DE102015205906B4 - Storage unit, method for producing a storage unit and method for releasing a fluid stored in a storage unit - Google Patents

Abstract

Storage unit (100) for storing a fluid (120), the storage unit (100) having the following features:- a housing unit (107) having a cavity (115) for receiving the fluid (120);- a closure membrane (125) which is designed and/or arranged to enclose a fluid (120) in the cavity (115) in a fluid-tight manner in the cavity (115);- an inlet opening (130) in a wall of the housing unit (107) for introducing a conveying fluid (135) and exerting a pneumatic and/or hydraulic pressure through the conveying fluid (135) on the closure membrane (125), the closure membrane (125) fluidically separating the inlet opening (130) from the cavity (115); and- an opening element (148) for opening the closure membrane (125) when the closure membrane (125) is subjected to the pneumatic and/or hydraulic pressure, wherein the opening element (148) is arranged on a side of the closure membrane (125) opposite the inlet opening (130), characterized by- a pressure membrane (200) which is arranged between the inlet opening (130) and the closure membrane (125) and which is designed to be more tear-resistant than the closure membrane (125), in particular wherein the pressure membrane (200) is designed to withstand a pneumatic and/or hydraulic pressure from the conveying fluid (135) to be supplied via the inlet opening (130).

Description

State of the art

The invention is based on a storage unit, a method for producing a storage unit and a method for releasing a fluid stored in a storage unit according to the preamble of the independent claims. The subject of the present invention is also a computer program.

Modern microfluidic devices are now often used for a wide variety of purposes where liquids need to be provided or transported on a chip. Such microfluidic devices can be used, for example, in so-called lab-on-a-chip systems (LOCs), in which the entire functionality of a macroscopic laboratory is accommodated on a plastic substrate the size of a credit card, for example, and complex biological, diagnostic, chemical or physical processes can be carried out in a miniaturized manner.

In many cases, LOC systems consist of polymer-based multilayer structures. This structure can consist of two polymer substrates that contain cavities in the form of chambers and channels. Between the polymer substrates there is a flexible polymer membrane that can be deflected using different pneumatic pressure levels in the adjacent cavities. Outside the cavities, the membrane is firmly connected to the adjacent polymer substrates (lid and substrate). For example, the flexible membrane can spread out throughout the chamber by applying compressed air and thus displace liquids, for example. This allows liquids to be transported from chamber to chamber via channels on a LOC system and reservoirs or chambers to be almost completely emptied. Pneumatically controlled membrane valves can also be opened or closed using the same principle. In EP 1 896 180 B1 A microfluidic system is described in which flexible membranes are used to move liquids within a lab-on-a-chip system. In order to run molecular diagnostic processes on a LOC system, a variety of liquids (water, saline solutions, detergents) are required. In order to avoid having to manually guide these liquids from the outside of the chip during processing, it is advantageous to store them directly on the chip (on-chip).

From the disclosure documents US 2011/0 198 221 A1 and US 2014/0 255 275 A1 Storage units for storing fluids are known.

Disclosure of the invention

Against this background, the approach presented here presents a storage unit, a method for producing such a storage unit, a method for releasing a fluid stored in a storage unit and a device that uses this method, as well as a corresponding computer program according to the main claims. The measures listed in the dependent claims enable advantageous further developments and improvements of the device specified in the independent claim.

• - eine Gehäuseeinheit, die eine Kavität zum Aufnehmen des Fluids aufweist;
• - eine Verschlussmembran, die ausgebildet und/oder angeordnet ist, um ein Fluid in der Kavität fluiddicht in der Kavität einzuschließen;
• - eine Einlassöffnung in einer Wand der Gehäuseeinheit zum Einleiten eines Förderfluids und Ausüben eines pneumatischen und/oder hydraulischen Drucks durch das Förderfluid auf die Verschlussmembran, wobei die Verschlussmembran die Einlassöffnung fluidisch von der Kavität trennt; und
• - ein Öffnungselement zum Öffnen der Verschlussmembran bei Beaufschlagung der Verschlussmembran mit dem pneumatischen und/oder hydraulischen Druck, wobei das Öffnungselement auf einer der Einlassöffnung gegenüberliegenden Seite der Verschlussmembran angeordnet ist.

The approach presented here creates a storage unit for storing a fluid in an analysis system, wherein the storage unit has the following features:

• - a housing unit having a cavity for receiving the fluid;
• - a sealing membrane which is designed and/or arranged to enclose a fluid in the cavity in a fluid-tight manner in the cavity;
• - an inlet opening in a wall of the housing unit for introducing a conveying fluid and exerting a pneumatic and/or hydraulic pressure through the conveying fluid on the closure membrane, wherein the closure membrane fluidically separates the inlet opening from the cavity; and
• - an opening element for opening the closure membrane when the closure membrane is subjected to pneumatic and/or hydraulic pressure, wherein the opening element is arranged on a side of the closure membrane opposite the inlet opening.

