BR102017002058A2 - ANALYTICAL SYSTEM AND METHOD FOR MANUFACTURING THE ANALYSIS SYSTEM - Google Patents

Description

Field of the Invention The invention relates to a test element analysis system for the analytical examination of a sample as well as to a method for manufacturing the same. . The devices and methods according to the present invention may be used primarily in the field of qualitative or quantitative detection of at least one analyte in a sample, such as a body fluid sample and / or for determining at least one sample parameter. Other fields of application are viable. Related Art In the field of medical and diagnostic technology, a large number of devices and methods are known for determining the presence and / or concentration of one or more analytes in samples, specifically fluid samples, such as body fluids. Without restricting the scope of the present invention, reference is made below mainly to the determination of blood clotting parameters or to blood glucose concentrations. It should be noted, however, that other sample types or other types of analytes or parameters may be used in a similar manner.

[003] For quick and simple measurements, several types of test elements are known, which are mainly based on the use of one or more test chemicals, that is, the use of one or more chemicals, one or more more chemical compounds or one or more chemical mixtures adapted to perform a detection reaction to detect the analyte. Test chemicals are often also cited as a test substance, a test reagent, a test chemical, or as a detector substance. For details of test chemicals and test elements comprising such test chemicals, which may also be used in the present invention, reference may be made to J. Hoenes et al. The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26. Other types of test elements and / or test substances are viable and may be used in the present invention.

By the use of one or more test chemicals, a detection reaction may be initiated whose course depends on the presence and / or concentration of at least one analyte to be determined. The detection reaction may preferably be analyte specific. Typically, as may also be the case in the present invention, test chemicals are adapted to perform at least one detection reaction when the analyte is present in the body fluid, wherein the extent and / or degree of the detection reaction is typically it depends on the concentration of the analyte. In general, the test chemical may be adapted to perform a detection reaction in the presence of the analyte, wherein at least one detectable property of at least one of the body fluids and the test chemical is changed due to the detection reaction. . At least one generally detectable property may be selected from a physical property and a chemical property. Next, without restricting other potential realizations, reference will be made primarily to detection reactions in which one or more physical properties are altered due to the detection reaction, such as one or more of at least one electrical property and at least one optical property. In addition, without restricting alternative solutions, reference will be made to detection reactions in which at least one chemical property that is electrically detectable is changed, for example, to electrochemical test elements. Other test elements, such as optical test elements, however, are also usable.

[005] In the technical field of analytical devices, the use of barcodes and barcode readers is possible, such as to provide information on specific details of the test element in use for the test element analysis system. Thus, as an example, lot-specific data, expiration date, calibration parameters or other test element information can be transferred to the analysis system.

EP 1 851 680 B1 and US 7,635,834 B2 disclose systems for optically object imaging, in particular information-carrying optical patterns or codes, in a detection device and in particular in a CCD element. or CMOS with the aid of an opening hole. Specifically, systems are described which have special devices that substantially compensate for imaging defects caused by the aperture hole and in particular the system's inherent peripheral decrease in the brightness of an image of the object formed by the aperture hole in the sensing device. .

Despite the advantages of known devices and methods, several technical challenges remain. Thus, specifically for handheld devices, the barcode reader volume and total optical system height are still a problem. This is mainly because barcodes typically extend over at least several millimeters in the test element. To read barcodes of said side dimensions, even wide-angle cameras can be used, yet the free working distance between the barcode and the barcode reader is preferably significant, which has to be taken. account as additional space and volume for the analytical system.

Problem to Be Solved It is therefore an object of the present invention to provide devices and methods that at least partially overcome the technical challenges identified above. Specifically, a test element analysis system for analytical examination of a sample and a method for manufacturing it should be proposed, which allow for a small volume and a reduction in workspace compared to conventional analytical devices that have a reader. of barcode.

Brief Description of the Invention This problem is solved by a test element analysis system for analytical examination of a sample and a method for manufacturing the same with the features of the independent claims. Preferred embodiments, which may be perceived in isolation or in any arbitrary combinations, are listed in the dependent claims.

As used below, the terms "have", "comprise" or "includes" or any grammatically arbitrary variations thereof are used in a non-exclusive manner. Thus, these terms may both refer to a situation in which, apart from the features introduced by these terms, no feature is present in the entity described in that context and to a situation in which one or more additional features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” can either refer to a situation where, apart from B, no other element is present in A (ie a wherein only A and exclusively consists of B) and a situation in which, in addition to B, one or more additional elements are present in entity A, as element C, elements C and D or even additional elements.

In addition, it should be noted that the terms "at least one", "one or more", or similar expressions indicating that a feature or element may be present once or more than once will typically be used only once. by entering its characteristic or element. Next, in most cases, when referring to the respective feature or element, the words "at least one" or "one or more" will not be repeated, notwithstanding the fact that the respective feature or element may be time or more than once.

In addition, as used below, the terms "preferably", "most preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with the optional features , without restriction of alternative possibilities. Accordingly, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled artisan will recognize, be realized by the use of alternative features. Similarly, features introduced by "in one embodiment of the invention" or similar expressions are intended to be optional features, without any restrictions on alternative embodiments of the invention, without any restrictions on the scope of the invention and without any restriction on regarding the possibility of combining the features thus introduced with other optional or non-optional features of the invention.

In a first aspect of the present invention, a test element analysis system for analytical examination of a sample, in particular a body fluid, is disclosed. The test element analysis system comprises at least one evaluation device with at least one test element holder for positioning at least one test element containing the sample. In addition, the evaluation device comprises at least one device for measuring a change in a test element measurement zone. The change is characteristic for an analyte or a sample parameter. In addition, the test element analysis system comprises at least one barcode reader for reading at least one barcode on the test element. The barcode reader comprises at least one circuit board. The circuit board has a barcode-facing front side of the test element positioned on the test element holder. In addition, the circuit board has at least one reverse side facing the opposite side of the test element. At least one electronic control element of the barcode reader is arranged on the circuit board. The circuit board comprises at least one cavity, which penetrates at least partially or fully into the circuit board. The barcode reader further comprises at least one camera carrier element being arranged on the reverse side of the circuit board and at least one camera. The camera is electrically connected to the camera carrier element, with the camera carrier element and camera being positioned so that the camera scans the barcode through the circuit board cavity.

