Disposable test sensor with improved sampling entrance

• US 9,523,653 B2
• Filed: 05/09/2013
• Issued: 12/20/2016
• 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 STEPHAN
• Application Number:
  US13/890,303
• Publication Number:
  US 20140332414A1
• Time in Patent Office: 1,321 Days
• US Class Current: 1/1
• 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 substantially rectangular first base layer, the first base layer being coated with three substantially parallel spaced-apart strips of conductive coating on a top surface, the three strips of conductive coating extending approximately from a front edge to a rear edge of the first base layer, the three strips of conductive coating serving as electrodes to electronically connect the sensor to a meter at the rear edge of the first base layer;

a substantially rectangular second base layer attached to the top surface of the first base layer, the second base layer forming three apertures at a front end, the three apertures extending completely through from an upper surface to a bottom surface of the second base layer to form a first well, a second well, and a third well, one of the three apertures being positioned to align over one of the three strips of conductive coating of the first base layer;

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

a substantially rectangular upper layer, the upper layer being positioned above the second base layer;

a spacer attached between a bottom surface of the upper layer and the upper surface of the second base layer, the spacer having a front edge, a first side edge and a second side edge, the spacer having a recessed portion on its front edge defining a fluid cavity, and being bounded by the recessed portion, the bottom of the upper layer, and the upper surface of the second base layer, wherein the fluid cavity is constructed and arranged to be in fluid communication with the first, second, and third well of the second base layer;

a first fluid inlet disposed along the front edge of the spacer, the first fluid inlet being an entrance to the fluid cavity;

wherein the shape and dimensions of the fluid cavity facilitate the drawing of a fluid sample into the fluid cavity using a capillary action; and

wherein the first fluid inlet serves as an air escape vent to facilitate the fluid sample being drawn into the fluid cavity using the capillary action.

2. The sensor of claim 1 wherein the second base layer is shorter in length than the first base layer to expose the electrodes at the rear edge of the first base layer.

3. 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.

4. The sensor of claim 3 wherein the chemical is formed from substrates selected from the group consisting of:

enzymes, antibodies, complexing reagents and combinations thereof.

5. The sensor of claim 3 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.

6. The sensor of claim 3 wherein the chemical further comprises a mediator that is an electron acceptor, the mediator being redox chemicals either in oxidized or reduced form.

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

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

9. The sensor of claim 1 wherein the cut-out is centrally disposed along the front edge of the spacer.

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

11. A sensor for sampling fluid samples comprising:

a substantially rectangular first base layer, the first base layer being coated with three substantially parallel spaced-apart strips of conductive coating on a top surface, the three strips of conductive coating extending approximately from a front edge to a rear edge of the first base layer, the three strips of conductive coating serving as electrodes to electronically connect the sensor to a meter at the rear edge of the first base layer;

a substantially rectangular second base layer attached to the top surface of the first base layer, the second base layer forming three apertures at a front end, the three apertures extending completely through from an upper surface to a bottom surface of the second base layer to form a first well, a second well, and a third well, one of the three apertures being positioned to align over one of the three strips of conductive coating of the first base layer;

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

a substantially rectangular upper layer, the upper layer being positioned above the second base layer;

a spacer attached between a bottom surface of the upper layer and the upper surface of the second base layer, the spacer having a front edge, a first side edge and a second side edge, the spacer having a recessed portion on its front edge defining a fluid cavity, the fluid cavity bounded by the recessed portion, the bottom of the upper layer and the upper surface of the second base layer, wherein the fluid cavity is constructed and arranged to be in fluid communication with the first, second, and third well of the second base layer; and

wherein the spacer is constructed and arranged to be slightly recessed in length relative to the first base layer, second base layer, and upper base layer when all are attached together leaving a first side opening defined by the spacer front edge, a first side edge of the second base layer and a first side edge of the upper layer, and the spacer leaving a second side opening defined by the spacer front edge, a second side edge of the second base layer, and a second side edge of the upper layer, wherein the first side opening, the second side opening and the front edge of the spacer together define a fluid inlet being an entrance to the fluid cavity that is accessible from an angle greater than 180 degrees such that a fluid may enter from the first side of the sensor, the second side of the sensor, and from a front of the sensor, the front being perpendicular to the first and second sides.

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

13. The sensor of claim 11 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.

14. The sensor of claim 11 wherein the first and second 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 edge is parallel to a surface that the fluid is on.

15. A sensor for sampling fluid samples comprising:

a substantially rectangular first base layer, the first base layer being coated with two substantially parallel spaced-apart strips of conductive coating on a top surface, the three strips of conductive coating extending approximately from a front edge to a rear edge of the first base layer, the three strips of conductive coating serving as electrodes to electronically connect the sensor to a meter at the rear edge of the first base layer;

a substantially rectangular second base layer attached to the top surface of the first base layer, the second base layer forming three apertures at a front end, the three apertures extending completely through from an upper surface to a bottom surface of the second base layer to form a first well, a second well, and a third well, one of the three apertures being positioned to align over one of the three strips of conductive coating of the first base layer;

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

a substantially rectangular upper layer, the upper layer being positioned above the second base layer;

a spacer attached between a bottom surface of the upper layer and the upper surface of the second base layer, the spacer having a front edge, a first side edge and a second side edge, the spacer having a recessed portion on its front edge defining a fluid cavity, wherein the recessed portion of the spacer forms a semi-circular cross section of the fluid cavity having a straight edge of the cross sectional semicircle facing a front edge of the sensor, the fluid cavity being symmetrical about a lengthwise centerline of the sensor, and being bounded by the recessed portion, the bottom of the upper layer, and the upper surface of the second base layer, wherein the fluid cavity is constructed and arranged to be in fluid communication with the first and second well of the second base layer;

wherein the shape and dimensions of the fluid cavity facilitate the drawing of a fluid sample into the fluid cavity using a capillary action; and

wherein the spacer is constructed and arranged to be slightly recessed in length relative to the first base layer, second base layer, and upper base layer when all are attached together leaving a first side opening defined by the spacer front edge, and a first side edge of the second base layer and a first side edge of the upper layer, and the spacer leaving a second side opening defined by the spacer front edge, and a second side edge of the second base layer and a second side edge of the upper layer, wherein the first side opening, the second side opening and the front edge of the spacer together define a fluid inlet being an entrance to the fluid cavity that is accessible from an angle greater than 180 degrees.

16. The sensor of claim 15 wherein the second bottom surface of the upper layer is a hydrophilic surface.

17. The sensor of claim 15 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.

18. The sensor of claim 15 wherein the first and second 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 edge is parallel to a surface that the fluid is on.