Products and manufacturing methods for providing membrane elements

Abstract

The present invention relates to an article for providing a membrane element, the membrane element comprising a carrier film and a membrane film, the membrane film including at least a support layer and a membrane layer, the membrane film being releasably bonded to the carrier film, the membrane film having a plurality of substantially separate membrane elements. The present invention also relates to a corresponding manufacturing process.

Description

[Technical Field]

[0001] The present invention relates to an article for providing a membrane element and a method for manufacturing such an article.

[0002] Test methods using membrane materials with immobilized DNA, RNA, and / or proteins are often used to detect specific substances, especially antibodies, in samples. This molecular biology method is particularly used in clinical laboratory medicine and pharmaceutical research, for example, as a "lateral flow assay" or test strip.

[0003] The membrane material can also be "functionalized," i.e., have surface structures that influence and / or control sample behavior, particularly microfluidic behavior, thereby, for example, increasing the strength of the sample reaction.

[0004] To run the test, the membrane is inserted into the analyzer after sample application, which requires cutting the membrane to the appropriate shape to ensure accurate positioning of the membrane within the analyzer.

[0005] However, cutting the membrane to shape increases labor and reduces testing capacity. The membrane can become misaligned and / or clogged, and it is often difficult to ensure that the membrane is securely inserted into the analyzer and / or test cartridge.

[0006] In light of the identified deficiencies, it is an object of the present invention to provide an article for the improved provision of membrane elements and a method for manufacturing such an article.

[0007] This problem is solved by the subject matter of the independent claims. Advantageous embodiments are defined in the dependent claims.

[0008] A first aspect of the present invention relates to an article for providing a membrane element, the membrane element comprising a carrier film and a membrane film comprising at least a support layer and a membrane layer, the membrane film being releasably bonded to the carrier film, the membrane film having a plurality of substantially distinct membrane elements.

[0009] The product is in particular adapted to provide a plurality (preferably 2 or more, more preferably more than 20, even more preferably more than 100) of membrane elements, which can be individually peeled and / or separated from the product. The support layer of the membrane film is advantageously releasably bonded to the carrier film so that the membrane film can be peeled, in particular peeled, from the carrier film.

[0010] The individual membrane elements are preferably adapted and / or shaped and / or shaped so that they can be inserted substantially precisely into a test cartridge and / or analyzer and / or sample holder.

[0011] Particularly preferably, the product has an elongated and / or oval and / or tape-like shape and is further preferably adapted to be unwound from a roll, which allows space-saving storage and advantageous provision of membrane elements, for example for use in analytical methods.

[0012] The support layer preferably comprises and / or consists of PET (polyethylene terephthalate), PE (polyethylene), EVA (ethylene-vinyl acetate copolymer), PP (polypropylene), PVC (polyvinyl chloride), EVOH (ethylene-vinyl alcohol copolymer), PA (polyamide), and / or similar materials, in particular materials having a low thickness and a high degree of flexibility and durability.

[0013] The support layer advantageously has a thickness of about 10 μm to about 20 μm, in particular about 12 μm.

[0014] The support layer is advantageously arranged at least locally between the carrier film and the membrane layer.

[0015] The membrane layer preferably comprises a porous material, especially a microporous material, and / or an absorbent, especially a highly absorbent material.

[0016] The porous absorbent material has, for example, a sponge structure and is adapted to collect and / or absorb fluids. The membrane layer preferably comprises a microfilter membrane layer and / or has a pore size, in particular a nominal, medium and / or maximum pore size, of about 0.1 μm to about 20 μm, preferably about 5 μm to 15 μm, which in particular creates an advantageous capillary effect of the membrane layer for transporting fluids over and / or through and / or along the membrane layer.

[0017] The membrane layer advantageously comprises and / or consists of cellulose, in particular cellulose nitrate (nitrocellulose) and / or cellulose acetate, and / or polysulfone, in particular polyethersulfone (PESU), dextran polymers, and / or materials with similar properties and / or characteristics, in particular substantially sponge-like materials and / or materials that allow lateral fluid flow. Materials with a high protein binding capacity are particularly advantageous for the above-mentioned analytical methods.

[0018] The membrane layer advantageously has a thickness of about 50 μm to about 200 μm.

[0019] The carrier film preferably comprises a carrier material having a silicone coating, more preferably a silicone-treated paper.

[0020] The silicone coating or similar coating particularly facilitates advantageous release of the carrier film from the support layer, and in particular essentially non-destructive release of the membrane film from the carrier material.

[0021] The carrier film advantageously has a thickness of about 100 μm to about 300 μm, more preferably about 120 μm to about 200 μm, in particular about 150 μm.

[0022] The support layer of the membrane film is preferably releasably bonded to the carrier film by an adhesive.

[0023] In the context of this application, "releasably bonded" refers to the ability to peel substantially without the influence of heat and / or solvents. In particular, "releasably bonded" describes the ability to substantially non-destructively separate two layers that are releasably bonded to one another, for example, by using tweezers or a similar tool. For example, a stack of Post-it Notes consists of multiple releasably bonded note sheets.

[0024] It is further preferred that the membrane layer of the membrane film is bonded to the support layer of the membrane film by an adhesive. In contrast to a substantially peelable bond of the support layer to the carrier film, the bond of the membrane layer to the support layer exhibits particularly increased strength and / or durability. In other words, the bonding and / or bonding of the membrane layer to the support layer is preferably 5 times, more preferably 10 times or more, more resistant than the bonding and / or bonding of the support layer to the carrier film. It is further preferred that the bond between the membrane layer and the support layer is substantially non-peelable, i.e., substantially non-destructive separation of the membrane layer and the support layer and / or separation of the layers of the membrane film is not possible.

