Patent ID: 12186745

DETAILED DESCRIPTION

The present invention describes a fluidic system including a chamber which has a flexible or movable part, usually the bottom or lid, in particular embodiments also movable walls, which, by lifting or bottoming, allows the intake, discharge, displacement, dilution or mixing of fluids or gases which are connected to the chamber via at least one channel or opening. An extension of the invention is achieved either by additional elements such as filters, membranes, frits or similar elements and/or integrated reagents, which may for example be arranged in the form of an array of identical or different reagents. This enables the separation, filtering, fractionation, and enrichment of fluids and their components as well as modification of fluids and their components and the detection of the components of the fluids. The individual use and combination of the additional elements can be carried out as desired.

The chamber and the movable part are configured such that, by a movement of the movable part from its initial position, a predetermined and adjustable volume of the chamber is displaced. In this way, predetermined volumes can be received or discharged in the chamber when the moving part is returned to another position or to the initial position. In other words, the volume is predetermined by the properties of the fluidic system or can be adjusted by the configuration of the fluidic system according to the invention.

FIGS.1ato1cshow an embodiment of the fluidic system.FIG.1aandFIG.1cshow a top view of the fluidic system, andFIG.1bshows a cross-sectional view of the fluidic system.

The fluidic system has a structured component1including a chamber2, wherein the chamber2is connected to a channel system3. The structured component1is essentially flat and/or plate-like. In other words, the structured component1has a first main side and a second main side which are parallel to each other. The chamber2and the channel system3are formed on the first main side on and/or in the surface of the structured component1. In other words, the chamber2and the channel system3are embedded at the main side into the surface of the structured component1. The chamber2and the channel system3thus are a recess on the surface of the structured component1. For example, the first main side is a top side of the structured component1, and the second main side is a bottom side of the structured component1, wherein an orientation of the top side and the bottom side is arbitrary and by turning the structured component the top side becomes the bottom side and vice versa. Side surfaces of the structured component1are arranged between the top side and the bottom side of the structured component1. The structured component1can, for example, be rectangular in shape. The structured component1can also be disc shaped. However, the structured component1can take on any shape as long as it is essentially flat. The structured component1can be formed as a platform, for example. Structured component1can be flat.

The chamber2and/or the channel system3thus has a top side which corresponds to the top side of the structured component1. A bottom side of the chamber2and/or the channel system3is formed inside the structured component1. The bottom side of the chamber2can also be referred to as a chamber bottom7. The interior of the chamber2is formed between the top side of the chamber2and the bottom side, wherein the top side and bottom sides can be either the top or bottom side, depending on an orientation.

The chamber2and/or the channel system3can be configured as a recess in the structured component1, for example on the top side or the bottom side of the structured component1. The chamber2and the channel system3can be configured as recesses of different depths, wherein the top side and bottom sides can be either the top or bottom side, depending on an orientation.

The chamber2and/or the channel system3are fluidically connected to the outside via one or more fluidic interfaces5. In other words, the fluidic interface5is an opening of the channel system3e.g. on a side surface of the structured component1. The opening of the fluidic interface5can also be arranged on an upper side or bottom side of the fluidic system. As can be seen inFIG.1a, the structured interface5can protrude as a projection from one side surface of the structured component1. In this case it is possible with the fluidic system to take in fluid directly from a fluid surface, for example fluid located in a container open at the top, by immersing the projection in the fluid and moving the flexible and/or movable part.

The fluidic system may have a plurality of fluidic interfaces5, each of which is connected to the channel system3. The fluidic interfaces5can be arranged at different surfaces of the structured component1, for example the top side, bottom side or side surfaces, preferably on opposite side surfaces. In other words, the openings of the fluidic interfaces5may point in different directions. They can therefore have different orientations with respect to the center of the structured component1.

A component4seals the channel system3and the chamber2fluid- and optionally gas-tight, so that the supply and discharge of fluids and gases can only take place via the one or more fluidic interfaces5. In other words, the component4is arranged at the surface of the structured component1in such a way that it closes the chamber2and the channel system3on the upper side of the structured component1. Component4can, for example, be glued, bonded, pressed, or welded to structured component1or sealed using sealing elements such as sealing soft components. Component4thus serves as a lid to seal the structured component1.

In other words, at the top side of the chamber2, the interior of the chamber2is bounded by the bottom side of the component4. Component4can be essentially made of a transparent material to observe the course of the fluids in the channel system3and/or in the chamber2.

Chamber2can have an essentially flat oval, rectangular or round shape. Thus, chamber2and/or the interior or volume of chamber2is defined by the structured component1on the one hand and by component4on the other hand.

Either the whole component4is flexible or the component4has a flexible or movable portion6. As shown inFIG.1b, the flexible portion6of the component4is located above the chamber2as a direct part of the component4. Alternatively, the flexible or movable portion6can be configured as an additional part of the fluidic system. The flexible and/or movable portion6of the component4should be arranged at least at one portion of the chamber2and/or the outside of the chamber2.

Component4can be for example a foil or strip and can be made of plastic or metal.

Alternative embodiments of the fluidic system are shown inFIG.2andFIG.3. In accordance with the alternative embodiment shown inFIG.2, the structured component1has a flexible portion7below the chamber2. In other words, the flexible portion7is located between the chamber bottom and the bottom side of the structured component1. The flexible portion7can be realized either by mounting or attaching the component for the flexible portion7in or on the structured component1. The flexible portion7can also be implemented as a partial material property of the structured component1itself or by manufacturing it from more than one material, e.g. by multi-component injection molding.

Another alternative embodiment is shown inFIG.3. According to the further alternative embodiment, the structured component1is closed with the component4and furthermore with a further component8, wherein one or both of the components4and8can have a flexible or movable portion9. In other words, the component4is arranged on the top side of the structured component1. This means that the upper side of the chamber2is closed with the component4. On the bottom side of the structured component1the further component8is arranged. This means that the bottom side of the chamber2, i.e. the chamber bottom, is closed with the further component8. As shown inFIG.3, a flexible portion9is provided in the further component8. Again, top side and bottom side can be both top side and bottom side, depending on the orientation.

The structured component1is preferably configured with a cover foil, which has sufficient flexibility for pushing in and lifting above and/or below the chamber2.

Preferably, the chamber2is configured in such a way that the flexible portion(s)6,7,9do not fill the entire chamber2when pushing into the chamber2. In other words, if the flexible portion6,7,9is pressed into the chamber2, the flexible portion will not be flush with the chamber bottom. This means that fluid or gas in the chamber2is not completely discharged from the chamber2by pushing in the flexible portion6,7,9. Furthermore, a tight sealing of the flexible portions6,7,9with the chamber bottom or the adjacent channel systems3is not necessary for the functionality, but the movement of the flexible portions6,7,9causes the movement of the medium.

