EP2433608B1 - Blood plasma collection bottle - Google Patents

Blood plasma collection bottle Download PDF

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Publication number
EP2433608B1
EP2433608B1 EP20110156309 EP11156309A EP2433608B1 EP 2433608 B1 EP2433608 B1 EP 2433608B1 EP 20110156309 EP20110156309 EP 20110156309 EP 11156309 A EP11156309 A EP 11156309A EP 2433608 B1 EP2433608 B1 EP 2433608B1
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EP
European Patent Office
Prior art keywords
flask
lid
blood plasma
neck
plasma collecting
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20110156309
Other languages
German (de)
French (fr)
Other versions
EP2433608A3 (en
EP2433608A2 (en
Inventor
Reinhard Rettinghaus
Hubert Franzaring
Jürgen Dr. Schulz
Uwe Dr. Taborski
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.)
Octapharma Plasma GmbH
Original Assignee
Deutsche Gesellschaft fuer Humanplasma mbH
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Publication date
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Priority to PL11156309T priority Critical patent/PL2433608T3/en
Publication of EP2433608A2 publication Critical patent/EP2433608A2/en
Publication of EP2433608A3 publication Critical patent/EP2433608A3/en
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Publication of EP2433608B1 publication Critical patent/EP2433608B1/en
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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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A61J1/12—Bag-type containers with means for holding samples of contents
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1425—Snap-fit type
    • 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
    • A61J1/1475—Inlet or outlet ports
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • 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
    • A61J1/1493—Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting

Description

Die vorliegende Erfindung betrifft eine Blutplasmasammelflasche aus Kunststoff zur Aufbewahrung von Blutplasma im gefrorenen Zustand mit einem Flaschenkörper, der insbesondere im Horizontalschnitt einen Querschnitt rechteckiger Grundform besitzt und an seiner Oberseite einen Flaschenhals aufweist.The present invention relates to a blood plasma collection bottle made of plastic for storing blood plasma in the frozen state with a bottle body, which has a cross section of rectangular basic shape in particular in horizontal section and has a bottleneck on its upper side.

Blutplasmasammelbehälter sind in Form von Kunststoffbeuteln seit vielen Jahren bekannt und haben sich durch den Einsatz von Materialien wie Ethylenvenylacetat (EVA) und Polyethylen (PE) beim Einfrieren bewährt. Der Nachteil von Blutplasmasammelbehältern in Form von Blutbeuteln besteht in der schlechten Handhabbarkeit, da sie ohne Hilfsmittel oder Sonderkonstruktionen nicht aufgestellt werden können und zudem die Gefahr besteht, dass sie im eingefrorenen Zustand beim Herunterfallen beschädigt werden. Zudem beulen sie unkontrolliert aus, so dass die Füllmenge nur schwer kontrollierbar ist.Blood plasma collection containers have been known in the form of plastic bags for many years and have proven themselves through the use of materials such as ethylene-vinyl acetate (EVA) and polyethylene (PE) during freezing. The disadvantage of blood plasma collection containers in the form of blood bags is the poor handling, as they can not be set up without tools or special designs and also there is a risk that they will be damaged in the frozen state when dropped. In addition, they bulge out unchecked, so that the amount is difficult to control.

Aus diesem Grund in der DE 20 2007 012 912 U1 vorgeschlagen, Blutplasmasammelflaschen aus Kunststoff einzusetzen, deren Flaschenkörper im Horizontalschnitt einen Querschnitt rechteckiger Grundform aufweist und an seiner Oberseite einen durch eine Abdeckplatte verschlossenen Flaschenhals besitzt. An der Abdeckplatte sind zwei Anschlussstellen vorgesehen, von denen die eine Anschlussstelle zum Befüllen des Flaschenkörpers mit Blutplasma vorgesehen ist und die andere Anschlussstelle der Entlüftung und Probenahme dient. An der Abdeckplatte ist zum Schutz der Anschlussstellen ein Deckel befestigbar. Dieser weist zwei Schlitze auf, die der Durchführung von an den Anschlussstellen fixierten Schläuchen dienen.For this reason in the DE 20 2007 012 912 U1 proposed to use blood plasma collection bottles made of plastic, the bottle body in horizontal section has a cross-section rectangular basic shape and has on its upper side a closed by a cover bottle neck. There are two connection points on the cover plate provided, one of which is provided a connection point for filling the bottle body with blood plasma and the other connection point of the venting and sampling serves. On the cover plate, a lid can be fastened to protect the connection points. This has two slots, which serve the implementation of fixed at the connection points hoses.

Während der Plasmaspende befindet sich der Deckel in einer Position, in der die Schläuche durch die Schlitze ungehindert hindurchgeführt sind. Nach Beendigung der Plasmaspende werden die Schläuche abgeschnitten und verschweißt. Um die freien Enden der abgeschnittenen Schläuche zu fixieren, wird der Deckel gedreht, wodurch die freien Enden in den Deckel gezogen werden.During the plasma dispensing, the lid is in a position where the tubing passes unhindered through the slots. After completion of the plasma donation, the tubes are cut off and welded. To fix the free ends of the cut tubes, the lid is rotated, pulling the free ends into the lid.

Die bekannte Blutplasmasammelflasche hat sich in der Praxis zwar bewährt, die Bestrebungen gehen jedoch dahin, die Funktionalität und Handhabbarkeit weiter zu verbessern.Although the known blood plasma collection bottle has proven itself in practice, efforts are still being made to further improve functionality and manageability.

