EP1652787B1 - Fermeture transperçable flexible pour couvrir un conteneur de liquide - Google Patents

Fermeture transperçable flexible pour couvrir un conteneur de liquide Download PDF

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Publication number
EP1652787B1
EP1652787B1 EP05022082A EP05022082A EP1652787B1 EP 1652787 B1 EP1652787 B1 EP 1652787B1 EP 05022082 A EP05022082 A EP 05022082A EP 05022082 A EP05022082 A EP 05022082A EP 1652787 B1 EP1652787 B1 EP 1652787B1
Authority
EP
European Patent Office
Prior art keywords
incisions
membrane
opening
container
reagent
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.)
Not-in-force
Application number
EP05022082A
Other languages
German (de)
English (en)
Other versions
EP1652787A1 (fr
Inventor
Michael Dr. Slama
Norbert Dr. Zander
Michael Heck
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.)
Siemens Healthcare Diagnostics Products GmbH
Original Assignee
Dade Behring Marburg GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dade Behring Marburg GmbH filed Critical Dade Behring Marburg GmbH
Publication of EP1652787A1 publication Critical patent/EP1652787A1/fr
Application granted granted Critical
Publication of EP1652787B1 publication Critical patent/EP1652787B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/142—Preventing evaporation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/049—Valves integrated in closure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0633—Valves, specific forms thereof with moving parts
    • B01L2400/0638—Valves, specific forms thereof with moving parts membrane valves, flap valves

