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HK1125999B - Apparatus for the analysis of a sample on a test element - Google Patents

Apparatus for the analysis of a sample on a test element Download PDF

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Publication number
HK1125999B
HK1125999B HK09103701.5A HK09103701A HK1125999B HK 1125999 B HK1125999 B HK 1125999B HK 09103701 A HK09103701 A HK 09103701A HK 1125999 B HK1125999 B HK 1125999B
Authority
HK
Hong Kong
Prior art keywords
contact
test element
analysis
test
injection
Prior art date
Application number
HK09103701.5A
Other languages
Chinese (zh)
Other versions
HK1125999A1 (en
Inventor
Stefan Riebel
Herbert Wieder
Gregor Bainczyk
Manfred Augstein
Albert Grosser
Oliver Kube
Dieter Meinecke
Bruno Thoes
Original Assignee
F. Hoffmann-La Roche Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from EP05023219A external-priority patent/EP1780541B1/en
Application filed by F. Hoffmann-La Roche Ag filed Critical F. Hoffmann-La Roche Ag
Publication of HK1125999A1 publication Critical patent/HK1125999A1/en
Publication of HK1125999B publication Critical patent/HK1125999B/en

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Description

Analysis device for analyzing a sample on a test element
Technical Field
The invention relates to an analysis device for analyzing a sample on a test element to be analyzed, comprising at least one component for electrical contacting for current transmission.
Background
For analyzing samples, such as body fluids like blood or urine, analytical instruments are frequently used on which the sample to be analyzed is placed on a test element before the sample is analyzed and, if appropriate, reacts with one or more reagents on the test element in a test field. Optical, in particular photometric, and electrochemical analysis of test elements are the most common methods for rapidly determining the concentration of an analyte in a sample. Analytical systems with test elements for sample analysis are generally used in the field of analytics, environmental analytics, and above all in the field of medical diagnostics. In particular, in the field of blood glucose diagnosis from capillary blood, measuring elements which are analyzed photometrically or electrochemically are of great value.
There are different types of test elements. Such as a sheet known as a substantially square, also called a Slide (Slide), in the middle of which a multi-layered test zone is arranged. The diagnostic test element configured in the form of a strip is then referred to as a test strip. Test elements are described in the prior art in full, for example in the documents DE-A19753847, EP-A0821233, EP-A0821234 or WO 97/02487. The invention relates to test elements of arbitrary shape, in particular strip-shaped test elements.
For the analytical examination of test specimens on test elements, test element analysis systems are known from the prior art, which comprise a test element receptacle for positioning the test element in a measuring position and a measuring and analyzing device for measuring and calculating the analytical results produced thereby.
WO 00/19185A 1 relates to a device for photometric analysis of a test element, comprising
A lighting unit having at least one first and one second light source,
a holder for holding a test element having a certification area such that the certification area is positioned relative to the lighting unit,
a detection unit having at least one detector which detects light reflected by or transmitted through the authentication zone,
a control unit which activates the two light sources and records the signal generated by the detection unit as a detection signal, an
An analysis unit for analyzing the detection signal for calculating the concentration of the analyte contained in the sample.
Other analytical instruments are for example disclosed in EP 0618443 a1 or WO 01/48461 a 1.
Blood glucose analysis instrument developed by Roche DiagnosticsCompact Plus measures the blood glucose level according to the measurement principle of photometric measurement. The test element is wetted beforehand with the patient's blood, and the discoloration in the test field provided on the test element is detected by an optical measuring module and electronically converted in the instrument into a value proportional to the blood glucose.The measurement process is started by switching on the key. The motor provided in the motor module then rotates the roller serving as a reservoir, in which the test element is stored, further through a chamber of the reservoir, and the second motor pushes the test element out by means of the plunger, so that the test element can be wetted with blood by the user outside the instrument. In the process, the test element remains in the analysis device to such an extent that the test field with the indicator chemical is positioned in the measurement module by the measurement optics. This measuring optical system has two diodes, a photoelectric cell and a lens. The change in the diffuse reflection is converted by the photocell into a signal current, which is processed by an electronic circuit on the printed circuit board and displayed on the LC display as the blood glucose level. The switch-on button is actuated again to terminate the measuring process, the measuring element is pushed out and the analysis device is switched off. The measuring and drive electronics are supplied with a total voltage of approximately 3V via the two batteries. In contrast to similar analytical devices in which, for example, the test element must be transported from the outside and the individual intermediate states must be manipulated manually, this device has an increased functional integration. The 17 individual test elements are stored in a roll-like supply container, the format of which is automatically recognized by means of a bar code reader in the analysis device. The replacement of this drum-shaped test element magazine is detected by a switch on the upper housing part after the test element magazine receiving cover has been opened and closed. The required state, such as the rotation of the test element magazine by one step and the different holding positions during the test element feeding, is reported by sliding contacts and dynamically resilient switching contacts with the electronics of the printed circuit board, without operating functions being required by the user. Dynamic elasticity in this respect means: loading and unloading of forces and multiple movements during operation. The core part of the analysis instrument for performing these electromechanical functions is the motor module. In addition, the motor module is used for receiving the drive motor and the transmission printed circuit board. The printed circuit board is screwed with the motor module. Is composed ofAll other contacts between the two components are embodied as releasable, static spring contacts, for example for supplying the drive motor and the measuring module. Static elasticity means in this respect that: force loading and movement is done once during instrument set-up. Due to the large number of functions integrated in the device, which must be controlled by the device software, the printed circuit board is constructed in a four-layer structure.
The analytical instruments disclosed in the prior art have a large number of parts which are electrically contacted. Such as those in Roche DiagnosticsThere are resilient, plug, solder or slide contacts that interconnect components of the printed circuit board, motor module, measurement module, roller cover switch, bar code reader and LCD (liquid crystal display). In the prior art, metal stamping and bending parts are used for this purpose, which have to be positioned and mounted on a single component, thereby requiring a large number of individual parts and resulting in high assembly effort and long tolerance chains. Further, in the case of using the punch and bend, the degree of freedom in designing the parts of the electrical contact is limited.
Disclosure of Invention
The object of the present invention is therefore to avoid the disadvantages of the prior art and to provide an analysis device for analyzing a sample on a test element with electrically contacting parts, in which reliable contacting is ensured while reducing the number of individual parts to be assembled.
According to the invention, this object is achieved by a test instrument for analyzing a sample on a test element, comprising at least one component for electrical contact for current transmission, which is suitable for establishing an electrical contact with at least one further component. The electrically contacted component is an injection-molded circuit carrier (MID), in particular a three-dimensional injection-molded circuit carrier.
injection-Molded circuit carriers (Molded interconnect devices-MIDs) and methods for producing them are known from the prior art, for example from DE 19717882 a1 or WO 00/67982 a 1.
The MID-process concept below summarizes different methods with which three-dimensional electronic components can be produced. The aim of these methods is to integrate the circuit structure into a polymeric (mostly thermoplastic) carrier component.
If conventional solutions for electrical contacts and electronics in instruments are investigated, spring contacts are often found that are inserted, glued or hot pressed in the housing (such as battery contacts in many small instruments). Another solution is a metal leaf spring or sliding contact that brings the peripheral electrical components into contact with the printed circuit board (e.g., a slide switch, a push button, or a dial wheel). The electronic circuits that control the functions of the instrument are mostly implemented on printed circuit boards. The printed circuit board is equipped with the necessary electronic components. In the simplest lines, cables are soldered or connected to each other by plugs for wiring. All of these construction and connection techniques have in common that, to construct a functionally capable system, multiple components must be automatically or manually positioned, joined and installed. In this case, either considerable equipment expenditure is incurred in automated production or considerable time and personnel expenditure is incurred in non-automated production.
In contrast, the use of MID processes for producing electrically contacted components in analytical instruments thus offers the possibility of reducing or eliminating these disadvantages of conventional solutions: the assembly process can be shortened or avoided altogether. The number of parts is reduced and the tolerance chain is shortened. Fewer different types of materials are used in the instrument, which facilitates waste disposal and recycling. In addition, some MID methods provide functionality that is not possible with conventional solutions.
