CA2611921C - Analysis system for analysing a sample on an analytical test element - Google Patents
Analysis system for analysing a sample on an analytical test element Download PDFInfo
- Publication number
- CA2611921C CA2611921C CA2611921A CA2611921A CA2611921C CA 2611921 C CA2611921 C CA 2611921C CA 2611921 A CA2611921 A CA 2611921A CA 2611921 A CA2611921 A CA 2611921A CA 2611921 C CA2611921 C CA 2611921C
- Authority
- CA
- Canada
- Prior art keywords
- diaphragm
- analysis system
- test element
- optical module
- molded part
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/8483—Investigating reagent band
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
Abstract
The invention relates to an analysis system for analysing a sample on an analytical test element comprising a measuring module for carrying out measurements on the sample on the analytical test element and an optical module, which comprises a lens and a diaphragm, by which the light can be focused. In this case, the lens and the diaphragm of the optical module are combined as one piece in a multi-component injection-molded part.
Description
Analysis system for analyzing a sample on an analytical test element The present invention relates to an analysis system for analyzing a sample on an analytical test element with an optical module comprising a lens and a diaphragm.
For the analysis of samples, for example body fluids such as blood or urine, use is often made of analysis systems in which the samples to be analyzed are located on a test element and possibly react in a test area with one or more reagents on the test element before they are analyzed. The optical, in particular photometric, and electrochemical evaluation of test elements are the most cormnonly used methods for rapidly determining the concentration of analytes in samples. Analysis systems with test elements for sample analysis are generally used in the field of analytics, environmental analytics and in particular in the field of medical diagnostics.
In particular in the field of blood glucose diagnostics using capillary blood, test elements which are photometrically or electrochemically evaluated are of great value.
There are various forms of test elements. Essentially square, small plates, also referred to as slides, in the middle of which there is a multilayered test area, are known for example. Diagnostic test elements of a strip-shaped form are referred to as test strips. Test elements are extensively described in the prior art, for example in the documents DE-A 19 753 847, EP-A 0 821 233, EP-A 0 831 234 or WO
97/02487. The present invention relates to test elements of any form, in particular to test elements in the form of strips.
For the analytical examination of a sample on a test element, the: prior art discloses test element analysis systems which contain a test element holder for positioning the test element in a measuring position and a measuring and evaluation device for carrying out a measurement and determining an analysis result resulting from this.
WO 00/19185 Al relates to a device for the photometric evaluation of test elements, comprising - an illuminating unit with at least a first and a second light source,
For the analysis of samples, for example body fluids such as blood or urine, use is often made of analysis systems in which the samples to be analyzed are located on a test element and possibly react in a test area with one or more reagents on the test element before they are analyzed. The optical, in particular photometric, and electrochemical evaluation of test elements are the most cormnonly used methods for rapidly determining the concentration of analytes in samples. Analysis systems with test elements for sample analysis are generally used in the field of analytics, environmental analytics and in particular in the field of medical diagnostics.
In particular in the field of blood glucose diagnostics using capillary blood, test elements which are photometrically or electrochemically evaluated are of great value.
There are various forms of test elements. Essentially square, small plates, also referred to as slides, in the middle of which there is a multilayered test area, are known for example. Diagnostic test elements of a strip-shaped form are referred to as test strips. Test elements are extensively described in the prior art, for example in the documents DE-A 19 753 847, EP-A 0 821 233, EP-A 0 831 234 or WO
97/02487. The present invention relates to test elements of any form, in particular to test elements in the form of strips.
For the analytical examination of a sample on a test element, the: prior art discloses test element analysis systems which contain a test element holder for positioning the test element in a measuring position and a measuring and evaluation device for carrying out a measurement and determining an analysis result resulting from this.
WO 00/19185 Al relates to a device for the photometric evaluation of test elements, comprising - an illuminating unit with at least a first and a second light source,
- 2 -- a holder for receiving a test element with a detection zone in such a way that the detection zone is positioned with respect to the illuminating unit, - a detection unit with at least one detector, which detects light reflected by the detection zone or transmitted through the detection zone, - a control unit, which activates the two light sources and records the signal generated by the detection unit as a detection signal, and - an evaluation unit, which evaluates the detection signals in order to determine the analyte concentration contained in the sample.
EP 0 618 443 Al relates to a test strip analysis system compi-ising an evaluation device with a test strip holder and suitable test strips. The strip holder serves the purpose of positioning the test strip in a defined position with respect to a measuring unit. It has a test strip support and a guide for the test strip.
WO 01/48461 Al concerns a test element analysis system for the analytical examination of a sample. The analysis system comprises test elements with a supporting film and a test area which is attached to a flat side of the supporting film and, to carry out the analysis, is brought into contact with the sample in such a way that liquid sample constituents penetrate into the test area, the test area containing a reagent system which, when it reacts with constituents of the sample, leads to an optically measurable change in a detection zone that is characteristic of the analysis and is on the side of the test area facing the supporting film.
Furthermore, the analysis system comprises an evaluation device with a test element holder for positioning a test element in a measuri.ng position and a measuring device for measuring the optically measurable charige in the detection zone, the measuring device having a light transmitter for illuminating the detection zone with primary light and a detector for detecting the secondary light thereby diffusely reflected by the detection zone.
Many such known analysis systems have at least one optical rnodule, which may comprise; inter alia, a lens and a diaphragm, by which the light can be focused.
These optical modules are produced in the prior art from a nLnnber of individual parts, which are put together and connected to one another for example by means of ultrasonic welding, hot caulking or adhesive bonding. When doing so, the lens and the diaphragm aperture must be spatially positioned exactly in relation to one another in a way corresponding to the path of rays of the light. The joining
EP 0 618 443 Al relates to a test strip analysis system compi-ising an evaluation device with a test strip holder and suitable test strips. The strip holder serves the purpose of positioning the test strip in a defined position with respect to a measuring unit. It has a test strip support and a guide for the test strip.
WO 01/48461 Al concerns a test element analysis system for the analytical examination of a sample. The analysis system comprises test elements with a supporting film and a test area which is attached to a flat side of the supporting film and, to carry out the analysis, is brought into contact with the sample in such a way that liquid sample constituents penetrate into the test area, the test area containing a reagent system which, when it reacts with constituents of the sample, leads to an optically measurable change in a detection zone that is characteristic of the analysis and is on the side of the test area facing the supporting film.
Furthermore, the analysis system comprises an evaluation device with a test element holder for positioning a test element in a measuri.ng position and a measuring device for measuring the optically measurable charige in the detection zone, the measuring device having a light transmitter for illuminating the detection zone with primary light and a detector for detecting the secondary light thereby diffusely reflected by the detection zone.
Many such known analysis systems have at least one optical rnodule, which may comprise; inter alia, a lens and a diaphragm, by which the light can be focused.
These optical modules are produced in the prior art from a nLnnber of individual parts, which are put together and connected to one another for example by means of ultrasonic welding, hot caulking or adhesive bonding. When doing so, the lens and the diaphragm aperture must be spatially positioned exactly in relation to one another in a way corresponding to the path of rays of the light. The joining
- 3 -together of the parts is only possible with great effort on account of their tolerances and small size. Furthermore, many individual parts result in a great overall tolerance of the optical module.
The object of the present invention is therefore to avoid the disadvantages of the prior art. In particular, the effort and the costs of assembling the analysis system are to be reduced.
This object is achieved according to the invention by an analysis system for analyzing a sample on an analytical test element, comprising - a measuring module for carrying out measurements on the sample on the analytical test element and - an optical module, which comprises a lens and a diaphragm, by which the light can be focused, - the lens and the diaphragm of the optical module being conlbined as one piece in a multi-component injection-molded part.
The analysis system according to the invention contains, inter alia, a measuring module for carrying out measurements on a sample on an analy:ical test element.
The sample is, for example, a body fluid, in particular blood or interstitial fluid.
The examination of blood samples or of interstitial fluid makes it possible in clinical diagnostics to provide early and reliable detection of pathological conditions and to carry out targeted and substantiated monitoring of physical states. Medical diagnostics always relies on the obtainment of a sample of blood or interstitial fluid from the individual to be examined.
To obtain the sample, the skin may be perforated, for example at the finger tip or the ear lobe of the person to be examined, with the aid of a sterile, sharp lancet, in order in this way to obtain a small amount of blood or interstitial fluid for the analysis. In particular, this method is suitable for the analysis of a sample that is carried out directly after the sample is obtained.
