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EP2036528B1 - Blood plasma container - Google Patents

Blood plasma container Download PDF

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Publication number
EP2036528B1
EP2036528B1 EP20080016046 EP08016046A EP2036528B1 EP 2036528 B1 EP2036528 B1 EP 2036528B1 EP 20080016046 EP20080016046 EP 20080016046 EP 08016046 A EP08016046 A EP 08016046A EP 2036528 B1 EP2036528 B1 EP 2036528B1
Authority
EP
European Patent Office
Prior art keywords
blood
plasma
container according
plasma container
container
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.)
Revoked
Application number
EP20080016046
Other languages
German (de)
French (fr)
Other versions
EP2036528A3 (en
EP2036528A2 (en
Inventor
Heinz Meise
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.)
Heinz Meise GmbH
Haemonetics Corp
Original Assignee
Heinz Meise GmbH
Haemonetics Corp
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Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38806450&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP2036528(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Heinz Meise GmbH, Haemonetics Corp filed Critical Heinz Meise GmbH
Priority to PL08016046T priority Critical patent/PL2036528T3/en
Publication of EP2036528A2 publication Critical patent/EP2036528A2/en
Publication of EP2036528A3 publication Critical patent/EP2036528A3/en
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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
    • A61J1/05—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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61J1/1487—Inlet or outlet ports with friction fit, e.g. connecting tubes directly to a protruding port
    • 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
    • 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
    • A61J1/1468—Containers characterised by specific material properties

