Encoded Biosensors and Methods of Manufacture and Use Thereof

• US 20130027064A1
• Filed: 07/29/2011
• Published: 01/31/2013
• Est. Priority Date: 07/29/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Austera, John T., Beaty, Terry A., Joseph, Abner D., Moore, Steven K., Pauley, James L. Jr., Riggles, Randall K., Manlove, Nathan E.
• Granted Patent: US 8,888,973 B2
• Time in Patent Office: Days
• US Class Current: 324/692
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

An analyte test sensor strip is disclosed having information coded thereon as well as a method of forming the same and conducting an analyte test using the analyte test sensor strip. Information relating to an attribute of the strip or batch/lot of strips may be coded based on resistance values pertaining to electrical aspects of the strip, such as a primary resistive element and a secondary resistive element, the secondary resistive element having one of a plurality of states defined by a location of a closed tap to form a unique resistive path for the secondary resistive element that includes a portion of the primary resistive element depending on the location of the closed tap. The states may be formed on the strip by a secondary processing step in the manufacture of the strip in which a plurality of taps are severed leaving only one tap in a closed state.

Claims

1. An analyte test sensor strip, comprising:

a non-conductive substrate;

a primary resistive element on said non-conductive substrate having a first end and a second end, wherein said primary resistive element has a predetermined configuration; and

a secondary resistive element on said non-conductive substrate having a tap connected to said primary resistive element at a predetermined connection point on said predetermined configuration thereby defining a unique resistive path through at least a portion of said predetermined configuration.

2. The analyte test sensor of claim 1, wherein said unique resistive path through said predetermined configuration has associated therewith a resistance falling within a respective one of a plurality of ranges of resistances.

3. The analyte test sensor of claim 2, wherein said resistance is determined as a function of a location of said predetermined connection point on said predetermined configuration.

4. The analyte test sensor of claim 1, wherein said unique resistive path is associated with an attribute of said analyte test sensor strip.

5. The analyte test sensor of claim 1, wherein said predetermined configuration is formed having a serpentine shape defining a plurality of proximal ends and a plurality of distal ends.

6. The analyte test sensor of claim 1, wherein said secondary resistive element includes a plurality of taps, wherein said respective tap that is connected with said predetermined configuration at said predetermined connection point is formed in a closed state and all other taps of said plurality of taps are formed in an open state.

7. The analyte test sensor of claim 1, wherein said first end of said primary resistive element is connected with a first contact pad and said second end is connected with a second contact pad, and wherein a third end of said secondary resistive element is connected with a third contact pad.

8. The analyte test sensor of claim 7, wherein said unique resistive path runs from said third contact pad through said secondary resistive element and then into said primary resistive element at said predetermined connection point and then through at least a portion of said primary resistive element to one of said first and second contact pads.

9. An analyte test sensor strip, comprising:

a non-conductive substrate;

a primary resistive element on said non-conductive substrate having a predetermined configuration having a first end connected with a first contact pad and a second end connected with a second contact pad;

an secondary resistive element on said non-conductive substrate having a plurality of taps, wherein one tap of said plurality of taps is connected with said primary resistive element at a predetermined location thereby being formed in a closed state and defining a unique resistive path through said primary resistive network and remaining taps of said plurality of taps being formed in an open state thereby being disconnected from said primary resistive network, wherein a portion of said secondary resistive element is connected with a secondary resistive element contact pad.

10. The analyte test sensor strip of claim 9, wherein said taps in said open state are ablated with a laser.

11. The analyte test sensor strip of claim 9, wherein said unique resistive path is associated with an attribute of said analyte test sensor strip.

12. The analyte test sensor strip of claim 9, further comprising an optical code on said non-conductive substrate.

13. The analyte test sensor strip of claim 9, further comprising a first resistance loop on said non-conductive substrate comprising a first measurement sense electrode in a spaced apart relationship from a first measurement electrode.

14. The anyalyte test sensor strip of claim 13, wherein said first measurement electrode is connected with said second end of said primary resistive element.

15. The analyte test sensor strip of claim 9, wherein said predetermined configuration comprises a serpentine configuration.

16. A method of forming a biosensor test strip, comprising:

forming a primary resistive element on a non-conductive substrate having a predetermined configuration including a first end and a second end; and

forming a secondary resistive element on said non-conductive substrate having at least one tap connected to a predetermined connection location on said primary resistive element thereby defining a unique resistive path through at least a portion of said primary resistive element having associated therewith a resistance falling within a respective one of a plurality of ranges of resistances.

