Measuring apparatus used for determining an analyte in a liquid sample, comprising polymer electronic components

• US 7,641,857 B2
• Filed: 11/14/2003
• Issued: 01/05/2010
• Est. Priority Date: 11/14/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: PolyIC GmbH & Co. KG (Leonhard KURZ Stiftung & Company KG)
• Inventors: Rosicke, Bernd, Gerlt, Axel, Clemens, Wolfgang
• Primary Examiner(s): Soohoo; Tony G
• Assistant Examiner(s): Eom; Robert
• Application Number:
  US10/534,678
• Publication Number:
  US 20060121625A1
• Time in Patent Office: 2,244 Days
• Field of Search: 436/169, 436/69, 436/86, 436/170, 422/63, 422/82.02, 422/82.05, 422/50, 422/55, 422/56
• US Class Current: 422/82.01
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply

Abstract

A measuring apparatus for determining an analyte in a liquid sample includes the following apparatus components: a test element with a test field for applying the liquid sample, the test element experiencing a detectable modification due to the analyte to be determined, a detector which detects the modification and generates an electrical detector signal as a function of it, an evaluation circuit arranged downstream of the detector, which evaluates the detector signal to form a measurement result, a display device connected to the evaluation circuit for displaying the measurement result, and an electrical power supply for supplying electrical power to the electrical apparatus components. At least some of the electrical apparatus components are formed on the basis of polymer electronics so that the analyte can be determined straightforwardly, conveniently and inexpensively.

Claims

1. A disposable one piece measuring apparatus for determining an analyte in a liquid sample comprising:

a one piece substrate; and

on the substrate;

a plurality of test elements;

a plurality of test fields each corresponding to a different test element for applying the liquid sample to the different test element, the different test elements each experiencing a detectable modification due to the analyte to be determined in response to the applied sample; and

a plurality of electrical components comprising;

a detector which corresponds to each test field and test element and detects the modification and generates an electrical detector signal as a function of the detected modification;

an evaluation circuit coupled to the detector to evaluate the detector signal and generate a measurement result;

a display device connected to the evaluation circuit for displaying the measurement result; and

an electrical power supply for supplying electrical power to the electrical components comprising the detector, evaluation circuit, and display device wherein at least a majority of the electrical components are formed on the basis of polymer electronics;

wherein the test fields are arranged at an edge region of the substrate in zones separated from one another by break lines and in that each zone is arranged to be broken off from the substrate at the break lines after the test field lying in it has been used.

2. The measuring apparatus as claimed in claim 1 wherein the electrical components further comprise a controller which controls the determination of the analyte in a measurement process.

3. The measuring apparatus as claimed in claim 1 wherein the electrical components include a controller which controls the determination of the analyte wherein the controller includes an arrangement for activating the measurement process, which arrangement responds to at least one of the following events:

an operating element on the measuring apparatus is actuated, a cover on the measuring apparatus is removed, and the liquid sample is applied onto the test field.

4. The measuring apparatus as claimed in claim 1 wherein the electrical components include a controller which controls the determination of the analyte wherein the controller includes an arrangement for preventing further measurement processes with the same test element.

5. The measuring apparatus as claimed in claim 1 wherein the electrical components include a controller which controls the determination of the analyte wherein the display device and controller are arranged to display that the measuring apparatus is unusable.

6. The measuring apparatus as claimed in claim 1 wherein the evaluation circuit includes a calibration data memory with calibration data for correcting the measurement results to be displayed.

7. The measuring apparatus as claimed in claim 1 wherein a pricking aid is coupled to the test field to obtain blood as the liquid sample.

8. The measuring apparatus as claimed in claim 1 wherein the detector comprises a plurality of detectors each corresponding to a different test field and that are connected via a selection circuit to the evaluation circuit and in that the selection circuit always selects only one of the detectors at a time and joins the selected one detector only for single use to the selection circuit and subsequently selects an as yet unused detector after the measurement has taken place.

9. The measuring apparatus as claimed in claim 8 wherein the substrate comprises a flat support.

10. The measuring apparatus as claimed in claim 9 wherein the detectors joined to the selection circuit are arranged in the regions of the break lines and in that the selection circuit detects zones having been broken off.

