EP2931428B1 - Film bag for storing a fluid and device for providing a fluid and method of making a film bag - Google Patents

Description

State of the art

The present invention relates to a foil bag for storing a fluid, to a device for providing a fluid for a biochemical evaluation unit, to a system for providing a fluid and to a method for opening a fluid-filled foil bag, to a method for producing a fluid-filled foil bag, and the like a method of making a system for providing a fluid.

In order to produce analytical systems that are easy to use and inexpensive to use in the field of medical technology or environmental analysis, compact units are often already provided in which the reagents required for a particular analytical reaction are already stored in this unit.

The DE 10 2009 045 685 A1 describes, for example, a microfluidic chip having an expandable membrane which is expandable under volume displacement into a liquid reservoir to move a liquid from the liquid reservoir through a liquid channel access into a liquid channel of the microfluidic chip.

Out US 2008/050830 A1 . US 2006/275852 A1 . WO 2009/152952 A1 and DE 10 2007 059533 A1 Foil bags for microfluidic systems are known. Out US 2002/0187225 A1 For example, a food packaging bag for heating in a microwave oven is known.

Disclosure of the invention

Against this background, the present invention provides a foil bag for storing a fluid, a system for providing a fluid, a method for opening a fluid-filled foil bag and a method for producing a fluid-filled foil bag, and finally a method for producing a system for providing a fluid according to FIG presented the main claims. Advantageous embodiments emerge from the respective subclaims and the following description.

Depending on their nature, plastics can be permeable to certain substances while impermeable to other substances. When various substances are stored in a unit of plastic with several immediately adjacent chambers, volatile substances can diffuse through the plastic and volatilize or contaminate other substances stored in adjacent chambers.

In order to exclude the contamination by diffusing substances in reagents and excipients within a unit of a biochemical analysis method, the reagents and excipients can be stored pre-portioned in diffusion-tight containers and these containers can be opened automatically (or manually if necessary) and the reagents and Auxiliary materials are transferred to an analysis area. The analysis area retains the reagents and excipients for the duration of the analysis procedure. Then the whole unit can be disposed of. In particular, volatile reagents (such as alcohol) and auxiliaries can be stored in diffusion-tight containers. Such a diffusion-tight container may be, for example, a diffusion-tight foil bag with a predetermined breaking point which is opened in response to a rearrangement command or a mechanical action, so that the reagent and / or the excipient can flow into the analysis area. The foil pouch can be stored inside the unit. The foil pouch may also be stored as a contiguous set of different reagents and / or adjuvants separate from the unit and placed in the unit immediately prior to performing an (analysis) procedure.

• eine Folie, die undurchlässig für das Fluid und Bestandteile des Fluids ist;
• eine Naht zwischen einem ersten Teilbereich der Folie und einem zweiten Teilbereich der Folie, wobei die Naht fluiddicht ausgeführt ist und die Folie zu einem fluiddichten Beutel zum Aufnehmen des Fluids ausformt, wobei der Beutel dazu ausgebildet ist, in einer Kammer einer Vorrichtung zum Bereitstellen eines Fluids für eine biochemische Auswerteeinheit angeordnet zu werden; und
• eine definierte irreversibel zerstörbare Sollbruchstelle, die aus der Folie ausgebildet ist und fluiddicht ist, wenn ein Fluiddruck in dem Folienbeutel kleiner als ein Grenzwert ist, und die zerstört wird, wenn der Fluiddruck größer als der Grenzwert ist.

A foil bag for storing a fluid, in particular a reagent or an adjuvant for a biochemical analysis method, has the following features:

• a film which is impermeable to the fluid and constituents of the fluid;
• a seam between a first portion of the film and a second portion of the film, wherein the seam is made fluid-tight and forms the film into a fluid-tight bag for receiving the fluid, wherein the bag is adapted to be in a chamber of a device for providing a fluid to be arranged for a biochemical evaluation unit; and
• a defined irreversibly destructible break point formed of the film and fluid-tight when a fluid pressure in the foil bag is less than a threshold and destroyed when the fluid pressure is greater than the threshold.

• eine Kammer zum Aufnehmen eines Folienbeutels zum Bevorraten eines Fluids, wobei die Kammer eine Schnittstelle zum Bereitstellen des Fluids für die Auswerteeinheit aufweist; und
• eine Einrichtung zum Öffnen einer Sollbruchstelle des Folienbeutels, um das Fluid an der Schnittstelle bereitzustellen.

An apparatus for providing a fluid for a biochemical evaluation unit has the following features:

• a chamber for receiving a foil bag for storing a fluid, the chamber having an interface for providing the fluid for the evaluation unit; and
• means for opening a predetermined breaking point of the foil bag to provide the fluid at the interface.

• zumindest eine Vorrichtung zum Bereitstellen gemäß dem hier vorgestellten Ansatz; und
• zumindest einen Folienbeutel zum Bevorraten gemäß dem hier vorgestellten Ansatz pro Vorrichtung, wobei der Folienbeutel in der Kammer der Vorrichtung angeordnet ist, und die Kammer verschlossen ist.

A system for providing a fluid for a biochemical evaluation unit has the following features:

• at least one device for providing according to the approach presented here; and
• at least one foil bag for storing according to the approach presented here per device, wherein the foil bag is arranged in the chamber of the device, and the chamber is closed.

In particular, a fluid can be understood as meaning a liquid such as, for example, alcohol in a form (ie, for example, a concentration of more than 80%). The fluid can be incompressible. A film may have a small thickness of, for example, 10 to 100 μm. For example, a biochemical analysis procedure may be run in an assay or a reaction procedure to detect a substance in a sample. The biochemical analysis method can be used in particular in infection diagnostics. A seam can be a joint. In particular, the seam may be a weld or an adhesive seam. In the region of the seam, two pieces or partial regions of the film can be connected to one another. For example, in the production of the seam, a material of the films in the region of the seam can be plasticized and the material can be joined under pressure. For example, the film can be folded, and formed with a circumferential seam into a bag and / or closed. Likewise, two non-contiguous sheets can be formed into the bag with an annular circumferential closed seam. Also, the film may be provided in a tubular shape to form the bag with a seam at a first end and another seam at a second end opposite the first end. A bag may be completely closed when filled with the fluid. The bag may have a filling opening. For example, the seam may have an interruption, which is closed only when the bag has been filled with the fluid. The seam can be realized or executed in various production steps. The bag can also be understood as a closed bag. For example, a first seam may be made first to make the bag, then the bag may be filled with the fluid, and then a second seam may fluidly close the bag to make the bag. The seam can be contoured. For example, a later outer contour of the foil bag can be defined via a contour of the seam. The film may overhang the seam and be trimmed outside the seam, or the film may be trimmed near the seam. The film can also be uncut, for example, to form adjacent to the bag at least one further bag that can be arranged in at least one adjacent chamber of the device. The seam can have different seam areas. For example, several parallel sealing lines can be arranged next to one another analogously to weld beads. It can one or more sealing lines for ensure the fluid-tightness of the filled fluid bag. One of the sealing lines can form a cut edge through the two interconnected foils.