Aufgabe der vorliegenden Erfindung ist es daher, eine Blutplasmasammelflasche aus Kunststoff zur Aufbewahrung von Plasma im gefrorenen Zustand der eingangs genannten Art so auszugestalten, dass ihre Handhabbarkeit verbessert wird. Dabei soll insbesondere die Bedienbarkeit vereinfacht und die Formstabilität erhöht werden.Object of the present invention is therefore to design a blood plasma collection bottle made of plastic for the storage of plasma in the frozen state of the type mentioned so that their handling is improved. In particular, the operability is simplified and the dimensional stability can be increased.

Diese Aufgabe ist erfindungsgemäß dadurch gelöst, dass die Blutplasmasammelflasche, die nicht zwangsläufig an eine flache Ausbildung des Flaschenkörpers gebunden ist, an der Oberseite des Flaschenkörpers auf gegenüberliegenden Seiten des Flaschenhalses und seitlich beabstandet von diesem Anschlussstellen aufweist, von denen die eine Anschlussstelle dem Befüllen des Flaschenkörpers mit Blutplasma dient und die andere Anschlussstelle der Endlüftung und Probenahme dient, und dass an den Anschlussstellen im Wesentlichen L-förmige Konnektoren (ellbow connectors) vorgesehen sind, wobei jeweils der eine Konnektorschenkel mit dem Flaschenkörper verbunden ist und der andere Konnektorschenkel zum Flaschenhals gerichtet ist und einen Schlauch trägt, der sich über den Flaschenhals erstreckt.This object is inventively achieved in that the blood plasma collection bottle, which is not necessarily bound to a flat configuration of the bottle body, at the top of the bottle body on opposite sides the bottleneck and laterally spaced from this connection points, one of which serves the connection filling the bottle body with blood plasma and the other terminal of the Endlüftung and sampling serves, and that at the connection points substantially L-shaped connectors (ellbow connectors) are provided wherein each of the one connector leg is connected to the bottle body and the other connector leg is directed to the bottle neck and carries a hose extending over the bottle neck.

Bei dieser Ausgestaltung sind die Anschlussstellen links und rechts von dem Flaschenhals angeordnet und nicht wie im Stand der Technik an dem Flaschenhals selbst, wodurch die Bauhöhe reduziert ist. An den Anschlussstellen sind im Wesentlichen L-förmige Konnektoren derart vorgesehen, dass die an den Konnektoren angeschlossenen Schläuche sich über den Flaschenhals erstrecken. Durch diese Ausgestaltung wird die Anordnung insgesamt kompakt.In this embodiment, the connection points are arranged on the left and right of the bottle neck and not as in the prior art on the bottle neck itself, whereby the height is reduced. Substantially L-shaped connectors are provided at the connection points in such a way that the hoses connected to the connectors extend over the bottleneck. By this configuration, the arrangement is compact overall.

In an sich bekannter Weise kann an dem Flaschenhals und insbesondere einer dem Flaschenhals an seiner Oberseite verschließenden Abdeckplatte ein Deckel fixiert oder fixierbar sein. Dieser ist derart ausgestaltet, dass er im fixierten Zustand die über den Flaschenhals ragenden Abschnitte der Schläuche übergreift und so positioniert.In a manner known per se, a lid can be fixed or fixable to the bottleneck and in particular to a cover flap closing the top of the bottle. This is designed such that it engages over the bottle neck protruding portions of the tubes in the fixed state and so positioned.

In Ausbildung der Erfindung ist vorgesehen, dass der Deckel den Konnektoren/Schläuchen zugeordnete und zu der Deckelunterseite hin offenen Aussparungen aufweist, die mit den über den Flaschenhals ragenden Schlauchabschnitten in Eingriff kommen und von diesen durchgriffen werden, wenn der Deckel an dem Flaschenhals fixiert wird. Zusätzlich kann der Deckel innenseitig Haltestege aufweisen, welche die langen Konnektorschenkel/Schlauchabschnitten übergreifen und positionieren, wenn der Deckel an dem Flaschenhals fixiert ist.In training of the invention it is provided that the lid associated with the connectors / tubes and to the lid underside open recesses, which with the projecting over the bottle neck tube sections in Engage and be penetrated by these, when the lid is fixed to the neck of the bottle. In addition, the lid may have on the inside holding webs, which engage over the long connector legs / hose sections and position when the lid is fixed to the bottle neck.