Definitions

  • the invention relates to a plastic blood plasma container with a body, on one side of which a neck is provided.
  • Blood in the body of humans fulfills a variety of functions. It takes on, for example, a transport function, because the circulation of the blood numerous dissolved substances and heat are transported from the place of their production or absorption to the place of their degradation or excretion, a respiratory function, a nutrient and rinse function and a defense function.
  • the blood consists of cells, the red blood cells (erythrocytes), the white blood cells (leukocytes) as well as the platelets and surrounding fluid, the blood plasma ( Deetjen / Speckmann "Physiology” Verlag Urban & Schwarzenberg, 1992, p. 261 ). Blood plasma is thus the cell-free blood fluid.
  • the plasma is a protein-rich fluid, the composition of which largely corresponds to the interstitial fluid (Deetjen / Speckmann, loc. Cit., P. 265).
  • Containers are used for receiving blood plasma. These are usually bags or bottles.
  • plasma bags are made from DE 93 17 359 U1 known and are referred to as transfer bags. They are made of plastic film and are used for the filling, storage, transport and supply of blood and blood components.
  • transfer bags are made of plastic film and are used for the filling, storage, transport and supply of blood and blood components.
  • a disadvantage of the use of the bags their behavior has been found in the frozen state of the plasma; in this condition, due to the material properties of the film, the bags tend to break when dropped.
  • Plasma bottles are for example from the DE 200 10 825 U1 known. They are usually made of plastic and are provided with a neck. The plasma bottles are stable and avoid the aforementioned disadvantage; However, during transport and storage, the shape of the bottles adversely affects because they require more space in relation to bags.
  • the invention has for its object to provide a blood plasma container, which allows a space-saving and thus inexpensive storage and transport and at the same time provides a high level of security against breakage even in the frozen state. According to the invention, this object is achieved with the features of claim 1.
  • a blood plasma container is created, which can be transported and stored in a space-saving manner, whereby the transport and storage costs are reduced.
  • the container is stable to survive undamaged fall even in the frozen state of the plasma.
  • a faster freezing of the plasma due to the flatter geometry is possible with the plasma container.
  • the flat geometry also allows shock-freezing in single cartridges that previously could only be used for plasma bags.
  • the body is externally provided with a ribbing.
  • the ribbing contributes to a stabilization of the container and avoids buckling of the container. This additionally ensures that the Blood plasma container does not exceed the dimensions of the individual cassettes for shock freezing.
  • the selected as embodiment blood plasma container is made of plastic.
  • the plastic is polyethylene, preferably high density polyethylene (HDPE). But also medium density polyethylene (MDPE) or low density polyethylene (LDPE) can be used. Important in the choice of material is in addition to meeting the hygienic requirements essentially sufficient stability of the container even in the frozen state of the plasma.
  • the container consists of a body 1 which has a substantially rectangular cross section in horizontal section.
  • the body 1 has a thickness, which corresponds to about one third of the diameter of known plasma bottles.
  • the dimensions of the container according to the invention correspond approximately to those of known plasma bags; they therefore have about the same filling volume.
  • the body 1 is externally provided with a ribbing 19, which stabilizes the container and avoids bulging.
  • the body 1 has at its one end a neck 2.
  • the neck 2 is closed with a container neck surface 3.
  • the container neck surface 3 is not detachably provided on the neck 2.
  • Bottle 1, neck 2 and container neck surface 3 are formed in one piece and are manufactured in one manufacturing step.
  • In the container neck surface 3 are in the embodiment of the FIGS. 1 to 3 provided two holes are attached to the nozzle 5.
  • the nozzle 5 are not detachable and mounted close to the container neck surface 3.
  • devices 5 are provided for connecting hoses.
  • the devices 5 are in the embodiment of L-shaped elbows that are not detachably connected to the nozzle 4.
  • the hoses are not detachably arranged.
  • connection bore 61 faces the neck 2 of the plasma container.
  • the connection bores 62 and 63 are aligned at right angles to the connection bore 61. They are diametrically opposed. From the connection bores 62 and 63, connections 64 and 65 each extend, which are provided with a right angle and thus open into the connection bore 61.
  • a tubular extension piece 66 is additionally provided, which protrudes into the connection bore 61.
  • the hoses connected to the devices 5 or the connector 6 are a ventilation hose 7 and a filling hose 8.
  • the hoses 7 and 8 are made of plastics which enable sterilization.
  • the ventilation and Verismesech includes a Y-piece, which is provided with a shut-off device 91 and a branch 92.
  • the shut-off device 91 is designed as a self-sealing filter. This is made of air-permeable, hydrophobic plastic, preferably polyethylene and closes itself when liquid contact independently. As long as the self-sealing filter does not come into contact with liquid, it is permeable to air and filters the air, preventing contamination of the blood plasma with bacteria in the air.
  • a coupling connection 10 connects, in which a rubber needle valve 101 is integrated.
  • the connection 10 serves to receive a sample tube (not shown) under vacuum.
  • a recovery unit is provided at its end facing away from the container. It is provided with a switch 11 to which two tubes 12 and 13 of different lengths are connected.
  • the hose 12 has at its end facing away from the switch 11 a receptacle 14 with a protective cap 15.
  • a centrifuge bowl is connected to the receptacle 14, a centrifuge bowl is connected during the dispensing process.
  • a piercing spike 16 is arranged, on whose free end a cap 17 can be attached.
  • the insertion mandrel 16 is used for removal from bottles with physiological saline.
  • the nozzle 4 and the devices 5 according to the embodiment of the FIGS. 1 to 3 and the connector 6 according to the embodiment of the FIGS. 4 to 6 can be covered with a rotating and cap 18. It is provided with a means for locking on the neck 2 of the container.
  • the cap 18 has two slots 181 which extend from their end facing towards the container and extending axially in the direction of the end of the cap 18 facing away from the container.
  • the slots 181 are arranged diametrically opposite each other in the embodiment and are used to pass the tubes 7 and 8.
  • the cap 18 is in a position in which the tubes 7 and 8 are passed through the slots 181 unhindered.
  • the tubes 7 and 8 are cut off by means of a thermo-tongs and welded.
  • the cap 18 is actuated.
  • the cap 18 is rotated.
  • the free ends of the tubes 7 and 8 are drawn into the cap 18 ( Figures 3 and 6 ).
  • the plasma container according to the invention is highly solid due to the materials chosen. This means that it is resistant to damage even in the frozen state of the plasma.
  • the flat shape of the container allows a rapid freezing of the plasma, since the container according to the invention in relation to known plasma bottles only one third of the thickness. This ensures the preservation of globolin and coagulation factors in the plasma.
  • the space-saving design of the container cost-effective storage and cost transport is possible.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Description

Die Erfindung betrifft einen Blutplasma-Behälter aus Kunststoff mit einem Korpus, an dessen einen Seite ein Hals vorgesehen ist.The invention relates to a plastic blood plasma container with a body, on one side of which a neck is provided.

