Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
  • G01N35/1095—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices for supplying the samples to flow-through analysers
  • G01N35/1097—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices for supplying the samples to flow-through analysers characterised by the valves
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
  • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/02—Devices for withdrawing samples
  • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
  • G01N1/20—Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials
  • G01N1/2035—Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials by deviating part of a fluid stream, e.g. by drawing-off or tapping
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T137/00—Fluid handling
  • Y10T137/2931—Diverse fluid containing pressure systems
  • Y10T137/3115—Gas pressure storage over or displacement of liquid

Definitions

• Disposable method and device for sampling and distributing liquid, especially under sterile conditions Disposable method and device for sampling and distributing liquid, especially under sterile conditions.
• the present invention relates to a disposable method and device for sampling and distributing liquid, in particular under sterile conditions.
• connection / disconnection operations Today, this type of operation is carried out by separate, successive actions which multiply the connection / disconnection operations.
• the multiplication of these connections / disconnections brings a high risk of contamination, either by venting, or due to improper handling by the operator.
• a typical application is, for example in parenteral nutrition, the preparation of batches of nutritive mixtures to be administered subsequently to the patient, from a certain number of stock solutions such as: an amino acid solution, a giucosed solution, an emulsion lipid, to which are added small volumes of complementary substrates such as trace elements, mineral salts and vitamins.
• stock solutions such as: an amino acid solution, a giucosed solution, an emulsion lipid, to which are added small volumes of complementary substrates such as trace elements, mineral salts and vitamins.
• composition of these mixtures is varied from day to day depending on the nutritional state of the patient and the need to provide him with a suitable caloric intake.
• a typical application is, for example in biotechnology, the repeatedly collecting samples of a solution in cell culture, throughout this same culture which spans several days. This repeated sampling makes it possible to count the cells in a given volume and thus follow their growth curve, or even to carry out sterility tests on the samples taken in order to ensure the absence of any contamination.
• this operation is generally carried out either on a laboratory bench, or under laminar air flow, or in a controlled production area.
• cells potentiated by genetic engineering must be distributed and then cultivated in multiple reproducible individual doses, for subsequent administration to the patient (autologous vaccine).
• This distribution requires the reproducibility of each of the doses and the transfer of these in sterile mode. This operation is generally carried out on laboratory bench, under laminar air flow.
• the present application relates to a process for dispensing a fluid, characterized in that a) a valve with multiple inlets and outlets provided with a non-return valve is connected simultaneously - a sampling device and injection of fluids such as a syringe, a gas inlet pipe such as air, a liquid inlet pipe for dispensing an outlet pipe preferably provided with a bypass towards a rejection container, b) it is withdrawn the liquid to be dispensed to transfer it to the withdrawal and injection device, c) it is injected into the outlet pipe, d) gas is drawn off to transfer it to the sampling and injection device, e) gas is injected into the outlet pipe to push the liquid remaining in the outlet pipe.
• fluids such as a syringe
• a gas inlet pipe such as air
• a liquid inlet pipe for dispensing an outlet pipe preferably provided with a bypass towards a rejection container
• the multiple inlet and outlet valve provided with a non-return valve is arranged to allow the entry of the liquid to be dispensed, its outlet to the withdrawal and injection device, its entry from the withdrawal and injection device without possibility of leaving via the inlet of the liquid to be dispensed (effect of the non-return valve), its outlet towards the outlet duct.
• check valves are well known. Mention may be made, for example, of the valves sold by the company Filtertek Inc (USA) under the name 3 way check valve.
• the liquid inlet pipe to be dispensed is connected to a container containing said liquid to be dispensed.
• This container can be for example a bottle or a pocket.
• This liquid inlet conduit is preferably provided with a valve allowing or not the communication between the container and said inlet.
• the liquid inlet pipe to be dispensed is connected to several containers containing several liquids to be dispensed and preferably to a container containing a rinsing liquid.
• said liquid inlet conduit can be supplied by several supply pipes, each preferably being provided with a valve.
• the gas inlet pipe can lead directly into the multiple inlet and outlet valve.
• the gas comes from a bypass conduit provided on the liquid inlet conduit.
• This bypass duct is also preferably provided with a valve authorizing or not the communication between the air intake and the liquid inlet duct.
• a preferably sterilizing filter is provided on the gas inlet pipe.
• the gas for example nitrogen or the air coming from this conduit, is sterile.
• the device for withdrawing and injecting fluids may for example be a pump, in particular a metering pump, but is preferably a syringe.
• the outlet conduit opens into a collection container such as a flexible bag and preferably into several collection containers.
• a collection container such as a flexible bag
• said outlet conduit can be separated into several pipes, each preferably being provided with a valve.
• the collection container is advantageously pre-connected, that is to say that the container comprises connections allowing the direct mounting of said collection container on the outlet duct (s).
• a fraction of a single liquid to be dispensed or a mixture of several fractions of different liquids can be collected.
• This outlet conduit is preferably provided with a bypass to a rejection container, provided with a valve. It is thus possible in particular to eliminate a rinsing fluid.