11. The measuring apparatus as claimed in claim 1 wherein the test fields are respectively covered with a corresponding cover to be removed before use, in that the detectors joined to a selection circuit are arranged in the regions of the covers and in that the selection circuit detects that the corresponding covers have been removed.

12. The measuring apparatus as claimed in claim 1 wherein the test fields are arranged in the zones so that they are respectively covered by a neighboring zone and are accessible only after this neighboring zone has been broken off.

15. The measuring apparatus of any one of claims 1, 13, or 14 wherein the detectors are connected via a selection circuit to the evaluation circuit such that the selection circuit always selects only one of the detectors and joins the selected one detectors only for single use to the selection circuit and subsequently selects an as yet unused detector after the measurement has taken place.

16. The measuring apparatus as claimed in claim 15 wherein the selection circuit is arranged to drive the display device, so that the display device displays the test field assigned to a currently usable detector, and wherein the test elements and the test fields are mounted on the substrate by break lines for selective separation of the corresponding test field from the substrate.

13. A disposable one piece measuring apparatus for determining an analyte in a liquid sample comprising:

a substrate;

and on the substrate;

a plurality of test elements each with a corresponding test field for applying the liquid sample to the corresponding test element, the test elements each experiencing a detectable modification due to the analyte to be determined; and

a plurality of electrical components comprising;

a detector corresponding to each test element and its corresponding test field, which detector detects the modification and generates an electrical detector signal as a function of the detected modification on the corresponding test element;

an evaluation circuit coupled to the detector to evaluate the detector signal and generate a measurement result;

a display device connected to the evaluation circuit for displaying the measurement result;

a controller which controls the determination of the analyte; and

an electrical power supply for supplying electrical power to the electrical components comprising the tester, detector, evaluation circuit, controller and display device such that at least a majority of the electrical components are formed on the basis of polymer electronics;

the test fields being arranged at an edge region of the substrate in zones separated from one another by break lines and in that each zone is arranged to be broken off from the substrate at the break lines after the test field lying in it has been used.

14. A disposable one piece measuring apparatus for determining an analyte in a liquid sample comprising:

a substrate;

and on the substrate;

a plurality of test elements each with a corresponding test field for applying the liquid sample to the corresponding test element for determination of the analyte, the test elements each experiencing a detectable modification due to the analyte to be determined; and

a plurality of electrical components comprising;

a detector corresponding to each test element and its corresponding test field, which detector detects the modification and generates an electrical detector signal as a function of the detected modification on the corresponding test element;

an evaluation circuit coupled to the detector to evaluate the detector signal and generate a measurement result;

a display device connected to the evaluation circuit for displaying the measurement result;

a controller which controls the determination of the analyte; and

an electrical power supply for supplying electrical power to the electrical components comprising the tester, detector, evaluation circuit, controller and display device such that at least a majority of the electrical components are formed on the basis of polymer electronics;

wherein the test fields are located in zones which are individually removable from the substrate and arranged so that they are each respectively covered by a neighboring zone and are accessible for only after the neighboring zone has been removed.

17. A disposable one piece measuring apparatus for determining an analyte in a liquid sample comprising:

a one piece substrate; and

on the substrate;

a plurality of test elements;

a plurality of test fields each corresponding to a different test element for applying the liquid sample to the different test element, the different test elements each experiencing a detectable modification due to the analyte to be determined in response to the applied sample; and

a plurality of electrical components comprising;

a detector which corresponds to each test field and test element and detects the modification and generates an electrical detector signal as a function of the detected modification;

an evaluation circuit coupled to the detector to evaluate the detector signal and generate a measurement result;

a display device connected to the evaluation circuit for displaying the measurement result; and

an electrical power supply for supplying electrical power to the electrical components comprising the detector, evaluation circuit, and display device wherein at least a majority of the electrical components are formed on the basis of polymer electronics;

wherein the test fields are located in zones which are individually removable from the substrate and arranged so that they are each respectively covered by a neighboring zone and are accessible only after the neighboring zone has been removed.