Method for producing plurality of analytical test elements
By using core-strip intermediate products, alternating bonding of transfer foils, and support foil transfer in the manufacturing of analytical test components, the time and cost problems in the manufacturing process of small-sized components in the prior art are solved, and efficient and low-cost continuous production is achieved.
Patent Information
- Application Number
- CN202480030861.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-05-08
- Filing Date
- 2024-05-07
- Publication Date
- 2025-12-12
AI Technical Summary
Existing technologies for manufacturing small-sized analytical test components involve time-consuming and costly subsequent transfer and packaging processes, as well as demanding equipment requirements, leading to uneconomical and inefficient manufacturing.
A method and apparatus are employed to form multiple analytical test elements by providing a core strip intermediate product, applying transfer foils and alternately joining them, separating the intermediate product, and then transferring the core strip onto a support foil, using a roll-to-roll process for continuous manufacturing.
It reduces the time and cost of manufacturing multiple analytical test elements, reduces equipment requirements, and improves production efficiency and throughput.
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Figure CN121127747A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present invention relates to a method of manufacturing a plurality of analytical test elements, in particular diagnostic test elements, and to a manufacturing apparatus for manufacturing a plurality of analytical test elements, in particular diagnostic test elements. As an example, the method and apparatus can be used for manufacturing a plurality of analytical test elements for lateral flow assays used in the field of medical diagnostics for detecting one or more properties of a sample of a body fluid, such as the presence and / or concentration of at least one analyte in the sample of the body fluid. However, other fields of application of the present invention are feasible as well. BACKGROUND
[0002] Analytical test elements comprising one or more test chemicals capable of performing one or more detectable detection reactions, such as optically detectable detection reactions, in the presence of an analyte to be detected are frequently used in analytical applications. For example, in the field of medical diagnostics, such as in point-of-care applications and / or in laboratories, samples of body fluids, such as saliva, blood, interstitial fluid, urine, salvia, sweat, serum or other types of body fluids, have to be analyzed, for example, in order to detect the presence and / or concentration of an analyte in the sample of the body fluid. Examples of analytes to be detected are antigenic proteins of viruses, such as antigenic proteins of the SARS-CoV-2 coronavirus, and other types of analytes, such as glucose, triglycerides, lactate, cholesterol or other types of analytes typically present in these body fluids.
[0003] Generally, methods and systems for producing these analytical test elements are known, which, for example, use a roll-to-roll process to manufacture a core tape, wherein the core tape can then be introduced into a disposable, such as a plastic housing, which has a larger size compared to the core tape. For example, US 2022 / 0305766 Al discloses a method of producing a plurality of analytical test strips using a roll-to-roll process, the method comprising: providing at least one continuous first layer web provided with at least one first electrode layer on a first side, the first layer web having a first layer edge; continuously disposing at least one continuous spacer layer web onto the first side of the first layer web, wherein the spacer layer web has a spacer layer edge, wherein the disposing is position controlled in a master-slave manner by using the position of the first layer edge as a master position and the position of the spacer layer edge as a slave position; and continuously disposing at least one continuous second layer web onto the spacer layer web, the second layer web provided with at least one second electrode layer on a first side, wherein the second layer web has a second layer edge.
[0004] US 2002 / 0076828 A1 describes a chromatographic immunoassay device that can be used more easily, is not affected by moisture and / or oxygen, and can be produced at low cost. The chromatographic immunoassay device is a device in which one or more chromatographic bands are adhered to a substrate made of a plate, each chromatographic band is sealed by tightly adhering a portion of the substrate around each chromatographic band to a sealing film located on the chromatographic band, and the sealing film and / or the substrate has a film including a moisture scavenger and / or a film including an oxygen absorber.
[0005] US 6,207,000 B1 discloses a method for producing an analytical device. The analytical device comprises analytical test elements having capillary-active zones for examining a liquid sample. In the process, a carrier layer is prepared, a spacer layer is laminated onto the carrier layer, a contour is punched, cut or embossed through the spacer layer laminated onto the carrier layer, which determines the shape of the capillary-active zones, those portions of the spacer layer which are not required for forming the capillary-active zones are removed from the carrier layer, and a cover layer is applied to the spacer layer to obtain the capillary-active zones. The process is preferably applied to the manufacture of analytical devices from a strip material.
[0006] US 2008 / 0289749 A1 describes a method for manufacturing a diagnostic test strip. The method includes the operations of providing an applicator sheet having a plurality of adhesive dots thereon, providing a first substrate layer having at least one feature thereon, and providing a second substrate layer. The method further includes the operations of transferring at least one of the plurality of adhesive dots located on the applicator sheet to the first substrate layer, aligning the first substrate layer with the second substrate layer, and attaching the first substrate layer and the second substrate layer using the transferred adhesive dot, wherein the attachment of the first substrate layer and the second substrate layer is performed without any additional alignment.
[0007] EP 2 907 573 A1 discloses a method for producing at least one analytical device. The analytical device has at least one capillary element. The method comprises the steps of a) providing at least one carrier layer; b) providing at least one spacer layer; c) applying the spacer layer on top of the carrier layer; d) providing at least one cover layer; e) applying the cover layer on top of the spacer layer. The method further comprises at least one cutting step, wherein at least one capillary channel of the capillary element is cut out of the spacer layer. The cutting step is performed by using at least two cutting tools, which complement each other to form the contour of the capillary channel.
[0008] While the known methods and devices have advantages, there are still several technical challenges. In particular, it is generally conceivable to introduce a small core tape (e.g. having a size of less than 10 mm in at least one dimension) into a disposable article or housing that exceeds the size of the core tape in order to improve handling of the analytical test element by a user. However, as outlined above, the core tape is typically produced using a continuous process, such as a roll-to-roll process. In a subsequent manufacturing step, the produced core tape can be transferred or introduced into the disposable article, e.g. by using pick-and-place methods, by packaging and labelling. These subsequent manufacturing steps are typically time-intensive and cost-intensive and require additional hardware equipment. Thus, in general, the known manufacturing methods and devices are disadvantageous in terms of manufacturing time and costs.
[0009] Problem to be solved
[0010] Therefore, it is desirable to provide methods and devices that at least partially solve the above-mentioned technical challenges. In particular, a manufacturing method and manufacturing device shall be proposed that enables manufacturing of a plurality of analytical test elements at low costs and / or high throughput and preferably reduces the equipment requirements. SUMMARY
[0011] The problem is solved by the method of manufacturing a plurality of analytical test elements and the manufacturing device having the features of the independent claims. In the dependent claims and throughout the specification, advantageous embodiments are listed that can be realized in a separate way or in any combination.
[0012] As used hereinafter, the terms "have", "comprise" or "include" or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms can both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions "A has B", "A comprises B" and "A includes B" can both refer to a situation in which, besides B, no further element is present in entity A (i.e. a situation in which A solely and exclusively consists of element B) and to a situation in which, besides B, one or more further elements are present in or elements A, such as element C, elements C and D or even further elements.
[0013] Further, it shall be noted that the terms "at least one", "one or more" or similar expressions indicating that a feature or element can be present once or more than once generally are used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions "at least one" or "one or more" will not be repeated, although the respective feature or element can be present once or more than once.
[0014] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, not with alternative possibilities. Thus, features introduced by such terms are optional features and do not mean that the scope of the claims is restricted to the features. It is in particular understood that, where such terms are used, the invention can as well be practiced with alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features and do not limit alternative embodiments of the invention in any way, nor the scope of the invention, nor the possibility to combine features introduced in such way with other optional or non-optional features of the invention.
[0015] In a first aspect of the present invention, a method of manufacturing a plurality of analytical test elements, in particular diagnostic test elements, comprising at least one core tape and at least one support foil tape is disclosed. In the following, the method can also be referred to as "manufacturing method".
[0016] The method comprises the following steps, which can be carried out in the given order as an example. However, it should be noted that different orders are also possible. Furthermore, one or more or even all of the method steps can be carried out once or repeatedly. Further, two or more method steps can be carried out simultaneously or in a timely overlapping manner. The method can comprise additional method steps which are not listed.
[0017] The method comprises:
[0018] i. providing at least one core tape intermediate product comprising at least one carrier foil and at least one analytical element attached to the at least one carrier foil, the carrier foil and the attached analytical element being cut in the carrier intermediate product such that a plurality of core tapes defining analytical test elements is defined, the core tapes being placed next to each other;
[0019] ii. applying a transfer foil to the front side and to the back side of the core tape intermediate product, wherein the transfer foil applied to the front side and the transfer foil applied to the back side engage with the core tapes in an alternating manner, the transfer foil on the front side and the core tapes engaging with the transfer foil on the front side forming a first transfer intermediate product, the transfer foil on the back side and the core tapes engaging with the transfer foil on the back side forming a second transfer intermediate product;
[0020] iii. separating the first transfer intermediate product and the second transfer intermediate product; and
[0021] iv. transferring the core tapes to the at least one support foil, wherein the core tapes are spaced apart from each other on the support foil by at least one width of a core tape.
[0022] As used herein, the term “manufacturing” is a broad term and should be given its ordinary and customary meaning to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term specifically can refer, without limitation, to a method of producing at least one final product from one or more base products. Specifically, the manufacturing process can include processing and / or transforming one or more base products into a final product. The final product of the manufacturing method can include a plurality of analytical test elements. The manufacturing of the plurality of analytical test elements can include handling at least one element and / or component in a manner such as retrieving the plurality of analytical test strips.
