HK1163807A - Method for producing an analytical consumable - Google Patents

Description

Method for producing an analytical consumable

Technical Field

The invention relates to a method and a device for producing an analytical consumable. Analytical consumables of this type are used in particular in medical diagnostics in order to qualitatively or quantitatively detect at least one analyte in a sample, for example a sample of a body fluid. However, other fields of application are also conceivable, for example in chemical analysis.

Background

In medical diagnostics in particular, various types of consumables are known, which are usually designed as disposables and which have to be produced quickly, reliably and inexpensively. In clinical diagnostics, therefore, the study of samples of, for example, blood or other body fluids, such as interstitial fluid, makes possible an early and reliable identification of pathological conditions and a suitable and acute control of the physical condition.

Medical diagnosis is usually premised on obtaining a sample of blood or interstitial fluid from a patient to be examined. For this purpose, the skin, for example on the finger pad or the earlobe, is usually punctured with the aid of a sterile, pointed or sharpened lancet/lancet (Lanzette) in order in this way to obtain a little blood for analysis. Self-help blood glucose determination is a worldwide-promoted method in diabetes screening today. In the prior art, blood glucose meters usually have an analytical device which interacts with at least one analytical consumable, in particular a test element. The sample to be analyzed is usually applied to the test field of the test element and, if possible, reacts in the test field with one or more reagents, which are usually selected to be specific for the analyte to be detected. The reaction can be detected, for example, optically and/or electrochemically.

Analytical consumables in the form of test elements are only one example of a large number of consumables used in analysis, in particular medical analysis. Many further applications using consumables are conceivable. In principle, the invention described below can be applied to all types of such analytical consumables according to the prior art.

However, with the use of analytical consumables of this type, in particular in medical diagnostics, a series of technical difficulties arise in practice, which must be overcome by expensive instrument solutions. It is therefore difficult that different kinds of analytical consumables which can be used in an analytical system may differ from one another. Thus, for example, differences can be made with respect to the manufacturer and/or the manufacturing method, with respect to the detection reagent used, with respect to the analyte to be detected, with respect to the analytical method and/or the analytical system to be used, with respect to the conditions under which the analysis should be carried out, with respect to the parameters and/or algorithms for analyzing the measurement results, with respect to the batch number, with respect to batch-specific characteristics, with respect to the production method, with respect to the number of analytical segments on the test element, etc. Therefore, information about the difference and/or other types of differences should be transmitted to the analysis instrument using the analysis aid. In the case of analytical aids with lancets or other types of medical disposables, item-specific information of this type, in particular information about the manufacturer, the lancet type, the lancet system to be used, etc., can also be derived. This type of information, which is provided to make it possible for at least one medical instrument to use the analytical consumable or a component of the analytical consumable correctly, is generally referred to below as functional information. This type of functional information can include, for example, the above-mentioned information and/or additional information described below. Alternatively or additionally, other information can also be included. The functional information can include, for example, consumable specific information and/or accessory specific information. Here, the expression consumable-specific information relates to the analytical consumable information as a whole, while the auxiliary-specific information relates primarily to the individual analytical aids, for example the individual test fields and/or lancets, which are included in the analytical consumable.

In many cases, therefore, the analytical consumable needs to be correspondingly coded, i.e. provided with a readable code, in order to be able to provide the information accordingly, as soon as it needs to be provided accordingly. An important example of an application is the automatic reading of functional information, for example consumable-specific information, by analytical instruments which are intended to use medical disposables, for example test strips, test strips or lancets. Since manual entry and reading of functional information of this type is generally unacceptable or even impractical for the patient, different methods and systems are known from the prior art in which functional information can be read in automatically. Systems are therefore known, for example, in which functional information of this type can be transmitted via a high-frequency tag separately written to a data carrier (for example a so-called ROM Key) or similar code carrier in a measuring instrument. However, an additional code carrier of this type as an additional component leads to higher costs in the production, which is generally not desirable. For this, user actions are usually required, for example writing a ROM-Key into the measuring instrument, which may incorporate the possibility of erroneous operation.

Systems in which the consumable itself is encoded are also known from the prior art. DE19849539a1 describes a portable blood glucose meter for self-examination by diabetics. The meter utilizes a test strip for determining blood glucose that is wound on a cartridge as a strip having a plurality of test sections. In this case, it is proposed, among other things, to code the production quality on the test strip in order to make possible an automatic calibration of the blood glucose meter for the respective production lot of the tape cassette.

A cassette for biochemical analysis having a long test membrane with detection reagents is known from EP0299517a 2. In this case, it is proposed, inter alia, that a coding region is provided on the test strip at the beginning of the test strip, which coding region contains at least one piece of information. The coded areas can be read, for example, with a detector applied for optical measurements.

However, known encoding methods, such as the one described in EP0299517a2, have in practice a number of disadvantages and technical difficulties. Thus, for example, this type of coding method is comparatively expensive, since it requires a structured application of the marking substance. This in turn places high technical demands on the production, since the structuring must be done with high resolution and must be able to adapt flexibly to the information written at the same time. It is also to be taken into account that the coding process must be carried out under high purity conditions, since the analytical aids contained in the analytical consumables should not be contaminated by the coding material.

Disclosure of Invention

It is therefore an object of the present invention to provide a method and a device for producing analytical consumables, which avoid the disadvantages of the known methods and make possible a coding with a high information density.

This object is achieved by a method and a device having the features of the independent claims. Advantageous developments of the invention, which can be realized individually or in combination, are indicated in the dependent claims. The proposed method can be carried out in particular using the device according to the invention and can be provided for carrying out the method according to the invention. In this connection, reference can be made to the description of the method and vice versa for the relevant possible embodiments of the device.