A chamber can be a depression in a base body, which can be closed fluid-tight by a cover. The foil bag, when filled, may have a shape that corresponds to a shape of the chamber or is smaller than the chamber to be inserted into the chamber. A defined predetermined breaking point may be a predefined area of the foil which can absorb lower forces than the rest of the foil bag. As a result, the predetermined breaking point can already be destroyed, while the rest of the bag is still structurally intact. For example, the forces in the foil may be tensile forces due to fluid pressure in the foil pouch. For example, the film may have a notch at the predetermined breaking point. Likewise, the film may be thinner at the predetermined breaking point than in the remainder of the bag. A device for opening the predetermined breaking point can be, for example, a movable punch which is pressed into the chamber for opening the fluid bag. The means for opening may also have a sharp edge for opening the predetermined breaking point, wherein the sharp edge can be pressed in response to the actuation in the predetermined breaking point.

According to a particular embodiment of the present invention, the film bag may be filled with a fluid, in particular with alcohol. According to a particular embodiment of the present invention, the fluid may have an alcohol concentration of more than 60 percent, in particular an alcohol concentration of more than 80%. Such an embodiment of the present invention offers the advantage of a particularly safe and low-leakage pre-storage of the fluid to a release of the fluid, in particular of the alcohol, at a time when the fluid is needed, for example, for a specific function.

The film may have a multilayer structure. In particular, the film may have an at least three-layer structure, wherein a middle layer is formed as a metal foil or comprises a metal foil. A multilayer construction may comprise at least two layers of different material, which are firmly connected to each other. In particular, the individual layers may be fused, glued or laminated together. The materials of each layer can each be impermeable to be certain components. If one of the materials is permeable to one or more substances, the other layers may be impermeable to the one or more substances. A three-layered structure may consist of a first layer of a first material, a second layer of a second material and a third layer of a third material. The first material may be the same material as the third material. In the seam, for example, an outer layer of the first portion of the film may be connected to an outer layer of the second portion. The outer layers may be squeezed in the seam to a predetermined thickness.

The predetermined breaking point can be formed as a section of the seam. In the predetermined breaking point, the seam can have a lower load capacity than outside the predetermined breaking point. The seam may, for example, have a smaller width in the region of the predetermined breaking point than outside the predetermined breaking point. For example, the seam may have fewer sealing lines there than outside the predetermined breaking point. By integrating the predetermined breaking point into the seam, the production of the foil bag can be simplified.

The seam may have at least one V-shaped configuration in the region of the predetermined breaking point. A V-shaped expression can cause a notch effect, from which a breakage of the predetermined breaking point can take place. Thereby, a position can be determined at which the fluid is to be pressed out of the bag.

The seam may be folded over toward the center of the bag and / or folded over. At least in a portion of the seam, the seam can be folded down. By reversing the seam, the load capacity of the seam can be increased. For example, the seam or the folded part of the seam can be fixed on the bag. By transferring it can be ensured that the fluid can not be pressed out of the bag at the folded position.

At least in a portion of the suture, another suture may be disposed adjacent the suture, toward the center of the sac, to reduce a volume enclosed by the sack. If the bag is filled with the fluid and is sealed fluid-tight by the seam, can in a portion of the Be sutured to attach the further seam further inward than the seam (ie towards the center of the fluid bag). In this case, the bag can be more plump than without the further seam, since the fluid can be filled under pressure only with great effort, for example under reduced pressure. If the bag is more plump, the fluid may already be under pressure. As a result, only a lesser additional pressure is required to burst the fluid bag at the predetermined breaking point.

According to the invention, the film bag has an additional element which is fastened to a foil extension of the film designed as a bending point, wherein the film extension is arranged on a side of the seam facing away from the center of the bag, the additional element being designed to be bent onto the bag or to be pressed to concentrate and / or increase pressure on the bag. A film extension may be film which is formed overhanging the seam during manufacture of the film bag. The additional element may be a more rigid or stiffer element than the bag, which is adapted to receive force in a bent on the bag state on a side facing away from the bag, larger surface and deliver on a side facing the bag, smaller contact surface to the bag. In this case, the internal pressure in the bag can be increased to allow the bag to burst securely at the predetermined breaking point. The additional element may be a structural member to stiffen the foil bag. The additional element can be clamped, glued or welded to the film extension. The additional element may also consist of stiffened foil.

The additional element further has an extension which protrudes on a side opposite the bending point from a main extension plane of the additional element and is designed to at least partially enclose the predetermined breaking point when the additional element is bent onto the bag. An extension can be a structural element which is designed to act as a depth stop when the additional element is pressed onto the bag. The extension can let the pressure act on the predetermined breaking point with a time delay. Thereby, a, the extension opposite side of the additional element can be pressed more strongly on the bag to squeeze or squeeze the fluid in the bag to the predetermined breaking point. This can ensure that the predetermined breaking point remains open and the fluid can escape. If on the additional element a predetermined minimum force acts, the extension may yield or fail, so that the bag can be completely emptied.

The means for opening may comprise a fluid-tight membrane disposed at least partially within the chamber and deformable by an actuating force and adapted to cause volume reduction of the chamber and to force the fluid at the predetermined breaking point from the foil bag to the interface , A membrane may for example consist of a plastic. An actuation force may be provided, for example, by an air pressure pulse. The membrane can be pushed into the chamber by the actuating force. In this case, the membrane can be pressed on one side of the foil bag to bring the foil bag to burst.

The chamber may have on a side facing away from the device for opening or opposite side of a depression as a discharge area for the fluid and / or to improve the opening behavior of the predetermined breaking point. The interface can be arranged in the recess. The depression can be arranged on the side opposite the device for opening. The recess may be formed by a step in the bottom of the chamber. The predetermined breaking point can be arranged in the region of the depression. Through the depression, the film bag can be exposed in the region of the depression, so that upon actuation of the device for opening a pressure gradient between a predetermined breaking point opposite part of the foil bag and a lying in the region of the predetermined breaking point of the foil bag sets, which can bring the breaking point to burst. Through the depression of the foil bag can be emptied. Likewise, can be reduced by the depression of the necessary opening pressure due to the favorable angle of the film at the predetermined breaking point.

The means for opening may include a pressure plate movably disposed within the chamber adapted to flatten the foil pouch between the pressure plate and a bottom of the chamber when the means for opening is actuated. A printing plate may be a rigid disk that distributes the compressive force over much of the film bag. The pressure plate can compress the foil bag evenly. As a result, the foil bag can be emptied.

The pressure plate may be attached to the device for opening. For example, the pressure plate may be glued or welded to the membrane. By placing the pressure plate in the chamber, the fluid can be pressed out of the foil bag particularly well. The pressure plate can be made smaller because the pressure plate is no longer movable during transport, and thus there is less risk of damage to the foil bag.

The pressure plate may have an extension which protrudes on one side from a main extension plane of the pressure plate and is designed to at least partially enclose or reach behind the predetermined breaking point. An extension can be a structural element that is designed to act as a depth stop when the pressure plate is pressed onto the bag. The extension can let the pressure act on the predetermined breaking point with a time delay. Thereby, a, the extension opposite side of the pressure plate can be pressed more strongly on the bag to squeeze or squeeze the fluid in the bag to the breaking point. This can ensure that the predetermined breaking point remains open and the fluid can escape. If a predetermined minimum force acts on the pressure plate, the extension can yield or fail, so that the bag can be completely emptied.