• valve with multiple inlets and outlets is provided with a conduit for a rinsing liquid.
• the rinsing liquid can be contained in one of the containers of liquid to be dispensed. This avoids the use of an additional inlet on the multiple inlet and outlet valve.
• the multiple-inlet valve is connected by a conduit to a rinsing liquid, a rinsing liquid is drawn off to transfer it to the sampling device and d injection, and it is injected into the outlet conduit to transfer it to a waste recovery container.
• the liquid inlet pipe to be dispensed is supplied, for example, by 1, 2, preferably 3 and particularly 4 containers of liquid to dispense or more.
• the outlet conduit opens, for example, into 1, 2, preferably 3 and particularly 4 or more receptacles for collecting the dispensed liquid (s).
• the other valves whose function is to direct the flows of liquid and gas during the implementation of the process can for example be taps or preferably reversible pliers.
• the above liquid sampling and distribution method is implemented under sterile conditions, particularly using single-use components.
• the present application also relates to a device usable in a process above for distributing a fluid, characterized in that it comprises a valve with multiple inlets and outlets provided with a non-return valve, said valve being provided with '' an adaptation to receive a device for withdrawing and injecting fluids such as a syringe (of the Luer-lock® type for example), of a gas inlet duct (for example air), - of a liquid inlet pipe to be dispensed from an outlet pipe preferably provided with a bypass towards a rejection container,
• a device for withdrawing and injecting fluids such as a syringe (of the Luer-lock® type for example), of a gas inlet duct (for example air), - of a liquid inlet pipe to be dispensed from an outlet pipe preferably provided with a bypass towards a rejection container,
• the liquid inlet duct to be dispensed above also contains an adaptation system for cooperating with a container containing a liquid to be dispensed.
• This adaptation system can be perforating, self-perforating, screw, bayonet, aseptic connections etc.
• the gas inlet pipe is a bypass of the liquid inlet pipe to be dispensed.
• the liquid inlet pipe to be dispensed comprises a trunk common on the side of the multiple inlet and outlet valve and in addition a bundle of pipes for several containers containing a liquid to be dispensed.
• the gas inlet pipe is preferably connected to the common trunk of the liquid inlet pipe to be dispensed.
• the outlet conduit comprises a common trunk on the side of the valve with multiple inlets and outlets and in addition a bundle of pipes for several containers which must contain a liquid to be dispensed .
• the conduit to the rejection container is preferably connected to the common trunk of the outlet conduit.
• the inlet pipe is also the supply pipe, advantageously in one piece.
• the process for dispensing a fluid which is the subject of the present invention has very advantageous qualities.
• it minimizes the number of connections under aseptic conditions and therefore reduces the risk of contamination by contact with the operator; it implements the concept of the closed system, independent of the ambient air and therefore reduces the risk of bacterial contamination; - it is for single use, thus eliminating any risk of cross-contamination, batch by batch; it allows precise measurement of the volume withdrawn or transferred; it authorizes the reproducibility of the transferred volume.
• Figure 1 which is a schematic representation of an example of mounting the invention with multiple inputs and outputs.
• a valve 1 with multiple inlets and outlets provided with a non-return valve. This non-return valve allows the introduction of the liquid withdrawn into the rigid body of a syringe 2 and its transfer, without return downstream, to the distribution line.
• Valve 1 with multiple inputs and outputs.
• Syringe 2 - which can be pre-connected or not - with a capacity for example of 10 ml to 500 ml allowing the precise measurement (to the tolerance close to the measurement on the syringe body) of the withdrawn volume.
• a distribution line with multiple pipes 5 allows the transfer and distribution of the withdrawn fluid towards the collection bags. They meet in an outlet duct 6 of the valve 1 with multiple inlets and outlets, which constitutes a common trunk.
• a hydrophobic sterilizing filter 8 is preconnected bypass. Its function is to allow the introduction of filtered air into the device and to drain the entire dead volume of liquid which could remain there.
• the dead volume of this closed system being constant, its purging makes it possible to reproduce the withdrawal and transfer operation as many times as desired, in a reproducible manner.
• a discharge bag 9 pre-connected in bypass of a volume for example of 1 to 5 liters, makes it possible to collect either the air or a part of the transferred liquid serving rinse aid between each transfer, if necessary.
• Reversible shutter clips On all branches of the device, a reversible shutter clamp 10 is installed wherever necessary in order to direct the flow of liquid or air during use (10S means that the clamp is installed on an outlet pipe, 10E that the clamp is installed on an inlet pipe,! 0F that the clamp is installed on the filter pipe and 10R that the clamp is installed on the pipe of the reject bag).
• the above device can be implemented according to the following method: 1) The clamp is opened on the desired input line, the desired volume of mother solution is drawn off by aspiration into the syringe 2, by measuring this volume on the syringe body.
• a device such as the one above is modular and can be produced from separate elements which may be versatile.
• valve 1 with multiple inputs and outputs, you can find conduits that may be just as suitable for entry as for exit, branched or not.
• the same type of branched duct is suitable for mounting the filter as well as the reject bag.
• a conduit moreover suitable at the inlet as at the outlet can be mounted on a part provided with a bundle of channels allowing the mounting of as many pipes.
• a fluid distribution assembly characterized in that it comprises a valve with multiple inlets and outlets provided with a non-return valve, said valve being provided with a device. for withdrawing and injecting fluids such as a syringe or an adaptation such as a cone for adaptation of a syringe, and two lines, one being provided with a bypass (Y-line), or four lines and a bypass end (3 lines connected to a bypass end corresponding to a line with a bypass).

