EP2391328A1 - Blood plasma container - Google Patents

Blood plasma container

Info

Publication number
EP2391328A1
EP2391328A1 EP09752117A EP09752117A EP2391328A1 EP 2391328 A1 EP2391328 A1 EP 2391328A1 EP 09752117 A EP09752117 A EP 09752117A EP 09752117 A EP09752117 A EP 09752117A EP 2391328 A1 EP2391328 A1 EP 2391328A1
Authority
EP
European Patent Office
Prior art keywords
blood plasma
container
plasma container
neck
plasma
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.)
Granted
Application number
EP09752117A
Other languages
German (de)
French (fr)
Other versions
EP2391328B1 (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
Original Assignee
Heinz Meise 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 Heinz Meise GmbH filed Critical Heinz Meise GmbH
Publication of EP2391328A1 publication Critical patent/EP2391328A1/en
Application granted granted Critical
Publication of EP2391328B1 publication Critical patent/EP2391328B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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
    • A61J1/1468—Containers characterised by specific material properties

Definitions

  • the invention relates to a blood plasma container made of plastic with a body, on one side of a neck is provided, wherein the body in horizontal section has a substantially rectangular cross-section.
  • 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 (leucocytes) and the platelets and surrounding fluid, the blood plasma (Deetjen / Speckmann "Physiology” Verlag Urban & Schwarzenberg, 1992, p 261)
  • the plasma is a liquid rich in proteins, the composition of which largely corresponds to the interstitial fluid (Deetjen / Speckmann, op. cit., p. 265) .These are usually used for the collection of blood plasma bottles.
  • Blood plasma containers of the aforementioned type are known per se (cf .. DE 20 2007 012 912 U1). They offer the possibility to store and transport recovered blood plasma reliably and space-saving. In addition, they have dimensions corresponding to those of plasma bags, so that the blood plasma containers are compatible with the transport and storage facilities provided for plasma bags.
  • the known blood plasma containers fulfill all requirements placed on them.
  • One disadvantage of using the known blood plasma containers is their behavior in the frozen state of the plasma. It has been found that during the freezing process, the containers Extend 1/7 of its volume. This leads to a bulging of the container, so that the given space-saving arrangement of a plurality of plasma containers is no longer guaranteed.
  • the sample collection tubes required for blood plasma collection are not easy to handle. As a result, the tubes are attached to the containers in the known blood plasma containers with rubber bands, whereby the handling and storage or the transport of the containers is adversely affected.
  • the invention aims to remedy this situation.
  • the invention has for its object to improve blood plasma containers.
  • this object is achieved, on the one hand, by providing a central web inside the body.
  • the risk of buckling of the container during the freezing process of the blood plasma is prevented.
  • the inventive blood plasma container retains its original shape, so that both storage and transport of the blood plasma container according to the invention in the known devices is possible.
  • the object is achieved on the other hand according to the invention in that at least one holder for sampling tube is arranged.
  • This provides the ability to attach the blood plasma sample collection tubes directly to the container without the need for the use of rubber bands or the like.
  • the use of the brackets offers the possibility of attaching the sampling tube directly to the container while still using the known storage and transport facilities.
  • the brackets are provided in the region of the central web.
  • the holders consist of recesses, which essentially reproduce the contour of the sampling tube. This makes it possible to introduce the sampling tube into the wells and to transport with the containers without the aid of other means. Because the Tubes are inserted into the wells, no supernatant is caused by the tubes, so that the handling is not adversely affected by the entrainment of the tubes.
  • FIG. 1 shows the view of a blood plasma container with closure cap, extraction and ventilation and Verprobungsaku
  • FIG. 2 is a plan view of the blood plasma container shown in FIG. 1;
  • FIG. FIG. 3 shows the plan view of the blood plasma container with twisted closure cap shown in FIG. 1;
  • FIG. 4 shows the view of a blood plasma container with a closure cap, an extraction and aeration and testing unit in a different embodiment
