Biosensor

• US 6,814,843 B1
• Filed: 11/01/2000
• Issued: 11/09/2004
• Est. Priority Date: 11/01/2000
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Walling, Douglas P., Hill, Brian S., Bhullar, Raghbir S.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/704,235
• Time in Patent Office: 1,469 Days
• Field of Search: 204/403.01, 204/403.14, 204/416, 422/58, 156/292, 156/291, 156/252
• US Class Current: 204/403.01
• CPC Class Codes: C12Q 1/001 Enzyme electrodes

Abstract

A biosensor is provided that comprises a substrate, a reagent positioned on the substrate, and a cover including a top side and a generally flat bottom side. The bottom side is coupled to the substrate to define a sealed portion and an unsealed portion. The unsealed portion cooperates with the substrate to define a channel extending across the reagent.

Claims

1. A biosensor comprising:

a substrate, at least a portion being non-embossed,

a reagent positioned on the non-embossed portion of the substrate, and

a cover positioned on the substrate, the cover including a top side and a generally flat non-embossed bottom side, the bottom side being sealed onto the substrate to define a sealed portion having an interior border and an unsealed portion positioned within the interior border of the sealed portion, at least a portion of the unsealed portion of the generally flat non-embossed bottom side cooperating with the substrate to define a channel positioned between the cover and the substrate, having sides defined by the interior border and extending across the reagent.

2. The biosensor of claim 1, wherein the cover includes an opening and the channel extends between the opening and the reagent.

3. The biosensor of claim 2, wherein the cover includes opposite ends and the channel extends between the opening and one of the ends.

4. The biosensor of claim 2, wherein the cover includes a second opening and the channel extends between the first and second openings.

5. The biosensor of claim 4, wherein the cover includes opposite edges and one opening is formed in each of the opposite edges.

6. The biosensor of claim 5, wherein each opening is defined by a disrupted concave surface.

7. The biosensor of claim 2, wherein the cover includes a second opening that is aligned with the reagent.

8. The biosensor of claim 7, wherein the channel converges from the first opening toward the second opening.

9. The biosensor of claim 1, further comprising electrodes positioned on the substrate and the channel extends across at least a portion of the electrodes.

10. The biosensor of claim 9, wherein the cover includes an opening to the channel that is spaced-apart from the electrodes.

11. The biosensor of claim 1, wherein the channel has a height that is less than 10 μ

m.

12. The biosensor of claim 1, further comprising an adhesive positioned between the cover and the substrate.

13. The biosensor of claim 1, wherein the cover includes an opening and the channel extends between the opening and the reagent.

14. The biosensor of claim 13, wherein the cover includes a second opening and the channel extends between the first and second openings.

15. The biosensor of claim 14, wherein the channel converges from the first opening toward the second opening.

16. The biosensor of claim 13, wherein the cover includes a second opening that is aligned with the reagent.

17. The biosensor of claim 1, wherein the channel has a height that is less than 10 μ

m.

18. The biosensor of claim 1, further comprising an adhesive positioned between the cover and the substrate.

19. A biosensor comprising:

a substrate, at least a portion being non-embossed,

a reagent positioned on the non-embossed portion of the substrate, and

a cover positioned on the substrate, the cover having a top side and a generally flat non-embossed bottom side, and an opening extending between the top and bottom sides, the bottom side being sealed onto the substrate to define a sealed portion having an interior border and an unsealed portion positioned within the interior border,

at least a portion of the unsealed portion of the generally flat non-embossed bottom side cooperating with the substrate to define a channel positioned between the cover and the substrate, having sides defined by the interior border and extending between the opening and the reagent.

20. The biosensor of claim 19, wherein the sealed portion has an interior border that is generally U-shaped.

21. The biosensor of claim 20, further comprising electrodes positioned on the substrate and at least a portion of the electrodes are positioned in the channel.

22. The biosensor of claim 19, wherein the sealed portion has an interior border that converges from the opening toward the reagent.

23. The biosensor of claim 19, wherein the cover includes two openings and the channel extends between the openings.

24. The biosensor of claim 23, wherein the cover includes opposite edges and the openings intersect the edges respectively.

25. The biosensor of claim 23, wherein the substrate includes notches that are aligned with the openings in the cover.

26. The biosensor of claim 23, wherein the sealed portion has an interior border that converges from the first opening toward the second opening.

27. A method of forming a biosensor having a capillary channel, the method comprising the steps of:

providing a substrate,

positioning a reagent on the substrate,

providing a cover having a top surface and a non-embossed bottom surface,

placing a thermoset adhesive on the bottom surface of the cover,

placing the adhesive-coated bottom surface on the substrate, and

heating portions of the thermoset adhesive to couple the bottom side to the substrate to define a sealed portion having an interior border and an unsealed portion positioned within the interior border, the unsealed portion cooperating with the substrate to define a capillary channel positioned between the cover and the substrate, having sides defined by the interior border and extending across the reagent.

28. The method of claim 27, further comprising the step of placing electrodes on the substrate.

29. The biosensor of claim 28, wherein the cover includes opposite ends and the channel extends between the opening and one of the ends.

30. A biosensor comprising:

a substrate,

a reagent positioned on the substrate,

a cover positioned on the substrate, the cover including a top side and a bottom side, the bottom side being coupled to the substrate to define a sealed portion having an interior border and an unsealed portion positioned within the interior border, and

a non-preformed channel positioned between the unsealed portion of the bottom side and the cover and having sides defined by the interior border, the channel extending across the reagent.

31. The biosensor of claim 30, further comprising electrodes positioned on the substrate and the channel extends across at least a portion of the electrodes.

32. A biosensor comprising:

a substrate,

a reagent positioned on the substrate,

a cover positioned on the substrate, the cover having a top side and a bottom side, and an opening extending between the top and bottom sides, the bottom side being coupled to the substrate to define a sealed portion having an interior border and an unsealed portion positioned within the interior border, and

a non-preformed channel positioned between the unsealed portion of the bottom side and the cover and having sides defined by the interior border, the channel extending between the opening and the reagent.

33. The biosensor of claim 32, wherein the sealed portion has an interior border that is generally U-shaped.

34. The biosensor of claim 33, further comprising electrodes positioned on the substrate and at least a portion of the electrodes are positioned in the channel.

35. The biosensor of claim 32, wherein the sealed portion has an interior border that converges from the opening toward the reagent.