A fluid can be understood as a liquid such as aqueous solutions, salty solutions, detergents, alcohol or an acid that is required for a reaction in the analysis system. The fluid should be able to be released in a controllable manner at a specific time, for example. The housing unit can be a plastic element (for example thermoplastics such as PC, COP, COC, PP, PE, PET, ABS). The housing unit is composed of several parts or can be composed. A cavity can be understood as a hollow space or a recess in the housing unit that is intended to hold the fluid. A sealing membrane can be a film, for example. (for example a barrier film, sealing film or polymer composite film) which encloses a fluid stored in the cavity in a fluid-tight manner. An inlet opening can be understood as an opening in the wall through which a (further) fluid in the form of the conveying fluid can be introduced into the interior of the storage unit. Such a conveying fluid can be, for example, a gas, such as preferably (compressed) air or a liquid. An opening element can primarily be understood as a projection which is intended to open or tear the sealing membrane when the sealing membrane is pressed directly or indirectly onto this projection under the action of the conveying fluid. For this purpose, the projection can advantageously have points or edges in order to ensure a defined tearing of the sealing membrane under certain conditions.

The present approach is based on the knowledge that the fluid in the cavity can be released very precisely and at a specific time if a conveying fluid is introduced through the inlet opening in the wall of the housing unit. In this case, the mechanical coupling of the elements of the storage unit causes the sealing membrane to rupture promptly and the fluid stored in the cavity can be released. The approach presented here offers the advantage that the very precise control of a conveying fluid allows the desired amount of fluid to be released from the cavity very easily and precisely and is then available for the reaction in the analysis system. This in turn makes it possible to bring about a desired reaction with certain reaction parameters precisely and controllably, so that there is a low probability of failure of the analysis system. At the same time, the storage unit presented here is technically very simple and therefore inexpensive to implement. In addition, reagents can be stored on the LOC system with long-term stability.

An embodiment of the approach presented here is advantageous in which the opening element has a structure that tapers in the direction of the closure membrane, in particular wherein the opening element has a separating section for separating the closure membrane on a side opposite the closure membrane. Such an embodiment of the approach presented here offers the advantage of a precise opening of the closure membrane when a certain volume of the conveying fluid is introduced through the inlet opening.

According to a further embodiment of the approach presented here, the opening element can be made at least partially from the material of the housing unit, in particular in one piece with a part of the housing unit and/or the opening element can at least partially comprise a metal. Such an embodiment of the approach presented here offers the advantage of a technically very simple production of the opening element while at the same time ensuring the desired function of this opening element.

The closure membrane can be opened particularly easily and precisely if, according to a further embodiment of the approach presented here, the opening element has a linear cutting edge in an area opposite the closure membrane.

An embodiment of the approach presented here is also conceivable in which the opening element is designed as a hollow needle, in particular to enable contact between the conveying fluid and a fluid stored in the cavity when the storage device is used and the closure membrane is opened. Such an embodiment of the approach presented here offers the possibility of particularly good guidance of the conveying fluid and thus advantageous expulsion of the fluid from the cavity.

According to a further embodiment of the approach presented here, the opening element can also extend from a substantially flat bottom region in the direction of the closure membrane. A flat bottom region can be understood, for example, as a region of the bottom of the cavity in which, on opposite sides of the opening element, the bottom of the cavity or recess has a substantially equal depth in relation to an end of the opening element opposite the closure membrane. For example, the depth of the cavity or recess should not deviate by more than 10% on both opposite sides of the opening element.

According to a further embodiment, the opening element can also form an edge of the cavity. This enables the fluid to be discharged from the cavity very easily and without disruption.

The fluid stored in the cavity can be released particularly easily if, according to another embodiment of the approach presented here, the closure membrane is prestressed by the opening element.

A storage unit can be manufactured particularly easily from a technical perspective if, according to one embodiment of the approach presented here, the housing unit has a fluid receiving part unit and a cover unit, wherein the fluid receiving unit comprises the cavity that can be closed and/or is closed with the closure membrane and wherein the cover unit has the inlet opening. The fluid receiving sub-unit and the cover unit can each form a component of the housing unit, which are joined together in a final manufacturing step.

Furthermore, a pressure membrane is provided which is arranged between the inlet opening and the closure membrane and which is designed to be more tear-resistant than the closure membrane. The pressure membrane can be designed to withstand pneumatic and/or hydraulic pressure from the conveying fluid to be supplied via the inlet opening. Such a pressure membrane can be understood as a film (for example made of a thermoplastic elastomer such as TPU, TPS, TPV...) which is mechanically very resilient and will not usually burst due to expected pneumatic and/or hydraulic pressure from the conveying fluid. This offers the advantage of being able to ensure a separation between the conveying fluid and the fluid when the fluid is released from the cavity. This prevents contamination of the fluid. At the same time, complete expulsion of the entire volume of fluid in the cavity can be ensured using technically simple means. The pressure membrane can advantageously be designed to be fluid-tight for the fluid stored or to be stored in the cavity.

The tearing or bursting of the pressure membrane on the opening element can be prevented particularly reliably if, according to a further embodiment of the approach presented here, the pressure membrane is fastened to a fastening section on the housing unit, wherein at least two partial sections of the pressure membrane arranged on opposite sides of the fastening section are movable in the direction of the closure membrane when the conveying fluid flows in through the inlet opening.

The fluid can be discharged from the cavity very safely and, if necessary, under the influence of gravity if, according to a further embodiment of the approach presented here, an outlet opening is provided for releasing the fluid that can be stored or is stored in the cavity, wherein the outlet opening is provided in a region of the attachment of the closure membrane to a part of the housing unit.