An exemplary operation of the embodiment shown inFIGS.1A to1Cis described below:

Fluid intake: In order to take fluids/gases into the fluidic system, or more precisely into the chamber2of the fluidic system, the flexible portion6is pushed downwards from the initial position manually and/or by hand, for example with a finger of a user, or by means of an operating device. In other words, the flexible portion6is moved from its initial position into the chamber2by pressure. This means that the flexible portion6is pushed from the top side into the interior of the chamber2. By pushing the flexible portion6into the chamber2, the interior space of the chamber2is reduced. Subsequently, the fluidic interface5is immersed in a fluid. The flexible portion6moves either automatically, due to the material properties of the flexible portion6, partially or completely back to the initial position, or is moved back to the initial position by a movement of the operating device, for example suction or lifting off. In other words, the interior of the chamber2is enlarged again by moving the flexible portion6back to its initial position. By increasing the volume of the interior space, a negative pressure is created in the chamber2and/or in the adjacent channel system3, which is connected to the fluid via the fluidic interface. This means that fluid is drawn into the fluidic system by the under pressure. In other words, a part of the fluid is first drawn into the channel system3by the negative pressure and then, if the negative pressure is sufficiently high, also into the chamber2. Fluid is thus taken into the fluidic system. By adjusting the volume of the interior of the chamber2displaced by pressing down the flexible portion6and/or by returning the flexible portion6to its initial position in a defined manner, the volume of the received fluid and/or the positioning of the fluid in the channel system3and/or in the chamber2of the fluidic system can be adjusted.

Mixing fluids: The received fluid is mixed by first drawing fluid into the chamber2, that means fluid is first taken into the fluidic system. Then either the flexible component6is moved or the fluidic system itself is moved. The fluidic system is moved, for example, by tilting the fluidic system several times. A fast shaking should be avoided to avoid the generation of air bubbles in the received fluid. The movement mixes the fluids in the fluidic system.

Discharge of fluids: Fluids are discharged from the fluidic system by pushing the flexible component6and/or the flexible components into the chamber2. In other words, the volume or the interior of the chamber2, which is bounded by the flexible component, is reduced by pushing the flexible component. The fluid, which is either in the chamber2or in the channel system3, is discharged from the fluidic system according to the volume displaced by the movement of the flexible portion6, i.e. by pressing the flexible portion6into the chamber2. This means that the displaced fluid is discharged from the chamber2via the channel system3through the fluidic interface5. The volume of the fluid discharged may correspond to the volume of the interior of the chamber2by which the chamber2is shrunk by pushing in the flexible portion6. In this case, fluid volumes can be discharged several times. Multiple discharging can be achieved by pushing the flexible portion6,7,9step by step further into the chamber2and/or the interior of the chamber2. Multiple discharging can also be achieved by first pressing the flexible portion6,7,9into the chamber2once and then moving the flexible portion6,7,9out of the chamber2by itself or by moving it out of the chamber2with the aid of an operating device as described above. The outward movement is accompanied by a backflow of at least part of the fluid in the channel system3connected to the chamber2. The outward movement is followed by a repeated push of the flexible portion6,7,9into the chamber2for another fluid discharge. In other words, by repeatedly and alternately pushing into the chamber2and moving out of the chamber2of the flexible portion6,7,9, a pumping movement and/or pumping functionality is performed. This leads to a repeated and alternating fluid intake and fluid discharge.

Closure of the fluidic interface5for sampling: A cap14closes the fluidic interface5for sampling. The cap14may also have integral projections that protrude into the channel system3when the cap is placed on the fluidic interface5. This allows fluid in the channel system3to be displaced and forced into the rest of the channel system3.

Preferably, one fluidic interface5is configured as an inlet5.1of the fluidic system, and another fluidic interface5is configured as an outlet5.2of the fluidic system. The inlet5.1, and the outlet5.2are preferably formed at the structured components1. The two fluidic interfaces5.1and5.2are formed on one side, preferably at an end face or narrow side of the chip (fluidic system). This means that the inlet and the outlet are arranged on one side of the system. This makes it possible to close the inlet and outlet with a cap14, also known as a jumper.

The cap14is preferably attached to the fluidic system, preferably to the structured component1. One or more caps14may be attached.

In a preferred configuration, only one cap14is provided, which can be attached to either the inlet5.1or the outlet5.2. This can then be used to selectively take in fluid at the inlet or discharge fluid at the outlet.

The one or more caps14are attached to the chip (fluidic system) by a flap44.

Addition of fluid: The complete or partial emptying of a fluid reservoir16transports the collected sample through a fluid and allows dilution or addition of reagents.

The flexible portion6can thus be pushed below a plane defined by the top side of the structured component1into the chamber2, or more precisely into the interior of the chamber2, by external pressure due to its flexibility. On the other hand, the flexible portion6can be pulled out of the interior of the chamber2again by pulling from the outside, for example by means of a negative pressure or an attached device. This means that it can be moved beyond the plane defined by the top side of the structured component1.

From these basic functionalities, i.e. the intake of fluid into the fluidic system, the discharge of fluid from the fluidic system and the mixing of fluid in the fluidic system, the following characteristics result for the fluidic system:

The intake, dilution, discharge, dosing and/or transport of fluids is possible. Fluid that has been taken into the fluidic system can be transported and stored using the fluidic system. A multiple intake and multiple discharge of fluids is possible. Mixing of fluids is possible.

The fluidic system can be used as a pipette with functions of fluid intake, fluid discharge and multiple intake and discharge of fluids, due to the configuration of the fluidic system according to the above-described embodiments and by the configuration of the chamber2and the flexible portion6,7,9. The pipette can be operated completely manually without any further aids or by means of an operating device.

FIG.4shows an embodiment of the fluidic interface5. The embodiments of the fluidic interface5according toFIG.4differ in their geometry. More precisely, the embodiments of the fluidic interface5each have an outlet10, wherein the shape of the outlet10differs in the embodiments shown here. By the particular and/or defined geometry of the outlet and/or by a surface modification and/or a material characteristic of the outlet10of the fluidic interface it can be adjusted, at which volume of a drop of the discharged fluid the drop separates from the outlet. By the defined geometry of the outlet10of the fluidic interface5, volumes, i.e. desired volumes, of the fluid drop of the discharged fluid can be pre-set. This means that the geometry of the outlet10of the fluidic interface5is also decisive for the volume of the discharged fluid. In other words, when fluid is to be discharged from the fluidic system, the flexible portion6,7,9is pushed into chamber2so that a drop of fluid forms at the outlet10of the fluidic interface5. The flexible portion6,7,9is pushed further into the chamber2until the drop of fluid separates from outlet10. Then the pushing-in of the flexible portion6,7,9and/or the discharging of fluid can be stopped. Alternatively, the flexible portion6,7,9can be pushed further into the chamber2to create another drop of fluid.

