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

Definitions

• 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.
• Analysis of samples often involves analysis systems in which the samples to be analyzed are on a test element and in a test field may react with one or more reagents on the test element before being analyzed.
• the optical, in particular photometric, and the electrochemical evaluation of test elements represent the most common methods for rapid determination of the concentration of analytes in samples.
• Analysis systems with test elements for sample analysis are generally used in the field of analytics, environmental analysis and especially in the field of medical diagnostics , Particularly in the field of blood glucose diagnostics of capillary blood, test elements that are evaluated photometrically or electrochemically are of great importance.
• test elements There are different forms of test elements. For example, essentially square platelets are known, which are also referred to as slides, in the middle of which a multilayer test field is located. Diagnostic test elements that are strip-shaped are referred to as test strips. Test elements are comprehensively described in the prior art, for example in documents DE-A 197 53 847, EP-A 0 821 233, EP-A 0 821 234 or WO 97/02487. The present invention relates to test elements of any shape, in particular to strip-shaped test elements.
• test element analysis systems For the analytical examination of a sample on a test element, test element analysis systems are known in the prior art which contain a test element receptacle for positioning the test element in a measurement position and a measurement and evaluation device for performing a measurement and determination of an analysis result resulting therefrom.
• WO 00/19185 A1 relates to a device for the photometric evaluation of test elements, including
• a lighting unit having at least a first and a second light source
• a holder for holding a test element with a detection zone in such a way that the detection zone is positioned opposite the illumination unit
• a detection unit with at least one detector which detects light reflected from the detection zone or transmitted through the detection zone
• control unit that activates the two light sources and receives the signal generated by the detection unit as a detection signal
• an evaluation unit that evaluates the detection signals to determine the analyte concentration contained in the sample.
• EP 0 618 443 A1 relates to a test strip analysis system consisting of an evaluation device with a test strip holder and the appropriate test strips.
• the test strip holder serves to position the test strip in a defined position relative to a measuring unit. It has a test strip support and a guide for the test strip.
• WO 01/48461 A1 relates to a test element analysis system for the analytical examination of a sample.
• the analysis system comprises test elements having a support sheet and a test pad attached to a flat side of the support sheet which is contacted with the sample for analysis such that liquid sample components enter the test field, the test field containing a reagent system whose reaction with components the sample leads to an optically measurable change characteristic of the analysis in a detection zone and on the side of the test field facing the carrier foil.
• the analysis system comprises an evaluation device with a test element holder for positioning a test element in a measuring position and a measuring device for measuring the optically measurable change in the detection zone, wherein the measuring device comprises a light emitter for illuminating the Detection zone with primary light and a detector for detecting the case of the detection zone diffusely reflected secondary light.
• optical module which includes, inter alia, a lens and a diaphragm through which light can be focused.
• optical modules are manufactured in the prior art from several individual parts, which are assembled and connected to each other, for example by means of ultrasonic welding, hot caulking or gluing.
• the lens and the lens are manufactured in the prior art from several individual parts, which are assembled and connected to each other, for example by means of ultrasonic welding, hot caulking or gluing.
• Aperture be positioned spatially exactly to each other according to the beam path of the light. The joining of the parts is only with great effort by their
• Object of the present invention is therefore to avoid the disadvantages of the prior art.
• the effort and costs are to be reduced in the assembly of the analysis system.
• an analysis system for analyzing a sample on an analytical test element comprising
• a measurement module for performing measurements on the sample on the analytical test element
• an optical module comprising a lens and a diaphragm through which light can be focused, wherein
• the lens and the aperture of the optical module are integrally combined in a multi-component injection molded part.
• the analysis system contains inter alia a measurement module for carrying out measurements on a sample on an analytical 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 in the clinical diagnosis allow the early and reliable detection of pathological conditions as well as the targeted and well-founded control of body conditions.
• the medical diagnostics always sets the extraction a sample of blood or interstitial fluid of the individual to be examined.
• the skin may be perforated, for example, on the fingertip or earlobe of the subject to be examined using a sterile, sharp lancet to obtain a small amount of blood or interstitial fluid for analysis.