The MID method is based on the selective provision of an electrically conductive metal layer on the injection-molded part. One such metallized polymeric injection-molded part may include an electrical function (e.g., the function of a printed conductor, a plug contact, or a sliding contact) as well as a mechanical function (e.g., the function of a fastener).
The most important MID methods that can be used to produce the injection-molded circuit carrier in the analysis device according to the invention are:
-two-component injection moulding,
-hot pressing die
Post-film-coating (Folienhiterspritzen) and
laser structuring (laserstrukturrieng).
In two-component injection molding, a metal-sprayable and a non-metal-sprayable thermoplastic material component are sprayed on top of one another in two working steps. In this case, the workpiece is supported in the die on the particular surface that has achieved its final contour during the first shot at the time of the second shot. After injection molding, the surface of the metal-sprayable thermoplastic is optionally made reactive and the desired metal layer thickness (for example copper layer thickness) is applied chemically or galvanically. In the subsequent step, surface hardening and tempering, such as Ni — Au, is performed. Palladium is mixed into the material composition that can be metallized, for example, and serves as a crystal nucleus for metallization. The palladium nuclei serve, for example, as decomposition centers for the stabilized nickel or copper solution. In other methods, plastic that is inherently metal-sprayable is used. The metal spraying method is classified into chemical metal spraying (without power supply) without external current and metal deposition (with power supply applied) by electroplating.
Possible metal-sprayable components which can be used in the two-component injection molding process are, for example, PES (polyethersulfone), PEI (polyetherimide), LCP (liquid crystal polymer), PA (polyamide), PPA (polyparaphenylene terephthalamide) or ABS (acrylonitrile-butadiene-styrene). As the non-metallizable component, for example, ABS + PSU (acrylonitrile butadiene styrene + polysulfone), PPA (poly-p-phenylene terephthalamide), PBT (polybutylene benzoate), PPS (polyphenylene sulfide), PES (polyether sulfone), PC (polycarbonate) or PA (polyamide) can be used.
In hot-pressing dies, the injection molding is followed in a work step by punching and die-casting of a metal foil (e.g. copper foil)Metal structures, such as printed conductors, are applied to the plastic substrate. In the hot-stamping technique, electrical contact can be achieved by filling the through-holes with a conductive paste. In hot-embossing, it is necessary to produce films in addition to the one-component injection molding of the substrates. Hot stamping films for MID applications are generally characterized by a three-layer structure consisting of an electrically conductive copper film, an adhesion layer on the lower side and a surface metal-sprayed layer serving as an oxide layer and for improved solderability and contactability. The copper film was electrolytically deposited directly on the rotating titanium roller in a copper sulfate solution. The low shear strength of the copper film required for shearing the metal structures (conductor tracks) during the stamping process is achieved during the film production by special processes which lead to oriented crystal growth perpendicular to the film surface. Before the use of different current loads, copper films with layer thicknesses of 12, 18, 35 and 100 micrometers were produced, with a layer thickness of 35 micrometers, which is frequently used in printed circuit board technology, being typical. The adhesion strength of the film to the substrate is achieved either by an adhesive layer on the underside of the film or by structuring of the underside of the film. Possible materials which can be used for the hot-embossing process are, for example, ABS (acrylonitrile-butadiene-styrene), PA (polyamide), PBT (polybutylene benzoate), PC + ABS (polycarbonate + acrylonitrile-butadiene-styrene) and PPS (polyphenylene sulfide).
In the film post-coating (Folienhiterspritzen), the desired pattern is first structured on the plastic film. The film can be structured, for example, using subtractive flexible printed circuit board technology or additively by means of a primer process (primertechnology) or hot embossing method. In the flex-pcb technology, a polymer film (for example made of polyamide) is metallized over the entire surface and subsequently structured by an etching process in a subtractive technology. In the primer process, a metal-sprayable adhesion promoter is applied to the plastic film by pressing.
After structuring, the film can be deformed and subsequently post-sprayed (Hinterspritzt). The metal coating of the plastic part can be carried out before or after the post-coating.
The post-sprayed plastic film may for example comprise PEI (polyetherimide), PC (polycarbonate) or PC/PBT (polycarbonate/polybutylene benzoate). Materials which can be used for post-spraying the film are, for example, PEI (polyetherimide), PC (polycarbonate), PBT (polybutylene terephthalate), PET (polyethylene terephthalate) or PEN (polyethylene naphthalate).
Another possible method for producing (three-dimensional) injection-molded circuit carriers for the analytical device according to the invention is laser structuring (laser structuring).
In subtractive laser structuring, the injection-molded workpiece is first plated with copper over its entire surface by wet-chemical methods and then electrolytically to the desired final layer thickness before the structuring of the conductor tracks. A resist, such as a photoresist or a plating resist (Galvanoresist), is applied to the copper layer, wherein a chemical reaction is triggered by means of energy added by means of ultraviolet radiation when the photoresist is used and wherein the plating resist is ablated by means of laser radiation. The resist is then structured by means of laser radiation, and the copper is subsequently etched away in the structured regions. And then carrying out surface hardening and tempering.
In additive laser structuring, thermoplastic materials are modified in such a way that complex organometallic compounds are present in the material in dissolved or finely dispersed form. The printed conductor to be realized is then activated in a targeted manner on the thermoplastic doped in this way by means of a laser and subsequently metallized in a chemical bath. Chemical copper electrolytes are commonly used for this process, which typically produce a 5 to 8 micron thick copper layer. A suitable surface polishing treatment may then be performed.
Laser structuring can be applied, for example, to PEI (polyetherimide), PA (polyamide), LCP (liquid crystal polymer), ABS (acrylonitrile butadiene styrene), PC (polycarbonate), PC + ABS (polycarbonate + acrylonitrile butadiene styrene), PBT (polybutylene terephthalate), PI (polyimide) or PET (polyethylene terephthalate), wherein the material must be doped if necessary.
The analysis device according to the invention can analyze the sample on the test element, for example, photometrically and/or electrochemically.
In the analysis device according to the invention, at least one electrically contacting component is present as a three-dimensional, injection-molded circuit carrier, which can be produced according to any of the methods described above. The electrically contacting component is adapted to establish an electrical contact with at least one further component, preferably an electrical contact selected from the group of resilient contacts, plug contacts, sliding contacts, soldering contacts or conductive glue contacts. Starting from such electrical contacts, the printed conductors lead to an electrical component, such as a sensor, a barcode reader, a further contact, a motor, etc., on the injection-molded circuit carrier (MID component). In this case, both contacts that are contacted statically and elastically at a single time and contacts that are contacted statically and elastically at a plurality of times are referred to as elastic contacts.
According to a preferred embodiment of the invention, the component of the electrical contact has at least one resilient contact plate for contacting the second component, which contact plate comprises a contact plate body made of injection-molded plastic and a metallic conductor structure. As the plastic to be injection molded, PEI (polyetherimide), PA (polyamide), LCP (liquid crystal polymer), ABS (acrylonitrile butadiene styrene), PC (polycarbonate), PC + ABS (polycarbonate + acrylonitrile butadiene styrene), PBT (polybutylene terephthalate), PI (polyimide), or PET (polyethylene terephthalate) may be used, for example, and may be a conductor structure of metal such as copper, gold, or nickel. The contact piece can be in contact with another stationary, another rotating or another linearly moving component of the analysis device in or on the analysis device.
In the analysis device according to the invention, the contacting component of the molded circuit carrier can be, for example, a functional component of the analysis device and the further contacting component can be a printed circuit board of the analysis device. The functional component is here, for example, a bar code reader device, a housing, a delivery unit for the test elements, a motor module, a measuring module, a positioning device for the test element magazine, a test element magazine receptacle containing a sensor, or a thermostat in the measuring module.