[0023] As used herein, the term “analytical test element” is a broad term and should be given its ordinary and customary meaning to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term specifically can refer, without limitation, to an element or device configured to determine the presence and / or concentration of at least one analyte in a liquid sample. The analytical test element specifically can be an analytical test strip, such as by having a strip form, as will be outlined in further detail below. The analytical test strip can include at least one component that changes at least one detectable property, specifically at least one of an optically and electrochemically detectable property, when the analyte is present in the liquid sample and / or depending on the concentration of the analyte in the liquid sample. The analytical test element can include at least one lateral flow assay. The analytical test element can be configured for in-vitro measurement. The analytical test element can be an electrochemical test strip. The analytical test element can include one or more electrodes, such as an electrode structure configured to electrically connect the analytical test element to a meter (e.g., a blood glucose meter). For example, the analytical test element can be a diagnostic test element. The analytical test element can be configured to determine the presence and / or concentration of at least one analyte in a body fluid, specifically in a sample of a body fluid. The analyte to be detected can be or can include at least one of an antigenic protein of a virus, such as an antigenic protein of a SARS-CoV-2 coronavirus, influenza virus A, influenza virus B, HIV, or other virus, and an analyte involved in metabolism, such as glucose, triglycerides, lactate, cholesterol, or any other analyte. The body fluid can be or can include saliva, nasal swab, throat swab, blood, interstitial fluid, urine, salvia, sweat, serum, or any other type of body fluid. As another example, the analytical test element can be a test element for the field of analytical chemistry, such as a test element involving one or more color-changing indicators. By way of example, such analytical test element can include a test element for determining the presence and / or concentration of at least one analyte in water, such as an analytical test element for testing the quality of fish tank water, specifically determining the presence and / or concentration of one or more of pH value, carbonate, nitrate, nitrite, total hardness, total alkalinity, and / or other chemical elements or compounds.
[0024] As used herein, the term "strip" or "striplike" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to an element having an elongated shape and a thickness, wherein the extension of the element in the lateral dimension exceeds the thickness of the element, such as by a factor of at least 2, preferably at least 5, more preferably at least 10, and most preferably at least 20 or even at least 30.
[0025] As used herein, the term "core strip" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to at least one functional element of an analytical test element. Specifically, the core strip can comprise one or more elements configured to provide an analytical function of the analytical test element individually or in combination with each other, such as one or more elements configured to determine the presence and / or concentration of at least one analyte in a liquid sample. The core strip can be a lateral flow assay of the analytical test element. As will be outlined in further detail below, the core strip can comprise at least one carrier material, such as at least one strip of a carrier foil, and at least one analytical element disposed thereon or therein. The core strip can be a striplike element as defined hereinabove. The core strip can be at least partially surrounded by one or more other elements of the analytical test element, for example by one or more other elements providing support and / or sealing for the core strip.
[0026] As used herein, the term "foil" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a thin sheet, plate, strip and / or web of a material. A foil can be referred to as a thin foil if its thickness does not exceed 1 cm, specifically does not exceed 5 mm, more specifically does not exceed 1 mm. The foil can be provided in a continuous form, for example on a roll or a reel. The foil can comprise at least one flexible or deformable material, such as at least one flexible or deformable plastic foil. The foil can comprise at least one plastic material, such as polyester, polyethylene terephthalate, polyethylene or the like. Additionally or alternatively, the foil can comprise at least one metal, such as aluminum, copper, tin, gold or the like.
[0027] As used herein, the term "support foil" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to at least one foil providing a substrate for at least one further element. The support foil can provide a substrate for the core tape, specifically for a plurality of core tapes from at least one of the transfer intermediate products. The support foil can be configured to receive the core tape. The support foil can be part of the manufactured plurality of analytical test elements. The support foil can be configured to at least partially enclose the core tape, for example by providing a seal for the manufactured plurality of analytical test elements, either alone or in combination with one or more further elements.
[0028] As used herein, the term "support foil strip" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a single strip of support foil. The support foil strip can be part of the support foil, for example by being cut out of the support foil and / or punched out of the support foil. Such cutting or punching step can be part of the manufacturing method. Alternatively, the support foil strip can not be separated during the manufacturing method. For example, the manufactured plurality of analytical test elements can comprise a plurality of support foil strips, wherein the plurality of support foil strips can be connected to each other, specifically to adjacent support foil strips. The plurality of support foil strips can be configured to be separated from each other, for example at the time of use of the analytical test elements by an on-site user. For example, the manufactured plurality of analytical test elements can be connected to each other to form at least one sheet or web, wherein the plurality of analytical test elements can be connected via their respective support foil strips.
[0029] As outlined above, step i. of the method comprises providing at least one core tape intermediate product. As used herein, the term "providing" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a process of supplying and / or making available. Specifically, providing the core tape intermediate product in step i. can comprise making the core tape intermediate product available for further processing. Providing the core tape intermediate product can comprise supplying the core tape intermediate product to a manufacturing device, as will be described in further detail below, and / or producing the core tape intermediate product from one or more base products.
[0030] The term "intermediate product" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to an element manufactured from a simpler base product and is intended to be further processed into a more complex product. Specifically, the intermediate product can be used for further processing to manufacture a plurality of analytical test elements. The intermediate product can at least partially form part of the manufactured plurality of analytical test elements. Alternatively, in other examples, the intermediate product can not be part of the manufactured plurality of analytical test elements, but can be used in one or more processing steps to manufacture said plurality of analytical test elements.
[0031] The term "core band intermediate product" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to an intermediate product comprising one or more core bands. Specifically, the core band intermediate product can comprise a plurality of core bands. The core band intermediate product can be provided as a sheet or web, specifically as a continuous sheet or web. For example, the core band intermediate product can be provided in a continuous form on a roll or a roll. The width of the core band intermediate product can exceed the width of the core band. The width of the core band intermediate product can exceed the width of the core band by a factor of 1.5, specifically by a factor of 2, more specifically by a factor of 3. For example, the core band can have a width of 70 mm. The core band intermediate product can have a width of 210 mm. The core band intermediate product can at least partially form part of the manufactured plurality of analytical test elements. Specifically, the core bands of the core band intermediate product can form part of the manufactured plurality of analytical test elements.
[0032] The core band intermediate product can be a base product for performing the manufacturing method. Alternatively, the manufacturing method can comprise manufacturing the core band intermediate product from one or more simpler base products. Step i. can comprise attaching at least one analytical element to at least one carrier foil and further cutting the carrier foil and the attached analytical elements such that a plurality of core bands is formed. Specifically, the core band intermediate product can be manufactured from the carrier foil by attaching the analytical elements to the carrier foil and cutting the carrier foil and the attached analytical elements.
[0033] The core band intermediate product can have an extended longitudinal direction, specifically an extended longitudinal direction of the carrier foil web. The core band intermediate product can be cut such that the plurality of core bands of analytical test elements are oriented substantially perpendicular to the extended longitudinal direction. The core band intermediate product can be cut such that the plurality of core bands of analytical test elements are defined by a plurality of parallel cutting lines.
[0034] As outlined above, the core tape intermediate product comprises at least one carrier foil and at least one analytical element attached to the at least one carrier foil. The term "carrier foil" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer to, without being limited to, a foil providing at least one substrate for carrying the analytical elements. Specifically, the carrier foil can have the analytical elements of the core tape disposed thereon or therein. The carrier foil can specifically be made of at least one plastic material, such as polyester, polyethylene terephthalate, polyethylene or the like, in particular polyethylene terephthalate.
[0035] As used herein, the term "analytical element" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer to, without being limited to, at least one element configured to provide the analytical function of the analytical test element, alone or in combination with each other, such as one or more elements configured to determine the presence and / or concentration of at least one analyte in a liquid sample. The analytical element can specifically be an element of the core tape. The analytical element can be selected from the group consisting of a spreading velvet for receiving at least one liquid sample, in particular a body fluid, and / or at least one liquid sample obtained from a body fluid; at least one detection material configured to change at least one measurable property, in particular at least one of an optically detectable property and an electrochemically detectable property, in the presence of at least one analyte to be detected; a sample application matrix; a blood cell separation matrix; a reagent or detection material storage matrix; a detection zone matrix; a wicking matrix. Examples of these analytical elements are disclosed, for example, in US 2005 / 0118662 A1.
[0036] As outlined above, step ii. of the method comprises applying the transfer foil to the front side and to the back side of the core tape intermediate product. As used herein, the term "applying" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer to, without being limited to, a process of attaching, connecting, disposing and / or placing at least one element onto at least one further element. Applying can comprise bringing at least two elements into contact with each other. Specifically, the applying in step ii. can comprise bringing the at least one transfer foil into contact with each of the front side and the back side of the core tape intermediate product.
[0037] As used herein, the term "transfer foil" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to at least one foil configured to carry one or more elements engaged therewith. Specifically, the transfer foil can be configured to engage with one or more elements and to carry the engaged elements to another place or location. The transfer foil can be configured to reversibly engage with one or more elements. The transfer foil can be configured to release one or more engaged elements, specifically at the other place or location to which they are transferred by the transfer foil. The transfer foil can be a support product in a manufacturing process, specifically not part of the plurality of analytical test elements manufactured.
[0038] As used herein, the term "front side" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to a front surface of an object or element. The front side can specifically refer to a surface of an object or element defined by specific features or elements disposed thereon or therein. Specifically, the front side of the core in-process product can be a surface, in particular a surface of the carrier foil, having analytical elements disposed thereon or therein. In other words, the front side of the core in-process product can be a surface facing the analytical elements attached to the carrier foil, in particular a surface of the carrier foil.
[0039] Accordingly, as used herein, the term "back side" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning and specifically can refer, without limitation, to a surface of an object or element opposite to the front side. The back side can specifically refer to a surface of an object or element defined by the absence of specific features or elements defining the front side of the object or element. The back side of the core in-process product can be a surface, in particular a surface of the carrier foil, not having analytical elements disposed thereon or therein. The back side of the core in-process product can be a surface facing away from the analytical elements attached to the carrier foil, in particular a surface of the carrier foil.
[0040] As outlined above, the transfer foils applied to the front side and the transfer foils applied to the back side are engaged with the core band in an alternating fashion, the transfer foils on the front side and the core band engaged with the transfer foils on the front side forming a first transfer intermediate product, the transfer foils on the back side and the core band engaged with the transfer foils on the back side forming a second transfer intermediate product. As used herein, the term "engaged" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art, and
[0041] As used herein, the term "alternating fashion" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art, and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a repeating pattern of operation. Specifically, the engagement of the transfer foils on the front side and the back side with the core band in an alternating fashion can comprise a regular engagement of the transfer foils on the front side and the back side with the core band. For example, both the transfer foils applied to the front side and the transfer foils applied to the back side can be engaged with every second one of the core bands of the core band intermediate product.