[0025] This is advantageous because it prevents, or at least makes more difficult, accidental and / or undesired peeling and / or separation of the membrane layer from the support layer when peeling and / or separating the membrane element from the product. This is preferably achieved by lower adhesion of the adhesive to the carrier film compared to the support layer and / or membrane layer. Alternatively and / or additionally, a different adhesive can be used, with the adhesive between the membrane layer and the support layer providing a stronger bond than the adhesive between the support layer and the carrier film. Alternatively and / or additionally, the carrier film can have a release agent and / or coating that reduces adhesive adhesion, such as silicone.

[0026] The adhesive preferably comprises a contact adhesive and / or a melt adhesive for releasably bonding the support layer to the carrier film and / or for bonding the membrane layer to the support layer.

[0027] Adhesives are generally essentially permanently adhesive, and the adhesively bonded and / or bonded parts can be substantially residue-free and / or non-destructively debonded and / or separated from one another. Dispersion adhesives and / or melt adhesives are particularly preferred. The adhesives are advantageously at least slightly hydrophobic, i.e., water-repellent, and / or do not mix with and / or absorb fluids, especially water. This is particularly advantageous, since any influence on the fluid being tested is prevented or at least reduced. In particular, adhesives, especially contact adhesives, do not contain volatile surfactants and / or alcohols.

[0028] Hot-melt adhesives, in particular, facilitate fast and reliable bonding and / or joining of adhesively bonded components. Hot-melt adhesives also generally have high chemical resistance, thus preventing or at least reducing the effects on the fluids applied to the membrane elements.

[0029] The adhesive properties of certain hot melt adhesives can also be reduced by heat exposure, thus achieving substantially non-destructive debonding of the adhesive bond. Hot melt adhesives are particularly advantageous for joining a support layer to a membrane layer, since these layers do not necessarily need to be peelable and / or unbondable to one another.

[0030] The adhesive more preferably has a layer thickness of about 8 μm to about 20 μm, preferably about 9 μm to about 14 μm, and particularly preferably about 10 μm.

[0031] The peelable and / or non-bondable membrane elements of the product each preferably include at least one region of the membrane layer, a corresponding and / or bonded region of the support layer, and at least a portion of an adhesive provided to connect these regions of the membrane layer to the support layer.

[0032] Preferably, the membrane element further comprises at least a portion of an adhesive provided for bonding the support layer to the carrier film, which is particularly advantageous as it allows for releasable bonding and / or adhesion of the membrane element to the analyzer to achieve a secure installation of the membrane element.

[0033] Advantageously, the membrane element is spaced apart along at least a portion of its periphery from one or more other membrane elements and / or at least other regions of the membrane film of the product, in other words, the membrane elements are preferably substantially distinct.

[0034] The membrane elements are preferably formed by ablating and / or cutting and / or melting regions of the membrane layer and support layer, and have substantially continuous and / or uninterrupted gaps at their peripheries with adjacent membrane elements and / or the membrane film of the product surrounding the membrane element.

[0035] Alternatively and / or additionally, the outer periphery of the membrane element may be at least locally perforated, i.e. provided with a plurality of holes, which also allows simple peeling and / or separation of the membrane element from the product.

[0036] In this context, it is particularly advantageous to define and / or form and / or shape the membrane elements by laser cutting, i.e., ablate and / or cut and / or melt the membrane layer and the support layer with laser radiation. Depending on the material and / or shape of the membrane element, the power, wavelength, pulse energy and / or pulse duration of the laser radiation can be adjusted accordingly. Alternatively and / or additionally, mechanical and / or chemical methods can be used.

[0037] For example, the membrane element is formed and / or shaped and / or defined to have one or more flow lines, for example, by removing the membrane layer and support layer in a central region of the membrane element so that the lateral regions of the membrane element are separated from one another.

[0038] Alternatively and / or additionally, the membrane element advantageously has an at least partially structured surface, preferably produced by at least partially and / or locally ablating the membrane layer. In particular, the membrane element can have one or more structures in the membrane layer. The structures preferably form one or more streamlines, in particular for guiding the fluid and / or controlling the fluid flow. As a result, the fluid can be advantageously guided on and / or within and / or along the membrane layer.

[0039] In particular, the different fluid paths may be substantially separated from one another, in particular to prevent, or at least reduce, influences between the fluid paths. The multiple streamlines are advantageously adapted to be substantially uniform, i.e., identical, so that the fluids can be tested under substantially identical conditions.

[0040] The shape of the membrane element can be formed, for example, by ablating and / or cutting a membrane film consisting of at least a membrane layer and a support layer. Alternatively and / or additionally, one or more structures in the membrane layer of the membrane element can be provided and / or adapted, for example, by ablating and / or cutting at least a portion of the thickness of the membrane layer.

[0041] In this context, laser cutting, i.e. ablation and / or cutting and / or melting by energy from laser radiation, is particularly advantageous. Depending on the material and / or shape and / or structure to be produced, the power, wavelength, pulse energy and / or pulse duration of the laser radiation can be adjusted accordingly.