  • Fig. 5 is a plan view of the blood plasma container shown in Fig. 4; 6 shows the plan view of the blood plasma container with twisted closure cap shown in FIG. 4; 7 shows the view of a blood plasma container with a closure cap, an extraction and aeration and testing unit in another embodiment;
  • FIG. 8 is a plan view of the blood plasma container shown in Fig. 7;
  • FIG. 9 is a plan view of the twisted closure blood plasma container shown in FIG. 7;
  • Fig. 10 is a bottom view of the blood plasma container shown in Fig. 7; 11 shows the view of a blood plasma container with closure cap, extraction and ventilation and Verprobungshim in a further embodiment.
  • Fig. 12 is a plan view of the blood plasma container shown in Fig. 11;
  • Fig. 13 is a plan view of the illustrated in Figure 11 blood plasma container with twisted cap and Fig. 14 is a bottom view of the blood plasma container shown in FIG.
  • 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. He has a neck 2 at one end. 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 produced in one production step.
  • 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.
  • a middle day 1a is provided inside the body 1.
  • the central web 1a extends from the bottom of the body 1 in the direction of the neck 2.
  • the central web 1a extends over approximately 70% of the height of the body 1, whereby a gap 1b is formed between the central web 1a and the neck 2.
  • the height of the central bar corresponds approximately to a filling level of 650 ml of blood plasma. Since plasma containers are usually filled with 650 to 850 ml of blood plasma, it is ensured in this way that the chambers formed on both sides of the central web 1 a are uniformly filled with blood plasma.
  • the central web 1a in principle creates a three-chamber system in the plasma container, namely one chamber on each side of the central tank. web 1a and a chamber above the central web 1a on both sides of the gap 1b. This results in a much improved freezing behavior of the plasma. While the plasma in a webless rectangular container requires a freezing time of about 2 to 2.25 hours, in the case of the container according to the invention under the same basic conditions, only a freezing time of 1.5 to 2 hours is required. Thus, the recovered plasma is much more ready for further processing.
  • two holes are provided in the embodiment of Figures 1 to 3, 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.
  • 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 that allow 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.
  • the branch 92 is adjoined by a coupling connection 10 into 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.
  • 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.
  • the nozzle 4 and the devices 5 according to the embodiment of Figures 1 to 3 and the connector 6 according to the embodiment of Figures 4 to 6 can be covered with a rotary 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 facing and axially in the direction of the container facing away from the end of the cap 18 extend.
  • 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. 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).
  • At least one holder 19 for blood plasma sample removal tubes 20 is arranged on the body 1.
  • a holder 19 is arranged on each side of the neck 2.
  • the brackets 19 are formed in the form of a web 192 and allow a Verclipsen the sampling tube.
  • 192 part-circular openings 191 are formed in the webs, whose diameter corresponds to the diameter of the sampling tube.
  • the tubes are pressed for fastening in a known manner in the openings 191 and are thereby reliably fixed to the container according to the invention.
  • brackets 19 are provided in the region of the central web 1a. They consist of recesses 193, which essentially reproduce the contour of the sampling tube 20.
  • the withdrawal tubes 20 can be inserted into the recesses and kept removable therefrom. When inserted, the head of the sampling tube 20 is flush with the bottom of the plasma container.

Abstract

The invention relates to a blood plasma container made of plastic and having a body (1) having a neck (2) on one side thereof, wherein the body comprises a substantially rectangular horizontal cross section, wherein a center bar (1a) is provided in the interior of the body (1). The invention further relates to a blood plasma container made of plastic and having a body (1) having a neck (2) on one side thereof, wherein the body comprises a substantially rectangular horizontal cross section, wherein at least one mounting element (19) is disposed for sample extraction tubes (20).