• - Einfüllen des Fluids in die Kavität der Komponente der Gehäuseeinheit;
• - Fluiddichtes Verschließen der Kavität in der Komponente der Gehäuseeinheit mit der Verschlussmembran; und
• - Zusammenfügen der Komponenten der Gehäuseeinheit, um die Bevorratungseinheit herzustellen.

Furthermore, an embodiment of the approach presented here is advantageous as a method for producing a storage unit according to one of the preceding claims, wherein components of the housing unit are provided for the method, wherein at least one component of the housing unit has the cavity and the opening element and one component of the housing unit has the inlet opening, wherein the method has the following steps;

• - Filling the fluid into the cavity of the housing unit component;
• - Fluid-tight sealing of the cavity in the housing unit component with the sealing membrane; and
• - Assembling the components of the housing unit to create the storage unit.

By means of such a method for producing the storage unit, this storage unit can be manufactured very cost-effectively, while nevertheless a precise function of this storage unit, i.e. a controllable release of the fluid stored in the storage unit, is possible.

• - Einleiten eines Förderfluids in die Einlassöffnung, um die Verschlussmembran durch pneumatischen und/oder hydraulischen Druck an das Öffnungselement zu drücken und hierdurch die Verschlussmembran zu öffnen, um das Fluid n der Kavität freizusetzen.

According to a further embodiment of the approach presented here, a method for releasing a fluid stored in a storage unit provided according to an embodiment presented here can also be provided, the method comprising the following step:

• - Introducing a conveying fluid into the inlet opening in order to press the sealing membrane against the opening element by pneumatic and/or hydraulic pressure and thereby open the sealing membrane to release the fluid into the cavity.

Such an embodiment of the approach proposed here also offers the advantage of a particularly precise and controllable release of the fluid in the storage unit.

According to a particular embodiment of the approach presented here, a step of sucking off the fluid can be carried out through an outlet channel of the storage unit.

These methods can be implemented, for example, in software or hardware or in a mixture of software and hardware, for example in a control unit.

The approach presented here also creates a device that is designed to carry out, control or implement the steps of a variant of a method presented here in corresponding devices. This embodiment of the invention in the form of a device can also quickly and efficiently solve the problem underlying the invention.

In the present case, a device can be understood as an electrical device that processes sensor signals and outputs control and/or data signals depending on them. The device can have an interface that can be designed as hardware and/or software. In a hardware design, the interfaces can, for example, be part of a so-called system ASIC, which contains a wide variety of functions of the device. However, it is also possible for the interfaces to be separate integrated circuits or to consist at least partially of discrete components. In a software design, the interfaces can be software modules that are present, for example, on a microcontroller alongside other software modules.

Also advantageous is a computer program product or computer program with program code that can be stored on a machine-readable carrier or storage medium such as a semiconductor memory, a hard disk memory or an optical memory and is used to carry out, implement and/or control the steps of the method according to one of the embodiments described above, in particular when the program product or program is executed on a computer or device.

• 1A-C Querschnittsdarstellungen durch ein erstes Ausführungsbeispiel einer Bevorratungseinheit;
• 2A-C Querschnittsdarstellungen durch ein weiteres Ausführungsbeispiel einer Bevorratungseinheit;
• 3A-C Querschnittsdarstellungen durch ein weiteres Ausführungsbeispiel einer Bevorratungseinheit;
• 4A-C Querschnittsdarstellungen durch ein weiteres Ausführungsbeispiel einer Bevorratungseinheit;
• 5A-C Querschnittsdarstellungen durch ein weiteres Ausführungsbeispiel einer Bevorratungseinheit;
• 6A-C Querschnittsdarstellungen durch ein weiteres Ausführungsbeispiel einer Bevorratungseinheit;
• 6D eine Draufsichtdarstellung auf das Ausführungsbeispiel einer Bevorratungseinheit aus den 6A-C;
• 7A-C Querschnittsdarstellungen durch ein weiteres Ausführungsbeispiel einer Bevorratungseinheit;
• 8A-E Querschnittsansichten von unterschiedlichen Ausführungsbeispielen von Öffnungselementen zur Verwendung in einem Ausführungsbeispiel einer Bevorratungseinheit;
• 9A-E Draufsichtdarstellungen von unterschiedlichen Ausführungsbeispielen von Öffnungselementen zur Verwendung in einem Ausführungsbeispiel einer Bevorratungseinheit;
• 10-11 Ablaufdiagramme von Verfahren gemäß Ausführungsbeispielen des hier vorgestellten Ansatzes; und
• 12-13 Blockschaltbilder von Vorrichtungen gemäß Ausführungsbeispielen des hier vorgestellten Ansatzes.

Embodiments of the invention are shown in the drawings and explained in more detail in the following description. It shows:

• 1A -C cross-sectional views through a first embodiment of a storage unit;
• 2A -C cross-sectional views through another embodiment of a storage unit;
• 3A -C cross-sectional views through another embodiment of a storage unit;
• 4A -C cross-sectional views through another embodiment of a storage unit;
• 5A -C cross-sectional views through another embodiment of a storage unit;
• 6A -C cross-sectional views through another embodiment of a storage unit;
• 6D a top view of the embodiment of a storage unit from the 6A -C;
• 7A -C cross-sectional views through another embodiment of a storage unit;
• 8A -E cross-sectional views of different embodiments of opening elements for use in an embodiment of a storage unit;
• 9A -E are plan views of different embodiments of opening elements for use in an embodiment of a storage unit;
• 10-11 Flowcharts of methods according to embodiments of the approach presented here; and
• 12-13 Block diagrams of devices according to embodiments of the approach presented here.