Blut im Körper von Menschen erfüllt eine Vielzahl von Funktionen. Es übernimmt beispielsweise eine Transportfunktion, weil mit dem Kreislauf des Blutes zahlreiche gelöste Substanzen sowie Wärme vom Ort ihrer Produktion oder Aufnahme zum Ort ihres Abbaus oder ihrer Ausscheidung transportiert werden, eine Atemfunktion, eine Nähr- und Spülfunktion sowie eine Abwehrfunktion. Das Blut besteht aus Zellen, den roten Blutzellen (Erythrozyten), den weißen Blutzellen (Leukozyten) sowie den Thrombozyten und umgebender Flüssigkeit, dem Blutplasma ( Deetjen/Speckmann "Physiologie" Verlag Urban & Schwarzenberg, 1992, S. 261 ). Bei Blutplasma handelt es sich folglich um die zellfreie Blutflüssigkeit. Das Plasma ist eine eiweissreiche Flüssigkeit, deren Zusammensetzung weitgehend der interstitiellen Flüssigkeit entspricht (Deetjen/Speckmann a.a.O. S. 265). Zur Aufnahme von Blutplasma finden Behälter Anwendung. Es handelt sich dabei in der Regel um Beutel oder Flaschen.Blood in the body of humans fulfills a variety of functions. It takes on, for example, a transport function, because the circulation of the blood numerous dissolved substances and heat are transported from the place of their production or absorption to the place of their degradation or excretion, a respiratory function, a nutrient and rinse function and a defense function. The blood consists of cells, the red blood cells (erythrocytes), the white blood cells (leukocytes) as well as the platelets and surrounding fluid, the blood plasma ( Deetjen / Speckmann "Physiology" Verlag Urban & Schwarzenberg, 1992, p. 261 ). Blood plasma is thus the cell-free blood fluid. The plasma is a protein-rich fluid, the composition of which largely corresponds to the interstitial fluid (Deetjen / Speckmann, loc. Cit., P. 265). Containers are used for receiving blood plasma. These are usually bags or bottles.

Plasma-Beutel sind beispielsweise aus der DE 93 17 359 U1 bekannt und werden als Transferbeutel bezeichnet. Sie sind aus Kunststofffolie hergestellt und finden Anwendung für die Abfüllung, die Aufbewahrung, den Transport und die Zuführung von Blut und Blutbestandteilen. Nachteilig bei der Verwendung der Beutel hat sich ihr Verhalten in gefrorenem Zustand des Plasmas herausgestellt; in diesem Zustand neigen die Beutel aufgrund der Materialeigenschaften der Folie nämlich zum Brechen, wenn sie herunterfallen.For example, plasma bags are made from DE 93 17 359 U1 known and are referred to as transfer bags. They are made of plastic film and are used for the filling, storage, transport and supply of blood and blood components. A disadvantage of the use of the bags, their behavior has been found in the frozen state of the plasma; in this condition, due to the material properties of the film, the bags tend to break when dropped.

Plasmaflaschen sind beispielsweise aus der DE 200 10 825 U1 bekannt. Sie bestehen in der Regel aus Kunststoff und sind mit einem Hals versehen. Die Plasmaflaschen sind stabil und vermeiden den vorgenannten Nachteil; beim Transport sowie der Lagerung wirkt sich jedoch die Form der Flaschen nachteilig aus, da sie im Verhältnis zu Beuteln mehr Platz benötigen.Plasma bottles are for example from the DE 200 10 825 U1 known. They are usually made of plastic and are provided with a neck. The plasma bottles are stable and avoid the aforementioned disadvantage; However, during transport and storage, the shape of the bottles adversely affects because they require more space in relation to bags.

Zur Beseitigung der vorgenannten Nachteile liegt der Erfindung die Aufgabe zugrunde, einen Blutplasma-Behälter zu schaffen, der eine platzsparende und damit preiswerte Lagerung sowie Transport ermöglicht und der gleichzeitig eine hohe Sicherheit gegen Brechen auch in gefrorenem Zustand bereitstellt. Gemäß der Erfindung wird diese Aufgabe mit den Merkmalen des Anspruchs 1 gelöst.To eliminate the aforementioned disadvantages, the invention has for its object to provide a blood plasma container, which allows a space-saving and thus inexpensive storage and transport and at the same time provides a high level of security against breakage even in the frozen state. According to the invention, this object is achieved with the features of claim 1.

