ELECTROCHEMICAL TEST SENSOR AND METHOD OF FORMING THE SAME

• US 20140061045A1
• Filed: 11/11/2013
• Published: 03/06/2014
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Zhu, Boru, Henley, Herbert Jr.
• Granted Patent: US 9,829,459 B2
• Time in Patent Office: Days
• US Class Current: 204/403.14
• CPC Class Codes: B05C 5/0225 characterised by flow controlling means, e.g. valves, located proximate the outlet B05C5/0258, B05C5/0275 take precedence; supply valves upstream the coating head B05C11/1036
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/128 Microapparatus
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A method of depositing reagent on an electrochemical test sensor adapted to determine information relating to an analyte includes providing a base and forming an electrode pattern on the base. The method further includes depositing the reagent on at least the electrode pattern using a reagent-dispensing system. The reagent-dispensing system applies mechanical force to the reagent in the reagent-dispensing system to assist in providing a wet reagent droplet on at least the electrode pattern.

Claims

1-16. -16. (canceled)

17. An electrochemical test sensor comprising a base, a lid, a plurality of electrodes and a dried reagent, the dried reagent including an enzyme, a mediator, and a sufficient amount of a multivalent salt such that dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than about 0.2.

18. The electrochemical test sensor of claim 17, wherein the dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than about 0.3.

19. The electrochemical test sensor of claim 17, wherein the dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than about 0.4.

20. A method of forming an electrochemical test sensor, the method comprising:

providing a base and a lid,

forming a plurality of electrodes on at least one of the base and the lid;

placing reagent solution so as to be in contact with at least one of the electrodes, the reagent solution including an enzyme, a mediator, and a multivalent salt, the multivalent salt having a concentration greater than 40 mM in the reagent solution; and

drying the reagent solution after placement thereof.

21. The method of claim 20, wherein the multivalent salt is sodium sulfate (Na2SO4), potassium sulfate (K2SO4), ammonium sulfate ((NH4)2SO4), dibasic sodium phosphate (Na2HPO4), dibasic potassium phosphate (K2HPO4), dibasic ammonium phosphate (NH4)2HPO4), sodium oxalate (Na2C2O4), potassium oxalate (K2C2O4), sodium succinate (Na2C4H4O4), potassium succinate (K2C4H4O4) or a combination thereof.

22. The method of claim 20, wherein the multivalent salt is a sulfate, a phosphate or a combination thereof.

23. The method of claim 20, wherein the multivalent salt has a concentration greater than 50 mM in the reagent solution.

24. The method of claim 23, wherein the multivalent salt has a concentration greater than 75 mM in the reagent solution.

25. The method of claim 20, wherein the dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than 0.3.

26. A method of forming an electrochemical test sensor, the method comprising:

providing a base and a lid,

forming a plurality of electrodes on at least one of the base and the lid;

placing a reagent solution so as to be in contact with at least one of the electrodes, the reagent solution including an enzyme, a mediator, and an electrolyte, the electrolyte including at least 0.1 wt. % of the reagent solution; and

drying the reagent solution after placement thereof.

27. The method of claim 26, wherein the polyelectrolyte includes carboxymethyl cellulose (CMC), homopolymer and copolymers of arylic acid, malaic acid, styrenesulfonic acid, vinylsulfonic acid, copolymers or salts thereof.

28. The method of claim 26, wherein the reagent solution includes at least about 0.2 wt. % polyelectrolytes.

29. The method of claim 28, wherein the reagent solution includes at least about 0.3 wt. % polyelectrolytes.

30. The method of claim 26, wherein the dried reagent has a uniformity in which the ratio of the thinnest point to the thickest point is greater than 0.3.