[0042] Particularly preferably, the plurality of membrane elements have substantially the same shape and / or structure. Alternatively and / or additionally, one or more membrane elements can have different shapes and / or structures. For example, this is advantageous when a product provides different membrane elements, which are required, for example, in successive process steps and / or inserted into different test cartridges or analyzers. In particular, the different membrane elements can be arranged in groups and / or repeating arrangements within and / or on the product.

[0043] Alternatively and / or additionally, the membrane element advantageously comprises one or more mixing and / or reaction zones and / or one or more application zones, preferably formed by one or more structures.

[0044] In particular, the mixing and / or reaction zone allows two or more fluids to be combined and mixed and / or reacted with one another. The mixing and / or reaction zone may further include a substance that reacts with one or more of the fluids. Embedding and / or arranging and / or immobilizing DNA, RNA and / or proteins (e.g., by a "dispenser" and / or "spotter") is particularly preferred. Alternatively, substances may be introduced into the mixing and / or reaction zone by other means, for example, by applying droplets with a pipette.

[0045] The application zone may in particular be an area on the membrane layer where a fluid is applied, the fluid preferably being distributed from the application zone at least locally into the membrane layer and / or over the entire surface of the membrane element (lateral flow).

[0046] The membrane element may include substantially straight and / or at least locally curved and / or arcuate lines for guiding the fluid. Various structures may be provided and / or regions of the membrane element may be shaped and / or adapted according to requirements, such as, for example, a defined flow rate of the fluid along the streamlines. The shaped and / or shaped streamlines and / or structures may, in particular, influence and / or control the microfluidic behavior of the fluid on and / or within the membrane layer.

[0047] The product may further include essentially continuous perforations, thereby achieving advantageous provision of the membrane element, for example, by conveying the product in a dispenser. Alternatively and / or additionally, corresponding mating parts may be present in the test cartridge and / or analyzer, allowing for accurate positioning and / or insertion.

[0048] A further embodiment relates to a method for producing a product for providing membrane elements, in particular a product according to the first embodiment of the invention, comprising the steps of providing a support layer, releasably bonding a carrier film to a first side of the support layer, in particular by means of a contact adhesive and / or a melt adhesive, bonding a membrane layer to a second side of the support layer, in particular by means of a contact adhesive and / or a melt adhesive, and forming a plurality of membrane elements by at least locally ablating the support layer and / or the membrane layer. Preferably, the membrane layer and the support layer are bonded to each other in a substantially non-peelable manner, i.e., bonding cannot essentially occur without at least partially destroying at least one of the layers.

[0049] The manufacturing method preferably includes first providing a support layer, such as a thin PET film, and bonding a carrier film, such as silicone-treated paper, to one side of the support layer. The method preferably further includes bonding a membrane layer, such as nitrocellulose, to the opposite side of the support layer. The method further preferably subsequently includes forming a plurality of membrane elements in the membrane film (membrane layer and support layer). The membrane elements are preferably formed by ablating and / or cutting and / or melting regions of the membrane layer and support layer.

[0050] In this context, it is particularly advantageous to define and / or form and / or shape the membrane elements by laser cutting, i.e., ablate and / or cut and / or melt areas of the membrane layer and corresponding areas of the support layer by laser radiation. Depending on the material and / or shape of the membrane element, the power, wavelength, pulse energy, and / or pulse duration can be adjusted accordingly. Alternatively and / or additionally, mechanical and / or chemical methods can be used.

[0051] Alternatively, the method may include the steps of forming a membrane film, which include providing a support layer and a membrane layer, bonding the support layer to the membrane layer, peelably bonding the support layer of the membrane film to a carrier film, and forming a plurality of membrane elements of the membrane film by at least locally ablating the support layer and the membrane layer (membrane film).

[0052] The order of the process steps can vary, and the membrane element is preferably formed and / or shaped after the membrane layer, support layer and carrier film are combined, such that the formed and / or shaped membrane element is secured and / or supported by the carrier film.

[0053] Advantageously, the method further comprises a step of structuring the membrane element by ablating at least a part of the membrane layer of the membrane element and / or at least one region of the membrane film.

[0054] At least part of the membrane element can in particular be structured before the membrane layer is bonded to the support layer, which has the advantage that the integrity of the support layer is not affected by the structuring.

[0055] Alternatively and / or additionally, the structuring can take place after the membrane layer has been bonded to the carrier film, which has the advantage that the membrane film is further strengthened and / or stabilized by the carrier film.

[0056] The membrane elements are advantageously formed and / or shaped and / or structured by laser cutting.

[0057] Advantageously, the method comprises the steps of: applying an adhesive to the support layer and / or the membrane layer to preferably substantially inseparably bond the support layer to the membrane layer; and / or applying an adhesive to the support layer and / or carrier film to releasably bond the support layer to the carrier film; Further comprising one or more of:

[0058] The strength and / or durability and / or resistance of the bond between the membrane layer and the support layer is preferably greater than the strength and / or durability and / or resistance between the support layer and the carrier film, in particular by more than 5 times. In other words, a greater force, in particular more than 5 times the force required to separate and / or peel the membrane layer from the support layer, is required than to separate and / or peel the support layer from the carrier film.

[0059] The adhesive is preferably applied at least locally to one or more surfaces of the support layer and / or membrane layer and / or carrier film, preferably in a layer thickness of about 8 μm to about 20 μm, in particular about 10 μm. The adhesive advantageously comprises a contact adhesive and / or a melt adhesive. The adhesive is advantageously applied substantially uniformly by spraying and / or brushing and / or other means.