Mit der Erfindung ist ein Blutplasma-Behälter geschaffen, der platzsparend transportier- und lagerbar ist, wodurch die Transport- und Lagerkosten reduziert sind. Zudem ist der Behälter stabil, um auch in gefrorenem Zustand des Plasmas einen Sturz unbeschädigt zu überstehen. Gleichzeitig ist mit dem Plasma-Behälter ein schnelleres Durchfrieren des Plasmas aufgrund der flacheren Geometrie möglich. Die flache Geometrie ermöglicht außerdem eine Schockgefrierung in Einzelkassetten, die bisher lediglich für Plasma-Beutel verwendet werden konnten.With the invention, a blood plasma container is created, which can be transported and stored in a space-saving manner, whereby the transport and storage costs are reduced. In addition, the container is stable to survive undamaged fall even in the frozen state of the plasma. At the same time, a faster freezing of the plasma due to the flatter geometry is possible with the plasma container. The flat geometry also allows shock-freezing in single cartridges that previously could only be used for plasma bags.

In Weiterbildung der Erfindung ist der Korpus außen mit einer Verrippung versehen. Die Verrippung trägt zu einer Stabilisierung des Behälters bei und vermeidet eine Ausbeulung des Behälters. Hierdurch ist zusätzlich gewährleistet, dass der Blutplasma-Behälter die Abmessungen der Einzelkassetten für die Schockgefrierung nicht überschreitet.In a further development of the invention, the body is externally provided with a ribbing. The ribbing contributes to a stabilization of the container and avoids buckling of the container. This additionally ensures that the Blood plasma container does not exceed the dimensions of the individual cassettes for shock freezing.

Andere Weiterbildungen und Ausgestaltungen der Erfindung sind in den übrigen Unteransprüchen angegeben. Ein Ausführungsbeispiel der Erfindung ist in der Zeichnung dargestellt und wird nachfolgend im Einzelnen beschrieben. Es zeigen:

Fig. 1
die Ansicht eines Blutplasma-Behälters mit Verschlusskappe, Gewin nungs- sowie Belüftungs- und Verprobungseinheit;
Fig. 2
die Draufsicht auf den in Figur 1 dargestellten Blutplasma-Behälter;
Fig. 3
die Draufsicht auf den in Figur 1 dargestellten Blutplasma-Behälter mit verdrehter Verschlusskappe;
Fig. 4
die Ansicht eines Blutplasma-Behälters mit Verschlusskappe, Gewin- nungs- sowie Belüftungs- und Verprobungseinheit in anderer Ausbil- dung;
Fig. 5
die Draufsicht auf den in Figur 4 dargestellten Blutplasma-Behälter;
Fig. 6
die Draufsicht auf den in Figur 4 dargestellten Blutplasma-Behälter mit verdrehter Verschlusskappe;
Fig. 7
die Ansicht eines Blutplasma-Behälters in einer weiteren Ausbildung;
Fig. 8
die Seitenansicht von links des in Figur 7 dargestellten Blutplasma- Behälters und
Fig. 9
die Draufsicht auf den in Figur 7 dargestellten Blutplasma-Behälter.
Other developments and refinements of the invention are specified in the remaining subclaims. An embodiment of the invention is illustrated in the drawing and will be described in detail below. Show it:
Fig. 1
the view of a blood plasma container with cap, Gewin tion and ventilation and Verprobungseinheit;
Fig. 2
the top view of the in FIG. 1 illustrated blood plasma container;
Fig. 3
the top view of the in FIG. 1 illustrated blood plasma container with twisted cap;
Fig. 4
the view of a blood plasma container with closure cap, recovery, ventilation and testing unit in a different form;
Fig. 5
the top view of the in FIG. 4 illustrated blood plasma container;
Fig. 6
the top view of the in FIG. 4 illustrated blood plasma container with twisted cap;
Fig. 7
the view of a blood plasma container in a further embodiment;
Fig. 8
the side view from the left of the in FIG. 7 illustrated blood plasma container and
Fig. 9
the top view of the in FIG. 7 illustrated blood plasma container.