As also used in the present application, the term "system" refers to an arbitrary set of interacting or interdependent component parts that form a whole. Specifically, components can interact with each other to fulfill at least one common function. At least two components may be independently handled or may be coupled or connectable. Thus, the term “test element analysis system” generally refers to a group or at least two elements or components that are capable of interacting to perform at least one analytical detection through interaction with an arbitrary test element, specifically at least one analytical detection of at least one sample analyte. The test element analysis system may also generally be referred to as an analytical system, an analytical kit, a sensor system or a measurement system.

As commonly used within the present invention, the terms "patient" and "user" may refer to a human or animal, regardless of whether the human or animal, respectively, may be in a healthy condition or may be suffer from one or more diseases. As an example, the patient or user may be a human or animal suffering from diabetes. However, additionally or alternatively, the invention may be applied to other types of users or patients or diseases.

In addition, as used in this application, the term "sample" may refer to an arbitrary material or combination of materials taken for analysis, testing or investigation. The sample may be a limited quantity of something that is intended to be similar and to represent a larger quantity. However, the sample may also comprise a complete copy. The sample may be a solid sample, a liquid sample or a gaseous sample or a combination thereof. Specifically, the sample may be a fluid sample, that is, a sample that is wholly or partially liquid and / or gaseous. A sample quantity can be described in terms of its volume, mass or size. However, other dimensions are viable. The sample may comprise only one material or only one compound. Alternatively, the sample may comprise various materials or compounds.

The term "analyte" generally refers to an arbitrary element, component or compound that may be present in the sample and in the presence and / or concentration that may be of interest to the user, patient or medical staff, such as a physician. . Particularly, the analyte may be or may comprise an arbitrary chemical or a chemical compound that may be part of the user's or patient's metabolism, such as at least one metabolite. Detecting at least one analyte may be specifically analyte specific detection.

The term "parameter" can generally refer to an arbitrary value as a measurement value that is obtained within or by an analytical test. For example, the parameter may correspond to a sample property and / or a property of at least one analyte as described above. Specifically, the parameter may be a coagulation parameter such as the analyte coagulation time. For further details on the term "coagulation parameter" as also used in the present application, reference may be made to US 2006/0035298.

As also used in the present application, the term "body fluid" may refer to a fluid that is typically present in a user's or patient's body or body tissue and / or that may be produced by the user's or patient's body. As an example of body tissue, interstitial tissue may be mentioned. Thus, as an example, body fluid can be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids may be used, such as saliva, tear fluid, urine or other body fluids. Upon detection of at least one analyte, body fluid may be present within the body or body tissue. Specifically, as will be described in more detail below, the sensor can be configured to detect at least one analyte and one body tissue.

The term "analytical examination" may generally refer to a process for determining the presence and / or quantity and / or concentration of at least one analyte or a process for determining a sample parameter that is characteristic of the properties of the sample, for example, a coagulation parameter that is characteristic of the coagulation properties of a blood sample. The detection may or may comprise qualitative detection, simply determining the presence of at least one analyte or the absence of at least one analyte, and / or may be or may comprise quantitative detection, which determines the amount and / or concentration. of at least one analyte. As a result of detection, at least one signal may be produced which characterizes the detection result as at least one measurement signal. At least one measurement signal may specifically be or may comprise at least one electrical signal such as at least one voltage and / or at least one current. At least one signal may be or may comprise at least one analog signal and / or may be or may comprise at least one digital signal.

The term "test element" can generally refer to an arbitrary device that is capable of detecting the analyte in the sample or determining the parameter of the sample. The test element may be specifically a strip-shaped test element. As used in the present application, the term "strip-shaped" refers to an element that has an elongated shape and thickness, with an extension of the element in a lateral dimension exceeding the thickness of the element as at least one. factor of 2, preferably by at least a factor of 5, more preferably by at least a factor of 10, and most preferably by at least a factor of 20 or even at least a factor of 30. Thus the element of Test can also be cited as a test strip.

The test element may comprise at least one component or at least one reagent that alters at least one detectable property when the analyte is present in the sample as a test chemistry. The term "test chemistry", also referred to as a test chemical, may refer to an arbitrary material or composition of materials adapted to alter at least one detectable property in the presence of the analyte. In general, this property may be selected from an electrochemically detectable property and / or an optically detectable property, such as a color change and / or a change in cross-reference properties. Specifically, the test chemistry may be a highly selective test chemistry, which changes property only if the analyte is present in the body fluid sample applied to the test element, while no change occurs if the analyte is not present. More preferably, the degree or change of property may be dependent on the concentration of analyte in body fluid to allow quantitative detection of the analyte.

Specifically, the test element may comprise at least one reagent configured to activate coagulation of body fluid components. The reagent may comprise reactive thromboplastin components and peptide substrate. Thus, if the reagent is exposed to the sample, thromboplastin can activate a coagulation and thrombin can be generated. Thrombin can cleave the peptide substrate and an electrochemical signal can be generated. The electrochemical signal can be evaluated in relation to the time of its occurrence. However, other reagents and / or measuring principles may be viable.

As used in the present application, the term "electrochemical detection" refers to the detection of an electrochemically detectable analyte property by electrochemical means, such as an electrochemical detection reaction. Thus, for example, the electrochemical detection reaction can be detected by comparing one or more electrode potentials, such as the potential of a working electrode with the potential of one or more additional electrodes such as a counter electrode or a reference electrode. Detection may be analyte specific. The detection may be qualitative and / or quantitative detection.

The test element may have at least one measurement zone capable of making at least one change being characteristic for the analyte or parameter. As also used in the present application, the term "measurement zone" may refer to an arbitrary area or region of an object, in which an arbitrary measurement, specifically an analytical measurement, is conducted. Specifically, the test chemistry as described above may be located within the measuring zone, particularly on a measuring zone surface.

The test element may be specifically an electrochemical test element. The term "electrochemical test element" may refer to an arbitrary test element configured to conduct at least one electrochemical detection. As used in the present application, the term "electrochemical detection" refers to the detection of an electrochemically detectable property of at least one arbitrary analyte, such as an electrochemical detection reaction. Thus, for example, the electrochemical sensing reaction can be detected by comparing one or more electrode potentials, such as the electrostatic potential of a working electrode with the electrostatic potential of one or more additional electrodes such as a counter electrode or an electrode. reference. Detection may be analyte specific. The detection may be qualitative and / or quantitative detection.