• this method is suitable for the analysis of a sample, which is carried out immediately after the sample extraction.
• the sample is applied to an analytical test element containing reagents (for example, in a test field) to perform the measurements.
• reagents for example, in a test field
• reaction of the analyte contained in the sample with the reagents results in a physically measurable change in the test element that correlates with the concentration of the analyte.
• the measuring module of the analysis system according to the invention serves to measure this change.
• the measured values obtained during the measurements of the measuring module serve to determine the concentration of the analyte in the sample.
• the test elements contain a reagent system whose reaction with the analyte results in a photometrically detectable change (a color change).
• the reagents are usually located in a test field of the test element, the color of which changes as a function of the concentration. This color change can be determined quantitatively by reflection photometry with the help of a measuring module.
• Electrochemical test elements contain an electrochemical reagent system whose reaction with the analyte determines the voltage between two poles of the test element and / or that between two poles of the test element at a defined voltage
• Voltage flowing current influenced.
• the voltage or Amperage the physically measurable size, which is determined by a corresponding integrated in the analysis system designed as voltage or current measuring device measuring module and their correlating with the concentration of the analyte change in the analysis data (concentration of the analyte) is converted.
• An optical module in the sense of the present invention is an assembly which contains inter alia at least one lens and one aperture. Through the lens and the aperture light can be focused.
• a lens is known as an optical component known to the person skilled in the art as an optical lens.
• a diaphragm in this context refers to an optical component which comprises an opaque diaphragm body and a translucent diaphragm aperture.
• An aperture prevents the propagation of light in certain spatial directions. It serves to limit the cross section of bundles of rays and to reduce scattered light.
• the lens and the diaphragm of the optical module are combined in one piece in a multi-component injection-molded component.
• Injection molding is a process known in the prior art, in which a plasticized material (injection molding compound) (in particular a thermoset or thermoset plastic) is injected into a forming tool (injection molding tool) at high pressure, where it changes to the solid state under the action of pressure. The injection molded part can then be removed from the injection mold.
• Multi-component injection molding is also a method known in the art.
• compound injection molding is suitable for producing the multicomponent injection-molded component for the analytical device according to the invention. In this case, two or more materials are injected successively into an injection mold, whereby they are joined together materially at their interfaces. The geometry of the cavity present in the injection mold is changed between the different injections.
• a plurality of lenses are produced as a one-piece multi-component injection-molded component, as described, for example, in DE 102 61 974 A1, US 2004/0120053 A1 or DE 44 31 744 A1.
• the one-piece combination of the lens and the diaphragm of the optical module in the multi-component injection-molded component results in a large number of advantages.
• An assembly of lens and diaphragm after their production is no longer necessary, whereby a step in the preparation of the analysis system of the invention is omitted. from that Among other things, cost savings result.
• the handling of the multi-component injection-molded component is simpler than that of the individual lens and the individual diaphragm. It is also possible to produce a reproducible unit of lens and aperture in series production. There are no tolerances between the lens and the diaphragm. This ensures exact positioning of the aperture relative to the lens.
• the entire optical module is a multi-component injection molded part.
• the multicomponent 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 preferably permeable to light in a wavelength range of 200 to 1700 nm, more preferably in a wavelength range of 600 to 950 nm, wherein the opaque plastic component is preferably substantially impermeable to light in this wavelength range.
• the lens integrated in the multi-component injection-molded part preferably consists of the translucent plastic.
• a region of the multi-component injection-molded part made of the translucent plastic is shaped so that it assumes the function of an optical lens.
• an opaque plastic may be used for portions of the multi-component injection molded part that perform the function of a visor body.
• the translucent plastic component may, for example, at least one plastic selected from the group of acrylonitrile-butadiene-styrene polymers (AB S), methyl methacrylate-acrylonitrile-butadiene-styrene copolymers (MABS), polycarbonate (PC), polycarbonate blends (PCB), Polysulfone (PSU), polyethersulfone (PES).
• the opaque plastic component preferably contains at least one plastic selected from the group acrylonitrile-butadiene-styrene polymers (ABS), polycarbonate blends (PCB) and polyethersulfone (PES).