The bar code reader device is, for example, comprised in the analysis device according to the invention for reading a bar code on a supply container of test elements by means of a bar code reader, which bar code contains, for example, information about the test elements contained in the supply container and their optimum analysis. In the prior art, the bar code reader is usually attached to a printed circuit board arm which projects into a housing section of the analytical instrument, in which a supply container (test element magazine) for test elements can be received. The electrical contact to the bar code reader is made here by means of an elongated printed circuit board arm.
In contrast, the analysis device according to the invention preferably comprises a bar code reader device, which in turn comprises a housing section of the analysis device, in which a bar code reader is arranged, wherein the housing section comprises conductor tracks extending toward the bar code reader and elastic contacts for contacting a printed circuit board, and the housing section with the conductor tracks and the elastic contacts is an injection-molded circuit carrier, in particular a three-dimensional injection-molded circuit carrier. In this embodiment, the elongated printed circuit board arm can be omitted. The bar code reader is connected to the housing section directly inside the housing (for example by means of soldered contacts). The housing section itself comprises the necessary printed conductors and the contact points, which are elastic and static, for contacting the printed circuit board in order to ensure the current supply of the bar code reader. This eliminates the associated components and assembly steps and also gains installation space within the analytical device.
For example, when the test elements are automatically removed from the test element magazine, positioning devices for the test element magazine are required in order to be able to specifically access the test elements. Such a positioning device rotates, for example, a roller-like test element magazine as described in DE 19854316 a 1. Once the test element magazine is correctly positioned, the test element can be removed therefrom by the delivery unit and delivered further in the analysis instrument.
In the prior art, the positioning device for a roller-shaped test element magazine is configured, for example, in such a way that a roller wheel provided as a drive wheel for the test element magazine rotates together with the test element magazine and the roller rotation is registered on the roller wheel by means of two spring contacts hot-pressed onto the transmission circuit board and a segmented slip ring (five individual components to be mounted are available in total).
According to a preferred embodiment of the invention, the analysis device according to the invention comprises a positioning device for the test element magazine, which positioning device comprises a printed circuit board for supplying power and a drive wheel which is driven by a motor and is used for driving the rotatable test element magazine, wherein the printed circuit board with spring contacts is designed as an injection-molded circuit carrier and the drive wheel with an electrically contactable segmented disk (Segmentscheibe) is designed as an injection-molded circuit carrier. Whereby the five individual components are replaced by two MID components. In addition, the advantage is provided in this case that the design of the installation space in the analysis device according to the invention is made more flexible by the more free shaping of the plastic part and the conductor tracks arranged thereon in the MID process.
In analytical devices for analyzing samples on test elements, the transport unit for the test elements is used for transporting the test elements in the analytical device, for example, from a test element magazine into a sample delivery position and into a measuring position. One such transport unit is known, for example, from DE 19902601 a 1. This publication relates to a method and a device for removing a consumable, in particular a test element, for analysis from a supply container having a chamber, wherein the chamber is closed by a membrane and the consumable is pushed out of the chamber by a plunger.
The tappet (push rod) is pushed in the axial direction by a motor. In this case, the push rod has a guide sleeve at one end, which is guided in a guide device during the displacement of the push rod. The guide device has a contact part designed as a punch-bent part with three contact webs for positioning the guide sleeve and thus for positioning the push rod. For this purpose, the contact lugs are pressed against the contact surfaces on the printed circuit board by the guide sleeve in the position of the guide sleeve.
According to one embodiment of the invention, the analysis device according to the invention comprises a transport unit for the test elements, which transport unit comprises a plunger for transporting the test elements inside the analysis device, wherein the plunger has a guide sleeve which can be guided in a guide device during the transport of the test elements. The guide sleeve has a resilient contact strip for contacting a printed circuit board, and the guide device comprises a switching element, which is arranged in such a way that it presses the contact strip against the printed circuit board in a specific position of the guide sleeve in the guide device, wherein the guide sleeve with the contact strip is an injection-molded circuit carrier (in particular a three-dimensional injection-molded circuit carrier). The switching function is thus integrated in the guide sleeve, whose contact lugs are pressed against the printed circuit board contacts, for example by means of injection-molded contact lugs on the guide. In this way, compared with the prior art, not only are machining steps, positioning steps and installation steps omitted, but also the possibility of saving space is provided when the guide bush is correspondingly designed.
Analysis instruments for analyzing samples on test elements, which are largely automated, comprise in the prior art a motor module which in turn comprises a motor. These motors are electric motors and are used, for example, for positioning a test element magazine or for driving a pusher for moving a test element inside the analysis instrument.
In the prior art, in order to supply the motor (electric block or push rod motor) with electric power, a contact plate is pressed into the motor bracket, which contact plate is electrically conductively connected to the printed circuit board via a resilient contact lug.
In a preferred embodiment of the invention, the analysis device according to the invention comprises a motor module comprising a motor and a motor carrier, wherein the motor carrier has a contact strip for contacting a printed circuit board, and the motor carrier with the contact strip is an injection-molded circuit carrier, in particular a three-dimensional injection-molded circuit carrier. The contact pads of the MID component may be soldered to the printed circuit board. By using the injection molded circuit carrier, the processing and mounting steps can be saved. In particular, the motor mount can be designed more simply, since, for example, the injection Dome (Dome) for fastening the separate contact plate can be dispensed with.
Furthermore, an analysis device for analyzing a sample on a test element, in which a large number of test elements can be accommodated in a test element magazine receptacle for storing test element magazines, can according to the invention comprise a sensor in the test element magazine receptacle, which sensor detects a replacement of a test element magazine. In the case of the analysis devices according to the prior art, the replacement of the magazine is recorded as soon as the analysis device cover covering the test element reception opening is opened and subsequently closed, since in the process the latching switch on the printed circuit board is actuated. However, if the analyzer lid is opened and closed without replacing the cartridge, the instrument also records a cartridge replacement despite the fact that the cartridge has not been replaced. As a result, the magazine is rotated for identification by the bar code reader and for the purpose of finding out the chamber filled with test elements, although this is not necessary. In the prior art, no sensor is present for detecting the actual cartridge change, since the position at which the cartridge change is detected cannot be reached by the two-dimensional printed circuit board present in the analysis device and cannot be contacted in a cost-effective manner, for example by soldered flexible cables.
According to one embodiment of the invention, the analysis device according to the invention comprises a test element magazine receptacle containing a sensor, which test element magazine receptacle comprises electrical conductor tracks extending towards the sensor, wherein the test element magazine receptacle with conductor tracks is an injection-molded circuit mount, in particular a three-dimensional injection-molded circuit mount. If the sensor is activated, for example, by the closing of contacts when the cartridge is removed, a signal can then be transmitted to the printed circuit board via the electrical conductor tracks.
The analytical devices for analyzing samples on test elements optionally comprise a temperature control device for the temperature control of the test element before and during the analysis (for example, when measuring blood coagulation). In the prior art, both instrument-side heaters (for example in measuring modules in which measurements are carried out with a sample on the test element) and heating elements integrated in the test element (for example from DE 10359160 a1) are known. The instrument-side heater is a ceramic element which is mounted in the test element receiving opening or is added to this test element receiving opening during the production of the test element receiving opening. However, problems with tightness often arise in installed heating elements. Liquids can intrude into the instrument and cause damage. Other problems arise if contamination occurs due to the sample material. Furthermore, a plurality of mounting steps are required for obtaining the finished assembly. The use of ceramic heaters generally has the disadvantage that ceramic cracking occurs and thus the functional capability of the instrument cannot be guaranteed. Furthermore, the use of the integrated ceramic heater places high demands on the manufacturing method used and adds significantly to the complexity of the manufacturing method.
