Maintaining electrode function during manufacture with a protective layer

• US 9,097,659 B2
• Filed: 03/14/2013
• Issued: 08/04/2015
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Charlton, Steven C., Edelbrock, Andy
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US13/829,447
• Publication Number:
  US 20140262772A1
• Time in Patent Office: 873 Days
• Field of Search: 20440301-40315, 298/85, 156/256
• US Class Current: 1/1
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: C23C 28/00 Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D
• 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 27/416 Systems G01N27/27 takes precedence
• CPC Class Codes: Y10T 29/49224 with coating

Abstract

The present disclosure relates to an electrochemical test sensor for detecting the concentration of an analyte in a fluid sample. The test sensor includes a working electrode, a counter electrode, and a trigger electrode. A temporary protective layer overlies the trigger electrode and helps to maintain the function of the trigger electrode during test sensor manufacture.

Claims

1. An electrochemical test sensor for detecting the concentration of an analyte in a fluid sample, the test sensor comprising:

a non-conductive base having a top surface, a bottom surface, and a peripheral edge extending between the top and bottom surfaces;

a trigger electrode, a working electrode, and a counter electrode overlying the non-conductive base, the trigger electrode adjacent the peripheral edge of the base;

a protective layer overlying at least a portion of the trigger electrode;

a reactive layer on at least a portion of the working electrode, the reactive layer including an enzyme for reacting with the analyte to produce electrons which are transferred to the working electrode, wherein the protective layer and the reactive layer are spaced a sufficient distance from each other so that they do not contact each other; and

a lid overlying the base, the lid having a top surface, a bottom surface, and an outer edge extending between the top and bottom surfaces, the outer edge extending beyond the peripheral edge of the base.

2. The test sensor of claim 1, wherein the protective layer is soluble upon contact with the fluid sample.

3. The test sensor of claim 1, wherein the protective layer is comprised of a polymer solution.

4. The test sensor of claim 3, wherein the polymer solution is carboxymethyl cellulose or hydroxyethyl cellulose.

5. The test sensor of claim 3, wherein the polymer solution has a concentration ranging between 0.25% to 1.0%.

6. The test sensor of claim 5, wherein the concentration of the polymer solution is 0.25%.

7. The test sensor of claim 5, wherein the concentration of the polymer solution is 1.0%.

8. The test sensor of claim 5, wherein the protective layer further comprises a surfactant or rheological additive for increased wettability or processability.

9. The test sensor of claim 1, wherein:

the base is laminated, printed, coated or sputtered with a conductive layer; and

each of the trigger, working, and counter electrodes is patterned from the conductive layer.

10. The test sensor of claim 9, wherein the conductive layer is comprised of a metallic material.

11. The test sensor of claim 9, wherein the conductive layer is comprised of a carbon or graphite.

12. The test sensor of claim 1, further comprising a spacer positioned between the base and the lid.

13. The test sensor of claim 12, wherein the spacer includes a spacer channel extending through a portion of the spacer, wherein the spacer is positioned over the base such that the spacer channel overlies each of the trigger, working, and counter electrodes and the protective and reactive layers.

14. An electrochemical test sensor for detecting the concentration of an analyte in a fluid sample, the test sensor comprising:

a base including a plurality of electrodes formed thereon, the plurality of electrodes including;

a working electrode having a reactive layer deposited on at least a portion of the working electrode;

a counter electrode; and

a reagent-free trigger electrode, wherein the trigger electrode is positioned adjacent an outermost edge of the base and includes a protective layer deposited on at least a portion of the trigger electrode, wherein the protective layer and the reactive layer are spaced sufficiently apart from one another so that they do not contact one another; and

a lid overlying the base, wherein an outermost edge of the lid extends beyond the outermost edge of the base.

15. A method of manufacturing an electrochemical test sensor for detecting the concentration of an analyte in a fluid sample, the method comprising:

patterning a plurality of electrodes from a conductive layer overlying a base, the plurality of electrodes including at least a trigger electrode, a working electrode, and a counter electrode;

depositing a protective layer overlying the trigger electrode;

depositing a reactive layer overlying the working electrode, wherein the protective layer and the reactive layer are deposited a sufficient distance from one another so that they do not contact one another;

positioning a spacer over the base;

creating a first opening extending through the spacer and the base;

creating a second opening in a lid;

positioning the lid over the spacer; and

excising a test sensor.

16. The method of claim 15, wherein the first opening has an inner peripheral edge and the second opening has an inner peripheral edge, wherein the step of positioning the lid over the spacer includes positioning the lid such that at least a portion of an inner peripheral edge of the second opening extends beyond an inner peripheral edge of the first opening so as to define an overhang portion.

17. The method of claim 15, wherein the step of depositing the protective layer includes depositing a polymer layer.

18. The method of claim 17, wherein the step of depositing a polymer layer comprises depositing a layer of carboxymethyl cellulose or hydroxyethyl cellulose.

19. The method of claim 15, wherein the step of patterning comprises ablating through at least a portion of the conductive layer with a laser so as to form an electrode pattern.

20. The method of claim 15, wherein the conductive layer overlying the base is comprised of at least one of gold, platinum, palladium, iridium, rhodium, and ruthenium.

21. The method of claim 15, wherein at least one of the steps of creating the first opening and creating the second opening comprises laser cutting the opening.

22. The method of claim 15, wherein the base is comprised of a flexible insulating substrate.

23. The method of claim 15, wherein the spacer includes a spacer channel extending through a portion of the spacer, and wherein the step of positioning the spacer over the base includes arranging the spacer relative to the base such that the spacer channel overlies each of the trigger, working, and counter electrodes and the protective and reactive layers.

24. The method of claim 23, wherein the step of positioning the lid over the spacer includes arranging the lid relative to the spacer such that the second opening of the lid overlies the spacer channel and an inner peripheral edge of the second opening extends beyond an edge of the trigger electrode.

25. The method of claim 15, wherein the protective layer comprises a polymer solution, and wherein the step of depositing the protective layer comprises using a drop placement technique to deposit at least one droplet of polymer solution on the trigger electrode.