The test element may comprise at least one capillary configured to receive the sample. The term "capillary" usually refers to an arbitrary, small, elongated void volume like a small tube. Generally, the capillary may comprise dimensions in millimeters or in the submillimeter range. Commonly, a fluid medium can migrate through the capillary by capillary action and the fluid medium can flow into narrow capillary spaces without the assistance of external forces such as gravity due to intermolecular forces between the fluid medium and a capillary surface facing the capillary. fluid medium.

The test element may further comprise at least one barcode. As also used in the present application, the term "barcode" may refer to an arbitrary information bearer that is configured to read through an optical output or by optoelectronic means that may have a plurality of optically detectable modules, each of which one can assume at least two different optically detectable states. Specifically, the barcode may carry at least one optical information item selected from the group consisting of: a test type; a lot or lot number; a date of manufacture; an expiration date; an item of information about a calibration. Still, other optical information is viable.

The term "module" can generally refer to a two-dimensional or three-dimensional region of the barcode. Specifically, the modules may be or may comprise two-dimensional regions defined on a barcode carrier surface, or other three-dimensional regions within the carrier material. Modules may be specifically the smallest unit of barcode information.

Important examples, for which, however, the application is not restricted, are the so-called linear codes or line codes, that is, one-dimensional barcodes where the modules comprise a sequence of rows that can assume at least one. minus two different values (for example, “white” and “black”). As an alternative or, in addition, use may also be made of two-dimensional barcodes, for example, so-called data matrix codes, wherein the modules are applied in two directions and, for example, arranged to form a matrix. . In this case, the modules can be, for example, made as squares or rectangles. However, at first, other achievements may also be viable. For possible barcodes, reference may be made, for example, to conventional barcodes according to EAN (European Article Number), UPC (Universal Product Code) or similar codes. Other known bar code standards also apply. For two-dimensional barcodes, reference may be made, for example, to data matrix codes, QR codes, codes according to the PDF standard or similar codes.

The barcode may be specifically a binary barcode comprising at least two different optically detectable states. In the case of binary codes, at least two states may be binary, ie a first state or a second state may be assumed. However, at first, other embodiments may also be viable, for example, embodiments in which more than two states may be viable which, for example, may be performed within the scope of the so-called gray scale codes.

Optically visible properties that can assume at least two states can be one of the different types of optical properties. For example, this may be reflectivity, a color, fluorescence, transparency or other types of optical properties or a combination of the foregoing and / or other properties. The optically visible property may, for example, be introduced directly into the barcode carrier, for example on a material and / or on the surface of the carrier, or may, as an additional marking material, for example, be applied to the carrier. . For example, reference may be made to the printing of a color on a carrier surface, as a result of which, for example, the reflectivity and / or transparency of the carrier surface and / or a fluorescent property of the carrier surface are altered. By way of example, this additional marking material may be printed, sprayed or dripped onto the carrier or otherwise applied to the carrier by means of a separate carrier element, for example an adhesive film. Alternatively, it may also be feasible to modify the carrier itself, for example by irradiation, for example, by means of a laser, whereby the barcode is applied or entered into the carrier material directly or, in turn, in a marking material attached to the carrier. Several achievements may be achievable.

The term "barcode reader" can generally refer to an arbitrary device that is configured to read the barcode at least as barcode information is converted to electrical signals or storage states. of a barcode reader data store. Therefore, the barcode reader may comprise at least one device with an optical emitter for emitting at least one type of electromagnetic radiation, preferably light in the visible and / or infrared and / or ultraviolet spectral range. The device can thus be cited as a light source.

In addition, the barcode reader comprises at least one camera. As further used in the present application, the term "camera" may refer to an arbitrary optical instrument configured to receive electromagnetic radiation, preferably light in the infrared and / or visible and / or ultraviolet spectral range. This way, the camera can be configured to record images that can be stored locally, transmitted to another location, or both. The camera can also be cited as a detector or optical detector.

Specifically, the term "camera" may refer to an arbitrary device that is configured to capture the properties of barcode modules, which may assume at least two states in a qualitative or preferably quantitative manner. The camera can be configured for at least one-dimensional barcode module capture. As also used in this application, the term barcode “information module capture” can generally refer to the camera's property of recording information in a temporal sequence, specifically in the case of barcode movement relative to the barcode reader. bar code.

The camera may be an integrated chip comprising one or more of a CCD or a CMOS camera. Specifically, the camera may comprise at least one optically sensitive element, for example a photodiode, a photocell, a CCD chip, a phototransistor or similar optically sensitive elements that may be configured to detect an intensity or changes in an incident electromagnetic radiation intensity. , more specifically light in the visible and / or infrared and / or ultraviolet spectral range. The term "charge-coupled device (CCD) camera" can generally refer to an arbitrary device comprising an array of a large number, specifically at least one hundred small light sensors aligned in a row. Each light sensor can be configured to measure a light intensity. The CCD camera can be configured to generate at least one voltage pattern identical to the pattern of an object that must be specifically represented by sequential voltage measurement across each light sensor in the row. The term "complementary metal-oxide semiconductor (CMOS) camera" can generally refer to an arbitrary device that comprises an array of pixel sensors, specifically photodetectors, and an active amplifier. Through this, the CMOS camera can be produced by complementary oxide metal semiconductor technology. In addition, the integrated chip camera may comprise one or more of a lens system or aperture system. The term "lens" may refer to an arbitrary transmitting optical device that is configured to affect a beam's focus through refraction and the term "aperture" may generally refer to an arbitrary hole or aperture through which light traffic.

