess 35 into the sleeve 38, a ring is introduced into the sleeve 38, which is welded to the sleeve 38 and so the ring chasers 41 trains.
  • the first chamber 32 is welded to the annular shoulder 40 of the sleeve 38.
  • the chambers 32, 33 are fluidly connected in the slightest extent, at least not sufficient to use only a pressure compensation device 1.
  • the first chamber 32 has a transfer barrel 39 and therein a bellows 7 welded to the base plate 4.
  • the Studentsschtubus 39 engages over the free end of the stable sleeve 38, both components are movable relative to each other and include locking means in the form of a recess 42 and a projection 43 which are in operative position engaged and fix the position of the cannula 36 in the Karpullen emotions 35.
  • a sterile package namely a blister pack 16 prior to the sterile connection with the other closed system Z and / or G.
  • the packaging has a smooth surface without depressions, to which a disinfectant, in particular 70% ethanol, is applied, since this is introduced into a clean room.

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  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (17)

  1. Système fermé destiné à transférer une substance entre le système fermé (G, G/Z, Z, G+G/Z) et au moins un système fermé supplémentaire, les systèmes (G, G/Z, Z, G+G/Z) pouvant être connectés de manière stérile les uns aux autres et séparés de manière stérile les uns des autres et comportant des moyens pour la transmission de la substance,
    caractérisé en ce que
    le système (G, G/Z, Z, G+G/Z) comprend un contenant (3), en ce que le contenant (3) comporte au moins un raccord (2) pour la connexion stérile avec au moins un raccord (2) pouvant être connecté de manière stérile du système supplémentaire (G, G/Z, Z, G+G/Z), en ce que le contenant (3) comprend un dispositif compensateur de pression (1) destiné à compenser les pressions différentielles pendant le transfert à l'intérieur des systèmes fermés pouvant être connectés de manière stérile les uns aux autres, qui est assemblé par écoulement avec le contenant (3), en ce que la substance est transférable à partir du système (G), notamment sous l'effet de la force de gravitation dans l'autre système (Z, G/Z) fermé, dans le contenant (3) du système (G) étant contenu un logement (17) sous la forme d'une bouteille ou d'une ampoule, à l'intérieur duquel se trouve la substance et dont la fermeture est tournée vers le fond, en position de service, les moyens pour la transmission de la substance comprenant une courte canule (18) pour le transfert de la substance, notamment d'un liquide et une longue canule (19) pour l'alimentation d'air et de gaz inerte et en position de service, les canules (18, 19) perçant la fermeture du logement (17) et saillant dans le logement (17) et la canule courte (18) étant assemblée par écoulement avec le raccord (2) et la longue canule (19) s'ouvrant dans le contenant (3) et étant de ce fait également assemblée par écoulement avec le dispositif compensateur de pression (1).
  2. Système fermé selon la revendication 1, caractérisé en ce qu'en position de repos, la canule courte (18) et la canule longue (19) sont placées dans un dispositif de maintien (6) sous la forme d'une douille fendue, qui s'appuie d'une part contre une plaque d'assise (4) du contenant (3), d'autre part contre le logement (17) et dans la position de service, entoure le logement (17), alors que les canules (18, 19) percent la fermeture du logement (17).
  3. Système fermé destiné à transférer une substance entre le système fermé (G, G/Z, Z, G+G/Z) et au moins un système fermé supplémentaire, les systèmes (G, G/Z, Z, G+G/Z) pouvant être connectés de manière stérile les uns aux autres et séparés de manière stérile les uns des autres et comportant des moyens de transfert de la substance,
    caractérisé en ce que
    le système (G, G/Z, Z, G+G/Z) comprend un contenant (3), en ce que le contenant (3) comporte au moins un raccord (2) pour la connexion stérile avec au moins un raccord (2) pouvant être connecté de manière stérile du système supplémentaire (G, G/Z, Z, G+G/Z), en ce que le contenant (3) comprend un dispositif compensateur de pression (1) destiné à compenser les pressions différentielles pendant le transfert à l'intérieur des systèmes fermés pouvant être connectés de manière stérile les uns aux autres, qui est relié par écoulement avec le contenant (3), en ce qu'en tant que moyen pour la transmission de la substance, est placée dans le contenant (3) du système fermé (G/, G/Z, Z, G+G/Z) une seringue calibrée avec un piston d'ampoule (25) et un corps d'ampoule (26) et en ce qu'au moins une partie de la paroi du contenant (3) est conçue sous forme souple, de telle sorte que la seringue soit actionnable au moins en partie par l'extérieur, par l'intermédiaire de la paroi flexible, notamment par l'intermédiaire d'un soufflet (7).
  4. Système fermé selon la revendication 3, caractérisé en ce qu'au niveau de la seringue, en fonction de son usage (remplir de substance ou en distribuer), le système (G/Z) a une fonction superposée de donneur et de receveur, lorsque le remplissage de substance et la délivrance de substance ont lieu dans le même système (G/Z).
  5. Système fermé selon la revendication 3 ou la revendication 4, caractérisé en ce qu'à l'intérieur du contenant (3), il est prévu une pièce d'assemblage (15) assemblée par écoulement avec le raccord (2), destiné à être assemblé avec la seringue et en ce que le pièce d'assemblage (15) se présente de préférence sous la forme d'un conduit intérieur (27).
  6. Système fermé selon l'une quelconque des revendications 3 à 5, caractérisé en ce que dans le contenant (3), il est prévu un logement (17) avec de la substance sous la forme d'une ampoule avec un bouchon traversant (20).