In particular in the area of so-called "home monitoring", that is to say where medically untrained people carrying out simple analyses of their own blood or interstitial fluid, and where in particular diabetics need to obtain blood regularly
The object of the present invention is therefore to avoid the disadvantages of the prior art. In particular, the effort and the costs of assembling the analysis system are to be reduced.
This object is achieved according to the invention by an analysis system for analyzing a sample on an analytical test element, comprising - a measuring module for carrying out measurements on the sample on the analytical test element and - an optical module, which comprises a lens and a diaphragm, by which the light can be focused, - the lens and the diaphragm of the optical module being conlbined as one piece in a multi-component injection-molded part.
The analysis system according to the invention contains, inter alia, a measuring module for carrying out measurements on a sample on an analy:ical test element.
The sample is, for example, a body fluid, in particular blood or interstitial fluid.
The examination of blood samples or of interstitial fluid makes it possible in clinical diagnostics to provide early and reliable detection of pathological conditions and to carry out targeted and substantiated monitoring of physical states. Medical diagnostics always relies on the obtainment of a sample of blood or interstitial fluid from the individual to be examined.
To obtain the sample, the skin may be perforated, for example at the finger tip or the ear lobe of the person to be examined, with the aid of a sterile, sharp lancet, in order in this way to obtain a small amount of blood or interstitial fluid for the analysis. In particular, this method is suitable for the analysis of a sample that is carried out directly after the sample is obtained.
In particular in the area of so-called "home monitoring", that is to say where medically untrained people carrying out simple analyses of their own blood or interstitial fluid, and where in particular diabetics need to obtain blood regularly
- 4 -several times a day to monitor blood glucose concentration, lancets and associated equipment (known as lancing devices) are offered, making it possible to obtain samples reproducibly and with as little pain as possible.
To carry out the measurements, the sample is applied to an analytical test element, which contains reagents (for example in a test area). When the reagents contact the sample, a reaction of the analyte contained in the sample with the reagents leads to a physically measurable change in the test element, which correlates with the concentration of the analyte.
The measuring module of the analysis system according to the invention serves for measuring this change. The measured values obtained in the measurements of the measuring module serve for determining the concentration o c the analyte in the sample.
In the case of photometric analysis systems, the test elements contain a reagent system, the reaction of which with the analyte leads to a photonietrically detectable change (a change in color). The reagents are in this case usually located in a test area of the test element, the color of which changes in dependence on the concentration. This change in color can be determined quantitatively by reflection photometry with the aid of a measuring module.
Electrochemical test elements contain an electrochemical reagent system, the reaction of which with the analyte influences the electric voltage between two poles of the test element and/or of the current intensity flowing between two poles of a test element with a defined voltage. In this case, the voltage or current intensity is therefore the physically measurable variable that is determined by a corresponding measuring module, which is integrated in the analysis system and designed as a voltage or current measuring device, and a change of which that correlates with the concentration of the light is converted into the analysis data (concentration of the analyte).
For the purposes of the present invention, an optical module is a subassembly which contains, inter alia, at least a lens and a diaphragm. Lighl: can be focused by the lens and the diaphragm. In this context, a lens refers to an optical component known to a person skilled in the art as an optical lens. In this context, a diaphragm refers to an optical component which comprises an opaque diaphragm body and a light-transmitting diaphragm aperture. The diaphragm prevents light from
To carry out the measurements, the sample is applied to an analytical test element, which contains reagents (for example in a test area). When the reagents contact the sample, a reaction of the analyte contained in the sample with the reagents leads to a physically measurable change in the test element, which correlates with the concentration of the analyte.
The measuring module of the analysis system according to the invention serves for measuring this change. The measured values obtained in the measurements of the measuring module serve for determining the concentration o c the analyte in the sample.
In the case of photometric analysis systems, the test elements contain a reagent system, the reaction of which with the analyte leads to a photonietrically detectable change (a change in color). The reagents are in this case usually located in a test area of the test element, the color of which changes in dependence on the concentration. This change in color can be determined quantitatively by reflection photometry with the aid of a measuring module.
Electrochemical test elements contain an electrochemical reagent system, the reaction of which with the analyte influences the electric voltage between two poles of the test element and/or of the current intensity flowing between two poles of a test element with a defined voltage. In this case, the voltage or current intensity is therefore the physically measurable variable that is determined by a corresponding measuring module, which is integrated in the analysis system and designed as a voltage or current measuring device, and a change of which that correlates with the concentration of the light is converted into the analysis data (concentration of the analyte).
For the purposes of the present invention, an optical module is a subassembly which contains, inter alia, at least a lens and a diaphragm. Lighl: can be focused by the lens and the diaphragm. In this context, a lens refers to an optical component known to a person skilled in the art as an optical lens. In this context, a diaphragm refers to an optical component which comprises an opaque diaphragm body and a light-transmitting diaphragm aperture. The diaphragm prevents light from
- 5 -spreading in certain spatial directions. It serves for delimiting the cross section of beams and for reducing stray light.
In the analysis system according to the invention, the lens and the diaphragm of the optical module are combined as one piece in a multi-component injection-molded part. Injection molding is a process known in the prior art in which a plasticized material (injection molding compound) (in particular a thermoplastic or thermoset) is injected into a forming tool (injection mold) at high pressure and transformed there under the effect of pressure into the solid state. The injection-molded part can then be removed from the injection mold. Multi-component injection molding is likewise a process known in the prior art. In particular, so-called sandwich molding is suitable for producing the multi-component inject:ion-molded part for the analysis device according to the invention. In this case, two or more materials are injected one after the other into an injection mold, whereby they are joined together with a material bond at their interfaces. The geornetry of the cavity present in the injection mold is changed between the two injections.
In the prior art, for example, a number of lenses are produced as a one-piece multi-component injection-molded part, as described for example in DE 102 61 974 Al, US 2004/0120053 Al or DE 44 31 744 A1.
In the case of the analysis system according to the invention, the one-piece combination of the lens and the diaphragm of the optical module in the multi-component injection-molded part provides many advantages. It is no longer necessary for the lens and the diaphragm to be joined tagether after their production, dispensing with a working step in the production of the analysis system according to the invention. One of the consequences is that costs are saved. The handling of the multi-component injection-molded part is easier than that of the individual lens and the individual diaphragm. A reproducibly exact unit of lens and diaphragm can also be mass-produced. There are no tolerances between the lens and the diaphragm. Therefore, exact positioning of the diaphragm in relation to the lens is ensured.
In the case of the analysis system according to the invention, not only the lens and the diaphragm but also further lenses and/or further diaphragms and/or fiu=ther component parts of the optical module may be combined in the injection-molded part of the optical module. If appropriate, the entire optical module is a multi-component injection-molded part.
In the analysis system according to the invention, the lens and the diaphragm of the optical module are combined as one piece in a multi-component injection-molded part. Injection molding is a process known in the prior art in which a plasticized material (injection molding compound) (in particular a thermoplastic or thermoset) is injected into a forming tool (injection mold) at high pressure and transformed there under the effect of pressure into the solid state. The injection-molded part can then be removed from the injection mold. Multi-component injection molding is likewise a process known in the prior art. In particular, so-called sandwich molding is suitable for producing the multi-component inject:ion-molded part for the analysis device according to the invention. In this case, two or more materials are injected one after the other into an injection mold, whereby they are joined together with a material bond at their interfaces. The geornetry of the cavity present in the injection mold is changed between the two injections.
In the prior art, for example, a number of lenses are produced as a one-piece multi-component injection-molded part, as described for example in DE 102 61 974 Al, US 2004/0120053 Al or DE 44 31 744 A1.
In the case of the analysis system according to the invention, the one-piece combination of the lens and the diaphragm of the optical module in the multi-component injection-molded part provides many advantages. It is no longer necessary for the lens and the diaphragm to be joined tagether after their production, dispensing with a working step in the production of the analysis system according to the invention. One of the consequences is that costs are saved. The handling of the multi-component injection-molded part is easier than that of the individual lens and the individual diaphragm. A reproducibly exact unit of lens and diaphragm can also be mass-produced. There are no tolerances between the lens and the diaphragm. Therefore, exact positioning of the diaphragm in relation to the lens is ensured.
In the case of the analysis system according to the invention, not only the lens and the diaphragm but also further lenses and/or further diaphragms and/or fiu=ther component parts of the optical module may be combined in the injection-molded part of the optical module. If appropriate, the entire optical module is a multi-component injection-molded part.