In bevorzugter Weise ist ein Rastmechanismus vorgesehen, über welchen der Deckel an dem Flaschenhals und insbesondere der Abdeckplatte fixiert wird, wenn der Deckel von oben auf den Flaschenhals gedrückt wird. Dabei weist der Rastmechanismus gemäß einem weiteren Aspekt der Erfindung eine erste Raststellung auf, in welcher der Deckel wieder von dem Flaschenhals gelöst werden kann, und eine zweite Raststellung, in welcher der Deckel weiter auf den Flaschenhals gedrückt ist als in der ersten Raststellung und in der ein Lösen des Deckels von dem Flaschenhals verhindert wird, auf. Bei dieser Ausgestaltung ist der Deckel im Anlieferungszustand lösbar an dem Flaschenhals befestigt, d.h. er ist im oberen, ersten Rastpunkt eingerastet. Damit besteht die Möglichkeit, den Deckel zum Befüllen der Blutplasmasammelflasche und anschließendem Abschweißen der Konnektoren von dem Flaschenhals zu lösen. Nach dem Abschweißen kann der Deckel dann an dem Flaschenhals endgültig fixiert werden, indem er in die zweite Raststellung gebracht wird, in der ein Lösen nicht mehr möglich ist.Preferably, a latching mechanism is provided, via which the lid is fixed to the bottle neck and in particular the cover plate when the lid is pressed onto the bottleneck from above. In this case, the latching mechanism according to a further aspect of the invention, a first detent position, in which the lid can be released again from the bottle neck, and a second detent position, in which the lid is further pressed onto the bottle neck than in the first detent position and in the a release of the lid is prevented from the bottleneck on. In this embodiment, the cover is releasably attached to the bottleneck as delivered, i. he is locked in the upper, first resting point. This makes it possible to detach the lid for filling the blood plasma collection bottle and then welding off the connectors from the bottleneck. After welding off the lid can then be finally fixed to the bottle neck by being brought into the second detent position in which a release is no longer possible.

In Ausgestaltung dieser Ausführungsform kann vorgesehen sein, dass an dem unteren, offenen Deckelrand Rastnasen ausgebildet sind, die beim Aufdrücken des Deckels auf den Flaschenhals mit einem an dem Flaschenhals ausgebildeten Haltesteg und insbesondere den äußeren Randbereich der Abdeckplatte in Eingriff kommen, elastisch aufgeweitet werden und beim weiteren Aufdrücken elastisch zurückfedern und unter Herstellung der ersten Raststellung den Haltesteg hintergreifen.In an embodiment of this embodiment can be provided that are formed on the lower, open edge of the lid locking lugs formed when pressing the lid on the bottleneck with a on the bottleneck Holding web and in particular the outer edge region of the cover come into engagement, are elastically expanded and resiliently spring back upon further pressing and engage behind the retaining web to produce the first detent position.

Des Weiteren kann vorgesehen sein, dass an der Oberseite des Flaschenhalses und insbesondere der Abdeckplatte ein aufrecht abragender Steg und an der Deckelinnenseite eine zu dem Steg korrespondierende Aufnahme ausgebildet sind, die miteinander in Eingriff kommen, wenn der Deckel auf den Flaschenhals gedrückt wird und dass an dem Steg und der Aufnahme Rastelemente des Rastmechanismus ausgebildet sind, die in der zweiten Raststellung miteinander in Eingriff kommen.Furthermore, it can be provided that at the top of the bottle neck and in particular the cover plate an upright projecting web and the lid inside a corresponding to the web receptacle are formed, which engage with each other when the lid is pressed onto the bottle neck and that The web and the recording locking elements of the locking mechanism are formed, which come into engagement with each other in the second detent position.

Dabei kann in dem Steg eine Rastöffnung ausgebildet sein, in welche in der zweiten Raststellung ein aufnahmeseitig vorgesehenes Rastelement eingreift.In this case, a latching opening may be formed in the web, in which engages a receiving side provided latching element in the second detent position.

In Ausbildung der Erfindung ist vorgesehen, dass an dem Deckel und insbesondere der Deckeloberseite Halteelemente, insbesondere Halteclips zur lösbaren Anbringung von Proberöhrchen vorgesehen sind. Diese Ausgestaltung bietet die Möglichkeit, die Proberöhrchen als Einheit mit der Blutplasmasammelflasche auszuliefern.In an embodiment of the invention it is provided that retaining elements, in particular holding clips for the detachable attachment of sample tubes, are provided on the lid and in particular on the top side of the lid. This embodiment offers the possibility to deliver the sample tubes as a unit with the blood plasma collection bottle.

Bei einer Weiterbildung der erfindungsgemäßen Blutplasmasammelflasche können die Seitenflächen des Flaschenkörpers jeweils einen ebenen oder leicht nach innen gewölbten Bereich definieren, an den sich zu den Stirnflächen abgerundete Bereiche anschließen. Es hat sich gezeigt, dass derartig gestaltete Flaschenkörper besonders formstabil sind. Dies gilt insbesondere, wenn die Bereiche leicht nach innen gewölbt sind, wobei die Wölbung eine maximale Tiefe von 2 mm, insbesondere von 1,5 mm gegenüber den Rändern der Wölbung aufweist. Durch die nach innen gerichtete Wölbung wird eine Art Vorspannung erzielt, die einem Ausbeulen des Flaschenkörpers beim Befüllen entgegenwirkt. Die Stabilität der Flasche wird weiterhin erhöht, wenn die ebenen oder leicht nach innen gewölbten Bereiche eine hexagonale Form besitzen, deren Grundseiten an den Übergangsbereichen der Seitenflächen zu der Oberseite und Unterseite des Flaschenkörpers liegen und vorzugsweise derart gleichmäßig hexagonal ausgestaltet sind, dass die zwischen den Grundseiten liegenden Ecken etwa auf mittiger Höhe des Flaschenkörpers positioniert sind. Der Flaschenkörper besitzt dann eine Form, die man erhält, wenn man einen ovalen bzw. runden Körper flach drückt, wobei in diesem Fall die zwischen den Grundseiten liegenden Seiten der hexagonalen Flächen leicht abgerundet sind.In a development of the blood plasma collection bottle according to the invention, the side surfaces of the bottle body can each define a flat or slightly inwardly curved region, to which the end surfaces are rounded Connect areas. It has been shown that bottle bodies shaped in this way are particularly dimensionally stable. This is especially true when the areas are slightly curved inward, with the dome having a maximum depth of 2mm, especially 1.5mm from the edges of the dome. The inward curvature a kind of bias is achieved, which counteracts buckling of the bottle body during filling. The stability of the bottle is further increased when the flat or slightly inwardly curved portions have a hexagonal shape, the bases are at the transition areas of the side surfaces to the top and bottom of the bottle body and preferably such hexagonal evenly designed that the between the bases lying corners are positioned approximately at the central height of the bottle body. The bottle body then has a shape obtained by flattening an oval or round body, in which case the sides of the hexagonal faces lying between the bases are slightly rounded.