The proposed method is used for manufacturing analytical consumables. The assay consumable has at least one carrier and at least one assay aid attached to the carrier. An analytical consumable is generally understood here to mean an object which is intended for a single use or for a use which comprises only a small number of times in an analysis, for example in a chemical and/or biochemical and/or medical analysis. A particular emphasis is here on medical analysis and/or diagnosis, that is to say on the detection of at least one analyte in a sample, in particular a liquid sample (for example a body fluid). In this case, the detection can be carried out qualitatively and/or quantitatively and can, for example, comprise the detection of metabolites. One particular emphasis is on the detection of glucose in blood (blood glucose) and/or urine and/or interstitial fluid. However, in principle also other types of analytes can be detected, so that measurements required in medical diagnostics can be performed, such as cholesterol measurements, lactate measurements, coagulation measurements, etc. Other types of measurements in liquids are also possible. In principle, the invention can also be transferred to other fields of science and/or technology where analysis is required.

Depending on the intended purpose of use, at least one analytical aid can also be formed. An analytical aid is understood to mean, in each case, a device which serves the respective analytical purpose of the consumable and/or supports said purpose. The device can be completely integrated with the remaining components of the analytical consumable, but can also be contained as a separate element within the analytical consumable. For example, the purpose for which the analytical aids are used can be to provide the sample to be analyzed and/or the sample analysis itself, in particular to detect at least one analyte. Accordingly, the analytical aids can comprise, for example, one or more of the following analytical aids: a test field for detecting at least one analyte in a sample, in particular for detecting a metabolite in a body fluid; device for generating and/or providing a liquid sample, in particular a lancet. The test zone can, for example, comprise a detection chemical having at least one detection reagent that changes at least one measurable property of a physical and/or chemical property in the presence of at least one analyte. The detection reagent is for example capable of performing a corresponding analyte-specific reaction which can be detected optically and/or electrochemically. Reference is made to the prior art with regard to possible embodiments of test zones and/or test chemicals of this type.

The device for generating and/or supplying a liquid sample can also be arranged in different ways. Thus, for example, lancets can be provided which have sharp cutting surfaces and/or points which are provided for piercing a skin region of a user. However, a complete set of devices is also possible, for example devices which are used for piercing purposes as well as for transport purposes (i.e. for example devices which additionally have at least one capillary and/or other transport elements).

One type of analytical aid can be provided in the analytical consumable or a plurality of different types of analytical aids can also be combined. Thus, for example, a plurality of lancets can be provided, for example on an analytical tape, or a plurality of test fields can be provided, for example also on an analytical tape or a test tape, or a layout with, for example, alternating test fields and lancets can also be provided instead. Different embodiments are also conceivable.

The analytical consumable can be configured in different ways and the analytical consumable can comprise at least one analytical aid, preferably a plurality of analytical aids, in different ways. For example, an analysis tape having a carrier tape and a plurality of analysis aids arranged on the carrier tape can be provided. A carrier tape is understood here to mean, for example, a plastic tape, a paper tape, a laminate tape, a textile tape, an endless chain or a similar, flexible and elongate carrier device. Alternatively or additionally, the analytical consumable can also comprise, for example, a test strip with at least one analytical aid, in particular a disposable, for example a disposable with one or more coding regions. Alternatively or additionally, the analytical consumable can also comprise a test disk with a plurality of analytical aids arranged on the surface and/or edge of the test disk (Testscheibe). Also alternatively or additionally, a foldable consumable can be provided, which has a plurality of analytical consumables, for example according to the Leporello principle.

Corresponding to the at least one analytical consumable and the at least one analytical aid, can also constitute a carrier. The carrier can thus be designed, for example, to be flexible and/or deformable or can also have hard properties depending on the purpose of use. Thus, for example, deformable carriers are preferably used in the case of carrier tapes and in the case of foldable consumables, whereas rigid carrier properties are generally desired in the case of test disks. Accordingly, the carrier can comprise, for example, a paper material, a plastic material, a ceramic material, a textile material or a combination of these and/or other materials.

Without limiting further possible embodiments of the invention, the invention is described below with reference to an analytical consumable in the form of a tape cassette (bandkasette) comprising an analytical tape with a carrier tape and a plurality of analytical aids arranged on the carrier tape. In this case, the emphasis is again placed in particular on the analytical aids in the form of test zones, wherein, however, as mentioned above, other embodiments are generally also possible.

In the production method according to the invention, at least one photosensitive material is applied to the carrier. The photosensitive material is arranged to perform at least one optically detectable change under the influence of electromagnetic radiation. The photosensitive material should preferably not coincide with the material of the carrier. That is, the step of applying the photosensitive material should be performed separately from the manufacture of the carrier. Alternatively or additionally, however, in principle other embodiments are also possible, i.e. embodiments in which, for example, the photosensitive material corresponds wholly or partly to one or more materials of the carrier are also possible. In this case, the application step of the photosensitive material can also be combined, in whole or in part, with the manufacture of the support itself.

The sensitivity of the electromagnetic radiation and thus of the photosensitive material can be in particular in the visible and/or infrared and/or ultraviolet spectral range, so that the presence of sensitivity to light is particularly preferred. In principle, photosensitive materials and/or combinations of photosensitive materials can be used here, which carry out any optically detectable change. This can be, for example, a change in the color properties, a change in the reflection properties, a change in the absorption properties or also a change in the refractive index. Combinations of the described and/or other optically detectable properties are also useful.

In the method according to the invention, furthermore, at least one piece of functional information about the analytical consumable is written into the photosensitive material in at least one coding step by means of electromagnetic radiation. The functional information is provided to make it possible for at least one analytical device (which interacts with the analytical consumable) to correctly use the analytical consumable. The analysis device can comprise, for example, a medical device, for example, a medical hand-held device, in particular a hand-held device which can be used for medical diagnosis. In this case, for example, a blood glucose meter with at least one measuring function and/or at least one sample acquisition function can be used, that is to say, for example, the measurement of the blood glucose content in a blood sample and/or the generation of a blood sample. However, other embodiments are also conceivable.

Functional information is generally understood here to mean information which relates to the interaction of the analytical consumable with the analytical instrument, i.e. which makes possible or supports the interaction. For possible contents or embodiments of the functional information, reference can be made, for example, to the above description of the prior art. The concept should not include information about analyzing the consumable for defects, that is to say defect information, for example information about defects, defect-free properties, quality degree or similar defect information. However, this type of defect information can be included in addition to the at least one function information.