- 6 -According to a preferred embodiment of the present invention, two diaphragms and one or two lenses are combined in the multi-component injection-molded part.
The multi-component injection-molded part is preferably a two-component injection-molded part, in particular a two-component injection-molded part with a first, translucent plastic component and a second, opaque plastic component.
The translucent plastic component is translucent with preference for light in a wavelength range from 200 to 1700 nm, with particular preference in a wavelength range from 600 to 950 nm, the opaque plastic component pref-.rably being largely non-transmitting for light in this wavelength range. The lens integrated in the multi-component injection-molded part preferably consists of the translucent plastic. For this purpose, a region of the multi-component injection-molded part is formed from the translucent plastic in such a way that it assumes the function of an optical lens. An opaque plastic may be used, for example, for regions of the multi-component injection-molded part that assume the function of a diaphragm body.
The translucent plastic component may, for example, contain at least one plastic selected from the group comprising acrylonitrile-butadien(:-styrene polymers (ABS), methyl methacrylate-butadiene-styrene copolymers (MABS), polycarbonate (PC), polycarbonate blends (PCB), polysulfone (PSU) and polyether sulfone (PES). The opaque plastic component preferably contains at least one plastic selected from the group comprising acrylonitrile-butadiene-styrene polymers (ABS), polycarbonate blends (PCB) and polyether sulfone (PES).
According to a preferred embodiment of the present invent:ion, the diaphragm comprises a diaphragm body of an opaque plastic and a diapllragm aperture, the 2 5 diaphragm aperture being filled with the translucent plastic. The diaphragm aperture is therefore closed by a protective window of the translucent plastic, which prevents contaminants from passing through the diaphragm aperture. It is particularly preferred in this respect for the lens and the diaphragm aperture filled with the translucent plastic to be combined in a contiguous region. They are in this case made of the translucent plastic and are combined in the multi-component injection-molded part. This simplifies the injection-molding process and the optical module and ensures a fixedly defined positioning of the diaphragm aperture (or of the window) in relation to the lens.
The diaphragm in the optical module of the analysis systenl according to the invention may, however, also comprise a diaphragm body of an opaque plastic and a diaphragm aperture, the diaphragm aperture being a clearance in the diaphragm body. The clearance is in this case not filled with material. As a result, less light
The multi-component injection-molded part is preferably a two-component injection-molded part, in particular a two-component injection-molded part with a first, translucent plastic component and a second, opaque plastic component.
The translucent plastic component is translucent with preference for light in a wavelength range from 200 to 1700 nm, with particular preference in a wavelength range from 600 to 950 nm, the opaque plastic component pref-.rably being largely non-transmitting for light in this wavelength range. The lens integrated in the multi-component injection-molded part preferably consists of the translucent plastic. For this purpose, a region of the multi-component injection-molded part is formed from the translucent plastic in such a way that it assumes the function of an optical lens. An opaque plastic may be used, for example, for regions of the multi-component injection-molded part that assume the function of a diaphragm body.
The translucent plastic component may, for example, contain at least one plastic selected from the group comprising acrylonitrile-butadien(:-styrene polymers (ABS), methyl methacrylate-butadiene-styrene copolymers (MABS), polycarbonate (PC), polycarbonate blends (PCB), polysulfone (PSU) and polyether sulfone (PES). The opaque plastic component preferably contains at least one plastic selected from the group comprising acrylonitrile-butadiene-styrene polymers (ABS), polycarbonate blends (PCB) and polyether sulfone (PES).
According to a preferred embodiment of the present invent:ion, the diaphragm comprises a diaphragm body of an opaque plastic and a diapllragm aperture, the 2 5 diaphragm aperture being filled with the translucent plastic. The diaphragm aperture is therefore closed by a protective window of the translucent plastic, which prevents contaminants from passing through the diaphragm aperture. It is particularly preferred in this respect for the lens and the diaphragm aperture filled with the translucent plastic to be combined in a contiguous region. They are in this case made of the translucent plastic and are combined in the multi-component injection-molded part. This simplifies the injection-molding process and the optical module and ensures a fixedly defined positioning of the diaphragm aperture (or of the window) in relation to the lens.
The diaphragm in the optical module of the analysis systenl according to the invention may, however, also comprise a diaphragm body of an opaque plastic and a diaphragm aperture, the diaphragm aperture being a clearance in the diaphragm body. The clearance is in this case not filled with material. As a result, less light
- 7 -is absorbed as it passes through the diaphragm aperture than if the diaphragm aperture is filled with a material.
According to a preferred embodiment of the present invention, the measuring module contains the optical module, the optical module servi:,.ig for carrying out optical measurements on the sample on the analytical test element. It is in this case in particular a measuring module that is intended for photometric measurements on the sample (for example a human or animal body fluid) and is designed for determining the concentration of an analyte (for example glucose) in the sample.
Currently in use in the prior art, for example in the AKKU CHEK -Compakt analysis system from Roche Diagnostics, Germany, is a measuring module which contains an optical module, the optical module being made up of two plastic parts, one of which contains a diaphragm with a plastic window as the diaphragm aperture and the other of which contains a lens. The parts are cf a small size (14.5 times 7.5 times 21 mm and 0.7 times 4 times 60 mm, respectively). The task of the measuring module in this prior-art analysis system is to position a test element for carrying out measurements and, with the aid of the optical module, to direct rays of light to determine blood sugar values optically. The two plastic parts of the optical module in the case of this analysis system are connected to one another by means of ultrasonic welding. High costs are incurred by the joining together of the two parts. The small overall size of the parts makes handling very complicated.
The welding requires an additional operation, which is carried out with great effort.
Additional tolerances as a result of two parts cannot be avoided. The position of the diaphragm is also determined here by its production tolerances.
In the analysis system according to the invention, the measuririg module contains an optical module in which at least one lens and at least one diaphragm are combined as one piece in a multi-component injection-molded part. It is particularly preferred for the entire optical module contained. in the measuring module to be a two-component injection-molded part, in which at least one lens and at least one diaphragm are contained. A great advantage of this is that the complete optical module can be injection-molded in one operation. For this purpose, the optical path of rays may have to be recalculated and the optical components contained in the optical module may have to be differently designed.
The measuring module in the analysis system according to the invention preferably comprises a light source, a detector and a test element holder, which are arranged _ 8 _ in such a way that light from the light source can pass through a translucent region of the multi-component injection-molded part to a test element arranged in the test element holder and be reflected by the test element through the translucent region to the detector. The light source is, for example, a light-emitting diode (LED).
The detector is, for example, a photodiode. The test element holder serves for receiving a test element, in particular during the carrying out of the measurements with the optical module. It is designed for guiding during the rnanual or automatic placement of the test element into the measuring module and for the exact positioning of the test element during the measurements. During the measurements, the test element is positioned in the test element holder in such a way that the light from the light source is directed via the translucent region of the multi-component injection molded part onto a test area on the test element, containing the sample and reagents. Depending on the concentration of the analyte in the sample, a proportion of the light hitting the test element is reflected at it in such a way that it passes through the translucent region of the multi-component injection-molded part to the detector.
According to another embodiment of the present invention, the measuring module comprises a light source, a detector and a test element holder, which are arranged in such a way that light from a light source can pass through a translucent region of the multi-component injection-molded part to a test element arranged in the test element holder and be transmitted by this to the detector.
According to a further preferred embodiment of the present invention, the analysis system contains a reading module for reading optically coded data, the reading module containing the optical module or a further optical modu'e.
In the prior art, there are known analysis systems that contain a storage container (magazine) with a multiplicity of test elements. In these systems, a test element is transported, for example, by a slide or pushrod from the magazine to the site of the measurement in the measuring module and, after carrying out the measurement, is automatically ejected from the analysis system or re-magazined in the magazine.
For example, DE 199 02 601 Al discloses a device for removing an analytical consumable, in particular a test element, from a storage container that has one or more chambers which contain the consumables. The chambers respectively have a removal opening for removing a consumable and a push-in opening, opposite the removal opening, for inserting a pushrod for transporting the consumable. The removal opening and the push-in opening are closed with a film to store the _ 9 _ consumable. The device comprises a pushrod, which can be made to move by means of a drive unit for the removal of a consumable.
