DE102010060328B4 - Container for a liquid medium, in particular blood bags - Google Patents

Abstract

The invention relates to a container (1) for a liquid medium (3), in particular a blood bag, with a flexible outer wall (5) and a device (13) connected to the container (1) for recording and / or storing data. According to the invention, the device (13) for acquiring and / or storing data is arranged within the flexible outer wall (5), positioning means (15) being provided which the device (13) for acquiring and / or storing data in the case of the liquid Hold the medium (3) filled container (1) floating in the liquid medium (3), and the device (13) or the device (13) and the positioning means (15) are designed such that the respectively displaced mass of liquid medium ( 3) is substantially equal to the mass of the device (13) or the mass of the device (13) and the positioning means (15).

Description

The invention relates to a container for a liquid medium, in particular blood bag, with a flexible outer wall and a device connected to the container for the detection and / or storage of data.

Blood products, in particular blood plasma and fresh blood, are subject to strict controls and must not be exposed to unintentional warming above given limits during processing, storage and transport and prior to administration to a patient. In addition, blood products must be clearly identifiable. For this purpose, such characteristics must be permanently connected to the product. In addition to the name, further details, such as the blood type and the Rhesus factor, of such a label must be available.

To monitor the cold chain from the removal of the blood from the vein of a blood donor on the processing of blood and its storage in a blood bank to the operating room in which a patient receives the blood donation, therefore, a continuous monitoring of the temperature of the blood is required.

For the monitoring of the cold chain of a blood product usually electronic loggers are used, which are attached to the outside of the blood bag and allow continuous recording of the temperature profile. A continuous recording should here also be understood as the storage of temporally discrete samples for the temperature, the sampling preferably taking place in equidistant time steps.

Such loggers are thus devices for the acquisition and / or storage of data that can be produced, for example, as an integrated chip or using one or more integrated chips. For detecting the temperature and / or other parameters, such a device has suitable sensors, such as a temperature sensor.

In addition to or instead of the acquired data, such a device for the acquisition and / or storage of data can also only be used to characterize the liquid medium, for example the blood or the blood plasma, characterizing parameters or data or the data identifying or characterizing the container to save. The stored data is preferably transmitted wirelessly to the device or retrieved therefrom.

Since such loggers are usually not firmly connected to the bag for the blood product, it is common to additionally attach on the blood bag labels on which at least the most necessary data are recognizable. A disadvantage of this prior art is thus the only loose connection of the logger with the bag for the blood product, as this can solve and the data in question are then lost. In addition, the logger in this case does not record the temperature of the liquid medium in the bag or container, but the ambient temperature or the temperature of the Behältniswandung.

Another problem is that such bags for blood products in certain applications must also be subjected to a centrifugation process. In such a process, accelerations of up to 5,000 g and more occur. An incorrectly attached to the bag or on the Beutelaußenwandung logger can very easily lead to damage to the blood bag. Of course, the logger itself can be damaged by these high acceleration forces due to improper attachment to the bag or inappropriate retention of the bag in the centrifuge.

If the logger is lost or damaged, so that the desired data are no longer available, the blood product must also be discarded as in the case of damage to the container, as in this case the sterility can no longer be guaranteed.

Based on this prior art, the invention has for its object to provide a container for a liquid medium, in particular blood bag, in which the device for capturing and / or storing data is permanently connected to the bag and in which also damage Both the container itself and the device for detecting and / or storing data is then avoided when high accelerations act on the container filled with the liquid medium.

The invention solves this problem with the features of patent claim 1.

The invention is based on the recognition that an inseparable connection between the container and the device for detecting and / or storing data can be ensured if the device is arranged inside the outer wall of the container.

In order to avoid destruction of the device even at high, acting on the container filled with liquid medium accelerations, positioning means are provided according to the invention, which hold the device for detecting and / or storage of data when filled with the liquid medium container floating in the liquid medium.

According to the invention, the device or the positioning means is designed together with the device so that the respective displaced mass of liquid medium is substantially equal to the mass of the device or the mass of the device together with the positioning means. In other words, the buoyancy force acting on the device or the positioning means together with the device is equal to zero or at least so small that it can be neglected.

In this way, it can be ensured that during centrifugation of liquid medium accommodated in such a container, the device arranged therein for the collection and / or storage of data can be kept floating in the container even at high accelerations without, in particular, through contact between the device and the inner wall of the container, destruction or damage to the device or the container may occur.

These effects and advantages of the invention also apply when the container, as usual with blood bags, has a flexible outer wall, which can be made, for example, from a flexible plastic film.

According to one embodiment of the invention, the positioning means on a plurality of flexible, radially extending arms, which are connected to the edge of the container. This results in an extremely easy manufacturability for the positioning.

According to the preferred embodiment of the invention, the data acquisition and / or storage device is arranged in a central region from which the radially extending arms extend outwardly.

Preferably, the arms and the central region may be formed of a flexible film or of a flexible plate-shaped material. In particular, it makes sense to make said positioning of the same material, for example, the same plastic film, as the wall of the container.

