Integrated lancet/electrochemical test sensor assembly

• US 9,874,536 B2
• Filed: 04/16/2015
• Issued: 01/23/2018
• Est. Priority Date: 09/08/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Wang, Yuan, Gifford, Raeann, Jiang, Hualin, Reynolds, Jeffery S., Fei, Jiangfeng
• Primary Examiner(s): Van, Luan V
• Assistant Examiner(s): Rosenwald, Steven E
• Application Number:
  US14/688,291
• Publication Number:
  US 20150219587A1
• Time in Patent Office: 1,013 Days
• Field of Search: None
• 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. An electrochemical test sensor/lancet assembly for detecting the concentration of an analyte in a fluid sample, the assembly comprising:

a lancet mechanism including a hollow lancet adapter and a lancet needle configured to flow the fluid sample therethrough; and

an electrochemical test sensor including a housing and an electrode assembly, the housing having a first end and a second opposing end, the first end being coupled to the hollow lancet adapter, the housing including an opening at the first end to receive the fluid sample received from the lancet needle, 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 working and counter electrodes extending to the edges of the solid substrate, the working and counter electrodes having a tip proximal to the opening, the electrode assembly being positioned within the housing to define a reaction channel, the reaction channel being located between the opening of the housing and the tip of the electrode assembly, 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.

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

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

L to about 0.3 μ

L.

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

L.

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

L.

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

L to about 0.5 μ

L.

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

8. The assembly of claim 1, wherein the reagent includes glucose oxidase or glucose dehydrogenase.

9. An integrated lancet/electrochemical test sensor assembly for detecting the concentration of an analyte in a fluid sample, the assembly comprising:

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 the fluid 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 working and counter electrodes extending to the edges 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; and

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.

10. The assembly of claim 9, wherein the lancet needle includes a fluid channel therein configured to pass the fluid sample from an incision via capillary action.

11. The assembly of claim 9, wherein the first and second capillary channels are in communication with one another at the reaction channel.

12. The assembly of claim 9, wherein the electrode assembly includes first and second sides located between the first and second surfaces, the first and second sides at one end being tapered toward each other.

13. The assembly of claim 9, wherein a volume of the reaction channel is from about 0.1 μ

L to about 0.3 μ

L.

14. The assembly of claim 9, wherein a volume of the reaction channel is less than 0.5 μ

L.

15. The assembly of claim 9, wherein a volume of the reaction channel is less than 0.3 μ

L.

16. The assembly of claim 9, wherein a volume of the reaction channel is from about 0.1 μ

L to about 0.5 μ

L.

17. The assembly of claim 9, wherein the housing at the first end has a circular cross-sectional shape.

18. The assembly of claim 9, wherein the reagent includes glucose oxidase or glucose dehydrogenase.

19. The assembly of claim 9, further comprising at least one underfill electrode disposed on at least one of the first and second surfaces of the solid substrate.

20. The assembly of claim 19, wherein the at least one underfill electrode includes an underfill electrode located on the first and second surfaces of the solid substrate.