Disposable test sensor with improved sampling entrance

• US 10,247,693 B2
• Filed: 11/08/2016
• Issued: 04/02/2019
• Est. Priority Date: 05/09/2013
• Status: Active Grant

• Current Assignee: Changsha Sinocare, Inc.
• Original Assignee: Changsha Sinocare, Inc.
• Inventors: Che, Hongli, Li, Shaobo
• Primary Examiner(s): Noguerola, Alexander S
• Application Number:
  US15/345,791
• Publication Number:
  US 20170052139A1
• Time in Patent Office: 875 Days
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A disposable electrochemical test sensor designed to facilitate sampling of fluid samples. It has a fluid chamber having a novel extra wide sampling entrance, but no additional air escape vent. The chamber provides a reservoir from which a sample fluid can be drawn into the chamber through capillary action. The sampling entrance provided can draw fluid into the chamber through any part of the opening, allowing easy targeting the samples with small volume, picking up smeared samples, and added tolerance to users who jam the tip of the sensor into users'"'"' finger. The sampling entrance also serves as air escape vent. Such one opening sensor alleviates over-flow issue often encountered in convenient sensors.

Claims

1. A sensor for sampling fluid samples comprising:

a base layer, comprising three wells at a front end, the three wells in electric communication with an electric contact end of the base layer;

a spacer attached to the base layer having a recessed portion on a front edge defining a fluid cavity, the fluid cavity constructed and arranged to be in fluid communication with the first, second, and third well of the base layer;

an upper layer, the upper layer positioned above the spacer and defining a top of the fluid cavity, a fluid inlet formed along a front edge of the spacer providing fluid access to the fluid cavity and defined by front edges of the base layer and the upper layer;

wherein the first well forms one of a reference electrode and a working electrode, and wherein the second and third wells are each the other of the reference or working electrode from the first well; and

wherein the three wells are arranged to define an approximate triangle, the first well positioned at a vertex angle opposite to the triangle base which is defined by the second and third wells, the first well being farther from a front edge of the base layer than the second and third wells, the well arrangement providing accurate current so long as a fluid is contacting at least two of the three wells.

2. The sensor of claim 1 wherein the base layer is formed of a first base layer, and a second base layer, the second base layer defining the first, second, and third wells by forming an aperture through its thickness.

3. The sensor of claim 1 wherein the shape and dimensions of the fluid cavity facilitate the drawing of a fluid sample into the fluid cavity using a capillary action.

4. The sensor of claim 3 wherein the fluid inlet serves as an air escape vent to facilitate the fluid sample being drawn into the fluid cavity using the capillary action.

5. The sensor of claim 1 wherein the recessed portion of the spacer forms a semi-circular cross section of the fluid cavity.

6. The sensor of claim 1 wherein the first, second, and third well serve to hold a chemical selected to react with an analyte in a fluid sample to produce an electrochemical signal.

7. The sensor of claim 6 wherein the chemical is formed from substrates selected from the group consisting of:

enzymes, antibodies, complexing reagents and combinations thereof.

8. The sensor of claim 6 wherein the chemical is formed from a mixture of a polymer, an enzyme, a surfactant, an electron acceptor, an electron donor, a buffer, a stabilizer and a binder.

9. The sensor of claim 6 wherein the chemical further comprises a mediator that is an electron acceptor, the mediator being redox chemicals either in oxidized or reduced form.

10. The sensor of claim 1 wherein the spacer is an electrically insulating material.

11. The sensor of claim 1 wherein the bottom surface of the upper layer is a hydrophilic surface.

12. The sensor of claim 1 wherein the recessed portion of the spacer is centrally disposed along the front edge of the spacer.

13. The sensor of claim 1 wherein the spacer is a double-sided adhesive tape.

14. The sensor of claim 1 wherein the front sampling end of the spacer is recessed from the front edge of the upper layer front sampling end and recessed from the front edge of the base layer front sampling end, the spacer recession defining two side openings, one on a first side of the test sensor and another on a second side of the test sensor.

15. The sensor of claim 14 wherein the two side openings are configured to allow a fluid to enter the fluid chamber through one of the two side openings when the first or second side of the test sensor is parallel to a surface that the fluid is on.

16. The sensor of claim 1 wherein the conductive coating is formed from materials selected from the group consisting of carbon, metals and metal oxides.

17. The sensor of claim 1 wherein the three wells are arranged to define an isosceles triangle.

18. A sensor for sampling fluid samples comprising:

a base layer, comprising three wells at a front end, the three wells in electric communication with an electric contact end of the base layer;

a spacer attached to the base layer having a recessed portion on a front edge defining a fluid cavity, the fluid cavity constructed and arranged to be in fluid communication with the first, second, and third well of the base layer;

wherein the first well forms one of a reference electrode and a working electrode, and wherein the second and third wells are each the other of the reference or working electrode from the first well; and

wherein the three wells are arranged to define an approximate triangle, the first well positioned at a vertex angle opposite to the triangle base which is defined by the second and third wells, the first well being farther from a front edge of the base layer than the second and third wells, the well arrangement providing accurate current so long as a fluid is contacting at least two of the three wells.