Definitions

  • the invention relates to a flexible device for covering liquid containers, which can be pierced by the action of a rod-shaped object and which returns to its original shape after removal of the rod-shaped object.
  • a criterion to be considered when establishing tests on fully automatic diagnostic devices is the shelf life of the reagents when stored in the device, the so-called on-board stability, which is significantly influenced by the conditions in the device. Particularly problematic is the evaporation-related mass loss of liquid reagents.
  • the use of reagents of a defined composition is essential, so that changes in concentration caused by fluid losses can impair the quality or the so-called performance of the entire test.
  • the reason for the evaporation of liquid reagents is that they have to be directly accessible to the automatic pipettors and therefore are not hermetically sealed as a rule.
  • a particularly impervious protection against evaporation are sealing caps that hermetically seal the opening of the reagent container, such as swivel or snap closures.
  • this type of evaporation protection is only suitable for those devices that also have a corresponding device that automatically performs the opening and reclosing.
  • sealing plugs which are preferably made of highly elastic materials, such. As rubber are made, widely used. Examples of such devices can be found in EP 0 509 281 B1 . EP 0 097 591 B1 and FR 27 72 727 A1 .
  • the advantage of these flexible plugs is that they have inlet openings for cannulas and other rod-shaped objects, which have a certain flexibility due to the elasticity of the material used. As a result, on the one hand, the inlet openings can adapt to the diameter of the inserted object and, on the other hand, reseal after removal of the object. Difficulties arise, however, if z.
  • the object of the present invention was therefore to provide a device for closing liquid containers, which is distinguished firstly by reducing evaporation effects and thus to a higher on-board stability of liquid reagents, secondly almost universally for a very wide variety of liquid containers and pipetting devices can be used in diagnostic devices without modifications to the design of the liquid containers themselves or even the devices would be required and thirdly represents a cost-effective alternative to the previously known closure devices.
  • the present device for covering liquid containers is preferably used for the cover of reagent containers used in equipment, which process steps, such as. B. perform the pipetting or mixing of liquids automatically.
  • the device consists of a membrane, that is to say a separating layer or separating layer, which is suitable for separating two partial regions or compartments.
  • the membrane is provided with at least two radially arranged cuts and is preferably mounted on an opening of a liquid container, so that its opening is completely covered.
  • the term "cut” is to be understood as a cut which completes the membrane, i. H. severed in their entire thickness.
  • the inventive device for covering liquid containers consists of a self-adhesive membrane, which is treated on one side, at least in the area which is to be brought into direct contact with the liquid container, with an adhesive, as z.
  • B. of commercially available self-adhesive films or adhesive labels is known.
  • This embodiment has the advantage that the self-adhesive membranes on a carrier layer, such. B. a protective film can be applied, from which they can be easily detached without losing their adhesive power. To allow easier handling of the membranes and z.
  • the inventive device may also be provided with one or more Abziehlaschen.
  • the attachment of the membrane may be by means of chemical or mechanical adhesion promoters which provide a sealing, fixing connection between the membrane and the edge of the liquid container defining the opening.
  • the chemical adhesion is the Adhesion, which is produced by means of adhesives, preferably with the aid of liquid adhesives, between two parts to be joined, while mechanical adhesion is to be understood as adhesion, which is influenced by the nature of surfaces, such. As the micro-clamping porous or fibrous surfaces such.
  • Velcro closures are examples of the Adhesion, which is produced by means of adhesives, preferably with the aid of liquid adhesives, between two parts to be joined.
  • a cap which fixes the membrane mechanically on the opening bounding a liquid container edge.
  • Coupling caps in the sense of the present invention have a preferably circular opening whose opening cross-section allows the passage of the rod-shaped object to be used.
  • Particularly advantageous is the use of such drilled screw caps, as long as the liquid container to be closed has a screw thread.
  • the device according to the invention may be advantageous not to fasten the device according to the invention on the edge of the liquid container itself, but on the edge of the cap. It is possible to mount the device both on the outer edge and on the edge facing the inside of the cap.
  • the inventive device for covering liquid containers consists of a flexible membrane, which is provided with at least two incisions, which meet in a common initial or apex, so are arranged radially.
  • the two incisions are arranged so that an angle of 10 ° to 180 °, preferably from 20 ° to 120 °, particularly preferably from 45 ° to 90 ° is formed.
  • the number of incisions and the angular intervals between the incisions can be varied so as to result in an optimum ratio between the passage width, minimum frictional resistance and the greatest possible evaporation protection.
  • a further preferred embodiment of the device according to the invention consists of a membrane which is provided with 3 to 12, preferably with 4 to 10, particularly preferably with 6 advantageously equally long incisions.
  • An incision can be made by means of a straight, wavy or serrated cut.
  • the incisions are arranged equiangularly to each other, so that a plurality of isosceles triangles arise whose bases are connected to the peripheral edge of the membrane.
  • the length of the incisions originating from the vertex can be varied and is preferably chosen so that the region of the rod-shaped object which has the largest diameter and which is still intended to penetrate the covering device is provided with passage.
  • the device according to the invention can be pierced by the action of a rod-shaped object and returns to its original shape after removal of the rod-shaped object.
