Analysis device with replaceable test field support

• US 8,398,845 B2
• Filed: 10/15/2007
• Issued: 03/19/2013
• Est. Priority Date: 04/14/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Marquant, Michael, Lungu, Mihail-Onoriu
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US11/872,506
• Publication Number:
  US 20080078680A1
• Time in Patent Office: 1,982 Days
• Field of Search: 20440301-40303, 204/406, 204/400, 205/777.5, 205/792, 422/82.01
• US Class Current: 205/792
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0858 Side walls
• CPC Class Codes: B01L 3/5085 for multiple samples, e.g. microtitration plates
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B

Abstract

A measuring device for analyzing a sample liquid having at least one analyte is provided. A test field support housed in the device includes a number of individual test fields in communication with electrochemical measuring cells of the test field support. Reagents can be assigned to the electrochemical measuring cells which can react with a sample liquid. The reaction can lead to a measurable change of at least one quantity characteristic of the presence or concentration of an analyte in the sample. The measuring device includes evaluation electronics. The individual test fields on the test field support are accessible to the user after the measuring device has been opened.

Claims

1. A measuring device for analyzing a sample liquid for presence or concentration of at least one analyte, comprising:

a measuring device body having an open position and a closed position;

evaluation electronics;

a test field support housed in the measuring device and coupled to the evaluation electronics, the test field support including a plurality of test fields, each test field of the plurality being accessible to a user when the measuring device body is in the open position;

each one of the plurality of test fields comprising an electrochemical measuring cell having a pair of sample sufficiency electrodes and a reagent adapted to react with a sample liquid to produce a response that is measurable by the evaluation electronics;

wherein the evaluation electronics are adapted to determine which one of the plurality of test fields has been wetted with the body fluid sample; and

wherein the device selectively provides visual indicia indicating which test fields of the plurality of test fields have been used and which remain unused.

2. The measuring device of claim 1, wherein the test field support is removably housed in the measuring device, whereby the test field support is replaceable.

3. The measuring device of claim 2, wherein each one of the plurality of test fields comprises at least one set of electrodes which electrically connect to the evaluation electronics upon insertion of the test field support in the measuring device.

4. The measuring device of claim 2, wherein the positions of the test fields on the test field support are fixed relative to the measuring device when the test field support is positioned in the measuring device.

5. The measuring device of claim 2, wherein the measuring device body comprises an upper shell and a lower shell, at least one of the upper shell and lower shell including an electrical contact to connect with a corresponding electrical contact of the test field support, and at least one of the upper shell and lower shell including a display for displaying a test result.

6. The measuring device of claim 1, wherein the test field support comprises multiple layers sandwiched together which cooperate to define the plurality of electrochemical measuring cells.

7. The measuring device of claim 1, wherein the plurality of test fields comprises a plurality of capillary sensors positioned side by side.

8. The measuring device of claim 1, wherein the plurality of test fields is arranged on the test field support in a matrix.

9. The measuring device of claim 1, further comprising a plurality of removable covers wherein each one of the plurality of test fields includes a sample reception well and wherein a separate one of the removable covers is configured to individually seal each of the sample reception wells.

10. The measuring device of claim 1, wherein the measuring device body comprises a module having a slot, a cover having an opening to removably receive the module, and a latch which can be triggered to allow removal of the module from the cover.

11. The measuring device of claim 1, wherein the test field support is removably and replacably receivable in the measuring device body, the test field support including an electrical contact which is connectable to a corresponding electrical contact carried by the measuring device body;

and

the test field support comprising multiple layers sandwiched together which cooperate to define the plurality of electrochemical measuring cells each of the electrochemical measuring cells having a sample receiving opening and a capillary channel configured to draw a liquid sample therein, each one of the plurality of test fields comprising a respective one of the electrochemical measuring cells.

12. The measuring device of claim 11, wherein the multiple layers include a base layer having a plurality of electrode sets thereon and a reagent layer at least partially covering each electrode set, each electrode set being positioned in a respective one of the plurality of electrochemical measuring cells.

