Low volume electrochemical sensor

• US 6,129,823 A
• Filed: 09/05/1997
• Issued: 10/10/2000
• Est. Priority Date: 09/05/1997
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: Bayliff, Simon William, Chambers, Geoffrey Roger, Hughes, Graham John
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US08/926,326
• Time in Patent Office: 1,131 Days
• Field of Search: 204/409, 204/403, 204/416, 204/415, 435/817
• US Class Current: 204/403.1
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

An electrochemical sensor electrode strip that measures analyte concentration in an aqueous sample as small as 2.5 to 2.0 μL is described. Reduction in the minimum sample size is achieved by means of a dielectric coating impregnated into peripheral regions of one or more hydrophilic mesh layers, thereby reducing sample dead volume. The mesh layers are located between an electrode support and a cover layer, which cover layer includes an aperture located upstream from an electrode arrangement.

Claims

1. In an elongated electrode strip for performing an electrochemical measurement of glucose in whole blood, in which the electrodes used to perform the measurement are covered with a mesh layer that extends a distance beyond the electrodes along the length of the strip, and the mesh is covered by a liquid impervious layer in which there is an aperture that does not overlay the electrodes, the improvement comprising:

a partial occlusion of the mesh that underlays the aperture, which partial occlusion reduces the total volume of blood needed to perform the measurement.

2. In the elongate electrode strip of claim 1, the further improvement comprising occluding at least about 50% of the mesh area underlaying the aperture.

3. The electrode strip of claim 2, wherein a whole blood sample of 2.5 microliters provides sufficient volume of sample to reach the electrodes and cause a measurement.

4. An electrode strip for use in an electrochemical sensor for measuring an analyte in an aqueous sample, comprising:

an electrode support

an electrode arrangement on said support, comprising a working electrode and a reference electrode, wherein said working electrode has an upstream end and a downstream end, and said reference electrode is adjacent to said downstream end of said working electrode;

a hydrophilic mesh layer overlaying a sample loading area and said electrode arrangement, said sample loading area being adjacent to said upstream end of said working electrode;

a cover layer defining an upper boundary of a cell volume encompassing said electrode arrangement;

an aperture in said cover layer, said aperture located above and defining the boundaries of said sample loading area, with no portion of said aperture located above said electrode arrangement;

a dielectric coating impregnated into peripheral regions of said mesh layer, thereby forming an occluded region of said mesh layer, said occluded region overlaying a portion of said sample loading area which lies beneath said aperture and defining side boundaries of said cell volume, said occluded region overlaying no portion of said electrode arrangement;

wherein said mesh layer draws said aqueous sample from said sample loading area onto said electrode arrangement, wherein said aqueous sample contacts said working electrode and said reference electrode.

5. The electrode strip of claim 4, wherein said electrode arrangement further comprises a dummy electrode.

6. The electrode strip of claim 4, comprising one mesh layer.

7. The electrode strip of claim 4, comprising two or more mesh layers.

8. The electrode strip of claim 4, wherein the total thickness of said mesh layer is between 40 and 200 μ

m.

9. The electrode strip of claim 4, wherein said mesh layer comprise an inherently hydrophilic mesh material.

10. The electrode strip of claim 4, wherein said hydrophilic mesh layer comprise a mesh material coated with a surfactant.

11. The electrode strip of claim 10, wherein said surfactant is FC 170C FLUORAD™

.

12. The electrode strip of claim 11, wherein said mesh material is woven nylon.

13. The electrode strip of claim 4, wherein said mesh layer comprise a woven mesh material having an open area of about 40 to about 45%, a mesh count of about 95 to about 115 strands per centimeter, a strand diameter of about 20 to about 40 μ

m, and a thickness of from about 40 to about 60 μ

m.

14. The electrode strip of claim 4, wherein said cover layer is substantially impermeable to aqueous liquids.

15. The electrode strip of claim 14, wherein said cover layer consists essentially of a polyester membrane.

16. The electrode strip of claim 4, wherein said electrode strip is between 4.5 and 6.5 mm wide.

17. The electrode strip of claim 16, wherein said aperture has a width between 2.5 and 3.5 mm and a length between 2.5 and 3.5 mm.

18. The electrode strip of claim 4, wherein said dielectric coating is hydrophobic.

19. The electrode strip of claim 4, wherein said occluded region forms a V-shaped sample flow channel in the sample loading area, wherein said V-shaped flow channel widens in the direction of said electrode arrangement.

20. The electrode strip of claim 19, wherein said V-shaped sample flow channel represents between 10 and 50% of the mesh layer area within said aperture.

21. The electrode strip of claim 4, wherein said dielectric coating has a color that contrasts with the color of said cover layer.

22. The electrode strip of claim 4, wherein said dielectric coating has a color that contrasts with the color of said cover electrode support.