In this context, at least one piece of functional information is not conceptually distinguished from its meaning and/or physical form in the following. The functional information can thus be present, for example, in a form recognizable and decodable to humans, for example, as alphanumeric symbols. Alternatively or additionally, however, the functional information can also be present in an encoded form, so that its information content is not recognizable and/or usable until after the respective decoding step. The latter are also referred to as codes, wherein, for example, a distinction can be made between codes that are readable by humans and codes that are only machine-readable.

Accordingly, the at least one function information can, for example (as embodied above), comprise at least one consumable-specific and/or auxiliary-specific information. For example, the at least one function information can include one or more of the following information: information about the manufacturer and/or the manufacturing method; information about the contained detection reagent; information about the analyte to be detected; information about the analysis method and/or analysis system to be used; information about the conditions under which the analysis should be performed; information about parameters and/or algorithms for analyzing the measurement results, in particular for at least one correction factor and/or at least one function curve; information about the lot number and/or at least one individual identification; information about batch-specific characteristics; information on the number of analytical aids; information about the type of device used for generating and/or providing the liquid sample, in particular the lancet; information about the device, in particular the lancet, to be used for generating and/or providing a liquid sample; durability information, particularly durability date and/or durability limit; and (4) use limitation. The use limit can, for example, limit the determined use of the analytical aid in the analytical instrument when the analytical instrument reads the use limit. The use restrictions in the analytical device can be used, for example, to prevent the use of a defined analytical consumable or a part thereof on the device or for similar purposes. The usage restriction can, for example, include inhibition information that inhibits use on a given instrument.

In particular, information about the manufacturer and/or the manufacturing method can be included. The manufacturer or the manufacturing method can relate to the analytical consumable as a whole or also to parts of the analytical consumable, for example one or more analytical aids, which are included in the analytical consumable. Alternatively or additionally, the functional information can include information about the contained detection reagent. For example, the type of detection reagent, expiration date, manufacturing date, lot-specific sensitivity, etc. can be included in the encoded form. Still alternatively or additionally, information about the analyte to be detected can be included. Also alternatively or additionally, information about the analysis method and/or analysis system to be used can be included. For example, it can contain in encoded form: what blood glucose meter is suitable for the respective analytical consumable and/or the one or more analytical aids contained in the analytical consumable. In this way, for example, operating errors can be detected in a timely manner, for example, by eliminating the use of unsuitable analytical instruments for the respective consumable or vice versa. In addition (again, alternatively or additionally) information about the conditions under which the analysis should be carried out can also be included. For example, parameters for optimal illumination can be specified in the optical test element and/or optimal current and/or voltage parameters can be specified in the electrochemical test element. Various other embodiments are conceivable. Alternatively or additionally, information about parameters and/or algorithms for evaluating the measurement results can be specified. In particular, in this way, for example, correction factors and/or at least one function curve can be specified, which may be necessary for the analysis of the analyte. In this way, in particular, batch-specific fluctuations can be compensated for by jointly providing a correction factor and/or a function curve for each batch of consumables and/or for each individual analytical aid in the consumable. This type of batch-specific feature is not necessary for individual input by the user and/or by means of an individual data carrier. Alternatively or additionally, the functional information can comprise, for example, a function relating to the number of analytical aids. Thus, for example, the total number of analytical aids in the consumable and/or the number of analytical aids still available for use and/or already in use can be specified. This information can be used, for example, by the analysis device to prompt the user to obtain and/or provide a new analytical consumable in a timely manner. Still alternatively or additionally, information about the type of device used for generating and/or providing the liquid sample can be included. As indicated above, the device can be in particular a lancet. This information can be used, for example, to use the correct drive system for the respective lancet and/or to exclude the use of an unsuitable lancet by the analysis device. As a further alternative or in addition, information about the device to be used for generating and/or providing the liquid sample, in particular the lancet, can also be included, so that the user can be prompted to use the correct device and/or the correct analytical consumable in the analytical instrument, for example from the beginning.

In contrast to known encoding methods, for example the encoding method disclosed in EP0299517a2, the encoding method proposed by the present invention can be designed comparatively simply, wherein, however, the encoding can be applied with a high information density. In contrast to known printing methods for applying color markings, bar codes or the like can, in contrast, carry out the application of the photosensitive material roughly, unstructured or structured only with low resolution. In this case, expensive printing methods can be completely dispensed with. The original encoding, which can be carried out with high resolution, can then be carried out in a structured manner by means of electromagnetic radiation, which can be used with high energy density.

In this case, a high resolution can be achieved by using suitable focused and/or focused radiation, for which purpose, for example, corresponding optics can be provided in the method according to the invention. One or more electromagnetic radiation sources can be provided, which can provide suitable electromagnetic radiation. In principle any type of such electromagnetic radiation source can be used. Due to the potentially high energy density and the potentially strong bunching and/or focusing, it is however particularly preferred to use one or more lasers, so that the electromagnetic radiation preferably comprises at least one laser radiation. For example, lasers in the ultraviolet spectral range and/or the visible spectral range and/or the infrared spectral range can be used here. Since laser radiation generally provides radiation in a very narrow band, adaptation of the electromagnetic radiation to the properties of the photosensitive material can be suitably carried out by means of a suitable selection of the wavelength of the laser radiation. Thus, for example, electromagnetic radiation in a wavelength range in which the photosensitive material has a high absorption, for example an absorption peak, can be selected. Damage to further components of the analytical consumable, for example to the carrier, can also be avoided by this suitable selection of the wavelength, for example by the carrier not being absorbed or only being absorbed very little in this wavelength range, whereas the light-sensitive material is absorbed in a larger amount. Thus, for example, the absorption of the photoactive material (e.g. the absorption coefficient of the photoactive material) is configured to be at least twice, preferably at least ten times, hundred times or more, the absorption of the carrier at the selected wavelength and/or in the selected wavelength range of the electromagnetic radiation.