FIGS.5ato5fshow pushing elements of the flexible portions according to different embodiments. The flexible portions6,7,9can have pushing elements11,12,13in order to allow a defined pushing of the flexible portions6,7,9into the chamber2and/or a defined pulling out and/or moving out of the flexible portions6,7,9from the chamber2. In other words, in order to prevent differences due to a person-dependent application of force or finger size when operated manually or by hand, pushing elements11,12,13can be arranged or applied on the flexible portions6,7,9. The pushing elements11,12,13can be used to ensure that by pressing the pushing portion6,7,9into the chamber2the same volume of the interior of the chamber2is always displaced. The pushing elements11,12,13can be operated either manually and/or by hand, for example with a finger, or by an operating device. The pushing elements11,12,13can be materials applied to the flexible portion6. For example, the pushing elements11can be configured as a silicone hemisphere, as shown inFIGS.5aand5b. Alternatively, the pushing elements12can be manufactured directly with a flexible portion8, for example by multi-component injection moulding, as shown inFIGS.5band5c. Alternatively, a defined pushing can also be provided using pushing elements13, which are provided as protruding elements in the structured component, as shown inFIGS.5eand5f. The pushing elements13shown inFIGS.5eand5fare arranged in the chamber2of the fluidic system, for example on the chamber bottom, and protrude into the interior of the chamber2. By means of the pushing elements13, the movement of the flexible portion6can be limited when pushing into the chamber2, so that only a predetermined maximum volume of the interior is displaced.FIGS.5a,5c, and5eeach show the initial state of the flexible portion6,7,9, i.e. the state when no force and/or pressure is applied to the flexible portion6,7,9.FIGS.5b,5dand5feach show a position prior to a fluid intake and/or during fluid discharge, i.e. a position of the flexible portion6,7,9when it is pushed into the chamber2.

FIGS.6aand6bshow further embodiments of the fluidic system, in which two separate fluidic interfaces5are arranged. As shown inFIGS.6aand6b, the fluidic interfaces5are arranged on different, more precisely opposite side surfaces of the structured component1and protrude from the respective side surfaces. Here the fluid intake can be performed by one of the two fluidic interfaces5, and the fluid can be discharged by the other of the two fluidic interfaces5. As shown inFIG.6b, the fluidic interfaces5can also be closed by one or more caps14to prevent contamination or leakage of fluid from the fluidic interface5. Only one cap14is shown inFIG.6b. The cap14allows the fluid received in the fluidic system to be transported and stored particularly safely and easily. In other words, the caps14can be placed on the fluidic interface5, or more precisely, on the openings formed by the fluidic interface5on the respective side surface of the structured component1and seal the fluidic interfaces5fluid-tight.

As shown inFIGS.7aand7b, the fluidic system can include a fluid reservoir16. The fluid reservoir16is connected to the channel system3and/or the chamber2via a channel. The channel can be part of the channel system3. The fluid reservoirs16can, for example, be formed by one or more so-called blisters, i.e. compartments filled with fluid, for example openable by piercing, which are mounted fluid-tight on the fluid system. Fluid intake from the blister is achieved by pressing out the blister itself, i.e. with positive pressure or by pressing down the flexible portion6as described above and moving the flexible portion6out of chamber2, wherein the resulting pressure in the chamber2and the channel system3allows to take in fluid from the fluid reservoir into the channel system3and/or chamber2via the connected channel. A leakage of fluid from the fluidic interface5is prevented by placing a cap14on the fluidic interface, such that further fluid due to the emptying of the fluid reservoir16urges the fluid in the channel system3into the chamber2and the fluid from the fluid reservoir16also flows into the chamber2. In other words, fluid taken into the fluidic system from the outside and located in the channel system3and/or the chamber2can be mixed with the fluid in the fluid reservoir16. Mixing can be facilitated and/or intensified by placing cap14on the fluidic interface, since with cap14on, the negative pressure created by moving the flexible portion6acts on the fluid in the fluid reservoir16. The fluid reservoir16can also be referred to as a reagent reservoir or fluid reagent reservoir, and can contain any type of fluid. In a preferred embodiment, these reagent reservoirs can also contain gases.

The fluids can be mixed by moving the fluidic system, moving the flexible portion6,7,9, or by inserting mixing elements. The mixing elements, for example balls made of silicone, hard plastic balls, metallic components or other particles, can be moved by manual movement of the fluidic system. Alternatively, or additionally, the mixing can be carried out by means of mixing elements made of magnetic materials, which are moved from the outside by a device for mixing.

FIGS.7aand7bshow an embodiment of the fluidic system which combines two types of fluid intake. On the one hand, for example, the sample intake is carried out via the fluidic interface5, which serves as the fluid inlet, by moving the flexible portion6,7,8of the chamber2into the chamber2and moving out the flexible portion as described above. Alternatively, an independent fluid intake into the fluidic system can be carried out via passive filling, i.e. by means of capillary forces or special surface properties of the channel system at the fluidic interface5. The suction effect caused by the negative pressure and/or the capillary forces, and thus the filling speed, can be increased and/or accelerated by a surface modification, for example hydrophilization of the channel surface of the channel system3.

Furthermore, the volume of the received fluid can be determined by means of passive valves in channel system3, for example capillary stop valves and channel tapers41, seeFIG.7a, of channel system3. A defined quantity of fluid is thus taken in, wherein a sealing cap14prevents the fluid from escaping when the fluid reservoir16is emptied.

FIGS.8ato8eshow an ejection mechanism for the fluid reservoir16according to an embodiment. For example, the ejection mechanism may be formed as a flap19, wherein the latching of the flap19, as shown inFIG.8d, causes the insertion of a defined amount of fluid from the fluid reservoir16into the channel system3of the fluidic system, thereby achieving a defined mixing ratio of the fluid from the fluid reservoir with the fluid (sample) received in the fluidic system.FIG.8dshows a state in which the flap19presses the fluid reservoir16(blister) onto the fluidic interface5of the channel of the channel system3. This principle can be extended to further fluid reservoirs16and can therefore be used for multiple mixtures.

FIG.8ashows an ejection mechanism with a seat17, which can be configured as a blister seat and has piercing elements18, for example small tips. The piercing elements18are only shown inFIG.8a.

FIG.8bshows an embodiment of an ejection mechanism, wherein the seat17has latching lugs20and the flap19is mounted in a hinge-like manner on the latching lugs20of the seat17. As shown inFIG.8b, the fluid reservoir16is arranged at the flap19. The ejection mechanism shown inFIG.8bmay also have a piercing18(not shown). One of the latching lugs20serves as hinge and another one of the latching lugs20serves as latching surface and/or seating surface for the flap19in order to limit a rotation of the flap19. This means that when the flap19is closed, the fluid reservoir16is pierced and the fluid from the fluid reservoir can be introduced into the channel system3of the fluidic system. By limiting the rotation of the flap19by the latching lugs20, a defined and/or predetermined amount of fluid can be discharged from the fluid reservoir to the fluidic system. The seat17can also be referred to as reservoir interface.