The term "circuit board" can generally refer to an arbitrary device that is configured to mechanically support and / or electrically connect electronic components, specifically through the use of cues, blocks, and / or other elements such as transistors and resistors. . The circuit board may specifically be a printed circuit board. The term "printed circuit board" may generally refer to an arbitrary circuit board in which tracks, blocks and / or other components may be etched from laminated copper blades onto a non-conductive substrate. The substrate may, for example, be made of at least one of fiberglass, composite epoxy, a laminated material. As described above, at least one electronic control element of the barcode reader is arranged on the circuit board. The term "electronic control element" can generally refer to an arbitrary electronic device that is configured to control one or more electrical systems or subsystems. Specifically, the electronic control element may comprise at least one electronic component that is configured for one or more of the bar code reading function targeting, monitoring or evaluation. The bar code evaluation device may be configured to control a bar code reading and / or for one or more of the recording, storage, evaluation, monitoring of optical information provided by the camera. Specifically, the barcode evaluation device may be configured to derive at least one item of information from the barcode. The barcode evaluation device may comprise software and / or hardware components. In addition, the electronic control element may comprise at least one data processing device, optionally with one or more volatile or nonvolatile storage elements. In addition, the electronic control element may comprise one or more operating elements, such as input commands and / or control data and / or other information. In addition, the electronic control element may comprise one or more display devices and / or other types of user interfaces. The electronic control element may be realized as a single component or may be realized as a series of parts, optionally also distributed over various regions of the circuit board. The control element may comprise one or more of a processor, an FPGA, a DSP or an ASIC. Other achievements are achievable.

As described above, the circuit board has the front side and the reverse side. The term "side" can usually refer to an arbitrary component or part of an object that can be visible from a perspective. If the object is cubic in shape, the term "side" may specifically refer to a cube surface. The terms "front side" and "reverse side" may be considered as a description without specifying an order and without excluding a possibility that various types of front sides and reverse sides may be applied.

As described above, the circuit board comprises at least one cavity that penetrates the circuit board. The term "cavity" can generally refer to an arbitrary void volume within the surface of a solid material. Specifically, the cavity may be a through hole in the circuit board. Optionally, the through hole may be covered with a layer, specifically a transparent layer. The layer may cover the through hole in one side of the circuit board, specifically the reverse side of the circuit board. In addition, the cavity may have at least one cross section selected from the group consisting of: a round cross section, an oval cross section, a polygonal cross section, particularly a rectangular cross section.

[0040] The term carrier element can generally refer to an arbitrary object that is configured to hold, support or receive another element. The other element may remain loose on the object or may remain firmly attached to the object. For example, the other element may remain attached to the object or may be integrated with the object. The term “bound” can usually refer to a property of an arbitrary element being fixedly attached to another object. Specifically, the element may be attached to the object by at least one adhesive material or by welding. However, other achievements may be viable. The term "integrated" can refer to a state in which two or more objects can be permanently constructed into at least one of two or more objects. This way, two or more objects can form a single piece. This way, the two or more objects can be arranged in a space-saving or compact manner. In addition, the two or more objects may be designed in a complementary manner so that the components may be able to interact with each other. By way of example, the camera carrier element may be one of those joined on the reverse side of the circuit board or may be integrated into the reverse side of the circuit board and / or connected to the reverse side of the circuit board through at least one. plug connection. Specifically, the circuit board and camera carrier element may be printed circuit boards and the camera carrier element printed circuit board may be connected on the reverse side of the circuit board.

The term "evaluation device" can generally refer to an arbitrary device being configured to derive at least one item or information from the data. Specifically, the rating device may be configured to derive at least one item of information regarding the presence and / or concentration of analyte in body fluid or a body fluid parameter of at least one signal.

As described above, the evaluation device comprises the measuring device. The term "measuring device" may generally refer to an arbitrary device, preferably an electronic device, which may be configured to detect at least one signal. The signal may be an optical signal and / or an electrochemical signal. The measuring device may be handled independently of the test element and may be adapted to interact with the test element to perform an analysis, such as by detecting at least one signal. Accordingly, the term “measuring device” can often also be referred to as a measuring device, an analytical device, a measuring device or a test device.

As described above, the evaluation device comprises the test element holder. The term "test element support" can generally refer to an arbitrary object that is configured to receive or support an arbitrary test element. Specifically, the test element may be positioned at a specific position within the test element holder such that a movement of the test element in at least one direction may be contained at least to a great extent. Thus, the metering zone and / or barcode of the test element may be located at a predetermined position relative to the metering device and camera respectively. The test element may be specifically configured to be reversibly placed in the test element holder. This way, the test element can be removable from the test element holder without further work. Still, other achievements are viable. The test element may be at least partially received on the test element holder. The term "being received" may generally refer to a condition of an object being located or inserted wholly or at least partially into a receptacle or opening of another element. This way, a part of the object can be located outside the other element. By way of example, the test element holder may comprise at least one receptacle configured to receive the test element. In this way, the receptacle may be formed complementary to the test element. Therefore, the receptacle and the test element may be configured to engage in a snap connection. The barcode reader and measuring device may be located on opposite sides of the receptacle. Still, other achievements are viable. The test element holder may comprise at least one contact element with the contact surfaces that allows electrical contact between the test element contact surfaces and the contact surfaces of the test element holder.

The camera carrier element may comprise electrical contacts electrically connected to the camera. Thus, electrical contacts can be electrically connected to at least one circuit board electrical contact. The electrical contact of the circuit board may be located on the reverse side of the circuit board. The circuit board may comprise at least one path that electrically connects the electrical contact of the reverse side circuit board with at least one control circuit element located on the front side. As used in the present application, the term "contact element" generally refers to an arbitrary element that is electrically conductive. In addition, the contact element may comprise one or more surfaces, specifically smooth surfaces, which may be configured to establish a close connection with other electrically conductive elements. The term "pathway" can generally refer to an arbitrary interlayer electrical connection that passes through at least one plane of one or more adjacent layers.

[0045] The camera carrier element may comprise at least one printed circuit board having at least one electrical contact block with the camera electrically connected thereon. As used in the present application, the term "contact block" generally refers to an element that has an open or electrically contactable surface that is electrically conductive. As an example, the contact blocks may be or may comprise at least one layer of at least one conductive material which may be directly or indirectly deposited on the substrate and providing an electrically contactable surface. In a dimension or direction parallel to the substrate surface, contact blocks can provide a contact surface area, such as an area that has a rectangular shape, a polygonal shape, or a round shape. Other formats are possible.

The camera carrier element may comprise a cavity of the camera carrier element. The camera carrier element may be positioned so that the camera carrier element cavity is wholly or partially located within the cavity or in an overlapping manner with the circuit board cavity. The camera may be mounted within the cavity of the camera carrier element. Specifically, the camera carrier element cavity may be a blind hole with an aperture in contact with the test element. The camera carrier element may comprise at least one electrical contact block within the cavity of the camera carrier element and the camera may be electrically wired on the electrical contact block.