According to one embodiment of the invention, the analysis device according to the invention comprises a test element receptacle for receiving a test element (for example during a measurement procedure), in which a thermostat device for the thermostatic treatment of the test element is contained, wherein the thermostat device comprises a heating coil and is an injection-molded line carrier, in particular a three-dimensional injection-molded line carrier. The conductor tracks serving as heating filaments are therefore integrated directly into the plastic of the test element receiving opening by means of MID technology. It is not necessary to integrate a ceramic heater here. The contacts for supplying the heating coil filament can be produced, for example, from a metallic stamping or bending part or also by the MID method. The contacts are capable of connecting the thermostat to a printed circuit board for power supply. The advantages of this embodiment of the analysis device according to the invention with a thermostat device are: the manufacturing process is simplified, problems caused by ceramic cracking are avoided, the manufacturing cost is reduced due to the omission of the ceramic manufacturing process, a sealed test element receiving opening is obtained, and a complicated and miniaturized shape can be realized.
According to a further embodiment of the invention, the analysis device according to the invention comprises a measuring module for measuring an analyte contained on a test element, which measuring module comprises a test element receiving opening for receiving the test element during measurement, in which test element receiving opening a temperature control device for temperature control of the test element is contained, wherein the test element receiving opening with the temperature control device containing a heating coil filament and a resilient contact is an injection-molded line carrier, in particular a three-dimensional injection-molded line carrier. The conductor tracks serving as heating filaments are therefore integrated directly into the plastic of the test element receiving opening by means of MID technology. It is not necessary to integrate a ceramic heater here. The elastic contact, which is also produced by the MID method, makes it possible to connect the thermostat to a printed circuit board for supplying power. Therefore, it is not necessary to use a Pin (Pin). The entire production process of the thermostat device is therefore preferably limited to the plastic forming by injection molding and the application of the metal structure on the MID part. The advantages of this embodiment of the analysis device according to the invention with a thermostat device are: the manufacturing process is simplified, problems caused by ceramic cracking are avoided, the manufacturing cost is reduced due to the omission of the ceramic manufacturing process, a sealed test element receiving opening is obtained, and a complicated and miniaturized shape can be realized.
In an analysis device for analyzing a sample on a test element, at least one test element receiving opening is provided for positioning the test element before and during the analysis (for example, when receiving the sample and in particular when performing an electrochemical or optical analysis of the sample). According to one embodiment of the invention, the test element receptacle comprises at least two elastic contacts for positioning a test element in the test element receptacle, wherein the test element receptacle with the at least two elastic contacts is an injection-molded circuit carrier (in particular a three-dimensional injection-molded circuit carrier). By means of such a test element receptacle, for example, it can be positioned in such a way that metallic, electrically conductive structures (for example, metallic areas) arranged on the test element short circuit the at least two elastic contacts once the test element is in the desired position. By means of this short circuit, a current can flow through the contact, where it can be detected and evaluated as a position signal.
According to one embodiment of the invention, the analysis device according to the invention comprises a contact element for performing an analysis of test elements in the analysis device as a component for electrical contacting of a molded circuit carrier, in particular a three-dimensional molded circuit carrier. The contact element for the test element analysis can be brought into contact with a test element to be analyzed electrochemically.
Electrochemical methods for determining the concentration of an analyte are based, for example, on amperometry or coulometry. Such processes are disclosed, for example, in publications US 4,654,197, EP 0505475B 1 or US 5,108,564. To carry out an electrochemical analysis, an electrical signal must be transmitted between the test element and the analysis system. The test elements incorporated in the analysis system must therefore be electrically contacted in the analysis system by means of an electrical connection system.
In the prior art, plug connectors are used as contact elements for making contact, which plug connectors are made of plastic parts and also of metal parts. The plastic part serves as a housing and takes over the guiding function of the test element. The metal elements are then used for electrical conduction and contact. The metal element is produced by a bending and stamping process and is either mounted on the plastic part or is directly injected into the plastic part. The design and layout constraints of the plug connector are mainly due to the limitations of the stamping and bending process and to the requirements of the mountability or the crushability of the metal parts. Due to the stamping and bending process, the layout and design of the contact elements is greatly limited in the prior art compared to the possibilities of plastic processes. Furthermore, the requirements of the installability or the crushability of the metal part must be taken into account during the design. In the analysis device according to the invention, the function of the electrical contact is not realized by the mounted metal parts, but the contact elements are produced by using the MID process.
According to one embodiment of the invention, the analysis device according to the invention comprises a contact element for the analysis of test elements, which contact element has a support surface for the test elements, wherein a plurality of contact bevels project beyond the support surface, which contact bevels are provided for establishing an electrical contact with the test elements positioned on the support surface and can be connected to a printed circuit board by means of conductor tracks running over the contact element, wherein the contact element is an injection-molded circuit carrier, in particular a three-dimensional injection-molded circuit carrier. The test element to be analyzed electrochemically is preferably pushed on the bearing surface of the contact element in the slot-like guide groove of the analysis device until it is positioned on the contact ramps in such a way that these contact ramps are pressed against the test element and contact the electrical contacts of the test element. The contact ramps can be embodied, for example, as ramp-like projections arranged on an extension of the support surface or as individual ramp-like elastic contact lugs. The conductor tracks extend on the contact element, for example, up to the end of the contact element, where they are soldered to the printed circuit board for power supply and signal processing.
According to one embodiment of the invention, the contact element for the analysis of test elements is integrated in a housing of the analysis device, wherein the housing comprises an injection-molded circuit carrier, in particular a three-dimensional injection-molded circuit carrier.
According to a further embodiment of the invention, the contact element for the analysis of test elements is integrated in a test element magazine. In this case, either a single contact can be realized for each test element or a common contact can be realized for all test elements contained in the magazine. An interface with the analytical instrument is additionally arranged on the cartridge. Via this interface, the test element is finally connected to the instrument. The advantages of this embodiment are: a space-saving design is achieved, the individual test elements do not have to be positioned precisely relative to the analytical instrument, and the contact in the magazine can be designed in a cost-effective manner, since only a limited number of test elements contained in the magazine need to be contacted at one time and subsequently removed together with the magazine.
The invention further relates to a storage container (test element magazine) for at least two test elements, wherein the test elements have electrical conductor tracks and the storage container comprises electrical contacts for contacting the conductor tracks of the test elements contained in the storage container during electrochemical analysis of a sample on the test elements.
The reservoir is, for example, a roller-shaped test element magazine, which can be designed, in particular, to a large extent as the reservoir described in DE 19854316 a 1. The inventive storage container has an electrical contact for making electrical contact with a test element to be analyzed electrochemically. The storage container according to the invention preferably has at least two separate chambers for receiving the test elements, wherein in each chamber an electrical contact is arranged for making contact with the conductor tracks of the test elements contained in the chamber when the sample on the test element is electrochemically analyzed.
In the prior art, electrochemical analyses are carried out in a measuring module of the analytical instrument, in which electrical contact is made with the test element and which is arranged in the analytical instrument at a distance from the test element supply container. The test elements are automatically transported out of the test element supply container, if necessary, by a transport unit in the analysis device, transferred to the measuring module and there positioned precisely relative to the electrical contacts. One such disadvantage of contacts in a measuring module is, for example: a large installation space is required inside the analysis device for the electrochemical analysis of the test element. Furthermore, the test element for contacting must be positioned precisely. The hand-over of test elements to contact points in the analytical instrument is a potential weakness in positioning, reliability and dynamic contact. Furthermore, the contacts of the measuring module in the analysis device are only suitable for a specific electrode structure on the test element.
In contrast, the solution according to the invention has the advantage that a simple, standardizable interface can be arranged between the analytical instrument and the magazine, resulting from the integration of the electrical contacts into the supply container (test element magazine), wherein the electrical contacts, for example, arranged in a chamber of the respective magazine are compatible with the electrode structure of the test element contained in this chamber and can be designed flexibly. Furthermore, the analytical device and the cartridge can be designed with a saving in installation space. In addition, the test element does not have to be positioned precisely outside the reservoir in the analysis instrument. The contact points of the test elements in the magazine can be designed cost-effectively, since they only have to come into contact with the test elements contained in the magazine and the magazine can subsequently be cleaned.