FIG.8cshows an embodiment of the ejection mechanism in which the fluid reservoir16is located on the surface of the structured component1. In this case, the flap19may have a bulge and/or projection as shown inFIG.8d, so that the fluid reservoir16is squeezed by the projection when the flap19is closed.FIG.8dshows the closed ejection mechanism, in this case the flap19.

FIG.8eis a top view of an ejection mechanism with seat17according to an embodiment.

FIGS.9aand9bshow a fluidic system with a long channel system3. As shown inFIGS.9aand9b, the channel system3meanders between the fluidic interface5and the chamber2, increasing the length of the channel system3. This creates a dwell distance for the fluid received in the fluidic system. The dwell distance can be filled with reagents such as dried reagents. This allows a long channel system3to be formed. The channel system3can also have widenings22for better mixing, as shown inFIG.9a, or another passive mixing element. As shown, the widenings can be formed elongated and/or in the direction of flow in the channel system3. Fluid and/or reagents can be introduced into the widenings22which is/are mixed with fluid taken into the channel system3and/or the fluidic system and/or discharged from the fluidic system. The channel system3may also have an optical detection chamber or reaction chamber22,21as shown inFIG.9b. A particular advantage is the configuration of the detection chamber21in different depths in order to extend the dynamic range of the measurement. In other words, the detection chamber21can be embedded to different depths in the structured component1, so that, for example, it has step-like detection chamber bottoms of different depths.

A further option for extending the chamber functionality is the insertion of a lateral flow strip23, as shown inFIGS.10ato10c, which can be filled in a defined manner using the pump function of the fluidic system and/or fills itself after wetting with fluid via capillary forces. Thus, a combination of filling by the pumping action of the chamber2in manual operation as described above and/or by means of an operating device and the suction action of the lateral flow strip can also be carried out. As shown inFIGS.10ato10c, the lateral flow strip is inserted and/or embedded into another chamber, which is also connected to the channel system3. The use of ventilation channels25or gas-permeable and fluid-tight membranes24, each connected to the channel system3and/or the chamber of the lateral flow strip, to operate the system is particularly advantageous. This is shown, for example, for the gas-permeable and fluid-tight membranes24inFIG.10band for the ventilation channels25inFIG.10c.

FIG.11shows a fluidic system according to a yet further embodiment. As shown inFIG.11, the structured component1has two chambers2which are embedded in the upper side of the structured component. The two chambers2are directly connected to each other via a first channel system3aand/or a channel3a. The two chambers2are also each connected to a fluidic interface5via a respective second channel system3band/or channel3b. This embodiment of the fluidic system can also be referred to as a combined chamber system. The use of combined chamber systems, which can then be used simultaneously as mixing, reaction, pump and/or dosing units, is a further embodiment of the fluidic system.

FIGS.12ato12dshow embodiments of the fluidic system with distribution systems26. As shown inFIGS.12ato12d, a chamber2is connected at one end to a distribution system26. Distribution system26can be part of the channel system3. The distribution system26has one or more channels leading away from the chamber2and branching from each other. The ends of the respective branched channels of the distribution system26are each connected to a fluidic interface5. As shown in the embodiments of the fluidic system ofFIGS.12ato12d, a respective channel leads away from the chamber2and branches into four channels, each of which is connected to a respective fluidic interface. By moving the flexible portion6,7,9and the associated change of the chamber volume, the distribution systems allow a simultaneous or successive fluid intake and/or fluid discharge.

FIGS.12aand12bshow a fluidic system including a distribution system26, wherein the channel leading away from the chamber2branches step by step, namely first into two further channels. The two further channels then branch into two further channels, so that the channel leading away from the chamber2branches into a total of four channels, which lead into the respective multiple fluidic interfaces5. InFIG.12aall fluidic interfaces5are simultaneously controlled by a movement of the flexible portion6,7,9.

As shown inFIG.12b, the branched channels of the distribution system26can have membrane valves27. The use of membrane valves27requires the membrane valves27to be pressed in and the membrane valves27to be sealed fluid-tight in order to close the respective channels individually or together and thus to be able to implement the fluid intake and/or fluid discharge via the fluidic interfaces5. In other words, the membrane valves27can be used to control the flow of fluid within the respective channels in a targeted and defined manner. This means that the individual fluidic interfaces5can be systematically controlled by means of the membrane valves27. This means that they can be controlled independently of each other. The membrane valves27can be brought or controlled in a state which does not allow any fluid flow in the respective channel, a state which allows an approximately undisturbed fluid flow in the respective channel and/or a state which allows a reduced fluid flow in the respective channel. Thus, a defined and/or simultaneous fluid intake and/or fluid discharge can be systematically controlled via the respective fluidic interfaces5.

FIGS.12cand12dshow an embodiment of the fluidic system including a distribution system26, in which the channel leading away from the chamber2branches at one point in a star shape into four further channels. As shown inFIG.12c, a rotary valve28can be arranged at the branching point, which can be operated from the outside either manually or by means of a device. With the help of the rotary valve28, a defined fluid flow can thus be connected between the channel leading away from the chamber2and one or more channels connected to the branched channels, i.e. to the fluidic interfaces5. The body of the rotary valve28may itself have one or more embedded channels29which, when positioned on the point of branching which may form the seat28aof the rotary valve28, connect the branched and/or connected channels. Depending on the configuration of a distribution channel29integrated in the rotary valve body28b, the option with a rotary valve28permits sequential or parallel fluid intake and/or fluid discharge via one or more fluidic interfaces5, which in turn is controlled by changing the chamber volume. It is also possible to combine one or more membrane valves27and/or rotary valves28in one fluidic system. This means that the individual fluidic interfaces5can also be systematically controlled by means of the rotary valves28. This means that they can be controlled independently from one another.

In general, the following applies to the fluidic system according to the present invention: all processes described for the use of fluids are equivalent to gases and a combination of fluid and gaseous substances is also possible with this fluidic system, for example the systematic supply of gases to fluids.

A further embodiment form is shown inFIG.13. Here, the structured component1has a flexible portion7below the chamber2, which is realized either by the application of another component into the structured component1or directly by the material property of the structured component1itself or by the manufacturing from more than one material, for example by multi-component injection moulding.

A further embodiment is shown inFIGS.14aand14bas a plan view and as a section view, respectively, wherein at a defined position above or below the chamber2and/or the channel system3a magnification function component42is provided in the structured component1, which is configured for example in the form of a lens in order to be able to better follow the reaching of certain positions in the channel system3by the fluid and also to be able to better read colour reactions as indicator reactions.

