Measurement system with distributed functions

• US 8,603,394 B2
• Filed: 05/02/2008
• Issued: 12/10/2013
• Est. Priority Date: 05/04/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim, Thoes, Bruno, Scherer, Joerg, Werner, Karl, Zimmer, Volker
• Primary Examiner(s): MERKLING, SALLY ANNE
• Application Number:
  US12/114,266
• Publication Number:
  US 20090022630A1
• Time in Patent Office: 2,048 Days
• Field of Search: None
• US Class Current: 422/68.1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

An analysis system is provided which comprises an integrated analysis device and a test strip magazine, for determining an analyte in a body fluid, wherein the analysis system comprises a first group comprising reusable components and a second group of components comprising a plurality of disposable articles. The second group includes non-electronic and electronic components, with critical interfaces configured between two or more such components, wherein non-electronic components can be disconnected from electronic components at a disconnection point. In one embodiment, critical interfaces are produced and tested during production of the analysis system.

Claims

1. An integrated analysis system for determining an analyte in a body fluid, the system comprising:

an analysis device including a device housing, a display, a display controller connected to the display operable to control the display, and calculation electronics connected to the display controller operable to calculate data displayed on the display;

a measurement unit for storing and evaluating test elements, the measurement unit including;

a magazine with a housing storing a plurality of test elements;

a measurement peripheral with measurement electronics configured to evaluate one or more test elements in the measurement unit that are wetted with the body fluid and an interface connected to the measurement electronics, the measurement peripheral being removably fitted to the housing of the magazine with the interface positioned relative to the magazine in order to facilitate connection with the analysis device; and

wherein the interface is configured to removably mechanically couple the magazine to the analysis device.

2. The analysis system according to claim 1, wherein the measurement peripheral includes at least one coding means integrated with the measurement electronics.

3. The analysis system according to claim 2, wherein the at least one coding means comprises an electronic memory chip.

4. The analysis system according to claim 1, wherein the measurement unit further comprises at least one energy store, wherein during production of the analysis system at least one critical interface is provided and tested between one or more pairings selected from the group consisting of the test element magazine and the measurement peripheral, the measurement peripheral and the measurement electronics, and the measurement electronics and the at least one energy store.

5. The analysis system according to claim 1, wherein the measurement electronics and the measurement peripheral can be fitted with a new, unused, magazine of test elements.

6. The analysis system according to claim 1, wherein the measurement peripheral comprises an optical evaluation system for optical evaluation of test elements which are stored in the magazine.

7. The analysis system according to claim 1, wherein the measurement peripheral comprises an electrochemical evaluation system for electrochemical evaluation of test elements which are stored in the magazine.

8. The analysis system according to claim 1, wherein the fitting of the test element magazine and the measurement peripheral is connected during production of the analysis system.

9. The analysis system according to claim 1, wherein the analysis system comprises at least one energy store included in the measurement unit.

10. The analysis system according to claim 1, wherein the analysis system comprises at least one energy store included in the analysis device.

11. The analysis system according to claim 1, wherein the measurement peripheral includes at least one circuit board including a serial interface, wherein the analysis device is configured to be plugged on to the serial interface to receive data relating a glucose measurement.

12. The analysis system according to claim 1, wherein the measurement peripheral includes at least one moisture sensor configured to measure a moisture content in a chamber of the magazine and at least one processor configured to determine at least one of a quality and a useful life of the test elements stored in the magazine based on the moisture content.

13. The analysis system according to claim 1, wherein the measurement unit includes an energy store that is detachably connected to the magazine, wherein the connection of the magazine to the measurement peripheral makes an electrical connection between the energy store and the measurement electronics.

14. The analysis system according to claim 1, wherein the measurement peripheral is operable to evaluate a selected test element from the magazine for at least one analyte in the body fluid sample applied to the test element.

15. The analysis system according to claim 1, wherein the measurement electronics include a circuit board and the interface is a serial interface connected to the circuit board configured to transmit signals from the measurement electronics to the calculation electronics of the analysis device.

16. The analysis system according to claim 1, wherein the analysis device is configured to be plugged onto the interface of the measurement unit.

17. The analysis system according to claim 1, wherein the analysis device includes a drive for driving test elements from the magazine.