Biosensor

• US 7,287,318 B2
• Filed: 11/07/2003
• Issued: 10/30/2007
• Est. Priority Date: 10/06/2000
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hill, Brian S., Bhullar, Raghbir S., Wilsey, Christopher D.
• Primary Examiner(s): Arbes; Carl J.
• Application Number:
  US10/703,408
• Publication Number:
  US 20040163953A1
• Time in Patent Office: 1,453 Days
• Field of Search: 295/921, 295/95, 298/25, 204/403.01, 204/403.14
• US Class Current: 29/825
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49007 Indicating transducer
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A biosensor is provided that comprises a plate element with a pre-determined reaction zone and a recess positioned adjacent to the reaction zone. The biosensor also comprises a reagent that is positioned on the reaction zone. In preferred embodiments, the recess circumscribes at least a portion of the reaction zone.

Claims

1. A method of forming an electrode set, comprising:

providing a plate element

forming recesses in the plate element;

positioning electrodes on the plate element, the electrodes cooperating to define an interdigitated electrode array, and

positioning a reagent on at least a portion of the electrodes, wherein at least one recess circumscribes at least a portion of the electrode array and wherein at least one recess is positioned within the electrode array.

2. The method of claim 1, wherein at least one of the recesses has a width that is less than 1000 μ

m.

3. The method of claim 1, wherein at least one recess has a width of 1 μ

m to 250 μ

m.

4. A method of forming a biosensor, the method comprising:

providing a top plate element and a bottom plate element, the bottom plate element having a first surface and a pre-determined reaction zone on the first surface,

forming a recess in the first surface adjacent to and circumscribing at least a portion of the reaction zone;

coating a reagent on at least a portion of the reaction zone; and

extending the top plate element across the reagent so that the top plate element cooperates with the bottom plate element to define a gap, the gap having a sample opening and being sized to transport a liquid sample from the opening to the reagent, wherein at least a portion of the recess is positioned in the gap between the sample opening and the reagent.

5. The method of claim 4, wherein the recesses are formed by laser ablation.

6. The method of claim 5, wherein the recesses are formed by laser ablation.

7. The method of claim 4, wherein discrete recesses are formed in the plate element.

8. The method of claim 7, further comprising the step of forming electrodes on the reaction zone and the reagent engages at least a portion of the electrodes.

9. The method of claim 8, wherein at least one of the recesses is formed to be linear in shape.

10. The method of claim 8, wherein the recesses cooperate with one another to circumscribe at least a portion of the reaction zone.

11. The method of claim 7, wherein at least one recess is formed to have a width that is less than 1000 μ

m.

12. The method of claim 7, wherein at least one recess is formed to have a width of 1 μ

m to 250 μ

m.

13. The method of claim 7, wherein the electrodes cooperate to define an electrode array with a pre-determined pattern.

14. The method of claim 7, wherein at least one of the recesses is fanned to be curved in shape.

15. The method of claim 14, wherein the recesses cooperate with one another to circumscribe at least a portion of the reaction zone.

16. The method of claim 4, wherein the recess is formed to have a width that is less than 1000 μ

m.

17. The method of claim 4, wherein the recess is formed to have a width of 1 μ

m to 250 μ

m.

18. The method of claim 4, wherein the recess has is formed to have height of 0.5 μ

m to 500 μ

m.

19. The method of claim 18, wherein the at least one wall is formed to have a height of 8 μ

m to 25 μ

m.

20. The method of claim 4, wherein the recess is formed to be rectangular in shape.

21. A method of Coming a biosensor, the method comprising:

providing a top plate element and a bottom plate element, the bottom plate element including a first surface;

forming a recess in the first surface;

positioning a reagent on the first surface adjacent to the recess; and

coupling the a top plate element to the bottom plate element so that the top plate element extends across the reagent and cooperates with the bottom plate element to define a gap, the gap having a sample opening and sized to transport a liquid sample from the opening to the reagent, wherein at least a portion of the recess is positioned in the gap between the sample opening and the reagent and the recess circumscribes at least a portion of the reagent.

22. The method of claim 21, further comprising the step of forming an electrode array having a pre-determined electrode pattern positioned between the top and bottom plate elements, wherein the reagent engages at least a portion of the electrode array.

23. The method of claim 22, wherein the biosensor includes two spaced-apart recesses.

24. The method of claim 23, wherein the recesses circumscribe at least a portion of the electrode array.

25. The method of claim 23, wherein the recesses are positioned within the electrode pattern of the array.

26. A method of forming a biosensor, the method comprises the steps of:

providing a plate element;

ablating at least one recess in. the plate element;

applying a reagent onto the plate element to define a reaction zone, wherein the at least one recess circumscribes at least a portion of the reaction zone; and

positioning a top plate element over the bottom plate element so that the top plate element extends across the reagent cooperates with the bottom plate element to create a gap having a liquid sample opening and at least a portion of at least one recess is positioned in the gap between the sample opening and the reaction zone.

27. The method of claim 26, further comprising the step of forming an electrode set in the reaction zone.

28. The method of claim 26, wherein the recesses are formed by laser ablation.

29. A method of forming a biosensor, the method comprising:

providing a plate element formed to include a first surface and a pre-determined reaction zone on the first surface,

forming discrete recesses in the first surface adjacent to and circumscribing at least a portion of the reaction zone;

positioning a reagent on at least a portion of the reaction zone; and

positioning electrodes on the reaction zone such that the electrodes cooperate to define an electrode array with a pre-determined pattern, wherein the reagent engages at least a portion of the electrodes and the discrete recesses are positioned within the pattern.