Der als Ausführungsbeispiel gewählte Blutplasma-Behälter ist aus Kunststoff hergestellt. Bei dem Kunststoff handelt es sich um Polyäthylen, vorzugsweise hochdichtes Polyäthylen (HDPE). Aber auch Polyäthylen mittlerer Dichte (MDPE) oder geringer Dichte (LDPE) sind verwendbar. Wichtig bei der Wahl des Materials ist neben der Erfüllung der hygienischen Anforderungen im Wesentlichen eine ausreichende Stabilität des Behälters auch in gefrorenem Zustand des Plasmas.The selected as embodiment blood plasma container is made of plastic. The plastic is polyethylene, preferably high density polyethylene (HDPE). But also medium density polyethylene (MDPE) or low density polyethylene (LDPE) can be used. Important in the choice of material is in addition to meeting the hygienic requirements essentially sufficient stability of the container even in the frozen state of the plasma.

Der Behälter besteht aus einem Korpus 1 der im Horizontalschnitt einen im Wesentlichen rechteckigen Querschnitt aufweist. Der Korpus 1 weist eine Dicke auf, die etwa ein Drittel des Durchmessers bekannter Plasma-Flaschen entspricht. Die Abmessungen des erfindungsgemäßen Behälters entsprechen etwa denjenigen bekannter Plasma-Beutel; sie weisen daher etwa das gleiche Füllvolumen auf. Im Ausführungsbeispiel nach den Figuren 7 bis 9 ist der Korpus 1 außen mit einer Verrippung 19 versehen, die den Behälter stabilisiert und eine Ausbeulung vermeidet.The container consists of a body 1 which has a substantially rectangular cross section in horizontal section. The body 1 has a thickness, which corresponds to about one third of the diameter of known plasma bottles. The dimensions of the container according to the invention correspond approximately to those of known plasma bags; they therefore have about the same filling volume. In the embodiment of the FIGS. 7 to 9 the body 1 is externally provided with a ribbing 19, which stabilizes the container and avoids bulging.

Der Korpus 1 weist an seinem einen Ende einen Hals 2 auf. Der Hals 2 ist mit einer Behälterhalsfläche 3 verschlossen. Die Behälterhalsfläche 3 ist an dem Hals 2 nicht lösbar vorgesehen. Flasche 1, Hals 2 und Behälterhalsfläche 3 sind in einem Stück gebildet und werden in einem Fertigungsschritt hergestellt. In der Behälterhalsfläche 3 sind im Ausführungsbeispiel nach den Figuren 1 bis 3 zwei Löcher vorgesehen, an die Stutzen 5 angebracht sind. Die Stutzen 5 sind nicht lösbar und dicht an der Behälterhalsfläche 3 angebracht. An den Stutzen 4 sind Vorrichtungen 5 zum Anschließen von Schläuchen vorgesehen. Die Vorrichtungen 5 bestehen im Ausführungsbeispiel aus L-förmigen Winkelstücken, die nicht lösbar mit den Stutzen 4 verbunden sind. An den den Stutzen 4 abgewandten Enden der Vorrichtungen 5 sind die Schläuche nicht lösbar angeordnet.The body 1 has at its one end a neck 2. The neck 2 is closed with a container neck surface 3. The container neck surface 3 is not detachably provided on the neck 2. Bottle 1, neck 2 and container neck surface 3 are formed in one piece and are manufactured in one manufacturing step. In the container neck surface 3 are in the embodiment of the FIGS. 1 to 3 provided two holes are attached to the nozzle 5. The nozzle 5 are not detachable and mounted close to the container neck surface 3. At the nozzle 4 devices 5 are provided for connecting hoses. The devices 5 are in the embodiment of L-shaped elbows that are not detachably connected to the nozzle 4. At the ends 4 of the devices 5 facing away from the nozzles, the hoses are not detachably arranged.