[0060] With reference to the drawings, examples of individual embodiments for solving problems will be described below. In some cases, the described individual embodiments have features that are not essential for carrying out the claimed scope, but that provide desired properties in a particular application. Therefore, an embodiment that does not have all the features of the embodiments described below is also considered to be disclosed as falling under the described technical teachings. Furthermore, to avoid unnecessary repetition, certain features will be mentioned only in relation to the individual embodiments described below. Therefore, it should be noted that the individual embodiments should be considered not only individually but also in combination. Based on this combined consideration, those skilled in the art will recognize that the individual embodiments can be modified by including individual or some features of other embodiments.

[0061] It should be noted that systematic combinations of individual embodiments with individual or certain features described with reference to other embodiments may be desirable and advantageous and therefore must be considered and considered to be included in the description. [Brief explanation of the drawings]

[0062] [Figure 1] 1 shows an exemplary embodiment of a product for providing a plurality of membrane elements, with the membrane elements removed from the product. [Figure 2] 1 shows an exemplary embodiment of a product for providing a plurality of membrane elements, with a portion of the membrane film peeled off from the carrier film of the product. [Figure 3] Exemplary structures 16 and gaps 24 are shown, as well as exemplary arrangements of elements of a preferred embodiment of product 1. [Figure 4a] 1 illustrates an exemplary method for manufacturing a product for providing a plurality of membrane elements. [Figure 4b] 1 illustrates an alternative exemplary method for manufacturing a product for providing a plurality of membrane elements. [Figure 5] 1 shows a membrane element having an exemplary structure provided by the product. [Figure 6] 1 illustrates additional exemplary membrane elements. [Figure 7] 1 illustrates details of an exemplary structured membrane element. DETAILED DESCRIPTION OF THE INVENTION

[0063] Detailed Description of the Drawings 1 shows an exemplary embodiment of a product 1 for providing a plurality of membrane elements 2, one of which is shown peeled and / or debonded from the product 1. The membrane element 2 is particularly adapted to be inserted into a provided portion of an analyzer and / or test cartridge.

[0064] 1 shows a cross section of a product 1 having an essentially elongated and / or tape-like shape. The product 1 preferably comprises at least one carrier film 8 and a (preferably multi-layer) membrane film comprising at least one support layer 6 and a membrane layer 4.

[0065] The membrane layer 4 comprises a porous, particularly microporous, and / or absorbent (especially highly absorbent) material, particularly including a sponge structure, suitable for absorbing and / or collecting fluids. Depending on the application, the membrane layer preferably has a nominal, average, and / or maximum pore size of about 5 μm or about 10 μm, particularly promoting the capillary effect of the membrane layer 4 for transporting fluids over and / or through and / or along the membrane layer. In particular, the membrane layer 4 has a thickness of about 50 μm to about 200 μm.

[0066] The membrane layer 4 advantageously comprises and / or consists of cellulose, in particular cellulose nitrate (nitrocellulose) and / or cellulose acetate, and / or polysulfone, in particular polyethersulfone (PESU), dextran polymers, and / or materials with similar properties and / or similar characteristics, in particular substantially sponge-like materials and / or materials that allow lateral flow of fluids.

[0067] The carrier film 8 comprises a carrier material having a silicone coating, such as silicone-treated paper, and therefore can be substantially easily peeled, and in particular substantially non-destructively peeled, from the support layer 6. The carrier film preferably has a material thickness of about 100 μm to about 300 μm.

[0068] The support layer 6 preferably has a thickness of about 10 μm to about 20 μm and is made of, for example, PET (polyethylene terephthalate), PE (polyethylene), EVA (ethylene-vinyl acetate copolymer), PP (polypropylene), PVC (polyvinyl chloride), EVOH (ethylene-vinyl alcohol copolymer), PA (polyamide), and / or similar materials having high flexibility and durability.

[0069] The carrier film 8 and the membrane film are at least locally arranged one above the other, and the support layer 6 of the membrane film is releasably bonded and / or connected to the carrier film 8. The membrane film is preferably releasably bonded to the carrier film 8 such that the membrane film, in particular the membrane element 2, can be peeled or debonded substantially non-destructively from the carrier film 8, for example with tweezers. In particular, the membrane film is releasably bonded to the carrier film 8 by an adhesive, including a contact adhesive and / or a melt adhesive.

[0070] The depicted portion of product 1 includes a plurality (e.g., three) of substantially discretely formed membrane elements 2. In this example, the membrane elements 2 are essentially identically formed and / or shaped, i.e., have substantially the same shape. Alternatively and / or additionally, one or more of the membrane elements 2 can have a deviating shape.

[0071] In the illustrated embodiment, the membrane layer 4 of the membrane element 2 is separated from the membrane layer 4'' that is not included in the membrane element 2 by a gap 24 along its periphery. The gap 24 can in particular be created by locally ablating and / or removing and / or melting at least the membrane film, i.e. the membrane layer 4 and the support layer 6. Laser cutting is particularly suitable for this purpose.

[0072] Furthermore, the illustrated membrane elements 2 are substantially identically structured. The membrane elements 2 include one or more (e.g., ten) streamlines 18 formed in the membrane layer 4 of the membrane element 2 and suitable for directing fluid applied to at least one application zone 22 away from the membrane element 2. The streamlines 18 are defined and / or formed by one or more structures 16 and / or are preferably spaced apart from one another, the one or more structures 16 being produced, in particular, by ablating and / or removing and / or melting (at least partially) the membrane layer 4, for example by laser cutting.