  7. Système fermé selon l'une quelconque des revendications 3 à 6, caractérisé en ce que le corps d'ampoule (26) comprend une canule (28) avec une fermeture de canule (31), laquelle est manipulable par l'extérieur, par l'intermédiaire de la paroi souple du contenant (3).
  8. Système fermé selon la revendication 7, caractérisé en ce que le contenant (3) comprend deux compartiments (32, 33) qui sont les deux assemblés par écoulement avec le dispositif compensateur de pression (1).
  9. Système fermé selon la revendication 8, caractérisé en ce que le premier compartiment (32) contient le piston d'ampoule (25) et en ce que le deuxième compartiment (33) contient le corps d'ampoule (26) avec la canule (28).
  10. Système fermé selon la revendication 8 ou la revendication 9, caractérisé en ce que sur la première extrémité opposée au premier compartiment (32), le deuxième compartiment (33) du contenant (3) forme le raccord (2) pour la connexion stérile avec le raccord (2) du système donneur (G) ou avec le raccord (2) du système receveur (Z).
  11. Système fermé selon l'une quelconque des revendications 7 à 10, caractérisé en ce que le piston d'ampoule (25) est relié par écoulement avec le corps d'ampoule (26).
  12. Système fermé selon la revendication 11, caractérisé en ce que par l'intermédiaire d'un raccord (2) équipé d'une barrière de dosage (13), le piston d'ampoule (25) peut s'assembler de manière stérile avec un système (G) fermé, en ce que le raccord (2) s'étend dans le piston d'ampoule (25) et de là s'ouvre dans le corps d'ampoule (26), en ce qu'à l'opposée du piston d'ampoule (25), le corps d'ampoule (26) comporte un raccord (2) équipé d'une barrière de dosage (13), pour la connexion stérile avec un système (Z) fermé, en ce que pour aspirer de la substance à partir du système fermé (G), la barrière de dosage (13) voisine du corps d'ampoule (26) est fermée et la barrière de dosage (13) voisine du piston d'ampoule (25) est ouverte et en ce que pour le transfert dans le système receveur (Z) de la substance aspirée dans le corps d'ampoule (26), la barrière de dosage (13) voisine du corps d'ampoule (26) est ouverte et la barrière de dosage (13) voisine du piston d'ampoule (25) est fermée.
  13. Système fermé selon l'une quelconque des revendications 3 à 12, caractérisé en ce que le raccord (2) est assemblé de manière stérile avec un système fermé (G/Z), lequel contient un conduit intérieur (27) et en ce que le système (G/Z) contenant le conduit intérieur (27) transfère la substance vers un système fermé (Z) suivant.
  14. Procédé destiné à transférer une substance entre des systèmes fermés, lors duquel on connecte au moins simplement de manière stérile les systèmes fermés, à savoir au moins un système donneur selon l'une quelconque des revendications 1, 3 et au moins un système receveur, la substance arrivant dans le système receveur et après le transfert de la substance, on sépare de manière stérile l'un de l'autre le système receveur et le système donneur et les pressions différentielles se produisant pendant le transfert de la substance étant compensées,
    caractérisé en ce que
    les pressions différentielles à l'intérieur du système fermé qui pendant le transfert de substance est constitué de système donneur et receveur connectés de manière stérile et est assemblé par écoulement de manière stérile avec un dispositif compensateur de pression sont compensées,
    de l'air refoulé ou du gaz inerte refoulé étant capté sans contact avec l'air ambiant dans le dispositif compensateur de pression et étant à disposition en relation avec des processus de prélèvement de substance, en évitant un vide.
  15. Procédé selon la revendication 14, caractérisé en ce que la substance introduite dans le système donneur, de préférence sous des conditions de salle blanche est transmise activement au système receveur par le système donneur, notamment par une seringue ou une carpule calibrée ou en ce que la substance est prélevée activement à partir du système donneur, notamment par une seringue calibrée ou en ce que la substance arrive dans le système receveur sous l'effet de la force de gravité.
  16. Procédé selon la revendication 14 ou la revendication 15, caractérisé en ce qu'on connecte de manière stérile le système donneur avec plusieurs autres systèmes receveurs.
  17. Procédé selon l'une quelconque des revendications 14 à 16, caractérisé en ce que le système receveur devient le système donneur lorsqu'on retransmet de la substance prélevée à un autre système receveur.
EP09776032.6A 2008-08-02 2009-07-30 Procédé et dispositif pour le transfert d'une substance entre des systèmes fermés Active EP2320851B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008035835.5A DE102008035835B4 (de) 2008-08-02 2008-08-02 Verfahren und Vorrichtung zum Transfer einer Substanz zwischen geschlossenen Systemen
PCT/DE2009/001062 WO2010015232A1 (fr) 2008-08-02 2009-07-30 Procédé et dispositif pour le transfert d'une substance entre des systèmes fermés

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EP2320851A1 EP2320851A1 (fr) 2011-05-18
EP2320851B1 true EP2320851B1 (fr) 2016-06-22

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US (1) US20110192489A1 (fr)
EP (1) EP2320851B1 (fr)
DE (1) DE102008035835B4 (fr)
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WO (1) WO2010015232A1 (fr)

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DE202011108638U1 (de) 2011-12-02 2013-03-07 Ulrich Gmbh & Co. Kg Vorrichtung zum sterilen Transfer eines Mediums.
DE102011120105B4 (de) 2011-12-02 2013-09-05 Ulrich Gmbh & Co. Kg Vorrichtung zum sterilen Transfer eines Mediums
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Publication number Publication date
DE102008035835A1 (de) 2010-02-04
US20110192489A1 (en) 2011-08-11
WO2010015232A1 (fr) 2010-02-11
DE102008035835B4 (de) 2015-02-19
EP2320851A1 (fr) 2011-05-18
ES2586656T3 (es) 2016-10-18

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