Im Ausführungsbeispiel nach den Figuren 4 bis 6 ist in der Behälterhalsfläche 3 lediglich ein Loch vorgesehen, in welches ein Konnektor 6 eingeführt ist. Der Konnektor 6 ist vergleichbar zu den Stutzen nicht lösbar und dicht an der Behälterhalsfläche 3 angebracht. Der Konnektor 6 hat im Querschnitt eine T-förmige Ausbildung. Der Konnektor 6 ist mit drei Anschlussbohrungen 61, 62, 63 versehen. Die Anschlussbohrung 61 ist dem Hals 2 des Plasma-Behälters zugewandt. Die Anschlussbohrungen 62 und 63 sind rechtwinklig zur Anschlussbohrung 61 ausgerichtet. Sie liegen sich diametral gegenüber. Von den Anschlussbohrungen 62 und 63 gehen jeweils Verbindungen 64 und 65 aus, die mit einem rechten Winkel versehen sind und somit in die Anschlussbohrung 61 münden. Bei der von der Anschlussbohrung 62 ausgehenden Verbindung 64 ist zudem ein rohrförmiges Verlängerungsstück 66 vorgesehen, das in die Anschlussbohrung 61 hineinragt.In the embodiment of the FIGS. 4 to 6 is provided in the container neck surface 3 only a hole into which a connector 6 is inserted. The connector 6 is similar to the nozzle not solvable and mounted close to the container neck surface 3. The connector 6 has a T-shaped configuration in cross section. The connector 6 is provided with three connection bores 61, 62, 63. The connection bore 61 faces the neck 2 of the plasma container. The connection bores 62 and 63 are aligned at right angles to the connection bore 61. They are diametrically opposed. From the connection bores 62 and 63, connections 64 and 65 each extend, which are provided with a right angle and thus open into the connection bore 61. In the case of the connection 64 extending from the connection bore 62, a tubular extension piece 66 is additionally provided, which protrudes into the connection bore 61.

Bei den an die Vorrichtungen 5 bzw. den Konnektor 6 angeschlossenen Schläuchen handelt es sich um einen Lüftungsschlauch 7 sowie einen Füllschlauch 8. Die Schläuche 7 und 8 sind aus Kunststoffen hergestellt, die eine Sterilisation ermöglichen.The hoses connected to the devices 5 or the connector 6 are a ventilation hose 7 and a filling hose 8. The hoses 7 and 8 are made of plastics which enable sterilization.

An dem dem Behälter abgewandten Ende des Lüftungsschlauchs 7 ist eine Lüftungs- und Verprobungseinheit vorgesehen. Die Lüftungs- und Verprobungseinheit umfasst ein Y-Stück, das mit einer Absperreinrichtung 91 und einem Abzweig 92 versehen ist. Im Ausführungsbeispiel ist die Absperreinrichtung 91 als Self-Sealing-Filter ausgebildet. Dieser ist aus luftdurchlässigem, hydrophobem Kunststoff, vorzugsweise Polyäthylen hergestellt und verschließt sich bei Flüssigkeitskontakt selbständig. Solange der Self-Sealing-Filter nicht mit Flüssigkeit in Berührung kommt, ist er luftdurchlässig und filtert dabei die Luft, sodass eine Kontamination des Blutplasmas mit in der Luft befindlichen Keimen verhindert ist.At the end of the ventilation hose 7 facing away from the container, a ventilation and testing unit is provided. The ventilation and Verprüfungseinheit includes a Y-piece, which is provided with a shut-off device 91 and a branch 92. In the exemplary embodiment, the shut-off device 91 is designed as a self-sealing filter. This is made of air-permeable, hydrophobic plastic, preferably polyethylene and closes itself when liquid contact independently. As long as the self-sealing filter does not come into contact with liquid, it is permeable to air and filters the air, preventing contamination of the blood plasma with bacteria in the air.

An den Abzweig 92 schließt sich ein Kupplungsanschluss 10 an, in den ein Gummi-Nadel-Ventil 101 integriert ist. Der Anschluss 10 dient der Aufnahme eines - nicht dargestellten - unter Vakuum stehenden Probeentnahmeröhrchens.At the branch 92, a coupling connection 10 connects, in which a rubber needle valve 101 is integrated. The connection 10 serves to receive a sample tube (not shown) under vacuum.

An dem Füllschlauch 8 ist an seinem dem Behälter abgewandten Ende eine Gewinnungseinheit vorgesehen. Sie ist mit einer Weiche 11 versehen, an die zwei Schläuche 12 und 13 unterschiedlicher Länge angeschlossen sind. Der Schlauch 12 weist an seinem der Weiche 11 abgewandten Ende eine Aufnahme 14 mit einer Schutzkappe 15 auf. An die Aufnahme 14 ist während des Spendevorgangs eine Zentrifugenglocke angeschlossen. An dem der Weiche 11 abgewandten Ende des Schlauches 13 ist ein Einstechdorn 16 angeordnet, auf dessen freies Ende eine Kappe 17 aufsteckbar ist. Der Einsteckdorn 16 dient zur Entnahme aus Flaschen mit physiologischer Kochsalzlösung.At the filling hose 8, a recovery unit is provided at its end facing away from the container. It is provided with a switch 11 to which two tubes 12 and 13 of different lengths are connected. The hose 12 has at its end facing away from the switch 11 a receptacle 14 with a protective cap 15. To the receptacle 14, a centrifuge bowl is connected during the dispensing process. At the end of the tube 13 facing away from the switch 11, a piercing spike 16 is arranged, on whose free end a cap 17 can be attached. The insertion mandrel 16 is used for removal from bottles with physiological saline.