The contact points in the storage container can then be realized by means of a mounted or extruded metal part. According to a preferred embodiment of the invention, the storage container according to the invention with the electrical contacts is essentially an injection-molded circuit carrier, in particular a three-dimensional injection-molded circuit carrier.
In the prior art, the electrode structures required in the test elements to be analyzed electrochemically are mostly produced by pressing or by laser ablation. For this purpose, the test element is first produced and the electrode structure is subsequently provided. The three-dimensional structure of the test element is thus greatly restricted or impossible to achieve. Larger test elements with multiple test fields or test fields for different parameters are therefore difficult to produce, since the size of the exposure window is limited in laser ablation and the design possibilities are greatly limited in the pressing process.
The invention therefore also relates to a test element comprising a test field for the electrochemical analysis of a liquid sample in an analysis device, wherein the test field is connected to electrical conductor tracks on the test element, wherein the test element with the electrical conductor tracks is essentially an injection-molded circuit carrier.
In the solution according to the invention, the electrode structure is integrated in the plastic sample carrier by means of the MID method. This results in great design freedom in designing the test element (true three-dimensional structure), simple production processes (injection molding) and the possibility of producing large test elements with a plurality of test fields.
The invention further relates to a method for producing an analysis device for analyzing a sample on a test element, comprising at least one electrically contacted component for transmitting electrical current. The method is suitable for establishing an electrical contact with at least one further contacting component, comprising the following method steps:
a) the component for electrical contact is produced by a method for producing an injection-molded circuit carrier (MID), in particular a three-dimensional injection-molded circuit carrier, comprising a base body and a metallic conductor structure, and
b) positioning and mounting the electrically contacted component in the analytical instrument for establishing electrical contact with another contacted component.
The method for producing an injection-molded circuit carrier (MID), in particular a three-dimensional injection-molded circuit carrier, is preferably a method selected from the group of two-component injection molding, hot-pressing, film post-coating and laser structuring methods.
Drawings
The invention is explained in detail below with the aid of the figures. Wherein:
figure 1.1 shows an analytical instrument according to the prior art,
figure 1.2 is an exploded view of the analysis instrument shown in figure 1.1,
figure 2 is an exploded view of the different components of an analysis instrument according to the prior art,
figure 3.1 is an exploded view of a positioning device for test element magazines in an analysis instrument according to the prior art,
FIG. 3.2 shows a positioning device for a test element magazine in an analysis apparatus according to the invention,
figure 4.1 shows a transport unit for test elements in an analysis instrument according to the prior art,
FIG. 4.2 shows a transport unit for test elements in an analysis apparatus according to the invention,
figure 5.1 is an exploded view of a motor module in an analysis instrument according to the prior art,
figure 5.2 shows a motor support of the motor module in the analysis instrument according to the invention,
figure 6.1 shows a bar code reader device in an analysis instrument according to the prior art,
figure 6.2 shows a bar code reader device in an analysis instrument according to the invention,
figure 7.1 shows a test element magazine receiving opening in an analysis instrument according to the prior art,
FIG. 7.2 shows a test element magazine receiving opening with a sensor in an analytical instrument according to the invention,
figure 8 shows a contact element for test element analysis in an analysis instrument according to the prior art,
figure 9 shows a first contact element for the analysis of a test element in an analysis instrument according to the invention,
FIG. 10 shows a second contact element for the analysis of a test element in an analysis instrument according to the invention,
figure 11.1 shows a thermostat in the measuring module of an analysis instrument according to the prior art,
figure 11.2 shows the back of a heating element according to the prior art,
figure 11.3 is the front side of a heating element according to the prior art,
figure 11.4 shows a thermostat in the measuring module of the analytical instrument according to the invention,
FIG. 12 shows a supply container according to the invention for test elements in an analytical instrument, and
FIG. 13 shows a first embodiment of a test element according to the invention, which is designed essentially as an injection-molded circuit carrier, and
fig. 14 shows a second embodiment of a test element according to the invention, which is designed essentially as an injection-molded circuit carrier.
Detailed Description
Fig. 1.1 shows an analysis device according to the prior art.
The analysis device 1 has a housing 2, which housing 2 comprises a display area 3(LCD4) and an operating area 5 (switch-on button 6). In the analysis instrument 1 shown in fig. 1.1, the test element magazine receptacle 7 can be seen, since the test element magazine receptacle cover has been removed. In the test element magazine receiving opening 7, a roller-shaped test element magazine 8 is provided, which can receive a large number of test elements. The test element magazine has a bar code 9 on the outer side, which bar code 9 contains information, for example, about the test elements contained in the test element magazine and can be read in by a bar code reader (not shown). The measurement process is started by means of the switch-on button 6. The (invisible) motor rotates the test element magazine 8 further through a chamber 10, and the (invisible) second motor pushes the test element 11 out of the chamber 10 of the test element magazine 8 by means of a plunger until the test element protrudes from the analysis instrument 1. In this position, a user can apply a sample (such as blood) to the test element 11. The measurement optics (not visible) provided in the analysis device 1 analyze the sample on the test element 11. The results of the analysis (e.g. blood glucose values) are displayed on an LC-display. On the side of the housing 2 of the analysis device 1, a removable lancing aid 12 is provided, which lancing aid 12 can be used for taking samples.
Fig. 1.2 shows an exploded view of the analysis instrument shown in fig. 1.1.
The test element magazine receiving bay cover 7, the upper housing half 14, the LC display 4, the printed circuit board 15, the measuring module 20, the motor module 16, the lower housing half 17, the model designation plate 18, the battery compartment cover 19 and the piercing aid 12 are shown in this order from the top. The lower housing half 17 has a flap 21 which can be opened, which flap 21 can be unlocked and opened by means of an unlocking button 22. The test element magazine can then be inserted into the test element magazine receiving opening 7 or replaced. The motor module 16 comprises a pusher motor module 23 and a cartridge motor module 24. Wherein the magazine motor module 24 has a drive wheel 27 which projects into the test element magazine receptacle 7, which drive wheel 27 has a tooth for engagement in the test element magazine to be driven. The printed circuit board 15 has a printed circuit board arm 25 which projects into the test element magazine receptacle 7, and a bar code reader 26 is fastened to this printed circuit board arm 25.
Fig. 2 shows an exploded view of the different components of an analysis device according to the prior art.
The different components have a large number of electrical contacts for the transmission of current. For classification, there are elastic contacts, plug contacts, solder contacts, and sliding contacts. To make an electrical distinction, these contacts are divided into signal transmission contacts and active current transmission contacts depending on the current load. Furthermore, the elastic contacts are divided mechanically into static elastic-bouncing (einfedernd) and dynamic elastic-bouncing contacts. Fig. 2 shows different types of contacts that connect the components of the motor module 16, the measuring module 20 and the bar code reader 26 to each other and to a printed circuit board (not shown). Specifically, fig. 2 shows the following components:
a) the transport unit for test elements comprises a push rod 29, a guide sleeve 30 and a guide 31, in which guide 31 the guide sleeve 30 can be guided. The principle of operation of the transport unit is explained in detail below with the aid of fig. 4.1.
b) The push rod motor module 23 includes a motor bracket 28 and a motor 32.
c) The cartridge motor module 24, likewise comprises a motor support 28 and a motor 32. The motor module is explained in detail later with the aid of fig. 5.1.
d) The positioning device 33 for the test element magazine comprises a drive wheel 27, a segmented disk 34 and a transmission printed circuit board 35. This positioning device is explained in detail later with the aid of fig. 3.1 and 3.2.
e) The bar code reader device 36 comprises a housing section 37 and a bar code reader 26, which bar code reader 26 is fixed to a printed circuit board arm (not shown) extending into said housing section 37. The barcode reader device 36 is explained in detail later with the aid of fig. 6.1.
f) The measurement module 20 includes a test element receiving port 38 and an optical printed circuit board 39.