Description

Blutplasma-Behälter Blood plasma container
Die Erfindung betrifft einen Blutplasma-Behälter aus Kunststoff mit einem Korpus, an dessen einen Seite ein Hals vorgesehen ist, wobei der Korpus im Horizontal- schnitt einen im Wesentlichen rechteckigen Querschnitt aufweist.The invention relates to a blood plasma container made of plastic with a body, on one side of a neck is provided, wherein the body in horizontal section has a substantially rectangular cross-section.
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 (leucocytes) and the platelets and surrounding fluid, the blood plasma (Deetjen / Speckmann "Physiology" Verlag Urban & Schwarzenberg, 1992, p 261) The plasma is a liquid rich in proteins, the composition of which largely corresponds to the interstitial fluid (Deetjen / Speckmann, op. cit., p. 265) .These are usually used for the collection of blood plasma bottles.
Blutplasma-Behälter der eingangs genannten Art sind an sich bekannt (vgl. DE 20 2007 012 912 U1). Sie bieten Die Möglichkeit, gewonnenes Blutplasma zuverlässig und platzsparend aufzubewahren und zu transportieren. Zudem weisen sie Abmessungen auf, die denjenigen von Plasma-Beuteln entsprechen, so dass die Blutplasma-Behälter mit den für Plasma-Beutel vorgesehenen Transport- und Lagerungs-Einrichtungen kompatibel sind.Blood plasma containers of the aforementioned type are known per se (cf .. DE 20 2007 012 912 U1). They offer the possibility to store and transport recovered blood plasma reliably and space-saving. In addition, they have dimensions corresponding to those of plasma bags, so that the blood plasma containers are compatible with the transport and storage facilities provided for plasma bags.
Die bekannten Blutplasma-Behälter erfüllen alle an sie gestellten Anforderungen. Nachteilig bei der Verwendung der bekannten Blutplasma-Behälter ist jedoch un- ter anderem ihr Verhalten im gefrorenen Zustand des Plasmas. Es hat sich nämlich herausgestellt, dass sich die Behälter während des Einfriervorgangs um ca. 1/7 ihres Volumens ausdehnen. Dies führt zu einem Ausbeulen der Behälter, so dass die an sich gegebene platzsparende Anordnung einer Vielzahl von Plasma- Behältern nicht mehr gewährleistet ist. Zudem hat sich herausgestellt, dass die für die Gewinnung des Blutplasmas erforderlichen Probe-Entnahmeröhrchen nicht handhabungsfreundlich zu transportieren sind. In Folge dessen werden die Röhrchen bei den bekannten Blutplasma-Behältern mit Gummibändern an den Behältern befestigt, wodurch die Handhabung und Lagerung bzw. der Transport der Behälter negativ beeinflusst ist.The known blood plasma containers fulfill all requirements placed on them. One disadvantage of using the known blood plasma containers, however, is their behavior in the frozen state of the plasma. It has been found that during the freezing process, the containers Extend 1/7 of its volume. This leads to a bulging of the container, so that the given space-saving arrangement of a plurality of plasma containers is no longer guaranteed. In addition, it has been found that the sample collection tubes required for blood plasma collection are not easy to handle. As a result, the tubes are attached to the containers in the known blood plasma containers with rubber bands, whereby the handling and storage or the transport of the containers is adversely affected.
Hier will die Erfindung Abhilfe schaffen. Der Erfindung liegt die Aufgabe zugrunde, Blutplasma-Behälter zu verbessern. Gemäß der Erfindung wird diese Aufgabe einerseits dadurch gelöst, dass im Inneren des Korpus ein Mittelsteg vorgesehen ist. Durch das Vorsehen eines Mittelsteges ist die Gefahr eines Ausbeulens des Behälters beim Einfriervorgang des Blutplasmas verhindert. Vielmehr behält der er- findungsgemäße Blutplasma-Behälter seine ursprüngliche Form, so dass sowohl Lagerung als auch Transport der erfindungsgemäßen Blutplasma-Behälter in den bekannten Vorrichtungen möglich ist.The invention aims to remedy this situation. The invention has for its object to improve blood plasma containers. According to the invention, this object is achieved, on the one hand, by providing a central web inside the body. By providing a central web, the risk of buckling of the container during the freezing process of the blood plasma is prevented. Rather, the inventive blood plasma container retains its original shape, so that both storage and transport of the blood plasma container according to the invention in the known devices is possible.