13. The measuring device of claim 12, wherein the base layer defines each pair of sample sufficiency electrodes thereon, each pair of sample sufficiency electrodes being positioned in a respective one of the plurality of electrochemical measuring cells.

14. The measuring device of claim 12, wherein the multiple layers further comprise a spacer layer overlying the base layer and a cover layer overlying the spacer layer.

15. The measuring device of claim 11, wherein each one of the test fields of the plurality of test fields comprises a sample reception well in communication with each respective electrochemical measuring cell, each sample reception well having a removable cover configured to seal the sample reception well.

16. The measuring device of claim 11, wherein the positions of the test fields on the test field support are fixed relative to the measuring device when the test field support is received in the measuring device.

17. The measuring device of claim 11, wherein the measuring device body comprises an upper shell and a lower shell, at least one of the upper shell and lower shell including an electrical contact to connect with a corresponding electrical contact of the test field support, and at least one of the upper shell and lower shell including a display for displaying a test result.

18. The measuring device of claim 1 further comprising a display wherein the visual indicia are presented on the display.

19. The measuring device of claim 1 wherein the selective provision of visual indicia indicating which test fields of the plurality of test fields have been used and which remain unused is determined by the evaluation electronics based upon the determinations of which one of the test fields have been wetted with the body fluid sample performed by the evaluation electronics.

20. The measuring device of claim 19 wherein the evaluation electronics repeatedly evaluate if the test fields have been wetted and the selective provision of visual indicia indicating which test fields of the plurality of test fields have been used and which remain unused is based upon the repeated evaluations performed by the evaluation electronics.

21. A method for determining presence or concentration of at least one analyte in a body fluid sample using a measurement device having a display, evaluation electronics, and a plurality of test fields provided on a test field support, the method comprising:

(a) opening the measurement device to provide simultaneous access to each one of the plurality of test fields;

(b) selecting one of the test fields from the plurality of test fields;

(c) depositing the body fluid sample on the selected test field;

(d) drawing the sample into an electrochemical cell of the selected test field;

(e) using the evaluation electronics to determine which one of the plurality of test fields has been wetted with the body fluid sample;

(f) analyzing the sample using the evaluation electronics;

(g) displaying on the display a result indicative of the presence or concentration of the analyte in the body fluid sample;

(h) providing visual indicia with the measuring device of which test fields of the plurality of test fields have been used or remain unused;

(i) closing the measurement device without exhausting all of the plurality of test fields; and

(j) repeating steps (a) through (h) with a second one of the test fields.

22. The method of claim 21, wherein each one of the test fields comprises a set of sample sufficiency electrodes, the method further comprising measuring an electrical parameter through or across each set of sample sufficiency electrodes.

23. The method of claim 21, further comprising repeating steps (a)-(h) until each of the test fields have been used.

24. The method of claim 23, further comprising:

removing the test field support from the measuring device;

inserting a new test field support in the measuring device; and

repeating steps (a)-(i) using the new test field support.

25. The method of claim 21, wherein the measurement device includes a plurality of removable covers with each one of the plurality of test fields having a separate one of the plurality of removable covers associated therewith and wherein the method further comprising, before step (c), removing the cover that seals the selected test field and replacing the cover after step (c).

26. The method of claim 21 wherein the visual indicia are presented on the display.

27. The method of claim 21 wherein the step of providing visual indicia comprises using the evaluation electronics to determine which of the test fields have been used and which remain unused based upon determinations made by the evaluation electronics of which one of the plurality of test fields have been wetted.

28. The method of claim 21 wherein the method further comprises using the evaluation electronics to repeatedly determine if any of the test fields have been wetted and wherein the step of providing visual indicia comprises using the evaluation electronics to determine which of the test fields have been used and which remain unused based upon determinations made by the evaluation electronics of which one of the plurality of test fields have been wetted.