[0042] As used herein, the term "transfer intermediate product" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art, and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to an intermediate product comprising a transfer foil and a core band. Specifically, the transfer intermediate product can comprise at least one of the transfer foils on the front side and the transfer foils on the back side, and the core band engaged therewith. The transfer intermediate product as a whole can not be part of the plurality of analytical test elements manufactured, but can be used in one or more subsequent processing steps to manufacture said plurality of analytical test elements, specifically in at least one or more subsequent separation and transfer method steps. Specifically, at least a portion of the transfer intermediate product can not be part of the plurality of analytical test elements manufactured, such as a transfer foil, wherein at least one other portion of the transfer intermediate product, such as a core band, can be part of the plurality of analytical test elements manufactured.
[0043] Generally, the terms "first" and "second" as used herein are only used for naming purposes and are not intended to imply a ranking or numbering and do not give any preference.
[0044] Further, the term "first transfer intermediate product" can refer to, but is not limited to, a transfer intermediate product having a transfer foil applied to the top of the analytical elements of the core tape. In other words, in the first transfer intermediate product, the analytical elements of the core tape can be located between the transfer foil and the carrier foil. In contrast, the term "second transfer intermediate product" can refer to, but is not limited to, a transfer intermediate product having a transfer foil applied to the opposite face of the analytical elements of the core tape. Thus, in the second transfer intermediate product, the analytical elements can not be covered by the transfer foil. The second transfer intermediate product can comprise a carrier foil located between the analytical elements and the transfer foil. The core tape consisting of the first transfer intermediate product and the second transfer intermediate product can be spaced apart from each other by one width of the core tape.
[0045] As further outlined above, the method comprises separating the first transfer intermediate product and the second transfer intermediate product in step iii. The term "separating" as used herein is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer to, but is not limited to, the process of disjoining or separating two or more connected elements. Specifically, the separating in step iii. can comprise disjoining or separating the first transfer intermediate product and the second transfer intermediate product from each other. The first transfer intermediate product and the second transfer intermediate product can be handled independently from each other after being separated in step iii.
[0046] Further, in step iv. the method comprises transferring the core tape onto at least one support foil, wherein the core tape is spaced apart from each other on the support foil by at least one width of one core tape, as outlined above. The term "transferring" as used herein is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer to, but is not limited to, the process of displacing, conveying or carrying one or more elements from one place or object to another place or object. Specifically, the transferring in step iv. can comprise displacing the core tape from the at least one transfer intermediate product onto the support foil. The transferring can comprise directly or indirectly displacing the core tape from the first transfer intermediate product and the second transfer intermediate product onto the support foil. For example, step iv. can comprise transferring the core tape directly from the first transfer intermediate product and the second transfer intermediate product onto the support foil, specifically without the need for additional processing steps. For example, step iv. can comprise transferring the core tape indirectly from the first transfer intermediate product and the second transfer intermediate product onto the support foil, wherein one or more additional transfer steps, inversion steps or other processing steps can be comprised before and / or during the core tape is finally transferred onto the support foil. Thus, in this case, the core tape in step iv. can be transferred from one or more of a third transfer intermediate product, a fourth transfer intermediate product and / or a fifth transfer intermediate product onto the support foil.
[0047] As used herein, the term "width" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to an extension of an element in a direction substantially perpendicular to an extending longitudinal direction. Specifically, the width of an element can be an extension perpendicular to an extending longitudinal direction of the element. For example, the element can be a core tape, specifically having an elongated or band-like form, as outlined above. The width of the core tape can be an extension of the core tape in a direction perpendicular to, i.e. at a right angle to, the direction of extension of the elongated or band-like form.
[0048] The method can specifically be performed as a continuous manufacturing process. As used herein, the term "continuous" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to an uninterrupted and / or ongoing character of a process or object.
[0049] Specifically, at least one of the carrier foil, the analytical test element, the core tape intermediate product, the transfer foil and the support foil can be provided as at least one web, specifically as at least one web provided via at least one roll, more specifically as a continuous sheet, more specifically as a continuous tape or web. As used herein, the term "web" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a continuous sheet or web material.
[0050] Specifically, the method can be performed as a reel-to-reel process. As used herein, the term "reel-to-reel process" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a process involving at least two rotating and / or revolving objects, such as at least two rotating wheels and / or reels. A reel-to-reel process can specifically comprise transferring at least one element, such as an element having a sheet form and / or a tape form, stored on a first roll to a second roll, wherein at least one processing step is performed during the transfer. Thus, as an example, a reel-to-reel process can refer to any process starting from a roll of material, e.g. from a first roll, and re-rolling into, e.g. an output roll, after performing the process, e.g. into a second roll. A reel-to-reel process can also be referred to as a roll-to-roll process.
[0051] The method can further comprise at least one cutting process, wherein in the cutting process at least one element is cut, in particular in longitudinal direction. The at least one element is selected from the group consisting of: the core tape intermediate product; the first transfer intermediate product; the second transfer intermediate product. As used herein, the term "cutting" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to a process of separating at least one object and / or element, wherein a defined and / or controlled edge and / or cut edge is generated. The cutting can comprise cutting the at least one element in the cutting process using at least one cutting blade, in particular with a cutting angle a between the surface of the element to be cut and the surface of the cutting blade, in particular with a cutting angle of 20° < a < 40°. The cutting process can in particular be a continuous cutting process. Additionally or alternatively, the method can comprise recycling at least a portion of the material cut off during the cutting process, in particular of the transfer foil.
[0052] The method can further comprise:
[0053] v. applying at least one further transfer foil to at least one of the first transfer intermediate product and the second transfer intermediate product, such that the core tape is embedded between the transfer foils, wherein the further transfer foil engages with every second one of the core tapes located on the at least one of the first transfer intermediate product and the second transfer intermediate product, thereby resulting in a third transfer intermediate product; and
[0054] vi. removing the further transfer foil and the core tapes engaged therewith from the third transfer intermediate product, such that the further transfer foil and the core tapes engaged therewith form a fourth transfer intermediate product, and such that the remaining transfer foils of the third transfer intermediate product and the core tapes engaged therewith form a fifth transfer intermediate product after the removal of the further transfer foil.
[0055] Steps v. and vi. can in particular be performed before step iv. (e.g. between step iii. and step iv.).
[0056] Likewise, in principle, the terms "third", "fourth" and "fifth" as used herein are only for naming purposes, are not intended to make an ordering or numbering, and are not to give any preference.
[0057] Further, the term "third transfer intermediate product" can refer to, but is not limited to, a transfer intermediate product having a further transfer foil applied to the side of the carrier foil facing away from the analytical elements of the core band or to the top of the analytical elements of the core band. Specifically, in case the further transfer foil is applied to the first intermediate transfer product, the third transfer intermediate product can comprise the further transfer foil applied to the side of the carrier foil facing away from the analytical elements of the core band of the first transfer intermediate product. In case the further transfer foil is applied to the second intermediate transfer product, the third transfer intermediate product can comprise the further transfer foil on top of the analytical elements of the core band of the second transfer intermediate product. The third transfer intermediate product can have the core band of the first or second transfer intermediate product between the transfer foil applied in step ii. and the further transfer foil applied in step v.
[0058] The term "fourth transfer intermediate product" can refer to, but is not limited to, a transfer intermediate product having the analytical elements of the core band facing away from or towards the further transfer foil. Specifically, in case the fourth transfer intermediate product is obtained from the first intermediate transfer product to which the further transfer foil is applied, the fourth transfer intermediate product can comprise the analytical elements of the core band facing away from the further transfer foil. In case the fourth transfer intermediate product is obtained from the second intermediate transfer product to which the further transfer foil is applied, the fourth transfer intermediate product can comprise the analytical elements of the core band facing towards the further transfer foil.
[0059] Similarly, the term "fifth transfer intermediate product" can refer to, but is not limited to, a transfer intermediate product having the analytical elements of the core band facing away from or towards the remaining transfer foil. Specifically, in case the fifth transfer intermediate product is obtained from the first intermediate transfer product to which the further transfer foil is applied, the fifth transfer intermediate product can comprise the analytical elements of the core band facing towards the remaining transfer foil. In case the fifth transfer intermediate product is obtained from the second intermediate transfer product to which the further transfer foil is applied, the fifth transfer intermediate product can comprise the analytical elements of the core band facing away from the remaining transfer foil.
[0060] In any case, the core bands constituted by the fourth and fifth transfer intermediate products can be spaced apart from each other by a width of three core bands.
[0061] Steps v. and vi. can be repeated, wherein after the first time steps v. and vi. are performed, at least one of the fourth transfer intermediate product and the fifth transfer intermediate product is subjected to step v. By repeating steps v. and vi., the pitch of the core bands on the fourth transfer intermediate product and the fifth transfer intermediate product can be further enlarged, in particular by a factor of two with each repetition of steps v. and vi.
[0062] The transfer foil can in particular comprise a plurality of through-holes arranged in rows, in particular rows oriented parallel to a longitudinal direction of extension of the respective transfer foil. As used herein, the term "through-hole" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term can in particular refer, without limitation, to any hollow structure extending completely through a material of an object. In particular, the through-holes can extend completely through the transfer foil, such as to provide openings through the transfer foil. The through-holes can be of any shape. For example, the through-holes can be circular holes. However, other forms of through-holes, such as rectangular shapes, elliptical shapes, polygonal shapes, or the like, are also possible.
[0063] The method can further comprise applying at least one adhesive tape to the transfer foil in such a way that at least one adhesive region of the adhesive tape engages with the carrier foil of the core band through the through-holes. As used herein, the term "adhesive tape" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term can in particular refer, without limitation, to a tape or ribbon configured for bonding to at least one separate element or object. In particular, the adhesive tape can be configured for bonding with and / or adhering to the carrier foil, thereby engaging with the carrier foil.
