Method and apparatus for electrochemical analysis

• US 20060266644A1
• Filed: 05/25/2005
• Published: 11/30/2006
• Est. Priority Date: 05/25/2005
• Status: Active Grant

• Current Assignee: Universal Biosensors Pty Ltd. (Universal Biosensors, Inc.)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Hodges, Alastair, Pugh, Jerry T., Chambers, Garry
• Granted Patent: US 8,323,464 B2
• Time in Patent Office: Days
• US Class Current: 204/400
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Electrochemical sensors for investigating a physiological sample and methods of manufacture are disclosed. The sensor includes a longitudinally extending reaction cell, having electrodes and a reagent, and laterally spaced electrical contact points for electrically communication with a meter. An array of such sensors is further disclosed including connective flaps for joining adjacent sensors. In use, the array of sensors can be stored in a folded configuration and dispensed individually.

Claims

1. An electrochemical device, comprising:

a first electrically conductive layer including a first electrode area and an opposing second electrically conductive layer include a second electrode area, the first and second electrically conductive layers being separated by an insulating spacing layer;

a reaction cell defined by the first and second electrically conductive layers, and a longitudinally extending opening in the spacing layer, the reaction cell including a proximal sample ingress opening; and

first and second electrical contact areas laterally spaced from the longitudinal reaction cell, the first electrical contact area positioned on the first electrically conductive layer and the second electrical contact area positioned on the second electrically conductive layer.

2. The device of claim 1, wherein the reaction cell extends from a proximal sidewall of the device to a distal sidewall of the device.

3. The device of claim 1, wherein the reaction cell includes a distal vent.

4. The device of claim 1, wherein the first and second electrically conductive layers are spaced such that a sample brought into contact with the proximal opening is drawn into the reaction cell via capillary action.

5. The device of claim 1, wherein the reaction cell is positioned along a central longitudinal axis.

6. The device of claim 5, wherein the first electrical contact area is positioned adjacent to a first lateral edge of the device and the second electrical contact area is positioned adjacent to a second lateral edge the device.

7. The device of claim 1, wherein a connective flap extends beyond the first and second electrically conductive layers for connecting with another electrochemical sensor.

8. The device of claim 1, wherein at least a portion of the spacing layer extends beyond the first and second electrically conductive layers to define a connective flap for connecting an adjacent electrochemical device.

9. The device of claim 8, further comprising two pairs of connective flaps.

10. The device of claim 1, wherein the first electrical contact area is positioned on a top surface of the device and the second electrical contact area is positioned on a bottom surface of the device.

11. The device of claim 1, wherein the first and second electrical contact areas are spaced longitudinally from the reaction cell.

12. The device of claim 1, wherein the first and second electrical contact areas are laterally spaced from one another.

13. A strip of connected electrochemical sensors, comprising:

at least two sensors;

a first sensor comprising,

(a) a first electrically conductive layer, second electrically conductive layer, and a spacer layer positioned therebetween, the spacer layer including a longitudinal aperture defining a reaction cell,

(b) first and second electrical contact areas laterally spaced from the longitudinal reaction cell, and

(c) at least one connective flap for connecting with another electrochemical sensor; and

a second sensor connected to the first sensor, comprising,

(a) a first electrically conductive layer, second electrically conductive layer, and a spacer layer positioned therebetween, the spacer layer including a longitudinal aperture defining a reaction cell,

(b) first and second electrical contact areas laterally spaced from the longitudinal reaction cell, and

(c) at least one connective flap connected to the at least one connective flap on the first sensor.

14. The sensors of claim 13, wherein the at least one connective flap of the first and second sensors comprises a portion of the spacer layer.

15. The sensors of claim 13, wherein the first and second sensors are adapted to pivot with respect to one another.

16. The sensors of claim 13, wherein the first and second sensors comprise an additional layer, and the additional layer provides the connective flap of the first and second sensor.

17. A method of manufacturing an array of sensors, comprising:

providing a longitudinally extending first electrically conductive layer having a first electrode surface, a longitudinally extending second electrically conductive layer having a second electrode surface, and a longitudinally extending spacer layer having longitudinal openings at regular intervals;

applying a reagent to the first electrically conductive layer;

combining the first electrically conductive layer, spacer layer, and second electrically conductive layer, such that the first and second electrode surfaces are opposing, and a portion of the first electrically conductive layer extends beyond the spacer layer and the second electrically conductive layer to define a first electrical contact area, and a portion of the second electrically conductive layer extends beyond the first electrically conductive layer and spacer layer to define a second electrical contact area;

cutting holes through the layers at regular intervals; and

singulating the combined layers to define discrete sensors held together by connective flaps.

18. The method of claim 17, wherein the step of combining the layers occurs before the step of cutting holes through the layers.

19. The method of claim 17, wherein an adhesive on the spacer layer holds the combined layers together.

20. The method of claim 17, wherein the longitudinal apertures in the spacer layer provide a reaction cell in each discrete sensor.

21. The method of claim 17, wherein the singulation step leaves only the spacer layer holding adjacent sensors together.

22. The method of claim 17, including cutting the first and second electrically conductive layers prior to combining the layers.