Electrochemical test sensor with light guide

• US 9,453,813 B2
• Filed: 07/15/2014
• Issued: 09/27/2016
• Est. Priority Date: 01/05/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Brenneman, Allen J., O'Sullivan, Dan
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US14/332,029
• Publication Number:
  US 20140326599A1
• Time in Patent Office: 805 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• 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 analyte concentration of a fluid test sample includes a base, a dielectric layer, a reagent layer, a light guide area, and a lid. The base provides a flow path for the test sample having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current. The dielectric layer forms a dielectric window therethrough. The reagent layer includes an enzyme that is adapted to react with the analyte. The lid is adapted to mate with the base and to assist in forming a capillary space with an opening for the introduction of the test sample thereto. The light guide area transmits light towards the capillary space.

Claims

1. A test sensor for cooperating with a meter to determine a concentration of an analyte in a fluid test sample, the meter including a light source, the test sensor comprising:

a base;

a reagent adapted to chemically react with the analyte; and

a lid attached to the base and forming therebetween a capillary space with an opening for receiving the fluid test sample, the lid including a polymeric light guide and an opaque area at least partially surrounding the polymeric light guide, the polymeric light guide being configured to transmit therethrough light generated by the light source of the meter from a first end of the lid to the capillary space.

2. The test sensor of claim 1, wherein the polymeric light guide extends continuously from the first end of the lid to an opposing second end of the lid.

3. The test sensor of claim 1, wherein the lid has at least one air vent adjacent the polymeric light guide.

4. The test sensor of claim 1, wherein the polymeric light guide is formed from at least one of acrylic, polyethylene terephthalate (PET), or polycarbonate.

5. The test sensor of claim 1, further comprising an electrically conductive counter electrode and an electrically conductive working electrode.

6. The test sensor of claim 5, further comprising an electrically conductive trigger electrode adjacent the counter and working electrodes.

7. The test sensor of claim 5, further comprising a first electrical conductor disposed between the working electrode and the base, and a second electrical conductor disposed between the counter electrode and the base.

8. The test sensor of claim 1, further comprising a dielectric layer between the lid and the base.

9. The test sensor of claim 8, wherein the dielectric layer defines therethrough a dielectric window.

10. The test sensor of claim 1, wherein the volume of the capillary space is less than about 1 μ

L.

11. The test sensor of claim 1, further comprising a spacer disposed between the lid and the base.

12. The test sensor of claim 1, wherein the reagent includes glucose oxidase or glucose dehydrogenase, or a combination thereof.

13. An analyte testing system for determining a concentration of an analyte in a fluid test sample, the analyte testing system comprising:

a meter having a light source; and

a test sensor with a base, a reagent, and a lid, the reagent including an enzyme adapted to chemically react with the analyte, and the lid mating with the base to form therebetween a capillary space with an opening for receiving the fluid test sample,

wherein the lid includes a polymeric light guide and an opaque area at least partially surrounding the polymeric light guide, the polymeric light guide being configured to transmit light generated by the light source from a first end of the lid to the capillary space.

14. An electrochemical test sensor for electrically connecting with a meter to determine a concentration of an analyte in a fluid test sample, the meter including an electrical current detector and a light source, the electrochemical test sensor comprising:

a base supporting a counter electrode and a working electrode each configured to electrically communicate with the electrical current detector of the meter;

a reagent supported by the base adjacent the working and counter electrodes, the reagent including an enzyme adapted to chemically react with the analyte in the fluid test sample; and

a lid mating with the base to form a capillary space with an opening for receiving the fluid test sample, the lid including a transparent or translucent polymeric light guide at least partially surrounded by an opaque area, the polymeric light guide being configured to transmit light generated by the light source from a first end of the lid to the capillary space at a second end of the lid.

15. The electrochemical test sensor of claim 14, wherein the lid defines therethrough at least one air vent adjacent the polymeric light guide.

16. The electrochemical test sensor of claim 14, wherein the polymeric light guide is embedded in the lid extending continuously between the first and second ends of the lid.

17. The electrochemical test sensor of claim 14, wherein the polymeric light guide is formed from at least one of acrylic, polyethylene terephthalate (PET), or polycarbonate.

18. The electrochemical test sensor of claim 14, further comprising an electrically conductive trigger electrode supported by the base adjacent the counter and working electrodes.

19. The electrochemical test sensor of claim 14, further comprising first and second electrical conductors supported by the base, the first electrical conductor being disposed between the working electrode and the base, and the second electrical conductor being disposed between the counter electrode and the base.

20. The electrochemical test sensor of claim 14, further comprising a dielectric layer between the lid and the base, the dielectric layer defining therethrough a dielectric window.