The camera may comprise a front face. The term "face", as also used in this application, may refer to an object that may be visible from a perspective. Specifically, the front face of the camera may refer to a part of the camera that is configured to record images. Thus, the term “front face” can be considered as a description without specifying an order and without excluding a possibility that several types of front faces and reverse faces may exist. A distance between the test element bar code inside the test element holder and the front side of the circuit board may be less than the distance between the bar code and the front face of the camera. Specifically, the distance between the barcode and the front side of the camera may exceed the distance between the barcode and the front side of the circuit board by at least the thickness of the circuit board. Also as used in the present application, the term "distance" may refer to a numerical description of the distance from each other between two or more objects. Specifically, the distance may refer to a physical length. The term "thickness" can usually refer to a dimension of an arbitrary object perpendicular to the direction of an object's extent. Specifically, the circuit board may have an elongate shape and the front side may refer to a side of the circuit board extending along the extension direction. Thus, the thickness may refer to a size of the circuit board perpendicular to the front side of the circuit board. Specifically, the thickness of the circuit board may contribute to a free working distance of the camera. The term “free working distance” can refer to a distance between an arbitrary camera, specifically a camera front lens, and an arbitrary focused object.

In a further aspect of the present invention, a method for manufacturing the test element analysis system according to any embodiment as described above or as further described below is disclosed. The method comprises the steps of the method as given in the independent claims and as listed below. The method steps can be performed in the given order. However, other orders of method steps are feasible. In addition, one or more of the method steps may be performed in parallel and / or in a way that overlaps at the right time. In addition, one or more of the method steps may be performed repeatedly. Additionally, additional method steps may be present that are not listed.

The method for manufacturing the test element analysis system comprises: a) providing the circuit board; b) provide the camera carrying element; c) connect the camera to the camera carrier element; d) connect the camera carrier element to the reverse side of the circuit board.

In step c), the camera can be connected to the camera carrier element by wiring. Specifically, the camera carrier element may be attached to the reverse side of the circuit board. Additionally or alternatively, the carrier element and the circuit board may be manufactured as one piece.

The proposed test element analysis system for analytical examination of a sample as well as the proposed method for manufacturing the test element analysis system provides many advantages over known devices and methods.

Overall, the height of component construction, specifically in the field of portable medical devices such as portable analysis systems, remains challenging. As not only with the construction height of the optical system elements themselves, but also the free working distance contributes to the total required construction height of cameras or camera systems, this aspect can be considered specifically.

Generally common test element analysis systems may generally comprise large installation spaces, large free working distances and / or may be costly. In general, in the case of small installation spaces, there may be a long focal length that may specifically lead to a large free working distance. In addition, building units may generally only be available in the short term (marked consumer).

Therefore, the test element analysis system according to the present invention may comprise the camera, which is placed in the cavity of the carrier element and may, by way of example, be welded to the carrier element and / or may be sealed. . This unit can be soldered to the reverse side of the circuit board with the camera facing downwards, ie towards the circuit board cavity. The camera may face a plane to be detected through the circuit board cavity. Therefore, the thickness of the circuit board can contribute to a free working distance.

In a further aspect, a barcode reader for reading at least one barcode is disclosed. The barcode reader comprises: at least one circuit board, the circuit board having a barcode facing front side and a reverse side facing the barcode facing side, wherein at least one element The electronic control bar code reader is arranged on the circuit board and wherein the circuit board comprises at least one cavity that penetrates the circuit board; at least one camera carrier element being arranged on the reverse side of the circuit board; at least one camera, the camera being electrically connected to the camera carrier element, with the camera carrier element and the camera positioned so that the camera scans the barcode through the cavity.

To define bar code reader characteristics and optional bar code reader details, reference may be made to one or more of the test element analysis system achievements as disclosed above or as disclosed in More details below. Specifically, the barcode reader may be realized having the features cited as the barcode reader according to one or more embodiments of the test element analysis system.

The advantages of the test element analysis system according to the present invention may be a low build height, specifically as the camera may be placed within the camera carrier element. In addition, the camera can be protected from mechanical stress and can be shielded from environmental influences such as humidity and / or ambient atmosphere, electromagnetic influences or the like. Protection can be specifically achieved by placing the camera within the camera carrier element and / or by sealing the camera, specifically by sealing the camera carrier element cavity. In addition, the free working distance can be increased, specifically as the camera can be configured through the circuit board cavity. By way of example, the cavity may be integrated into the camera carrier element. This may eventually lead to a shorter free working distance that can be compensated for by a larger circuit board thickness.

In summary the findings of the present invention, the following embodiments are preferred.

Embodiment 1: A test element analysis system for the analytical examination of a sample, in particular a body fluid, comprising: at least one evaluation device with at least one test element holder for positioning at least one test element. at least one test element containing the sample and at least one measuring device for measuring a change in a test element measurement zone, the change being characteristic for a sample analyte or parameter; at least one barcode reader for reading at least one barcode on the test element, wherein the barcode reader comprises: the at least one circuit board, the circuit board having a front side facing the bar code of the test element positioned on the test element holder and at a reverse side facing the opposite side of the test element, wherein at least one electronic control element of the bar code reader is disposed on the circuit board and wherein the circuit board comprises at least one cavity that penetrates the circuit board; at least one camera carrier element being disposed on the reverse side of the circuit board; o At least one camera, the camera being electrically connected to the camera carrier element, with the camera carrier element and the camera being positioned so that the camera scans the barcode through the cavity.

Embodiment 2: The test element analysis system according to the previous embodiment, wherein the camera carrier element is one of those joined on the reverse side of the circuit board, integrated on the reverse side of the circuit board. circuit or connected to the reverse side of the circuit board through at least one plug connection.

Embodiment 3: The test element analysis system according to any of the preceding embodiments, wherein the camera carrier element comprises at least one printed circuit board having at least one electrical contact block with the camera electrically connected on it.

Embodiment 4: The test element analysis system according to any of the foregoing embodiments, wherein the circuit board and camera carrier element are printed circuit boards, wherein the printed circuit board of the Camera carrier element is connected on the reverse side of the circuit board.

Embodiment 5: The test element analysis system according to any of the preceding embodiments, wherein the cavity is a through hole in the circuit board.

