Electrochemical test sensor

• US 9,034,172 B2
• Filed: 09/08/2010
• Issued: 05/19/2015
• Est. Priority Date: 09/08/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wang, Yuan, Gifford, Raeann, Jiang, Hualin, Reynolds, Jeffery S., Fei, Jianfeng
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US12/877,207
• Publication Number:
  US 20110056848A1
• Time in Patent Office: 1,714 Days
• Field of Search: 205/792, 600/435, 600/437
• US Class Current: 205/792
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

An electrochemical test sensor for detecting the concentration of an analyte in a fluid sample. The electrochemical test sensor includes a housing that has a first end and a second opposing end. The housing includes an opening at the first end to receive a fluid test sample. An electrode assembly includes a substrate, a working electrode, a counter electrode and a reagent. The substrate has a first surface and an opposing second surface. The working electrode is disposed on the first surface of the substrate, and the counter electrode is disposed on the second surface of the substrate. The electrode assembly is positioned within the housing to define a reaction channel. The electrochemical test sensor may be used with a removable lancet mechanism or integrated within a lancet mechanism to form one integral unit.

Claims

1. A method for continuously determining the concentration of an analyte in a fluid sample with a test sensor, the method comprising:

providing an electrochemical test sensor including a housing and an electrode assembly, the housing having a first end and a second opposing end, the housing including an opening at the first end to receive a fluid test sample, the electrode assembly including a solid substrate, a working electrode, a counter electrode and a reagent, the solid substrate having a first surface and an opposing second surface, the working electrode being disposed on the first surface of the solid substrate, the counter electrode being disposed on the second surface of the solid substrate, the electrode assembly being positioned within the housing to define a reaction channel, the electrode assembly extending across a width dimension of an interior of the housing to form a first capillary channel being exposed to the working electrode and a second capillary channel being exposed to the counter electrode;

providing the fluid sample to the reaction channel such that the fluid sample flows only on the exterior of the solid substrate so as to contact the working and counter electrodes;

providing an integrated lancet being exposed outside of the opening, the lancet being integrated with the electrochemical test sensor, the integrated lancet including a lancet needle, the lancet needle including a fluid channel therein configured to pass the fluid sample from an incision via capillary action;

reacting the analyte of the fluid sample with the reagent to generate an electrical signal in the sensor in response to the presence of the analyte in the fluid sample; and

continuously determining the analyte concentration using the electrical signal.

2. The method of claim 1, wherein the first and second capillary channels are in communication with one another at the reaction channel.

3. The method of claim 1, wherein the electrode assembly includes first and second sides located between first and second surfaces, the first and second sides at one end being tapered toward each other.

4. The method of claim 1, wherein a volume of the fluid sample is from about 0.1 μ

L to about 0.3 μ

L.

5. The method of claim 1, wherein a volume of the reaction channel is less than 0.5 μ

L.

6. The method of claim 1, wherein a volume of the reaction channel is less than 0.3 μ

L.

7. The method of claim 1, wherein a volume of the reaction channel is from about 0.1 μ

L to about 0.5 μ

L.

8. The method of claim 1, wherein the housing at a first end has a circular cross-sectional shape.

9. The method of claim 1, wherein the integrated lancet includes a tapered tip to assist in inserting into the skin.

10. A method for continuously determining the concentration of glucose in a fluid sample with a test sensor, the method comprising:

providing an electrochemical test sensor including a housing and an electrode assembly, the housing having a first end and a second opposing end, the housing including an opening at the first end to receive a fluid test sample, the electrode assembly including a solid substrate, a working electrode, a counter electrode and a reagent, the solid substrate having a first surface and an opposing second surface, the working electrode being disposed on the first surface of the solid substrate, the counter electrode being disposed on the second surface of the solid substrate, the electrode assembly being positioned within the housing to define a reaction channel, the electrode assembly extending across a width dimension of an interior of the housing to form a first capillary channel being exposed to the working electrode and a second capillary channel being exposed to the counter electrode;

providing the fluid sample to the reaction channel such that the fluid sample flows only on the exterior of the solid substrate so as to contact the working and counter electrodes;

providing an integrated lancet being exposed outside of the opening, the lancet being integrated with the electrochemical test sensor, the integrated lancet including a lancet needle, the lancet needle including a fluid channel therein configured to pass the fluid sample from an incision via capillary action;

reacting the glucose of the fluid sample with the reagent to generate an electrical signal in the sensor in response to the presence of the glucose in the fluid sample; and

continuously determining the glucose concentration using the electrical signal.

11. The method of claim 10, wherein the first and second capillary channels are in communication with one another at the reaction channel.

12. The method of claim 10, wherein the electrode assembly includes first and second sides located between first and second surfaces, the first and second sides at one end being tapered toward each other.

13. The method of claim 10, wherein a volume of the fluid sample is from about 0.1 μ

L to about 0.3 μ

L.

14. The method of claim 10, wherein a volume of the reaction channel is less than 0.5 μ

L.

15. The method of claim 10, wherein a volume of the reaction channel is less than 0.3 μ

L.

16. The method of claim 10, wherein a volume of the reaction channel is from about 0.1 μ

L to about 0.5 μ

L.

17. The method of claim 10, wherein the housing at a first end has a circular cross-sectional shape.

18. The method of claim 10, wherein the integrated lancet includes a tapered tip to assist in inserting into the skin.

19. A method for continuously determining the concentration of an analyte in a fluid sample with a test sensor, the method comprising:

providing an electrochemical test sensor including a housing and an electrode assembly, the housing having a first end and a second opposing end, the housing including an opening at the first end to receive a fluid test sample, the electrode assembly including a solid substrate, a working electrode, a counter electrode and a reagent, the solid substrate having a first surface and an opposing second surface, the working electrode being disposed on the first surface of the solid substrate, the counter electrode being disposed on the second surface of the solid substrate, the electrode assembly being positioned within the housing to define a reaction channel, the electrode assembly extending across a width dimension of an interior of the housing to form a first capillary channel being exposed to the working electrode and a second capillary channel being exposed to the counter electrode;

providing the fluid sample to the reaction channel such that the fluid sample contacts the working and counter electrodes;

providing an integrated lancet being exposed outside of the opening, the lancet being integrated with the electrochemical test sensor, the integrated lancet including a lancet needle,

reacting the analyte of the fluid sample with the reagent to generate an electrical signal in the sensor in response to the presence of the analyte in the fluid sample; and

continuously determining the analyte concentration using the electrical signal.

20. The method of claim 19, wherein the analyte is glucose.

21. The method of claim 19, wherein the first and second capillary channels are in communication with one another at the reaction channel.

22. The method of claim 19, wherein the electrode assembly includes first and second sides located between first and second surfaces, the first and second sides at one end being tapered toward each other.

23. The method of claim 19, wherein the housing at a first end has a circular cross-sectional shape.

24. The method of claim 19, wherein the integrated lancet includes a tapered tip to assist in inserting into the skin.