Die Aufgabe wird andererseits erfindungsgemäß dadurch gelöst, dass mindestens eine Halterung für Entnahmeröhrchen angeordnet ist. Hierdurch ist die Möglichkeit geschaffen, die Blutplasma-Probe-Entnahmeröhrchen unmittelbar an dem Behälter zu befestigen, ohne dass hierzu die Verwendung von Gummibändern oder der Gleichen erforderlich ist. Gleichzeitig bietet die Verwendung der Halterungen die Möglichkeit, die Entnahmeröhrchen unmittelbar an den Behälter zu befestigen und gleichzeitig noch die bekannten Lagerungs- und Transporteinrichtungen nutzen zu können.The object is achieved on the other hand according to the invention in that at least one holder for sampling tube is arranged. This provides the ability to attach the blood plasma sample collection tubes directly to the container without the need for the use of rubber bands or the like. At the same time, the use of the brackets offers the possibility of attaching the sampling tube directly to the container while still using the known storage and transport facilities.
In vorteilhafter Weiterbildung der Erfindung sind die Halterungen im Bereich des Mittelsteges vorgesehen. Bevorzugt bestehen die Halterungen aus Vertiefungen, die im Wesentlichen die Kontur der Entnahmeröhrchen nachbilden. Hierdurch besteht die Möglichkeit die Entnahmeröhrchen in die Vertiefungen einzuführen und mit den Behältern ohne Zuhilfenahme weiterer Mittel zu transportieren. Da die Röhrchen in die Vertiefungen einführbar sind, ist kein Überstand durch die Röhrchen hervorgerufen, sodass die Handhabbarkeit durch das Mitführen der Röhrchen nicht negativ beeinträchtigt ist.In an advantageous embodiment of the invention, the brackets are provided in the region of the central web. Preferably, the holders consist of recesses, which essentially reproduce the contour of the sampling tube. This makes it possible to introduce the sampling tube into the wells and to transport with the containers without the aid of other means. Because the Tubes are inserted into the wells, no supernatant is caused by the tubes, so that the handling is not adversely affected by the entrainment of the tubes.
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: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 die Ansicht eines Blutplasma-Behälters mit Verschlusskappe, Gewin- nungs- sowie Belüftungs- und Verprobungseinheit;1 shows the view of a blood plasma container with closure cap, extraction and ventilation and 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. 2 is a plan view of the blood plasma container shown in FIG. 1; FIG. FIG. 3 shows the plan view of the blood plasma container with twisted closure cap shown in FIG. 1; FIG.
Fig. 4 die Ansicht eines Blutplasma-Behälters mit Verschlusskappe, Gewin- nungs- sowie Belüftungs- und Verprobungseinheit in anderer Ausbildung;4 shows the view of a blood plasma container with a closure cap, an extraction and aeration and testing unit in a different embodiment;
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 mit Verschlusskappe, Gewin- nungs- sowie Belüftungs- und Verprobungseinheit in anderer Ausgestaltung;Fig. 5 is a plan view of the blood plasma container shown in Fig. 4; 6 shows the plan view of the blood plasma container with twisted closure cap shown in FIG. 4; 7 shows the view of a blood plasma container with a closure cap, an extraction and aeration and testing unit in another embodiment;
Fig. 8 die Draufsicht auf den in Figur 7 dargestellten Blutplasma-Behälter; Fig. 9 die Draufsicht auf den in Figur 7 dargestellten Blutplasma-Behälter mit verdrehter Verschlusskappe;Fig. 8 is a plan view of the blood plasma container shown in Fig. 7; FIG. 9 is a plan view of the twisted closure blood plasma container shown in FIG. 7; FIG.
