Analyte sensors and methods of using same

• US 9,983,161 B2
• Filed: 11/23/2016
• Issued: 05/29/2018
• Est. Priority Date: 07/25/2012
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Feldman, Benjamin J., Liu, Zenghe, Ouyang, Tianmei, Qian, Suyue
• Primary Examiner(s): Williams, Hezron E
• Assistant Examiner(s): Eyassu, Marrit
• Application Number:
  US15/360,120
• Publication Number:
  US 20170138886A1
• Time in Patent Office: 552 Days
• Field of Search: 73 6143
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Provided are sensors for determining the concentration of an analyte in a sample fluid. In certain embodiments, the sensors include conductive particles and exhibit improved uniformity of distribution of one or more sensing chemistry components, increased effective working electrode surface area, and/or reduced entry of interfering components into a sample chamber of the sensor. Methods of using and manufacturing the sensors are also provided.

Claims

1. A biosensor, comprising:

a first substrate;

a second substrate disposed over the first substrate;

an electrode disposed between the first substrate and second substrate;

a spacer disposed between the first and second substrates and defining a sample chamber; and

a dry composition disposed on an area of the electrode, the composition comprising an analyte detection reagent and electrically conductive particles in an amount of about 10² to about 10¹⁰ conductive particles/mm²,

wherein the analyte detection reagent comprises an analyte-responsive enzyme and a redox mediator and the electrically conductive particles provide for uniform distribution of the analyte-responsive enzyme and the redox mediator on the area of the electrode.

2. The biosensor of claim 1, wherein the amount of conductive particles is about 10⁴ to about 10⁷ conductive particles/mm².

3. The biosensor of claim 1, wherein the conductive particles comprise a carbon nanopowder.

4. The biosensor of claim 1, wherein the conductive particles are microspheres.

5. The biosensor of claim 4, wherein the microspheres comprise a polymer coated with a conducting material.

6. The biosensor of claim 5, wherein the microspheres are gold-coated polystyrene microspheres.

7. The biosensor of claim 4, wherein the microspheres have a diameter of 0.5 μ

m to about 100 μ

m.

8. The biosensor of claim 1, wherein the electrode is a working electrode and the sensor further comprises a counter electrode comprising a polymer layer disposed on the counter electrode.

9. The biosensor of claim 8, wherein the polymer layer is configured to prevent the conductive particles disposed on the working electrode from forming an electrical connection between the working electrode and the counter electrode.

10. The biosensor of claim 8, wherein the polymer layer comprises a copolymer of vinyl pyridine and styrene.

11. The biosensor of claim 10, wherein the vinyl pyridine and styrene are grafted with propyl sulfonate and polyethylene glycol.

12. The biosensor of claim 8, wherein the polymer layer comprises a polyurethane-based resin.

13. The biosensor of claim 12, wherein the polyurethane-based resin comprises carboxyl functional groups.

14. The biosensor of claim 1, wherein the electrode and comprises a material selected from the group consisting of:

gold, carbon, platinum, ruthenium, palladium, silver, silver chloride, silver bromide, and combinations thereof.

15. The biosensor of claim 1, wherein the electrode is disposed on the first substrate.

16. The biosensor of claim 1, wherein the electrode is disposed on the second substrate.

17. The biosensor of claim 1, wherein the analyte is glucose or a ketone body.

18. The biosensor of claim 17, wherein the analyte is glucose, and wherein the analyte-responsive enzyme is glucose dehydrogenase or glucose oxidase.

19. The biosensor of claim 1, wherein the redox mediator comprises a transition metal complex.

20. The biosensor of claim 19, wherein the transition metal complex comprises a transition metal selected from the group consisting of osmium, ruthenium, iron and cobalt.

21. The biosensor of claim 20, wherein the transition metal is osmium.

22. The biosensor of claim 19, wherein the transition metal complex comprises two or more ligands coordinately bound to a transition metal, wherein at least one of the ligands is a heterocyclic nitrogen-containing bidentate ligand.

23. The biosensor of claim 1, wherein the sample chamber is sized to contain a volume of no more than about 1 μ

L of sample fluid.

24. The biosensor of claim 1, wherein the sample chamber is sized to contain a volume of no more than about 0.5 μ

L of sample fluid.

25. The biosensor of claim 1, wherein the conductive particles comprise nanoparticles.

26. The biosensor of claim 25, wherein the nanoparticles have a diameter of 35 nm to 200 nm.