Disposable test sensor

• US 9,897,566 B2
• Filed: 01/13/2014
• Issued: 02/20/2018
• Est. Priority Date: 01/13/2014
• Status: Active Grant

• Current Assignee: Changsha Sinocare, Inc.
• Original Assignee: Changsha Sinocare, Inc.
• Inventors: Cai, Xiaohua, Che, Hongli, Li, Shaobo
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Tavares, Julie
• Application Number:
  US14/153,654
• Publication Number:
  US 20150198554A1
• Time in Patent Office: 1,499 Days
• Field of Search: 20440301
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

The present invention relates to disposable test sensors having improved sample application and measuring properties and their uses for detection, preferably, quantitative measurement, of analyte in a liquid sample like blood. In particular, the invention provides for an electrochemical biosensor which has a thin-layer fluid chamber having funnel-like shape with a novel extra wide opening as sampling entrance and a vent opening at the tip of the chamber for air escape. The thin-layer fluid chamber provides a reservoir from which a sample fluid can be drawn into it through capillary action. The extra wide sampling entrance provided by the present invention can draw blood into the chamber through any part of the opening, thus it allows easy targeting the samples with small volume, picking up smeared samples and it is more tolerant to users who jam the tip of the sensor into users'"'"' finger.

Claims

1. An electrochemical test sensor comprising:

a continuous base layer having a sampling end and an electric contact end, the base layer having electrodes at the sampling end, and electric contacts at the electric contact end, the electrodes being in communication with the electric contacts;

a middle layer formed of an electrically insulating material having a width approximately equal to a width of the base layer, and having a sampling end and an electric contact end, the middle layer being attached to the base layer, the middle layer forming a cutout region defined by a portion of a front edge being recessed from the middle layer sampling end along the width of the middle layer;

wherein the cutout region is funnel shaped, having inwardly tapering sides;

an upper layer having a sampling end and an electric contact end, the upper layer being attached to the middle layer; and

a fluid chamber defined on a top by the upper layer, on a bottom by the base layer, on a side by the recessed edge of the middle layer defining the cutout region, wherein the cutout region funnel shape extends towards the electric contact end away from the sampling end, the fluid chamber sized and configured to receive a fluid by capillary action, and sized and configured to expose the electrodes of the base layer to the fluid;

wherein the sampling end of the middle layer is slightly recessed from a front edge of the upper layer sampling end and slightly recessed from a front edge of the base layer sampling end, wherein the upper layer, middle layer, and base layer define two side openings in communication with the fluid chamber, a first side opening being on a first side of the sensor at the sampling end, a second side opening being on a second opposite side of the sensor at the sampling end, the two side openings being defined by the middle layer sampling end being slightly recessed from the front edge of the upper layer and base layer sampling ends;

the fluid chamber having a continuous sampling entrance to the fluid chamber defined by an open front opposite to the recessed edge of the middle layer and also defined by the two side openings;

wherein a combined length of the open front and the two side openings of the fluid chamber is less than a perimeter length of the middle layer cutout region; and

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

2. The electrochemical test sensor of claim 1 wherein each of the inwardly tapering sides of the cutout region is formed with a curving inward shape, forming a concave face.

3. The electrochemical test sensor of claim 2 wherein the curving inward shape of each inwardly tapering side is an arc.

4. The electrochemical test sensor of claim 1 wherein the upper layer defines a vent opening through its thickness, the vent positioned over a portion of the fluid chamber, the vent allowing gas to escape from the fluid chamber.

5. The electrochemical test sensor of claim 1 wherein the middle layer is formed of a two-sided adhesive tape.

6. The electrochemical test sensor of claim 1 wherein the upper layer further comprises a hydrophilic material on a surface facing the fluid chamber.

7. The electrochemical test sensor of claim 1 wherein the base layer further comprises a chemistry within the electrodes configured to cause an electrochemical signal once exposed to the fluid within the fluid chamber.

8. The electrochemical test sensor of claim 1 wherein the two side openings immediately exposes and are aligned with a second working electrode, a remainder of the electrodes positioned beneath the middle layer cutout region.

9. The electrochemical test sensor of claim 1 wherein the fluid chamber is adapted to receive a fluid sample of less than one microliter.

10. The electrochemical test sensor of claim 8 wherein the second working electrode exposed by and aligned with the two side openings has no chemistry, and is exposed to fluid before the remainder of the electrodes to establish a background signal before the fluid is exposed to the remainder of the electrodes.

11. The electrochemical test sensor of claim 10 wherein the second working electrode extends to the sampling end of the base layer.

12. The electrochemical test sensor of claim 8 wherein the electrodes are positioned on the base layer such that a fluid flow into the fluid chamber first contacts the second working electrode, then contacts a first working electrode, and then contacts a reference electrode.

13. An electrochemical test sensor comprising:

a base layer having a sampling end and an electric contact end, the base layer having electrodes at the sampling end, and electric contacts at the electric contact end;

a middle layer formed of an electrically insulating material having a width approximately equal to a width of the base layer, and having a sampling end and an electric contact end, the middle layer being attached to the base layer such that a portion of the electric contact end of the base layer extends beyond the electric contact end of the middle layer, while a portion of the base sampling end extends beyond the middle layer sampling end, the middle layer forming a cutout region defined by a recessed front edge portion from the middle layer sampling end;

wherein the cutout region is funnel shaped, having inwardly tapering sides;

an upper layer having a sampling end and an electric contact end, the upper layer being attached to the specified separately for each thread. This can be useful for example for graphicsmiddle layer such that the upper layer sampling end extends slightly beyond the middle layer sampling end, and such that the electric contact end is approximately aligned with the electric contact end of the middle layer;

a fluid chamber defined on a top by the upper layer, on a bottom by the base layer, on a side by the recessed edge of the middle layer defining the cutout region wherein the cutout region funnel shape extends towards the electric contact end away from the sampling end;

wherein the upper layer, middle layer, and base layer define two side openings at the sampling end in communication with the fluid chamber, the two side openings being defined by the upper layer and base layer extending beyond the sampling end of the middle layer, each of the two side openings extending from the front edge corners of the sensor; and

wherein the fluid chamber is sized and configured to receive a fluid by capillary action, and sized and configured to expose the electrodes of the base layer to the fluid;

the fluid chamber having a continuous sampling entrance to the fluid chamber defined by an open front opposite to the recessed edge of the middle layer and also defined by the two side openings;

wherein a combined length of the open front and the two side openings of the fluid chamber is less than a perimeter length of the middle layer cutout region; and

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

14. The electrochemical test sensor of claim 13 wherein each of the inwardly tapering sides of the cutout region is formed with a curving inward shape, forming a concave face.

15. The electrochemical test sensor of claim 14 wherein the curving inward shape of each inwardly tapering side is an arc.

16. The electrochemical test sensor of claim 13 wherein the upper layer defines a vent opening through its thickness, the vent positioned at the top of the fluid chamber.

17. The electrochemical test sensor of claim 13 wherein the middle layer is formed of a two-sided adhesive tape.

18. The electrochemical test sensor of claim 13 wherein the upper layer further comprises a hydrophilic material on a surface facing the fluid chamber.