[0073] In the embodiment shown in Figure 1, the membrane layer 4 and the adhesive 10 (see Figure 3) at least partially connecting the membrane layer 4 to the support layer 6 have been removed along the structure 16 so that the support layer 6 remains there and is particularly visible. This has the particular advantage that the shape of the membrane element 2 is stabilized by the support layer 6 present (i.e. partially bridging) between the flow lines 18 and / or the structural stability of the membrane element 2 is substantially maintained after the membrane element 2 has been peeled off from the product 1.

[0074] FIG. 2 shows an exemplary embodiment of a product 1 for providing a plurality of membrane elements 2, in which the membrane layer 4'' and the support layer 6'' of the membrane film that are not included in and / or are not part of the membrane elements 2 have been peeled off from the carrier film 8 of the product 1. In the illustrated product 1, the membrane elements 2 are not formed over the entire surface of the membrane film of the product 1. The membrane layer 4'' and the support layer 6'' between the membrane elements 2 preferably have essentially the same characteristics or properties as the membrane layer 4 or the support layer 6, respectively, of the membrane element 2. Notably, as shown in FIG. 2, the membrane layer 4'' and / or the support layer 6'' can also be separated (peeled off or debonded).

[0075] By pulling away and / or peeling and / or debonding the membrane layer 4'' and the support layer 6'' that are not included in the membrane element 2, the provision of the membrane element 2 can be improved, as only the membrane element 2 remains on the product 1. This makes it possible to more easily identify and / or grasp and / or manipulate the membrane element 2 and remove and / or debond the membrane element 2 from the product 1, for example by means of tweezers.

[0076] FIG. 3 shows an exemplary structure 16 and gap 24, as well as an exemplary arrangement of elements of a preferred embodiment of product 1.

[0077] The illustrated product 1 includes at least one carrier film 8 releasably bonded to a support layer 6 by an adhesive 10. The adhesive 10 preferably includes a contact adhesive and / or a melt adhesive. The carrier film 8 preferably has a material thickness of about 100 μm to about 300 μm, for example about 150 μm. The carrier film 8 preferably includes a carrier material having a silicone coating, more preferably silicone-treated paper. Alternatively and / or additionally, the carrier film 8 can include another material, preferably a material having similar non-adhesive properties, thus achieving a releasable bond and enabling substantially non-destructive removal of the support layer 6 from the carrier film 8a.

[0078] The support layer 6 preferably has a material thickness of about 10 μm to about 20 μm, for example about 12 μm. The support layer 6 preferably comprises and / or consists of PET (polyethylene terephthalate), PE (polyethylene), EVA (ethylene-vinyl acetate copolymer), PP (polypropylene), PVC (polyvinyl chloride), EVOH (ethylene-vinyl alcohol copolymer), PA (polyamide), and / or similar materials. The support layer 6 is used, in particular, to support and / or stabilize the membrane element 2 and / or the membrane layer 4.

[0079] The support layer 6 is preferably bonded and / or connected to the membrane layer 4 by an adhesive 10, which may be substantially the same as or different from the adhesive 10 provided between the support layer 6 and the carrier film 8. The thicknesses of the different adhesive layers 10 may be substantially the same or different. The membrane layer 4 preferably has a material thickness of about 50 μm to about 200 μm. The membrane layer 4 preferably comprises a porous, particularly microporous, and / or absorbent, particularly highly absorbent, material, such as cellulose, particularly cellulose nitrate (nitrocellulose) and / or cellulose acetate, and / or polysulfone, particularly polyethersulfone (PESU), dextran polymers, and / or materials with similar properties and / or similar characteristics.

[0080] Preferably, adhesive 10 comprises a contact adhesive and / or a melt adhesive for releasably bonding support layer 6 to carrier film 8 and / or for bonding membrane layer 4 to support layer 6, preferably substantially non-releasably. Furthermore, the bond between membrane layer 4 and support layer 6 preferably has greater adhesive and / or resistance strength compared to the bond between support layer 6 and carrier film 8. Also preferred are adhesives 10 that allow bonded and / or connected adhesively bonded components to be debonded and / or separated from one another substantially residue-free and / or non-destructively. Adhesive 10 is advantageously at least slightly hydrophobic, i.e., water-repellent, and / or immiscible with fluids, particularly water.

[0081] The adhesive forces of the bond and / or connection between the support layer 6 and the membrane layer 4 are preferably greater and / or more resistant than between the support layer 6 and the carrier film 8. This can be achieved, for example, by a correspondingly different adhesive 10 and / or by appropriately selected materials and / or treatments of the membrane layer 4 and the carrier film 8.

[0082] In particular, when silicone-treated paper is used as the carrier film 8, a relatively low adhesion between the membrane film and the carrier film 8 can be achieved, and therefore easy peeling of the membrane film from the carrier film 8 can be achieved.

[0083] The depicted portion of the product 1 in Figure 3 includes a plurality (e.g., five) of substantially discretely formed, i.e., substantially separated from one another, membrane elements 2. The membrane elements 2 are separated and / or spaced apart from one another by gaps 24a-24d. Thus, individual membrane elements 2 can be peeled or removed from the carrier film 8 independently of the other membrane elements 2.

[0084] As shown, gap 24a is formed differently from gaps 24b to 24d. Gap 24a extends through the entire thickness of the membrane film, i.e., through membrane layer 4, support layer 6, and adhesive 10 connecting membrane layer 4 and support layer 6. Membrane element 2e can be debonded from product 1 by forming membrane element 2 with such gap 24a. Membrane element 2e includes membrane film (particularly membrane layer 4, support layer 6, and adhesive 10 located therebetween). This is particularly advantageous when the peeled membrane element 2e is not intended to have adhesive 10 on the outside of support layer 6, for example, to facilitate handling of membrane element 2e.