The device for opening can be arranged in a movable cover of the chamber, which is designed to close the chamber in a fluid-tight manner. Through an open lid of the foil bag can be particularly easily inserted into the chamber. If the foil bag is in the chamber, the chamber can be closed fluid-tight. For example, the lid can be welded on. Likewise, the lid can be locked. By arranging the means for opening in the lid, the lid can for example be made in several parts and the means for opening when assembling the lid or when closing the lid are completed.

The foil pouch may be located off-center in the chamber and at least a portion of the seam may be bent from a wall of the chamber or may contact the wall of the chamber. The film bag may be arranged so close to the wall that the seam, for example, in the direction of Device is bent to open. By bending the seam with the help of the wall can be dispensed with a bending of the seam in the production of the film bag. By bending, the seam can withstand a greater load in the bent area. As a result, the foil bag can rise safely at the predetermined breaking point.

A method of opening a fluid-filled film bag includes the following step:
Applying a force to a portion of the film bag to increase an internal pressure of the film bag to an ambient pressure until a predetermined breaking point of the film bag tears to open the film bag.

• Bereitstellen eines Folienbeutels zum Bevorraten eines Fluids, wobei der Beutel eine Einfüllöffnung aufweist, wobei der Fluidbeutel eine Folie aufweist, die undurchlässig für das Fluid und Bestandteile des Fluids ist;
• Befüllen des Beutels mit dem Fluid durch die Einfüllöffnung; und

A method for producing a fluid-filled film bag comprises the following steps:

• Providing a foil bag for storing a fluid, the bag having a filling opening, the fluid bag having a foil which is impermeable to the fluid and constituents of the fluid;
• Filling the bag with the fluid through the filling opening; and

Closing the filling opening of the film bag with a seam to seal the film bag, wherein the seam is applied between a first portion of the film and a second portion of the film, the seam is made fluid-tight and the film to a fluid-tight bag for receiving the fluid wherein the bag is adapted to be disposed in a chamber of a device for providing a fluid for a biochemical evaluation unit and wherein in the step of closing an irreversibly destructible predetermined breaking point is formed, which is formed from the film and fluid-tight, if Fluid pressure in the foil bag is less than a limit, and is destroyed when the fluid pressure is greater than the limit.

A filling opening may be an unsealed seam of the film bag. The filling opening may also be an additional fluid-tight sealable opening in the bag of the film bag.

• Bereitstellen eines Fluidbeutels gemäß einer hier vorgestellten Ausführungsform und Vorrichtung einer zum Bereitstellen eines Fluids für eine biochemische Auswerteeinheit;
• Einbringen des Fluidbeutels in die Kammer der Vorrichtung; und

Furthermore, a method is proposed for producing a system for providing a fluid for a biochemical evaluation unit, the method having the following steps:

• Providing a fluid bag according to an embodiment presented here and a device for providing a fluid for a biochemical evaluation unit;
• Introducing the fluid bag into the chamber of the device; and

Closing the device to produce the system for providing the fluid to a biochemical evaluation unit.

Also of advantage is a computer program product with program code which can be stored on a machine-readable carrier such as a semiconductor memory, a hard disk memory or an optical memory and used to drive a device according to one of the embodiments described above, if the program product is on a computer or a device is performed.

Fig. 1

eine Darstellung einer Vorrichtung zum Bereitstellen eines Fluids für eine biochemische Auswerteeinheit als Hintergrund zur vorliegenden Erfindung;

Fig. 2

eine Darstellung eines Folienbeutels zum Bevorraten eines Fluids als Hintergrund zur vorliegenden Erfindung;

Fig. 3

eine Darstellung eines Systems zum Bereitstellen eines Fluids für eine biochemische Auswerteeinheit als Hintergrund zur vorliegenden Erfindung;

Fig. 4

eine Darstellung eines Systems zum Bereitstellen eines Fluids für eine biochemische Auswerteeinheit während des Betätigens als Hintergrund zur vorliegenden Erfindung;

Fig. 5

eine Darstellung eines Systems zum Bereitstellen eines Fluids mit gestuftem Boden und umgeklappter Naht als Hintergrund zur vorliegenden Erfindung;

Fig. 6

eine Darstellung eines Systems zum Bereitstellen eines Fluids mit einer Druckplatte als Hintergrund zur vorliegenden Erfindung;

Fig. 7

eine Darstellung eines Systems zum Bereitstellen eines Fluids mit einer Umlagerungskammer als Hintergrund zur vorliegenden Erfindung;

Fig. 8A

eine Querschnittsdarstellung eines Folienbeutels zum Bevorraten eines Fluids mit einer weiteren Naht als Hintergrund zur vorliegenden Erfindung;

Fig. 8B

eine Draufsichtdarstellung des Folienbeutels zum Bevorraten eines Fluids mit der weiteren Naht als Hintergrund zur vorliegenden Erfindung;

Fig. 9A

ein Ablaufdiagramm eines Verfahrens zum Herstellen eines fluidgefüllten Folienbeutels als Hintergrund zur vorliegenden Erfindung;

Fig. 9B

ein Ablaufdiagramm eines Verfahrens zur Herstellung eines Systems als Hintergrund zur vorliegenden Erfindung;

Fig. 10

ein Ablaufdiagramm eines Verfahrens zum Öffnen eines fluidgefüllten Folienbeutels als Hintergrund zur vorliegenden Erfindung;

Fig. 11

eine Darstellung eines Folienbeutels zum Bevorraten eines Fluids mit einem Zusatzelement gemäß einem Ausführungsbeispiel der vorliegenden Erfindung;

Fig. 12

eine Darstellung eines Systems zum Bereitstellen eines Fluids mit einem Folienbeutel mit Zusatzelement gemäß einem Ausführungsbeispiel der vorliegenden Erfindung;

Fig. 13

eine Darstellung eines Systems zum Bereitstellen eines Fluids mit einem Folienbeutel mit Zusatzelement aus Folie als Hintergrund zurvorliegenden Erfindung; und

Fig. 14

eine Darstellung eines Systems zum Bereitstellen eines Fluids mit einer befestigten Druckplatte als Hintergrund zur Erfindung.

The invention will now be described by way of example with reference to the accompanying drawings. Show it:

Fig. 1

a representation of an apparatus for providing a fluid for a biochemical evaluation unit as background to the present invention;

Fig. 2

an illustration of a film bag for storing a fluid as background to the present invention;

Fig. 3

a representation of a system for providing a fluid for a biochemical evaluation unit as background to the present invention;

Fig. 4

a representation of a system for providing a fluid for a biochemical evaluation unit during actuation as background to the present invention;

Fig. 5

a representation of a system for providing a fluid with a stepped bottom and folded seam as a background to the present invention;

Fig. 6

an illustration of a system for providing a fluid with a printing plate as background to the present invention;

Fig. 7

a representation of a system for providing a fluid with a rearrangement chamber as background to the present invention;

Fig. 8A

a cross-sectional view of a film bag for storing a fluid with another seam as background to the present invention;

Fig. 8B

a plan view of the film bag for storing a fluid with the further seam as background to the present invention;

Fig. 9A

a flow diagram of a method for producing a fluid-filled film bag as background to the present invention;

Fig. 9B

a flow chart of a method for producing a system as background to the present invention;

Fig. 10

a flow diagram of a method for opening a fluid-filled film bag as background to the present invention;

Fig. 11

an illustration of a foil bag for storing a fluid with an additional element according to an embodiment of the present invention;

Fig. 12

an illustration of a system for providing a fluid with a foil bag with additional element according to an embodiment of the present invention;

Fig. 13

a representation of a system for providing a fluid with a film bag with additional element of foil as background to the present invention; and

Fig. 14

a representation of a system for providing a fluid with a fixed pressure plate as background to the invention.