Fig. 10 die Untersicht auf den in Figur 7 dargestellten Blutplasma-Behälter; Fig. 11 die Ansicht eines Blutplasma-Behälters mit Verschlusskappe, Gewin- nungs- sowie Belüftungs- und Verprobungseinheit in einer weiteren Ausgestaltung; Fig. 12 die Draufsicht auf den in Figur 11 dargestellten Blutplasma-Behälter;Fig. 10 is a bottom view of the blood plasma container shown in Fig. 7; 11 shows the view of a blood plasma container with closure cap, extraction and ventilation and Verprobungseinheit in a further embodiment. Fig. 12 is a plan view of the blood plasma container shown in Fig. 11;
Fig. 13 die Draufsicht auf den in Figur 11 dargestellten Blutplasma-Behälter mit verdrehter Verschlusskappe und Fig. 14 die Untersicht auf den in Figur 11 dargestellten Blutplasma-Behälter.Fig. 13 is a plan view of the illustrated in Figure 11 blood plasma container with twisted cap and Fig. 14 is a bottom view of the blood plasma container shown in FIG.
Der als Ausführungsbeispiel gewählte Blutplasma-Behälter ist aus Kunststoff hergestellt. Bei dem Kunststoff handelt es sich um Polyäthylen, vorzugsweise hoch- dichtes 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. Er 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 Ferti- gungsschritt hergestellt.The container consists of a body 1 which has a substantially rectangular cross section in horizontal section. He has a neck 2 at one end. 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 produced in one production step.
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.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.
Im Inneren des Korpus 1 ist ein Mittelstag 1a vorgesehen. Der Mittelsteg 1a erstreckt sich von dem Boden des Korpus 1 in Richtung des Halses 2. Der Mittelsteg 1a erstreckt sich über ca. 70 % der Höhe des Korpus 1 , wodurch zwischen dem Mittelsteg 1a und dem Hals 2 ein Spalt 1b ausgebildet ist. Die Höhe des Mittelsteges entspricht etwa einer Füllstandshöhe von 650 ml Blutplasma. Da Plasma-Behälter üblicherweise mit 650 bis 850 ml Blutplasma gefüllt werden, ist auf diese Weise sichergestellt, dass die beiderseits des Mittelsteges 1 a ausgebildeten Kammern gleichmäßig mit Blutplasma gefüllt werden.Inside the body 1, a middle day 1a is provided. The central web 1a extends from the bottom of the body 1 in the direction of the neck 2. The central web 1a extends over approximately 70% of the height of the body 1, whereby a gap 1b is formed between the central web 1a and the neck 2. The height of the central bar corresponds approximately to a filling level of 650 ml of blood plasma. Since plasma containers are usually filled with 650 to 850 ml of blood plasma, it is ensured in this way that the chambers formed on both sides of the central web 1 a are uniformly filled with blood plasma.
Zudem ist durch den Mittelsteg 1a im Prinzip ein Drei-Kammer-System in dem Plasma-Behälter geschaffen, nämlich jeweils eine Kammer beiderseits des Mittel- steges 1a und eine Kammer oberhalb des Mittelsteges 1a beiderseits des Spaltes 1b. Dies hat ein wesentlich verbessertes Einfrierverhalten des Plasmas zur Folge. Während nämlich das Plasma in einem steglosen Rechteckbehälter eine Einfrierzeit von ca. 2 bis 2,25 Stunden benötigt, wird bei dem erfindungsgemäßen Behäl- ter bei gleichen Rahmenbedingungen lediglich eine Einfrierzeit von 1 ,5 bis 2 Stunden benötigt. Somit steht das gewonnene Plasma wesentlich eher zur weiteren Verarbeitung bereit.In addition, the central web 1a in principle creates a three-chamber system in the plasma container, namely one chamber on each side of the central tank. web 1a and a chamber above the central web 1a on both sides of the gap 1b. This results in a much improved freezing behavior of the plasma. While the plasma in a webless rectangular container requires a freezing time of about 2 to 2.25 hours, in the case of the container according to the invention under the same basic conditions, only a freezing time of 1.5 to 2 hours is required. Thus, the recovered plasma is much more ready for further processing.