  • a rod-shaped object Become by the action of, for example, a pipettor the free ends of the triangles, which are cut into the membrane, displaced into the interior of the liquid container, whereby an opening is ensteht, which adapts flexibly, ie with low friction to the diameter of the pipettor.
  • the membrane triangles After removal of the pipettor, the membrane triangles return to their original position due to the elasticity of the material used and thus close the opening of the liquid container. This process is repeatable many times.
  • Rod-shaped objects for the purposes of the present invention are, for example, devices for the transfer of liquids, such as pipettors or cannulas or devices for mixing liquids, such as stirring rods, and are generally cylindrical or conically shaped. The end of such rod-shaped objects may be pointed, rounded or blunt.
  • the flexible membrane preferably consists of an elastic, vapor-impermeable material.
  • the expert should of course take into account that for the cover of liquid containers, the so different liquids such.
  • an adequate membrane material is used, which is not affected by the liquid to be covered or their vapors.
  • the membrane particularly preferably consists of a material from the group polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polystyrene (PS), polyamide (PA), polybutylene terephthalate (PBT), polycarbonate, (PC), polyimides (PI) , Natural rubber, silicone, bromobutyl and chlorobutyl rubber.
  • suitable are membranes which consist of mixtures of these materials or of at least two different layers of these materials.
  • it is possible, for. B. to combine a cellulosic layer with a layer of elastic material.
  • the thickness of the flexible membrane is preferably not greater than 150 ⁇ m and is advantageously between 40 ⁇ m and 100 ⁇ m, more preferably between 50 ⁇ m and 80 ⁇ m.
  • the device according to the invention is characterized in that arranged at the apex of the radiating th incisions is a circular, oval or polygonal opening, the z. B. can be created by punching.
  • the diameter of this opening corresponds to the diameter of that part of the rod-shaped object which passes first when entering the liquid container and at the exit last the closure device, so that z. B. liquid residues that adhere to the outside of a pipettor are stripped on the membrane. In this way, excessive contamination of the closure device can be avoided, whereby the risk of mixing of z. As different reagents is reduced.
  • Example 1 Reduction of evaporation-related weight losses
  • D-dimer cross-linked fibrin derivatives containing the D-dimer domain
  • All three reagents are aqueous solutions that are mixed with a plasma sample to perform the assay.
  • reagent B is a suspension of latex particles coated with a D-dimer specific monoclonal antibody (see eg. EP 0 122 478-B2 )
  • reagents A and C are essentially buffered saline solutions.
  • agglutination of the latex particles occurs, which can be quantified by turbidity. This test procedure was established on the automatic coagulation analyzer Sysmex® CA-560 (Dade Behring Marburg GmbH, Marburg, Germany) for automatic processing.
  • the Sysmex® CA-560 Analyzer (CA-560 for short) has a temperature-controllable position (15 ⁇ 1 ° C) for a test reagent container and other reagent container positions that can not be adjusted for temperature and therefore at room temperature (approx 25 ° C).
  • Test reagent A was placed in the tempered position while test reagents B and C were placed in non-tempered positions.
  • the reagent containers were 5 ml glass threaded bottles with an opening diameter of about 11 mm.
  • reagent containers A, B and C were opened and placed in the designated positions of the CA-560, either with or without the use of a capping device according to the present invention.
  • a self-adhesive polypropylene membrane was used, which was coated on one side with cellulose and treated on the other side with an adhesive was, so that a total film thickness of 62 microns and a weight of 93 g / qm resulted.
  • the membranes were circular cut, had a diameter of about 12 mm and were provided with 8 radial, equiangularly arranged and equally long incisions.
  • the membranes were glued to the upper edges of the reagent containers and additionally stabilized with a drilled screw cap, as well as in Fig. 2a shown.
  • Each of the reagent containers contained 2 ml of reagent liquid at time t (0).
  • a mass determination of the filled reagent containers was carried out at time t (0) and after 18 hours, at time t (18).
  • the relative mass loss of the reagent liquids was determined from the difference ( ⁇ ) of the mass at time t (0) and the mass at time t (18).
  • the reagent containers each containing 2 ml of reagent liquid, were first opened, placed in the CA-560, and at time t (0), a test for quantitative determination of D-dimer in a lower D plasma sample -Dimer concentration (control LOW) and performed in a plasma sample of high D-dimer concentration (control HIGH).
  • control LOW D plasma sample -Dimer concentration
  • control HIGH plasma sample of high D-dimer concentration
  • the reagents were stored in the equipment under the conditions described in 1), 2) or 3), and after 18 hours another test run was performed on the same samples.
  • the relative deviations of the raw values at time t (18) from the corresponding reference values at time t (0) were determined as well as the relative deviations of the D-dimer concentration determined from the raw values.
  • Table 2 shows the results from these on-board stability studies. ⁇ b> Table 2 ⁇ / b> Reference at t (0) Storage closed Storage open Storage with cover device Time t [h] 0 18 18 18 Control LOW Raw values signal [mOD / min] 17.2 16.2 18.9 17.5 Relative deviation [%] -5.8% 9.9% 1.7% D-dimer concentration [ ⁇ g / L] 416 397 447 422 Relative deviation [%] -4.6% 7.5% 1.4% Control HIGH Raw values signal [mOD / min] 152.9 153.7 165.2 149.2 Relative deviation [%] 0.5% 8.0% -2.4% D-dimer concentration [ ⁇ g / L] 3638 3673 4200 3476 Relative deviation [%] 1.0% 15.4% -4.5%
  • the use of the inventive cover device also achieves an improved on-board stability of the entire test. Compared with the measured raw D-dimer concentrations obtained with the open-retained reagents after 18 hours, the deviation of the test results obtained with the reagents is over the 18-hour storage with a device according to the invention were significantly lower. Due to the better preservation of the test accuracy (performance) after 18 hours of storage of the test reagents in the devices (on-board), the use of the covering device according to the invention over the open storage of the test reagents is to be preferred.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Analytical Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Sampling And Sample Adjustment (AREA)