[0085] Alternatively, the gaps 24b-24d can be formed by ablation and / or removal and / or melting of the membrane layer 4, the support layer 6 and the adhesive layer 10, which connect the membrane layer 4 to the support layer 6 or the support layer 6 to the carrier film 8. This is particularly advantageous for obtaining a peeled membrane element 2d that at least locally comprises the adhesive 10 on the side opposite the membrane layer 4. In other words, the membrane element 2d peeled or debonded in this way has at least locally the adhesive 10 on the side that is peeled from the carrier film 8. Such a membrane element 2d is advantageous, for example, for securely holding the membrane element 2d in an analyzer.

[0086] The membrane element 2d can be adhered to the surface of the support layer 6 in the analyzer by adhesive 10 and / or releasably bonded to said adhesive, thereby particularly achieving reliable positioning of the membrane element 2 in the analyzer and / or test cartridge.

[0087] 3 further illustrates a cross section of a membrane element 2c having an exemplary structured membrane layer 4. Membrane element 2c includes, among other things, two flow lines 18a and 18b formed by structures 16a-16c within membrane layer 4.

[0088] The one or more structures 16 are preferably formed and / or generated by ablating and / or cutting and / or removing and / or melting the membrane layer 4 and optionally the adhesive layer 10 of the membrane film. Laser cutting is particularly suitable for this purpose, as will be explained in more detail with respect to Figures 4a and 4b.

[0089] The streamlines 18a and 18b are particularly adapted to guide a fluid along and / or within the membrane layer 4. The membrane layer 4 forming the streamlines 18a and 18b is substantially separated and / or separated from the respective adjacent membrane layers 4'a and 4'b of the membrane element 2c by the structure 16. Thus, in particular, the membrane layers 4'a and 4'b are not in contact with the fluid guided by the streamlines 18a and 18b.

[0090] The structures 16 preferably extend through at least a portion of the thickness of the membrane layer 4, and more preferably through substantially the entire thickness of the membrane layer 4 (see structures 16a and 16b of membrane element 2c), or alternatively, the structures 16 penetrate the membrane layer 4 and through at least a portion of the thickness of the adhesive layer 10 connecting the membrane layer 4 and the support layer 6 (see structure 16c).

[0091] 4a shows an exemplary method for producing a product for providing a plurality of membrane elements 2, or an apparatus suitable for carrying out the method for producing a product. A support layer 6 is preferably initially provided, for example from a roll. One side of the support layer 6 is at least locally coated and / or sprayed with adhesive 10 of at least one bonding device 12 and / or one side of the support layer 6 is at least locally wetted with adhesive 10. Application of an essentially uniform and / or continuous layer of adhesive 10 by at least one bonding device 12 is preferred.

[0092] Subsequently, the carrier film 8 is preferably unwound from a roll and placed on the side of the support layer 6 that contains the adhesive 10 and / or bonded and / or connected.

[0093] It is also preferred to apply adhesive 10 to the side of support layer 6 opposite carrier film 8. This is in particular the same adhesive 10 that is provided between support layer 6 and carrier film 8. Subsequently, membrane layer 4 is placed on support layer 6 or bonded or connected to support layer 6.

[0094] The plurality of membrane elements 2 are then preferably formed and / or shaped and / or structured, for example by one or more ablation devices 14. The ablation devices 14 are particularly adapted to at least locally ablate and / or remove at least a portion of the product 1, in particular the membrane film. In particular, the ablation devices 14 are adapted to selectively form gaps 24, as shown in FIG. 3, in the membrane layer 4, the support layer 6, and the adhesive layer 10. The ablation devices 14 are particularly adapted to selectively form one or more structures 16 in the membrane elements 2 (in particular the membrane layer 4).

[0095] To this end, the ablation device 14 may comprise one or more means for cutting and / or melting at least a portion of the membrane layer 4 and / or adhesive 10 and / or support layer 6 .

[0096] The ablation device 14 preferably comprises one or more means for laser cutting to shape and / or form the membrane element 2 and / or to form one or more structures 16 in at least the membrane layer 4 of the membrane element 2. Alternatively and / or additionally, the ablation device 14 may comprise one or more drilling and / or milling tools for forming and / or structuring the membrane element 2.

[0097] Advantageously, the individual steps of the manufacture or method of product 1 are carried out substantially continuously and / or in parallel so as to enable the manufacture of large quantities of product 1 in a time-efficient manner. The support layer 6, carrier film 8 and membrane layer 4 in particular are most suitably supplied as shown in Figure 4, i.e., unwound from rolls and supplied substantially continuously to the various process steps.

[0098] Optionally, the apparatus preferably comprises one or more devices for tempering, supporting, pressing and / or inspecting the product 1 and / or its components (not shown), in particular to obtain or ensure improved product quality.

[0099] 4b shows an alternative exemplary method for manufacturing a product for providing a plurality of membrane elements. Compared to the method shown in FIG. 4a, a membrane film is first manufactured by bonding a membrane layer 4 to a support layer 6 with an adhesive 10. Subsequently, a carrier film 8 is peelably bonded to the support layer 6 of the membrane film with an adhesive and fed to an ablation device 14 to form and / or structure the membrane element 2. The peelable bonding allows for simple and / or substantially non-destructive separation of the support layer 6 from the carrier film 8.

