Method of depositing reagent material in a test sensor

• US 8,609,180 B2
• Filed: 12/10/2008
• Issued: 12/17/2013
• 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.
• Primary Examiner(s): Tucker, Philip
• Assistant Examiner(s): EFTA, ALEX B
• Application Number:
  US12/316,157
• Publication Number:
  US 20090145756A1
• Time in Patent Office: 1,833 Days
• Field of Search: 156/278, 427/58, 204/403.14
• US Class Current: 427/58
• 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. A method of depositing reagent solution on an electrochemical test sensor as a wet reagent droplet, the method comprising:

providing a base of the test sensor;

forming an electrode pattern on the base;

depositing the reagent solution on at least the electrode pattern as a wet reagent droplet using a reagent-dispensing system such that the wet reagent droplet directly contacts a portion of the electrode pattern, the depositing including applying mechanical force to at least a portion of the reagent solution via the reagent-dispensing system; and

drying the wet reagent droplet to form a dry reagent layer, the reagent solution including an enzyme and a polyelectrolyte, the polyelectrolyte aiding in providing a dry reagent layer having a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.2.

2. The method of claim 1, further comprising:

providing the reagent-dispensing system for depositing the wet reagent droplet on at least the electrode pattern, the reagent-dispensing system including a compression member, a piston-needle assembly, an air chamber, a fluid chamber, a nozzle, and a body, the compression member having a compression-adjustment mechanism for adjusting the amount of compression, the piston-needle assembly having a closed position and an open position;

supplying the reagent solution into the fluid chamber, the fluid chamber having a fluid input and a fluid output, the fluid output having an open position and a closed position corresponding to the open and closed positions of the piston-needle assembly;

supplying pressurized air to the air chamber to cause the piston-needle assembly to compress the compression member, the piston-needle assembly being in the open position, the fluid output being in the open position; and

releasing the supplied pressurized air from the air chamber to allow the compression member to force the piston-needle assembly into the closed position, the piston-needle assembly mechanically forcing the at least a portion of the reagent solution in the fluid chamber out of the nozzle.

3. The method of claim 1, further comprising:

providing a lid of the test sensor; and

attaching the lid to the base to assist in forming a channel in the test sensor, the channel assisting in allowing a fluid sample to contact the dry reagent layer on at least the electrode pattern.

4. The method of claim 1, further comprising providing the reagent-dispensing system for depositing the wet reagent droplet on at least the electrode pattern, the reagent-dispensing system including a solenoid control valve, a plunger, a compression member, and a nozzle, the nozzle having an output diameter, the solenoid control valve having an open position and a closed position;

pressurizing the reagent solution; and

opening the control valve of the reagent-dispensing system to cause the pressurized reagent solution to be dispensed through the nozzle and deposited on at least the electrode pattern as the wet reagent droplet.

5. The method of claim 1, wherein the dried reagent layer has a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.4.

6. The method of claim 1, wherein the dried reagent layer has a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.6.

7. The method of claim 1, wherein the reagent solution includes the enzyme, the polyelectrolyte, a mediator, and a multivalent salt, the multivalent salt having a concentration greater than 40 mM in the reagent solution.

8. The method of claim 7, wherein the multivalent salt has a concentration greater than 75 mM in the reagent solution.

9. The method of claim 7, 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 (K2C204), sodium succinate (Na2C4H4O4), potassium succinate (K2C4H4O4) or a combination thereof.

10. The method of claim 7, wherein the multivalent salt is a sulfate, a phosphate or a combination thereof.

11. The method of claim 1, wherein the reagent solution includes the enzyme, a mediator, and the polyelectrolyte, the polyelectrolyte being at least about 0.1 weight percent of the reagent solution.

12. The method of claim 11, wherein the polyelectrolyte includes carboxymethyl cellulose (CMC), homopolymer and copolymers of arylic acid, malaic acid, styrenesulfonic acid, vinylsulfonic acid, copolymers or salts, or a combination thereof.

13. The method of claim 11, wherein the reagent solution includes at least about 0.3 weight percent polyelectrolytes.

14. The method of claim 1, wherein the reagent solution includes about 15 weight percent reagent solid such that the deposited wet reagent droplet has a thickness of less than 50 micrometers.

15. The method of claim 1, wherein the dried reagent layer has a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.4, and wherein the reagent solution includes the enzyme, a mediator, a multivalent salt, and the polyelectrolyte, the multivalent salt having a concentration greater than 40 mM in the reagent solution and the polyelectrolyte being at least about 0.1 weight percent of the reagent solution.