In the AKKU CHEK -Compakt analysis system from I:oche Diagnostics, Germany, there is contained, for example, a reading module (with a barcode reader), which can read a barcode on the outer surface of a test element magazine in the form of a drum that is placed into the analysis system. The barcode contains, for example, information on the test elements contained in the magazine that are relevant for the evaluation of the data measured by the measuring module and are taken into consideration in the evaluation. In the prior art, the reading module contains two individual plastic injection-molded parts and a printed circuit board, which are joined together during the production of the reading module.
The one injection-molded part contains a diaphragm and the other contains a lens arrangement. The printed circuit board and the two injection-molded parts are connected to one another in a complicated adhesive-bondirig operation. The joining together is only possible in this case with great effort., for one reason on account of the tolerances of the injection-molded parts. The handling is problematic because of the small size of the parts. The many individual parts result in a great overall tolerance of the optical module.
In a preferred embodiment of the present invention, the two injection-molded parts are combined as one piece in a multi-component injection-molded part.
Consequently, the diaphragm and the lens arrangement can be produced positionally exactly in relation to one another and the disadvantages mentioned can be avoided.
No adhesive-bonding operation is necessary between the cliaphragm and the optical module. Reproducibly exact parts are also obtained i:a mass production.
The handling of the three-component injection-molded part is easier than the handling of the two individual parts. There are no tolerances between the optical module and the diaphragm. The construction is less expensive, so that a cost saving is achieved.
The printed circuit board of the reading module can be subsequently attached to the multi-component injection-molded part. The printed circuit board carries, for example, a detector (for example a photodiode) and a light source (for example an LED).
According to a preferred embodiment of the present invention, the reading module comprises a light source, a detector and a magazine holder, which are arranged in such a way that light from the light source can pass through a translucent region of the multi-component injection-molded part to a test element magazine held in the magazine holder and be reflected by the test element magazine through the translucent region to the detector.
The printed circuit board, which preferably carries the detector and the light source, is preferably positioned, with the aid of pins engaging in recesses, in relation to the multi-component injection-molded part and then connected to the latter, for example by adhesive bonding, ultrasonic welding or hot caulking.
In this case, the multi-component injection-molded part has recesses and/or pins and the printed circuit board has matching pins and/or recesses.
The invention also relates to a method for producing an analysis system for analyzing a sample on an analytical test element, the analysis system containing a measuring module and an optical module, the optical module comprising a lens and a diaphragm, characterized by the following steps:
- multi-component injection molding of a one-piece multi-component injection-molded part, in which the lens and the diaphragm are combined, and - positioning and mounting of the multi-component injection--molded part in the analysis system.
The invention is explained in more detail below on the basis of the drawing, in which:
Figure 1 shows a section through an optical module which is contained in a measuring module of an analysis system from the prior art, Figure 2 shows a section through an optical module which is contained in a measuring module of an analysis system according to the invention, Figure 3 shows a section through a measuring module of an analysis system according to the invention with a test element, Figure 4 shows the path of rays in the measuring module according to Figure ~
Figure 5 schematically shows a comparison of component parts of a reading module in an analysis system from the prior art and in an analysis system according to the invention, Figure 6 schematically shows a reading module in an analysis system according to the invention, Figure 7 shows the path of rays in the reading module frorn Figure 6, Figure 8 shows the printed circuit board and multi-component injection-molded part of an analysis system according to the invention and Figure 9 shows various ways of attaching the printed circuit board to the multi-component injection-molded part.
Figure 1 shows a section through an optical module which is contained in a measuring module of an analysis system from the prior art.
The optical module 1 comprises a lens 2 and a diaphragm 3, which contains a diaphragm body 4 and a diaphragm aperture 5. The diaphragm aperture 5 is filled by a translucent window 6. The lens 2 and the diaphragm 3 are individual components, which are adhesively bonded to an optical module base body 7. The mount 8 of the lens 2 serves as a further diaphragm. In the optical module base body 7 there is a large cavity 9 and a small cavity 10. Rays of light from a light source (not represented) can pass from the small cavity 10 through the lens 2, through the large cavity 9 and through the translucent window 6, closing the diaphragm opening 5, to a test element (not represented), which is located above the diaphragm 3 in a test element holder 15. Light reflected by the test element can then pass back through the window 6 into the large cavity 9 and from there through an opening 11 to a detector (not represented). This optical module comprising many individual parts that are adhesively bonded to one another has the already mentioned disadvantages of the prior art.
Figure 2 shows a section through an optical module, which. is contained in a measuring module of an analysis system according to the invention.
The optical module 1 is in this case a two-component injection-molded part, which combines the diaphragm 3 (including the diaphragm body 4 and the window 6 serving as the diaphragm aperture 5), the lens 2 and the optical module base body 7 as one piece. The optical module base body 7, the diaphragm body 4 and the mount 8 of the lens 2 are in this case injection-molded from an opaque plastic.
The lens 2 and the window 6 in the diaphragm aperture 5 are combined in a continuous region 12 of a translucent plastic in the two-component injection-molded part.
Figure 3 shows a section through a measuring module of an analysis system according to the invention with a test element.
Contained in the measuring module 13 are an optical module 1 according to Figure 2 and a printed circuit board 14. The optical module 1 comprises the optical module base body 7, the lens 2, the diaphragm 3, the mount 8 of the lens 2, the cavities 9, 10 and a test element holder 15. The optical module 1 is configured as a two-component injection-molded part with a first, translucent plastic component (region 12) and a second, opaque plastic component. In the test element holder there is a strip-shaped analytical test element 16, the test area 17 of which, in which a sample to be analyzed is located, is arranged above the window 6.
On the printed circuit board 14 there are a detector 18 and a lig:At source 19, which protrude into the large cavity 9 and into the small cavity 10, respectively.
The printed circuit board 14 is, for example, adhesively fixed to l'he two-component injection-molded part.
Figure 4 shows the path of rays in the measuring module according to Figure 3.
A light source 19 emits light for the photometric analysis of a sample on the test area 17 of the test element 16, which is focused onto the test element 16 by the continuous translucent region 12. In dependence on its optical properties (for example its coloration), on the test area 17 part of the light is reflected and returns through the region 12 into the large cavity 9 to the detector 18, from the signal of which the concentration of an analyte in the sample can be determined (for example in an evaluation module (not represented) of th:~ analysis system according to the invention).
Figure 5 schematically shows a comparison of component parts of a reading module in an analysis device from the prior art and in an analysis system according to the invention.
In the prior art (Figure 5a), a reading module comprises a printed circuit board 20, a diaphragm 21 and a lens arrangement 22 with at least one lens, these being produced as three separate components and subsequently joined. together.
According to the present invention (Figure 5b), in the reading module, the lens arrangement 22 and the diaphragm 21 are combined as a one-piece multi-component injection-molded part 23. The multi-component injection-molded part is joined together with the printed circuit board 20.
Figure 6 schematically shows a reading module in an analysis system according to the invention.
The reading module 24 contains, inter alia, an optical module 25 and a printed circuit board 20. In the optical module 25, a first lens 26 (shown in section), a second lens 27 and a diaphragm 21 are combined to form a one-piece two-component injection-molded part. The lenses 26, 27 are injecl::ion-molded from a first, translucent component (translucent region 38) and the diaphragm 21 is injection-molded from a second, opaque component. The printed circuit board 20 is connected to the optical module, for example by means of an adhesive bond.
It carries a light source 28 and a detector (not represented), which protrude into cavities 29 of the optical module 25. The printed circuit board is, for example, attached to an analysis system board 30.
Also represented in Figure 6 is a test element magazine 31 in the form of a drum, which serves for storing a multiplicity of test elements. On its circumferential surface 32, the magazine 31 has a barcode 33, which the reading module 24 can read. The magazine 31 is located in a magazine holder in the i-eading module 24, whereby it is positioned in relation to the optical module 25 for reading the barcode 33.
Figure 7 shows the path of rays in the reading module from Figure 6.
For better clearness, the analysis system board 30, the printed circuit board 20 and the optical module 25 are represented separately. The path of rays 37 is indicated by arrows. Light from a light source 28 propagates through the first cavity 34, the diaphragm 21 and the translucent region 38, including the first lens 26, to the barcode 33, is reflected by it and reaches the detector 36 through the translucent region 3 8 with the second lens 27, the diaphragm 21 and the second cavity 35.
Figure 8 demonstrates how the printed circuit board and the multi-component injection-molded part can be connected to one another in an analysis system according to the invention.