Furthermore, the assembly has the following electrical contacts: battery contacts 40, magazine motor contacts 41, push rod motor contacts 42, measuring module contacts 43, position switch contacts 44 of the drive wheel 27, push rod switch contacts 45, sliding contacts 46 with the drive wheel 27, test element contacts 47 in the measuring module 20, optical printed circuit board contacts 48 in the measuring module 20, bar code reader contacts 49, motor contacts 50, and magazine position contacts 51 in the form of a segmented disk 34.
In this prior art analysis device, more than 67 contacts are provided, which are realized by more than 19 individual components. In the analysis device according to the invention, the individual components and the resulting assembly steps can be largely dispensed with by integrating them in the electrically contacted MID components.
Fig. 3.1 shows an exploded view of a positioning device for a test element in an analysis device according to the prior art.
The positioning device 33 comprises a transmission printed circuit board 35, a metallic segment disc 34 and a drive wheel 27. The drive wheel 27 is rotated by means of a motor (not shown). The test element magazine (not shown) is rotated together by means of the toothing 52 on the drive wheel 27. The rotation of the test element magazine is detected in the prior art on the segment plate 34 by means of two sliding contacts 46 which are hot-pressed onto the transmission printed circuit board 35. The signals are transmitted to a printed circuit board (not shown) via two further position switch contacts 44.
Fig. 3.2 shows a positioning device 33 for a test element magazine in an analysis device according to the invention. Instead of five separate parts, the positioning device comprises only two separate parts: a printed circuit board 53 (part 123 in electrical contact) designed as an injection-molded circuit carrier and a drive wheel 54 (part 124 in electrical contact) also designed as an injection-molded circuit carrier. Spring contacts 55 are integrated into the MID printed circuit boards 53, 123, said spring contacts 55 being used for contacting the segmented disk 56 with a further printed circuit board (not shown). The segment disk 56 is integrated in the drive wheel 54, 124.
Fig. 4.1 shows a transport unit for test elements in an analysis device according to the prior art.
The pusher 29 belongs to the transport unit 57, with which pusher 29 the test element can be moved in the axial direction 58. The push rod 29 is driven by a push rod motor (not shown). The plunger 29 has a guide sleeve 30, which guide sleeve 30 is guided in a longitudinal bore 59 which is open at the top of the guide 31. An upwardly projecting spacer 60 is mounted on the guide bush 30. On the guide 31, a plunger switch contact 45 is fastened, which is designed as a metallic stamped and bent part. The three contact lugs 61 of the push rod switch contact 45 are pressed upward by the spacer washer 60 in three different positions of the guide sleeve 30 in the longitudinal bore 59 toward the contact surface of the printed circuit board (not shown), so that the respective position is identified.
Fig. 4.2 shows a transport unit for test elements in an analysis device according to the invention.
This delivery unit also comprises a guide sleeve 62 for the push rod 29 (not shown) and a guide 63 which is coordinated with the guide sleeve 62. The guide 63 comprises a longitudinal bore 64 which is open at the top and in which longitudinal bore 64 the guide sleeve 62 is guided. The guide sleeve 62 has a contact lug 65, which contact lug 65 is designed to be elastic in a direction 66. The guide sleeve 62 (electrically contacting component 125) with the contact lugs 65 connected by the spacer 67 is an injection-molded circuit carrier (MID). The guide 63 is an injection-molded part and has a switching element 68, which switching element 68 presses the contact lug 65 in three different positions of the guide sleeve 62, upward toward the contact surface of the printed circuit board (not shown). These three positions can thus be recognized by the analysis device.
Fig. 5.1 shows an exploded view of a motor module in an analysis device according to the prior art.
The motor module 69 may for example be a push rod motor module or a cartridge motor module. It includes a motor 32 and a motor bracket 28. In order to supply the motor 32 with current, a contact plate 70 is pressed into the motor mount 28, which contact plate 70 is electrically conductively connected to a printed circuit board (not shown) via a resilient contact strip 71.
Fig. 5.2 shows a motor mount of a motor module in an analysis device according to the invention.
The motor mount 72 (the part 126 in electrical contact) is an injection-molded circuit carrier (MID). Integrated in this electrically contacted MID part are the motor mount 72 and an electrical contact in the form of a contact lug 73 with a conductor track 74 which originates from the contact lug 73. The contact pads 73 may be soldered to the printed circuit board.
Fig. 6.1 shows a bar code reader device in an analysis device according to the prior art.
A bar code reader 26 is attached to a printed circuit board arm 25 of the printed circuit board 15, the bar code reader 26 is powered by the printed circuit board 15, and a signal is output via the printed circuit board 15. Furthermore, the printed circuit board arm 25 has further components 75 which are not explained in detail. The bar code reader 26 is arranged on the printed circuit board arm 25 such that it projects into a test element magazine receiving opening (not shown) in order to be able to read in a bar code provided on a correspondingly received test element magazine there.
Fig. 6.2 shows a bar code reader device in an analysis instrument according to the invention.
The bar code reader device 76 comprises a housing section 77 of the analysis device according to the invention, in which housing section 77 the bar code reader 26 is arranged. The housing section 77 comprises printed conductors 78 extending towards the bar code reader 26 and resilient contacts 79 for printed circuit board contact (not shown). The housing section 77 (electrically contacting element 127) with the conductor tracks 78 and the elastic contacts 79 is a three-dimensional, injection-molded circuit carrier. Since the current conduction to and from the bar code reader 26 takes place in this embodiment via the MID housing section 77, it is possible (provided that a further solution is likewise found for the other components 75 in fig. 6.1) to dispense with the prior art printed circuit board mounting arm 25 (see fig. 6.1). This results in a space in the analysis device and the printed circuit board can be produced in a more advantageous batch with less scrap.
Fig. 7.1 shows a test element magazine receptacle in an analysis device according to the prior art.
A test element magazine 8 can be inserted into the test element magazine receptacle 7. In the analytical device according to the prior art, the replacement of the test element magazine 8 is registered by the opening and closing of a test element magazine receptacle cover (not shown), as a result of which the locking switch 80 is actuated. If the test element cartridge receiving opening cover is opened and closed without replacing the test element cartridge 8, the analysis instrument incorrectly registers a replacement of the test element cartridge 8.
Fig. 7.2 shows a test element cartridge receiving opening with a sensor for detecting a replacement of a test element cartridge in an analysis device according to the invention.
In the analysis device according to the invention, a replacement of a test element magazine 8 is detected if the spindle sleeve 81 supporting the test element magazine 8 in position 82 is released from the locked position by the stop 83, moved in the opening direction 84 and, after the test element magazine receptacle cover has been closed, moved again in the closing direction 85. The sensor 86 for detecting such a movement is designed in such a way that a contact projection (not shown) on the spindle sleeve 81 closes a contact and transmits a signal via the spring contact 87 to a printed circuit board (not shown). This can largely prevent incorrect recognition of the replacement of the test element magazine 8. The test element magazine receiving opening 89 (part 128 of the electrical contact) comprises in this embodiment a spring contact 87 and a printed conductor 88 connecting the spring contact 87 with the sensor 86 and is a three-dimensional injection-molded circuit carrier (MID).
Fig. 8 shows a contact element for the analysis of a test element in an analysis device according to the prior art.
The contact element 90 serves for the electrical contacting of a test element (not shown) to be analyzed electrochemically. The contact element 90 is composed of a plastic part 91 and a metal part 92. The metal element 92 is manufactured by a bending and stamping process, mounted or directly injected on the plastic part 91. For the contacting, the test element on the support surface 93 is pushed in the direction of the contact ramp 94 until the contact ramp 94 presses against the contact surface on the test element and thereby comes into contact with the test element. The contact pads 95 are soldered to the printed circuit board in the analysis apparatus. The plug 96 serves to orient the contact element 90 when the contact element 90 is mounted in an analytical instrument. In the design and arrangement of contact elements according to the prior art, there are limitations due to the limitations of the stamping and bending process and due to the requirements of the mountability and the crushable envelope of the metal element.