Embodiment 6: The test element analysis system according to any of the foregoing embodiments, wherein the camera carrier element comprises a cavity of the camera carrier element, wherein the camera carrier element is positioned in a position. so that the camera carrier element cavity is wholly or partially located within the cavity or in a manner superimposed on the circuit board cavity, wherein the camera is mounted within the camera carrier element cavity.

Embodiment 7: The test element analysis system according to the previous embodiment, wherein the cavity of the camera carrier element is a blind hole with an opening facing the test element.

Embodiment 8: The test element analysis system according to any of the foregoing embodiments, wherein the camera carrier element comprises at least one electrical contact block within the camera carrier element cavity with the camera being electrically wired over the electrical contact block.

Embodiment 9: The test element analysis system according to any of the preceding embodiments, wherein the camera comprises a front face, wherein a distance between the test element bar code when placed within the test element holder and the front side of the circuit board is less than a distance between the barcode and the front face of the camera.

Embodiment 10: The test element analysis system according to the previous embodiment, wherein the distance between the bar code and the front face of the camera exceeds the distance between the bar code and the front side of the camera. circuit board by at least the thickness of the circuit board.

Embodiment 11: The test element analysis system according to the previous embodiment, wherein the thickness of the circuit board contributes to a free working distance of the camera.

Achievement 12: The test element analysis system according to any of the preceding embodiments, wherein the test element holder contains contact surfaces with contact surfaces that allow electrical contact between the contact surfaces. of the test element and the contact surfaces of the test element holder.

Embodiment 13: The test element analysis system according to any of the preceding embodiments, wherein the test element holder comprises at least one receptacle configured to receive the test element.

Embodiment 14: The test element analysis system according to the previous embodiment, wherein the barcode reader and measuring device are located on opposite sides of the receptacle.

Embodiment 15: The test element analysis system according to any of the preceding embodiments, wherein the test element analysis system further comprises at least one test element having at least one measuring zone. capable of making at least one change being characteristic for the analyte or the parameter, the test element further having at least one barcode.

Embodiment 16: The test element analysis system according to the previous embodiment, wherein the test element is an electrochemical test element.

Embodiment 17: The test element analysis system according to either of the previous two embodiments, wherein the barcode carries at least one optical information selected from the group consisting of: a test type ; a lot or lot number; a date of manufacture; an expiration date; an item of information about a calibration.

Embodiment 18: The test element analysis system according to any of the foregoing three embodiments, wherein the test element comprises at least one capillary configured to receive the sample.

Embodiment 19: The test element analysis system according to any of the above four embodiments, wherein the test element comprises at least one reagent configured to activate a coagulation of body fluid components.

Embodiment 20: The test element analysis system according to any of the preceding embodiments, wherein the electronic control element comprises at least one barcode evaluation device configured for at least one of recordings, storage, evaluation, monitoring of optical information provided by the camera.

Embodiment 21: The test element analysis system according to any of the preceding embodiments, wherein the camera is an integrated camera chip comprising one or more of a CCD camera or a CMOS.

Embodiment 22: The test element analysis system according to the previous embodiment, wherein the integrated camera chip further comprises one or more of a lens system or an aperture system.

Embodiment 23: The test element analysis system according to any of the foregoing embodiments, wherein the camera carrier element comprises electrical contacts electrically connected to the camera.

Embodiment 24: The test element analysis system according to any of the preceding embodiments, wherein the camera carrier element electrical contacts are electrically connected to at least one circuit board electrical contact.

Embodiment 25: The test element analysis system according to the previous embodiment, wherein the electrical contact of the circuit board is located on the reverse side of the circuit board and wherein the circuit board comprises at least an electrical connection path of the circuit board electrical contact with at least one electronic control element disposed on the front side.

Embodiment 26: A method for manufacturing the test element analysis system according to any of the preceding embodiments, the method of which comprises: a) providing the circuit board; b) provide the camera carrying element; c) connect the camera to the camera carrier element; d) connect the camera carrier element to the reverse side of the circuit board.

Embodiment 27: The method according to the previous embodiment, wherein the camera is attached to the camera carrier element by gluing.

Embodiment 28: The method according to any of the preceding embodiments, wherein the camera carrier element is attached to the reverse side of the circuit board.

Embodiment 29: The method according to either of embodiments 26 or 27, wherein the camera carrier element and circuit board are manufactured as a single part.

Embodiment 30: A barcode reader for reading at least one barcode, wherein the barcode reader comprises: at least one circuit board, the circuit board having a code-facing front side bar and at a reverse side facing the opposite side of the bar code, wherein at least one electronic control element of the bar code reader is arranged on the circuit board and wherein the circuit board comprises at least one cavity. that penetrates the circuit board; at least one camera carrier element being arranged on the reverse side of the circuit board; at least one camera, the camera being electrically connected to the camera carrier element, with the camera carrier element and the camera positioned so that the camera scans the barcode through the cavity.

Embodiment 31: The barcode reader according to the previous embodiment is the barcode reader having the characteristics of a barcode reader as disclosed in one or more of embodiments 1 to 25.

BRIEF DESCRIPTION OF THE FIGURES Additional optional features and embodiments of the invention will be disclosed in more detail in the subsequent description of the preferred embodiments, preferably in conjunction with the dependent embodiments. In these, the respective optional features may be understood in isolation, as well as in any viable arbitrary combination, as the person skilled in the art will understand. The scope of the invention is not restricted by preferred embodiments. The embodiments are shown schematically in the Figures. In these, identical reference numerals in these Figures refer to identical or functionally comparable elements.

In Figures: Figures 1A and 1B show an exemplary embodiment of a camera carrier element in a rear view (Figure 1 A) and a front view (Figure 1B);

Figures 2A and 2B show an exemplary embodiment of a camera carrier element in a perspective view (Figure 2A) and a front view (Figure 2B);

Figures 3A and 3B show exemplary embodiments of a barcode reader in cross-sectional views; and Figure 4 shows an exemplary embodiment of a test element analysis system in a cross-sectional view.