[0064] Further, the core bands can be placed adjacent to each other on a core band intermediate product having a pitch p, in particular a pitch corresponding to a pitch of the core bands. As used herein, the term "pitch" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term can in particular refer, without limitation, to a distance between corresponding features in a spatially repetitive frequency or periodic structure. As an example, the pitch can be determined from center to center of repeating adjacent structures. For example, the pitch of the core bands on the core band intermediate product can comprise a pitch of the core bands, in particular determined from center to center of the core bands.
[0065] Further, the through-holes of each row have a pitch s, wherein:
[0066] s = 2 m * p, wherein m is a positive integer.
[0067] Each of the transfer foils can specifically comprise a plurality of at least two different rows of through-holes, which are different from each other with respect to their pitch s of the through-holes. The transfer foil can comprise at least one first row of through-holes, specifically two first rows of through-holes, with m = 1, and at least one second row of through-holes, specifically two second rows of through-holes, with m = 2, and optionally at least one third row of through-holes, specifically two third rows of through-holes, with m = 3.
[0068] Additionally or alternatively, in step ii. the transfer foils on the front side and on the back side can be offset by an offset distance of s / 2 in the longitudinal direction of the transfer foils, such that the transfer foils on the opposite faces of the core tape engage with the core tape in an alternating manner via their respective adhesive strips.
[0069] The method can further comprise at least one edge cutting process. In the edge cutting process, at least one portion of at least one of the transfer foils can specifically be cut off in the longitudinal direction. The cut-off at least one portion comprises at least one row of through-holes. The edge cutting process can be a continuous cutting process.
[0070] The core tape intermediate product can further comprise a rim portion, specifically an uncut rim portion, specifically a rim portion extending in the extended longitudinal direction along an edge of the core tape intermediate product. As used herein, the term "rim portion" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer to, but is not limited to, at least one edge region of an object. The rim portion can specifically be at least one edge region of the core tape intermediate product, for example two edge regions limiting the dimensions of the core tape intermediate product perpendicular to the extended longitudinal direction. A plurality of core tapes can be located between the rim portions. Further, the plurality of core tapes can be held in place by the rim portions before separating the first transfer intermediate product and the second transfer intermediate product in step iii. Additionally or alternatively, the method can further comprise removing the rim portions, specifically cutting off the rim portions, before separating the first transfer intermediate product and the second transfer intermediate product in step iii.
[0071] The method can further comprise:
[0072] vii. covering the core tapes on the support foil with at least one cover foil.
[0073] As used herein, the term "covering" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a process of applying at least one element onto at least one further element. Specifically, the covering of the core band can comprise applying at least one element onto the core band, the applied element being configured for sealing and / or protecting the covered core band. The element applied onto the core band can specifically be a foil, such as a metal foil, for example an aluminum foil. Thus, the element applied onto the core band can be referred to as "cover sealing foil".
[0074] The method can further comprise applying a perforation line into the support foil, wherein the core band is disposed thereon, and optionally also into the cover sealing foil, such that at least one perforation line is disposed between adjacent core bands. As used herein, the term "perforation line" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a non-continuous process of an element, for example a hole, allowing to separate two or more sections adjacent to the element process. The perforation line can specifically be a straight line of holes, which allows to separate two analytical test elements of adjacent separation lines. However, other forms, for example curved perforation lines, are feasible.
[0075] The core bands can be placed adjacent to each other on the core band intermediate product having a pitch p, specifically having a spacing corresponding to the width of the core band. On the support foil, the core bands can be spaced apart from each other by a separation distance d:
[0076] d = (2 n - 1)*p, wherein n is a positive integer.
[0077] In other words, the core bands on the support foil can have a separation distance from each other, specifically from adjacent core bands, wherein the separation distance can exceed the distance of the core bands on the core band intermediate product.
[0078] The core bands can each have a contact face, and in step iv. can be applied to the support foil with their contact face. As used herein, the term "contact face" is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to the side of the carrier foil facing away from the analytical elements of the corresponding core band.
[0079] Specifically, in step iv. the core bands can be attached to the support foil by using an adhesive method, specifically the adhesive method is selected from the group consisting of gluing, specifically by using a hot-melt adhesive; welding.
[0080] Alternatively or in addition, as described in further detail above, some of the transfer intermediates can be implemented such that the contact face of the core tape faces the transfer foil of the respective transfer intermediate. In this case, the method can further comprise:
[0081] viii. inverting the core tape having the contact face facing its respective transfer foil, the inverting comprising applying an inverted transfer foil to the core tape on the face opposite to the contact face of the core tape, the inverting further comprising removing the transfer foil from the contact face of the core tape.
[0082] As used herein, the term "inverting" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to a process of turning an element upside down. Specifically, after inverting an element, the top face of the element can be the lower face and vice versa. Inverting of the core tape can be such that the contact face faces its respective transfer foil. The inverting can comprise applying an inverted transfer foil, which specifically can be implemented as identical to the transfer foil and / or to a further transfer foil, to the core tape of the respective transfer intermediate, specifically on the analytical elements of the core tape, cutting the through-holes of at least one row of the inverted transfer foil and the transfer intermediate, and removing the transfer foil from the transfer intermediate.
[0083] At least one of the transfer foils can comprise a plurality of positioning markers, specifically, positioning markers arranged in rows, more specifically, in rows perpendicular to the longitudinal direction of the transfer foil. The positioning markers can comprise through-holes through the transfer foil. At least two rows of positioning markers can be located on opposite edges of the transfer foil. The positioning markers can be arranged in at least one row, specifically at least one row extending in the longitudinal direction of the transfer foil. The positioning markers in the row can have a pitch l, wherein the core tapes placed next to each other on the core tape intermediate can have a pitch p, wherein
[0084] p = q * l, wherein q is a positive integer.
[0085] In another aspect of the application, a manufacturing device for manufacturing a plurality of analytical test elements, specifically diagnostic test elements, comprising at least one core tape and at least one support foil tape is disclosed.
[0086] The term "manufacturing device" as used herein is a broad term and shall be given its ordinary and customary meaning to a person of ordinary skill in the art and shall not be limited to a special or customized meaning. The term specifically can refer, without limitation, to a device configured for manufacturing any device or set of interacting / interdependent devices as defined above. The manufacturing device can be or can comprise a single device or a set of at least two interacting or interdependent components or devices forming a whole in order to achieve at least one common function of the manufacturing. The at least two components can be handled independently or can be coupled or connectable. The manufacturing device can specifically be configured for carrying out a method of manufacturing a plurality of analytical test elements according to the present application, such as according to any of the embodiments disclosed above or according to any of the embodiments disclosed in more detail below. Thus, for the definition and possible embodiments of the terms of the method or product, reference is made to the description of the method above.
[0087] The manufacturing device comprises:
[0088] I. at least one core tape intermediate product supply device configured for supplying, specifically continuously supplying, at least one core tape intermediate product comprising at least one carrier foil and at least one analytical element attached to the at least one carrier foil, the carrier foil and the attached analytical element being cut in the core tape intermediate product such that a plurality of core tapes defining analytical test elements are placed next to each other;
[0089] II. at least one transfer foil application device configured for applying a transfer foil to a front side and to a back side of the core tape intermediate product, wherein the transfer foil applied to the front side and the transfer foil applied to the back side engage with the core tapes in an alternating manner, the transfer foil on the front side and the core tapes engaging with the transfer foil on the front side forming a first transfer intermediate product, the transfer foil on the back side and the core tapes engaging with the transfer foil on the back side forming a second transfer intermediate product;
[0090] III. at least one separation device configured for separating the first transfer intermediate product and the second transfer intermediate product; and
[0091] IV. at least one transfer device configured for transferring, specifically continuously transferring, the core tapes onto at least one support foil such that the core tapes are spaced apart from each other on the support foil by at least one width of a core tape.
[0092] The manufacturing device can specifically be configured for carrying out and / or implementing a method of manufacturing a plurality of analytical test elements according to the present application, such as according to any of the embodiments described above and / or according to any of the embodiments described in further detail below. Thus, for the possible options and / or definitions of the device and its components, reference can be made to the description of the method as given herein.
[0093] As used herein, the term "core tape intermediate product supply device" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to a device configured to provide any of the devices or sets of interacting / interdependent devices as defined above. The core tape intermediate product supply device can specifically be configured to provide a core tape intermediate product.
[0094] As used herein, the term "transfer foil application device" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to a device configured to apply any of the devices or sets of interacting / interdependent devices as defined above. The transfer foil application device can specifically be configured to apply at least one of a transfer foil, a further transfer foil, and a reverse transfer foil to a respective intermediate product, in particular to at least one of a core tape intermediate product or a transfer intermediate product.
[0095] As used herein, the term "separation device" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to a device configured to separate any of the devices or sets of interacting / interdependent devices as defined above. The separation device can specifically be configured to separate at least one of a first transfer intermediate product and a second transfer intermediate product, a further transfer foil from a third transfer intermediate product, and a transfer foil from a core tape, in particular after being transferred onto a support foil.
[0096] As used herein, the term "transfer device" is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically can refer, without limitation, to a device configured to transfer any of the devices or sets of interacting / interdependent devices as defined above. The transfer device can specifically be configured to transfer a core tape from at least one transfer intermediate product, in particular from at least one of a first transfer intermediate product and a second transfer intermediate product or a fourth transfer intermediate product and a fifth transfer intermediate product, onto a support foil.
[0097] In another aspect of the application, a plurality of analytical test elements is disclosed, which is produced by a method of manufacturing a plurality of analytical test elements according to the application, such as according to any of the embodiments disclosed above or according to any of the embodiments disclosed in more detail below. The plurality of analytical test elements produced by the method of manufacturing according to the application can be identified by being assembled in a unit of the plurality of analytical test elements manufactured, for example, in a roll or sheet unit of 10, 20, 50 or even 100 analytical test elements, which have perforation lines between adjacent analytical test elements. Additionally or alternatively, the plurality of analytical test elements produced by the method of manufacturing according to the application can be identified at the cutting edge between two separations of the plurality of analytical test elements, for example, at the common cutting edge of a batch manufacturing method or at the beveled cutting edge of a continuous manufacturing method.