According to the preferred embodiment of the invention, the device for capturing and / or storing data in the central region of the material forming the central region is surrounded in a liquid-tight manner. As a result, isolation of the device from the liquid medium to be received in the container can be achieved in a simple manner.

According to one embodiment of the invention, the radial arms and / or the central region can be formed from two interconnected layers of films or from two interconnected layers of a flexible plate-shaped material.

In this way, results in a very easy to produce container with positioning provided therein, which in turn record the device for detecting and / or storage of data liquid-tight.

According to a further embodiment of the invention acting in the direction perpendicular to the plane spanned on the arms level spacing means are provided, which span the device for detecting and / or storage of data and avoid contact between the device and the wall of the container. As a result, an even further improved security against damage to the device or the wall of the container is additionally achieved.

In order to design the mass of the device and the volume of the device so that a buoyant force of substantially zero for a given liquid of a given density results, a material for balancing the mass of the device may be accommodated in a housing of the device. Of course, the housing itself may consist of such a material. As such material, for example, a granular product may be used, for example, small polystyrene beads, glass beads or so-called "microbubbles".

As already stated above, the device for acquiring and / or storing data may in particular comprise a sensor for detecting the temperature of the liquid medium in the immediate vicinity of the device. In this way, the core temperature of the liquid medium received in the container can be detected.

Further embodiments of the invention will become apparent from the dependent claims.

The invention will be explained in more detail with reference to an embodiment shown in the drawing. In the drawing show

1 a broken plan view of a container in the form of a blood bag according to the invention and

2 a broken side view of the embodiment in 1 ,

This in 1 in a broken plan view shown container 1 for a liquid medium 3 , which may be, for example, a blood bag, has a wall 5 on, which may for example consist of a flexible, sufficiently stable plastic film. To produce, for example, two film parts on the outer edge 7 of the container 1 be welded or glued together. At the top of the in the 1 and 2 shown container one or more (in the illustrated embodiment, two) filling or dispensing nozzle 9 be arranged. Also at the top of the container 1 is a tab 11 provided, which serves to the container 1 to attach to a support, in particular hang.

Inside the container 1 or the wall 5 is a device 13 arranged for the collection and / or storage of data. The device 13 can be designed as a miniaturized electronic circuit, which preferably has a housing which protects the electronic components contained therein against environmental influences and mechanical effects. The device for acquiring and / or storing data 13 preferably comprises a temperature sensor (not shown) which the temperature of the immediate vicinity of the device 13 and thus the core temperature of the liquid medium 3 in the container 1 detected. The measured values can be detected continuously or quasi-continuously in relatively narrow time intervals and stored in a memory of the device.

In addition or instead (waiving a temperature sensor), further data may be stored in the device, which the container 1 or characterize or identify the liquid medium received therein. Among these data may also be a fixed serial number for the device 13 or the container 1 which are immutable as a fixed value in the device 13 is stored.

The device is preferably designed so that it can communicate wirelessly with a higher-level electronic unit (not shown). This can also be a mobile communication device that is used by a person when using or processing or processing the container 1 or the liquid medium received therein and for checking or changing the device 13 recorded data can serve.

The device 13 is like in the 1 and 2 represented by means of positioning substantially centrally within the container 1 held. The positioning means can, as in 1 shown, several from a central area 17 radially outwardly extending arms 19 exhibit that with the edge 7 of the container 1 are connected. The central area 17 and the arms extending radially outwardly therefrom 19 For example, they may also be made of a sufficiently stable, flexible plastic film or a flexible, plate-shaped material. The bag, as explained above, from two superimposed, at the edge 7 produced welded plastic films, such a positioning can be placed on the edge between the two plastic films and sealed together with these or welded.

Of course it is not necessary as in 1 shown, exactly four arms for fixing the device 13 in the container 1 to use or arrange them so that their ends in each case in the corners of a substantially rectangular container with the wall 5 are connected. For example, a wider strip of a plastic film or a plate-shaped material could be arranged so that this substantially centrally through the container 1 runs, leaving the device 13 again in a corresponding central area substantially centrally in the container 1 is held.

Of course, instead of a central positioning of the device 13 These may also be held at any other position within the container.

While it provides in the manufacture of the container 1 after the 1 and 2 Benefits, if the positioning means with the edge 5 the container are connected, but this is not mandatory. It is also conceivable, a corresponding positioning means, for example in the form of a plastic strip or in another form, at any, opposite areas of the wall 7 to fix.

In the in the 1 and 2 In the embodiment shown, the positioning means may be designed such that the device 13 in the central area 17 is tightly received within the positioning. For example, the central area 17 have a recess in which the device 13 is included. In this case, the recess may preferably be the outer contour of the device 13 correspond. On both sides of the device 13 can then be provided a plastic film which the device 13 each completely covers, wherein the edge regions of the plastic film in turn with the respective surface of the central region 17 connected, for example, welded or glued. This is the device 13 liquid-tight in the positioning received.