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 abgewand- ten Enden der Vorrichtungen 5 sind die Schläuche nicht lösbar angeordnet.In the container neck surface 3, two holes are provided in the embodiment of Figures 1 to 3, 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 of the devices 5 facing away from the connection 4, 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 Kon- nektor 6 ist vergleichbar zu den Stutzen nicht lösbar und dicht an der Behälterhals- fläche 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 exemplary embodiment according to FIGS. 4 to 6, only one hole is provided in the container neck surface 3 into which a connector 6 is inserted. The connector 6 is comparable to the nozzle not detachable and attached tightly 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 that allow sterilization.
An dem dem Behälter abgewandten Ende des Lüftungsschlauchs 7 ist eine Lüf- tungs- 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-Sea- ling-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 verifying 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 Gum- mi-Nadel-Ventil 101 integriert ist. Der Anschluss 10 dient der Aufnahme eines - nicht dargestellten - unter Vakuum stehenden Probeentnahmeröhrchens.The branch 92 is adjoined by a coupling connection 10 into 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. DerAt 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. Of the
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.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 zu- gewandten 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 Figures 1 to 3 and the connector 6 according to the embodiment of Figures 4 to 6 can be covered with a rotary 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 facing and axially in the direction of the container facing away from the end of the cap 18 extend. 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).
An dem Korpus 1 ist mindestens eine Halterung 19 für Blutplasma-Proben-Entnah- meröhrchen 20 angeordnet. Im Ausführungsbeispiel nach den Figuren 1 bis 6 ist beidseitig des Halses 2 jeweils eine Halterung 19 angeordnet. Die Halterungen 19 sind in Form eines Steges 192 ausgebildet und ermöglichen ein Verclipsen der Entnahmeröhrchen. Hierzu sind in den Stegen 192 teilkreisförmige Öffnungen 191 ausgebildet, deren Durchmesser dem Durchmesser der Entnahmeröhrchen entspricht. Die Röhrchen werden zum Befestigen in bekannter Weise in die Öffnungen 191 eingedrückt und sind dadurch zuverlässig an dem erfindungsgemäßen Behälter befestigt.At least one holder 19 for blood plasma sample removal tubes 20 is arranged on the body 1. In the exemplary embodiment according to FIGS. 1 to 6, a holder 19 is arranged on each side of the neck 2. The brackets 19 are formed in the form of a web 192 and allow a Verclipsen the sampling tube. For this purpose, 192 part-circular openings 191 are formed in the webs, whose diameter corresponds to the diameter of the sampling tube. The tubes are pressed for fastening in a known manner in the openings 191 and are thereby reliably fixed to the container according to the invention.
In den Ausführungsbeispielen nach den Figuren 7 bis 14 sind die Halterungen 19 im Bereich des Mittelsteges 1a vorgesehen. Sie bestehen aus Vertiefungen 193, die im Wesentlichen die Kontur der Entnahmeröhrchen 20 nachbilden. Die Ent- nahmeröhrchen 20 sind in die Vertiefungen einschiebbar und in diesen wieder entnehmbar gehalten. In eingeschobenem Zustand schließt der Kopf der Entnahmeröhrchen 20 bündig mit der Unterseite des Plasma-Behälters ab. In the embodiments of Figures 7 to 14, the brackets 19 are provided in the region of the central web 1a. They consist of recesses 193, which essentially reproduce the contour of the sampling tube 20. The withdrawal tubes 20 can be inserted into the recesses and kept removable therefrom. When inserted, the head of the sampling tube 20 is flush with the bottom of the plasma container.