[0098] The method of manufacturing and the manufacturing device according to the application can provide further advantages compared to known methods or devices, in particular. The method of manufacturing and the manufacturing device according to the application, in particular in a continuous manufacturing process, for example, as a roll-to-roll process, allows for continuously manufacturing disposable items, i.e. a plurality of analytical test elements. Further, the plurality of analytical test elements can be manufactured as a roll, wherein the core bands composed of the plurality of analytical test elements manufactured can be spaced apart from each other by a defined distance. A cover sealing foil, for example, an aluminum foil, can individually seal the core bands, in particular each core band. The cover sealing foil and / or the support foil can comprise perforation lines, such that the analytical test elements can be isolated from the plurality of analytical test elements by a user.
[0099] The method of manufacturing and the manufacturing device according to the application can in particular require a lower device effort, but still be suitable for manufacturing a plurality of analytical test elements in high throughput and at low production costs.
[0100] Summarizing and without excluding other possible embodiments, the following embodiments can be envisaged:
[0101] Embodiment 1. A method of manufacturing a plurality of analytical test elements, in particular diagnostic test elements, comprising at least one core band and at least one support foil band, the method comprising:
[0102] i. providing at least one core band intermediate product, the core band intermediate product comprising at least one carrier foil and at least one analytical element attached to the at least one carrier foil, the carrier foil and the attached analytical element being cut in the carrier intermediate product such that a plurality of core bands defining analytical test elements are placed next to each other;
[0103] ii. applying a transfer foil to the front side of the core tape intermediate product and to the back side of the core tape intermediate product, wherein the transfer foil applied to the front side and the transfer foil applied to the back side engage with the core tape in an alternating manner, the transfer foil on the front side and the core tape engaging with the transfer foil on the front side forming a first transfer intermediate product, the transfer foil on the back side and the core tape engaging with the transfer foil on the back side forming a second transfer intermediate product;
[0104] iii. separating the first transfer intermediate product and the second transfer intermediate product; and
[0105] iv. transferring the core tapes to at least one support foil, wherein the core tapes are spaced apart from each other on the support foil by at least one width of a core tape.
[0106] Embodiment 2. The method according to the preceding embodiment, wherein the method is carried out as a continuous manufacturing process.
[0107] Embodiment 3. The method according to the preceding embodiments, wherein at least one of the carrier foil, the analytical test element, the core tape intermediate product, the transfer foil and the support foil is provided as at least one web, in particular as at least one web provided via at least one roll, more in particular as a continuous sheet, more in particular as a continuous strip or web.
[0108] Embodiment 4. The method according to any one of the preceding embodiments, wherein the method is carried out as a roll-to-roll process.
[0109] Embodiment 5. The method according to any one of the preceding embodiments, further comprising at least one cutting process, wherein, in the cutting process, in particular in the longitudinal direction, at least a portion of at least one element is cut, wherein the at least one element is selected from the group consisting of: the core tape intermediate product; the first transfer intermediate product; the second transfer intermediate product.
[0110] Embodiment 6. The method according to the preceding embodiment, wherein the cutting process is a continuous cutting process.
[0111] Embodiment 7. The method according to any one of the two preceding embodiments, comprising recycling at least a portion of the material cut off, in particular the material of the transfer foil, during the cutting process.
[0112] Embodiment 8. The method according to any one of the preceding embodiments, further comprising:
[0113] v. applying at least one further transfer foil to at least one of the first transfer intermediate product and the second transfer intermediate product such that the core ribbon is embedded between the transfer foils, wherein the further transfer foil engages with every other one of the core ribbon located on the at least one of the first transfer intermediate product and the second transfer intermediate product, thereby resulting in a third transfer intermediate product; and
[0114] vi. removing the further transfer foil and the core ribbon engaged therewith from the third transfer intermediate product such that the further transfer foil and the core ribbon engaged therewith form a fourth transfer intermediate product, and such that after removal of the further transfer foil, the remaining transfer foils and the core ribbon engaged therewith of the third transfer intermediate product form a fifth transfer intermediate product.
[0115] Embodiment 9. The method according to the preceding embodiments, wherein steps v. and vi. are repeated, wherein after the first time steps v. and vi. are performed, steps v. are performed on at least one of the fourth transfer intermediate product and the fifth transfer intermediate product.
[0116] Embodiment 10. The method according to any one of the preceding embodiments, wherein the transfer foils comprise a plurality of through-holes arranged in rows, in particular rows oriented parallel to a longitudinal direction of extension of the respective transfer foil, wherein the method further comprises applying at least one adhesive tape to the transfer foils in such a way that at least one adhesive region of the adhesive tape engages with the carrier foil of the core ribbon through the through-holes.
[0117] Embodiment 11. The method according to the preceding embodiments, wherein the core ribbons placed next to each other on the core ribbon intermediate product have a pitch p, in particular a pitch corresponding to the width of the core ribbon, wherein the through-holes of each row have a pitch s, wherein:
[0118] s = 2 m * p, wherein m is a positive integer.
[0119] Embodiment 12. The method according to the preceding embodiments, wherein the transfer foils each comprise a plurality of at least two different rows of through-holes which differ from each other with respect to their pitch s of through-holes.
[0120] Embodiment 13. The method according to the preceding embodiments, wherein the transfer foils comprise at least one first row of through-holes, in particular two first rows of through-holes, wherein m = 1 ; and at least one second row of through-holes, in particular two second rows of through-holes, wherein m = 2; and optionally, at least one third row of through-holes, in particular two third rows of through-holes, wherein m = 3.
[0121] Example 14. The method according to any one of the three preceding examples, wherein, in step ii., the transfer foils on the front side and on the back side are offset by an offset distance of s / 2 in the longitudinal direction of the transfer foils, such that the transfer foils on the opposite faces of the core tapes are engaged with the core tapes in an alternating fashion via their respective adhesive strips.
[0122] Example 15. The method according to any one of the five preceding examples, further comprising at least one edge cutting process, wherein, in the edge cutting process, at least one portion of at least one of the transfer foils is cut off, in particular in the longitudinal direction, wherein the at least one portion that is cut off comprises at least one row of through-holes.
[0123] Example 16. The method according to the preceding example, wherein the edge cutting process is a continuous cutting process.
[0124] Example 17. The method according to any one of the preceding examples, wherein step i. comprises attaching at least one analytical element to at least one carrier foil, and further cutting the carrier foil and the attached analytical element, such that a plurality of core tapes is formed.
[0125] Example 18. The method according to any one of the preceding examples, wherein the core tape intermediate product has an extended longitudinal direction, in particular of the carrier foil web, wherein the core tape intermediate product is cut such that the plurality of core tapes of analytical test elements is oriented substantially perpendicular to the extended longitudinal direction.
[0126] Example 19. The method according to any one of the preceding examples, wherein the core tape intermediate product is cut such that the plurality of core tapes of analytical test elements is defined by a plurality of parallel cutting lines.
[0127] Example 20. The method according to any one of the preceding examples, wherein the core tape intermediate product further comprises a rim portion, in particular an uncut rim portion, in particular a rim portion extending in the extended longitudinal direction along the edges of the core tape intermediate product, wherein the plurality of core tapes is located between the rim portions.
[0128] Example 21. The method according to the preceding example, wherein, prior to separating the first transfer intermediate product and the second transfer intermediate product in step iii., the plurality of core tapes is held in place by the rim portions.
[0129] Example 22. The method according to any one of the two preceding examples, further comprising removing the rim portions, in particular cutting off the rim portions, prior to separating the first transfer intermediate product and the second transfer intermediate product in step iii.
[0130] Example 23. The method according to any one of the preceding examples, further comprising:
[0131] vii. covering the core tapes on the support foil with at least one lid sealing foil.
[0132] Example 24. The method according to any one of the preceding examples, which method can further comprise applying a perforation line into the support foil, wherein the core tapes are disposed thereon, and optionally also into the lid sealing foil, such that at least one perforation line is disposed between adjacent core tapes.
[0133] Example 25. The method according to any one of the preceding examples, wherein the core tapes placed next to each other on the core tape intermediate product have a pitch p, in particular a pitch corresponding to the core tape width, wherein on the support foil the core tapes are spaced apart from each other by a separation distance d:
[0134] d = (2 n - 1)*p, wherein n is a positive integer.
[0135] Example 26. The method according to any one of the preceding examples, wherein the at least one analytical element is selected from the group consisting of: a spreading velvet for receiving at least one liquid sample, in particular a bodily fluid, and / or at least one liquid sample obtained from a bodily fluid; at least one detection material configured for changing at least one measurable property, in particular at least one of an optically detectable property and an electrochemically detectable property, in the presence of at least one analyte to be detected; a sample application matrix; a blood cell separation matrix; a reagent or detection material storage matrix; a detection zone matrix; a wicking matrix.
[0136] Example 27. The method according to any one of the preceding examples, wherein each core tape has a contact face, and in step iv. is applied to the support foil with its contact face.
[0137] Example 28. The method according to the preceding example, wherein, in step iv., the core tapes are attached to the support foil by using an adhesive method, in particular selected from the group consisting of: gluing, in particular by using a hot-melt adhesive; welding.
[0138] Example 29. The method according to any one of the two preceding examples, wherein some of the transfer intermediates are realized such that the contact face of the core tape faces the transfer foil of the respective transfer intermediate, wherein the method further comprises:
[0139] viii. reversing the core tape having a contact face facing its respective transfer foil, the reversing comprising applying a reverse transfer foil to the core tape on a face opposite to the contact face of the core tape, the reversing further comprising removing the transfer foil from the contact face of the core tape.
[0140] Embodiment 30. The method according to any one of the preceding embodiments, wherein at least one of the transfer foils comprises a plurality of positioning markers, in particular positioning markers arranged in rows, more particularly in rows perpendicular to the longitudinal direction of the transfer foil.