A further embodiment is shown inFIGS.15ato15c, wherein longer channel elements are provided in the fluid flow in the channel system3as flow limiters43, in order to enable controlled fluid intake and discharge. The flow limiters43are formed in a meander shape and/or are configured as channel tapering to control the flow of a fluid and/or limit the velocity.

As shown inFIGS.6ato7bandFIGS.9aand15c, according to all of these embodiments the chamber2can be connected to several channels and/or the channel systems3, each of which leads to at least one fluidic interface5. The fluidic system can therefore have a plurality of fluidic interfaces5and the chamber2can have several outgoing channels and/or channel systems3.

FIG.16shows an embodiment of the fluidic system (chip) in a view from above. It shows the structured component1with a chamber2and the channel system3. The channel system3connects the inlet5.1, with the chamber2and connects the chamber with the outlet5.2.

A flow restrictor43is integrated in the channel system3upstream of chamber2, which is meander-shaped and/or can include channel tapers41(not shown here), with which the flow velocity of the fluid can be controlled and/or reduced. A reservoir interface17with a fluid reservoir is connected to the channel system3.

The inlet5.1and the outlet5.2can be closed with a cap14, which is attached to the chip by a flap44. Preferably, only one cap14is provided, which can be fitted alternately on the inlet5.1or the outlet5.2to selectively enable the chip to receive fluids when the inlet5.1is open, i.e. without the cap14, and the outlet5.2is closed with a cap14. Thus, a required negative pressure can be built up to take in a fluid via the fluidic interface5.1(inlet). After the intake and corresponding analysis in the chip, the fluid should be discharged again. To this end, the cap14is placed on the inlet5.1and the inlet5.1is sealed fluid-tight. The fluid can then be discharged via the outlet5.2. Thus, the cap14can be used to switch between two functions of the chip.

In a further configuration, it is possible to attach several caps14to the chip, for example to allow the chip to be transported or stored, wherein either the inside of the chip is protected from contamination and/or leakage of fluids present inside is prevented.

A fluidic system is provided, comprising a structured component1having a chamber2and a channel system3, wherein at least the chamber2is closed in a fluid-tight manner by a component4and is fluidically connected to the outside via the channel system3and a fluidic interface5, wherein the component4has a flexible or movable portion6which can be moved at least into a portion of the chamber2or beyond a plane of the chamber2, wherein by a movement of the flexible or movable portion6fluids or gases can be taken in or discharged through the fluidic interface5and/or moved in the fluidic system, and wherein the flexible or movable portion6is movable by hand or with an operating device, and a pushing or an elevating of the flexible or movable portion6is possible.

A fluidic system is provided, comprising a flat structured component1with a chamber2and a channel system3, wherein at least the chamber2is closed fluid-tightly with at least one component4, wherein the chamber2is fluidically connected to the outside via a channel system3and at least one fluidic interface5, wherein the component4and/or the structured component1has a flexible or movable portion6, which at least partially adjoins the chamber2, wherein the flexible or movable portion6is configured to be pressed into or moved out of the chamber2manually or with an operating device so that fluids or gases are taken into or discharged via the at least one fluidic interface5and/or moved in the fluidic system.

A fluidic system may comprise a structured component1having a chamber2and a channel system3, wherein the chamber2and the channel system3are closed in a fluid-tight manner by a component4, wherein the chamber2is fluidically connected to the outside via the channel system3and the fluidic interface5, and wherein the structured component1has a flexible or movable portion6forming side walls of said chamber2.

A fluidic system may comprise a structured component1having a chamber2and a channel system3, a component4which closes the chamber2and the channel system3in a fluid-tight manner, wherein the chamber2is connected to the outside via the channel system3and a fluidic interface5, and wherein the structured component1is configured such that a bottom of the chamber7is flexibly configured and pressable.

Preferably, the flexible or movable portion6is formed on at least one side wall of the chamber2within the structured component1.

In these embodiments of the fluidic system, the chamber2can be connected to another fluidic interface5, preferably via a further channel system3. Preferably at least one of the fluidic interfaces5can be closed with a cap14.

The fluidic system may further comprise a venting device for the chamber2, wherein the venting device is arranged such that venting can take place via an additional channel25connected to the outside or a gas-permeable membrane24.

The fluidic system may further comprise an inlet channel which has a passive stopping function and is filled either by capillary action or by a change in the chamber volume caused by the flexible or movable components and takes in a defined quantity of fluid.

The fluidic system may also include an additional reagent reservoir16. The additional reagent reservoir can be configured as a blister16.

The reagent reservoir16may include a blister seat17having piercing elements18adapted to pierce the blister16fluid-tightly connected above the piercing elements18, a flap19, which is pushable in a defined manner using guide elements20in the blister seat17, wherein a defined volume dosage is possible.

Preferably, a channel3leading to the chamber2can have widenings or expansions22.

Preferably, a cavity or detection chamber21for optical readout and/or reaction observation can be connected to the channel system3, preferably having different depths. The outwardly facing surface of the cavity can be transparent to allow a reaction of the fluid by the incident light and/or an optical readout of the reaction or constituents present in the detection chamber21.

The component4and/or the structured component1can be transparent at least in some areas. This allows observation of the movement of the fluid within the channel system3. Depending on the analyses to be performed, the component4and/or the structured component1can also be opaque at least in some areas to prevent a reaction of the fluid with the incident light.

Preferably, the fluidic system may have a lateral flow strip23, the filling of which is made possible by an operation of the chamber2, wherein a venting membrane24and/or a venting channel25is connected to the lateral flow strip23.

Preferably, the fluidic system can have at least two chambers2, wherein the at least two chambers2are directly connected to each other via a channel system3a.

Preferably, the fluidic system may have attachments11,12,13on the flexible or movable component6, which are either located outside the chamber2or extend into the chamber2.

Preferably, the chamber2may contain reagents.

Preferably, the fluidic system may include movable elements introduced into the chamber2for mixing. Preferably, mixing of fluids takes place within the chamber2by a manual movement of the fluidic system and/or by a mixing device.

The channel system3may have alignment marks, which are arranged next to, below or above the channel system3, and which enable a volume indication.

With the fluidic system it is possible to perform multiple fluid intake and/or fluid discharge.

Preferably, there may be several fluidic interfaces5pointing in different directions or arranged on different sides of the fluidic system or leaving the fluidic system at a predetermined angle.

Preferably, the fluidic system may have a rotary valve28, which can be used to control the intake and/or discharge of fluids.

Preferably, the fluidic system may have one or more membrane valves27connected to the channel system3, with which the intake and/or discharge of fluids can be controlled.

The fluidic system may preferably have a passive stop function, which is configured as a capillary stop valve, a channel tapering and/or a surface modification.

Preferably, the reagent reservoir16may have guide elements20, which allow multi-stage volume dosing.

Preferably, the fluidic system may have a cap as a fluid-tight seal of the fluidic interface5.