In the following description, the same or similar reference numerals are used for the elements shown in the various figures and similarly acting, wherein a repeated description of these elements is omitted.

Fig. 1 shows a representation of an apparatus 100 for providing a fluid for a biochemical evaluation unit as background to the present invention. The apparatus 100 includes a chamber 102 and opening means 104. The chamber 102 is formed as a recess or as an insert mold in a base body 106. The chamber 102 is adapted to receive a foil bag for storing the fluid. The chamber 102 has a smaller depth than width. In a bottom of the chamber 102, an interface 108 for providing the fluid for the evaluation unit is arranged. The interface 108 is designed as an outlet channel. The chamber 102 is covered by a lid 110. The lid 110 forms the means for opening 104 of a predetermined breaking point of the film bag. In this embodiment, the lid 110 is pierced by an air passage 112. Between the cover 110 and the main body 106, a fluid-tight membrane 114, for example made of TPE is arranged. The diaphragm 114 is deformable and, upon actuation of the opening device 104, may be deformed into the chamber 102 by means of pressurized air flowing through the air passage 112 to provide the fluid at the interface 108.

Fig. 2 Fig. 11 is an illustration of a film bag 200 for storing a fluid as background to the present invention. The foil bag 200 or the tubular bag 200 is in particular designed to store a reagent or an adjuvant for a biochemical analysis method. The film bag 200 has a film 202, a seam 204 and a predetermined breaking point 206. The foil bag 200 is shown filled with the fluid. The film 202 is impermeable to the fluid and constituents of the fluid. The seam 204 connects a first portion 208 of the film 202 to a second portion 210 of the film 202. The seam 204 is made fluid-tight and forms the film 202 into a fluid-tight bag 212 for receiving the fluid. The bag 212 is adapted to enter a chamber of a device for providing a fluid to a biochemical evaluation unit as shown in FIG Fig. 1 is shown to be arranged. The predetermined breaking point 206 is designed to be irreversibly destructible. The predetermined breaking point 206 is formed of the film 202 and is fluid-tight when a fluid pressure of the fluid in the film bag 200 is smaller than a threshold value. The predetermined breaking point 206 is destroyed when the fluid pressure is greater than the limit value. The predetermined breaking point 206 can be designed as a peel seam.

The approach presented here allows the long-term stable inclusion of volatile fluids or substances such. As alcohols in a LoC platform and the possibility of this automated, so without the usual manual filling, continue to process in the system. Above all, the use of a pneumatic actuation achieves a high design degree of freedom because the opening force (the pressure) can be arbitrarily distributed on the LoC. By an independently selectable from the materials of the LoC system seal coating (inner coating of the blister 212 and bag 212), it is possible especially for sensitive substances such as enzymes to adapt so that no interactions and / or high long-term stability is achieved.

The diffusion-proof packaging film 202 has a 3-layer structure. Inside is a predominantly polyethylene adhesive polymer layer, which is welded to itself in a thermal process. The adhesive seam 204 is the only remaining diffusion path, but due to its small thickness of only a few micrometers and its width of typically more than 2 mm achieves a very high level of tightness. The actual diffusion barrier is the middle layer of metal (preferably aluminum), which can be referred to as pinhole-free and thus diffusion-tight from a thickness of about 12 μm. The outer polymer layer ensures mechanical stability. Films with this construction allow blister 200 or microfinance bag 200 of high tightness. Due to the temperature of the sealing process, the bonding force can be adjusted and adapted to the boundary conditions of the opening mechanism.

In addition, the geometry of the sealing seams 204, 206, z. B can be used by V-shaped design with freely selectable angle for adjusting the opening behavior. Due to the seam shape, seam width and different sealing temperatures, a preferred side 206 for the opening of microshrinkable bags 200 can be achieved.

Fig. 3 FIG. 11 is an illustration of a system 300 for providing a fluid for a biochemical evaluation unit as background to the present invention. The system 300 includes a device 100 for providing a fluid as shown in FIG Fig. 1 and a foil bag 200 for storing the fluid as shown in FIG Fig. 2 is shown on. The foil bag 200 is disposed in the chamber 102 of the device 100. The chamber 102 is closed in a fluid-tight manner by means of the cover 110. The predetermined breaking point 206 of the film bag 200 is arranged in the region of the interface 108. The predetermined breaking point 206 can be embodied as part of the seam 204. As in Fig. 1 the device 104 is integrated in the lid 110 for opening. The system 300 is shown in an unused condition, ie, the membrane 114 is undeformed, and the film bag 200 is sealed fluid-tight and filled with the fluid. The foil bag 200 is arranged centrally in the chamber 102. Around the film bag 200, there is a gap between the base body 106 and the film bag 200.

The blister 200 or bag 200 are placed in a preformed compartment 102 of the LoC system, which on at least one side by a stretchable film 114, for. B. is limited from thermoplastic elastomer. By preferably pneumatically deflecting the elastic film 114 and by the counterforce of the rigid insert mold 106, a pressure load on the blister 200 or bag 200 is exerted, which leads to the bursting of the predetermined breaking point 206. Alternatively, the emptying can also be achieved via a mechanical punch that presses on the elastic film 114. This is especially useful for very small volumes in which pneumatically not the required opening pressure can be achieved.

In other words shows Fig. 3 a fully integrated, long-term stable reagent pre-storage for lab-on-chip systems as a schematic diagram with tubular bag 200. Automated Lab-On-Chip (LoC) systems for diagnostic applications are becoming increasingly important, above all when fast results are needed, ie the typical throughput times through a central laboratory are not tolerable, in order to obtain timely diagnoses about health conditions of patients. In addition, LoC systems are more user-friendly than standard manual biochemical assays that have been used in diagnostics. LoC systems require fewer manual steps by the user. LoC systems are based on customized and optimized standard diagnostic procedures and are disposable products that are inexpensively manufactured from plastics. Standardized biochemical assays for diagnostics generally consist of several coordinated steps, which can be represented in a kind of flowchart. This consists in a simplified way of sampling, lysis of the sample, purification, duplication and subsequent detection. For this flow chart, besides various buffers, enzymes, primers, polymerases and DNA fragments for their functional sequence, alcohols such as ethanol, butanol or alcohol-water or buffer mixtures are required. All reagents are stored directly in the LoC system.

