Electrochemical test strips

• US 8,172,995 B2
• Filed: 07/24/2008
• Issued: 05/08/2012
• Est. Priority Date: 07/26/2007
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Iyengar, Sridhar
• Primary Examiner(s): Barton, Jeffrey T
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US12/179,393
• Publication Number:
  US 20090026074A1
• Time in Patent Office: 1,384 Days
• Field of Search: 20440301-40315
• 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 easily manufactured electrochemical test strip is made with facing electrode but side by side connectors for insertion into an electrochemical test meter. Current is conducted from the electrode on one layer to a connector on the other by a conductive layer disposed adjacent the end of a spacer layer, or by displacing the layer to bring a conductive surface on it into contact with the connector.

Claims

1. A test strip comprising:

(a) a base substrate having disposed thereon

(i) a first electrode and connector track, said first electrode and connector track comprising a first electrode connector, and

(ii) a second electrode connector,

(b) a dielectric layer comprising two strips of dielectric material extending longitudinally along the base substrate from a measurement end to a connector end, said dielectric strips having an open space between them defined by inner longitudinal edges, said open space exposing a portion of the first electrode and connector track and extending less than the entire length of the base substrate, such that a first of said strips of dielectric leaves a portion the first electrode connector exposed at the connector end of the first dielectric strip, and the second of said strips leaves at least a portion of the second electrode connector exposed at the connector end of the second dielectric strip, said exposed portion of the second electrode connector being greater in length than the exposed portion of the first electrode connector,

(c) a spacer layer comprising two strips of insulating material disposed over the dielectric layer, said insulating strips having an open space between them exposing the inner longitudinal edges of the dielectric strips and extending less than the entire length of the base substrate such that a first of said insulating strips leaves a portion of the first electrode connector exposed, and the second of said insulating strips leaves at least a portion of the second electrode connector exposed, said exposed portion of the second electrode connector being greater in length than the exposed portion of the first electrode connector,

(d) a conductive material disposed to make conductive contact with the exposed portion of the second electrode connector, and

(e) a top layer comprising a substrate having disposed thereon a second electrode and connector track, wherein a portion of the second electrode and connector track is disposed in opposition to the exposed portion of the first electrode and connector track, and a portion of the second connector track is disposed in contact with the conductive material, said top layer being shorter than the base substrate such that a connector portion of the base substrate having the exposed portions of the first electrode connector and the second electrode connector remains exposed.

2. The test strip according to claim 1, wherein the first electrode and connector track and the second electrode and connector track are each in the form of a loop with an extension foaming the first electrode connector.

3. The test strip of claim 1, further comprising a protective layer adhered to the connector portion of the base substrate to the exterior surface of the top layer and extending therebetween, said protective layer being sized such that the connector portion of the base substrate is not fully covered.

4. The test strip of claim 1, wherein a hole is punched through one or both of the substrates at a location adjacent to the inner edge of the exposed portion of the first electrode and connector track.

5. The test strip of claim 1, wherein the base substrate is coated with a hydrophobic coating in a region adjacent to the inner edge of the exposed portion of the first electrode and connector track.

6. The test strip of claim 1, where the exposed portion of the first electrode, and dielectric layers, the spacer layers and the top layer define a test cell having a volume of less than 1 μ

l.

7. The test strip of claim 1, wherein the conductive material disposed to make conductive contact with the second electrode connector is a layer of conductive material that is distinct from the second electrode connector and the second electrode and connector track.

8. The test strip according to claim 7, wherein the first electrode and connector track and the second electrode and connector track are each in the form of a loop with an extension forming the first electrode connector.

9. The test strip of claim 7, further comprising a protective layer adhered to the connector portion of the base substrate to the exterior surface of the top layer and extending therebetween, said protective layer being sized such that the connector portion of the base substrate is not fully covered.

10. The test strip of claim 7, wherein a hole is punched through one or both of the substrates at a location adjacent to the inner edge of the exposed portion of the first electrode and connector track.

11. The test strip of claim 7, wherein the base substrate is coated with a hydrophobic coating in a region adjacent to the inner edge of the exposed portion of the first electrode and connector track.

12. The test strip of claim 7, where the exposed portion of the first electrode track, and dielectric layers, the spacer layers and the top layer define a test cell having a volume of less than 1 μ

l.

13. The test strip of claim 1, wherein the top layer is displaceable to press the second electrode and connector track into conductive contact with the second electrode connector.