Despite the possibility of applying the photosensitive material unstructured or structured only with low resolution to the support, for example with one or more coding regions having a size range of at least 500 μm, preferably at least 1mm, a high information density can still be achieved by means of electromagnetic radiation. Thus, one-, two-or three-dimensional structures can be introduced, in particular written, into the photosensitive material in a finely structured manner. For example, at least one-dimensional barcode and/or two-dimensional barcode and/or at least one three-dimensional barcode can be introduced into the light-sensitive material in the encoding step. In this case, for example, standardized barcodes can be provided, which can be analyzed using a conventional barcode reader and/or using a conventional decoding algorithm for barcodes in order to decode the functional information contained therein. In this case, however, a barcode is understood to mean in principle any marking which can be used as an information carrier, in particular as an optical information carrier, for example as an information carrier having a plurality of information fields.

For reading the at least one functional information, generally any detector can be used, which can be wholly or partially included in the analysis instrument. In this case, additional detectors can be used, which are independent of the remaining functions of the analysis device. Alternatively or additionally, however, it is also possible to use a detector which can be present anyway within the analysis instrument by being able to use it in a multifunctional manner. For example, if an analytical instrument in the form of an optical measuring instrument, for example an optically based blood glucose meter, is used, at least one optical detector is usually present in the analytical instrument, which optical detector records, for example, the color or the color change in one or more test fields of the analytical consumable. The detector can be used in a multifunctional manner in order to additionally also read out the at least one function information. For example, position sensors, measuring optics or additional sensors present on the instrument side can be used for reading the functional information (which can be present in encoded form). The at least one functional information can be provided, for example, in one or more coding regions. The coding region can be accessible on the tape, for example, via a position sensor window present in the cassette housing, via an additional window and/or via a transparent housing, for example a plastic housing.

The analytical consumable can accordingly have at least one housing in which the analytical aids are at least partially accommodated. The housing can have at least one transparent region, in particular a window, wherein the transparent region can be at least partially transparent to electromagnetic radiation, for example laser radiation. Alternatively or additionally, the at least one transparent area can also be at least partially transparent for the optical detection of the optically detectable change, that is to say for example for at least one detection wavelength and/or detection wavelength range used in the detection. In this way, the coding region printed on the tape can be written and/or read, for example, through a position sensor window, through an additional window or through a plastic housing that is transparent to laser light or detection wavelengths.

If the sensor within the analysis instrument is used in a multifunctional manner, it is possible, for example, to use a strip sensor and/or measuring optics, which have the following capabilities: at least one piece of functional information, for example a bar code with batch calibration information, is also read through the window for the detection of the position of the strip or for the analysis of the test field or the test chemical through the measurement window.

As indicated above, the light-sensitive material can be applied to the carrier, for example, in the form of at least one coding region. For example, polygonal, in particular rectangular, and/or near-round (round), for example circular and/or oval, coding regions can be used. In this case, it is advantageous in the proposed method that the coding regions (as shown above) can be applied with low resolution. The coding region can thus have, for example, lateral dimensions, such as a diameter and/or edge length, which are at least 200 μm, in particular at least 500 μm and preferably at least 1 mm. The functional information that can be originally introduced with high resolution is then introduced by means of electromagnetic radiation, which, as described above, can be done with high resolution without high technical expenditure. In this regard, a high information density can be obtained.

For applying the coding region, for example, a printing method can be used, in which the photosensitive material and/or the starting material of the photosensitive material is printed onto the carrier. By starting material is herein understood a material which forms a photosensitive material after at least one conversion step. The conversion step may be any physical and/or chemical step, such as a reaction and/or phase conversion and/or drying and/or crosslinking (vernetzen). Alternatively or additionally, a lamination process can be used, in which at least one film of photosensitive material is laminated and/or glued to a carrier. In this way, for example, the coding region can be completed beforehand in order to then apply the coding region as a whole to the vector. For this purpose, for example, conventional labeling methods can be used.

The at least one coding region is preferably arranged spatially separated from the at least one analytical aid. If a plurality of analytical aids are provided, one or more specific coding regions can be assigned in each case a single analytical aid, a group of analytical aids or all analytical aids. For example, a strip can be provided on which a plurality of analytical aids are arranged. In this case, for example, at least one coding region which exclusively carries functional information for at least one analytical aid can be arranged alternately with the analytical aids before and/or after each analytical aid, every second analytical aid or every nth analytical aid. However, still other embodiments are possible.

At least one coding region can also take over further functions. Thus, the at least one coding region can, for example, additionally take over the function of a position marker and/or be combined with one or more position markers on the analytical consumable. The coding region can be arranged, for example, at a plurality of predefined and/or known positions on the analytical consumable, wherein the coding region is arranged for use in whole or in part as a position marker. The setting can be done, for example, by arranging it at a known position. Alternatively or additionally, the coding region can also have a geometric form that can be easily recognized by an analysis instrument in order to perform position marking or position determination in this way. This type of position marking is advantageous in particular in cassettes. As indicated above, the photosensitive material can be configured in different ways. The light-sensitive material as the additional color zone can thus be printed as a code carrier for functional information on a carrier, for example a reagent carrier tape. The photosensitive material can be embodied, for example, as a laser-activatable material. Accordingly, the at least one coding region can be embodied, for example, as a laser-activatable region.