Des Weiteren kann der Flaschenkörper mehrere Versteifungswulste aufweisen, die sich um den Flaschenkörper erstrecken und vorzugsweise so positioniert sind, dass sie zumindest teilweise als Füllhöhenanzeige fungieren. Hierfür können insgesamt vier Versteifungswulste an dem Flaschenkörper ausgebildet sein, wobei insbesondere zwei Versteifungswulste an der oberen Flaschenkörperhälfte und zwei Versteifungswulste in der unteren Flaschenkörperhälfte vorgesehen sind.Furthermore, the bottle body may include a plurality of stiffening beads that extend around the bottle body and are preferably positioned to function, at least in part, as a level indicator. For this purpose, a total of four stiffening beads may be formed on the bottle body, wherein in particular two stiffening beads are provided on the upper bottle body half and two stiffening beads in the lower bottle body half.

Um die erfindungsgemäße Blutplasmaflasche stabil aufstellen zu können, können an der Unterseite des Flaschenkörpers drei Stellfüße vorgesehen sein.In order to be able to set up the blood plasma bottle according to the invention stably, three leveling feet can be provided on the underside of the bottle body.

Hinsichtlich weiterer vorteilhafter Ausgestaltungen der Erfindung wird auf die Unteransprüche sowie die nachfolgende Beschreibung eines Ausführungsbeispiels unter Bezugnahme auf die beiliegende Zeichnung verwiesen. In der Zeichnung zeigt:

Figur 1
eine Blutplasmasammelflasche gemäß der vorliegenden Erfindung in Vorderansicht;
Figur 2
die Blutplasmasammelflasche aus Figur 1 in perspektivischer Explosionsansicht;
Figur 3
die Blutplasmasammelflasche aus Figur 1 in perspektivischer Darstellung von schräg unten;
Figur 4
die Blutplasmasammelflasche aus Figur 1 von unten betrachtet;
Figur 5
die Blutplasmasammelflasche aus Figur 1 in Draufsicht;
Figur 6
in vergrößerter Darstellung den oberen Bereich der Blutplasmasammelflasche bei entferntem Deckel;
Figur 7
die Blutplasmasammelflasche aus Figur 1 in einer Seitenansicht; und
Figur 8
in perspektivischer Darstellung den Deckel der Blutplasmasammelflasche von schräg unten.
With regard to further advantageous embodiments of the invention, reference is made to the dependent claims and the following description of an embodiment with reference to the accompanying drawings. In the drawing shows:
FIG. 1
a blood plasma collection bottle according to the present invention in front view;
FIG. 2
the blood plasma collection bottle FIG. 1 in a perspective exploded view;
FIG. 3
the blood plasma collection bottle FIG. 1 in perspective view obliquely from below;
FIG. 4
the blood plasma collection bottle FIG. 1 viewed from below;
FIG. 5
the blood plasma collection bottle FIG. 1 in plan view;
FIG. 6
on an enlarged scale, the upper area of the blood plasma collection bottle with the lid removed;
FIG. 7
the blood plasma collection bottle FIG. 1 in a side view; and
FIG. 8
in perspective view of the lid of the blood plasma collection bottle from diagonally below.