[0141] Embodiment 31. The method according to the preceding embodiment, wherein the positioning markers comprise through-holes through the transfer foil.
[0142] Embodiment 32. The method according to any one of the two preceding embodiments, wherein at least two rows of positioning markers are located on opposite edges of the transfer foil.
[0143] Embodiment 33. The method according to any one of the three preceding embodiments, wherein the positioning markers are arranged in at least one row, in particular at least one row extending in the longitudinal direction of the transfer foil, wherein the positioning markers in the row have a pitch l, wherein the core tapes placed next to each other on the core tape intermediate product have a pitch p, wherein
[0144] p = q * l, wherein q is a positive integer.
[0145] Embodiment 34. A manufacturing device for manufacturing a plurality of analytical test elements, in particular diagnostic test elements, comprising at least one core tape and at least one support foil tape, wherein the manufacturing device comprises:
[0146] I. at least one core tape intermediate product supply device configured for supplying, in particular continuously supplying, at least one core tape intermediate product comprising at least one carrier foil and at least one analytical element attached to the at least one carrier foil, the carrier foil and the attached analytical element being cut in the core tape intermediate product such that a plurality of core tapes defining analytical test elements are placed next to each other;
[0147] II. at least one transfer foil application device configured for applying transfer foils to the front side and to the back side of the core tape intermediate product, wherein the transfer foils applied to the front side and the transfer foils applied to the back side engage with the core tapes in an alternating manner, the transfer foils on the front side and the core tapes engaging with the transfer foils on the front side forming a first transfer intermediate product, the transfer foils on the back side and the core tapes engaging with the transfer foils on the back side forming a second transfer intermediate product;
[0148] III. at least one separation device configured for separating the first transfer intermediate product and the second transfer intermediate product; and
[0149] IV. at least one transfer device configured for transferring, in particular continuously transferring, the core tapes to the at least one support foil such that the core tapes are spaced apart from each other on the support foil by at least one width of a core tape.
[0150] Embodiment 35. The manufacturing device according to any of the preceding embodiments, wherein the manufacturing device is configured for carrying out a method according to any of the preceding embodiments referring to a method for manufacturing a plurality of analytical test elements.
[0151] Embodiment 36. A plurality of analytical test elements produced by a method according to any of the preceding embodiments referring to a method for manufacturing a plurality of analytical test elements. BRIEF DESCRIPTION OF DRAWINGS
[0152] Further optional features and embodiments will be disclosed in more detail in the subsequent embodiment description, preferably in combination with dependent claims. Therein, as the skilled person will recognize, individual respective optional features can be realized in a separate manner as well as in any arbitrary feasible combination. The scope of the present application is not limited to the preferred embodiments. Embodiments are schematically depicted in the drawings. Therein, identical reference signs in these drawings refer to identical or functionally equivalent elements.
[0153] In the drawings:
[0154] Fig. 1 shows in a schematic view an embodiment of a manufacturing device according to the present application;
[0155] Fig. 2 shows a flow chart of an embodiment of a method for manufacturing a plurality of analytical test elements according to the present application; and
[0156] Figs. 3A to 3U show exemplary intermediate products and exemplary analytical test elements. DETAILED DESCRIPTION
[0157] Fig. 1 shows in a schematic view an exemplary embodiment of a manufacturing device 110 for measuring a plurality of analytical test elements, in particular diagnostic test elements 112 (see Figs. 3T and 3U), comprising at least one core tape 114 and at least one support foil tape 116. The manufacturing device 110 can in particular be configured for carrying out a method for manufacturing a plurality of analytical test elements 112 according to the present application, such as according to the embodiment shown in Fig. 2 and / or according to any other embodiment disclosed herein. Thus, with respect to the detailed description of the manufacturing method, reference is made to the description of Fig. 2.
[0158] The manufacturing device 110 comprises at least one core tape intermediate product supply device 118 configured for supplying at least one core tape intermediate product 120, in particular continuously, comprising at least one carrier foil 122 and at least one analytical element 124 attached to the at least one carrier foil 122, the carrier foil 122 and the attached analytical element 124 being cut in the core tape intermediate product 120 such that a plurality of core tapes 114 defining analytical test elements 112 are placed next to each other. In Fig. 1 the cutting line in the core tape intermediate product 120 supplied by the core tape intermediate product supply device 118 can not be visible as the width of the cutting line can be extremely small compared to the width of one core tape 116.
[0159] The manufacturing device 110 further comprises at least one transfer foil application device 126 configured for applying a transfer foil 128 to a front side 130 and to a back side 132 of the core tape intermediate product 120, wherein the transfer foil 128 applied to the front side 130 and the transfer foil 128 applied to the back side 132 are joined with the core tapes 114 in an alternating fashion, the transfer foil 128 on the front side 130 and the core tapes 114 joined with the transfer foil 128 on the front side 130 forming a first transfer intermediate product 134, the transfer foil 128 on the back side 132 and the core tapes 114 joined with the transfer foil 128 on the back side 132 forming a second transfer intermediate product 136.
[0160] The manufacturing device 110 further comprises at least one separation device 138 configured for separating the first transfer intermediate product 134 and the second transfer intermediate product 136. The manufacturing device 110 further comprises at least one transfer device 140 configured for transferring the core tapes 114, in particular continuously, onto at least one support foil 142 such that the core tapes 114 on the support foil 142 are spaced apart from each other by at least one width of one core tape 114. The manufacturing of the plurality of analytical test elements 112 can comprise at least one cutting step, in particular comprising cutting the core tape intermediate product 120, as will be outlined in further detail below, before separating the first transfer intermediate product 134 and the second transfer intermediate product 136. The cutting of the core tape intermediate product 120 can be performed before the separation step of the first transfer intermediate product 134 and the second transfer intermediate product 136 by the separation device 138.
[0161] In the example of Fig. 1, the manufacturing device 110 can be configured for carrying out the manufacturing method as a continuous manufacturing process, in particular as a roll-to-roll process. Thus, in the present example, the devices of the manufacturing device 110 can be or can comprise rolls for carrying out the respective manufacturing steps
[0162] Fig. 2 shows a flow chart of an exemplary embodiment of a method of manufacturing a plurality of analytical test elements 112 comprising at least one core tape 114 and at least one support foil tape 116 according to the present application. Figs. 3A to 3U show exemplary intermediate products and exemplary analytical test elements 112 obtained during carrying out the manufacturing method. Thus, the following description is made in connection with Figs. 2 to 3U.
[0163] The method comprises steps as shown in Fig. 2, which can be carried out in the given order as an example. However, it should be noted that different orders are also possible. Furthermore, one or more or even all of the method steps can be carried out once or repeatedly. Further, two or more method steps can be carried out simultaneously or in a timely overlapping manner. The method can comprise additional method steps which are not listed. Further, only steps i. to iv. of the manufacturing method can be carried out.
[0164] The method comprises providing at least one core tape intermediate product 120 (indicated by reference numeral 144). An exemplary embodiment of a core tape intermediate product 120 is shown in a top view in Fig. 3A. As can be seen from Fig. 3A, the core tape intermediate product 120 comprises at least one carrier foil 122 and at least one analytical element 124 attached to the at least one carrier foil 122. In the exemplary embodiment of a core tape intermediate product 120 shown in Fig. 3A, a plurality of analytical elements 124 can be attached to the at least one carrier foil 122 adjacent to each other. By attaching various different analytical elements 124, when a liquid sample is applied, an analytical assay can be conducted through a series of analytical elements 124, in particular by attaching analytical elements 124 selected from the group consisting of: a spreading fluff for receiving at least one liquid sample; at least one detection material configured to change at least one measurable property in the presence of at least one analyte to be detected; a sample application matrix; a blood cell separation matrix; a reagent or detection material storage matrix; a detection zone matrix; a wicking matrix in an interconnected manner at the at least one carrier foil 122. The carrier foil 122 in the carrier intermediate product 120 and the at least one analytical element 124 attached thereto are cut such that a plurality of core tapes 114 defining analytical test elements 112 are placed adjacent to each other. The core tapes 114 can in particular be placed adjacent to each other on the core tape intermediate product 120 having a pitch p (indicated by reference numeral 145), in particular having a pitch corresponding to the width of the core tapes 114.
[0165] Further, as shown in Fig. 3A, the core tape intermediate product 120 can have an extended longitudinal direction, in particular an extended longitudinal direction of the carrier foil web. The core tape intermediate product 120 can be cut such that the plurality of core tapes 114 of analytical test elements 112 are oriented substantially perpendicular to the extended longitudinal direction. The core tape intermediate product 120 can be cut such that the plurality of core tapes 114 of analytical test elements 112 are defined by a plurality of parallel cut lines 146. Further, in the present example, the core tape intermediate product 120 can further comprise a rim portion 148, in particular an uncut rim portion, in particular a rim portion 148 extending in the extended longitudinal direction along an edge of the core tape intermediate product 120. The plurality of core tapes 114 can be located between the rim portions 148.
[0166] The method further comprises applying the transfer foil 128 to the front side 130 and to the back side 132 of the core ribbon intermediate product 120 (indicated by reference numeral 150), wherein the transfer foil 128 applied to the front side 130 and the transfer foil 128 applied to the back side 132 are engaged with the core ribbon 114 in an alternating fashion, the transfer foil 128 on the front side 130 and the core ribbon 114 engaged with the transfer foil 128 on the front side 130 forming a first transfer intermediate product 134, the transfer foil 128 on the back side 132 and the core ribbon 114 engaged with the transfer foil 128 on the back side 132 forming a second transfer intermediate product 136.
[0167] An exemplary embodiment of the transfer foil 128 is shown in a top view in Fig. 3B. It can be seen that the transfer foil 128 can comprise a plurality of through-holes 152 arranged in rows, specifically rows oriented parallel to a longitudinal direction of extension of the respective transfer foil. The through-holes 152 of each row have a pitch s, wherein:
[0168] s = 2 m * p, wherein m is a positive integer.