Instead of providing a recess in the central area 17 can the positioning means 15 also in turn consist of two correspondingly designed plastic films, wherein the device 13 in the central area 17 is placed between the two plastic films or plate-like materials and then wherein the two plastic films at least in the central region in a closed, the device surrounding ring connected to each other, for example, welded or glued. Also in this way results in a simple and inexpensive manufacturability for a liquid-tight in the positioning 15 enclosed device 13 ,

Like from the 1 and 2 can be seen on both sides of the positioning 15 in the central area 17 spacer 21 be provided, which in the central area 17 held device 13 span. It may, as in particular 2 seen to act two curved elements, which consist of a sufficiently rigid, but preferably also sufficiently flexible material, for example, of a thicker plastic film. These bent positioning means 21 span the device on both sides 13 and are on edges 23 with the central area 17 the positioning means 15 connected, for example, in turn, welded or glued.

The positioning means 21 thus avoiding that in case of more extreme mechanical forces or accelerations acting on the device 13 act, the device with the wall 7 of the container 1 comes into contact and so the wall or the device will be damaged. Sufficient flexibility of the spacer means 21 ensures that it does not damage the wall 7 comes. A sufficient strength or rigidity of the spacers 21 Make sure the device too 13 can not be harmed. The spacers 21 preferably have a resilient and buffering effect.

Of course, the spacing means 21 be formed in a different way than this from the 1 and 2 is apparent. For example, one or more brackets may be provided, which the device 13 spanning on both sides.

The device 13 is preferably configured such that the mass of liquid medium 3 displaced by it and possibly additionally by the positioning means is as exactly as possible relative to the mass of the device 13 or the mass of the device 13 plus the mass of the positioning corresponds. This affects the device 13 or the positioning means practically no buoyancy forces. The device 13 Thus, by the positioning floating weightless in the container 1 absorbed liquid medium 3 held.

This way it can work well even at high accelerations on the container 1 together with its content, not to damage the device 13 or the container 1 come. Such a trained container can thus together with the device provided therein 13 For example, survive a centrifugation harmless.

The device 13 is thus always with the container 1 connected, so that identification data always clearly the container 1 assigned. In addition, by the in the container 1 held device 13 the temperature of the liquid medium received therein 3 be constantly recorded and logged.

LIST OF REFERENCE NUMBERS

1

container

3

liquid medium

5

wall

7

outer edge

9

discharge port

11

flap

13

Device for acquiring and / or storing data

17

central area of the positioning means

19

radial arm of the positioning

21

spacer

23

Edge of the spacer means

Claims (10)

Container for a liquid medium, in particular blood bags, with a flexible outer wall ( 5 ) and one with the container ( 1 ) associated device for collecting and / or storing data ( 13 ), characterized in that (a) the device ( 13 ) for collecting and / or storing data within the flexible outer wall ( 5 ) is arranged and (b) that positioning means are provided, which the device for collecting and / or storing data ( 13 ) with the liquid medium ( 3 ) filled container ( 1 ) floating in the liquid medium ( 3 ) hold, (c) wherein the device ( 13 ) or the device and the positioning means are designed so that the respective displaced mass of liquid medium ( 3 ) substantially equal to the mass of the device ( 13 ) or the mass of the device ( 13 ) and the positioning means Container according to claim 1, characterized in that the positioning means a plurality of flexible, radially extending arms ( 19 ), which with the edge ( 7 ) of the container ( 1 ) are connected. Container according to claim 2, characterized in that the device ( 13 ) for collecting and / or storing data in a central area ( 17 ) is arranged, from which the radially extending arms ( 19 ) extend outwards. Container according to claim 3, characterized in that the arms and the central area ( 17 ) are formed of a flexible film or of a flexible plate-shaped material. Container according to claim 3 or 4, characterized in that the device ( 13 ) for collecting and / or storing data in the central area ( 17 ) is surrounded in a liquid-tight manner by the material forming the central region. Container according to claim 5, characterized in that the radial arms ( 19 ) and / or the central area ( 17 ) is formed of two interconnected layers of films or flexible plate-shaped material. Container according to one of claims 2 to 6, characterized in that in the direction perpendicular to the through the arms ( 19 ) spanned level acting spacers ( 21 ) are provided, which the device ( 13 ) for the acquisition and / or storage of data and a contact between the device ( 13 ) and the flexible outer wall ( 5 ) of the container. Container according to one of the preceding claims, characterized in that the device ( 13 ) for the detection and / or storage of data comprises a housing in which a material for adjusting the mass of the device according to feature (c) of claim 1 is taken or which consists of such material. Container according to one of the preceding claims, characterized in that the device ( 13 ) for collecting and / or storing data, a sensor for detecting the temperature of the liquid medium ( 3 ) in the immediate vicinity of the device ( 13 ) having. Container according to one of the preceding claims, characterized in that the device ( 13 ) for collecting and / or storing data for storage of the container ( 1 ) and / or the liquid medium ( 3 ) characterizing data is designed and provided and that the device ( 13 ) for preferably wireless transmission of the data from or to the device ( 13 ) is trained.

Images