As mentioned above, the optically detectable change of the at least one light-sensitive material is performed locally in the encoding step. Correspondingly, the at least one photosensitive material can comprise a large number of known materials which undergo an optically detectable change of this type under the action of at least one electromagnetic radiation. For example, the material can be a dye, for example a dye which discolors and/or performs a color change under the action of electromagnetic radiation, in particular also a change from black to white or vice versa, which causes fluorescence and/or phosphorescence or which likewise changes its absorption and/or transmission properties. The dyes can be used here as a single layer, but in particular can also be dissolved and/or dispersed or otherwise introduced in the matrix material. For example, laser-activatable dyes can be used. Furthermore, pigments, that is to say inorganic or organic, chromatic or achromatic colorants which are not present in dissolved form, can also be used. In this case, for example, laser-activatable pigments can be used. As already mentioned above, also alternatively or additionally, the optically detectable change can also comprise, for example, a change in the refractive index. In this case, for example, techniques can be used which are typically used in holographic data storage, so that, for example, holograms of this type can be introduced into the photosensitive material. For example, plastic materials can be used for this purpose. In particular, plastics can be used here, which change the refractive index under the effect of electromagnetic radiation. Thus, for example, instead of or in addition to the laser-activatable printing, which makes a black-white change possible, suitable film materials can also be structured in an optically recognizable manner, for example, similar to known holograms which can be burned into adhesive films. By means of a suitable sensor, for example also a laser sensor, the optically detectable change obtained thereby can be detected and, in turn, at least one functional information can be read out, analogously to the holographic data storage. Different embodiments are conceivable.

Particularly preferably, the coding step is an end method step or a method step close to the end of the production method. It is particularly preferred when, in addition, the method further comprises at least one calibration step, wherein at least one property of at least one analytical aid comprised in the analytical consumable is measured in the calibration step. The at least one property can then be used in whole or in part as a constituent of at least one piece of functional information. For example, calibration measurements can be performed at one or more test zones to determine manufacturing-specific and/or lot-specific differences. In this way, for example, measurement-related information, such as calibration factors and/or function curves, can be determined with regard to the parameters and/or algorithms used for evaluating the measurement results. Alternatively or additionally, other types of characteristics can also be determined in the calibration step. Known detection methods can be used for performing the calibration step. The determined characteristic is then preferably at least partially converted into functional information or a part of said functional information, and the above-described encoding step is then performed. In this way, the respective properties of the consumable and/or of the individual or several analytical aids contained in the consumable can be determined in a suitable manner, so that, for example, analytical measurements can be carried out with high precision and with close to complete exclusion of fluctuations determined by the consumable, which analytical measurements are carried out with this type of consumable.

For example, initially at the time of manufacture, an additional coding region, for example a color region, can be printed as a code carrier on a strip, for example a reagent carrier strip, which is embodied, for example, as a laser-activatable region. In other cases, the at least one property can be determined in a calibration step after the consumable has been prepared at least as far as possible, in order then to convert the property into at least one functional information and apply it to the coding region. Thus, after the batch calibration, a barcode can be generated, for example, in a coding region, for example a colored region (pimentert field), by means of a laser process, which barcode can comprise the necessary batch code, for example.

An important advantage of the downstream encoding compared to an encoding in which the calibration information has been printed directly onto the strip is therefore that the encoding can be done at a later point in time, in particular as late as possible. This calibration step can be carried out in a state in which it is only necessary that the analytical consumable still does not significantly act on it, so that a change in the properties of the analytical consumable and/or of the individual analytical aids in the analytical consumable can be at least avoided as far as possible. By means of the calibration step and the subsequent encoding in the encoding step, the analytical consumable itself is therefore only insignificantly influenced with regard to its properties. Accordingly, this aspect of the invention is particularly advantageous in combination with the above-described embodiments of the invention, in which the analytical consumable has a housing with at least one transparent region, by means of which the coding can be carried out, for example, by means of electromagnetic radiation. The transparency can also be formed, for example, at least exclusively in the range of wavelengths used for the coding and/or for the optical detection of optically detectable changes. In other wavelength ranges, for example, low transparency or opacity can be present. In contrast, in the known coding methods by means of printing processes, it is necessary to open the housing completely, which, however, may lead to contamination of the individual or of the plurality of analytical aids.

As indicated above, in a further aspect, the invention relates to a device for producing an analytical consumable, in particular which can be provided for carrying out the method according to one or more of the above-described embodiments. Here, an analytical consumable is manufactured according to the above description, which analytical consumable comprises at least one carrier and at least one analytical aid connected to the carrier. The device comprises at least one application device for applying a photosensitive material to the carrier, wherein the photosensitive material is arranged to perform at least one optically detectable change under the influence of electromagnetic radiation. Furthermore, the device comprises at least one coding device, which is provided for introducing at least one piece of functional information about the analytical consumable into the light-sensitive material by means of electromagnetic radiation. As indicated above, the functional information is provided to make it possible for at least one analysis instrument to use the analysis consumable correctly.

For possible embodiments of the individual components of the device, reference can be made, for example, to the above description. The coding device can comprise, for example, at least one data processing device, which can be provided in terms of programming technology for providing at least one piece of functional information. The coding device can comprise a data input, for example, via which at least one required item of information, for example information about the properties of at least one analysis aid, can be received. The at least one message is then converted into a functional message or a functional message including the message is generated. For this purpose, the data processing device can be provided, for example, in a programming manner. Furthermore, as mentioned above, the coding device can also comprise at least one radiation source, for example at least one laser, for generating electromagnetic radiation.

In order to carry out the further method steps described above, the device can provide corresponding individual devices which are provided for carrying out the mentioned steps.

Drawings

Further details and features of the invention emerge from the following description of preferred embodiments, in particular in conjunction with the dependent claims. Here, the respective features can be implemented individually or in combination of a plurality of them. The invention is not limited to the embodiments described. The embodiments are schematically shown in the figures. In the figures, identical reference symbols denote identical or functionally corresponding elements.

Showing in detail:

fig. 1 shows a schematic embodiment of an apparatus for manufacturing an analytical consumable;

FIG. 2 shows an embodiment of an analysis tape as part of an analysis consumable;

fig. 3 shows an embodiment of the encoding step with laser marking through the housing.

Detailed Description

Fig. 1 shows an exemplary embodiment of a device 110 according to the present invention for producing an analytical consumable 112. A possible embodiment of the method according to the invention for producing an analytical consumable 112 is also to be explained with the aid of the device 110. It is to be noted that the device 110 can also comprise additional components, which are not shown in fig. 1, in accordance with additional possible method steps. The order of the method steps indicated in fig. 1 is also not necessarily essential, so that the method steps can also be transposed with respect to their order, can be executed laterally in parallel or repeatedly. In fig. 1, an In-Line process (In-Line process) is depicted, In which the method steps are carried out In succession. Alternatively or additionally, it is, however, also possible to execute one or more of the method steps in parallel in time, for example separate devices which operate independently of one another.