[0169] Each of the transfer foils 128 can specifically comprise a plurality of at least two different rows of through-holes 152, the at least two different rows of through-holes 152 differing from each other with respect to their pitch s of through-holes 152. For example, in the exemplary embodiment of Fig. 3B, the transfer foil 128 can comprise at least one first row 154 of through-holes 152, specifically two first rows 154 of through-holes 152, wherein m = 1, and at least one second row 156 of through-holes 152, specifically two second rows 156 of through-holes 152, wherein m = 2, and at least one third row 158 of through-holes 152, specifically two third rows 158 of through-holes 152, wherein m = 3.
[0170] The method can further comprise, for example in step ii., applying at least one adhesive tape 160 to the transfer foil 128 in such a way that at least one adhesive zone of the adhesive tape 160 is joined with the carrier foil 122 of the core tape 114 through the through holes 152. An exemplary embodiment of the first transfer intermediate product 134 or the second transfer intermediate product 136 can be seen in the top view of Fig. 3C. In particular, Fig. 3C shows another exemplary embodiment of the transfer foil 128 applied to the core tape intermediate product 120 to form the first transfer intermediate product 134 or the second transfer intermediate product 136. In the following, the exemplary embodiment of the transfer foil 128 shown in Fig. 3C will be used. The corresponding first transfer intermediate product 134 or the second transfer intermediate product 136 of the example of Fig. 3C can comprise the respective transfer foil 128 which is offset by an offset distance of s / 2 in the longitudinal direction of the transfer foil 128 such that the transfer foil 128 on the opposite face of the core tape 114 is joined with the core tape 114 in an alternating fashion via its respective adhesive tape 160, in particular by the respective through holes 152. This can be seen from Fig. 3D. Fig. 3D shows the first transfer intermediate product 134 or the second transfer intermediate product 136 in a schematic side cut view along the through holes 152 of the first row 154 as indicated by the cutting line labeled III D in Fig. 3C. As shown in Fig. 3D, the transfer foil 128 applied to the front face 130 of the core tape intermediate product 120 can be joined with every second one of the core tapes 114 via the respective adhesive tape 160 through the through holes 152, wherein the transfer foil 128 applied to the back face 132 of the core tape intermediate product 120 can be offset by an offset distance of s / 2, in particular with respect to the transfer foil 128 applied to the front face 130 of the core tape intermediate product 120, and thus can be joined with the remaining core tapes 114 via the respective adhesive tape 160 through the through holes 152.
[0171] Further, as can be seen from Fig. 3C, at least one of the transfer foils 128, in particular both of the transfer foils 128 applied to the front side 130 and the back side 132, can comprise a plurality of positioning marks 162, in particular positioning marks 162 arranged in rows, more particularly in rows perpendicular to the longitudinal direction of the transfer foil 128. The positioning marks 162 can comprise through-holes through the transfer foil 128. At least two rows of positioning marks 162 can be located on opposite edges of the transfer foil 128. The positioning marks 162 can be arranged in at least one row, in particular at least one row extending in the longitudinal direction of the transfer foil 128. The positioning marks 162 in the row can have a pitch / , wherein the core bands 114 placed next to each other on the core band intermediate product 120 can have a pitch p, wherein
[0172] p = q * / , wherein q is a positive integer.
[0173] The method further comprises separating the first transfer intermediate product 134 and the second transfer intermediate product 136 (indicated by reference numeral 164). In particular, in the present example, the plurality of core bands 114 can be held in place by the rim portion 148 before separating the first transfer intermediate product 134 and the second transfer intermediate product 136 in step iii. The method can further comprise removing the rim portion 148, in particular cutting the rim portion 148, before separating the first transfer intermediate product 134 and the second transfer intermediate product 136 in step iii. Fig. 3E shows an exemplary embodiment of the separated first transfer intermediate product 134 and the second transfer intermediate product 136 in a top view. With respect to the first transfer intermediate product 134 (shown in the left part of Fig. 3E), the analytical elements 124 composed of core bands 114 are seen back-to-back from the perspective of the viewer, wherein the analytical elements 124 composed of core bands 114 of the second transfer intermediate product 136 (shown in the right part of Fig. 3E) are seen face-to-face from the perspective of the viewer. Thus, the analytical elements 124 of the first transfer intermediate product 134 are not visible in the view shown in Fig. 3E.
[0174] The method can further include applying at least one further transfer foil 166 to at least one of the first transfer intermediate product 134 and the second transfer intermediate product 136 (denoted by reference numeral 168) such that the core ribbon 114 is embedded between the transfer foils 128, 166, wherein the further transfer foil 166 is engaged with every other one of the core ribbon 114 located on at least one of the first transfer intermediate product 134 and the second transfer intermediate product 136, thereby resulting in a third transfer intermediate product 170. Exemplary embodiments of the third transfer intermediate product 170 are shown in FIG. 3F, FIG. 3G, and FIG. 3H. Specifically, FIG. 3F shows a top view of the third transfer intermediate product 170. FIG. 3G shows a schematic side cut view along the via 152 of the first row 154 of the third transfer intermediate product 170 obtained by applying the further transfer foil 166 to the second transfer intermediate product 136, as indicated by the cut line through the first row 154 denoted as III G in FIG. 3F. FIG. 3H shows a schematic side cut view along the via 152 of the first row 154 of the third transfer intermediate product 170 obtained by applying the further transfer foil 166 to the first transfer intermediate product 134, as indicated by the cut line through the first row 154 denoted as III G in FIG. 3F. As can be seen from FIG. 3G and FIG. 3H, the third transfer intermediate product 170 obtained from the first transfer intermediate product 134 and the second transfer intermediate product 136 can be inverted relative to each other.
[0175] The method can further comprise removing the further transfer foil 166 and the core tape 114 engaged therewith from the third transfer intermediate product 170 (indicated by reference 172) such that the further transfer foil 166 and the core tape 114 engaged therewith form a fourth transfer intermediate product 174 and such that after removal of the further transfer foil 166, the remaining transfer foil 128 of the third transfer intermediate product 170 and the core tape 114 engaged therewith form a fifth transfer intermediate product 176. Similar to step iii., the method can comprise at least one edge cutting process before removal of the further transfer foil 166. In the edge cutting process, at least one portion of at least one of the transfer foils 128 can be cut off, in particular in the longitudinal direction. The cut off at least one portion comprises at least one row of the through holes 152. In the present example, separating the fourth transfer intermediate product 174 and the fifth transfer intermediate product 176 can comprise cutting off the through holes 152 of the first row 154. Figures 31 and 3J exemplarily show the removal of the further transfer foil 166. Figure 31 shows an exemplary embodiment of the third transfer intermediate product 170 after cutting off the through holes 152 of the first row 154 in a schematic side view cut along the through holes 152 of the second row 156, as indicated by the cutting line III I through the second row 156 in Figure 3F. After cutting, the further transfer foil 166 can be removed with the core tape 114 engaged therewith, as exemplarily shown in Figure 3J in a top perspective view. Exemplary embodiments of the obtained fourth transfer intermediate product 174 and the fifth transfer intermediate product 176 are shown in Figure 3K in a top view. As can be seen from Figure 3K, the fifth transfer intermediate product 176 can comprise the analytical elements 124 of the core tape 114 facing away from the remaining transfer foil 128. With regard to the fourth transfer intermediate product 174 (shown in the left part of Figure 3K), the analytical elements 124 composed of the core tape 114 face away from the perspective of the viewer, wherein the analytical elements 124 composed of the core tape 114 of the fifth transfer intermediate product 176 (shown in the right part of Figure 3K) face towards the perspective of the viewer. Thus, the analytical elements 124 of the fourth transfer intermediate product 174 are not visible in the view shown in Figure 3K.
[0176] Accordingly, in the present exemplary embodiment, the method can further comprise reversing the core ribbon 114 having the contact face facing its respective transfer foil 128, in particular reversing the core ribbon 114 of the fifth transfer intermediate product 176 (denoted by reference numeral 178). Alternatively, for example, in case the core ribbon 114 can be transferred from the first transfer intermediate product 134 and the second transfer intermediate product 136 directly to the support foil 142, the method can comprise reversing the core ribbon 114 having the contact face facing its respective transfer foil 128, in particular reversing the core ribbon 114 of the second transfer intermediate product 136 (not shown in the figures). The reversing can comprise applying a reverse transfer foil 180 to the core ribbon 114 on a face opposite to the contact face of the core ribbon 114, the reversing further comprising removing the transfer foil 128 from the contact face of the core ribbon 114. The reversing can in particular comprise applying a reverse transfer foil 180 to the core ribbon 114 of the fifth transfer intermediate product 176, the reverse transfer foil in particular can be implemented identical to the transfer foil 128 and / or the further transfer foil 166. An exemplary embodiment of the reverse transfer foil 180 applied on the fifth transfer intermediate product 176 is shown in Fig. 3L and Fig. 3M. Fig. 3L shows in a top view the fifth transfer intermediate product 176 and an exemplary embodiment of the reverse transfer foil 180 applied, wherein Fig. 3M shows in a schematic side view cut along a via 152 of the third row 158 the fifth transfer intermediate product 176 and an exemplary embodiment of the reverse transfer foil 180 applied.
[0177] The reversing can further comprise cutting at least one row of vias 152 of the reverse transfer foil 180, in particular cutting the vias 152 of the second row 156 of the reverse transfer foil 180 and removing the transfer foil 128 from the fifth transfer intermediate product 176. An exemplary result of the reversing step is shown in Fig. 3N in a top view. Fig. 3N shows the reverse transfer foil 180 engaged with the core ribbon 114, wherein the contact face 182 can face away from the reverse transfer foil 180.
[0178] Returning to Fig. 2, the method further comprises transferring the core ribbons 114 onto at least one support foil 142 (indicated by reference numeral 184), wherein the core ribbons 114 on the support foil 142 are spaced apart from each other by at least one width of a core ribbon 114. An exemplary embodiment of the support foil 142 is shown in a top view in Fig. 30. In the present example, the support foil 142 can comprise at least one aluminum foil 186 and at least one adhesive foil 188 applied thereto. An exemplary embodiment of the core ribbons 114 transferred onto the support foil 142 is shown in a top view in Fig. 3P. As can be taken from Fig. 3P, the analysis elements 124 of the core ribbons 114 can face away from the support foil 142.