In the following description of advantageous embodiments of the present invention, the same or similar reference numerals are used for the elements shown in the various figures and having a similar effect, whereby a repeated description of these elements is omitted.

1A shows a cross-sectional view through a first embodiment of a storage unit 100 according to the approach presented here in a resting state. This consists of a first polymer substrate 105, which acts here as a cover element of a housing unit 107 and which is in contact with a second polymer substrate 110, which acts as a fluid receiving element of the housing unit 107. The second polymer substrate 110 contains a cavity 115 in which a liquid (for example an alcohol) is stored as a fluid 120 for a reaction to be carried out in the 1A not shown analysis unit. The cavity 115 is closed (fluid-tight) by a sealing film as a closure membrane 125, which overlaps the cavity 115 and is fluidically tightly connected to the first polymer substrate 105 or the second polymer substrate 110 in the overlapping area 127. In the first polymer substrate 105 there is also a microfluidic access as an inlet opening 130, which allows a pneumatic (or hydraulic) overpressure of a conveying fluid 135 (such as air) to be applied to the surface of the sealing film or closure membrane 125 facing away from the cavity 115. A gap 140 located between the closure membrane 125 and the cover element 105 is discharged laterally in the form of an outlet channel 145, to which a 1A not shown fluidic network, for example, can connect to the analysis device, which further processes the upstream liquid 120 in a suitable manner. The Storage unit 100 can, for example, be an integral part of the analysis unit.

Also located within the cavity 115 is an opening element 148, which has a holding element 150 with a cutting element 155, the cutting element 155 being suitable for cutting through or perforating the sealing film or closure membrane 125 under mechanical stress. The cutting element 155 can be formed as an opening element 148, for example, in one piece with the holding element 150 or even in one piece with the holding element 150 and the second polymer substrate 110 and can have a point-like or linear effect. The cutting element 155 can be made of the same material as the holding element 150, e.g. a polymer, or can be designed in the form of a metal cutting edge, for example.

In order to provide the upstream liquid 125 via the outlet channel 145, a pneumatic overpressure is applied via the access 130, which causes the sealing film or sealing membrane 125 to experience a force in the direction of the cavity 115. This leads to tensions, particularly in the area of the contact surface of the cutting element 155 of the opening element 148, which become so strong from a certain pneumatic pressure of the conveying fluid 135 that the sealing film or sealing membrane 125 is severed. As a result, the sealing film 125 is displaced into the cavity 115 in the direction of the (essentially flat) bottom 160 of the cavity 115 and the liquid or, more generally, the fluid 120 is released.

1 B shows a cross-sectional view of an embodiment of the storage unit 100 in a state at a first time t ₁ in which the pneumatic overpressure of the conveying fluid 135 has been increased so much that the sealing membrane 125 has torn open and been pressed into the cavity 115. It is particularly advantageous to use gravity in such a way that the liquid or fluid 125 collects above the outlet channel 145. By maintaining the pneumatic pressure of the conveying fluid 135, the liquid or fluid 120 is conveyed through the outlet channel 145 and made available to a subsequent microfluidic network in the analysis unit (not shown). In addition, it is possible to remove the pressure again after the sealing membrane has been opened. The liquid can then be emptied either by gravity or actively sucked in by the LOC system.

1C shows a cross-sectional view of an embodiment of the storage unit 100 in a state at a second time t ₂ after the first time t ₁ , in which the pneumatic overpressure of the conveying fluid 135 has been maintained to such an extent that the closure membrane 125 is completely pressed down to the bottom of the cavity 115 and the fluid 120 can flow out through the outlet channel or the outlet opening 145.

An important goal of the approach presented here can be seen in the fact that a pneumatic-mechanical provision of liquid reagents for LoC systems becomes possible in order to store liquid reagents for LoC applications in a long-term stable manner and to provide them on demand while ensuring efficient emptying of the reservoirs.

The approach presented here enables long-term stable storage and reliable provision of liquid reagents in polymer-based, microfluidic LoC systems (e.g. credit card-sized LoC cartridges). The liquid, i.e. in this case the fluid 120, is stored in a reservoir, i.e. in this case the cavity 115, and sealed with a barrier film as a sealing membrane 125. The barrier film 125 is, for example, a polymer composite film consisting of a sealing layer (polypropylene, polyethylene, hot melt adhesive, ...) and an aluminum layer. Optionally, the aluminum layer is additionally provided with a protective layer made of PET or varnish. In the reservoir 115 there are mechanical stops such as the opening element 148, which is designed as a tip or hollow needle, for example, which lead to a local increase in the stress of the barrier film 125 through a pneumatic deflection of the barrier film 125 or flexible membrane, which is designed here as a pressure membrane. When a defined pneumatic pressure is reached, this leads to the barrier film 125 breaking open and, once the pneumatic pressure is removed, to the release of the liquid 120. In addition to possible gravity emptying, this can also be actively sucked in for further processing in an analysis unit. This suction can also take place without a flexible membrane. The deflection of the barrier film 125 by pneumatic pressure through the conveying fluid 135 against mechanical stops, tips or hollow needles as opening elements 148 in the reservoir 115 to increase the tension of the barrier film 125 and the resulting reagent release represents a main aspect of the approach presented here.