Detailed Description of Embodiments Figures 1A to 1B show an exemplary embodiment of a test element (110) in a rear view (Figure 1A) and a front view (Figure 1B). Test element (110) may specifically be a strip-shaped test element (112) and may also be referred to as a test strip (114). Test element (110) may specifically be an electrochemical test element (116). The electrochemical test element 116 may be configured to perform at least one electrochemical detection. Therefore, the test element 110 may have at least one measuring zone 118 capable of making at least one change being characteristic for the analyte or sample parameter. An electrical quantity can be measured by electrodes (not shown) provided in the metering zone (118). The test element (110) may comprise electrical conductive contact surfaces (120). An electrical signal may be passed over the electrical conductive contact surfaces (120) via conductive pathways (122). Test element 110 may comprise at least one capillary 124 configured to receive the sample. The capillary 124 may be configured such that a fluid medium such as the sample can migrate through the capillary by capillary action. The capillary (124) may comprise at least one inlet (126) and at least one vent (128).

The test element 110 may further comprise at least one barcode 130 as shown in Figure 1B. The barcode 130 may be a two-dimensional barcode 132, specifically a data matrix code 134. The barcode 130 may comprise a plurality of modules 136. Modules 136 may be exemplarily realized as squares or rectangles. Specifically, bar code 130 may carry at least one optical information item selected from the group consisting of: a test type; a batch or batch number; a date of manufacture; an expiration date; a calibration information item. Still, other optical information is viable. The barcode 130 may be configured to read by optical or optoelectronic means. Thus, modules 136 may be configured to assume at least two different optically detectable states.

Figures 2A to 2B show an exemplary embodiment of a camera carrier element (138) in a perspective view (Figure 2A) and a front view (Figure 2B). The camera carrier element 138 may specifically be a printed circuit board 140 and may, for example, have a rectangular shape. Still, other achievements are viable. The camera carrier element (138) may specifically comprise at least one cavity of the camera carrier element (142). Specifically, the cavity of the camera carrier element (142) may be a blind hole (144) with an opening (146). Aperture (146) may be directed toward a test element (110), such as test element (110), as described in Figures 1A to 1B, when placed within a test element holder of a device. of evaluation. The cavity of the camera carrier element 142 may have a round cross section. Still, other achievements are viable. In addition, the camera carrier element (142) may comprise at least one electrical contact block (148) within the cavity of the camera carrier element (142).

Figures 3A and 3B show exemplary embodiments of a barcode reader (150) in cross-sectional views. The barcode reader (150) comprises at least one circuit board (152), at least one camera (154) and at least one camera carrying element (138). The camera carrier element 138 may at least largely correspond to the camera carrier element 138 as illustrated in Figures 2A and 2B. Thus, a reference may be made to the description of Figures 2A and 2B above.

The circuit board (152) has a front side (156) and a reverse side (158). The front side (156) faces the barcode (130) of the test element (110) (not shown in Figure 3), positioned on a test element holder (160) (not shown in Figure 3). The reverse side (158) faces the opposite side of the test element (110). The circuit board (152) comprises at least one cavity (162). The cavity (162) fully or partially penetrates the circuit board (152). Specifically, the cavity 162 may be a through hole 164 in the circuit board 152. By way of example, cavity 162 may have a round cross-section or a rectangular cross-section. Still, other achievements are viable. In addition, the circuit board (152) comprises at least one electronic control element (166) of the barcode reader (150). The electronic control element (166) is disposed on the circuit board (152). The barcode reader (150) may comprise at least one barcode evaluation device (167) configured for at least one of the following: recording, storing, evaluating, monitoring optical information provided by the camera (154). The bar code evaluation device (167) may be part of the electronic control element (166).

[00100] The camera carrier element (138) is disposed on the reverse side (158) of the circuit board (152). For example, as shown in Figure 3A, the camera carrier element (138) is connected to the reverse side (158) of the circuit board (152). Alternatively, as shown in Figure 3B, the camera carrier element (138) may be integrated into the reverse side (158) of the circuit board (152).

The camera (154) may be an integrated camera chip (168), exemplarily comprising a CCD camera (170). In addition, the integrated chip camera (168) may comprise one or more of: a lens system or aperture system (not shown). Camera (154) is electrically connected to camera carrier element (138). Specifically, the camera (154) may be electrically wired over the electrical contact block (148) of the camera carrier element (138). The camera carrier element (138) and the camera (154) are positioned so that the camera (154) observes the bar code (130) (not shown in Figure 3) through the circuit board cavity (162) ( 152). The camera (154) may comprise a front face (172). A distance between the bar code (130) of the test element (110) within the test element holder (160) and the front side (156) of the circuit board (152) may be less than the distance between the bar code (130) and the front face (172) of the camera (154). Specifically, the distance between the barcode (130) and the front face (172) of the camera (154) may exceed the distance between the barcode (130) and the front side (156) of the circuit board (152). at least the thickness t of the circuit board (152). The thickness t of the circuit board (152) may contribute to a free working distance of the camera (154).

[00102] Figure 4 shows an exemplary embodiment of a test element analysis system (174) in a cross-sectional view. Test element analysis system 174 is configured for analytical examination of a sample, in particular of a body fluid. The test element analysis system (174) comprises at least one evaluation device (176) with a test element holder (160) and a measuring device (178). In addition, the test element analysis system (174) comprises at least one barcode reader (150). The barcode reader (150) comprises at least one circuit board (152), at least one camera carrier element (138) and at least one camera (154). The barcode reader 150 corresponds at least in large part to the barcode reader 150 as illustrated in Figures 3A and 3B. Thus, a reference may be made to the description of Figures 3A and 3B above. Test element 110 may at least largely correspond to test element 110 as shown in Figures 1A and 1B. Thus, a reference may be made to the description of Figures 1A and 1B above.

The test element holder (160) is configured to position a test element (110) containing the sample. Therefore, the test element (160) may comprise at least one receptacle (180) configured to receive the test element (110). In this way, the receptacle (180) may be formed complementary to the test element (110). The receptacle (180) and test element (110) may be configured to engage in a snap connection. Specifically, the test element (110) may be fixedly positioned at a specific position within the test element holder (160), so that a movement of the test element (110) in at least one direction may be contained. at least to a great extent. Thus, the metering zone (118) and / or barcode (130) of the test element (110) may be located at a predetermined position relative to the metering device (178) and the camera (154), respectively. Specifically, the barcode reader (150) and metering device (178) may be located on opposite sides of the receptacle (180). Still, other achievements are viable.