• the diaphragm comprises a diaphragm body of an opaque plastic and an aperture, wherein the aperture is filled with a translucent plastic.
• the aperture is thus closed with a protective window made of translucent plastic, which prevents contamination through the aperture.
• the lens and the diaphragm opening filled with the translucent plastic are particularly preferably combined in a coherent region. They are made of the translucent plastic and are summarized in the multi-component injection molded part. This simplifies the injection molding process and the optical module and ensures a well-defined positioning of the aperture (or of the window) relative to the lens.
• the diaphragm in the optical module of the analysis system according to the invention may also include a diaphragm body made of an opaque plastic and an aperture, wherein the aperture is a recess in the diaphragm body.
• the recess is not filled with material. As a result, less light is absorbed when crossing the aperture than when the aperture is filled with a material.
• the measurement module contains the optical module, wherein the optical module is used for performing optical measurements on the sample on the analytical test element.
• the optical module is used for performing optical measurements on the sample on the analytical test element.
• it is a measuring module provided for photometric measurements on the sample (for example a body fluid of humans or animals), which is designed to determine the concentration of an analyte (for example glucose) in the sample.
• the optical module is composed of two plastic parts, the one of which a diaphragm with plastic windows as aperture and the other contains a lens.
• the parts have a small size (14.5 x 7.5 x 21 mm or 0.7 x 4 x 6 mm).
• the task of the measuring module in this analysis system of the prior art is to position a test element for performing measurements and to direct light rays to it with the aid of the optical module in order to optically
• the two plastic parts of the optics module are included This analysis system connected by ultrasonic welding together. This results from the joining of the two parts high costs. Due to the small size of the parts handling is very complicated. The welding requires an additional operation, which is carried out with great effort. Additional tolerances by two parts can not be avoided. The position of the aperture is also determined by their manufacturing tolerances.
• the measuring module contains an optical module in which at least one lens and at least one diaphragm are combined in one piece in a multi-component injection-molded part. It is particularly preferred that the entire optical module contained in the measuring module is a two-component injection-molded part, in which at least one lens and at least one aperture are contained.
• a big advantage lies in the fact that the complete optics module can be injected in one go. For this purpose, if necessary, the optical beam path must be recalculated and it may be necessary to design the optical components contained in the optical module differently.
• the measurement module comprises a light source, a detector and a test element receptacle, which are arranged such that light from the light source passes through a light-transmissive region of the multicomponent injection-molded part to a test element arranged in the test element receptacle and reflects from the test element through the light-permeable region can get to the detector.
• the light source is, for example, a light-emitting diode (LED).
• the detector is for example a photodiode.
• the Testelementaufhahme serves to receive a test element, in particular during the performance of the measurements with the optical module.
• test element in the test element receptacle is positioned so that the light from the light source is directed across the translucent region of the multicomponent injection molding onto a test field containing the sample and reagents on the test element.
• a portion of the light striking the test element is reflected thereon so that it passes through the transparent area of the multicomponent injection-molded part to the detector.
• the measurement module comprises a light source, a detector and a test element receptacle, which thus are arranged so that light from the light source through a light-transmissive region of the multi-component injection molded part can reach a arranged in the test element receiving test element and transmitted through this to the detector.
• the analysis system includes a read module for reading optically encoded data, the read module containing the or another optical module.
• Analysis systems are known in the prior art which contain a storage container (magazine) with a multiplicity of test elements.
• a test element is transported, for example with a slide or pestle from the magazine to the place of measurement in the measuring module and automatically ejected from the analysis system after the measurement is carried out or remagazine in the magazine.
• a storage container magazine
• a test element is transported, for example with a slide or pestle from the magazine to the place of measurement in the measuring module and automatically ejected from the analysis system after the measurement is carried out or remagazine in the magazine.
• Al a device for removing an analytical consumable, in particular a test element, from a storage container known having one or more chambers containing the consumables.
• the chambers each have one
• the Ent.ffhung and the Einschuböffhung are closed for storage of the consumable with a foil.
• the device comprises a plunger, which can be moved by a drive unit to remove a consumable.