In fig. 1, the analytical consumable 112 is symbolized in the form of an analytical tape 114, which analytical tape 114 in the illustrated state is still in each case formed as a semi-finished product or intermediate product. In this description, no conceptual distinction is made between the semifinished product and/or intermediate product and the finished analytical consumable 112. The analytical consumable 112 can also be designed in other ways and can additionally, for example, also comprise further components for the analytical tape 114, as explained in more detail below. One example of a possible embodiment of the analytical tape 114 is shown in fig. 2 and is set forth in detail below.

The analysis tape 114 comprises a carrier 116, which in the exemplary embodiment is designed in the form of a tape. The carrier 116, which can be designed as a carrier tape, can comprise, for example, a plastic carrier tape. In the exemplary embodiment shown, consumable 112 also comprises a plurality of analytical aids 118, which analytical aids 118 can be designed, for example, as test zones 120. Each of the test zones 120 can comprise at least one detection chemical having at least one detection reagent which preferably reacts exclusively with the analyte to be detected and, for example, performs a color reaction in the presence of the analyte. It is to be noted that the embodiment of the analytical aids 118 as test zones 120 shows only one of a plurality of possibilities. Alternatively or additionally, the analytical aids 118 can also comprise, for example, electrochemical test fields 120 and/or lancets and/or other types of analytical aids. For example, a plurality of lancets can be arranged on the carrier body 116. An alternating arrangement of a plurality of different types of analytical aids 118 is also possible, for example an alternating arrangement of lancets and test fields 120.

In accordance with the analysis aid 118, the device 110 comprises at least one device 122 for applying the analysis aid 118. In the exemplary embodiment shown in fig. 1, the device 122 is represented symbolically as a labeling device, by means of which the test fields 120 can be applied to the strip-shaped carrier 116 in the form of labels. Here, the direction of travel of the belt is symbolized in fig. 1 by reference numeral 124 during production. It is noted that this shows one embodiment of mass production in the roll method (Rolle-zu-Rolle-Verfahren). Alternatively or additionally, however, other types of manufacturing methods can also be used, for example batch methods in which not a continuous carrier 116 is used, but rather a carrier which already has small, limited dimensions.

In addition, the apparatus 110 further comprises an application device 126. The application device 126 is provided for applying at least one photosensitive material 128 to the carrier 116. In the embodiment shown in fig. 1, application is accomplished by applying photosensitive material 128 to carrier 116 in the form of encoded region 130. Accordingly, the application device 126 can comprise, for example, a printing device which prints the code region 130 onto the strip-shaped carrier 116. All customary printing methods can be used here, such as embossing (Tampondruck), screen printing, flexographic printing, inkjet printing, dispensing methods (dispersieverfahren), and the like. Alternatively or additionally, other application techniques can also be used, for example again using lamination techniques, for example similar to the device 122.

Furthermore, the device 110 in the embodiment shown in fig. 1 further comprises a calibration device 132. A calibration device 132, symbolically shown in fig. 1 as having a calibration light source 134 and a calibration detector 136, is provided for determining at least one property of the analytical consumable 112. This can be, for example, a characteristic of at least one analytical aid 118, for example one or more of the test zones 120. In this way, for example, calibration information, for example correction factors and/or function curves, which are symbolized in fig. 1 by reference numeral 138, can be generated. These calibration information 138 (as indicated in fig. 1) can be provided, for example, to a data processing device 140, which data processing device 140 can, for example, be a component of an encoding device 142 explained in detail below. However, other embodiments are possible. The data processing device 140 can also be a component of the calibration device 132, for example, in whole or in part, and/or a central data processing device 140 and/or a central data memory can be used. In the exemplary embodiment shown in fig. 1, each individual analysis aid 118 is calibrated by means of a calibration device 132. Alternatively, however, the analytical aids 118 can also be calibrated in groups, or an overall calibration can be carried out for the analytical consumable 112 and the entirely contained analytical aids 118 and/or the entirely contained test zones 120. Different embodiments are also conceivable and achievable for the skilled person.

It is further noted that in fig. 1, the calibration step is illustrated by means of a calibration device 132 which is still present on the unfinished intermediate product of the analytical consumable 112. Alternatively or additionally, the calibration step can however also be carried out in a later stage by means of the calibration device 132, for example in a higher intermediate stage in which the analysis band 114 of the analysis consumable 112 has already been combined with further components of the analysis consumable 112 into a finished or finished analysis consumable 112. This is explained in more detail below with reference to fig. 3, in which fig. 3 the analytical tape 114 is integrated into the housing.

Furthermore, in the embodiment shown in fig. 1, the device 110 further comprises the encoding means 142 already mentioned above. In addition to the optional data processing device 140, the coding device 142 can comprise a radiation source 144 for generating electromagnetic radiation and, if possible, a positioning device 148. Both are indicated only in fig. 1. The electromagnetic radiation source 144 can include, for example, one or more lasers. The positioning device 148 can, for example, comprise a scanning device and/or other type of writing device, so that the individual regions of the coding region 130 can be appropriately loaded with electromagnetic radiation 146. Writing functional information into the encoding region 130 can be done in this way. Alternatively or additionally, however, a simultaneous exposure of more, for example larger, regions of, for example, the coding region 130 can also be achieved, for example, by using a corresponding masking technique (maskenechniken). The shielding can also be implemented flexibly, for example by using micro-mirror arrays and/or so-called SLMs (Spatial Light modulators), so that alternately changing information can also be read in. Different embodiments are conceivable and can be realized by the skilled person.