[0179] Further, as can be taken from Figs. 3A and 3P, the core ribbons 114 can be placed next to each other on the core ribbon intermediate product 120 having a pitch p, in particular a pitch corresponding to the width of the core ribbons 114 (see Fig. 3A). On the support foil 142 (see Fig. 3P), the core ribbons 114 can be spaced apart from each other by a separation distance d (indicated by reference numeral 190):
[0180] d = (2 n - 1)*p, wherein n is a positive integer.
[0181] In the present example, the separation distance can be d = 3*p.
[0182] An exemplary embodiment of the support foil 142 with the core ribbons 114 transferred thereon is shown in a schematic side cut view along the through-holes 152 of the third row 158 in Fig. 3Q. As can be taken from Fig. 3Q, the contact faces 182 of the core ribbons 114 can face the support foil 142 and the analysis elements 124 can face away from the support foil 142, in particular be covered by the inversion foil 180.
[0183] Further, the method can comprise cutting the through-holes 152 of the third row 158, removing the transfer foil 128 and / or the counterfoil 180, and covering the core tape 114 on the support foil 142 with at least one cover seal foil 192 (indicated by reference numeral 194). The covering of the core tape 114 on the support foil 142 is exemplarily shown in a top view in Fig. 3R. Fig. 3S shows the covered core tape 114 in a schematic side view cut. Further, covering the core tape 114 on the support foil 142 with the cover seal foil 192 can comprise sealing the core tape 114. In the present example, the cover seal foil 192 can be an aluminum foil. The sealing can comprise welding the cover seal 192 to the support foil 142, more specifically between and / or around the core tape 114 on the support foil 142. The seal can specifically be a gas-tight seal of the core tape 114. Thus, by sealing the core tape 114, the core tape 114 consisting of the analytical test elements 112 can be enclosed in a gas- and water-tight environment between the support foil 142 and the cover seal foil 192.
[0184] Further, the method can comprise applying a perforation line 196 into the support foil 142, wherein the core tape 114 is arranged thereon, and further into the cover seal foil 192, such that at least one perforation line 196 is arranged between adjacent core tapes 114. The manufactured plurality of analytical test elements 112 is shown in a top view in Fig. 3T and in a bottom view in Fig. 3U. As can be seen from Figs. 3T and 3U, the plurality of analytical test elements 112 produced by the manufacturing method according to the present application can be identified by assembling in units of the manufactured plurality of analytical test elements 112, for example in a roll or sheet unit of 10, 20, 50 or even 100 analytical test elements 112, which have a perforation line 196 between adjacent analytical test elements. As can be seen from Figs. 3T and 3U, the plurality of analytical test elements 112 can each comprise an indication for opening the analytical test element 112, such as an arrow indicating the opening direction, specifically for a simple opening of the analytical test element 112, for example by separating the cover seal foil 192 from the support foil 142, thereby revealing the core tape 114 having the analytical elements 124 consisting of the analytical test elements 112.
[0185] List of reference signs
[0186]
Claims
1. A method for manufacturing a plurality of analytical test elements (112) comprising at least one core strip (114) and at least one support foil strip (116), the method comprising: i. Provide at least one core strip intermediate product (120), the core strip intermediate product (120) comprising at least one carrier foil (122) and at least one analytical element (124) attached to the at least one carrier foil (122), the carrier foil (122) and the attached analytical element (124) being cut in the carrier intermediate product (120) such that a plurality of core strips (114) defining the analytical test element (112) are placed adjacent to each other; ii. A transfer foil (128) is applied to the front (130) and back (132) of the core strip intermediate product (120), wherein the transfer foil (128) applied to the front (130) and the transfer foil (128) applied to the back (132) are alternately bonded to the core strip (114), the transfer foil (128) on the front (130) and the core strip (114) bonded to the transfer foil (128) on the front (130) form a first transfer intermediate product (134), and the transfer foil (128) on the back (132) and the core strip (114) bonded to the transfer foil (128) on the back (132) form a second transfer intermediate product (136); iii. Separate the first transfer intermediate product (134) and the second transfer intermediate product (136); as well as iv. Transfer the core strip (114) onto at least one support foil (142), wherein the core strips (114) are spaced apart from each other on the support foil (142) by at least the width of one core strip (114).
2. The method according to the preceding claim, wherein the method is performed as a roll-to-roll process.
3. The method according to any one of the preceding claims, the method further comprising at least one cutting process, wherein, During the cutting process, at least a portion of at least one element is cut, wherein the at least one element is selected from the group consisting of: the core strip intermediate product (120); the first transfer intermediate product (134); and the second transfer intermediate product (136).
4. The method according to any one of the preceding claims, further comprising: v. Applying at least one additional transfer foil (166) to at least one of the first transfer intermediate product (134) and the second transfer intermediate product (136), such that the core strip (114) is embedded between the transfer foils (128, 166), wherein the additional transfer foil (166) engages with every other core strip (114) located on at least one of the first transfer intermediate product (134) and the second transfer intermediate product (136), thereby producing a third transfer intermediate product (170); and vi. Remove the additional transfer foil (166) and the core strip (114) attached thereto from the third transfer intermediate product (170), such that the additional transfer foil (166) and the core strip (114) attached thereto form a fourth transfer intermediate product (174), and such that after removing the additional transfer foil (166), the remaining transfer foil (128) of the third transfer intermediate product (170) and the core strip (114) attached thereto form a fifth transfer intermediate product (176).
5. The method according to any one of the preceding claims, wherein the transfer foil (128) includes a plurality of through holes (152) arranged in a row, wherein the method further comprises applying at least one adhesive tape (160) to the transfer foil (128) in such a manner that at least one adhesive area of the adhesive tape (160) is engaged with the carrier foil (122) of the core tape (114) through the through holes (152).
6. The method according to the preceding claim, wherein the core strips (114) placed adjacent to each other on the core strip intermediate product (120) have a pitch p (145), wherein the through holes (152) in each row have a pitch s, wherein: s = 2 m * p, where m is a positive integer.
7. The method according to the preceding claim, wherein each of the transfer foils (128) comprises a plurality of at least two different rows of through holes (152), the at least two different rows of through holes (152) having different pitches s with respect to their through holes (152).
8. The method according to any one of the preceding two claims, wherein, In step ii., the transfer foil (128) on the front side (130) and the back side (132) is offset by an offset distance of s / 2 in the longitudinal direction of the transfer foil (128), such that the transfer foil (128) on the opposite side of the core strip (114) is alternately bonded to the core strip (114) via its respective adhesive tape (160).
9. The method according to any one of the preceding four claims, the method further comprising at least one edge cutting process, wherein, During the edge cutting process, at least a portion of at least one transfer foil in the transfer foil (128) is cut off, wherein the cut-off at least one portion includes at least one row of through holes (152).
10. The method according to any one of the preceding claims, wherein the core strip intermediate product (120) further includes an edge portion (148), wherein the plurality of core strips (114) are located between the edge portions (148), the method further comprising removing the edge portions (148) before separating the first transfer intermediate product (134) and the second transfer intermediate product (136) in step iii.
11. The method according to any one of the preceding claims, further comprising: vii. Cover the core strip (114) on the support foil (142) with at least one capping foil.
12. The method according to any one of the preceding claims, wherein the core strips (114) placed adjacent to each other on the core strip intermediate product (120) have a pitch p (145), wherein, On the support foil (142), the core strips (114) are spaced apart from each other by a separation distance d (190): d = (2 n - 1)*p, where n is a positive integer.
13. The method according to any one of the preceding claims, wherein each of the core strips (114) has a contact surface (182) and is applied to the support foil (142) with its contact surface (182) in step iv., wherein some of the transfer intermediate products (134, 136, 170, 174, 176) are configured such that the contact surface (182) of the core strip (114) faces the transfer foil (128) of the corresponding transfer intermediate product (134, 136, 170, 174, 176), wherein the method further comprises: viii. Reversing the core strip (114) having a contact surface (182) facing its respective transfer foil (128), the reversal comprising applying a reversing transfer foil (180) to the core strip (114) on the surface of the core strip (114) opposite to the contact surface (182), the reversal further comprising removing the transfer foil (128) from the contact surface (182) of the core strip (114).
14. A manufacturing apparatus (110) for manufacturing a plurality of analytical test elements (112) comprising at least one core strip (114) and at least one support foil strip (116), wherein the manufacturing apparatus (100) comprises: I. At least one core strip intermediate product supply device (118) configured to supply at least one core strip intermediate product (120), the core strip intermediate product (120) comprising at least one carrier foil (122) and at least one analytical element (124) attached to the at least one carrier foil (122), the carrier foil (122) and the attached analytical element (124) being cut in the core strip intermediate product (120) such that a plurality of core strips (114) defining the analytical test element (112) are placed adjacent to each other; II. At least one transfer foil application device (126) configured to apply a transfer foil (128) to the front (130) and back (132) of the core strip intermediate product (120), wherein the transfer foil (128) applied to the front (130) and the transfer foil (128) applied to the back (132) are alternately engaged with the core strip (114), the transfer foil (128) on the front (130) and the core strip (114) engaged with the transfer foil (128) on the front (130) form a first transfer intermediate product (134), and the transfer foil (128) on the back (132) and the core strip (114) engaged with the transfer foil (128) on the back (132) form a second transfer intermediate product (136); III. At least one separation device (138) configured to separate the first transfer intermediate product (134) and the second transfer intermediate product (136); as well as IV. At least one transfer device (140) configured to transfer the core strip (114) onto at least one support foil (142) such that the core strips (114) are spaced apart from each other on the support foil (142) by at least the width of one core strip (114).
15. A plurality of analytical test elements (112) wherein the plurality of analytical test elements (112) are manufactured by the method according to any one of the preceding claims relating to the manufacture of the plurality of analytical test elements (112).
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