• the AKKU CHEK ® -Compact analyzer contains a reader module (with a barcode reader) that can read a barcode on the outer surface of a drum-shaped test element magazine inserted in the analysis system.
• the barcode contains, for example, information about the test elements contained in the magazine, which are relevant for the evaluation of the data measured by the measuring module and are taken into account.
• the read module includes two individual plastic injection molded parts and a board, which are assembled in the manufacture of the reading module.
• One injection-molded part contains a diaphragm and the other contains a lens arrangement. The board and the two injection molded parts are connected together in a complicated bonding process.
• the joining is possible only with great effort, inter alia, due to the tolerances of the injection molded.
• the handling is problematic because of the small size of the parts. Due to the many individual parts creates a great overall tolerance of the optics module.
• the two injection molded parts are combined in one piece in a preferred embodiment of the present invention in a multi-component injection molded part.
• aperture and lens arrangement can be produced with exact position relative to one another and the stated disadvantages can be avoided.
• the board of the reading module can be subsequently attached to the multi-component injection-molded part.
• the board carries, for example, a detector (for example a photodiode) and a light source (for example an LED).
• the reading module comprises a light source, a detector and a magazine receptacle, which are arranged such that light from the light source passes through a transparent area of the multicomponent injection-molded part to a test element magazine accommodated in the magazine receptacle and reflected by the test element. Magazine can pass through the translucent area to the detector.
• the board which preferably supports the detector and the light source, is preferably positioned relative to the multi-component injection molded part by means of recessed pins and then connected thereto by, for example, gluing, ultrasonic welding or hot caulking.
• the multi-component injection-molded part has recesses and / or pins and the board matching pins and / or recesses.
• the invention further relates to a method for producing an analysis system for analyzing a sample on an analytical test element, the analysis system comprising a measurement module and an optical module, the optical module comprising a lens and a diaphragm, characterized by the following steps:
• FIG. 1 shows a section through an optical module, in a measuring module of a
• FIG. 2 a section through an optical module which is contained in a measuring module of an analysis system according to the invention
• FIG. 3 shows a section through a measuring module of an analysis system according to the invention with a test element
• FIG. 4 shows the beam path in the measuring module according to FIG. 3,
• FIG. 5 schematically shows a comparison of components of a reading module in a prior art analysis system and in an analysis system according to the invention
• FIG. 6 schematically shows a reading module in an analysis system according to the invention
• FIG. 7 shows the beam path in the reading module from FIG. 6,
• Figure 9 mounting variants for the board on the multi-component injection molded part.
• FIG. 1 shows a section through an optical module which is contained in a measuring module of a prior art analysis system.
• the optical module 1 comprises a lens 2 and a diaphragm 3, which contains a diaphragm body 4 and a diaphragm opening 5.
• the 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 main body 7.
• the skirt 8 of the lens 2 serves as another aperture.
• In the optical module main body 7 are a large cavity 9 and a small cavity 10. Light rays from a (not shown) light source can from the small cavity 10 through the lens 2, through the large cavity 9 and through the aperture 5 closing translucent window.
• FIG. 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 a two-component injection-molded part which integrally combines the diaphragm 3 (including the diaphragm body 4 and the window 6 serving as diaphragm aperture 5), the lens 2 and the optical module main body 7.
• the optical module main body 7, the diaphragm body 4 and the skirt 8 of the lens 2 are injection-molded from an opaque plastic.
• Aperture 5 are summarized in a continuous region 12 made of a translucent plastic in the two-component injection-molded part.
• FIG. 3 shows a section through a measuring module of an analysis system according to the invention with a test element.
• the optical module 1 comprises the optical module main body 7, the lens 2, the diaphragm 3, the surround 8 of the lens 2, the cavities 9, 10 and a test element holder 15.
• the optical module 1 is a two-component injection molded part with a first, translucent plastic component (area 12) and a second, opaque plastic component.
• the test element holder 15 is a strip-shaped analytical test element 16, the test field 17, in which a sample to be analyzed is located above the window 6.
• On the board 14 are a detector 18 and a light source 19, which protrude into the large cavity 9 and into the small cavity 10.