By storing at least the volatile reagents and auxiliaries in foil bags 200 in accordance with the approach presented here, the pre-storage of alcohols on LoC systems is particularly simple. Due to the diffusion-tight film of the film bag 200, the physicochemical properties of alcohol, such as high vapor pressure and low boiling point, and consequently high permeation rate in plastics pose no problem. Cross-contamination of the adjacent reagents can thus be prevented. The enzymes upstream of the LoC platform are very sensitive to interactions with alcohols. Their activity can be inhibited by alcohol, which could make the entire schedule no longer accurate and reliable. By the storage of at least the alcohols in the sealed foil bags 200 can also be excluded in addition to a swelling of plastics and thereby a change in the surface and a leakage of the system 300. By providing a system 300 according to the approach presented here, alcohols can therefore be stored directly in the LoC system and need not be supplied just before the start of the assay, resulting in a much more user-friendly and less error-prone process.

The approach presented here provides a long-term stable solution for the pre-storage of all required reagents and auxiliaries, which can be integrated into the fully automatic process of the evaluation unit, d. H. No more manual refilling or refilling steps required. However, the life of the product is determined only by the lifetime of the ingredients but not by their diffusion into adjacent chambers or the environment. The release of reagents for the diagnostic process is due to existing Aktorikansteuerung, z. B. compressed air possible. The provisioning system 300 may be used, for example, in medical diagnostic devices and disposable lab-on-chips for infection diagnostics.

Fig. 4 FIG. 11 is an illustration of a system 300 for providing a fluid to a biochemical evaluation unit during actuation as background to the present invention. FIG. The system 300 corresponds to the system in FIG Fig. 3 , In contrast to Fig. 3 the membrane 114 is deformed by introducing compressed air 400 through the air passage 112 into the chamber 102 inside. The membrane 114 presses on the film bag 200 and thus increases an internal pressure in the film bag 200 until the film bag 200 bursts at the predetermined breaking point 206 and the fluid exits from the interface 108. The membrane 114 remains fluid-tight during deformation. The deformation of the membrane 114 is irreversibly plastic because the system 300 is designed for single use and is subsequently disposed of for use.

Fig. 5 FIG. 11 is an illustration of a system 300 for providing a fluid having a well 500 as background to the present invention. The system 300 essentially corresponds to the system in FIG Fig. 3 , In addition to Fig. 3 The system 300 includes a step 502 in the bottom of the chamber 102. The foil bag 200 is arranged on the step 502 such that the predetermined breaking point 206 is arranged above the depression 500. Furthermore, the foil bag 200 is arranged off-center in the chamber 102. The seal seam 204 on one side of the film bag 200 is folded upwards and lies on the film bag 200 in order to reinforce the seam 204 at this point. For this purpose, an insert 504 has been introduced into the chamber 102, which bends over the seam 204 and reduces the chamber 102. Now, when the opening device 104 is actuated, the membrane 114 first flattens the film bag 200 in the area of the step 502. In the region of the recess 500, the film bag 200 remains free-hanging, so that the predetermined breaking point 206 of the membrane 114 is not is pressed against the bottom of the chamber 102. To support the opening behavior of the bag 200, the insert mold 106 may be formed step-shaped, whereby the opening behavior improves. In the case of tubular bags 200, the side which is not intended to open can be additionally protected from accidental opening by folding over the sealing seam 204.

Fig. 6 FIG. 12 is an illustration of a system 300 for providing a fluid with a pressure plate 600 as background to the present invention. The system 300 essentially corresponds to the system in FIG Fig. 3 , In addition to Fig. 3 The system 300 includes a pressure plate 600 in the chamber 102. The pressure plate 600 is movably disposed within the chamber 102. The pressure plate 600 can be moved up and down. The pressure plate 600 is disposed between the membrane 114 and on the foil bag 200. When the means for opening 104 is actuated, the membrane 114 presses on the pressure plate 600 over a large area. The pressure plate 600 then acts like a rigid piston and concentrates the pressure force on the foil bag 200. The foil pouch 200 is squeezed between the pressure plate 600 and the base body 106 , As a result, the internal pressure in the film bag 200 can be increased particularly efficiently until the predetermined breaking point 206 bursts. Subsequently, the pressure plate 600 moves straight from the lid 110 to the bottom of the chamber 102 and allows complete emptying of the film bag 200 through the interface 108. The insert plate 600, the pressure of the elastic membrane 114 can be reduced to the sealed seam 204, thereby the opening behavior improved.

Fig. 7 FIG. 12 is an illustration of a system 300 for providing a fluid having a rearrangement chamber 700 as background to the present invention. The system 300 essentially corresponds to the system in FIG Fig. 3 , but is shown rotated by 90 °. As in Fig. 3 For example, the system 300 includes a device 100 for providing and a foil bag 200 for storing. The foil bag 200 is designed asymmetrically in this embodiment. The foil bag 200 is designed as an aluminum-polymer composite foil blister 200. The first portion 208 of the film 202 is larger than the second portion 210. As a result, the film bag 200 in the form of a liquid drop on a horizontal plane with partial wetting. The foil bag 200 is fixed to the bottom of the chamber 102. The device 100 largely corresponds to the device in FIG Fig. 1 , additionally A channel 702 connects the chamber 102 to the rearrangement chamber 700. The chamber 102 is separated from the rearrangement chamber 700 by a wall. The rearrangement chamber 700 is disposed below the chamber 102. The predetermined breaking point 106 is arranged in the region of an input to the channel 702. The rearrangement chamber 700 has a controllable valve 704, which is designed as the interface to the biochemical evaluation unit. When the fluid from the foil pouch 200 has been forced into the rearrangement chamber 700 through the channel 702 in response to the actuation of the pneumatic opening device 104, the fluid may be metered by gravity via the valve 704. In this embodiment, the valve 704 is formed using the same membrane 114 of, for example, TPE as the means 104 for opening. The valve 704 has its own control channel 706, through which, for example, a vacuum can deflect the diaphragm 114 to selectively release the valve 704 (the interface) to a channel into the system in response to a PC or fluidics. The reagents contained in the foil bag 200 can be transferred almost completely into the delivery chamber 700 by pneumatic expressions.

Fig. 8A Figure 11 shows an illustration of a foil bag 200 for storing a fluid with another seam 800 as background to the present invention. The foil bag 200 corresponds to the foil bag in Fig. 2 , In addition to the standard seal 204, the further seam 800 has been attached to the filled foil pouch 200 as a re-seal to reduce an internal volume of the pouch 200. As a result, the film bag 200 is plumper and is under an overpressure. The further seam 800 is arranged parallel to a seam 204. For example, the further seam 800 can be arranged next to a bottom seam 204 or a top seam 204 of the film bag 200. In particular, the additional seam 800 can be arranged opposite the predetermined breaking point if the predetermined breaking point is designed as the region of the seam 204, since the film bag 200 is particularly stable in the region of the further seam 800. Two-stage sealing (re-sealing) of the tubular bag 200 to increase the "bumpiness" also improves the opening behavior. The generation of a predetermined breaking point 206 can also be effected by partial removal of the outer polymer layer by means of laser.

Fig. 8B shows a plan view of the according to Fig. 8A constructed foil bag for storing a fluid with the other seam.