Die Stutzen 4 sowie die Vorrichtungen 5 entsprechend dem Ausführungsbeispiel nach den Figuren 1 bis 3 sowie der Konnektor 6 gemäß dem Ausführungsbeispiel nach den Figuren 4 bis 6 sind mit einer Dreh- und Verschlusskappe 18 abdeckbar. Sie ist mit einem Mittel zum Verrasten an dem Hals 2 des Behälters versehen. Zudem weist die Kappe 18 zwei Schlitze 181 auf, die sich von ihren dem Behälter zugewandten und axial in Richtung des dem Behälter abgewandten Ende der Kappe 18 erstrecken. Die Schlitze 181 sind im Ausführungsbeispiel diametral zueinander angeordnet und dienen zum Durchführen der Schläuche 7 und 8. Während der Plasma-Spende befindet sich die Kappe 18 in einer Position, in der die Schläuche 7 und 8 durch die Schlitze 181 ungehindert hindurchgeführt sind. Nach Beendigung der Plasmaspende werden bekanntermaßen die Schläuche 7 und 8 mittels einer Thermo-Zange abgeschnitten und verschweißt. Um die freien Enden der abgeschnittenen Schläuche 7 und 8 zu fixieren wird die Kappe 18 betätigt. Hierzu wird die Kappe 18 gedreht. Dabei werden die freien Enden der Schläuche 7 und 8 in die Kappe 18 eingezogen (Figuren 3 und 6).The nozzle 4 and the devices 5 according to the embodiment of the FIGS. 1 to 3 and the connector 6 according to the embodiment of the FIGS. 4 to 6 can be covered with a rotating and cap 18. It is provided with a means for locking on the neck 2 of the container. In addition, the cap 18 has two slots 181 which extend from their end facing towards the container and extending axially in the direction of the end of the cap 18 facing away from the container. The slots 181 are arranged diametrically opposite each other in the embodiment and are used to pass the tubes 7 and 8. During the plasma donation, the cap 18 is in a position in which the tubes 7 and 8 are passed through the slots 181 unhindered. After completion of the plasma donation, it is known that the tubes 7 and 8 are cut off by means of a thermo-tongs and welded. To fix the free ends of the cut tubes 7 and 8, the cap 18 is actuated. For this purpose, the cap 18 is rotated. In this case, the free ends of the tubes 7 and 8 are drawn into the cap 18 ( Figures 3 and 6 ).

Der erfindungsgemäße Plasmabehälter ist aufgrund der gewählten Materialen hoch fest. Das bedeutet, dass er auch in gefrorenem Zustand des Plasmas gegen Beschädigungen resistent ist. Zudem ermöglicht die flache Form des Behälters ein schnelles Durchfrieren des Plasmas, da der erfindungsgemäße Behälter im Verhältnis zu bekannter Plasma-Flaschen nur ein Drittel der Dicke aufweist. Dadurch ist die Erhaltung von Globolinen- und Gerinnungsfaktoren im Plasma gewährleistet. Darüber hinaus besteht die Möglichkeit, die für Plasma-Beutel entwickelten Einzelkassetten zur Schockgefrierung des Plasmas auch für den erfindungsgemäßen Plasmabehälter zu verwenden, sodass der Behälter ohne zusätzlichen Aufwand in den bereits vorhandenen Vorrichtungen verwendbar ist. Zudem ist durch die Platz sparende Gestaltung des Behälters eine kostengünstige Lagerung sowie eine kostengünstige Transport möglich.The plasma container according to the invention is highly solid due to the materials chosen. This means that it is resistant to damage even in the frozen state of the plasma. In addition, the flat shape of the container allows a rapid freezing of the plasma, since the container according to the invention in relation to known plasma bottles only one third of the thickness. This ensures the preservation of globolin and coagulation factors in the plasma. In addition, it is possible to use the individual cassettes developed for plasma bags for flash freezing of the plasma also for the plasma container according to the invention, so that the container can be used without any additional effort in the already existing devices. In addition, the space-saving design of the container cost-effective storage and cost transport is possible.