In der Zeichnung ist eine Blutplasmasammelflasche zur Aufbewahrung von Blutplasma im gefrorenen Zustand gemäß der vorliegenden Erfindung dargestellt. Die Blutplasmasammelflasche besteht aus Kunststoff, insbesondere aus Polyethylen (PE) und besitzt einen Flaschenkörper 1, der im Horizontalschnitt einen Querschnitt rechteckiger Grundform besitzt und an seiner Oberseite einen Flaschenhals 2 mit einer obenseitig vorgesehenen Abdeckplatte 2a trägt. Wie in der Zeichnung gut erkennbar ist, definieren die Seitenflächen des Flaschenkörpers 1 jeweils einen ebenen Bereich 3 hexagonaler Form, dessen Grundseiten 3a, 3b an den Übergangsbereichen der Seitenflächen zu der Oberseite und Unterseite des Flaschenkörpers 1 liegen, wobei die zwischen den Grundseiten 3a, 3b liegenden Ecken E etwa auf mittiger Höhe des Flaschenkörpers 1 positioniert sind. Dabei sind die zwischen den Grundseiten 3a, 3b liegenden Seiten 3c, 3d, 3e, 3f der hexagonalen Fläche 3 leicht abgerundet. An die ebenen Seitenflächen des Flaschenkörpers 1 schließen sich die Stirnflächen an, die eine abgerundete Form besitzen. Insgesamt besitzt somit der Flaschenkörper 1 einer Form, die man erhält, wenn man einen Grundkörper runder oder ovaler Form flachdrückt. In der Zeichnung nicht erkennbar ist, dass die ebenen Bereiche 3 auch leicht nach innen gewölbt sein können, wobei die Wölbung in der Mitte des hexagonalen Bereiches 3 eine Tiefe von etwa 1,5 mm gegenüber den Rändern der hexagonalen Fläche 3 aufweist. Durch diese Ausgestaltung wird eine Art Vorspannung erzielt, die einem Ausbeulen des Flaschenkörpers 1 beim Befüllen mit Blutplasma entgegenwirkt.In the drawing, a blood plasma collection bottle for storing blood plasma in the frozen state according to the present invention is shown. The blood plasma collection bottle is made of plastic, in particular polyethylene (PE) and has a bottle body 1, which has a cross-section rectangular basic shape in horizontal section and carries on its upper side a bottle neck 2 with a top provided cover plate 2a. As can be clearly seen in the drawing, the side surfaces of the bottle body 1 each define a flat portion 3 of hexagonal shape, the bases 3a, 3b lie at the transition areas of the side surfaces to the top and bottom of the bottle body 1, wherein between the bases 3a, 3b lying corners E are positioned approximately at the central height of the bottle body 1. In this case, the sides 3c, 3d, 3e, 3f of the hexagonal surface 3 lying between the base sides 3a, 3b are slightly rounded off. On the flat side surfaces of the bottle body 1 close to the end faces, which have a rounded shape. Overall, therefore, the bottle body 1 has a shape that is obtained when flattening a base round or oval shape. It can not be seen in the drawing that the flat areas 3 can also be slightly curved inwards, the curvature in the center of the hexagonal area 3 having a depth of about 1.5 mm with respect to the edges of the hexagonal area 3. By this configuration, a kind of bias is achieved, the bulging of the Bottle body 1 counteracts when filling with blood plasma.

Des Weiteren weist der Flaschenkörper 1 insgesamt vier Versteifungswulste 5 auf, die sich um den Flaschenkörper 1 erstrecken, wobei zwei Versteifungswulste 5 in der oberen Flaschenkörperhälfte und zwei Versteifungswulste 5 in der unteren Flaschenkörperhälfte vorgesehen sind. Die oberen beiden Versteifungswulste 5 fungieren dabei als Füllhöhenanzeige.Furthermore, the bottle body 1 has a total of four stiffening beads 5, which extend around the bottle body 1, wherein two stiffening beads 5 are provided in the upper bottle body half and two stiffening beads 5 in the lower bottle body half. The upper two stiffening beads 5 act as a level indicator.

An der Unterseite des Flaschenkörpers 1 sind drei Stellfüße 4 vorgesehen, durch welche sichergestellt wird, dass die flache Blutplasmasammelflasche stabil aufgestellt werden kann.On the underside of the bottle body 1, three adjustable feet 4 are provided, by which it is ensured that the flat blood plasma collection bottle can be stably placed.

An der Oberseite des Flaschenkörpers 1 sind auf gegenüberliegenden Seiten des Flaschenhalses 2 und seitlich beabstandet von diesem zwei Anschlussstellen 7a, 7b vorgesehen, von denen die eine Anschlussstelle 7a dem Befüllen des Flaschenkörpers 1 mit Blutplasma dient und die andere Anschlussstelle 7b der Entlüftung und Probenahme dient. An den Anschlussstellen 7a, 7b sind mit dem Flaschenkörper 1 fest verbundene Anschlussstutzen 8 vorgesehen, an denen L-förmige Konnektoren 9 unlösbar gehalten sind. An den von den Anschlussstutzen 8 wegweisenden Konnektorschenkeln sind Schläuche 10 angebracht. Die Anordnung ist dabei so getroffen, dass die vom Anschlussstutzen wegweisenden Konnektorschenkel zum Flaschenhals 2 gerichtet sind, so dass die daran gehaltenen Schläuche 10 sich über die Abdeckplatte 2a des Flaschenhalses 2 erstrecken. In der Zeichnung sind die Schläuche 10 im abgeschweißten Zustand dargestellt, in welchem die Schlauch-enden unmittelbar oberhalb der Abdeckplatte 2a liegen. In unabgeschweißtem Zustand sind die Schläuche 10 deutlich länger, wobei der eine Schlauch sich bis zum Plasmapherese-Gerät erstreckt und der andere Schlauch eine Entlüftungsöffnung sowie eine Vorrichtung zur Probenahme trägt.At the top of the bottle body 1, two connection points 7a, 7b are provided on opposite sides of the bottle neck 2 and laterally spaced therefrom, one of which 7a serves to fill the bottle body 1 with blood plasma and the other connection point 7b serves for venting and sampling. At the connection points 7a, 7b firmly connected to the bottle body 1 connecting piece 8 are provided, on which L-shaped connectors 9 are held insoluble. At the points away from the connecting piece 8 connector legs hoses 10 are attached. The arrangement is made such that the connector legs facing away from the connecting piece are directed towards the bottle neck 2, so that the tubes 10 held thereon extend over the cover plate 2a of the bottle neck 2. In the drawing are the Hoses 10 shown in the welded state in which the hose ends are located directly above the cover plate 2a. When unsealed, the tubes 10 are significantly longer, with one tube extending to the plasmapheresis device and the other tube carrying a vent and a sampling device.