• the circuit board 14 is glued to the two-component injection-molded part, for example.
• FIG. 4 shows the beam path in the measuring module according to FIG. 3.
• the light source 19 emits light for the photometric analysis of a sample on the test field 17 of the test element 16 passing through the transmissive area
• the test element 12 is focused on the test element 17. Depending on its optical properties (for example its coloration), a portion of the light is reflected on the test field 17 and falls through the region 12 back into the large cavity 9 on the
• Detector 18 from whose signal the concentration of an analyte in the sample can be determined (for example, in an evaluation module, not shown, of the analysis system according to the invention).
• FIG. 5 schematically shows a comparison of components of a read module in an analysis device from the prior art and in an analysis system according to the invention.
• a reading module comprises a circuit board 20, a diaphragm 21 and a lens arrangement 22 with at least one lens, these being manufactured as three separate components and subsequently joined together.
• the lens arrangement 22 and the diaphragm 21 are integrally combined in a multi-component injection-molded part 23.
• the multi-component injection-molded part is joined to the board 20.
• FIG. 6 schematically shows a reading module in an analysis system according to the invention.
• the read module 24 contains inter alia an optical module 25 and a circuit board 20.
• 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 made of a first, translucent component (translucent area 38) and the aperture 21 of a second, opaque component injected.
• the circuit board 20 is connected to the optical module, for example via an adhesive connection. It carries a light source 28 and a (not shown) detector, which protrude into cavities 29 of the optical module 25.
• the board is attached to an analysis system board 30.
• FIG. 6 also shows a drum-shaped test element magazine 31, which serves to store a multiplicity of test elements.
• the magazine 31 On its lateral surface 32, the magazine 31 has a bar code 33, which the reading module 24 can read.
• the magazine 31 is located in a magazine receptacle in the reading module 24, whereby it is positioned relative to the optical module 25 for reading the bar code 33.
• FIG. 7 shows the beam path in the read module from FIG. 6.
• the analysis system board 30, the board 20 and the optical module 25 are shown separately.
• the beam path 37 is indicated by arrows.
• Light from a light source 28 propagates through the first cavity 34, the aperture 21, and the translucent area 38 including the first lens 26 toward the bar code 33, is reflected therefrom and reaches the translucent area 38 with the second lens 27, the aperture 21 and the second cavity 35 the detector 36th
• Figure 8 demonstrates how the circuit board can be interconnected with the multi-component injection molded part in an analytical system according to the invention.
• the board 20 has two pins 39, which can engage in openings provided for this purpose (bore 40 in slot 41) in the multi-component injection-molded part 23.
• the light source 28 and the detector 36 are positioned so 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 those skilled in the art.
• the multi-component injection-molded part 23 is, for example, the optical module of a reading module.
• FIG. 9 shows various fastening variants a) to c) for the printed circuit board.
• the board 20 has two pins 39, which are arranged offset to one another.
• Variant b) corresponds to the variant shown in Figure 8 with two lying on a central line pins 39 which engage in a bore 40 and in a milled slot 41.
• the two pins 39 lie on a common lateral line and on a line in extension to the light source 28 and to the detector 36, respectively.

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• 2005
  • 2005-06-22 EP EP05013452A patent/EP1736774B1/de not_active Expired - Lifetime
  • 2005-06-22 ES ES05013452T patent/ES2299920T3/es not_active Expired - Lifetime
  • 2005-06-22 DE DE502005002762T patent/DE502005002762D1/de not_active Expired - Lifetime
  • 2005-06-22 AT AT05013452T patent/ATE385571T1/de active
• 2006
  • 2006-06-13 WO PCT/EP2006/063145 patent/WO2006136512A2/de not_active Ceased
  • 2006-06-13 CA CA2611921A patent/CA2611921C/en not_active Expired - Fee Related
  • 2006-06-13 JP JP2008517462A patent/JP4804535B2/ja not_active Expired - Fee Related
  • 2006-06-13 CN CN200680022146.XA patent/CN101203755B/zh active Active
• 2007
  • 2007-12-22 US US11/963,801 patent/US7808645B2/en active Active

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