For this purpose, the printed circuit board 20 has two pins 39, which can engage in openings provided for them (bore 40 and oblong hole 41) in the multi-component injection-molded part 23. In this case, the light source 28 and the detector 36 are positioned in such a way that they are aligned exactly within the cavities 34, 35.
Then, the two parts 20, 23 are joined together by a joining process known to a person skilled in the art. The multi-component injection-molded part 23 is, for example, the optical module of a reading module.
Figure 9 shows various ways a) to c) of attaching the printed circuit board.
In variant a), the printed circuit board 20 has two pins 39, which are arranged offset in relation to one another. Variant b) corresponds to the variant shown in Figure 8, with two pins 39 that lie on a central line and engage in a bore 40 and a milled oblong hole 41. In variant c), the two pins 39 lie on a common lateral line and on a line taken as an extension of the light source 28 and of the detector 36, respectively.
List of designations 1 optical module 35 second cavity 2 lens 36 detector 3 diaphragm 37 path of rays 4 diaphragm body 38 translucent region diaphragm aperture 39 pins 6 translucent window 40 bore 7 optical module base body 41 oblong hole
According to a preferred embodiment of the present invention, the measuring module contains the optical module, the optical module servi:,.ig for carrying out optical measurements on the sample on the analytical test element. It is in this case in particular a measuring module that is intended for photometric measurements on the sample (for example a human or animal body fluid) and is designed for determining the concentration of an analyte (for example glucose) in the sample.
Currently in use in the prior art, for example in the AKKU CHEK -Compakt analysis system from Roche Diagnostics, Germany, is a measuring module which contains an optical module, the optical module being made up of two plastic parts, one of which contains a diaphragm with a plastic window as the diaphragm aperture and the other of which contains a lens. The parts are cf a small size (14.5 times 7.5 times 21 mm and 0.7 times 4 times 60 mm, respectively). The task of the measuring module in this prior-art analysis system is to position a test element for carrying out measurements and, with the aid of the optical module, to direct rays of light to determine blood sugar values optically. The two plastic parts of the optical module in the case of this analysis system are connected to one another by means of ultrasonic welding. High costs are incurred by the joining together of the two parts. The small overall size of the parts makes handling very complicated.
The welding requires an additional operation, which is carried out with great effort.
Additional tolerances as a result of two parts cannot be avoided. The position of the diaphragm is also determined here by its production tolerances.
In the analysis system according to the invention, the measuririg module contains an optical module in which at least one lens and at least one diaphragm are combined as one piece in a multi-component injection-molded part. It is particularly preferred for the entire optical module contained. in the measuring module to be a two-component injection-molded part, in which at least one lens and at least one diaphragm are contained. A great advantage of this is that the complete optical module can be injection-molded in one operation. For this purpose, the optical path of rays may have to be recalculated and the optical components contained in the optical module may have to be differently designed.
The measuring module in the analysis system according to the invention preferably comprises a light source, a detector and a test element holder, which are arranged _ 8 _ in such a way that light from the light source can pass through a translucent region of the multi-component injection-molded part to a test element arranged in the test element holder and be reflected by the test element through the translucent region to the detector. The light source is, for example, a light-emitting diode (LED).
The detector is, for example, a photodiode. The test element holder serves for receiving a test element, in particular during the carrying out of the measurements with the optical module. It is designed for guiding during the rnanual or automatic placement of the test element into the measuring module and for the exact positioning of the test element during the measurements. During the measurements, the test element is positioned in the test element holder in such a way that the light from the light source is directed via the translucent region of the multi-component injection molded part onto a test area on the test element, containing the sample and reagents. Depending on the concentration of the analyte in the sample, a proportion of the light hitting the test element is reflected at it in such a way that it passes through the translucent region of the multi-component injection-molded part to the detector.
According to another embodiment of the present invention, the measuring module comprises a light source, a detector and a test element holder, which are arranged in such a way that light from a light source can pass through a translucent region of the multi-component injection-molded part to a test element arranged in the test element holder and be transmitted by this to the detector.
According to a further preferred embodiment of the present invention, the analysis system contains a reading module for reading optically coded data, the reading module containing the optical module or a further optical modu'e.
In the prior art, there are known analysis systems that contain a storage container (magazine) with a multiplicity of test elements. In these systems, a test element is transported, for example, by a slide or pushrod from the magazine to the site of the measurement in the measuring module and, after carrying out the measurement, is automatically ejected from the analysis system or re-magazined in the magazine.
For example, DE 199 02 601 Al discloses a device for removing an analytical consumable, in particular a test element, from a storage container that has one or more chambers which contain the consumables. The chambers respectively have a removal opening for removing a consumable and a push-in opening, opposite the removal opening, for inserting a pushrod for transporting the consumable. The removal opening and the push-in opening are closed with a film to store the _ 9 _ consumable. The device comprises a pushrod, which can be made to move by means of a drive unit for the removal of a consumable.
In the AKKU CHEK -Compakt analysis system from I:oche Diagnostics, Germany, there is contained, for example, a reading module (with a barcode reader), which can read a barcode on the outer surface of a test element magazine in the form of a drum that is placed into the analysis system. The barcode contains, for example, information on the test elements contained in the magazine that are relevant for the evaluation of the data measured by the measuring module and are taken into consideration in the evaluation. In the prior art, the reading module contains two individual plastic injection-molded parts and a printed circuit board, which are joined together during the production of the reading module.
The one injection-molded part contains a diaphragm and the other contains a lens arrangement. The printed circuit board and the two injection-molded parts are connected to one another in a complicated adhesive-bondirig operation. The joining together is only possible in this case with great effort., for one reason on account of the tolerances of the injection-molded parts. The handling is problematic because of the small size of the parts. The many individual parts result in a great overall tolerance of the optical module.
In a preferred embodiment of the present invention, the two injection-molded parts are combined as one piece in a multi-component injection-molded part.
Consequently, the diaphragm and the lens arrangement can be produced positionally exactly in relation to one another and the disadvantages mentioned can be avoided.
No adhesive-bonding operation is necessary between the cliaphragm and the optical module. Reproducibly exact parts are also obtained i:a mass production.
The handling of the three-component injection-molded part is easier than the handling of the two individual parts. There are no tolerances between the optical module and the diaphragm. The construction is less expensive, so that a cost saving is achieved.
The printed circuit board of the reading module can be subsequently attached to the multi-component injection-molded part. The printed circuit board carries, for example, a detector (for example a photodiode) and a light source (for example an LED).
According to a preferred embodiment of the present invention, the reading module comprises a light source, a detector and a magazine holder, which are arranged in such a way that light from the light source can pass through a translucent region of the multi-component injection-molded part to a test element magazine held in the magazine holder and be reflected by the test element magazine through the translucent region to the detector.
The printed circuit board, which preferably carries the detector and the light source, is preferably positioned, with the aid of pins engaging in recesses, in relation to the multi-component injection-molded part and then connected to the latter, for example by adhesive bonding, ultrasonic welding or hot caulking.
In this case, the multi-component injection-molded part has recesses and/or pins and the printed circuit board has matching pins and/or recesses.
The invention also relates to a method for producing an analysis system for analyzing a sample on an analytical test element, the analysis system containing a measuring module and an optical module, the optical module comprising a lens and a diaphragm, characterized by the following steps:
- multi-component injection molding of a one-piece multi-component injection-molded part, in which the lens and the diaphragm are combined, and - positioning and mounting of the multi-component injection--molded part in the analysis system.
The invention is explained in more detail below on the basis of the drawing, in which:
Figure 1 shows a section through an optical module which is contained in a measuring module of an analysis system from the prior art, Figure 2 shows a section through an optical module which is contained in a measuring module of an analysis system according to the invention, Figure 3 shows a section through a measuring module of an analysis system according to the invention with a test element, Figure 4 shows the path of rays in the measuring module according to Figure ~
Figure 5 schematically shows a comparison of component parts of a reading module in an analysis system from the prior art and in an analysis system according to the invention, Figure 6 schematically shows a reading module in an analysis system according to the invention, Figure 7 shows the path of rays in the reading module frorn Figure 6, Figure 8 shows the printed circuit board and multi-component injection-molded part of an analysis system according to the invention and Figure 9 shows various ways of attaching the printed circuit board to the multi-component injection-molded part.
Figure 1 shows a section through an optical module which is contained in a measuring module of an analysis system from the prior art.