In the exemplary embodiment shown in fig. 1, the calibration information 138 is converted into functional information in a data processing device 140, alternatively or additionally the data processing device 140 can also be a component of other components of the device 110 in whole or in part. This functional information is symbolized in fig. 1 by reference numeral 150. As implemented above, in the framework of the description of the invention, no conceptual distinction is made between functional information and its content and/or physical form. This functional information can be transmitted directly to the electromagnetic radiation source 144 and/or the positioning device 148, for example. Alternatively or additionally, however, corresponding control commands can also be transmitted, for example control commands that control the radiation source 144 and/or the positioning device 148 such that the functional information 150 is converted into a corresponding code in the coding region 130 by a corresponding local exposure.

An example of a code 152 of this type can be seen in fig. 2, said code 152 being characterized by reference numeral 150. In this case, the code 152 is designed as a bar code 154, which bar code 154 is written into the coding region 130. The barcode 154 can be formed, for example, in a color-changing manner in the coding region 130, for example, in such a way that the unexposed regions have a different color than the exposed regions. As indicated above, however, optically detectable changes of other configurations can also be used in the encoded regions 130. Alternatively to the bar code 154, other types of bar codes can be used, such as two-dimensional or three-dimensional bar codes.

The embodiment of the analytical consumable 112 according to fig. 2 in turn comprises (as shown above) an analytical tape 114, to which an analytical aid 118 is applied in the form of a test zone 120. Other embodiments are also possible, such as those described above.

Additionally to the test zones 120 or analytical consumables 118, in the embodiment shown in fig. 2, the analytical tape 114 comprises a plurality of position markers 156. The position markers (the embodiment and layout of which is shown only by way of example in fig. 2) enable an analytical instrument, for example a blood glucose meter, to precisely locate a defined test field 120 in front of the detector. The entire winding process of the analysis tape 114 can be controlled in this way.

In the embodiment shown in fig. 2, the position marker 156 is bound in whole or in part to the coding region 130. Thus, for example, the photosensitive material 128 can be used for all, several or a single one of the position markers 156. For example, the photosensitive material can be designed such that it is dark, for example black, in comparison with the carrier 116 in the unexposed state. A color change, for example to white and/or bright colors, can then be obtained locally by corresponding exposure with electromagnetic radiation 146. Thus, the code 152 can be configured as an "inverse" code that utilizes light encoding regions on a dark background and/or a "normal" code that utilizes dark encoding regions on a light background. Alternatively or additionally, however, other embodiments are also possible, for example the use of different colors.

Alternatively or additionally to the combination of coding region 130 with position marker 156, however, separate embodiments of coding region 130 can also be accomplished. Thus, for example, in addition to position markers 156, coding region 130, which is spatially separated from position markers 156, can be applied to vector 116.

Furthermore, it is not necessary that each analytical aid 118 is assigned its own coding region 130, as is indicated in the exemplary embodiment in fig. 2. For example, a plurality of analytical aids 118 can also be combined and then the set of analytical aids 118 is assigned a common coding region 130. It is also possible to code the entire analysis zone 114 with only a single coding region 130 or a small group of coding regions 130, which coding regions 130 can then, for example, contain functional information 150 for the entire analysis zone 114 or the entire analysis consumable 112. Different embodiments are possible and can be realized by the skilled person within the framework of the description of the invention.

Finally, the analytical consumable 112 is schematically shown in fig. 3 in the form of a tape cassette 158. The tape cassette 158 can comprise a housing 160, in which housing 160 an analysis tape 114 can be accommodated, for example according to the embodiment illustrated in fig. 2. The analytical tape 114 is wound through the housing 160 by means of one or more winders 162, which are only indicated in fig. 3.

The cartridge 158 includes an application location, which is designated by reference numeral 164 in fig. 3. In this application site 164, application of a liquid sample, for example, a body fluid (for example, blood), on the test field 120 can take place. Furthermore, the measurement can also be carried out in this application site 164. Thus, the cassette 158 can have, for example, a measuring chamber, which is symbolized in fig. 3 by reference numeral 166, into which a corresponding detector of the analysis instrument can be introduced. However, the detector can also be integrated fixedly in the tape cassette 158. By means of said detector, which is not shown in fig. 3, it is possible, for example, to observe a reflectometry measurement of the analyte-dependent color change in the test field and then to make qualitative and/or quantitative inferences about the presence of the analyte, for example the presence of a blood glucose concentration, using the measurement results. In principle, however, other measuring methods are also conceivable.

Further, in the embodiment shown in fig. 3, the housing 160 of the cartridge 158 further includes a window 168. The window 168 can be configured, for example, as a simple opening in the housing 160. Preferably, however, to avoid contamination of the analysis strip 114, the window 168 comprises a material transparent to the electromagnetic radiation 146, such as plastic. Here, there can be penetrability to electromagnetic radiation 146 used in the encoding device 142 and/or penetrability to detection light 170. By means of the detection light 170 (which is likewise indicated in fig. 3), it is possible, for example, to read a detectable change of the coding region 130 in the region of the code 152, for example by means of a simple bar code reader. Other embodiments are possible.

The cassette 158 shown in fig. 3 offers the advantage that the cassette 158 can be prepared to a large extent first, in addition to the calibration steps described above. A calibration step, for example according to fig. 1, can then be performed. In an encoding step following the calibration step, the functional information 150 (the functional information 150 for example contains the calibration information 138) can then be written into the encoding region 130 or into the respective encoding region or into one of the encoding regions of the encoding region 130 by means of electromagnetic radiation 146, for example by means of a laser beam, through the window 168. During the encoding process, the analysis strip 114 is completely protected by the housing 160, so that no soiling or other damaging environmental influences can act on the analysis strip 114.

Subsequently, when running the analytical consumable 112, the code 152 can be read again, for example via the window 168, in order to retrieve the functional information 150 again. The reading can be carried out, for example, with a detector which is present in the analysis instrument itself. Thus, for example, the reading of the functional information 150 can be carried out separately in the application site 164, for example by means of a detector which also analyzes the test field 120 and its discoloration. Alternatively or additionally, other detectors can also be used, for example a detector for detecting the position mark 156. This can likewise be carried out again, for example, in the application site 164. Alternatively or additionally, it is also possible to arrange a detector for the position marks, such that it determines or records the detection light 170 in the region of the window 168, in order to record the position marks 156 and/or the code 152 in this way. Different embodiments are also conceivable.

