Electrochemical test sensor with light guide

• US 8,815,079 B2
• Filed: 12/21/2007
• Issued: 08/26/2014
• Est. Priority Date: 01/05/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brenneman, Allen J., O'Sullivan, Dan
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US12/521,829
• Publication Number:
  US 20100012509A1
• Time in Patent Office: 2,440 Days
• Field of Search: 204400-40315, 20440301-40315, 205/777.5, 205/778, 205/792, 205/775, 600345-348, 422/82.05, 422400-430, 422500-570, 422/68.1, 422/82.01, 435/287.1
• US Class Current: 205/792
• 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 method for determining the concentration of an analyte in a fluid sample with a test sensor, the method comprising:

providing a meter having a light source;

providing an electrochemical test sensor including a base, a dielectric layer, a reagent, a light guide area, and a lid, the base having a flow path for the fluid test sample, the base having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current, the dielectric layer forming a dielectric window therethrough, the reagent including an enzyme that is adapted to react with the analyte, the lid mating with the base and assisting in forming a capillary space with an opening for the introduction of the fluid test sample thereto, the light guide area having a transparent or translucent polymeric light guide at least partially surrounded by an opaque area, the polymeric light guide being adapted to transmit light therethrough towards the capillary space, the dielectric layer and the reagent layer being located between the base and the lid, the lid including the polymeric light guide and the opaque area;

transmitting light through the polymeric light guide from the light source towards the fluid sample to assist a user in positioning the sample with respect to the test sensor;

illuminating the fluid sample with the light transmitting through the polymeric light guide;

contacting the reagent layer with the fluid sample via the capillary space;

generating an electrical signal in the test sensor in response to the presence of the analyte; and

determining a level of the analyte from the electrical signal.

2. The method of claim 1, wherein the analyte is glucose.

3. The method of claim 1, wherein the light guide area is embedded in the lid.

4. The method of claim 1, wherein the polymeric light guide is embedded within the lid extending continuously from a first end of the lid to an opposing second end of the lid.

5. The method of claim 1, wherein the lid further includes at least one air vent proximate the light guide area.

6. The method of claim 1, wherein the polymeric light guide is formed from at least one of acrylic, Polyethylene Terephthalate (PET), or polycarbonate.

7. The method of claim 1, wherein the volume of the capillary space is less than about 1 μ

L.

8. The method of claim 1, wherein the electrochemical test sensor further includes a spacer, the spacer being located between the lid and the reagent layer.

9. An electrochemical test system for detecting the concentration of an analyte in a fluid test sample, the system comprising:

a meter having a light source; and

an electrochemical test sensor including a base, a dielectric layer, a reagent, and a lid, the base having a flow path for the fluid test sample, the base bearing a counter electrode and a working electrode adapted to electrically communicate electrical current, the dielectric layer forming a dielectric window therethrough, the reagent including an enzyme that is adapted to react with the analyte, and the lid mating with the base and assisting in forming a capillary space with an opening for the introduction of the fluid test sample thereto,

wherein the lid includes a light guide area with a transparent or translucent polymeric light guide and an opaque area at least partially surrounding the light guide area, the polymeric light guide being adapted to transmit therethrough light generated by the light source from a first end of the test sensor towards the capillary space to assist a user in positioning the sample with respect to the test sensor.

10. The system of claim 9, wherein the polymeric light guide is formed from at least one of acrylic, Polyethylene Terephthalate (PET), or polycarbonate.

11. The system of claim 9, wherein the reagent includes glucose oxidase or glucose dehydrogenase.

12. The system of claim 9, wherein the volume of the capillary space is less than about 1 μ

L.

13. The system of claim 9, further including a spacer, the spacer being located between the lid and the reagent.

14. An electrochemical test system for detecting the concentration of an analyte in a fluid test sample, the system comprising:

a meter having a light source; and

an electrochemical test sensor including a base, a dielectric layer, a reagent, and a lid, the base having a flow path for the fluid test sample, the base bearing a counter electrode and a working electrode adapted to electrically communicate electrical current, the dielectric layer forming a dielectric window therethrough, the reagent including an enzyme that is adapted to react with the analyte, and the lid mating with the base and assisting in forming a capillary space with an opening for the introduction of the fluid test sample thereto,

wherein the lid includes a light guide area with a polymeric light guide embedded within the lid and extending continuously from a first end of the lid to an opposing second end of the lid, the polymeric light guide being adapted to transmit light generated by the light source from a first end of the test sensor towards the capillary space to assist a user in positioning the sample with respect to the test sensor.

15. A combination of a meter and an electrochemical test sensor for detecting the concentration of an analyte in a fluid test sample, the combination comprising:

the meter having a light source; and

the electrochemical test sensor including a base, a dielectric layer, a reagent, a lid, and a light guide layer, the base defining a flow path for the fluid test sample, the base having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current, the dielectric layer forming a dielectric window therethrough, the reagent including an enzyme that is adapted to react with the analyte, the lid mating with the base and assisting in forming a capillary space with an opening for the introduction of the fluid test sample thereto, and the light guide layer having a transparent or translucent polymeric light guide at least partially surrounded by an opaque area, the polymeric light guide being adapted to transmit therethrough light generated by the light source from a first end of the test sensor towards the capillary space to assist a user in positioning the sample with respect to the test sensor, the lid including the polymeric light guide and the opaque area,

wherein the dielectric layer and the reagent layer are located between the base and the lid.

16. The combination of the meter and the electrochemical test sensor of claim 15, wherein the lid has at least one air vent adjacent the light guide layer.

17. The combination of the meter and the electrochemical test sensor of claim 15, wherein the polymeric light guide extends continuously between opposing first and second ends of the lid.

18. The combination of the meter and the electrochemical test sensor of claim 15, wherein the reagent includes glucose oxidase or glucose dehydrogenase.

19. The combination of the meter and the electrochemical test sensor of claim 15, wherein the polymeric light guide includes at least one of acrylic, Polyethylene Terephthalate (PET), or polycarbonate.

20. The combination of the meter and the electrochemical test sensor of claim 15, wherein the volume of the capillary space is less than about 1 μ

L.