Claims

Patentansprüche claims
1. Blutplasma-Behälter aus Kunststoff mit einem Korpus, an dessen einen Seite ein Hals vorgesehen ist, wobei der Korpus im Horizontalschnitt einen im We- sentlichen rechteckigen Querschnitt aufweist, dadurch gekennzeichnet, dass im Inneren des Korpus (1) ein Mittelstag (1a) vorgesehen ist.1. A blood plasma container made of plastic with a body, on one side of which a neck is provided, wherein the body has a substantially rectangular cross-section in horizontal section, characterized in that inside the body (1) a middle day (1a) is provided.
2. Blutplasma-Behälter nach Anspruch 1 , dadurch gekennzeichnet, dass sich der Mittelsteg (1a) von dem Boden des Korpus (1) in Richtung des Halses (2) erstreckt.2. A blood plasma container according to claim 1, characterized in that the central web (1 a) from the bottom of the body (1) in the direction of the neck (2).
3. Blutplasma-Behälter nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass zwischen dem Mittelsteg (1a) und dem Hals (2) ein Spalt (1 b) ausgebildet ist.3. blood plasma container according to claim 1 or 2, characterized in that between the central web (1 a) and the neck (2), a gap (1 b) is formed.
4. Blutplasma-Behälter aus Kunststoff mit einem Korpus, an dessen einen Seite ein Hals vorgesehen ist, wobei der Korpus im Horizontalschnitt einen im Wesentlichen rechteckigen Querschnitt aufweist, dadurch gekennzeichnet, dass mindestens eine Halterung (19) für Proben-Entnahmeröhrchen (20) angeordnet ist.4. A blood plasma container made of plastic with a body, on one side of a neck is provided, wherein the body in horizontal section has a substantially rectangular cross-section, characterized in that at least one holder (19) for sample collection tube (20) is.
5. Blutplasma-Behälter nach Anspruch 4, dadurch gekennzeichnet, dass beidseitig des Halses (2) jeweils eine Halterung (19) angeordnet ist.5. blood plasma container according to claim 4, characterized in that on both sides of the neck (2) each have a holder (19) is arranged.
6. Blutplasma-Behälter nach Anspruch 4 oder 5, dadurch gekennzeichnet, dass die Halterungen (19) ein Verclipsen der Entnahmeröhrchen ermöglichen.6. blood plasma container according to claim 4 or 5, characterized in that the holders (19) allow a clipping of the sampling tube.
7. Blutplasma-Behälter nach Anspruch 4, dadurch gekennzeichnet, dass die Halterungen (19) im Bereich des Mittelsteges (1a) vorgesehen.7. blood plasma container according to claim 4, characterized in that the holders (19) provided in the region of the central web (1 a).
8. Blutplasma-Behälter nach einem oder mehreren der vorgenannten Ansprüche, dadurch gekennzeichnet, dass die Halterungen (19) aus Vertiefungen (193) bestehen, die im Wesentlichen die Kontur der Entnahmeröhrchen (20) nachbilden. 8. blood plasma container according to one or more of the preceding claims, characterized in that the holders (19) consist of recesses (193), which essentially reproduce the contour of the sampling tube (20).
EP09752117.3A 2009-01-28 2009-11-03 Blood plasma container Not-in-force EP2391328B1 (en)

Applications Claiming Priority (2)

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DE200920001068 DE202009001068U1 (en) 2009-01-28 2009-01-28 Blood plasma container
PCT/EP2009/007846 WO2010085990A1 (en) 2009-01-28 2009-11-03 Blood plasma container

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WO2011142752A1 (en) * 2010-05-12 2011-11-17 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
CN102048640B (en) * 2011-01-28 2013-04-24 周小君 Integrated plastic double-color cover with double pipes and double valves for packaging large infusion soft bags and bottles
DE202011052056U1 (en) 2011-11-22 2011-12-30 Deutsche Gesellschaft für Humanplasma mbH Blood plasma collection bottle
HUE054412T2 (en) 2016-05-16 2021-09-28 Haemonetics Corp Sealer-less plasma bottle and top for same
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