Preferably, the cap14may have a flexible portion that is configured to be pushed in or pulled out after it is placed on the fluidic interface, thereby moving the fluid in the channel system3.

Preferably, the gas-permeable membrane and/or the venting device is configured to be closeable.

Preferably, the at least two chambers2are arranged in one and/or several planes.

The movable mixing elements are preferably configured as balls or rods.

Preferably, the fluidic system includes structural elements in the chamber2and/or in the channel system3to enhance mixing.

Preferably, the fluidic interface5has an outlet10, wherein the volume of a discharged fluid drop is determined by means of a geometry of the outlet10.

The fluidic system may have a plurality of fluidic interfaces5, which are connected to a distribution system26in the structured component1, wherein the plurality of fluidic interfaces5can be selectively controlled.

Preferably, the channel system3and/or the fluidic interface5is configured in such a way that an autonomous fluid intake into the fluidic system takes place by means of the capillary forces of the channel system3at the fluidic interface5.

Preferably, the fluidic system may have an inlet5.1and an outlet5.2located on one side of the system, with a cap14attached to the fluidic system, preferably to the structured component1, which can be fitted to either the inlet5.1or the outlet5.2to allow a fluid to be taken in at the inlet5.1or discharged at the outlet5.2.

Preferably, the fluidic system may have a reservoir interface17, by means of which a fluid reservoir16can be connected to the structured component1. The reservoir interface17can be fluidically connected to the channel system3and/or to the chamber2.

The channel system3can have valves, which allow the intake of defined volumes of fluid. The valve function can be created and/or enhanced by surface functionalization.

Dry reagents are preferably arranged or stored in the channel system3, wherein the dry reagents are taken in by the flowing fluids and mixed with them.

Preferably, a reagent is placed at a defined position in or on the channel system3and colors fluid flowing over it, so that reaching a position and thus reaching a certain volume or a defined dwell time is indicated.

Preferably, a magnifying device is arranged at at least one defined position above or below the channel system3or the chamber2so that reaching at least one defined position in the channel system3can be detected by fluid and/or by a color reaction. The magnifying device can be configured as a lens.

The fluidic system may preferably have extended channel elements as flow limiters43, which are inserted into the fluid flow of the channel system3to enable controlled fluid intake and discharge.

The reservoir interface17can include a flap19to allow defined volumes to be extracted from the blister16.

Preferably, geometric elements or attachments11,12,13are provided to enable a defined movement of the flexible portion6,7,9.

The flap19and the geometric elements or attachments11,12configured as pressure elements are preferably connected, combined and/or coupled with each other on the flexible or movable portion6,7,9.

A multi-channel distribution system26may be provided, which opens into a corresponding number of fluidic interfaces5to allow simultaneous intake and discharge of fluids.

Equal distribution of fluids in the distribution system26can be supported by integrated passive valves27.

The channel system3and/or the distribution system26connected thereto may have one or more valves27,28to allow a defined fluid delivery from individual fluid interfaces5.

The fluidic interface5can passively absorb fluid without moving the flexible or movable portion6,7,9.

The above-mentioned embodiments can have one or more functional elements. This results in the following embodiments:additional functional elements such as filters, membranes, frits, paper or similar elements, functional elements such as filters, membranes, frits, paper or similar elements which are provided with reactants, orby certain reagents applied to the structured component or the sealing component4, in particular in the form of arrays of identical or different agents, or by any combination of the embodiments mentioned under a-c.

The one or more functional elements45such as filters, membranes, frits, paper or similar elements are located in or on the structured component.

These functional elements45can be attached in such a way that they are flooded vertically (FIG.17a) or horizontally (FIG.17c) by the penetration of fluids or gases.

FIG.17includesFIGS.17a,17band17c, in which a fluidic system is shown in a sectional view. The fluidic system has two fluidic interfaces5.1and5.2, which are also called fluidic inlet or fluidic outlet. The fluidic system has a structured component1with a chamber2and a channel system3. The channel system3can run on the bottom and/or top side of the structured component1, wherein the channel sections on the bottom and/or top side of the structured component1are connected to each other by means of drill holes or openings. In this embodiment, the structured component1is covered by two components4on the bottom and on the top side. In addition to chamber2, the structured component1has a reaction cavity or cavity47in which a functional element45, in particular a membrane45, is inserted, which is arranged in such a way that a fluid that is introduced into the channel system3from the inlet5.1can pass through the membrane45. A cavity47is provided above the membrane45. After passing through the membrane45, the fluid enters chamber2, which can create a vacuum by actuating the flexible portion6to suck in the fluid, move it through the membrane45, and discharge it through the outlet5.2.FIG.17ashows a vertical flow through membrane45or functional element45in only one direction (flow direction46).

FIG.17b, on the other hand, indicates that, by actuating the flexible portion6, fluid in channel system3can also flow back vertically through functional element45, in particular membrane45, from bottom to top, i.e. in the opposite direction to the flow direction46as shown inFIG.17a.

FIG.17cshows an embodiment in which the fluid flows through the membrane45horizontally.

FIG.17dshows a variant in which the fluid flows through the functional element45both horizontally and vertically. In this embodiment, two parallel channel lines3are provided.

The flow can be in one direction only (FIG.17a) or from one direction and then from the opposite direction (FIG.17b). A combination of vertical and horizontal flow is also possible (FIG.17d).

The flow can be active or passive. A pressure or a vacuum can be applied. However, a passive exchange via concentration gradients or interactions between the areas separated by the functional element45is also possible. A cavity47can be located above the functional element45, which is part of the channel system3, wherein the functional element45is fluidically connected to the channel system3.

Furthermore, this invention comprises a combination of several of these functional elements on the thumb pump.

The thumb pump experiences a further extension of its function if, according to the invention, reactants are applied in or on the functional elements, such as a filter, a membrane, frits, a paper or similar elements, in order to react with the medium or fluid flowing through it and/or with the components or fluid on one or another side of the chamber.

A time-delayed resuspension of reagents is particularly advantageous if the functional element is intended to first retain particles/components and then to react with the reagents.

According to the invention, reagents can be applied to the structured component1or the at least one component4(lid, bottom), wherein in a particularly preferred variant these reagents are provided as an arrangement or array48. An array can be formed by the same or different reagents, e.g., DNA molecules, antibodies, apatmers, etc., as a capture molecule; this can be a DANN or protein array.

The area of the applied reagents is called the reaction space and can thus be part of the channel system3and/or an expansion (reaction cavity, cavity47) or recess of the channel system.

Alternatively or additionally, these reagents can also be applied to one or more functional elements45, such as filter, membrane, frit, paper or similar elements (FIG.18c).

This allows the use of the thumb pump e.g. for biological detection reactions, wherein the functionality of the thumb pump can be extended by fluid reservoirs16applied to the thumb pump.

