Analyte sensors and methods of using same

• US 9,535,027 B2
• Filed: 07/24/2013
• Issued: 01/03/2017
• Est. Priority Date: 07/25/2012
• Status: Expired due to Fees

• 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): Eyassu, Marrit
• Application Number:
  US13/949,996
• Publication Number:
  US 20140026646A1
• Time in Patent Office: 1,259 Days
• Field of Search: 73/614.3
• US Class Current: 1/1
• 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 sensor for determining the concentration of an analyte in a sample fluid, the sensor comprising:

a first substrate having a proximal end and a distal end, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate, the distal end being configured and arranged for insertion into a sensor reader;

a second substrate disposed over the first substrate;

a working electrode disposed on one of the first and second substrates;

a counter electrode disposed on one of the first and second substrates;

a spacer disposed between the first and second substrates and defining a sample chamber that comprises the working electrode and the counter electrode; and

a dry composition disposed on an area of the working electrode, the composition comprising an analyte detection reagent and electrically conductive particles,

wherein the analyte detection reagent comprises an analyte-responsive enzyme and a redox mediator, wherein the analyte-responsive enzyme and the redox mediator are uniformly distributed on the area of the working electrode, wherein the electrically conductive particles provide for the uniform distribution of the analyte-responsive enzyme and the redox mediator on the area of the working electrode, wherein the conductive particles comprise nanoparticles or microspheres, wherein the dry composition is not disposed on the counter electrode.

2. The sensor of claim 1, wherein the area of the working electrode on which the composition is disposed comprises between about 10⁴ and 10⁷ conductive particles/mm².

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

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

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

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

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

m to about 100 μ

m.

8. The sensor of claim 1, wherein the sensor comprises a polymer layer disposed on the counter electrode.

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

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

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

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

14. The sensor of claim 1, wherein the working electrode and counter electrode independently comprise a material selected from the group consisting of:

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

15. The sensor of claim 1, wherein the counter electrode comprises Ag/AgCl.

16. The sensor of claim 1, wherein the working electrode is disposed on the first substrate and the counter electrode is disposed on the second substrate.

17. The sensor of claim 1, wherein the working electrode and the counter electrode are disposed on the same substrate.

18. The sensor of claim 1, wherein the analyte is glucose or a ketone body.

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

20. The sensor of claim 1, wherein the redox mediator comprises a transition metal complex.

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

22. The sensor of claim 21, wherein the transition metal is osmium.

23. The sensor of claim 20, 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.

24. The sensor of claim 23, wherein the transition metal is osmium.

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

L of sample fluid.

26. The sensor 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.

27. The sensor of claim 1, wherein the conductive particles comprise nanoparticles.

28. The sensor of claim 27, wherein the nanoparticles have a diameter of 35 nm to 200 nm.