List of reference marks

110 device for producing analytical consumables

112 consumable

114 analytical tape

116 Carrier

118 analytical aids

120 test area

122 device for applying an analytical aid

124 direction of travel

126 applicator

128 photosensitive material

130 coding region

132 calibration device

134 calibration light source

136 calibrated detector

138 calibration information

140 data processing device

142 encoding device

144 radiation source

146 electromagnetic radiation

148 positioning device

150 function information

152 code

154 Bar code

156 position mark

158 tape cassette

160 casing

162 winder

164 application site

166 measuring chamber

168 window

170 detecting light

Claims (15)

1. Method for producing an analytical consumable (112), wherein the analytical consumable (112) has at least one carrier (116) and at least one analytical aid (118) connected to the carrier (116), wherein at least one photosensitive material (128) is applied to the carrier (116), wherein the photosensitive material (128) is provided for carrying out at least one optically detectable change under the action of electromagnetic radiation (146), wherein at least one piece of functional information (150) about the analytical consumable (112) is introduced into the photosensitive material (128) by means of the electromagnetic radiation (146) in at least one coding step, wherein the functional information (150) is provided for making it possible for at least one analytical instrument to use the analytical consumable (112) correctly.

2. The method of the preceding claim, wherein the electromagnetic radiation (146) comprises laser radiation.

3. The method according to one of the preceding claims, wherein in the encoding step at least one-dimensional barcode and/or at least one two-dimensional barcode and/or at least one three-dimensional barcode (152, 154) is introduced into the light-sensitive material (128).

4. Method according to one of the preceding claims, wherein the light-sensitive material (128) is applied onto the carrier (116) in the form of at least one coding region (130), in particular in the form of polygonal and/or near-circular coding regions (130).

5. Method according to the preceding claim, wherein for applying the coding region (130) at least one of the following methods is used: a printing method in which the photosensitive material (128) and/or a starting material of the photosensitive material (128) is printed onto the carrier (116); a lamination process in which a film of the photosensitive material (128) is laminated and/or affixed to the carrier (116).

6. Method according to one of the two preceding claims, wherein the analytical consumable (112) comprises a plurality of analytical aids (118), wherein each analytical aid (118) is assigned at least one coding region (130).

7. The method according to one of the three preceding claims, wherein the coding region (130) is arranged at a plurality of predefined and known positions of the analytical consumable (112), wherein the coding region (130) is provided for use in whole or in part as a position marker (156).

8. The method according to one of the preceding claims, wherein the optically detectable change comprises a change in at least one of the following physical properties of the light-sensitive material (128): a color characteristic; a reflective property; an absorption characteristic; refractive index.

9. The method according to one of the preceding claims, wherein the photosensitive material (128) comprises at least one of the following materials: a dye, in particular a dye dissolved and/or dispersed in a matrix material; a pigment, in particular a laser-activatable pigment; a plastic, in particular a plastic that changes refractive index under the action of said electromagnetic radiation (146).

10. Method according to one of the preceding claims, wherein the functional information (150) comprises at least one consumable-specific and/or auxiliary-specific information, in particular at least one of the following information: information about the manufacturer and/or the manufacturing method; information about the contained detection reagent; information about the analyte to be detected; information about the analysis method and/or analysis system to be used; information about conditions under which analysis should be performed; information about parameters and/or algorithms for analyzing the measurement results, in particular at least one correction factor and/or at least one function curve; information about the lot number and/or at least one individual identification; information about batch-specific characteristics; information about the number of analysis aids (118); information about the type of device used for generating and/or providing the liquid sample, in particular the lancet; information about the device, in particular the lancet, to be used for generating and/or providing a liquid sample; durability information, particularly durability date and/or durability limit; and (4) use limitation.

11. The method according to one of the preceding claims, wherein the analytical consumable (112) comprises at least one of the following consumables (112): an analysis strip (114) having a carrier strip and a plurality of analysis aids (118) arranged on the carrier strip; a test strip having at least one analytical aid (118); a test disc having a plurality of analytical aids (118) arranged on a surface and/or edge of the test disc; a collapsible consumable (112) having a plurality of analytical aids (118).

12. Method according to one of the preceding claims, wherein the analysis aid (118) comprises at least one of the following analysis aids (118): a test field (120) for detecting at least one analyte in a sample, in particular for detecting a metabolite in a body fluid; device for generating and/or providing a liquid sample, in particular a lancet.

13. Method according to one of the preceding claims, wherein the analytical consumable (112) has at least one housing (160), wherein the analytical aid (118) is at least partially accommodated in the housing (160), wherein the housing (160) has at least one transparent region, in particular a window (168), which is at least partially transparent to the electromagnetic radiation (146) and/or to the optical detection of an optically detectable change, in particular at the wavelength of the electromagnetic radiation and/or at the wavelength used for the optical detection of the optically detectable change.

14. Method according to one of the preceding claims, further comprising at least one calibration step, wherein in the calibration step at least one property of at least one analytical aid (118) comprised in the analytical consumable (112) is measured, wherein the property is at least partially converted into the functional information (150) or a part of the functional information (150), wherein the encoding step is subsequently performed.

15. Device (110) for producing an analytical consumable (112), in particular a device (110) for producing an analytical consumable (112) using a method according to one of the preceding method claims, wherein the analytical consumable (112) comprises at least one carrier (116) and at least one analytical aid (118) connected to the carrier (116), wherein the device (110) comprises at least one application device (126) for applying a photosensitive material (128) to the carrier (116), wherein the photosensitive material (128) is provided for carrying out at least one optically detectable change under the action of electromagnetic radiation (146), wherein the device (110) furthermore comprises at least one coding device (142), wherein the coding device (142) is provided for introducing at least one functional information (150) relating to the analytical consumable (112) into the photosensitive material by means of the electromagnetic radiation (146) -a material (128), wherein the functional information (150) is provided for enabling a correct use of the analytical consumable (112) by at least one analytical instrument.