Claims (16)

  1. Dispositif flexible destiné à la fermeture de conteneurs de liquides, pouvant être transpercé par un objet en forme de tige et qui, après enlèvement de l'objet en forme de tige, revient à sa forme initiale, caractérisé en ce qu'il est composé d'une membrane élastique auto-collante, pourvue d'au moins deux incisions, ces incisions étant disposées en forme d'étoile, et en ce que la membrane, au moins dans la zone où elle est en contact direct avec le conteneur de liquides, est traitée avec une colle.
  2. Dispositif correspondant à la revendication 1, caractérisé en ce que la membrane est pourvue de 3 à 12 incisions, de préférence de 4 à 10, de manière encore préférée de 6 incisions.
  3. Dispositif correspondant aux revendications 1 et 2, caractérisé en ce que les incisions sont disposées au même angle les unes par rapport aux autres.
  4. Dispositif correspondant aux revendications 2 et 3, caractérisé en ce qu'il existe une ouverture circulaire ou polygonale au point de convergence contact des incisions disposées en forme d'étoile.
  5. Dispositif correspondant à la revendication 1, caractérisé en ce que la membrane est pourvue de deux incisions disposées de manière à former un angle de 10° à 180°, de préférence de 20° à 120°, de manière encore préférée de 45° à 90°.
  6. Dispositif correspondant aux revendications 1 à 5, caractérisé en ce que les incisions sont toutes de même longueur.
  7. Dispositif correspondant aux revendications 1 à 5, caractérisé en ce que les incisions ne sont pas toutes de la même longueur.
  8. Dispositif correspondant aux revendications 1 à 7, caractérisé en ce que la membrane est épaisse de 40 µm à 150 µm, de préférence de 40 µm à 100 µm, de manière encore préférée de 50 µm à 80µm.
  9. Dispositif correspondant aux revendications 1 à 8, caractérisé en ce que la membrane élastique est faite d'un matériau étanche à la vapeur.
  10. Dispositif correspondant aux revendications 1 à 9, caractérisé en ce que la membrane élastique est faite d'un matériau du groupe polyéthylène, polypropylène, polyéthylène téréphtalate, polystyrol, polyamides, polybutylène téréphtalate, polycarbonate, polyimide, caoutchouc naturel, silicone, caoutchouc brombutyle ou chlorbutyle ou de mélanges des ces matériaux.
  11. Dispositif correspondant à la revendication 10, caractérisé en ce que la membrane élastique est composée d'au moins deux couches de matériaux différents.
  12. Dispositif correspondant aux revendications de 1 à 11 destiné à la fermeture de conteneurs de réactif.
  13. Conteneur de réactif caractérisé en ce que son ouverture est recouverte par un ou plusieurs dispositifs correspondant à une ou plusieurs des revendications 1 à 11.
  14. Conteneur de réactif correspondant à la revendication 13, caractérisé en ce que le dispositif correspondant aux revendications 1 à 11 est fixé, par adhésion chimique, sur le bord délimitant l'ouverture du conteneur de réactif.
  15. Conteneur de réaction correspondant à la revendication 14, caractérisé en ce que le dispositif correspondant aux revendications 1 à 11 est de plus stabilisé par un capuchon d'obturation ayant une ouverture, de préférence circulaire, prévue pour le passage d'un objet en forme de tige.
  16. Conteneur de réaction correspondant à la revendication 13, caractérisé en ce que le dispositif correspondant aux revendications 1 à 11 est fixé, par adhésion chimique, sur le bord délimitant l'ouverture d'un capuchon d'obturation.
EP05022082A 2004-10-26 2005-10-11 Fermeture transperçable flexible pour couvrir un conteneur de liquide Not-in-force EP1652787B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102004052082A DE102004052082A1 (de) 2004-10-26 2004-10-26 Durchstoßbare, flexible Vorrichtung zur Abdeckung von Flüssigkeitsbehältnissen

Publications (2)

Publication Number Publication Date
EP1652787A1 EP1652787A1 (fr) 2006-05-03
EP1652787B1 true EP1652787B1 (fr) 2008-03-12

Family

ID=35602156

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05022082A Not-in-force EP1652787B1 (fr) 2004-10-26 2005-10-11 Fermeture transperçable flexible pour couvrir un conteneur de liquide

Country Status (7)

Country Link
US (1) US20060088446A1 (fr)
EP (1) EP1652787B1 (fr)
JP (1) JP2006124035A (fr)
AT (1) ATE388904T1 (fr)
CA (1) CA2524314A1 (fr)
DE (2) DE102004052082A1 (fr)
ES (1) ES2300919T3 (fr)

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GB201012494D0 (en) 2010-07-26 2010-09-08 Randox Lab Ltd Reagent bottles, valves thereof, washing modules and methods and apparatus for dispensing reagents
DE102012007887A1 (de) * 2012-04-23 2013-10-24 Erwin Quarder Systemtechnik Gmbh Probengefäß für ein insbesondere flüssiges Medium sowie Deckelteil für ein solches Probengefäß
GB2504300A (en) * 2012-07-24 2014-01-29 Genevac Ltd Apparatus and method for evaporating a solvent from a sample
AT513559B1 (de) * 2012-11-06 2016-02-15 Gerhard Bonecker Photometrische Messeinrichtung und photometrisches Messverfahren für eine Probenflüssigkeit
JP6294735B2 (ja) * 2013-04-05 2018-03-14 協和メデックス株式会社 試薬ボトル用キャップおよび試薬容器
EP3563929B1 (fr) * 2018-04-30 2022-04-13 Firmenich SA Appareil de production personnalisée d'un mélange d'agents aromatisants
WO2020142592A1 (fr) * 2019-01-04 2020-07-09 Instrumentation Laboratory Company Bouchon de récipient pour applications à nombre de perforation élevé
CN114789843B (zh) * 2022-04-24 2022-11-22 四川先通原子医药科技有限公司 放射性颗粒的容器及其用途

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Also Published As

Publication number Publication date
ATE388904T1 (de) 2008-03-15
US20060088446A1 (en) 2006-04-27
ES2300919T3 (es) 2008-06-16
DE102004052082A1 (de) 2006-04-27
CA2524314A1 (fr) 2006-04-26
EP1652787A1 (fr) 2006-05-03
JP2006124035A (ja) 2006-05-18
DE502005003180D1 (de) 2008-04-24

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