Analytical Test Element With Wireless Data Transmission

• US 20070237678A1
• Filed: 04/09/2007
• Published: 10/11/2007
• Est. Priority Date: 10/07/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Seidenstricker, Manfred, Roesicke, Bernd
• Granted Patent: US 7,988,917 B2
• Time in Patent Office: Days
• US Class Current: 422/82.10
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/0228 using calibration standards
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape

Abstract

The present invention concerns embodiments of a system for determining the concentration of an analyte in a body fluid which comprises an analytical test element and an instrument separate therefrom, wherein at least a part of the electrical components of the system are comprised of polymer electronics. Embodiments of the analytical test element comprise an area with reagent chemistry for the detection of an analyte and a transponder configured for wireless transmission of lot-specific data and/or measured values. The instrument has a reading module configured for wireless transmission of data, or data and energy, to the test element and an evaluation unit for evaluating the data or measured values received by the transponder.

Claims

1. A system for determining the concentration of an analyte in a body fluid comprising:

an analytical test element having an area with reagent chemistry for detecting the analyte in a body fluid;

an instrument separate from said analytical test element, said instrument comprising an evaluation unit for evaluating data

wherein said analytical test element comprises electrical components at least in part comprising polymer electronics.

2. A system according to claim 1, wherein

the analytical test element has a transmitting module configured for wireless transmission of data;

and

the instrument has a reading module configured for wireless transmission of data.

3. A system according to one of the claim 1, wherein

the analytical test element has a memory for storing data.

4. A system according to claim 1, wherein the analytical test element further comprises a transmitting module configured for wireless transmission of data and energy, and the instrument comprises a reading module configured for wireless transmission of data and energy.

5. A system according to claim 1, wherein the electronic circuit on the analytical test element comprises at least two electrodes in contact with the reagent chemistry and a plurality of galvanically separated electronic circuits and a plurality of parallel transmitting modules configured for wireless transmission of data or data and energy, the instrument further comprising a plurality of parallel reading modules configured for wireless transmission of data or data and energy.

6. A system according to claim 2, wherein data which are transmitted in a wireless manner between the transmitting module on the analytical test element and the reading module on the instrument at least partially comprise analog data.

7. A system according to claim 1, wherein the analytical test element further comprises a memory for storing data, wherein the memory is writable when the analytical test element is located in a package.

8. A system according to claim 1, wherein a transmitting module and a reading module are located on the analytical test element and data or data and energy are transmitted in a wireless manner within the analytical test element between the modules.

9. A system according to claim 1, wherein the instrument comprises a holder for positioning the analytical test element.

10. A system for determining the concentration of an analyte in a body fluid comprising

one or more analytical test elements which have an area with reagent chemistry for detecting the analyte in a body fluid,

an instrument separate from the one or more analytical test elements, the instrument having an evaluation unit for evaluating data and a reading module configured for wireless transmission of data, and

a package in which the one or more of the analytical test elements are packaged, the package having electrical components comprising a memory for storing data and a transmitting module configured for wireless transmission of data,

wherein at least a part of the electrical components of the package comprise polymer electronics.

11. A system according to claim 10, wherein the instrument comprises a holder for positioning the package.

12. An analytical test element for determining the concentration of an analyte in a body fluid which has an area with reagent chemistry for detecting the analyte in a body fluid and one or more electrical components, wherein at least a part of the one or more electrical components of the analytical test element comprise polymer electronics.

13. An analytical test element according to claim 12, wherein the analytical test element comprises a transmitting module configured for wireless transmission of data.

14. A package in which one or more analytical test elements are packaged, the package having a memory for storing data and a transmitting module configured for wireless transmission of data.

15. A process for producing an analytical test element which has an area with reagent chemistry for detecting an analyte in a body fluid, a memory for storing data and a transmitting module for the wireless transmission of data, wherein the production comprises the steps of:

packaging the analytical test element, and

storing calibration data on the packaged analytical test element.

16. A process for producing an analytical test element according to claim 15, further comprising the step of:

storing a lot identification on the analytical test element prior to the packaging step.

17. A process for producing an analytical test element which has an area with reagent chemistry for detecting an analyte in a body fluid wherein the production comprises the steps of:

packaging the analytical test element in the package, and

storing calibration data on the package.

18. A process for producing an analytical test element according to claim 17, further comprising the step of storing a lot identification on a package which has a memory for storing data and a transmitting module for the wireless transmission of data, said storing step being performed before said packaging step.

19. A method for determining the concentration of an analyte in a body fluid comprising the steps:

placing a transmitting module of an analytical test element in a transmitting and receiving range of a reading module of an instrument, wherein

the analytical test element has an area with reagent chemistry for detecting an analyte in a body fluid, a memory for storing data and a transmitting module configured for wireless transmission of the data, and the instrument has an evaluation unit for evaluating the data and a reading module configured for wireless transmission of the data,

applying the body fluid to the analytical test element,

wirelessly transmitting the data from the analytical test element to the instrument, and

evaluating the data in the evaluation unit of the instrument.

20. A method according to claim 19, wherein the analytical test element is placed or inserted in the instrument, wherein the transmitting module of the analytical test element is moved into range for transmitting and receiving for the reading module of the instrument.

21. A method for determining the concentration of an analyte in a body fluid comprising the steps of:

placing a transmitting module of a package in which one or more analytical test elements with reagent chemistry for detecting an analyte in a body fluid are packaged in a transmitting and receiving range of a reading module of an instrument,

wherein

the package has a memory for storing data and a transmitting module configured for wireless transmission of the data and the instrument has an evaluation unit for evaluating the data and a reading module configured for wireless transmission of the data

providing an analytical test element from the package

applying the body fluid to the analytical test element

wirelessly transmitting the data front the package to the instrument and

evaluating the data in the evaluation unit of the instrument.

22. A method according to claim 21, wherein the package is placed or inserted into the instrument, wherein the transmitting module of the package is moved into range for transmitting and receiving for the reading module of the instrument.