17. The method of claim 16, wherein said secondary resistive element includes a plurality of taps, wherein all of said plurality of taps but said tap connected to said predetermined location on said primary resistive element are ablated thereby disconnecting said ablated taps from said primary resistive element.

18. The method of claim 17, wherein said primary resistive element includes a plurality of predetermined connection locations, the method further comprising the step of selecting a connection location to be connected with said tap as a function of an attribute associated with said biosensor test strip.

19. The method of claim 16, further comprising forming an optical code on said non-conductive substrate.

20. The method of claim 16, wherein said unique resistive path is associated with an attribute of said biosensor test strip.

21. The method of claim 16, wherein said predetermined configuration comprises a serpentine configuration.

22. The method of claim 21, wherein said serpentine configuration includes a plurality of proximal ends and a plurality of distal ends, wherein said tap connected at said predetermined connection location is connected with a respective proximal end of said serpentine configuration.

23. The method of claim 16, wherein each range of resistances contained in said plurality of ranges of resistances is associated with a unique attribute of said biosensor test strip.

24. An analyte test sensor strip, comprising:

a non-conductive substrate;

means for conducting quantitative or qualitative analysis of an analyte in a sample of fluid; and

an information circuit provided on said non-conductive substrate, said information circuit comprising;

a conductive primary path between a first end and a second end having a predetermined configuration between said first and second ends, wherein said conductive primary path has a resistance falling within a first predetermined range; and

a conductive secondary path between said first end of said conductive primary path and a third end, wherein said conductive secondary path is substantially defined by a plurality of open taps and a closed tap, wherein said closed tap selectively connects said third end with said conductive primary path at a predetermined location thereby defining a unique resistive path between the first end and the third end through at least a portion of said conductive primary path, wherein said unique resistive path has a second resistance falling within a second predetermined range.

25. The analyte test sensor strip of claim 24, wherein a ratio of said first resistance and said second resistance selectively correlates to an attribute of said analyte test sensor strip.

26. The analyte test sensor strip of claim 24, wherein said first end is connected with a first contact pad, said second end is connected with a second contact pad, and said third end is connected with a third contact pad.

27. The analyte test sensor strip of claim 24, wherein said predetermined configuration comprises a serpentine configuration having a plurality of proximal ends and a plurality of distal ends.

28. The analyte test sensor strip of claim 27, wherein said closed tap is connected to a respective proximal end.

29. The analyte test sensor strip of claim 24, wherein which tap comprises said closed tap is selected as a function of an attribute of said analyte test sensor strip.

30. The analyte test sensor strip of claim 24, further comprising an optical code on said non-conductive substrate.

31. The analyte test sensor strip of claim 30, wherein said optical code contains at least one informational attribute associated with said analyte test sensor strip selected from the group consisting of a product expiration date, a product identification, intercepts of blood and control solution information, a strip lot identification, and a strip performance algorithm identifier.

32. A method for measuring a concentration of an analyte in a sample of fluid, comprising:

providing a test meter;

providing a test strip, said test strip comprising;

a non-conductive substrate;

a working electrode on said non-conductive substrate connectable to said test meter;

a counter electrode on said non-conductive substrate connectable to said test meter;

a reagent part bridging between said working electrode and said counter electrode;

a primary resistive element on said non-conductive substrate having a first end connectable to said test meter and a second end connectable to said test meter, wherein said primary resistive element has a predetermined configuration; and

a secondary resistive element on said non-conductive substrate having a third end connectable to said test meter, wherein said secondary resistive element has a tap connected to said primary resistive element at a predetermined connection point on said predetermined configuration thereby defining a unique resistive path through at least a portion of said predetermined configuration having a resistance value;

receiving said test strip into the test meter;

operatively connecting said working electrode, said counter electrode, said primary resistive element, and said secondary resistive element with said test meter; and

determining an attribute associated with test strip as a function of a measurement associated with at least said resistance value associated with said unique resistive path.

33. The method of claim 32, wherein said primary resistive element has a primary element resistance value and said attribute is determined as a function of a resistance ratio determined by comparing said resistance value of said unique resistive path with said primary element resistance value.

34. The method of claim 32, further comprising adjusting said test meter to output a concentration measurement output associated with said analyte as a function of said attribute.

35. The method of claim 32, wherein an end of said primary resistive element is connected with said counter electrode.