• - Es braucht keine vorangehende Strukturierung der Barrierefolie 125 zur Erzeugung einer Sollbruchstelle erfolgen. Dies führt zu einer drastischen Vereinfachung des Fertigungsprozesses und damit zu einer Reduktion der Herstellkosten.
• - Auf eine Bereitstellungskammer kann verzichtet werden, was zu einer deutlichen Flächenreduktion führt. Hierdurch werden die Herstell-, Lager- und Transportkosten einer Kartusche verringert.
• - Alle Elemente, die zum Aufbrechen der Barrierefolie 125 dienen sollen, wie beispielsweise Spitzen, Hohlnadeln oder Zacken können direkt auf dem Chip bzw. einer entsprechend ausgestalteten Gehäuseeinheit 107 oder Komponenten davon wie der Deckeleinheit 105 und oder der Fluidaufnahmeeinheit 110, durch Spritzguss erfolgen. Auch hier ist kein zusätzlicher Prozessschritt notwendig bei der Einbringung einer Sollbruchstelle.
• - Die Vorlagerung der Flüssigreagenzien 120 kann direkt auf dem Chip also der Bevorratungsvorrichtung 100 erfolgen, die beispielsweise integraler Bestandteil der Analyseeinheit sein kann. Es sind keine separaten Behältnisse (Blister, Stickpacks) erforderlich. Hierdurch werden die Produktionskosten deutlich gesenkt.
• - Auf einen externen mechanischen beweglichen Aktuator (z. B. Stempel) zum Entleeren der Flüssigkeit 120 kann verzichtet werden, was Kontaminationsrisiken von außen und die Komplexität der externen Steuereinheit reduziert. Hierdurch werden Kosten gesenkt und eine größere Sicherheit im Betrieb erreicht.

The approach presented here offers several advantages:

• - There is no need for prior structuring of the barrier film 125 to create a predetermined breaking point. This leads to a drastic simplification of the manufacturing process and thus to a reduction in manufacturing costs.
• - A supply chamber can be dispensed with, which leads to a significant reduction in space. This reduces the manufacturing, storage and transport costs of a cartridge.
• - All elements intended to break open the barrier film 125, such as tips, hollow needles or spikes, can be injection molded directly onto the chip or a correspondingly designed housing unit 107 or components thereof such as the cover unit 105 and/or the fluid intake unit 110. Here, too, no additional process step is necessary when introducing a predetermined breaking point.
• - The liquid reagents 120 can be stored directly on the chip, i.e. the storage device 100, which can be an integral part of the analysis unit, for example. No separate containers (blisters, stick packs) are required. This significantly reduces production costs.
• - An external mechanical moving actuator (e.g. piston) for emptying the liquid 120 can be omitted, which reduces the risk of external contamination and the complexity of the external control unit. This reduces costs and achieves greater operational safety.

2A shows a cross-sectional view of another embodiment of a storage unit 100 presented here in a rest state. In this embodiment, compared to the storage unit 100 shown in the 1A to 1C In the embodiment shown, an elastic polymer membrane is additionally used as a pressure (transfer) membrane 200, which is arranged between the first polymer substrate 105 and the second polymer substrate 110, so that the pneumatic pressure of the conveying fluid 135 introduced via the access or inlet connection 130 does not act directly on the sealing film or

The force acting on the sealing membrane 125 does not act on the sealing film or sealing membrane 125, but initially only on the polymer membrane or pressure membrane 200. The polymer membrane or pressure membrane 200 is not connected to the first polymer substrate 105 in the area opposite the cavity 115. Due to the elasticity of the polymer membrane or pressure membrane 200, the force acting on the sealing film or sealing membrane 125 is transferred directly to the sealing film or sealing membrane 125 until it is severed by the cutting element 155 of the opening element 148. The polymer membrane or pressure membrane 200 then expands into the cavity 115 (see 2 B , which represents the state at a first point in time after the activation of the storage unit 100), so that the liquid or fluid 120 contained therein is displaced into the outlet channel 145 (see 2C , which reflects the state at a second point in time following the first point in time after the activation of the storage unit 100). This embodiment has the particular advantage that the process of displacing the liquid or fluid 120 is self-limiting in the sense that the pneumatic pressure of the conveying fluid 135 provided via the access or inlet opening 130 does not need to be removed in order to stop the liquid or fluid 120 from advancing in the subsequent microfluidic network of the analysis unit not shown in the figures. This makes it possible to generate a well-defined initial state (“upstream liquid is ready”) for subsequent process steps after a certain waiting time.

As an alternative to the embodiments described above and below, the pneumatic pressure of the conveying fluid 135 can be reduced via access or the inlet opening 130 after opening the sealing film or closure membrane 125 and the liquid 120 in the cavity 115 can be emptied, for example by a downstream microfluidic pump not shown in the figures. For this purpose, it is particularly advantageous to provide an additional venting channel between the first substrate 105 (cover element) and the second substrate 110 (fluid receiving element) of the housing unit 107.