FIG.18ashows an embodiment in which an array48with reagents is arranged in the reaction cavity47. This array48with reagents is flown through by the fluid according to the flow direction46in the channel system3from left to right or from the inlet interface5.1to the outlet interface5.2.FIG.18ashows only one component4, which covers the structured component1from above.

FIG.18bshows a top view of the reaction cavity47with the array48arranged in the reaction cavity47and the reaction cavity47connected to the channel system3and through which the fluid flows.

FIG.18cshows a structured component1, which is covered with a component4on the top side and bottom side of the structured component1, since the channel system3is located on both sides of the structured component1, respectively on the top side and bottom side.

FIG.18cshows an arrangement in which a functional element45, here in particular a membrane45, is provided with an array48of reagents, for example in the form of an array of catcher molecules, which are arranged in a reaction cavity47, wherein the fluid flows in the flow direction46in the channel system3from the inlet interface5.1to the outlet interface5.2via the chamber2when the flexible portion6is actuated.

A preferred embodiment is shown inFIG.19, where the fluid is first taken in via the fluidic interface, inlet5.1, then passed through the functional element (filter/membrane/frit/paper or similar element), enters the chamber2of the thumb pump and then, when pressurized, can be passed through another functional element45and discharged via the outlet5.2. For this purpose, preferably the fluidic interface5.1serving as an inlet is closed with a cap14after the fluid has been absorbed.

FIG.19ashows an embodiment of a fluidic system in which two functional elements45in the form of a filter, a membrane, a frit or a functional paper are connected in front of and behind the chamber2. The functional elements45can be similar or different, i.e. the functional element45in front of the chamber2can be configured as a filter, whereas the functional element45behind the chamber2or between the chamber2and the outlet5.2of the fluidic system is configured as a filter45, membrane45or frit45or functional paper45, which, for example, allow fluids with a different particle size to pass through. In the side view shown inFIG.19b, the structured component1is covered on its top side and bottom side with a component4each to cover and seal the channel system3on the top side and bottom side. The reaction cavity47is located upstream of the chamber2, where a first functional component45is located. A second reaction cavity47is located downstream of the chamber2and is provided with a further functional component45. InFIG.19c, the inlet5.1, is closed with the cap14, in order to selectively discharge the fluid only at the outlet5.2when pressure is applied to the chamber2.

Another embodiment is shown inFIG.20, where two functional elements45are arranged, wherein a first functional element45is located between the inlet5.1and the chamber2and a channel3leads from the first functional element45to the second functional element45without passing through the chamber2. In this embodiment, the fluid is first taken in via the fluidic interface (inlet5.1), then passed through the first functional element45(filter/membrane/frit/paper or similar element), then, when pressure is applied to the thumb pump, passed through a further functional element45and finally discharged via a further fluidic interface (5.2, outlet) by applying pressure to the chamber2. For this purpose, the fluidic interface (5.1) serving as inlet is preferably closed with a cap (14) or otherwise after the fluid has been received.

In contrast toFIG.19a,FIG.20aalso shows two functional elements45. However, the second functional element45is not directly connected to the chamber2before the outlet5.2. The first upstream functional element45after the inlet5.1is coupled to the chamber2so that a flow direction in the first functional element45can be specified by a negative or positive pressure in the chamber2when the flexible portion6is actuated. In addition to the flow through the first functional element45, the fluid3in the parallel channel string is guided past the chamber2directly to the second functional element45.FIG.20cthen shows how to close the inlet5.1with a cap in order to cause a flow through the first functional element45through the parallel channel string to the second functional element45when the flexible portion6of the chamber2is actuated, in order to discharge the fluid via the outlet5.2.

FIG.21shows a further embodiment, in which the fluid is first taken in via the fluidic interface (inlet5.1), then passed through the first functional element45(filter/membrane/frit/paper or similar element) and then into the chamber2of the thumb pump. By discharging fluid from a fluid reservoir16e.g. in the form of a blister, fluid is added to the fluid. A mixture of fluid and added fluid can be achieved either by adding the fluid itself or by moving the thumb pump or the flexible portion6, and can be guided through another functional element45by pressurization, and the diluted fluid or the fluid mixed with the added fluid is discharged via the outlet5.2by pressurization of the chamber2. For this purpose, preferably the inlet5.1is closed with a cap14after the fluid has been absorbed.

FIG.21ashows an alternative embodiment of the fluidic system in which the first functional element45is directly connected to a fluid reservoir16and where the fluid in the functional element45can be diluted by adding fluid from the fluid reservoir16. Here, for example, a fluid can first be taken in in the inlet5.1by actuating the flexible portion6at the chamber2and passed through the first functional element45, wherein, for example, certain particles can be deposited.

FIG.21bshows the sectional view of this embodiment, whereinFIG.21cshows that the inlet5.1is provided with a cap14in order to add fluid from the fluid reservoir16, wherein, after actuating the fluid reservoir16and releasing the fluid by pressurizing the flexible portion6of chamber2, the fluid is diluted in the first functional element45or in the second functional element45between chamber2and outlet5.2.

FIG.22shows a further embodiment, in which the fluid is first taken in via the fluidic interface (inlet5.1), then passed through the first functional element45(filter/membrane/frit/paper or similar element) and then into the chamber2of the thumb pump.

By discharging fluid from a fluid reservoir16, e.g. in the form of a blister, fluid is added to the fluid that has already passed through the functional element45. The addition of fluid from the blister16is only carried out after passing through the functional element45, i.e. a mixture of fluid and added fluid is achieved after processing the fluid in the functional element45. This mixing can be achieved either by adding the fluid itself and/or by moving the thumb pump or the flexible portion6. The mixed fluid can then be passed through another functional element45by pressurization and discharged via the further fluidic interface (5.2, outlet) by pressurizing the chamber2. For this purpose, preferably the fluidic interface5.1serving as inlet is closed with a cap14after the fluid has been taken in. This means that when the fluid is added from blister16, the5.1, inlet is closed.

FIG.23shows another example where the outlet5.2is closed by a cap14. This means that when pressure is applied to the flexible portion6of chamber2, a fluid is taken in via the inlet5.1and passed through the functional element45and then enters chamber2. Chamber2is coupled to a venting membrane24to vent any air remaining in the system. Afterwards, the inlet5.1is closed with a cap (FIG.23c) and fluid is discharged from one of the fluid reservoirs16, flushing the functional element45in front of chamber2with the fluid from the one fluid reservoir16. In this way, components can be removed from the functional element45or a reaction can be triggered at the functional element45by the fluid. The supplied fluid then collects in the chamber2which can be vented via the venting membrane24.

