WO2010091793A2 - Dispositif de mesure d'analytes avec un arrière-plan de codage sur bandelette - Google Patents

Dispositif de mesure d'analytes avec un arrière-plan de codage sur bandelette Download PDF

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Publication number
WO2010091793A2
WO2010091793A2 PCT/EP2010/000539 EP2010000539W WO2010091793A2 WO 2010091793 A2 WO2010091793 A2 WO 2010091793A2 EP 2010000539 W EP2010000539 W EP 2010000539W WO 2010091793 A2 WO2010091793 A2 WO 2010091793A2
Authority
WO
WIPO (PCT)
Prior art keywords
connector pads
strip
glucose
glucose strip
bridged
Prior art date
Application number
PCT/EP2010/000539
Other languages
English (en)
Other versions
WO2010091793A3 (fr
Inventor
Georg Reith
Robert Bartetzko
Norbert Bartetzko
Bernfried Specht
Original Assignee
Pelikan Technologies Gmbh & Co. Kg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pelikan Technologies Gmbh & Co. Kg filed Critical Pelikan Technologies Gmbh & Co. Kg
Publication of WO2010091793A2 publication Critical patent/WO2010091793A2/fr
Publication of WO2010091793A3 publication Critical patent/WO2010091793A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48771—Coding of information, e.g. calibration data, lot number
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
    • A61B2562/085—Sensors provided with means for identification, e.g. barcodes or memory chips combined with means for recording calibration data
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099—Characterised by type of test elements
    • G01N2035/00108—Test strips, e.g. paper
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G01N2035/00821—Identification of carriers, materials or components in automatic analysers nature of coded information
    • G01N2035/00851—Identification of carriers, materials or components in automatic analysers nature of coded information process control parameters

Definitions

  • This invention relates generally to for blood glucose monitoring systems, and more particularly to blood glucose monitoring systems with strips that have No-Coding.
  • Test strips are know in the medical health-care products industry for analyzing analyte levels such as but not limited to, glucose levels in blood.
  • a drop of blood is typically obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin.
  • a test strip is brought by the user to the blood droplet at the wound and engaged in a manner to bring blood to an analysis site on the test strip.
  • the test strip is then coupled to a metering device which typically uses an electrochemical technique to determine the amount of glucose in the blood.
  • a metering device typically uses an electrochemical technique to determine the amount of glucose in the blood.
  • Early methods of using test required a relatively substantial volume of blood to obtain an accurate glucose measurement. This large blood requirement made the monitoring experience a painful one for user since the user may need to lance deeper than comfortable to obtain sufficient blood generation.
  • Non-coding means that the diabetic patient does not need to perform any steps for coding the system. This reduces the chance of mixing up of different test strip lots (e.g. transponder). This can be realized by a very stable manufacturing process leading to strip lots describable with one single calibration code. This can be implemented in the meter software and recognizing a communication between the strip and the meter.
  • An object of the present invention is to provide a blood glucose monitoring system that covers a broad range of response curves and provides a possibility to increase the yield of strip lots with master calibration curves has been developed.
  • a glucose strip in one embodiment, has a three-electrode configuration for the electrochemical detection of glucose.
  • the glucose strip has three electrodes at the top and three connector pads at the bottom. These three connector pads ensure the contact between meter and glucose strip and are necessary for the electrochemical detection of the glucose, "conventional connector pads”. With the present invention of "On-Strip Coding" the glucose strip has three additional connector pads. These three additional connections between the meter and glucose strip enables the transfer of the information.
  • a blood glucose monitoring system that has No-Coding. This provides an improvement in view of avoiding any mistakes by the end-user to do a wrong calibration of the test strips.
  • On-Strip Coding is provided for to eight master calibration curves.
  • the glucose strip can be produced by using screen-printing technology.
  • the manufacturing process for the glucose strip of the present invention involves seven printing steps. A "semi-finished product' is created that comprises the first three printing steps. This semi-finished product can be stored for several weeks.
  • the glucose strip has a three-electrode configuration for the electrochemical detection of the glucose.
  • the glucose strip has three electrodes at the top and three connector pads at the bottom. These three connector pads ensure the contact between meter and glucose strip and are necessary for the electrochemical detection of the glucose, later called “conventional connector pads”. "With the present invention of On-Strip Coding", the glucose strip has three additional connector pads. These three additional connections are between the meter and the glucose strip. The three additional connections enable the transfer of the information.
  • two methods can be used to integrate the information onto the glucose strip.
  • three additional connector pads are together with three conventional connector pads by using a screen-printing technique.
  • one class of semi-finished product is printed with a following process step, including but not limited to laser, for the generation of the different classes. Eight different semi-finished products are printed that carry the information.
  • a foil is laminated that carries the information.
  • the meter has to be change as well. These changes depend on the strategy for the realization of the manufacturing process for the three additional connector pads with either the method of, screen- printing or lamination.
  • Figure 1 illustrates an overlay-plot of the response curves from fifteen sensor lots is shown. These sensor lots can be described with two calibration codes.
  • the first set consists of seven lots illustrated in Figure 2 (a) that can be described with the master calibration curve 1 shown in Figure 2 (C).
  • the second set consists of seven lots, as illustrated in Figure 2 (b) and can be described with the master calibration curve 2 in Figure 2 (c) in context to the calibration methodology of the present invention.
  • FIG 3 illustrates the principle design of the glucose strip of the present invention for On-Strip Coding and figure 4 show the eight combinations.
  • the additional three connector pads and the three conventional connector pads are printed as one structure. A laser or other device is then used to remove carbon particles to generate the pattern specific for the glucose strip lot.
  • Figure 5 illustrates principle of creating a specific semi-finished product using a process step that include the use of a laser or other device.
  • the additional connector pads and conductive lines are printed together with the conventional conductive layer, in this case, eight different screens have to be available for the manufacturing of the eight different conductive layers, including connector pads.
  • the following printing steps are the same.
  • up to eight different semi-finished products are produced and stored on stock.
  • the meter has to be changed with regard to the connector and the electronic circuit, both hardware and software.
  • Figure 6 illustrates the electronic hardware without the method of present invention.
  • Figure 7 illustrates the electronic circuit of the present invention without the unit for the detection of the strip-class is shown.
  • Figure 7 an additional electronic circuit is needed for the identification of the class of the glucose strip.
  • Figure 8 illustrates the principle of the electronic circuit of the binary converter with the input and output leads.
  • Figure 9 illustrates the design of the glucose strip for On-Strip Coding using the lamination method of the present invention.
  • Figure 10 illustrates an overview of the five combinations.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente invention a pour objet un système constitué de plots de connexion situés sur une bandelette de détection du glucose et reliés à une borne d'entrée de données dans l'instrument, un motif de plots de connexion pontés sur une bandelette de détection du glucose, et un procédé de lecture des informations de code sur la bandelette de détection du glucose comprenant les étapes consistant : a) à insérer une bandelette de détection du glucose pourvue d'un motif spécifique au code de plots de connexion pontés; b) à appliquer une tension aux plots de connexion supplémentaires; c) à lire le signal sur des plots de connexion classiques; d) à traduire le signal en informations de code.
PCT/EP2010/000539 2009-01-30 2010-01-29 Dispositif de mesure d'analytes avec un arrière-plan de codage sur bandelette WO2010091793A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14877309P 2009-01-30 2009-01-30
US61/148,773 2009-01-30