The subfigures of the 3 each show a cross-sectional view of another embodiment of a storage unit 100 presented here in a rest state ( 3A) , a state at a first time after the activation of the storage unit 100 ( 3B) and a state at a second time following the first time after the activation of the storage unit 100 ( 3C In this embodiment, compared to the 2A to 2C In the embodiment shown, the polymer membrane or pressure membrane 200 is not free over the entire surface opposite the cavity 115, but is connected to the first polymer substrate 105 (cover element) in a fastening section 300 above the cutting element 155 of the opening element 148. If a pneumatic overpressure of the conveying fluid 135 is provided via the access or inlet opening 130, the contact between the polymer membrane or pressure membrane 200 and the first polymer substrate 105 remains, while the remaining area of the pressure membrane 200, i.e. the area opposite the fastening section 300 Partial elements 310 of the pressure membrane 300 can spread out or deflect in the direction of the cavity 115 and the sealing film or closure membrane 125 is severed. This embodiment has the particular advantage that there is no direct contact between the polymer membrane or the pressure membrane 200 and the cutting element 155 of the opening element 148. This reduces the risk of the polymer membrane or pressure membrane 200 being severed by the cutting element 155 of the opening element 148 and increases reliability.

The subfigures of the 4 each show a cross-sectional view of another embodiment of a storage unit 100 presented here in a rest state ( 4A) , a state at a first time after the activation of the storage unit 100 ( 4B) and a state at a second time following the first time after the activation of the storage unit 100 ( 4C In this embodiment, compared to the 2A to 2C In the embodiment shown, the dimensions of the holding element 150 and cutting element 155 of the opening element 148 are selected such that the sealing seam of the closure membrane 125 in the area of the housing unit 107 is already subjected to mechanical stress in the basic state. This embodiment has the particular advantage that the sealing film or closure membrane 125 is severed at particularly low pneumatic pressures of the conveying fluid 135. This increases reliability.

The subfigures of the 5 each show a cross-sectional view of another embodiment of a storage unit 100 presented here in a rest state ( 5A) , a state at a first time after the activation of the storage unit 100 ( 5B) and a state at a second time following the first time after the activation of the storage unit 100 ( 5C ). In this embodiment, the cutting element 155 of the opening element 148 is located opposite the 2A to 4C illustrated embodiments at the edge of the cavity 155, preferably at the highest point of the cavity 155, which forms the edge 500 of the cavity 115 in the direction of the closure membrane 125. This embodiment has the particular advantage that the emptying of the fluid 120 from the cavity 115 can be supported by gravity and the fluid 120 is guided directly to the outlet channel 145 when the closure membrane 125 is open. It is also possible to reduce the risk of air bubbles entering the outlet channel 145. This enables even more reproducible emptying of the cavity 115.

The subfigures of the 6 each show a cross-sectional view of another embodiment of a storage unit 100 presented here in a rest state ( 6A) , a state at a first time after the activation of the storage unit 100 ( 6B) and a state at a second time following the first time after the activation of the storage unit 100 ( 6C ). In this embodiment, in addition to the 5A to 5C In the embodiment shown, at least one further opening element 148' is provided, which is arranged on an edge 500' of the cavity 155 opposite the edge 500 in the direction of the closure membrane 125. The opening element 148 and the further opening element 148' each have a cutting element 155 or 155'. By actuating the pneumatic pressure of the conveying fluid 135, the polymer membrane or pressure membrane 200 is deflected and presses via the sealing film or closure membrane 125 onto the cutting elements 155 or 155' of the opening element 148 or 148', which leads to the sealing film or closure membrane 125 breaking open. After opening the sealing film or sealing membrane 125, the pneumatic pressure on the conveying fluid 135 is removed, so that the liquid or fluid 120 can be emptied through the openings of the sealing film or sealing membrane 125 with the help of gravity via the outlet channel or outlet opening 145. In order to create openings in the sealing film or sealing membrane 125 that are as permeable as possible, it is particularly advantageous to design the cutting elements 155 or 155` in an arc shape (e.g. in the form of a semicircle), as shown in the top view according to the 6D is shown.

The subfigures of the 7 each show a cross-sectional view of another embodiment of a storage unit 100 presented here in a rest state ( 7A) , a state at a first time after the activation of the storage unit 100 ( 7B) and a state at a second time following the first time after the activation of the storage unit 100 ( 7C ). In this embodiment, in addition to the 2A to 6C In the embodiment shown, the layer structure of the housing unit 107 consists of three substrates 105, 110 and 700, whereby the substrate 700 can be designed as an intermediate carrier element and is installed between the cover element 105 and the fluid receiving element 110. In addition, the sealing film or the closure membrane 125 is applied in sections and the channel 710 between the cover element 105 and the fluid receiving element 110 is interrupted by two webs 720. This makes it possible to apply pneumatic pressure via the accesses or inlet openings 130 to deflect the pressure membrane 200 so that the sealing foil 125 is cut at the cutting elements 155 or 155` of the opening elements 148 or 148` (see 7B) . The cutting elements 155 and 155` of the opening elements 148 and 148` are particularly advantageously designed in the form of hollow needles. After cutting through the sealing film 125, a pneumatic pressure of the conveying fluid 135 can then be reduced or completely eliminated (see state from 7C ) and a pressure is applied via the channel piece 730 (or the liquid is again actively sucked in, which was not possible in the previous embodiment), which is transferred via the channel 750 into the cavity 3. As a result, the liquid or the fluid 120 is conveyed through the channel 760 to the outlet channel 145 and thus made available to the analysis unit.