Fig. 9A FIG. 11 is a flow chart of a method 900 for producing a fluid-filled film pouch as background to the present invention. The method 900 includes a step 902 of providing, a step 904 of filling, and a step 906 of closing. In step 902 of providing, a foil bag is provided for storing a fluid, as shown in FIG Fig. 2 is shown provided. The bag has a filling opening. In step 904 of filling, the bag is filled with the fluid through the filling opening. In step 906 of the closing, the filling opening of the film bag is seamed to seal the film bag.

Fig. 9B FIG. 12 is a flowchart of a method 950 for fabricating a system 300 as background to the present invention. The method 950 comprises a step 952 of providing a fluid bag according to a variant presented here and a device 100 for providing a fluid for a biochemical evaluation unit according to a variant presented here. Furthermore, the method 950 includes a step 954 of introducing the fluid bag 200 into the chamber 102 of the device 100 and a step 956 of closing the device 100 to produce the system 300 for providing the fluid to a biochemical evaluation unit.

The reagents are placed in blisters or microfilter sticks (stickpacks) as in the Figures 2 and 8th shown, including, which consist of diffusion-tight composite film. As a result, a loss-free, almost temperature-independent long-term storage is possible. In addition to the low cost, this 900 packaging process also offers the opportunity to meet the high sterility requirements and package the reagents under an inert inert gas atmosphere. The blisters or bags have a predetermined breaking point, the z. B. in the form of a peel seam. The opening behavior (opening pressure) of the peel seam can be adapted to the requirements via a temperature during the production of the seam, a geometry of the sealed seam, an adhesive coating of the film, a degree of filling of the film bag.

Fig. 10 FIG. 10 shows a flow chart of a method 1000 for opening a fluid-filled film bag as background to the present invention. The method 1000 includes a step 1002 of applying. In step 1002 of application, a force is applied to a portion of the film bag to increase an internal pressure of the film bag to an ambient pressure until a predetermined breaking point of the film bag tears due to the internal pressure to open the film bag.

The opening of the blister or bag can by an external force, the z. B. pneumatically via an elastic membrane or via mechanical stamp actuators. As a result, the stored liquid is transferred to a supply chamber of the lab-on-chip system.

Fig. 11 shows a representation of a foil bag 200 for storing a fluid with an additional element 1100 according to an embodiment of the present invention. The foil bag 200 corresponds to the foil bag in FIG Fig. 2 or Fig. 8 , In addition, opposite to the predetermined breaking point 206 in extension of the seam 204, the foil bag 200 has an extended foil extension 1102 which is connected to the additional element 1100. The additional element 1100 has in this embodiment, a clamping portion 1104 in which the film extension 1102 is attached. In the clamping region 1104, the foil extension 1102 is clamped between two clamping wings, which securely fix the foil extension 1102. The additional element 1100 has a plate-like pressure surface 1106 and an extension 1108 angled to it. At the extension 1108 a latch 1110 is arranged. The film extension 1102 is bent over at a bending point 1112, so that the additional element 1100 abuts with the pressure surface 1106 in a pressure region 1114 on the bag 212. The extension 1108 partially encloses the foil bag 200. The predetermined breaking point 206 is engaged in the locking lug 1110, so that the bag 212 is held in abutment with the pressure region 1114 and is thus easy to handle. The pressure surface 1106 is designed to concentrate the pressure upon actuation of the device for opening onto the pressure region 1114 of the film bag 200 (stick-pack), so that the predetermined breaking point 206 reliably bursts. The projection 1108 is designed to protect the predetermined breaking point 206, so that the predetermined breaking point 206 can not be squeezed when the device is operated for opening. The pressure surface 1106 further comprises handling surfaces 1116 for an automatic gripper, so that the Foil bag can be moved and processed fully automatically during production and also be inserted fully automatically in the device for providing. In this particular embodiment, the pouch 212 has an intermediate layer 1118 which separates the pouch 212 into a first chamber 1120 for storing a first fluid and a second chamber 1122 for storing a second fluid. The intermediate layer 1118 is here arranged centrally in the bag 212, so that the first chamber 1120 and the second chamber 1122 are the same size. When the predetermined breaking point 206 is destroyed, the first fluid mixes with the second fluid.

In other words shows Fig. 11 the structural design of an additional element 1100 for safely opening bag 200 and blister 212 in LOC (Lab-on-Chip) cartridges.

The additional element 1100 is made of plastic, wherein sheet metal or other materials are also possible, and is formed with film hinges. By the film hinges, the bag 212 can be clamped to the seam 204 and thus be held securely, wherein bonding or welding are also possible as a connection alternative. The additional element 1100 is shaped accordingly, so that upon pressing the elastic membrane, the pressure is applied to the center of the bag 212 and squeezes the bag 212 defined defines. The additional element 1100 is formed on the underside so that it is flat except in the region of the predetermined breaking point 206 (peel seam) in order to empty the pliable bag 212 almost completely. The peculiarity of the approach presented here is that the additional element 1100 is either attached to the bag 212, as in FIG Fig. 11 can be shown or attached to the membrane, as in Fig. 14 is shown. By a constructional formation 1108, the area of the predetermined breaking point 206 is not pressurized, so that it can burst due to the pressure on the bag 212 and the liquid deflates defined. The peel seam 206 has a clip 1110 at the peel seam 206 for securely opening the seam 206. The bag 212 is fastened to the additional element 1100 via a clamping mechanism 1104.

The additional element 1100 is formed so that the pliable bag 212 is completely received and the outer dimensions are determined primarily by the element 1100. The additional element 1100 has a Stop edge 1110, so that the bag 212 is always the same fixed to the additional element 1100. The additional element 1100 has handling surfaces 1116 for automatic assembly with grippers.

Fig. 12 FIG. 11 shows an illustration of a system 300 for providing a fluid with a foil pouch 200 with additional element 1100 according to an exemplary embodiment of the present invention. The system 300 corresponds to the system in FIG Fig. 3 , The foil bag 200 corresponds to the foil bag in FIG Fig. 11 , The foil bag 200 is disposed in the chamber 102. The pressure surface 1106 is arranged facing the membrane 114. The extension 1108 and the predetermined breaking point 206 are arranged above the interface 108. As the membrane 114 is pressed into the chamber 102, the membrane 114 presses evenly on the pressure surface 1106. The pressure surface 1106 concentrates the pressure force on the pressure region 1116 to burst the predetermined breaking point 206. The extension 1108 supports the additional element 1100 on one side on the bottom of the chamber 102. As a result, the additional element 1100 tilts on the side of the bending point 1112 until it also rests on the ground. Then, the bag 212 is pushed flat by the pressing surface 1106 from the side of the bending point 1112 and thus squeezed toward the interface 108. The extension 1108 ensures that the predetermined breaking point 206 can not be squeezed off from the membrane 114 and the interface 108 can not be closed during the entire process.

In Lab on Chip (LOC) products or so-called micro-fluidic platforms (μTAS), medical and biological fluids are processed on a carrier to analyze patient samples for the presence of pathogens and bacteria. Lab-on-chip platforms can be constructed as so-called cartridges, which receive and process the patient sample as a disposable article. For the process flow on the cartridge liquids are needed, which can either be stored on the cartridge or added later for the expiration by an operator.