An der Abdeckplatte 2a des Flaschenhalses 2 ist ein Deckel 11 fixiert. Dieser ist derart ausgestaltet, dass er im fixierten Zustand die über den Flaschenhals 2 ragenden Abschnitte der Schläuche 10 übergreift und vor einem Zugriff von außen schützt. Konkret weist der Deckel 11 den Schläuchen 10 zugeordnete und zu der Deckelunterseite hin offene, schlitzförmige Aussparungen 12 auf, die mit den über den Flaschenhals 2 ragenden Schlauchabschnitten in Eingriff kommen und von diesen durchgriffen werden, wenn der Deckel 11 von dem Flaschenhals 2 fixiert wird.On the cover plate 2a of the bottle neck 2, a lid 11 is fixed. This is designed such that it overlaps in the fixed state over the bottle neck 2 projecting portions of the tubes 10 and protects against access from the outside. Specifically, the lid 11 the hoses 10 associated and open to the underside of the lid, slot-shaped recesses 12, which come into engagement with the protruding over the bottle neck 2 tube sections and are penetrated by these, when the lid 11 is fixed by the bottle neck 2.

Die Fixierung des Deckels 11 an dem Flaschenhals 2 erfolgt über einen Rastmechanismus, wenn der Deckel 11 von oben auf den Flaschenhals 2 gedrückt wird. Dabei umfasst der Rastmechanismus ein erste Raststellung, in welcher der Deckel 11 wieder von dem Flaschenhals 2 gelöst werden kann, und eine zweite Raststellung, in welcher ein Lösen des Deckels 11 von dem Flaschenhals 2 im Wesentlichen nicht mehr möglich ist. Konkret sind an dem unteren, offenen Deckelrand Rastnasen 13 ausgebildet, die beim Niederdrücken des Deckels 11 auf dem Flaschenhals 2 mit dem äußeren Randbereich der Abdeckplatte 2a in Eingriff kommen, elastisch aufgeweitet werden und beim weiteren Niederdrücken des Deckels 11 elastisch zurückfedern und unter Herstellung der ersten Raststellung die Abdeckplatte 2a hintergreifen. In der Figur 8 ist gut erkennbar, dass sich die Rastnasen 13 im Wesentlichen über den gesamten unteren Randbereich des Deckels 11 erstrecken. Die erforderliche Elastizität zum Aufweiten erhält der Deckel 11 durch die Aussparungen 12 für die Schläuche 10. Der Eingriff zwischen den Rastnasen 13 und der Abdeckplatte 2akann wieder gelöst werden, indem die unteren Randbereiche des Deckels 11 manuell nach außen gebogen werden.The fixing of the lid 11 to the bottle neck 2 via a latching mechanism when the lid 11 is pressed from above onto the bottle neck 2. In this case, the latching mechanism comprises a first detent position, in which the lid 11 can be released again from the bottle neck 2, and a second detent position, in which a release of the lid 11 of the bottle neck 2 is substantially no longer possible. Specifically, locking lugs 13 are formed on the lower, open lid edge, which come when depressing the lid 11 on the bottle neck 2 with the outer edge region of the cover plate 2 engage, are elastically expanded and further depression of the lid 11th resiliently spring back and engage behind the cover plate 2a to produce the first detent position. In the FIG. 8 is clearly visible that the locking lugs 13 extend substantially over the entire lower edge region of the lid 11. The required elasticity for widening the cover 11 is replaced by the recesses 12 for the tubes 10. The engagement between the locking lugs 13 and the cover 2akann be solved again by the lower edge regions of the lid 11 are bent manually outwards.

In den Figuren 6 und 8 ist ferner gut erkennbar, dass an der Oberseite der Abdeckplatte 2a ein aufrecht abragender Steg 14 und an der Deckelinnenseite eine zu dem Steg 14 korrespondierende Aufnahme 15 ausgebildet sind, die miteinander in Eingriff kommen, wenn der Deckel 11 auf den Flaschenhals 2 gedrückt wird. Dabei ist an dem Steg 14 ruhende Rastöffnung 16 ausgebildet, mit welcher ein aufnahmeseitig vorgesehener Rastzahn 12 in Eingriff kommt, wenn der Deckel 11 über die erste Raststellung hinaus weiter auf den Flaschenhals 2 in die zweite Raststellung gedrückt wird. Der Eingriffsbereich zwischen der Rastöffnung 16 und dem Rastzahn 17 ist von außen nicht zugänglich, so dass ein Lösen dieser Verbindung verhindert wird.In the FIGS. 6 and 8th Furthermore, it can be clearly seen that an upright projecting web 14 is formed on the upper side of the cover plate 2a and a receptacle 15 corresponding to the web 14 is formed on the inner side of the cover, which engage with one another when the cover 11 is pressed onto the bottle neck 2. In this case, 14 resting latching opening 16 is formed on the web, with which a receiving side provided latching tooth 12 engages when the lid 11 is pushed beyond the first detent position on the bottle neck 2 in the second detent position. The engagement region between the latching opening 16 and the latching tooth 17 is not accessible from the outside, so that a release of this connection is prevented.

Schließlich ist in der Figur 7 gut erkennbar, dass der Deckel 11 an seiner Oberseite Halteclips 18 zur lösbaren Anbringung von Proberöhrchen 19 trägt.Finally, in the FIG. 7 clearly recognizable that the lid 11 carries at its top retaining clips 18 for releasably attaching sample tube 19.