FIG.23shows that the fluidic interface5.2serving as outlet is closed at the beginning, e.g. with a cap14and the fluid is taken in via the fluidic interface (inlet5.1), then passed through the functional element (filter/membrane/frit/paper or similar element) and enters the chamber2of the thumb pump. After the fluid has been taken in, the inlet5.1is closed, preferably by a cap14. By discharging fluid from a fluid reservoir16, e.g. in the form of a blister, the functional element45is flooded and thus components are removed or a reaction with components located on the functional element45takes place, e.g. antibodies for binding the antigens of a sample, reagents that cause cells to lyse, salts that change the properties of the sample or dyes for visualizations etc. The added fluid collects in the chamber2, which is vented via a venting membrane24. By completely filling chamber2, it can also be ensured that, before flushing the functional element45with a fluid that dissolves the target components, these components reach outlet5.2, from which the cap14was previously removed. In this case, the fluid is discharged through outlet5.2by the fluid flow generated by the fluid reservoir16.

FIG.24shows, similar toFIG.23, another embodiment of the fluidic system, in which the chamber2is connected to the outside via another fluidic interface5, wherein the chamber2can be vented via this interface5. If this additional interface5is closed by a cap14not shown, the cap can be removed from the outlet5.2, which allows the fluid from the functional element45and the dissolved components to be flushed out by further fluid supply from one of the fluid reservoirs16. It is also possible that the cap14remains at the outlet5.2and the fluid is discharged via the other interface5.

A further embodiment is shown inFIG.24, in which the fluidic interface5.2serving as outlet is closed at the beginning, for example with a cap14and the fluid is taken in via the fluidic interface, the inlet5.1, then passed through the functional element45(filter/membrane/frit/paper or similar element) and enters chamber2of the thumb pump. After taking up the fluid, the inlet5.1is closed, preferably by a cap14. By discharging the fluid from a fluid reservoir16, e.g. in the form of a blister, the functional element45is flooded and thus components are removed or a reaction with components located on the functional element45takes place, e.g. antibodies for binding the antigens of a sample, reagents that cause lysing of cells, salts that change the properties of the sample or dyes for visualizations, etc. The fluid to be supplied collects in the chamber2, which is aerated via a fluidic interface5. If this fluidic interface is closed e.g. by a cap14and the cap14is removed at outlet5.2, the fluid and components separated from the functional element45are flushed out by supplying fluid from one of the fluid reservoirs16.

A further embodiment is shown inFIG.25, in which the fluidic interface5.2serving as outlet is closed at the beginning, for example with a cap14and the fluid is taken in via the fluidic interface, the inlet5.1, then passed through the functional element45(filter/membrane/frit/paper or similar element) and enters chamber2of the thumb pump. After the fluid has been taken in, the inlet5.1is closed, preferably by a cap14. By discharging fluid from one of the fluid reservoirs16, e.g. in the form of a blister, the reaction chamber47and the functional element45are flooded and thus components are removed or a reaction with components on the functional element45, e.g. the lysis of cells, takes place. The supplied fluid and components dissolved from the functional element45collect in the chamber2, which is aerated via another fluidic interface5. If this further fluidic interface is closed e.g. by a cap14and the cap14is removed from the outlet5.2, the fluid and components separated from the functional element45are flushed out by the fluid supply from one of the fluid reservoirs16.

FIGS.25a,25band25cshow a further configuration of the fluidic system, in which two functional elements45are provided and three fluid reservoirs16, each of which can discharge a fluid and supply it to the first functional element45or the channel system3. Chamber2is further connected to another interface5, which either serves to ventilate chamber2, so that chamber2can fill completely with fluid and a good mixing of the fluids and the fluid from the fluid reservoirs16can take place there. On the other hand, the additional interface5can also be used as an alternative outlet. If this alternative outlet5is closed, the diluted fluid can also be discharged via the second functional element45via outlet5.2.

FIGS.26a, bshow an alternative embodiment of the fluidic system, where the fluid from the fluidic interface, inlet5.1, flows through the first functional element45in the flow direction and the fluid is then forced by capillary forces, surface forces, etc. or actuating the flexible portion6to come into contact with the lateral flow strip23, and the lateral flow strip23is flooded with the fluid by its intrinsic suction forces or an under pressure applied via the fluidic interface configured as a gas-permeable membrane24, which supports the transfer of the fluid to the lateral flow strip23. When using the flexible portion6to further transfer the fluid to the lateral flow strip23, the inlet5.1is preferably closed with a cap.

FIGS.27a, bshow an alternative embodiment of the fluidic system, in which the fluid from the fluidic interface5.1flows through the first functional element45in the flow direction, the fluid then passes through a further functional element45and the fluid is then forced by capillary forces, surface forces, etc. or actuating the flexible portion6to come into contact with the lateral flow strip23, and the lateral flow strip23is flooded with the fluid by its intrinsic suction forces or an under pressure applied via the fluidic interface configured as a gas-permeable membrane24, which supports the transfer of the fluid to the lateral flow strip. If the flexible portion6is used to further transfer the fluid to the lateral flow strip23, the inlet5.1is preferably closed with a cap.

FIGS.28a-28cshow an alternative embodiment of the fluidic system, in which the fluid from the fluidic interface, inlet,5.1flows through the first functional element45in the flow direction, the fluid then passes through a further functional element45and the fluid is then forced by capillary forces, surface forces, etc. or actuation of the flexible portion6to come into contact with the lateral flow strip23and the lateral flow strip23is flooded with the fluid by its intrinsic suction forces or an under pressure applied via the fluidic interface configured as a gas-permeable membrane24, which further supports the transfer of the fluid to the lateral flow strip. If the flexible portion6is used to further transfer the fluid to the lateral flow strip23, the inlet5.1is preferably closed with a cap. A channel which opens at any position before or after the functional element45but before the lateral flow strip23or in the area of the lateral flow strip23, and which is connected to one or more fluid reservoirs16, allows for fluid transfer, dilution and reagent supply. In addition, a waste reservoir49can hold used reagents, preferably connected to the channel system3at the end of the lateral flow strip23.

LIST OF REFERENCE NUMERALS

1structured module/structured component2chamber3channel system/channel3.1parts of the cannel system leading from the reagent reservoir4component5fluidic interface5.1inlet5.2outlet6flexible or movable portion (on component4)7flexible or movable portion (on structured component1)8second component9flexible or movable portion (on second component8)10outlet (of the fluidic interface5)11,12,13pushing elements, geometric elements, attachments14cap16fluid reservoir, blister17seat/reservoir interface18piercing elements19flap20latching lugs21detection chamber22widening23lateral flow strip24venting membrane (gas-permeable, fluid-impermeable membrane)25ventilation channels26distribution system27membrane valve28rotary valve28arotary valve seat28brotary valve body29distribution channel41capillary stop valves/channel tapers42magnifying device43flow limiter44flap45functional element (filter, membrane, frit, paper or similar elements)46flow direction47cavity/reaction cavity (part of the channel system)48reagent array, integrated reagents (e.g. DNA, RNA, protein arrays)49waste reservoir (part of the waste system)