16. The method of claim 15, wherein the reagent-dispensing system includes a nozzle having an output diameter from about 3.5 mils to about 9.5 mils, the method further comprising, prior to the depositing, locating the nozzle of the reagent-dispensing system at a dispensing height of from about 50 mils to about 600 mils above a top surface of the electrode pattern.

17. A method of forming a test sensor, comprising:

providing a base of the test sensor;

forming an electrode pattern on the base;

depositing reagent solution on the base as a wet reagent droplet using a reagent-dispensing system such that the wet reagent droplet directly contacts a portion of the electrode pattern; and

drying the wet reagent droplet to form a dry reagent layer, the reagent solution including an enzyme and a polyelectrolyte, the polyelectrolyte aiding in providing a dry reagent layer having a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.2.

18. The method of claim 17, wherein the wet reagent droplet has a covering area of from about 1 square millimeter to about 20 square millimeters, and wherein the dried reagent layer has a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.5.

19. The method of claim 17, wherein the reagent solution includes the polyelectrolyte, the enzyme, a mediator, and a multivalent salt, the multivalent salt having a concentration greater than 40 mM in the reagent solution.

20. The method of claim 17, wherein the reagent solution includes the enzyme, a mediator, and the polyelectrolyte, the polyelectrolyte being at least about 0.1 weight percent of the reagent solution.

21. The method of claim 17, wherein the reagent solution includes about 15 weight percent reagent solid.

22. The method of claim 17, wherein the dried reagent layer has a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.4, and wherein the reagent solution includes the enzyme, a mediator, a multivalent salt, and the polyelectrolyte, the multivalent salt having a concentration greater than 40 mM in the reagent solution and the polyelectrolyte being at least about 0.1 weight percent of the reagent solution, and wherein the reagent-dispensing system includes a nozzle having an output diameter from about 3.5 mils to about 9.5 mils, the method further comprising, prior to the depositing, locating the nozzle of the reagent-dispensing system at a dispensing height of from about 50 mils to about 600 mils above a top surface of the base.

23. A method of forming a test sensor, comprising:

providing a base of the test sensor;

forming an electrode pattern on the base;

depositing reagent solution on the base as a wet reagent droplet using a reagent-dispensing system such that the wet reagent droplet directly contacts a portion of the electrode pattern, the reagent solution including about 15 weight percent reagent solid and about 85 weight percent water such that the average thickness of the deposited wet reagent droplet is less than 100 micrometers, the reagent solid including an enzyme and a polyelectrolyte; and

drying the wet reagent droplet to remove the water from the wet reagent droplet thereby forming a dry reagent layer on the base of the test sensor, the dry reagent layer having a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.2.

24. The method of claim 23, wherein the reagent solid includes the enzyme, a mediator, a binder, multivalent salt, and the polyelectrolyte.

25. The method of claim 23, wherein the wet reagent droplet has a covering area of from about 1 square millimeter to about 20 square millimeters, and wherein the dried reagent layer has a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.5.

26. The method of claim 23, wherein the reagent solution includes the polyelectrolyte, the enzyme, a mediator, and a multivalent salt, the multivalent salt having a concentration greater than 50 mM in the reagent solution, the multivalent salt being 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.

27. The method of claim 23, wherein the reagent solution includes the enzyme, a mediator, and the polyelectrolyte, the polyelectrolyte being at least about 0.2 weight percent of the reagent solution, the polyelectrolyte being carboxymethyl cellulose (CMC), homopolymer and copolymers of arylic acid, malaic acid, styrenesulfonic acid, vinylsulfonic acid, copolymers or salts, or a combination thereof.

28. The method of claim 23, wherein the average thickness of the deposited wet reagent droplet is less than 50 micrometers and the wet reagent droplet has a covering area of from about 1 square millimeter to about 20 square millimeters, and wherein the dried reagent layer has a uniformity in which the ratio of the thinnest point to the thickest point is at least about 0.4, and wherein the reagent solution includes the enzyme, a mediator, a multivalent salt, and the polyelectrolyte, the multivalent salt having a concentration greater than 40 mM in the reagent solution and the polyelectrolyte being at least about 0.1 weight percent of the reagent solution, the reagent-dispensing system including a nozzle having an output diameter from about 3.5 mils to about 9.5 mils, the method further comprising, prior to the depositing, locating the nozzle of the reagent-dispensing system at a dispensing height of from about 50 mils to about 600 mils above a top surface of the base.