[0100] Alternatively and / or additionally, the at least one ablation device 14 may be arranged and / or positioned to structure the membrane layer 4 before the carrier film 8 is applied and / or bonded thereto.

[0101] FIG. 5 shows a membrane element 2 peeled from a product 1 having an exemplary shape and / or configuration.

[0102] At one end of the membrane layer 4, the structured membrane element 2 of FIG. 5 a) is particularly suitable for applying the fluid to be tested and comprises an application zone 22 from which extend a plurality (e.g., four) of streamlines 18 each having a plurality (e.g., three) of successive mixing and / or reaction zones 20, the width of the streamlines 18 being smaller than the width of the membrane element 2. The formation of such streamlines 18 increases the concentration of the fluid on and / or along the streamlines 18 and the mixing and / or reaction zones 20, thus achieving an increased reaction intensity in these mixing and / or reaction zones 20.

[0103] Furthermore, the membrane element 2 in FIG. 5a) has a structure 16 at the end opposite the application zone 22, which structure 16 forms a portion of the surface of the membrane element 2, for example, about one-fifth to one-quarter. In particular, the membrane layer 4' is substantially ablated and / or removed on the surface at this structure 16. Such a conformation is particularly advantageous for achieving improved handling of the membrane element 2. In particular, the membrane element 2 can be gripped at this end with tweezers without damaging the membrane layer 4, which is necessary for carrying out the test. The membrane element 2 can also be labeled in this area.

[0104] The application zone 22 , flow lines 18 , and mixing and / or reaction zone 20 are preferably formed and / or shaped by structures 16 and / or gaps 24 .

[0105] In the illustrated example, the membrane element 2 of FIG. 5 a) preferably comprises a plurality of substantially separated membrane layers 4′, which are substantially separated and / or spaced apart from the application zone 22, the flow lines 18, and the mixing and / or reaction zone 20, such that the fluid applied in the application zone 22 cannot essentially reach these separated membrane layers 4′. In particular, these separated membrane layers 4′ are arranged between the flow lines 18, spacing them apart from one another. Such an embodiment of the membrane element 2 is particularly advantageous, as it results in a reduced processing effort for removing and / or cutting and / or melting the membrane layers 4, for example, by the ablation device 14. Furthermore, the presence of one or more separated membrane layers 4′ allows for a visual reference to the distribution of the fluid within the flow lines 18.

[0106] At one end of the membrane layer 4, the structured membrane element 2 according to FIG. 5b) comprises an application zone 22 for applying a fluid, from which a plurality of (ten in the illustrated example) streamlines 18 extend. The streamlines 18 are substantially fan-shaped in a first region of the membrane element 2 and are arranged substantially parallel to one another in a second region. Compared to the membrane element 2 according to FIG. 5a), there are no separated membrane layers 4' between the streamlines 18 of the membrane element 2 according to FIG. 5b). In other words, the structure 16 of the membrane element 2 according to FIG. 5b), which forms the streamlines 18, extends over the entire distance of each streamline 18 and separates them from one another. Such an adaptation is particularly advantageous for achieving improved separation of the streamlines 18 relative to one another.

[0107] The membrane element 2 of FIG. 5b) further comprises a separated membrane layer 4' at the end of the membrane element 2 opposite the coating zone 22. With respect to the membrane element 2 of FIG. 5a), this particularly facilitates improved handling of the membrane element 2.

[0108] However, since the insulating film layer 4' is not ablated and / or removed, the effort required to manufacture the membrane element 2 of FIG. 5b) is reduced.

[0109] As explained in particular with respect to Figure 3, the peeled membrane elements 2 of Figures 5a) and 5b) may at least locally comprise an adhesive at their bottom (not shown) to enable advantageous fixation of the membrane elements 2, for example within an analyzer.

[0110] 6 shows an exemplary configuration of membrane elements, each of which forms a plurality (e.g., five or ten) of streamlines 18, each of which extends from an application zone 22. The streamlines 18 each extend locally in a substantially fan-like fashion, i.e., they extend from the application zone 22 at different angles and / or spaced apart from one another, with the angles of the outer streamlines 18 (e.g., about 135°) being greater than the angle of the central streamline (e.g., about 90°).

[0111] The membrane element 2 of Figure 6a) is formed substantially axisymmetrically and comprises two opposing application zones 22 and several (e.g., five) mixing and / or reaction zones 20 having a substantially circular shape and located substantially centrally between the attachment zones 22. The flow lines 18 extend substantially in a fan shape from each one of the application zones 22 to each one of the mixing and / or reaction zones 20. This embodiment is particularly advantageous when two fluids are applied separately to the membrane element 2 and are mixed with each other and / or react with each other in specific regions of the membrane layer 4.

[0112] In contrast to the membrane element 2 of Figure 6a), the membrane element 6b) is not symmetrical. The membrane element 2 of Figure 6b) in particular comprises a single fork and / or branch 26 in the flow line 18.

[0113] The forks 26 split the fluid applied to the lower application zone 22 and flowing along the corresponding flow lines 18 into two flow lines 18 such that the fluid moves to the corresponding mixing and / or reaction zone 20 at a reduced concentration. The membrane element 2 can be equipped with multiple such and / or similar forks 26 for (re)directing the fluid.