Im Anlieferungszustand ist der Deckel 11 über den oberen, ersten Rastpunkt an dem Flaschenhals 2 fixiert. Nachdem die Blutplasmasammelflasche in üblicher Weise gefüllt worden ist, wird der Deckel 11 entfernt, und dann werden die Schläuche 10 so abgeschweißt, dass sie unter dem Deckel 11 Platz finden. Nach dem Abschweißen wird der Deckel 11 wieder an dem Flaschenhals 2 befestigt und dabei soweit niedergedrückt, dass eine Fixierung über die zweite Raststellung erfolgt, so dass ein erneutes Entfernen des Deckels 11 verhindert wird. Damit sind die Schläuche 10 für nachträgliche Manipulationen unzugänglich.In the delivery state, the lid 11 is fixed on the bottleneck 2 via the upper, first latching point. after the Blood plasma collection bottle has been filled in a conventional manner, the lid 11 is removed, and then the tubes 10 are welded so that they find space under the lid 11. After welding, the lid 11 is again attached to the bottle neck 2 and thereby depressed so far that a fixation on the second detent position takes place, so that a renewed removal of the lid 11 is prevented. Thus, the hoses 10 are inaccessible for subsequent manipulation.

Claims (15)

  1. The blood plasma collecting flask made of plastic for the storage of blood plasma in the frozen state, comprising a flask body (1) which preferably in the horizontal section has a cross-section with a rectangular basic shape and has on its upper side a flask neck (2), characterised in that connection points (7a, 7b) are provided on the upper side of the flask body (1) on opposite sides of the flask neck (2) and spaced apart from the latter to the side, of which one connection point (7a) is used for filling the flask body (1) with blood plasma, and the other connection point (7b) is used for ventilation and the taking of samples, and in that substantially L-shaped connectors (9) are provided at the connection points (7a, 7b), the one connector arm respectively being connected to the flask body (1), and the other connector arm being directed towards the flask neck (2) and bearing a tube (10) which extends over the flask neck (2) .
  2. The blood plasma collecting flask according to Claim 1, characterised in that the connector arms facing away from the flask body (2) are aligned such that the tubes (10) connected to the latter are spaced apart from one another over the flask neck (2).
  3. The blood plasma collecting flask according to Claim 1 or 2, characterised in that a lid (11) is fixed or is fixable to the flask neck (2), and in particular to a covering plate (2a) closing the flask neck (2) on its upper side, and the lid (11) is designed such that in the fixed state it overlaps the sections of the tubes (10) projecting over the flask neck (2) and protects them against access from the outside.
  4. The blood plasma collecting flask according to Claim 3, characterised in that the lid (11) has notches (12) assigned to the tubes (10) and open towards the lower side of the lid which engage with the tube sections projecting over the flask neck (2) and are passed through by the latter when the lid (11) is fixed onto the flask neck.
  5. The blood plasma collecting flask according to Claim 3 or 4, characterised in that the lid (11) has on the inside holding bars which overlap and position the tube sections projecting over the flask neck (2) when the lid (11) is fixed onto the flask neck 2.
  6. The blood plasma collecting flask according to claims 3 to 5, characterised in that a locking mechanism is provided by means of which the lid (11) is fixed onto the flask neck (2) and in particular onto the covering plate (2a) when the lid (11) is pushed onto the flask neck (2) from above, the locking mechanism having a first locking position in which the lid (11) can be released again from the flask neck (2), and a second locking position in which the lid (11) is pushed further onto the flask neck (2) than in the first locking position and in which the lid (11) is prevented from being released from the flask neck (2).
  7. The blood plasma collecting flask according to Claim 6, characterised in that lugs (13) are formed on the lower, open lid edge which, upon pushing the lid (11) onto the flask neck (2), engage with a holding bar formed on the flask neck (2), and in particular onto the outer edge region of the covering plate (2a), are elastically expanded, and when pushed on further spring back elastically and engage behind the holding bar thus establishing the first locking position.
  8. The blood plasma collecting flask according to Claim 6 or 7, characterised in that on the upper side of the flask neck (2), and in particular on the covering plate (2a), a bar (14) projecting perpendicularly and on the inside of the lid a retainer (15) corresponding to the bar (14) are formed which engage with one another when the lid (11) is pushed onto the flask neck (2), and that locking elements (16, 17) of the locking mechanism are formed on the bar (14) and the retainer (15) which engage with one another in the second locking position.
  9. The blood plasma collecting flask according to Claim 8, characterised in that a locking opening (16) is formed in the bar (14) in which a locking element (17) on the retainer side engages in the second locking position.
  10. The blood plasma collecting flask according to any of Claims 5 to 9, characterised in that holding elements, in particular holding clips (18), are provided on the lid (11), and in particular on the upper side of the lid, for releaseably attaching test tubes (19).
  11. A blood plasma collecting flask according to any preceding claim, characterised in that the lateral faces of the flask body (2) respectively define a flat or slightly inwardly curved area (3) adjoining which are areas rounded towards the face surfaces.
  12. The blood plasma collecting flask according to Claim 11, characterised in that the lateral faces of the flask body (2) respectively define a slightly inwardly curved area (3), the curvature having a maximum depth of 2 mm, in particular of 1.5 mm.
  13. The blood plasma collecting flask according to Claim 11 or 12, characterised in that the flat or slightly inwardly curved areas (3) have a hexagonal form the base sides (3a, 3b) of which lie on the crossover areas of the lateral faces to the upper side and lower side of the flask body (1), wherein in particular the flat or slightly curved areas (3) have a uniformly hexagonal form such that the corners (E) lying between the base sides (3a, 3b) are positioned approximately half way up the flask body (1).
  14. The blood plasma collecting flask according to Claim 13, characterised in that the sides of the hexagonal areas (3) lying between the base sides (3a, 3b) are slightly rounded.
  15. The blood plasma collecting flask according to any of the preceding claims, characterised in that the flask body (1) has a number of reinforcing ridges (5) that extend around the flask body (1) and in particular act at least partially as filling height indicators, wherein preferably two reinforcing ridges (5) being provided in the upper half of the flask body and two reinforcing ridges (5) being provided in the lower half of the flask body.
EP20110156309 2010-09-22 2011-02-28 Blood plasma collection bottle Active EP2433608B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL11156309T PL2433608T3 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle

Applications Claiming Priority (1)

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DE201020012728 DE202010012728U1 (en) 2010-09-22 2010-09-22 Blood plasma collection bottle

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EP2433608A2 EP2433608A2 (en) 2012-03-28
EP2433608A3 EP2433608A3 (en) 2013-02-27
EP2433608B1 true EP2433608B1 (en) 2014-08-13

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EP20110156309 Active EP2433608B1 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle
EP20110156317 Withdrawn EP2433610A3 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle
EP11156313.6A Not-in-force EP2433609B1 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle
EP11156307.8A Not-in-force EP2433607B1 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle

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EP20110156317 Withdrawn EP2433610A3 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle
EP11156313.6A Not-in-force EP2433609B1 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle
EP11156307.8A Not-in-force EP2433607B1 (en) 2010-09-22 2011-02-28 Blood plasma collection bottle

Country Status (5)

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US (1) US8834435B2 (en)
EP (4) EP2433608B1 (en)
DE (1) DE202010012728U1 (en)
HU (1) HUE035040T2 (en)
PL (1) PL2433608T3 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202011052056U1 (en) 2011-11-22 2011-12-30 Deutsche Gesellschaft für Humanplasma mbH Blood plasma collection bottle
DE202015102323U1 (en) * 2015-05-06 2016-08-09 Octapharma Plasma Gmbh Blood plasma collection bottle

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US2808053A (en) * 1955-06-21 1957-10-01 Baxter Laboratories Inc Serology sample container
FR1449600A (en) * 1964-09-14 1966-05-06 Fr Des Laboratoires Labaz Soc Improvements to flexible material bottles, especially for medicinal products
US3304977A (en) * 1965-01-11 1967-02-21 Velikanje Moore & Countryman Blood container
US4080989A (en) * 1976-05-19 1978-03-28 Michlin Chemical Corporation Tube connector for fluid container
US4568345A (en) * 1982-09-13 1986-02-04 Baxter Travenol Laboratories, Inc. Container and associated cap assembly for plasma collection and the like
CN1011030B (en) * 1984-10-30 1991-01-02 东洋制罐株式会社 Transfusion bottle
JPH06114Y2 (en) * 1990-05-28 1994-01-05 株式会社ニッショー Infusion container
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DE10138191B4 (en) * 2001-08-03 2004-02-26 Helvoet Pharma Belgium N.V. Cap for infusion or transfusion bottles
US7931629B2 (en) * 2001-11-01 2011-04-26 Medindica-Pak, Inc. Sterile liquid materials distribution, consumption and material waste disposal method and apparatus
JP4775638B2 (en) * 2006-03-31 2011-09-21 株式会社ジェイ・エム・エス Communication member, medical container using the same, and infusion dispensing device set
BRPI0717293A2 (en) * 2006-09-25 2013-10-15 Nipro Corp BLOW INFUSION MOLDED PLASTIC CONTAINER
FR2912384B1 (en) * 2007-02-09 2009-04-10 Biocorp Rech Et Dev Sa CLOSURE DEVICE FOR A CONTAINER, CONTAINER EQUIPPED WITH SUCH A DEVICE AND METHOD FOR CLOSING A LOT OF SUCH A CONTAINER
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DE202009001068U1 (en) * 2009-01-28 2009-04-09 Heinz Meise Gmbh Blood plasma container
FR2950865B1 (en) * 2009-10-01 2011-10-28 Raymond A & Cie LOCKING CAP FOR A COLLARED CONTAINER WITH A FASTENING CAPSULE

Also Published As

Publication number Publication date
EP2433607A3 (en) 2013-06-19
US8834435B2 (en) 2014-09-16
HUE035040T2 (en) 2018-05-02
EP2433608A3 (en) 2013-02-27
EP2433607B1 (en) 2015-11-25
EP2433608A2 (en) 2012-03-28
EP2433609B1 (en) 2017-04-05
US20120067886A1 (en) 2012-03-22
EP2433609A3 (en) 2013-05-22
EP2433610A3 (en) 2013-05-22
EP2433610A2 (en) 2012-03-28
EP2433607A2 (en) 2012-03-28
PL2433608T3 (en) 2015-01-30
EP2433609A2 (en) 2012-03-28
DE202010012728U1 (en) 2011-11-29

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