The optical module 1 comprises a lens 2 and a diaphragm 3, which contains a diaphragm body 4 and a diaphragm aperture 5. The diaphragm aperture 5 is filled by a translucent window 6. The lens 2 and the diaphragm 3 are individual components, which are adhesively bonded to an optical module base body 7. The mount 8 of the lens 2 serves as a further diaphragm. In the optical module base body 7 there is a large cavity 9 and a small cavity 10. Rays of light from a light source (not represented) can pass from the small cavity 10 through the lens 2, through the large cavity 9 and through the translucent window 6, closing the diaphragm opening 5, to a test element (not represented), which is located above the diaphragm 3 in a test element holder 15. Light reflected by the test element can then pass back through the window 6 into the large cavity 9 and from there through an opening 11 to a detector (not represented). This optical module comprising many individual parts that are adhesively bonded to one another has the already mentioned disadvantages of the prior art.
Figure 2 shows a section through an optical module, which. is contained in a measuring module of an analysis system according to the invention.
The optical module 1 is in this case a two-component injection-molded part, which combines the diaphragm 3 (including the diaphragm body 4 and the window 6 serving as the diaphragm aperture 5), the lens 2 and the optical module base body 7 as one piece. The optical module base body 7, the diaphragm body 4 and the mount 8 of the lens 2 are in this case injection-molded from an opaque plastic.
The lens 2 and the window 6 in the diaphragm aperture 5 are combined in a continuous region 12 of a translucent plastic in the two-component injection-molded part.
Figure 3 shows a section through a measuring module of an analysis system according to the invention with a test element.
Contained in the measuring module 13 are an optical module 1 according to Figure 2 and a printed circuit board 14. The optical module 1 comprises the optical module base body 7, the lens 2, the diaphragm 3, the mount 8 of the lens 2, the cavities 9, 10 and a test element holder 15. The optical module 1 is configured as a two-component injection-molded part with a first, translucent plastic component (region 12) and a second, opaque plastic component. In the test element holder there is a strip-shaped analytical test element 16, the test area 17 of which, in which a sample to be analyzed is located, is arranged above the window 6.
On the printed circuit board 14 there are a detector 18 and a lig:At source 19, which protrude into the large cavity 9 and into the small cavity 10, respectively.
The printed circuit board 14 is, for example, adhesively fixed to l'he two-component injection-molded part.
Figure 4 shows the path of rays in the measuring module according to Figure 3.
A light source 19 emits light for the photometric analysis of a sample on the test area 17 of the test element 16, which is focused onto the test element 16 by the continuous translucent region 12. In dependence on its optical properties (for example its coloration), on the test area 17 part of the light is reflected and returns through the region 12 into the large cavity 9 to the detector 18, from the signal of which the concentration of an analyte in the sample can be determined (for example in an evaluation module (not represented) of th:~ analysis system according to the invention).
Figure 5 schematically shows a comparison of component parts of a reading module in an analysis device from the prior art and in an analysis system according to the invention.
In the prior art (Figure 5a), a reading module comprises a printed circuit board 20, a diaphragm 21 and a lens arrangement 22 with at least one lens, these being produced as three separate components and subsequently joined. together.
According to the present invention (Figure 5b), in the reading module, the lens arrangement 22 and the diaphragm 21 are combined as a one-piece multi-component injection-molded part 23. The multi-component injection-molded part is joined together with the printed circuit board 20.
Figure 6 schematically shows a reading module in an analysis system according to the invention.
The reading module 24 contains, inter alia, an optical module 25 and a printed circuit board 20. In the optical module 25, a first lens 26 (shown in section), a second lens 27 and a diaphragm 21 are combined to form a one-piece two-component injection-molded part. The lenses 26, 27 are injecl::ion-molded from a first, translucent component (translucent region 38) and the diaphragm 21 is injection-molded from a second, opaque component. The printed circuit board 20 is connected to the optical module, for example by means of an adhesive bond.
It carries a light source 28 and a detector (not represented), which protrude into cavities 29 of the optical module 25. The printed circuit board is, for example, attached to an analysis system board 30.
Also represented in Figure 6 is a test element magazine 31 in the form of a drum, which serves for storing a multiplicity of test elements. On its circumferential surface 32, the magazine 31 has a barcode 33, which the reading module 24 can read. The magazine 31 is located in a magazine holder in the i-eading module 24, whereby it is positioned in relation to the optical module 25 for reading the barcode 33.
Figure 7 shows the path of rays in the reading module from Figure 6.
For better clearness, the analysis system board 30, the printed circuit board 20 and the optical module 25 are represented separately. The path of rays 37 is indicated by arrows. Light from a light source 28 propagates through the first cavity 34, the diaphragm 21 and the translucent region 38, including the first lens 26, to the barcode 33, is reflected by it and reaches the detector 36 through the translucent region 3 8 with the second lens 27, the diaphragm 21 and the second cavity 35.
Figure 8 demonstrates how the printed circuit board and the multi-component injection-molded part can be connected to one another in an analysis system according to the invention.
For this purpose, the printed circuit board 20 has two pins 39, which can engage in openings provided for them (bore 40 and oblong hole 41) in the multi-component injection-molded part 23. In this case, the light source 28 and the detector 36 are positioned in such a way that they are aligned exactly within the cavities 34, 35.
Then, the two parts 20, 23 are joined together by a joining process known to a person skilled in the art. The multi-component injection-molded part 23 is, for example, the optical module of a reading module.
Figure 9 shows various ways a) to c) of attaching the printed circuit board.
In variant a), the printed circuit board 20 has two pins 39, which are arranged offset in relation to one another. Variant b) corresponds to the variant shown in Figure 8, with two pins 39 that lie on a central line and engage in a bore 40 and a milled oblong hole 41. In variant c), the two pins 39 lie on a common lateral line and on a line taken as an extension of the light source 28 and of the detector 36, respectively.
List of designations 1 optical module 35 second cavity 2 lens 36 detector 3 diaphragm 37 path of rays 4 diaphragm body 38 translucent region diaphragm aperture 39 pins 6 translucent window 40 bore 7 optical module base body 41 oblong hole
8 mount of the lens
9 large cavity small cavity 11 opening 12 continuous region 13 measuring module 14 printed circuit board test element holder 16 test element 17 test area 18 detector 19 light source printed circuit board 21 diaphragm 22 lens arrangement 23 multi-component injection-molded part 24 reading module optical module 26 first lens 27 second lens 28 light source 29 cavities analysis system board 31 test element magazine 32 circumferential surface 33 barcode 34 first cavity
Claims (12)
1. An analysis system for analyzing a sample on an analytical test element (16), comprising:
a measuring module (13) for carrying out measurements on the sample on the analytical test element (16) and an optical module (1, 25), which comprises a lens (2, 26, 27) and a diaphragm (3, 21), by which the light can be focused, wherein the lens (2, 26, 27) and the diaphragm (3, 21) of the optical module (1, 25) are combined as one piece in a multi-component injection-molded part (23).
a measuring module (13) for carrying out measurements on the sample on the analytical test element (16) and an optical module (1, 25), which comprises a lens (2, 26, 27) and a diaphragm (3, 21), by which the light can be focused, wherein the lens (2, 26, 27) and the diaphragm (3, 21) of the optical module (1, 25) are combined as one piece in a multi-component injection-molded part (23).
2. The analysis system as claimed in claim 1, wherein the multi-component injection-molded part (23) is a two-component injection-molded part with a first, translucent plastic component and a second, opaque plastic component.
3. The analysis system as claimed in any one of claims 1 and 2, wherein the diaphragm (3, 21) comprises a diaphragm body (4) of an. opaque plastic and a diaphragm aperture (5), the diaphragm aperture (5) being filled with a translucent plastic.
4. The analysis system as claimed in claim 3, wherein the lens (2, 26, 27) consists of the translucent plastic.
5. The analysis system as claimed in claim 4, wherein the lens (2, 26, 27) and the diaphragm aperture (5) filled with the translucent plastic are combined in a continuous region (12) of the translucent plastic in the multi-component injection-molded part (23).
6. The analysis system as claimed in any one of claims 1 and 2, wherein the diaphragm (3, 21) comprises a diaphragm body (4) of an opaque plastic and a diaphragm aperture (5), the diaphragm aperture (5) being a clearance in the diaphragm body (4).
7. The analysis system as claimed in any one of claims 1 to 6, wherein the measuring module (13) contains the optical module (7), the optical module (7) serving for carrying out optical measurements on the sample on the analytical test element (16).
