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WO2010091793A2 - Analyte measurement device with on-strip coding background - Google Patents

Analyte measurement device with on-strip coding background 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
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.)
Ceased
Application number
PCT/EP2010/000539
Other languages
French (fr)
Other versions
WO2010091793A3 (en
Inventor
Georg Reith
Robert Bartetzko
Norbert Bartetzko
Bernfried Specht
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pelikan Technologies GmbH and Co KG
Original Assignee
Pelikan Technologies GmbH and 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 and Co KG filed Critical Pelikan Technologies GmbH and Co KG
Publication of WO2010091793A2 publication Critical patent/WO2010091793A2/en
Publication of WO2010091793A3 publication Critical patent/WO2010091793A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means 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.

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  • 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)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

The invention relates to a system comprising of connector pads on a glucose strip connected to a data input port in the instrument, a pattern of bridged connector pads on a glucose strip, and a read out process of the code information on the glucose strip: a) insert glucose strip with code specific pattern of bridged connector pads. b) Apply voltage to the additional connector pads. c) Read the signal on conventional connector pads. d) Translate the signal to code information.

Description

ANALYTE MEASUREMENT DEVICE WITH ON-STRIP CODING
BACKGROUND
Field of the Invention: This invention relates generally to for blood glucose monitoring systems, and more particularly to blood glucose monitoring systems with strips that have No-Coding.
Description of the Related Art:
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. For this type of analysis, 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. 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.
Alternatively, if insufficient blood is spontaneously generated, the user may need to "milk" the wound to squeeze enough blood to skin surface. Neither method is desirable as they take additional user effort and may be painful. The discomfort and inconvenience associated with such lancing events ma deter a user from testing their blood glucose levels in a rigorous manner sufficient to control their diabetes. A further impediment to patient compliance is the amount of time that it take for a glucose measurement to be completed. Know devices can take a substantial amount of time to arrive at a glucose level. The more time it takes to arrive at a measurement, the less the likely that the user will stay with their testing regime. Known glucose test strips also use traditional manufacturing techniques that make it challenging to create the structures that may be used in improved, low volume analyte testing devices.
Blood glucose monitoring systems currently available have coding and non-coding. 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.
Currently, the produced strip lots can be clustered into two different classes.
There is a need for blood glucose monitoring systems that cover a broader range of response curves and provide a possibility to increase the yield of strip lots with master calibration curves.
SUMMARY
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.
DETAILED DESCRIPTION
In one embodiment of the present invention, a glucose strip is provided that 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.
In on embodiment of the present invention, a blood glucose monitoring system is provided 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. With the present invention, On-Strip Coding is provided for to eight master calibration curves. In on embodiment of the present invention, 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.
In one embodiment of the present invention, 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.
With the present invention, two methods can be used to integrate the information onto the glucose strip. In the first method, three additional connector pads are together with three conventional connector pads by using a screen-printing technique. In this embodiment, 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. In a second embodiment, a foil is laminated that carries the information.
Additionally, 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.
By way of illustration, 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.
Figure 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. Thus, 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. In
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.

Claims

Claims
1. System comprising of connector pads on a glucose strip connected to a data input port in the instrument.
2. Pattern of bridged connector pads on a glucose strip.
3. Pattern of bridged connector pads on a glucose strip generated by laser structuring process.
4. Read out process of the code information on the glucose strip: a) insert glucose strip with code specific pattern of bridged connector pads. b) Apply voltage to the additional connector pads c) Read the signal on conventional connector pads d) Translate the signal to code information
5. Manufacturing of all connector pads and the conductive layer for the electrodes in the same manufacturing step
6. Information coded by conventional connector pads and additional connector pads.
PCT/EP2010/000539 2009-01-30 2010-01-29 Analyte measurement device with on-strip coding background Ceased WO2010091793A2 (en)

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 (en) 2010-08-19
WO2010091793A3 WO2010091793A3 (en) 2011-03-24

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PCT/EP2010/000539 Ceased WO2010091793A2 (en) 2009-01-30 2010-01-29 Analyte measurement device with on-strip coding background

Country Status (1)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2550917A1 (en) * 2011-07-27 2013-01-30 Bioptik Technology, Inc. Multifunctional detector providing automatic identification of detection modes and test specimen used thereof
WO2014096826A1 (en) * 2012-12-20 2014-06-26 Lifescan Scotland Limited Electrical connector for substrate having conductive tracks
WO2015070699A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
CN105181967A (en) * 2015-07-16 2015-12-23 贾晓轻 Blood glucose diagnostic test kit and test method
CN110988088A (en) * 2014-03-07 2020-04-10 安晟信医疗科技控股公司 Test sensor, method, biosensor and system for determining analyte concentration

Family Cites Families (4)

* Cited by examiner, † Cited by third party
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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 (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2550917A1 (en) * 2011-07-27 2013-01-30 Bioptik Technology, Inc. Multifunctional detector providing automatic identification of detection modes and test specimen used thereof
WO2014096826A1 (en) * 2012-12-20 2014-06-26 Lifescan Scotland Limited Electrical connector for substrate having conductive tracks
US8926369B2 (en) 2012-12-20 2015-01-06 Lifescan Scotland Limited Electrical connector for substrate having conductive tracks
CN105008921A (en) * 2012-12-20 2015-10-28 生命扫描苏格兰有限公司 Electrical connectors for substrates with conductive traces
EP3620791A1 (en) * 2012-12-20 2020-03-11 Lifescan Scotland Limited Electrical connector for substrate having conductive tracks
WO2015070699A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
CN110988088A (en) * 2014-03-07 2020-04-10 安晟信医疗科技控股公司 Test sensor, method, biosensor and system for determining analyte concentration
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 (en) * 2014-03-07 2023-01-03 安晟信医疗科技控股公司 Test sensor, method, biosensor and system for determining analyte concentration
CN105181967A (en) * 2015-07-16 2015-12-23 贾晓轻 Blood glucose diagnostic test kit and test method
CN105181967B (en) * 2015-07-16 2017-05-31 万言珍 Blood diagnostic test kit and test method

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