• Dicke Polymersubstrat (Deckelelement 105 oder Fluidaufnahmelement 110); 0,5 bis 5 mm
• Volumen des Fluids 120, das in der Kavität 115 vorgelagert wird: 5µl-10ml Flexible Polymermembran: thermoplastische Elastomere (TPU, TPS, TPV), Silikon, PDMS, Elastomere...
• Dicke Polymermembran (Druckmembran): 5 bis 1mm Polymersubstrate (Deckelelement, Fluidaufnahmeelement, Zweichenträgerelement): COP, COC, PP, PE, PC, PET, ABS

Exemplary dimensions of the different components of the above-mentioned embodiments can be given as follows:

• Thickness of polymer substrate (cover element 105 or fluid receiving element 110); 0.5 to 5 mm
• Volume of fluid 120 stored in cavity 115: 5µl-10ml Flexible polymer membrane: thermoplastic elastomers (TPU, TPS, TPV), silicone, PDMS, elastomers...
• Thickness of polymer membrane (pressure membrane): 5 to 1mm Polymer substrates (cover element, fluid absorption element, cell carrier element): COP, COC, PP, PE, PC, PET, ABS

The cutting elements 155 and 155' of the opening elements 148 and 148' can be manufactured from the same polymers as the substrates 105, 110 and 700 by injection molding. In addition, these cutting elements 155 and 155' can also consist of metal(s) such as steel, stainless steel, aluminum, gold, silver, copper, titanium, which can be countersunk directly into or onto the holding elements 150 before the injection molding process, for example, in order to produce the respective opening element 148. The cutting elements 155 and 155' can also be attached to the polymer substrates 105, 110 or 700 by other joining methods (for example, gluing).

With regard to the sealing membrane as a preferably multi-layer sealing film, the following can be mentioned as an example
Thickness of barrier layer (usually aluminum): 10 µm to 500 µm
Thickness of sealing layer (e.g. PP, PE, hot glue): 5 µm to 500 µm
Thickness of protective layer (e.g. PET, polyester, PP, PE, protective varnish): 5 µm to 500 µm

In addition to the exemplary embodiments, any other geometric connections between the polymer membrane (pressure membrane) and the polymer substrate (cover element, fluid absorption element) are possible in order to promote the preferred direction of the membrane 125 or 200 and its deflection. The required polymer substrates (starting material) and the required structures such as the opening elements 148 in the polymer substrates 105, 110 or 700 can be produced, for example, by milling, injection molding, hot stamping or laser structuring. The openings 130 in the polymer membrane or the cover element 105 can be produced by punching or laser structuring.

With regard to the geometry of the cutting elements (stops, tips or hollow needles) of the opening elements, the following can be noted.

In the embodiments according to the 1A to 5C In the simplest case, the cutting elements can have the geometry of a concentric tip (see for example 8A in a cross-sectional view and 9A in a top view). Here, further geometries for the cutting elements 155 and 155` are possible, for example pyramid-shaped tips (see for example 8B in a cross-sectional view and 9B in a top view). In a further embodiment, the cutting elements 155 or 155` can have the shape of a simple cutting edge. This cutting edge can also be designed in an arc shape, e.g., the curves of the cavity 115 can be depicted as an edge 500 in order to reproducibly break through the barrier film 125 over a larger area (see, for example, 8C in a cross-sectional view and 9C in a top view).

With regard to the embodiments from the 6A to 7C It should be noted that in addition to stops or tips as a shape for the cutting elements 155, hollow needles can also be used. These hollow needles have a concentric shape with an inner channel as a microfluidic path (see for example 8D in a cross-sectional view and 9d in a top view). The hollow needles should be designed to be comparatively pointed at their edges in order to reproducibly break open the barrier film 125 under load, as is particularly advantageous in the embodiment according to the 7A to 7C In a further advantageous embodiment, the hollow needles can be designed semicircularly, as in the embodiment according to the 6A to 6C This form of hollow needles allows the approach presented here to remain suitable for injection molding, since there are no undercuts in the channel 750 as in the Example according to the 6A to 6C be generated.

10 shows a flow chart of an embodiment of the approach presented here as a method 1000 for producing a storage unit according to an embodiment presented here, wherein components of the housing unit are provided for the method, wherein at least one component of the housing unit has the cavity and the opening element and one component of the housing unit has the inlet opening. The method 1000 comprises a step of filling 1010 the fluid into the cavity of the component of the housing unit and a step 1020 of fluid-tightly closing the cavity in the component of the housing unit with the sealing membrane. Finally, the method comprises a step 1030 of assembling the components of the housing unit to produce the storage unit.

11 shows a flow chart of an embodiment of the approach presented here as a method 1100 for releasing a fluid stored in a storage unit according to an embodiment presented here, wherein the method 1100 has the following step 1110 of introducing a conveying fluid into the inlet opening in order to press the closure membrane against the opening element by pneumatic and/or hydraulic pressure and thereby open the closure membrane in order to release the fluid in the cavity.