8. The analysis system as claimed in claim 7, wherein the measuring module (13) comprises a light source (19), a detector (18) and a test element holder (15), which are arranged in such a way that light from the light source (19) can pass through a translucent region (12) of the multi-component injection-molded part (23) to a test element (16) arranged in the test element holder (15) and be reflected by the test element (16) through the translucent region (12) to the detector (18).
9. The analysis system as claimed in any one of claims 1 to 8, wherein a reading module (24) for reading optically coded data, the reading module (24) containing the optical module or a further optical module (25).
10. The analysis system as claimed in claim 9, wherein the reading module (24) also comprises a light source (28), a detector (36) and a magazine holder, which are arranged in such a way that light from the light source (28) can pass through a translucent region (38) of the multi-component injection-molded part (23) to a test element magazine (31) held in the magazine holder and be reflected by the test element magazine (31) through the translucent region (38) to the detector (36).
11. The analysis system as claimed in claim 10, wherein the light source (28) and the detector (36) are arranged on a printed circuit board (20), which is connected to the optical module (35).
12. A method for producing an analysis system for analyzing a sample on an analytical test element, the analysis system containing a measuring module and an optical module, the optical module comprising a lens and a diaphragm, the method comprising the following steps:
multi-component injection molding of the lens and the diaphragm in a one-piece multi-component injection-molded part and positioning and mounting of the multi-component injection-molded part in the analysis system.
multi-component injection molding of the lens and the diaphragm in a one-piece multi-component injection-molded part and positioning and mounting of the multi-component injection-molded part in the analysis system.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05013452A EP1736774B1 (en) | 2005-06-22 | 2005-06-22 | Analytic system for the analysis of a sample on an analytic test element |
| EP05013452.7 | 2005-06-22 | ||
| PCT/EP2006/063145 WO2006136512A2 (en) | 2005-06-22 | 2006-06-13 | Analysis system for analysing a sample on an analytical test element |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2611921A1 CA2611921A1 (en) | 2006-12-28 |
| CA2611921C true CA2611921C (en) | 2011-05-10 |
Family
ID=35539656
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2611921A Expired - Fee Related CA2611921C (en) | 2005-06-22 | 2006-06-13 | Analysis system for analysing a sample on an analytical test element |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US7808645B2 (en) |
| EP (1) | EP1736774B1 (en) |
| JP (1) | JP4804535B2 (en) |
| CN (1) | CN101203755B (en) |
| AT (1) | ATE385571T1 (en) |
| CA (1) | CA2611921C (en) |
| DE (1) | DE502005002762D1 (en) |
| ES (1) | ES2299920T3 (en) |
| HK (1) | HK1124117A1 (en) |
| WO (1) | WO2006136512A2 (en) |
Families Citing this family (55)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6391005B1 (en) | 1998-03-30 | 2002-05-21 | Agilent Technologies, Inc. | Apparatus and method for penetration with shaft having a sensor for sensing penetration depth |
| US8641644B2 (en) | 2000-11-21 | 2014-02-04 | Sanofi-Aventis Deutschland Gmbh | Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means |
| US7025774B2 (en) | 2001-06-12 | 2006-04-11 | Pelikan Technologies, Inc. | Tissue penetration device |
| US9226699B2 (en) | 2002-04-19 | 2016-01-05 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling module with a continuous compression tissue interface surface |
| DE60238119D1 (en) | 2001-06-12 | 2010-12-09 | Pelikan Technologies Inc | ELECTRIC ACTUATOR ELEMENT FOR A LANZETTE |
| US9427532B2 (en) | 2001-06-12 | 2016-08-30 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
| US8337419B2 (en) | 2002-04-19 | 2012-12-25 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
| US7316700B2 (en) | 2001-06-12 | 2008-01-08 | Pelikan Technologies, Inc. | Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties |
| US9795747B2 (en) | 2010-06-02 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
| US7981056B2 (en) | 2002-04-19 | 2011-07-19 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
| US7749174B2 (en) | 2001-06-12 | 2010-07-06 | Pelikan Technologies, Inc. | Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge |
| US8221334B2 (en) | 2002-04-19 | 2012-07-17 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
| US7175642B2 (en) | 2002-04-19 | 2007-02-13 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
| US7713214B2 (en) | 2002-04-19 | 2010-05-11 | Pelikan Technologies, Inc. | Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing |
| US8579831B2 (en) | 2002-04-19 | 2013-11-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
| US8360992B2 (en) | 2002-04-19 | 2013-01-29 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
| US7976476B2 (en) | 2002-04-19 | 2011-07-12 | Pelikan Technologies, Inc. | Device and method for variable speed lancet |
| US8784335B2 (en) | 2002-04-19 | 2014-07-22 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling device with a capacitive sensor |
| US9795334B2 (en) | 2002-04-19 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
| US9248267B2 (en) | 2002-04-19 | 2016-02-02 | Sanofi-Aventis Deustchland Gmbh | Tissue penetration device |
| US7909778B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US7491178B2 (en) | 2002-04-19 | 2009-02-17 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US7547287B2 (en) | 2002-04-19 | 2009-06-16 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US9314194B2 (en) | 2002-04-19 | 2016-04-19 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
| US7297122B2 (en) | 2002-04-19 | 2007-11-20 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US7331931B2 (en) | 2002-04-19 | 2008-02-19 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US7674232B2 (en) | 2002-04-19 | 2010-03-09 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US7892183B2 (en) | 2002-04-19 | 2011-02-22 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
| US7901362B2 (en) | 2002-04-19 | 2011-03-08 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US7229458B2 (en) | 2002-04-19 | 2007-06-12 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US8372016B2 (en) | 2002-04-19 | 2013-02-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling and analyte sensing |
| US7232451B2 (en) | 2002-04-19 | 2007-06-19 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
| US8267870B2 (en) | 2002-04-19 | 2012-09-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling with hybrid actuation |
| US8702624B2 (en) | 2006-09-29 | 2014-04-22 | Sanofi-Aventis Deutschland Gmbh | Analyte measurement device with a single shot actuator |
| US8574895B2 (en) | 2002-12-30 | 2013-11-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus using optical techniques to measure analyte levels |
| US8262614B2 (en) | 2003-05-30 | 2012-09-11 | Pelikan Technologies, Inc. | Method and apparatus for fluid injection |
| US7850621B2 (en) | 2003-06-06 | 2010-12-14 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
| WO2006001797A1 (en) | 2004-06-14 | 2006-01-05 | Pelikan Technologies, Inc. | Low pain penetrating |
| WO2005033659A2 (en) | 2003-09-29 | 2005-04-14 | Pelikan Technologies, Inc. | Method and apparatus for an improved sample capture device |
| EP1680014A4 (en) | 2003-10-14 | 2009-01-21 | Pelikan Technologies Inc | Method and apparatus for a variable user interface |
| US7822454B1 (en) | 2005-01-03 | 2010-10-26 | Pelikan Technologies, Inc. | Fluid sampling device with improved analyte detecting member configuration |
| US8668656B2 (en) | 2003-12-31 | 2014-03-11 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for improving fluidic flow and sample capture |
| WO2006011062A2 (en) | 2004-05-20 | 2006-02-02 | Albatros Technologies Gmbh & Co. Kg | Printable hydrogel for biosensors |
| EP1765194A4 (en) | 2004-06-03 | 2010-09-29 | Pelikan Technologies Inc | Method and apparatus for a fluid sampling device |
