Disposable test sensor with improved sampling entrance

• US 10,088,444 B2
• Filed: 11/08/2016
• Issued: 10/02/2018
• Est. Priority Date: 12/06/2013
• Status: Active Grant

• Current Assignee: Changsha Sinocare, Inc.
• Original Assignee: Changsha Sinocare, Inc.
• Inventors: Cai, Xiaohua, Che, Hongli, Li, Shaobo
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US15/345,760
• Publication Number:
  US 20170052138A1
• Time in Patent Office: 693 Days
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/16 Surface properties and coatings
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0694 vents used to stop and induce flow, backpressure valves
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

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

an upper layer having a front sampling end and an electric contact end;

a middle layer having a front sampling end and an electric contact end, the middle layer being positioned between the base layer and the upper layer such that a portion of the electric contact end of the base layer extends beyond the electric contact end of the middle layer, the middle layer forming a cutout region at the front sampling end defined by a portion of a front edge being recessed from the middle layer front sampling end;

wherein the front sampling end of the middle layer is recessed from a front edge of the upper layer front sampling end and recessed from a front edge of the base layer front sampling end, the middle layer recession defining two side openings, one on a first side of the test sensor and another on a second side of the test sensor;

wherein the base layer and upper layer form a rectangular shaped test sensor such that the first and second side edge of the test sensor are approximately perpendicular to the front sampling end;

a fluid chamber defined on a top by the upper layer, on a bottom by the base layer, on one side by the recessed edge of the middle layer defining the cutout region, and having a sampling entrance defined by the two side openings and an open side opposite to the recessed edge of the middle layer; and

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.

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

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

4. The electrochemical test sensor of claim 1 wherein the upper layer prevents a passage of air through it, and wherein the base layer prevents a passage of air through it.

5. 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.

6. The electrochemical test sensor of claim 1 wherein the cutout of the middle layer is semi-circular, the semi-circular cutout having a diameter slightly less than the width of the middle layer.

7. An electrochemical test sensor comprising:

a base layer having a front sampling end and an electric contact end and being coated with a conductive coating, the base layer having electrodes at the front 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 front 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, the middle layer forming a cutout region defined by a recessed front edge portion from the middle layer front sampling end;

an upper layer having a front sampling end and an electric contact end, the upper layer being attached to the middle layer such that the front sampling end is aligned with the front sampling end of the middle layer and such that the electric contact end is aligned with the electric contact end of the middle layer;

wherein the front sampling end of the middle layer is recessed from the front edges of the upper layer front sampling end and recessed from the base layer front sampling end, the middle layer recession defining two side openings;

wherein the base layer and upper layer form a rectangular shaped test sensor such that the first and second side edge of the test sensor are approximately perpendicular to the front sampling end;

a fluid chamber defined on a top by the upper layer, on a bottom by the base layer, on one side by the recessed edge of the middle layer defining the cutout region, and having a sampling entrance defined by the two side openings and an open side opposite to the one side; and

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

8. The electrochemical test sensor of claim 7 wherein the middle layer is formed of a two-sided adhesive tape.

9. The electrochemical test sensor of claim 7 wherein the upper layer further comprises a hydrophilic material on a surface facing the fluid chamber.

10. The electrochemical test sensor of claim 7 wherein the cutout of the middle layer is semi-circular.

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

12. An electrochemical test sensor comprising:

a base layer having a front sampling end and an electric contact end and being coated with a conductive coating, the base layer having electrodes at the front sampling end, and electric contacts at the electric contact end;

an upper layer having a front sampling end and an 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 front sampling end and an electric contact end, the middle layer being positioned between the base layer and the upper layer such that a portion of the electric contact end of the base layer extends beyond the electric contact end of the middle layer, and such that the electric contact end of the upper layer is aligned with the electric contact end of the middle layer, while a portion of the base layer front sampling end and upper layer front sampling end extend beyond the middle layer front sampling end, the middle layer forming a semi-circular cutout region defined by a recessed front edge portion from the middle layer front sampling end;

a fluid chamber defined on a top by the upper layer, on a bottom by the base layer, on one side by the recessed edge of the middle layer defining the cutout region, and having a sampling entrance on an open side opposite to the one side;

wherein the base layer and upper layer form a rectangular shaped test sensor such that the first and second side edge of the test sensor are approximately perpendicular to the front sampling end;

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

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; and

wherein the two side openings are configured to allow fluid to enter the fluid chamber through one of the two side openings when one of two lengthwise side edges of the base layer is parallel to a surface that the fluid is on.

13. The electrochemical test sensor of claim 12 wherein the middle layer is formed of a two-sided adhesive tape.

14. The electrochemical test sensor of claim 12 wherein the upper layer further comprises a hydrophilic material on a surface facing the fluid chamber.

15. The electrochemical test sensor of claim 12 wherein the upper layer is a continuous layer that prevents a passage of air through it, and wherein the base layer is a continuous layer that prevents a passage of air through it.

16. The electrochemical test sensor of claim 12 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.

17. The electrochemical test sensor of claim 12 wherein the sampling entrance comprises the open side, and the two side openings, the open side being along an entire front width of the sensor, the two side openings being adjacent to the open side, and defining a continuous opening.

18. The electrochemical test sensor of claim 17 wherein the sampling entrance is sized to allow an escape of air simultaneously with an entrance of fluid.