12 shows a block diagram of an embodiment of the approach presented here as a device 1200 for producing a storage unit according to an embodiment presented here, wherein components of the housing unit are provided for the production, wherein at least one component of the housing unit has the cavity and the opening element and one component of the housing unit has the inlet opening. The device 1200 comprises a unit 1210 for filling the fluid into the cavity of the component of the housing unit and a unit 1220 for fluid-tightly closing the cavity in the component of the housing unit with the sealing membrane. Finally, the device 1200 comprises a unit 1030 for assembling the components of the housing unit to produce the storage unit.

11 shows a block diagram of an embodiment of the approach presented here as a device 1100 for releasing a fluid stored in a storage unit according to an embodiment presented here, wherein the device 1300 has a unit 1310 for introducing a conveying fluid into the inlet opening in order to press the closure membrane against the opening element by pneumatic and/or hydraulic pressure and thereby open the closure membrane in order to release the fluid in the cavity.

If an embodiment includes an “and/or” connection between a first feature and a second feature, this is to be read as meaning that the embodiment according to one embodiment has both the first feature and the second feature and according to another embodiment has either only the first feature or only the second feature.

Claims (13)

Storage unit (100) for storing a fluid (120), the storage unit (100) having the following features: - a housing unit (107) having a cavity (115) for receiving the fluid (120); - a closure membrane (125) which is designed and/or arranged to enclose a fluid (120) in the cavity (115) in a fluid-tight manner in the cavity (115); - an inlet opening (130) in a wall of the housing unit (107) for introducing a conveying fluid (135) and exerting a pneumatic and/or hydraulic pressure through the conveying fluid (135) on the closure membrane (125), the closure membrane (125) fluidically separating the inlet opening (130) from the cavity (115); and - an opening element (148) for opening the closure membrane (125) when the closure membrane (125) is subjected to the pneumatic and/or hydraulic pressure, wherein the opening element (148) is arranged on a side of the closure membrane (125) opposite the inlet opening (130), characterized by - a pressure membrane (200) which is arranged between the inlet opening (130) and the closure membrane (125) and which is designed to be more tear-resistant than the closure membrane (125), in particular wherein the pressure membrane (200) is designed to withstand a pneumatic and/or hydraulic pressure from the conveying fluid (135) to be supplied via the inlet opening (130). Storage unit (100) according to Claim 1 , characterized in that the opening element (148) has a structure (155) tapering in the direction of the closure membrane (125), in particular wherein the opening element (148) has a cutting element (155) for separating the closure membrane (125) on a side opposite the closure membrane (125). Storage unit (100) according to one of the preceding claims, characterized in that the opening element (148) is designed as a hollow needle (155), in particular to enable contact of the conveying fluid (135) with a fluid (120) stored in the cavity (115) when the storage unit (100) is used and the closure membrane (125) is opened. Storage unit (100) according to one of the preceding claims, characterized in that the opening element (148) extends from a substantially flat bottom region (160) in the direction of the closure membrane (125). Storage unit (100) according to one of the preceding claims, characterized in that the opening element (148) forms an edge (500) of the cavity (115). Storage unit (100) according to one of the preceding claims, characterized in that the housing unit (107) has a fluid receiving unit (110) and a cover unit (105), wherein the fluid receiving unit (110) comprises the cavity (115) which is closable and/or closed with the closure membrane (125) and wherein the cover unit (105) has the inlet opening (130). Storage unit (100) according to one of the preceding claims, characterized in that the pressure membrane (200) is fastened to a fastening section (300) on the housing unit (107), wherein at least two partial sections (310) of the pressure membrane (200) arranged on opposite sides of the fastening section (300) are movable in the direction of the closure membrane (125) when the conveying fluid (135) flows in through the inlet opening (130). Storage unit (100) according to one of the preceding claims, characterized by an outlet opening for releasing the fluid (120) storable or stored in the cavity (115), wherein the outlet opening (145) is provided in a region of an attachment of the closure membrane (125) to a part of the housing unit (107). Method (1000) for producing a storage unit (100) according to one of the preceding claims, wherein components of the housing unit (107) are provided for the method (1000), wherein at least one component (110) of the housing unit (107) has the cavity (115) and the opening element (148) and one component (105) of the housing unit (107) has the inlet opening (130), wherein the method (1000) has the following steps: - filling (1010) the fluid (120) into the cavity (115) of the component of the housing unit (107); - fluid-tight (1020) closing of the cavity (115) in the component of the housing unit (107) with the closing membrane (125); and - assembling (1030) the components (105, 110) of the housing unit (107) to produce the storage unit (100). Method (1100) for releasing a fluid (120) stored in a storage unit (100) according to one of the preceding claims, the method (1100) comprising the following step: - introducing (1110) a conveying fluid (135) into the inlet opening (130) in order to press the closure membrane (125) against the opening element (148) by means of pneumatic and/or hydraulic pressure on the pressure membrane (200) and thereby open the closure membrane (125) in order to release the fluid (120) in the cavity (115). Procedure according to Claim 10 , characterized by a step of sucking the fluid through an outlet channel (145) of the storage unit (100). Computer program configured to execute, implement and/or control the method (1200, 1300) according to one of the preceding claims. Machine-readable storage medium on which the computer program is Claim 12 is stored.

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