Claims (12)

  1. Blood-plasma container made of a type of plastic whose material characteristics ensure that it is proof against damage even when the plasma is in the deep-frozen state, whose dimensions and volume correspond substantially to those of blood-plasma bags, and on one side of whose body (1) a neck (2) is provided, characterised in that the body (1) has a continuous and substantially rectangular cross-section.
  2. Blood-plasma container according to claim 1, characterised in that the plastic is polyethylene.
  3. Blood-plasma container according to claim 2, characterised in that the plastic is high-density polyethylene.
  4. Blood-plasma container according to claim 2, characterised in that the plastic is medium-density polyethylene.
  5. Blood-plasma container according to claim 2, characterised in that the plastic is low-density polyethylene.
  6. Blood-plasma container according to any of the claims 1 to 5, characterised in that a connector (6) is provided for connection with hoses (7, 8).
  7. Blood-plasma container according to claim 6, characterised in that the connector (6) has a T-shaped formation in its cross-section.
  8. Blood-plasma container according to claim 6 or claim 7, characterised in that the connector (6) is provided with three connecting holes (61, 62, 63).
  9. Blood-plasma container according to claim 8, characterised in that the connecting holes (62 and 63) are aligned at right angles to connecting hole (61).
  10. Blood-plasma container according to claim 9, characterised in that a tubular extension (66) is provided for connection with the connecting hole (62), and which projects into the connecting hole (61).
  11. Blood-plasma container according to one or more of the above claims, characterised in that the body (1) is provided with ribbing (19) on the outside.
  12. The use of a container according to one or more of the above claims for storing and transporting blood plasma.
EP20080016046 2007-09-14 2008-09-11 Blood plasma container Revoked EP2036528B1 (en)

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PL08016046T PL2036528T3 (en) 2007-09-14 2008-09-11 Blood plasma container

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DE200720012912 DE202007012912U1 (en) 2007-09-14 2007-09-14 Blood plasma container

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EP2036528A2 EP2036528A2 (en) 2009-03-18
EP2036528A3 EP2036528A3 (en) 2009-11-04
EP2036528B1 true EP2036528B1 (en) 2012-06-20

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Families Citing this family (6)

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Publication number Priority date Publication date Assignee Title
DE202009001068U1 (en) 2009-01-28 2009-04-09 Heinz Meise Gmbh Blood plasma container
EP2568949B1 (en) * 2010-05-12 2015-07-08 Haemonetics Corporation Blood plasma storage bottle with locking cap
DE202010012728U1 (en) 2010-09-22 2011-11-29 Deutsche Gesellschaft für Humanplasma mbH Blood plasma collection bottle
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
DE202016104706U1 (en) 2016-08-26 2016-09-30 Heinz Meise Gmbh Blood plasma container

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US20070181605A1 (en) * 2006-02-06 2007-08-09 Yang David U Fluid dispenser for minimizing residual fluid content

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Publication number Priority date Publication date Assignee Title
GB1216534A (en) * 1967-03-03 1970-12-23 Braun Internat G M B H B Improvements in or relating to containers for storing and dispensing medicinal liquids
BE792441A (en) * 1972-12-08 1973-06-08 Rit Rech Ind Therapeut SEMI-RIGID PLASTIC FLASKS.
DE9317359U1 (en) 1993-10-19 1994-02-10 Heinz Meise GmbH, 58579 Schalksmühle Blood transfer bags
DE20010825U1 (en) 2000-06-17 2000-10-12 Haemonetics GmbH, 81477 München Closure for blood plasma bottles
DE20310937U1 (en) * 2003-07-17 2003-12-04 Heinz Meise Gmbh Blood plasma bottle is provided with a ventilation and testing unit incorporating a blocking device with an air filter
KR20090057271A (en) * 2006-09-25 2009-06-04 니프로 가부시키가이샤 Blow Molding Sap Containers of Plastics

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US20070181605A1 (en) * 2006-02-06 2007-08-09 Yang David U Fluid dispenser for minimizing residual fluid content

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PL2036528T3 (en) 2012-11-30
DE202007012912U1 (en) 2007-12-06
EP2036528A3 (en) 2009-11-04
EP2036528A2 (en) 2009-03-18

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