[00104] The measuring device (178) is configured to measure a change in the measuring zone (118) of the test element (110), the change being characteristic for the analyte or sample parameter. The test element holder (160) may comprise contact elements (182) with contact surfaces (184) that may allow electrical contact between the electrically conductive contact surfaces (120) of the test element (110). The contact element (182) may be connected to the measurement and evaluation electronics (186), which may be highly integrated for very compact and highly reliable construction. Measurement and evaluation electronics (186) may specifically comprise a printed circuit board (188) and an integrated circuit (190). Still, other achievements are viable.

Reference Number List 110 test element 112 strip-shaped test element 114 test strip 116 electrochemical test element 118 measuring zone 120 contact surfaces 122 conductive pathways 124 capillary 126 inlet 128 vent opening 130 barcode 132 two-dimensional barcode 134 data matrix code 136 module 138 camera carrier element 140 printed circuit board 142 camera carrier element cavity 144 blind hole 146 opening 148 electrical contact block 150 barcode reader 152 circuit board 154 camera 156 front side 158 reverse side 160 test element holder 162 cavity 164 through hole 166 electronic control element 167 barcode evaluation device 168 integrated camera chip 170 CCD camera 172 front face 174 element analysis system test 176 rating device 178 measuring device 180 receptacle 182 he contact surface 184 contact surface 186 measurement and evaluation electronics 188 printed circuit board 190 integrated circuit

Claims (15)

1. Test element analysis system (174) for analytical examination of a sample, in particular of a body fluid, comprising: at least one evaluation device (176) with at least one element holder (160) to position at least one test element (110) containing the sample and at least one measuring device (178) to measure a change in a measuring zone (118) of the test element (110), the change being characteristic for an analyte or a sample parameter; at least one barcode reader (150) for reading at least one barcode (130) on the test element (110), wherein the barcode reader (150) comprises: at least one circuit board (152), circuit board (152) having a front side (156) facing the barcode (130) of the test element (110) positioned on the test element holder (160) and at least one reverse side (158) facing the opposite side of the test element (110), wherein at least one electronic control element (166) of the barcode reader (150) is disposed on the circuit board (152) and on whereas the circuit board (152) comprises at least one cavity (162) that penetrates the circuit board (152); at least one camera carrier element (138) being disposed on the reverse side (158) of the circuit board (152); and at least one camera (154), the camera (154) being electrically connected to the camera carrier element (138), with the camera carrier element (138) and camera (154) being positioned so that the camera ( 154) looks at the bar code (130) through the cavity (162). Test element analysis system (174) according to the preceding claim, characterized in that the camera carrier element (138) is one of those joined on the reverse side (158) of the circuit board (152). , integrated into the reverse side (158) of the circuit board (152) or connected to the reverse side (158) of the circuit board (152) through at least one plug connection. Test element analysis system (174) according to any one of the preceding claims, characterized in that the camera carrier element (138) comprises at least one printed circuit board (140) having at least one block. (148) with the camera electrically connected to it. Test element analysis system (174) according to any one of the preceding claims, characterized in that the circuit board (152) and the camera carrier element (138) are printed circuit boards, wherein the The printed circuit board (140) of the camera carrier element (138) is joined to the reverse side (158) of the circuit board (152). Test element analysis system (174) according to any one of the preceding claims, characterized in that the cavity (162) is a through hole (164) in the circuit board (152). Test element analysis system (174) according to any one of the preceding claims, characterized in that the camera carrier element (138) comprises a cavity of the camera carrier element (142), wherein the carrier element (138) is positioned such that the cavity of the camera carrier element (142) is wholly or partially located within the cavity (162) of the circuit board (152) or overlapping the cavity (162) of the circuit board. (152), wherein the camera (154) is mounted within the cavity of the camera carrier element (142). Test element analysis system (174) according to either of the preceding two claims, characterized in that the camera carrier element (138) comprises at least one electrical contact block within the camera carrier element cavity. (142), wherein the camera is electrically connected to the electrical contact block (148) of the camera carrier element. Test element analysis system (174) according to either of the preceding two claims, characterized in that the camera (154) comprises a front face (172), wherein a distance between the barcode ( 130) of the test element (110) when placed inside the test element holder (160) and the front side (156) of the circuit board (152) is less than a distance between the bar code (130) and the front face (172) of the camera (154). Test element analysis system (174) according to any one of the preceding claims, characterized in that the distance between the barcode (130) and the front face (172) of the camera (154) exceeds the distance between the bar code (130) and the front side (156) of the circuit board (152) by at least the thickness of the circuit board (152). Test element ANALYSIS (174) according to any one of the preceding claims, characterized in that the test element holder (160) comprises at least one receptacle (180) configured to receive the test element; wherein the barcode reader (150) and metering device (178) are located on opposite sides of the receptacle (180). Test element analysis system (174) according to any one of the preceding claims, further comprising at least one test element (110) having at least one measuring zone (118) capable of making at least one change being characteristic for the analyte or sample parameter, the test element (110) further having at least one barcode (130). Test element analysis system (174) according to the preceding claim, characterized in that the bar code (130) carries at least one optical information selected from the group consisting of: a type of test; a batch number; a lot number; a date of manufacture; an expiration date; an item of information about a calibration. Test element analysis system (174) according to any one of the preceding claims, characterized in that the bar code reader (150) comprises at least one bar code evaluation device (167) configured to at least one of the recording, storage, evaluation, monitoring of optical information provided by the camera. Test element analysis system (174) according to any one of the preceding claims, characterized in that the camera carrier element (138) comprises an electrically connected electrical contact to the camera (154), wherein the electrical contacts of the camera carrier element (138) is electrically connected to at least one circuit board electrical contact (152), wherein the circuit board electrical contact (152) is located on the reverse side (158) of the circuit board (152) ) and wherein the circuit board (152) comprises at least one electrical connection path of the circuit board electrical contact (152) with at least one electronic control element (166) disposed on the front side (156). Method for manufacturing the test element ANALYSIS SYSTEM (174) according to any one of the preceding claims, characterized in that the method comprises: a) providing the circuit board (152); b) providing the camera carrier element (138); c) connect the camera (154) to the camera carrier element (138) d) connect the camera carrier element (138) to the reverse side (158) of the circuit board (152).