[0114] Furthermore, the membrane element 2 of Figure 6b) preferably forms one or more further mixing and / or reaction zones 20 along the flow line 18 into which DNA, RNA and / or proteins can preferably be introduced, for example by means of a "dispenser" and / or "spotter". This is used in particular to test the fluid before it reaches the substantially centrally located mixing and / or reaction zone 20 between the application zones 22. Thus, the quality and / or concentration and / or other properties of the fluid can be tested and / or verified before the fluid reaches the centrally located mixing and / or reaction zone 20.

[0115] The membrane element 2 of Figures 6a) and 6b) further comprises a substantially separated membrane layer 4' present between the corners and the flow lines 18. Alternatively, the separated membrane layer 4' can be ablated to expose the underlying support layer 6.

[0116] 7 shows details of an exemplary structured membrane element 2 comprising multiple (e.g., six) streamlines 18 within the membrane layer 4. In this example, the streamlines 18 are arranged substantially parallel and extend substantially coextensively in a serpentine arrangement over the membrane element 2. Such adaptation, in particular, improves the capillary effect of the streamlines 18, advantageously directing fluid along said streamlines.

[0117] Each of the flow lines 18 preferably includes a mixing and / or reaction zone 20 into which, for example, DNA, RNA, and / or proteins are introduced.

[0118] When the fluid to be tested reaches the mixing and / or reaction zone 20 containing DNA, RNA, and / or protein, the mixture can react with the DNA, RNA, and / or protein. The reaction preferably results in a visible color change in at least a portion of the mixing and / or reaction zone 20, which can be detected, inter alia, by an analyzer. If no reaction occurs, the fluid to be tested likely lacks or has too low a concentration of a substance necessary for the reaction, such as a particular antibody.

[0119] 7 is formed by the structure 16, preferably by removing at least a portion of the thickness of the membrane layer 4. Alternatively and / or additionally, the streamlines 18 can be formed at least in part by forming gaps 24 in the membrane layer 4 and the support layer 6. The membrane element 2 further comprises a plurality (e.g., four) separated membrane layers 4' that are not reached by the fluid guided by the streamlines 18. The separated membrane layers 4' are particularly intended to improve handling and / or shape stability of the membrane element 2. [Explanation of symbols]

[0120] 1. Products for providing membrane elements 2. Membrane element 4 membrane layers 4' Separated membrane layers of membrane elements 4'' membrane layer without membrane element 6 Support layer 6'' Support layer without membrane element 8. Carrier Film 10. Adhesive 12 Gluing device 14 Ablation Device 16 Structure 18 Streamline 20 Mixing and / or reaction zone 22 Application Zone 24 Gap 26 Fork

Claims

1. a carrier film (8); A membrane film including at least a support layer (6) and a membrane layer (4), The membrane film is releasably bonded to the carrier film (8), The membrane film comprises a plurality of substantially separate membrane elements (2), The membrane layer (4) comprises a porous material. Product (1) for providing a membrane element.

2. 2. The product (1) according to claim 1, wherein the support layer (6) is arranged between the carrier film (8) and the membrane layer (4).

3. The membrane layer (4) comprises a porous absorbent material; The membrane layer (4) is cellulose and / or Polysulfone 3. Product (1) according to claim 1 or 2, comprising:

4. said membrane layer (4) having a thickness of between 50 μm and 200 μm; and / or 3. The product (1) according to claim 1 or 2, wherein the carrier film (8) comprises a carrier material having a silicone coating.

5. the carrier film (8) has a thickness of 100 μm to 300 μm, and / or 3. Product (1) according to claim 1 or 2, wherein the support layer (6) has a thickness of between 10 μm and 20 μm.

6. the support layer (6) of the membrane film is releasably bonded to the carrier film (8) by means of an adhesive, and / or 3. Product (1) according to claim 1 or 2, wherein the membrane layer (4) of the membrane film is bonded to the support layer (6) of the membrane film by means of an adhesive (10).

7. 7. The product (1) of claim 6, wherein the adhesive (10) comprises a contact adhesive and / or a hot melt adhesive.

8. 7. Product (1) according to claim 6, wherein the adhesive (10) has a layer thickness of between 8 μm and 20 μm.

9. 3. The product (1) according to claim 1 or 2, wherein the membrane element (2) has an at least partially structured surface.

10. 3. The product (1) according to claim 1 or 2, wherein the membrane element (2) has one or more structures (16) within the membrane layer (4).

11. The one or more structures (16) in the membrane layer (4) are formed by at least partial ablation of the membrane layer (4), and / or The structure (16) forms one or more streamlines (18) for guiding the fluid and / or controlling the flow of the fluid; and / or 11. The product (1) of claim 10, wherein the structure (16) forms one or more mixing and / or reaction zones (20).

12. A method for producing a product (1) for providing a membrane element (2), comprising: Providing a support layer (6); peelably bonding a carrier film (8) to a first surface of said support layer (6); bonding a membrane layer (4) to the second side of said support layer (6); forming a plurality of membrane elements (2) by at least partial ablation of the support layer and the membrane layer (4); Including, The method, wherein the membrane layer (4) comprises a porous material.

13. 13. The method according to claim 12, wherein the membrane element (2) is formed and / or structured by laser cutting.

14. applying an adhesive (10) to the support layer (6) and / or the membrane layer (4) to bond the support layer (6) to the membrane layer (4); and / or Applying an adhesive (10) to the support layer (6) and / or the carrier film (8) to releasably bond the support layer (6) to the carrier film (8).

14. The method of claim 12 or 13, further comprising:

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