Fig. 9 shows a first contact element for the analysis of a test element in an analysis device according to the invention.
This contact element 97 (electrically contacting component 129) is a three-dimensional molded circuit carrier (MID). The conductor tracks 98 and the contact ramps 99 are realized as electrically conductive regions directly on the injection-molded plastic part 100. The conductor tracks 98 extend from contact pads 101, which can be connected to a printed circuit board, through the test element support surface 102 to the contact ramps 99. The contact ramp 99 is formed by a plastic projection on the surface of the plastic part 100, the metal conductor track 98 extending over the plastic projection.
Fig. 10 shows a second contact element for the analysis of a test element in an analysis device according to the invention.
This contact element 103 (part 130 of the electrical contact) is likewise a three-dimensional molded circuit carrier (MID) with conductor tracks 98 and contact ramps 99 provided on a molded plastic part 100, which plastic part 100 has a test element support surface 102. In contrast to the embodiment shown in fig. 9, a separate contact lug 104 and a separate contact ramp 105 are provided for each conductor track 98.
Fig. 11.1 shows a thermostat in a measuring module of an analysis device according to the prior art.
The ceramic heating element is installed or introduced directly into the analytical instrument housing half 106 during the production process. The electrical connections 107 of the ceramic heating element can be seen in fig. 11.1.
The ceramic heating element 108 can be seen from the rear in fig. 11.2, while the ceramic heating element 108 can be seen from the front in fig. 11.3. For simplicity, only two of the four electrical connectors 107 are shown in fig. 11.3. The two electrical connections 107 are connected to a heating coil 109 on a ceramic plate 110.
Fig. 11.4 shows a thermostat in the measuring module of the analysis device according to the invention.
The measuring module 111 is arranged in the analysis instrument housing half 112 and comprises a test element receiving opening 113, in which test element receiving opening 113 a thermostatic device 114 is integrated. The test element receptacle 113 (part 131 of the electrical contact) comprises a heating coil 115 and a resilient contact 116 and is a three-dimensional injection-molded circuit carrier.
Fig. 12 shows a supply container for test elements in an analytical instrument according to the invention.
The reservoir 117 is a roller-shaped test element magazine having 17 individual chambers 118 for receiving 17 strip-shaped test elements 119. The storage container 117 has a bar code 120 on its outer side. The test element 119 is a test element 119 to be analyzed electrochemically and provided with electrical conductor tracks 121. The reservoir 117 according to the invention contains in each chamber 118 an electrical contact 122 for making contact with a conductor track 121 of a test element 119 contained in each chamber 118 during the electrochemical analysis of a sample on the test element. The test element 119 shown in fig. 12, which projects partially from the supply container 117, is slightly bent, so that the conductor tracks 121 arranged above the test element 119 are pressed against the electrical contacts 122 of the supply container 117 and are thereby contacted. However, it is also possible to make contact if the test element 119 is inserted completely into the supply container 117. For the contacting, for example, elastic contacts can also be provided in the chamber 118. The storage container 117 (electrically contacting component 132) can be, for example, a three-dimensional injection molded circuit carrier (MID).
Fig. 13 shows a first embodiment of a test element according to the invention, which is designed essentially as an injection-molded circuit carrier.
The test element 150 has a base body 151 made of plastic. A plurality of test fields 152 for electrochemical analysis of a liquid sample are arranged on the base body 151. A dry chemical that reacts with the liquid sample is located on the test area 152. The test fields 152 are connected to electrical conductor tracks 153 on the test elements 150, respectively, the conductor tracks 153 terminating on the one hand in an electrode structure 154 and on the other hand in a contact structure 155. The electrode structures 154 accordingly project into the test field 152, and the contact structures 155 are used for connection to the measurement electronics (not shown) of the analysis device. The substrate 151 with the electrical conductor tracks 153, the electrode structures 154 and the contact structures 155 is an injection-molded circuit carrier (MID). The test element 150 is designed as a circular disk on which the test field 152 is arranged concentrically with the associated conductor track 153. In an analytical instrument, this test element 150 can be automatically or manually rotated into a position in which electrical contact is made with the desired test zone 152 and electrochemical analysis of the sample present on the test zone 152 is carried out.
Fig. 14 shows a second embodiment of the test element according to the invention, which is designed essentially as an injection-molded circuit carrier.
The test element 160 has a base body 161 made of plastic. A recess 162 is provided in the base body 161, which recess 162 can receive the sample to be analyzed and, if necessary, can contain an analysis agent. For the analysis of the sample, electrical conductor tracks 163 are provided, which conductor tracks 163 terminate on the one hand in the electrode structures 164 and on the other hand in the contact structures 165. The electrode structures 164 each project into the recess 162, and the contact structures 165 serve for connection to the measurement electronics (not shown) of the analysis device. The substrate 161 with the electrical conductor tracks 163, the electrode structures 164 and the contact structures 165 is an injection-molded circuit carrier (MID). The test element 160 is configured as a quadrilateral wafer. The test element 160 includes six recesses 162. The electrical conductor tracks 163 are arranged on the test element 160 in such a way that all contact structures 165 are positioned in a limited area on the test element 160. This simplifies the positioning of the test element 160, which positioning of the test element 160 is used for electrical contacting with samples in different recesses in the analysis device.
List of reference numerals
1 analytical instrument 34 segmented disk
2 housing 35 drive device printed circuit board
3 display area 36 bar code reader device
4 LCD (liquid crystal display) 37 casing section
5 operating area 38 test element receiving opening
6-contact key 39 optical printed circuit board
7 test element Cartridge receiving Port 40 Battery contact
8 test element magazine 41 magazine motor contact
9 Bar code 42 push rod Motor contact
10 chamber 43 measurement module contact
11 test element 44 position switch contact
12 penetration aid 45 push rod switch contact
13 test element Cartridge receiving Port cover 46 sliding contact
Housing half 47 test element contact on 14
15 printed circuit board 48 optical printed circuit board contact
16 motor module 49 bar code reader contacts
17 lower housing half 50 motor contact
Position contact of 18 model nameplate 51 magazine
19 battery compartment cover 52 tooth part
20 measuring module 53 printed circuit board (MID)
21 cover plate 54 driving wheel (MID)
22 unlock button 55 spring contact
23 pushrod motor Module 56 segmented disk
24 magazine motor module 57 delivery unit
25 axial direction of printed circuit board support arm 58
26 bar code reader 59 longitudinal bore
27 drive wheel 60 spacer
28 motor support 61 contact piece
29 push rod 62 guide sleeve (MID)
Guide device of 30 guide shaft sleeve 63
31 guide 64 longitudinal bore
32 motor 65 contact piece
33 orientation of positioning pocket 66 for test element magazine
Device for placing
68 switching element 67 spacer
69 motor module 104 individual contact pads
70 contact plate 105 individual contact ramp
Shell half of 71 elastic contact sheet 106 analytical instrument
72 Motor Mounting (MID) 107 electric connection of heating element
73 contact piece 108 ceramic heating element
74 printed conductor 109 heating coiled filament
75 remaining part 110 ceramic plate
76 bar code reader device 111 measurement module
77 housing half of a housing section (MID) 112 analysis instrument
78 printed conductor 113 test element receiving opening (MID)
79 resilient contact 114 thermostat
80 latching switch 115 heating coil filament
81 mandrel sleeve 116 resilient contact
82 support position 117 stock container, test element magazine
83 stopper 118 chamber
84 open direction 119 test element
85 closed orientation 120 bar code
86 sensor 121 electrical conductor track
87 spring contact 122 electrical contact
88 printed conductor 123 first electrical contact
89 part of a second electrical contact of a test element cartridge receiving opening (MID) 124
90 contact element 125 third electrical contact feature
91 part of Plastic 126 for fourth Electrical contact
92 parts of a fifth electrical contact of the metal element 127
93 member bearing surface 128 for sixth electrical contact
94 contact ramp 129 part of seventh electrical contact
Member of the eighth electrical contact of 95 contact tab 130
96 plug
97 first contact element (MID)
98 printed conductor
99 contact ramp
100 Plastic part
101 contact piece
102 bearing surface
103 second contact element (MID)
131 parts of ninth electrical contact
132 tenth electrical contact
150 test element
151 base body
152 test zone
153 electric conductor track
154 electrode structure
155 contact structure
160 test element
161 base
162 recess
163 electrical conductor track
164 electrode structure
165 contact structure

Claims (16)

1. Analytical instrument for analyzing a sample on a test element, comprising at least one component (123, 124, 125, 126, 127, 128, 129, 130, 131, 132) adapted to establish an electrical contact with at least one further component for current transmission, characterized in that the component (123, 124, 125, 126, 127, 128, 129, 130, 131, 132) for electrical contacting is an injection-molded circuit carrier, wherein the component (123, 124, 125, 126, 127, 128, 129, 130, 131, 132) for electrical contacting has at least one elastic contact strip (55, 65, 73, 79, 87, 101, 104, 116) for contacting the other component, the contact piece comprises a contact piece body made of injection-molded plastic and a metal conductor structure, wherein the contact strip (55, 65, 73, 79, 87, 101, 104, 116) is in contact with a further rotating or a further linearly moving component of the analysis apparatus.