The approach presented here describes storage of the liquids in blisters 200 or bags 212 within the cartridge. The bags 212 may be opened by an external force. The opening pressure is introduced via an elastic membrane 114. The membrane 114 becomes either pneumatically deflected or moved by a plunger. A separate diagnostic unit (DxU) either generates the pneumatic air for pneumatic actuation or includes the movable plungers which press on the diaphragm 114. Without the additional element 1100 presented here, the location of the introduction of force into the flexible bag 212 can be undefined and lead to a large scattering at the opening pressure. In part, the membrane 114 may close the predetermined breaking point 206 and robust squeezing of the bags 212 may be prevented. Furthermore, pouches 212 / stick-packs 200 may have unfavorable geometric dimensions, so that the outer dimensions of the cartridge may increase as the pouches 212 are installed.

By that, in the Figures 11 and 13 shown attached to the stick pack 212 additional element 1100, which is integrated into the chamber 102, a robust opening of the bag 212 can be ensured. In this case, a precise pressure force on the bag 212 at a defined point 1116 can be initiated during the actuation by the diagnostic device. Unintentional opening of the bags 212 during transport of the cartridge can also be avoided. The handling in the automatic production of the flexible bag 200 can also be improved by the additional element 1100. Due to the rigid element 1100, the outer dimensions of the flexible bag 200 can be advantageously adapted, whereby a space-saving installation within the cartridge is possible.

To the blister / bag 212, a rigid additional element 1100 is attached. By the additional element 1100, the force is applied to the stick pack 212 at a defined point 1116. This reduces the opening force and prevents the predetermined breaking point 206 is pressed. The opening force provided by the external operating unit can be reduced. The pouches 212, when actuated by the actuator unit, open stably and inadvertent opening during transport and storage is avoided. The quality of the LoC system 300 is increased. The attachment 1100 compresses the entire bag 212, thereby deflating the contents of the entire bag 212. Residues of the reagents in the bag 212 are thus avoided. Especially expensive reagents can be used more efficiently by the additional element, which results in a cost advantage. By the additional element 1100, the shape of the stick pack 200th be adapted and the additional element 1100 and the stick pack 200 are installed smaller and more flexible within the cartridge. The cartridge dimensions are reduced, resulting in further cost advantages. By the additional element 1100 automatic assembly of the pliable bag 212 is possible. Automatic grippers can grasp the unit 200 defined in bag 212 and additional element 1100 and insert it into the cartridge. This results in a cycle time reduction and a cost reduction.

Fig. 13 FIG. 12 shows a representation of a system 300 for providing a fluid with a film bag 200 with additional sheet 1300 element as background to the present invention. The system 300 corresponds to the system in FIG Fig. 3 , The foil bag 200 has, as in Fig. 11 a film extension 1102 on. In contrast to Fig. 11 the film extension 1102 is formed here directly as the additional element 1300. For this purpose, the foil extension 1102 is made stiffened. The additional element of film 1300 extends in a first embodiment of the bending point 1112 over an entire length of the bag 212 to the predetermined breaking point 206. In a second embodiment, the additional element of foil 1300 in the region of the predetermined breaking point 206 has a further bending point 1302 and extends again over the entire length of the bag 212 to the bending point 1112 back. As a result of the stiffening, the additional element made of foil 1300, when the device is actuated, concentrates the pressure force of the membrane 114 on the pressure region 1116 in order to burst the predetermined breaking point 206.

In Fig. 13 Another embodiment is shown, in which the integration of the additional element 1300 is shown on the stick pack 200 itself. For this purpose, the fixed sealing side (compared to the peel seam 206) is formed so long that it by one or more fold over even as peelnahtentlastendes additional element 1300 acts. For mechanical reinforcement, the layers can be glued with multiple kinking. For easier handling of the arrangement 200, the tab can also be fixed to the stickpack 200 by means of adhesion. The integrated additional element shown in a simple design shown in solid lines and shown in dashed lines in two versions.

Fig. 14 Figure 11 shows a representation of a system 300 for providing a fluid with a fixed pressure plate 600 as background to the present invention. The system 300 corresponds to the system in FIG Fig. 6 , The pressure plate 600 assumes the function of the additional element and is fixed to the elastic membrane 114 here. In addition to the illustration in Fig. 6 For example, the pressure plate 600 is connected to the membrane 114 at a splice 1400. Thereby, the pressure plate 600 is held in a predetermined position and the fluid is pressed out of the foil bag 200 under controlled conditions upon actuation of the device.

Furthermore, method steps can be repeated and executed in a different order than in the order described.

If an exemplary embodiment comprises a "and / or" link between a first feature and a second feature, then this is to be read so that the embodiment according to one embodiment, both the first feature and the second feature and according to another embodiment either only first feature or only the second feature.

Claims (15)

1. Film bag (200) for storing a fluid, in particular a reagent or an auxiliary agent for a biochemical analysis method, wherein the film bag (200) comprises the following features:

   a film (202) which is impermeable to the fluid and constituent parts of the fluid;

   a seam (204) between a first part region (208) of the film (202) and a second part region (210) of the film (202), wherein the seam (204) is realized in a fluid-tight manner and the film (202) forms into a fluid-tight bag (212) for receiving the fluid, wherein the bag (212) is realized for the purpose of being arranged in a chamber (102) of a device (100) for providing a fluid for a biochemical evaluation unit; and

   a defined irreversibly destructible predetermined breaking point (206) which is realized from the film (202) and is fluid-tight when a fluid pressure in the film bag (200) is less than a limit value, and which is destroyed when the fluid pressure is greater than the limit value,

   characterized in that

   there is furthermore provided an additional element (1100) which is fastened on a film continuation (1102) of the film (202) that is realized as a bend point (1112), wherein the film continuation (1102) is arranged on a side of the seam (204) that is remote from the centre of the bag (212), wherein the additional element (1100) is realized for the purpose of being bent and/or pressed onto the bag (212) in order to concentrate and/or increase a pressure onto the bag (212), wherein the additional element (1100) comprises a continuation (1108) which protrudes on a side located opposite the bend point (1112) out of a main extension plane of the additional element (1110) and is realized for the purpose of surrounding the predetermined breaking point (206) at least in part when the additional element (1100) is bent onto the bag (212).
2. Film bag (200) according to Claim 1, where the film (202) comprises a multi-layered design, wherein the film (202) comprises in particular a three-layered design, wherein a central layer includes a metal film or consists of a metal film.
3. Film bag (200) according to one of the preceding claims, where the predetermined breaking point (206) is realized as a portion of the seam (204), in particular wherein the seam (204) comprises at least one V-shaped characteristic in the region of the predetermined breaking point (206).
4. Film bag (200) according to Claim 3, which is filled with a fluid, in particular with alcohol.
5. Film bag (200) according to one of the preceding claims, where the seam (204) is folded around and/or bent around in the direction of a center of the bag (212).
6. Film bag (200) according to one of the preceding claims, where a further seam (800) is arranged at least in a part region of the seam (204) next to the seam (204), in the direction of a center of the bag (212), in order to reduce a volume that is surrounded by the bag (212).
7. Device (100) for providing a fluid for a biochemical evaluation unit, wherein the device (100) comprises the following features:

   a chamber (102) for receiving a film bag (200) for storing a fluid, wherein the chamber (102) comprises an interface (108) for providing the fluid for the evaluation unit; and

   a device (104) for opening a predetermined breaking point (206) of the film bag (200) in order to provide the fluid at the interface (108),

   characterized in that

   the device (104) for opening comprises a pressure plate (600) which is arranged so as to be movable inside the chamber (102) and is realized for the purpose of pressing the film bag (200) flat between the pressure plate (600) and a bottom of the chamber (102) when the device (104) for opening is actuated, wherein the pressure plate (600) comprises a continuation which protrudes on one side from a main extension plane of the pressure plate (600) and is realized for the purpose of surrounding or engaging behind the predetermined breaking point (206) at least in part.
8. Device (100) according to Claim 7, where the device (104) for opening comprises a fluid-tight diaphragm (114) which is arranged at least in part inside the chamber (102), and is deformable as a result of an actuating force and wherein the diaphragm (114) is realized in order to bring about a reduction in the volume of the chamber (102) and to press the fluid at the predetermined breaking point (206) out of the film bag (200) to the interface (108).
9. Device (100) according to either of Claims 7 or 8, where the chamber (102), on a side that is remote from the device (104) for opening, comprises an indentation (500) as a drainage region for the fluid and/or for improving the opening procedure of the predetermined breaking point, wherein the interface (108) is arranged in the indentation (500).
10. Device (100) according to Claims 7 to 9, where the pressure plate (600) is fastened on the device (104) for opening.
11. Device (100) according to one of Claims 7 to 10, where the device (104) for opening is arranged in a movable cover (110) of the chamber (102) which is realized for the purpose of closing the chamber (102) in a fluid-tight manner.
12. System (300) for providing a fluid for a biochemical evaluation unit, wherein the system (300) comprises the following features:

    at least one film bag (200) according to one of Claims 1 to 6
    and

    a device (100) for providing a fluid for a biochemical evaluation unit, having a chamber (102) for receiving a film bag (200) for storing a fluid, wherein the chamber (102) comprises an interface (108) for providing the fluid for the evaluation unit and having a device (104) for opening a predetermined breaking point (206) of the film bag (200) in order to provide the fluid at the interface (108)
    or

    at least one device (100) for providing according to one of Claims 7 to 11; and

    at least one film bag (200) for storing a fluid, in particular a reagent or an auxiliary agent for a biochemical analysis method, wherein the film bag (200) comprises a film (202), a seam (204) and a defined irreversibly destructible predetermined breaking point (206),

    wherein the film (202) is impermeable to the fluid and constituent parts of the fluid,

    wherein the seam (204) is arranged between a first part region (208) of the film (202) and a second part region (210) of the film (202), wherein the seam (204) is realized in a fluid-tight manner and the film (202) forms into a fluid-tight bag (212) for receiving the fluid, wherein the bag (212) is realized for the purpose of being arranged in a chamber (102) of a device (100) for providing a fluid for a biochemical evaluation unit; and

    wherein the defined irreversibly destructible predetermined breaking point (206) is realized from the film (202) and is fluid-tight when a fluid pressure in the film bag (200) is less than a limit value, and which is destroyed when the fluid pressure is greater than the limit value,

    wherein the film bag (200) is arranged in the chamber (102) of the device (100), and the chamber (102) is closed.
13. System (300) according to claim 12, where the film bag (200) is arranged eccentrically in the chamber (102) and at least one part region of the seam (204) is bent around by a wall of the chamber (102) and/or wherein the seam (204) follows the wall of the chamber (102).
14. Method (900) for producing a fluid-filled film bag (200), wherein the method (900) comprises the following steps:

    providing (902) a film bag (200) for storing a fluid, wherein the bag (212) comprises a fill opening, wherein the fluid bag (200) comprises a film (202) which is impermeable to the fluid and constituents of the fluid;

    filling (904) the bag (212) with the fluid through the fill opening; and

    closing (906) the fill opening of the film bag (200) by way of a seam (204) in order to seal the film bag (200), wherein the seam (204) is applied between a first part region (208) of the film (202) and a second part region (210) of the film (202), wherein the seam (204) is realized so as to be fluid-tight and the film (202) forms into a fluid-tight bag (212) for receiving the fluid, wherein the bag (212) is realized for the purpose of being arranged in a chamber (102) of a device (100) for providing a fluid for a biochemical evaluation unit and wherein in the step of closing (906), an irreversibly destructible predetermined breaking point (206) is realized which is realized from the film (202) and is fluid-tight when a fluid pressure in the film bag (200) is less than a limit value, and which is destroyed when the fluid pressure is greater than the limit value,

    characterized in that

    during closing (906) furthermore an additional element (1100) is attached to the film bag (200), which additional element is fastened on a film continuation (1102) of the film (202) that is realized as a bend point (1112), wherein the film continuation (1102) is arranged on a side of the seam (204) that is remote from the center of the bag (212), wherein the additional element (1100) is realized for the purpose of being bent and/or pressed onto the bag (212) in order to concentrate and/or increase a pressure onto the bag (212), wherein the additional element (1100) comprises a continuation (1108) which protrudes on a side located opposite the bend point (1112) out of a main extension plane of the additional element (1110) and is realized for the purpose of surrounding the predetermined breaking point (206) at least in part when the additional element (1100) is bent onto the bag (212).
15. Method (950) for producing a system (300) according to either of Claims 12 or 13, wherein the method comprises the following steps:

    providing (952) a fluid bag (200) according to one of Claims 1 to 6 and a device (100) for providing a fluid for a biochemical evaluation unit, having a chamber (102) for receiving a film bag (200) for storing a fluid, wherein the chamber (102) comprises an interface (108) for providing the fluid for the evaluation unit and having a device (104) for opening a predetermined breaking point (206) of the film bag (200) in order to provide the fluid at the interface (108),

    or providing (952) a device (100) according to one of the Claims 7 to 11 and a film bag (200) for storing a fluid, in particular a reagent or an auxiliary agent for a biochemical analysis method, wherein the film bag (200) comprises a film (202), a seam (204) and a defined irreversibly destructible predetermined breaking point (206)

    wherein the film (202) is impermeable to the fluid and constituent parts of the fluid

    wherein the seam (204) is arranged between a first part region (208) of the film (202) and a second part region (210) of the film (202), wherein the seam (204) is realized in a fluid-tight manner and the film (202) forms into a fluid-tight bag (212) for receiving the fluid, wherein the bag (212) is realized for the purpose of being arranged in a chamber (102) of a device (100) for providing a fluid for a biochemical evaluation unit; and

    wherein the defined irreversibly destructible predetermined breaking point (206) is realized from the film (202) and is fluid-tight when a fluid pressure in the film bag (200) is less than a limit value, and which is destroyed when the fluid pressure is greater than the limit value;

    moving (954) the fluid bag (200) into the chamber (102) of the device (100); and

    closing (956) the device (100) in order to produce the system (300) for providing the fluid for a biochemical evaluation unit.

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