Publications (2)

Publication Number Publication Date
WO2010091793A2 true WO2010091793A2 (fr) 2010-08-19
WO2010091793A3 WO2010091793A3 (fr) 2011-03-24

Family

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Family Applications (1)

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PCT/EP2010/000539 WO2010091793A2 (fr) 2009-01-30 2010-01-29 Dispositif de mesure d'analytes avec un arrière-plan de codage sur bandelette

Country Status (1)

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WO (1) WO2010091793A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2550917A1 (fr) * 2011-07-27 2013-01-30 Bioptik Technology, Inc. Détecteur multifonctionnel permettant l'identification automatique de modes de détection et spécimen de test utilisé dans celui-ci
WO2014096826A1 (fr) * 2012-12-20 2014-06-26 Lifescan Scotland Limited Connecteur électrique pour substrat présentant des pistes conductrices
WO2015070699A1 (fr) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Carte de bande de test marquée par des points quantiques
CN105181967A (zh) * 2015-07-16 2015-12-23 贾晓轻 血糖诊断测试盒以及测试方法
CN110988088A (zh) * 2014-03-07 2020-04-10 安晟信医疗科技控股公司 确定分析物浓度的测试传感器、方法、生物传感器及其系统

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6814844B2 (en) * 2001-08-29 2004-11-09 Roche Diagnostics Corporation Biosensor with code pattern
US7718439B2 (en) * 2003-06-20 2010-05-18 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
US7776559B2 (en) * 2004-01-22 2010-08-17 Hewlett-Packard Development Company, L.P. Disposable blood test device
US20080083618A1 (en) * 2006-09-05 2008-04-10 Neel Gary T System and Methods for Determining an Analyte Concentration Incorporating a Hematocrit Correction

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2550917A1 (fr) * 2011-07-27 2013-01-30 Bioptik Technology, Inc. Détecteur multifonctionnel permettant l'identification automatique de modes de détection et spécimen de test utilisé dans celui-ci
WO2014096826A1 (fr) * 2012-12-20 2014-06-26 Lifescan Scotland Limited Connecteur électrique pour substrat présentant des pistes conductrices
US8926369B2 (en) 2012-12-20 2015-01-06 Lifescan Scotland Limited Electrical connector for substrate having conductive tracks
CN105008921A (zh) * 2012-12-20 2015-10-28 生命扫描苏格兰有限公司 用于具有导电迹线的基板的电连接器
EP3620791A1 (fr) * 2012-12-20 2020-03-11 Lifescan Scotland Limited Connecteur électrique pour substrat disposant de pistes conductrices
WO2015070699A1 (fr) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Carte de bande de test marquée par des points quantiques
CN110988088A (zh) * 2014-03-07 2020-04-10 安晟信医疗科技控股公司 确定分析物浓度的测试传感器、方法、生物传感器及其系统
US20210164962A1 (en) * 2014-03-07 2021-06-03 Ascensia Diabetes Care Holdings Ag Biosensor calibration coding systems and methods
US11499960B2 (en) * 2014-03-07 2022-11-15 Ascensia Diabetes Care Holdings Ag Biosensor calibration coding systems and methods
CN110988088B (zh) * 2014-03-07 2023-01-03 安晟信医疗科技控股公司 确定分析物浓度的测试传感器、方法、生物传感器及其系统
CN105181967A (zh) * 2015-07-16 2015-12-23 贾晓轻 血糖诊断测试盒以及测试方法

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