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Biochemistry (AREA)
• Analytical Chemistry (AREA)
• Physics & Mathematics (AREA)
• General Physics & Mathematics (AREA)
• Immunology (AREA)
• Pathology (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Pharmacology & Pharmacy (AREA)
• Medicinal Chemistry (AREA)
• Nutrition Science (AREA)
• Hydrology & Water Resources (AREA)
• Heart & Thoracic Surgery (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Sampling And Sample Adjustment (AREA)
• Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
• Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
• Apparatus Associated With Microorganisms And Enzymes (AREA)

Priority Applications (9)

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Citations (5)

Family Cites Families (8)

• 2003
  • 2003-03-11 FR FR0303016A patent/FR2852259B1/fr not_active Expired - Fee Related
• 2004
  • 2004-03-05 MX MXPA05009672A patent/MXPA05009672A/es not_active Application Discontinuation
  • 2004-03-05 JP JP2006505702A patent/JP2006524126A/ja active Pending
  • 2004-03-05 US US10/548,443 patent/US20060231139A1/en not_active Abandoned
  • 2004-03-05 WO PCT/FR2004/000533 patent/WO2004082829A2/fr not_active Application Discontinuation
  • 2004-03-05 CN CNA2004800056302A patent/CN1756523A/zh active Pending
  • 2004-03-05 BR BRPI0408122 patent/BRPI0408122A/pt not_active IP Right Cessation
  • 2004-03-05 KR KR1020057016803A patent/KR20050107507A/ko not_active Application Discontinuation
  • 2004-03-05 AU AU2004222541A patent/AU2004222541A1/en not_active Abandoned
  • 2004-03-05 EP EP04717661A patent/EP1608465A2/fr not_active Withdrawn
  • 2004-03-05 CA CA 2517898 patent/CA2517898A1/fr not_active Abandoned
  • 2004-03-05 NZ NZ542425A patent/NZ542425A/en unknown
• 2005
  • 2005-07-27 NO NO20053652A patent/NO20053652L/no not_active Application Discontinuation

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