14. A test strip comprising:

(a) a base substrate having disposed thereon

(i) a first electrode and connector track, said first electrode and connector track comprising a first electrode connector, and

(ii) a second electrode connector,

(b) a dielectric layer comprising two strips of dielectric material extending longitudinally along the base substrate, said dielectric strips having an open space between them defined by inner longitudinal edges, said open space exposing a portion of the first electrode and connector track and extending less than the entire length of the base substrate, such that a first of said strips of dielectric leaves a portion the first electrode connector exposed, and the second of said strips leaves at least a portion of the second electrode connector exposed, said exposed portion of the second electrode connector being greater in length than the exposed portion of the first electrode connector,

(c) a spacer layer comprising two strip of insulating material disposed over the dielectric layer, said insulating strips having an open space between them exposing the inner longitudinal edges of the dielectric strips and extending less than the entire length of the base substrate such that a first of said insulating strips leaves a portion of the first electrode connector exposed, and the second of said insulating strips leaves at least a portion of the second electrode connector exposed, said exposed portion of the second electrode connector being greater in length than the exposed portion of the first electrode connector,

(d) a conductive material disposed to make conductive contact with the exposed portion of the second electrode connector, and

(e) a top layer comprising a substrate having disposed thereon a second electrode and connector track, wherein a portion of the second electrode and connector track is disposed in opposition to the exposed portion of the first electrode and connector track, and a portion of the second connector track is disposed in contact with the conductive material, said top layer being shorter than the base substrate such that a connector portion of the base substrate having the exposed portions of the first electrode connector and the second electrode connector remain exposed, wherein the first electrode and connector track and the second electrode and connector track are each in the form of a loop with an extension forming the first electrode connector,

further comprising a protective layer adhered to the connector portion of the base substrate to the exterior surface of the top layer and extending therebetween, said protective layer being sized such that the connector portion of the base substrate is not fully covered.

15. The test strip of claim 14, wherein a hole is punched through one or both of the substrates at a location adjacent to the inner edge of the exposed portion of the first electrode and connector track.

16. The test strip of claim 14, wherein the base substrate is coated with a hydrophobic coating in a region adjacent to the inner edge of the exposed portion of the first electrode and connector track.

17. The test strip of claim 14, where the exposed portion of the first electrode, and dielectric layers, the spacer layers and the top layer define a test cell having a volume of less than 1 μ

l.

18. The test strip of claim 14, wherein the top layer is displaceable to press the second electrode and connector track into conductive contact with the second electrode connector.

19. A test strip comprising:

(a) a base substrate having disposed thereon

(i) a first electrode and connector track, said first electrode and connector track comprising a first electrode connector, and

(ii) a second electrode connector,

(b) a dielectric layer comprising two strips of dielectric material extending longitudinally along the base substrate, said dielectric strips having an open space between them defined by inner longitudinal edges, said open space exposing a portion of the first electrode and connector track and extending less than the entire length of the base substrate, such that a first of said strips of dielectric leaves a portion the first electrode connector exposed, and the second of said strips leaves at least a portion of the second electrode connector exposed, said exposed portion of the second electrode connector being greater in length than the exposed portion of the first electrode connector,

(c) a spacer layer comprising two strips of insulating material disposed over the dielectric layer, said insulating strips having an open space between them exposing the inner longitudinal edges of the dielectric strips and extending less than the entire length of the base substrate such that a first of said insulating strips leaves a portion of the first electrode connector exposed, and the second of said insulating strips leaves at least a portion of the second electrode connector exposed, said exposed portion of the second electrode connector being greater in length than the exposed portion of the first electrode connector,

(d) a conductive material disposed to make conductive contact with the exposed portion of the second electrode connector, and

(e) a top layer comprising a substrate having disposed thereon a second electrode and connector track, wherein a portion of the second electrode and connector track is disposed in opposition to the exposed portion of the first electrode and connector track, and a portion of the second connector track is disposed in contact with the conductive material, said top layer being shorter than the base substrate such that a connector portion of the base substrate having the exposed portions of the first electrode connector and the second electrode connector remains exposed, wherein the conductive material disposed to make conductive contact with the second electrode connector is a part of the second electrode and connector track, and said top layer is displaceable to press the second electrode and connector track into conductive contact with the second electrode connector, and wherein the top layer is displaced to press the second electrode and connector track into conductive contact with the second electrode connector by a protective layer adhered to the connector portion of the base substrate to the exterior surface of the top layer and extending therebetween, said protective layer being sized such that the connector portion of the base substrate is not fully covered.

20. The test strip of claim 19, wherein the said top layer is displaceable to press the second electrode and connector track into conductive contact with the second electrode connector upon insertion of the test strip into a strip port connector of a test meter.