Biosensor

• US 6,645,359 B1
• Filed: 10/06/2000
• Issued: 11/11/2003
• Est. Priority Date: 10/06/2000
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Hill, Brian S., Bhullar, Raghbir S., Wilsey, Christopher D.
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/684,257
• Time in Patent Office: 1,131 Days
• Field of Search: 204/403, 204/409, 204/403.01, 204/403.04, 204/403.08, 204/403.1, 204/403.14, 422/52, 422/56, 422/57, 427/2.13
• US Class Current: 204/403.01
• 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 biosensor comprising:

a bottom plate element formed to include a first surface, a pre-determined reaction zone on the first surface, and a recess formed in the first surface and positioned adjacent to and circumscribing at least a portion of the reaction zone; and

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

a top plate element extending across the reagent and cooperating 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.

2. The biosensor of claim 1, wherein the plate element includes discrete recesses.

3. The biosensor of claim 2, further comprising electrodes positioned on the reaction zone and the reagent engages at least a portion of the electrodes.

4. The biosensor of claim 3, wherein at least one of the recesses is linear in shape.

5. The biosensor of claim 3, wherein the recesses cooperate with one another to circumscribe at least a portion of the reaction zone.

6. The biosensor of claim 2, wherein at least one recess has a width that is less than 1000 μ

m.

7. The biosensor of claim 2, wherein at least one recess has a width of 1 μ

m to 250 μ

m.

8. The biosensor of claim 2, wherein at least one of the recesses is curved in shape.

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

10. The biosensor of claim 1, wherein the recess has a width that is less than 1000 μ

m.

11. The biosensor of claim 1, wherein the recess has a width of 1 μ

m to 250 μ

m.

12. The biosensor of claim 1, wherein the recess has height of 0.5 μ

m to 500 μ

m.

13. The biosensor of claim 12, wherein at least one wall defines the recess and the at least one wall has a height of 8 μ

m to 25 μ

m.

14. The biosensor of claim 1, wherein the recess is rectangular in shape.

15. A biosensor comprising:

a plate element formed to include a first surface, a pre-determined reaction zone on the first surface, and a recess formed in the first surface and positioned adjacent to and circumscribing at least a portion of the reaction zone;

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

electrodes positioned on the reaction zone and the reagent engages at least a portion of the electrodes,

wherein the plate element includes discrete recesses and the electrodes cooperate to define an electrode array with a pre-determined pattern and the recesses are positioned within the pattern.

16. The biosensor of claim 15, wherein the reagent extends across the array and into the recesses positioned within the electrode pattern.

17. The biosensor of claim 15, wherein at least one of the recesses is linear in shape.

18. The biosensor of claim 15, wherein at least one recess has a width that is less than 1000 μ

m.

19. The biosensor of claim 18, wherein at least one recess has a width of 1 μ

m to 250 μ

m.

20. The biosensor of claim 15, wherein at least one of the recesses is curved in shape.

21. The biosensor of claim 15, wherein at least one of the recesses has height of 0.5 μ

m to 500 μ

m.

22. A biosensor comprising:

a bottom plate element including a first surface formed to include a recess therein;

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

a top plate clement extending across the reagent, being coupled to the bottom plate element, and cooperating 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.

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

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

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

26. A biosensor comprising:

a bottom plate element including a first surface formed to include at least two spaced-apart recesses therein;

an array defining an electrode pattern,

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

a top plate element coupled to the bottom plate element, wherein at least one of the recesses is positioned within the electrode pattern of the array.

27. An electrode set, comprising:

a plate element formed to include recesses therein,

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

a reagent positioned 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.

28. The electrode set of claim 27, wherein the at least one recess has a width that is less than 1000 μ

m.

29. The biosensor of claim 27, wherein at least one recess has a width of 1 μ

m to 250 μ

m.

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

providing a bottom plate element;

laser ablating recesses in the bottom plate element;

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

coupling a top plate element to 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.

31. The method of claim 30, further comprising the step of forming an electrode set in the reaction zone.

32. A biosensor comprising:

electrodes formed by tracks that cooperate to form an array and leads that extend from the array,

a plate element formed to include a first surface supporting the electrodes and discrete recesses formed in the first surface on opposite sides of the array, wherein at least one of the recesses is positioned between the leads;

a reagent coated on at least a portion of the electrodes, and

a top plate element cooperating with the 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.

33. The biosensor of claim 32, wherein the recesses cooperate with one another to circumscribe at least a portion of the electrodes.

34. The biosensor of claim 32, wherein at least one of the recesses has a width that is less than 1000 μ

m.

35. The biosensor of claim 34, wherein at least one of the recesses has a width of 1 μ

m to 250 μ

m.

36. A biosensor comprising:

electrodes formed by tracks that cooperate to form an array and leads that extend from the array,

a plate element formed to include a first surface supporting the electrodes and discrete recesses formed in the first surface on opposite sides of the array, wherein at least one of the recesses is positioned between the leads, and

a reagent coated on at least a portion of the electrodes,

wherein the electrodes cooperate to define an electrode array with a pre-determined pattern and the recesses are positioned within the pattern.