| US9775553B2 (en) | 2004-06-03 | 2017-10-03 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a fluid sampling device |
| US8652831B2 (en) | 2004-12-30 | 2014-02-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte measurement test time |
| EP2265324B1 (en) | 2008-04-11 | 2015-01-28 | Sanofi-Aventis Deutschland GmbH | Integrated analyte measurement system |
| US8346380B2 (en) | 2008-09-25 | 2013-01-01 | Lg Electronics Inc. | Method and an apparatus for processing a signal |
| US9375169B2 (en) | 2009-01-30 | 2016-06-28 | Sanofi-Aventis Deutschland Gmbh | Cam drive for managing disposable penetrating member actions with a single motor and motor and control system |
| EP2265102B1 (en) * | 2009-06-19 | 2014-06-25 | Baumer Innotec AG | Sensor device without housing |
| US8965476B2 (en) | 2010-04-16 | 2015-02-24 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
| EP2690428B1 (en) * | 2011-03-23 | 2019-11-13 | Terumo Kabushiki Kaisha | Component measurement device |
| DE102012018015B3 (en) * | 2012-09-06 | 2013-12-05 | Jenoptik Polymer Systems Gmbh | Measuring module for remission photometric analysis and method for its production |
| CN104730000A (en) * | 2015-04-13 | 2015-06-24 | 大连理工大学 | Photoelectric quantitative testing device for immune chromatography reaction results |
| EP3557285B1 (en) * | 2018-04-19 | 2022-02-23 | Leica Geosystems AG | Laser distance measurer |
Family Cites Families (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2637514A1 (en) * | 1976-08-20 | 1978-02-23 | Agfa Gevaert Ag | OPTICAL IMAGING SYSTEM FOR COPY DEVICES |
| US5360410A (en) | 1991-01-16 | 1994-11-01 | Senetek Plc | Safety syringe for mixing two-component medicaments |
| DE4310583A1 (en) * | 1993-03-31 | 1994-10-06 | Boehringer Mannheim Gmbh | Test strip analysis system |
| US5706140A (en) | 1993-09-06 | 1998-01-06 | Kansei Corp. | Optical distance measuring equipment |
| US5762770A (en) | 1994-02-21 | 1998-06-09 | Boehringer Mannheim Corporation | Electrochemical biosensor test strip |
| US5515170A (en) * | 1994-09-08 | 1996-05-07 | Lifescan, Inc. | Analyte detection device having a serpentine passageway for indicator strips |
| JPH1023204A (en) * | 1996-07-09 | 1998-01-23 | Canon Inc | Image sensor and information processor |
| IL121279A (en) * | 1996-07-16 | 2001-05-20 | Roche Diagnostics Gmbh | Analytical system with means for detecting too small sample volumes |
| DE19629656A1 (en) | 1996-07-23 | 1998-01-29 | Boehringer Mannheim Gmbh | Diagnostic test carrier with multilayer test field and method for the determination of analyte with its aid |
| DE19629657A1 (en) | 1996-07-23 | 1998-01-29 | Boehringer Mannheim Gmbh | Volume-independent diagnostic test carrier and method for determining analyte with its aid |
| US5945341A (en) * | 1996-10-21 | 1999-08-31 | Bayer Corporation | System for the optical identification of coding on a diagnostic test strip |
| AU1449699A (en) * | 1997-10-31 | 1999-05-24 | Technical Chemicals & Products, Inc. | Reflectometer |
| DE19753847A1 (en) | 1997-12-04 | 1999-06-10 | Roche Diagnostics Gmbh | Analytical test element with capillary channel |
| DE19861428B4 (en) * | 1998-03-17 | 2008-01-10 | Robert Bosch Gmbh | Optical sensor |
| US5995236A (en) * | 1998-04-13 | 1999-11-30 | Mit Development Corporation | Blood fluid characteristics analysis instrument |
| DE19844500A1 (en) * | 1998-09-29 | 2000-03-30 | Roche Diagnostics Gmbh | Process for the photometric evaluation of test elements |
| JP2000206842A (en) * | 1999-01-19 | 2000-07-28 | Sharp Corp | Image forming device |
| KR100816799B1 (en) * | 1999-12-24 | 2008-03-26 | 로셰 디아그노스틱스 게엠베하 | Test element analysis system and method for analytical investigation using the same |
| JP2001350075A (en) * | 2000-06-07 | 2001-12-21 | Enplas Corp | Image pickup lens |
| DE10061327A1 (en) * | 2000-12-08 | 2002-06-20 | Braun Gmbh | toothbrush housing |
| DE10109064A1 (en) * | 2001-02-24 | 2002-09-05 | Beiersdorf Ag | Opening system with back ventilation mechanism |
| JP2004524644A (en) * | 2001-04-25 | 2004-08-12 | コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ | Scanning device with high numerical aperture plastic objective lens |
| US7279130B2 (en) * | 2001-08-13 | 2007-10-09 | Bayer Healthcare Llc | Sensor dispensing instrument having an activation mechanism and methods of using the same |
| JP2003174040A (en) * | 2001-12-04 | 2003-06-20 | Fuji Electric Co Ltd | Manufacturing method for optical semiconductor device |
| DE10261974A1 (en) | 2002-05-10 | 2004-02-05 | Hella Kg Hueck & Co. | Plastic lens and method for producing a plastic lens |
| DE10220671B4 (en) * | 2002-05-10 | 2004-08-26 | Hella Kg Hueck & Co. | Optical system for a camera |
| AT413979B (en) * | 2003-01-20 | 2006-07-15 | Bamed Ag | DRINKING-NOSE |
| JP3981348B2 (en) * | 2003-05-30 | 2007-09-26 | 松下電器産業株式会社 | Imaging device and manufacturing method thereof |
| EP1879018B1 (en) * | 2006-07-12 | 2015-08-19 | F. Hoffmann-La Roche AG | Analysis system and method for analysing a sample on an analytical test element |
-
2005
- 2005-06-22 DE DE502005002762T patent/DE502005002762D1/en active Active
- 2005-06-22 ES ES05013452T patent/ES2299920T3/en active Active
- 2005-06-22 EP EP05013452A patent/EP1736774B1/en active Active
- 2005-06-22 AT AT05013452T patent/ATE385571T1/en active
-
2006
- 2006-06-13 CA CA2611921A patent/CA2611921C/en not_active Expired - Fee Related
- 2006-06-13 WO PCT/EP2006/063145 patent/WO2006136512A2/en active Application Filing
- 2006-06-13 JP JP2008517462A patent/JP4804535B2/en not_active Expired - Fee Related
- 2006-06-13 CN CN200680022146.XA patent/CN101203755B/en active Active
-
2007
- 2007-12-22 US US11/963,801 patent/US7808645B2/en active Active
-
2008
- 2008-12-09 HK HK08113384.9A patent/HK1124117A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2611921A1 (en) | 2006-12-28 |
| US7808645B2 (en) | 2010-10-05 |
| CN101203755B (en) | 2013-04-24 |
| EP1736774A1 (en) | 2006-12-27 |
| US20080144022A1 (en) | 2008-06-19 |
| WO2006136512A3 (en) | 2007-05-10 |
| ATE385571T1 (en) | 2008-02-15 |
| JP2008544265A (en) | 2008-12-04 |
| ES2299920T3 (en) | 2008-06-01 |
| HK1124117A1 (en) | 2009-07-03 |
| WO2006136512A2 (en) | 2006-12-28 |
| EP1736774B1 (en) | 2008-02-06 |
| JP4804535B2 (en) | 2011-11-02 |
| CN101203755A (en) | 2008-06-18 |
| DE502005002762D1 (en) | 2008-03-20 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2611921C (en) | Analysis system for analysing a sample on an analytical test element | |
| JP2008544265A5 (en) | ||
| US7951331B2 (en) | Analysis system and method for analyzing a sample on an analytical test element | |
| US6009632A (en) | Alignment system for optical analyte testing meter components | |
| EP2781907B1 (en) | Reflective absorbance measuring device, and integral apparatus for analyzing reflective absorbance and lateral flow | |
| JP5232003B2 (en) | Multi-part body fluid sampling and analysis cartridge | |
| EP2315007B1 (en) | Light guide test sensor for use in determining an analyte in a fluid sample | |
| KR101516563B1 (en) | Diagnostic strip insertion type reading device | |
| US6906802B2 (en) | System for analyzing sample liquids containing a position control unit | |
| HUT77371A (en) | Monitoring methods and devices for use therein | |
| KR19980024133A (en) | Test kits and devices | |
| JP2004317487A (en) | Multiwavelength read head used for measuring analyte in body fluid | |
| WO2011008581A2 (en) | Devices, methods, and kits for determining analyte concentrations | |
| RU2519505C2 (en) | Sensor device for target substance identification | |
| CA3152784A1 (en) | Device and method to evaluate a fluid sample on a single-use multianalyte consumable | |
| WO2019138681A1 (en) | Component measurement system, measurement device, and measurement tip | |
| CN210142078U (en) | Electronic reading device | |
| KR102252241B1 (en) | Method for determining analyte concentration in body fluid and device for measuring analyte concentration | |
| CN112997067A (en) | Test strip and component measurement system | |
| CN210090318U (en) | Reading device and reading device for reading detection result | |
| CN111426684A (en) | Reading device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20150615 |