2. An analysis instrument as claimed in claim 1, characterized in that the electrically contacting elements (123, 124, 125, 126, 127, 128, 129, 130, 131, 132) are constructed so as to be suitable for establishing at least one electrical contact selected from the group of resilient contacts, plug contacts, soldering contacts, sliding contacts and conductive glue contacts with another element.
3. The analysis apparatus according to claim 1 or 2, characterized in that the electrically contacted component (123, 124, 125, 126, 127, 128, 129, 130, 131, 132) is a functional component of the analysis apparatus (1) and the further contacted component is a printed circuit board (15) of the analysis apparatus (1).
4. Analytical instrument according to claim 3, characterized in that the functional component is a bar code reader device (76), a delivery unit (57) for test elements, a motor module (69), a measuring module (20), a positioning device (33) for test element magazines (8), test element magazine receptacles (89) containing sensors (86), or a thermostat device (114).
5. The analysis device according to claim 1 or 2, characterized in that the electrically contacted component is a contact element (97, 103) for performing a test element analysis on the analysis device (1) and the other component contacted is a test element (119) to be analyzed electrochemically.
6. The analytical instrument of claim 5, wherein the contact elements for the analysis of test elements are integrated in a test element magazine (117).
7. The analysis apparatus as claimed in claim 1, wherein the analysis apparatus (1) comprises a positioning device (33) for the test element magazine (8), which positioning device (33) comprises a printed circuit board (53) for supplying power and a motor-driven drive wheel (54) for driving the rotatable test element magazine (8), characterized in that the printed circuit board (53) having spring contacts (55) is designed as an injection-molded circuit carrier and the drive wheel (54) having electrically contactable segment disks (56) is designed as an injection-molded circuit carrier.
8. The analysis apparatus as claimed in claim 1, wherein the analysis apparatus (1) comprises a transport unit (57) for the test elements, the transport unit (57) comprises a pusher (29) for transporting the test elements in the analysis device (1), wherein the push rod (29) has a guide sleeve (62), the guide sleeve (62) can be guided in a guide device (63) when the test element is conveyed, characterized in that the guide sleeve (62) has an elastic contact strip (65) for contacting a printed circuit board, and the guiding means (63) comprising a switching element (68), the switching element (68) being arranged, so that it presses the contact plate (65) against the printed circuit board in a defined position of the guide sleeve (62) in the guide (63), wherein the guide sleeve (62) with the contact strip (65) is an injection-molded circuit carrier.
9. The analysis apparatus as claimed in claim 1, wherein the analysis apparatus (1) comprises a bar code reader device (76), the bar code reader device (76) comprising a housing section (77) of the analysis apparatus (1), in which housing section (77) a bar code reader (26) is arranged, characterized in that the housing section (77) comprises conductor tracks (78) extending toward the bar code reader (26) and elastic contacts (79) for contacting a printed circuit board, and in that the housing section (77) with the conductor tracks (78) and the elastic contacts (79) is an injection-molded circuit carrier.
10. The analytical instrument of claim 1, wherein the analytical instrument (1) comprises a test element magazine receiving opening (89) containing a sensor (86), the test element magazine receiving opening (89) comprising an electrical conductor track (88) extending towards the sensor (86), wherein the test element magazine receiving opening (89) with the conductor track (88) is an injection-molded circuit carrier.
11. The analysis device according to claim 1, wherein the analysis device (1) comprises a motor module (69), the motor module (69) comprising a motor (32) and a motor support (72), wherein the motor support (72) has contact lugs (73) for contacting the printed circuit board, and the motor support (72) with the contact lugs (71) is an injection-molded circuit carrier.
12. The analysis instrument as claimed in claim 1, wherein the analysis instrument (1) comprises a measuring module (111) for measuring an analyte contained on a test element, the measuring module (111) comprising a test element receiving opening (113) for receiving the test element during the measurement, a temperature control device (114) for temperature-controlled treatment of the test element being contained in the test element receiving opening (113), characterized in that the test element receiving opening (113) with the temperature control device (114) comprising a heating coil (115) and a resilient contact (116) is an injection-molded line carrier.
13. The analysis device according to claim 1, wherein the analysis device (1) comprises a contact element (97, 103) for the analysis of test elements, the contact element (97, 103) having a support surface (102) for the test elements, wherein a plurality of contact bevels (99, 105) project from the support surface (102), wherein the contact bevels (99, 105) are provided for establishing electrical contact with the test elements positioned on the support surface (102) and wherein the contact bevels (99, 105) can be connected to a printed circuit board via conductor tracks (98) extending over the contact element (97, 103), wherein the contact element (97, 103) is an injection-molded circuit carrier.
14. A test element for use in an analysis device according to any one of claims 1 to 13, comprising a test field for electrochemical analysis of a liquid sample in the analysis device, wherein the test field on the test element is connected to an electrical conductor track, characterized in that the test element with the electrical conductor track is essentially an injection-molded circuit carrier.
15. Method for producing an analytical instrument for analyzing a sample on a test element, the analysis instrument comprises at least one electrically contacted member adapted to establish electrical contact with at least one further member for current transmission, wherein the parts (123, 124, 125, 126, 127, 128, 129, 130, 131, 132) of the electrical contact have at least one elastic contact piece (55, 65, 73, 79, 87, 101, 104, 116) for contacting the other part, the contact piece comprises a contact piece body made of injection-molded plastic and a metal conductor structure, wherein the contact strip (55, 65, 73, 79, 87, 101, 104, 116) is in contact with a further rotating or a further linearly moving component of the analysis apparatus, wherein the method has the following steps:
A) the component for electrical contact is produced by a method for producing an injection-molded circuit carrier, said component comprising a base body and a metallic conductor structure, and
B) positioning and mounting the electrically contacted components in the analytical instrument.
16. The method of claim 15, wherein the method for producing the injection-molded circuit carrier is a method selected from the group consisting of two-component injection molding, hot-molding, film post-coating, and laser structuring.
HK09103701.5A 2005-10-25 2006-10-24 Apparatus for the analysis of a sample on a test element HK1125999B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP05023219A EP1780541B1 (en) 2005-10-25 2005-10-25 Analysis device for analysing a sample on a test element
EP05023219.8 2005-10-25
PCT/EP2006/067709 WO2007048785A2 (en) 2005-10-25 2006-10-24 Apparatus for the analysis of a sample on a test element

Publications (2)

Publication Number Publication Date
HK1125999A1 HK1125999A1 (en) 2009-08-21
HK1125999B true HK1125999B (en) 2013-06-14

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