Disposable sensor with enhanced sample port inlet

• US 6,837,976 B2
• Filed: 04/19/2002
• Issued: 01/04/2005
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Original Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Inventors: Cai, Xiaohua, Winarta, Handani, Young, Chung Chang, Vo, Andy
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/126,819
• Publication Number:
  US 20040224369A1
• Time in Patent Office: 991 Days
• Field of Search: 20440301-40315
• US Class Current: 204/403.14
• 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

Abstract

A disposable biosensor for testing a fluid sample including a laminated strip with a first and second end, a reference electrode embedded in the laminated strip proximate to the first end, at least one working electrode embedded in the laminated strip proximate to the first end and the reference electrode, an open path for receiving a fluid sample beginning from the first end and connecting to a vent spaced from the first end, the open path being sufficiently long to expose the reference electrode and the working electrode to the fluid sample, and conductive contacts located at the second end of the laminated strip. The laminated strip has a base layer with a conductive coating, a reagent holding layer, a channel forming layer and a cover having an inlet notch at the first end. The working electrode contains a reagent having an enzyme.

Claims

1. A disposable biosensor comprising:

a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer with at least three electrodes delineated thereon, a reagent holding layer carried on said base layer, said reagent holding layer having at least two cutouts, a channel forming layer carried on said reagent holding layer, and a cover having a notch at said first strip end;

an enclosed channel between said first strip end and said vent opening, said enclosed channel containing said at least two cutouts;

a first reagent disposed in a first cutout of said at least two cutouts forming a reference electrode;

a second reagent disposed in a second cutout of said at least two cutouts forming a first working electrode, said second reagent containing an enzyme; and

conductive contacts at said second strip end and insulated from said enclosed channel.

2. The biosensor of claim 1 wherein said enzyme is selected from the group consisting of glucose oxidase, lactate oxidase, cholesterol oxidase, and creatinine amidohydrolase.

3. The biosensor of claim 1 wherein said reagent holding layer has a third cutout.

4. The biosensor of claim 3 further comprising a third reagent disposed in said third cutout forming a second working electrode, said third reagent being substantially similar to said first reagent.

5. The biosensor of claim 1 wherein said reagents contain a redox mediator.

6. The biosensor of claim 5 wherein said reagents further contain at least one of a stabilizer, a binder, a surfactant, and a buffer.

7. The biosensor of claim 6 wherein said stabilizer is a polyalkylene glycol, said binder is a cellulose material, and said surfactant is a polyoxyethylene ether.

8. The biosensor of claim 7 wherein said stabilizer is polyethylene glycol, said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.

9. The biosensor of claim 8 wherein said reagents are made from a mixture having starting components comprising about 1 wt % to about 6.5 wt % of said redox mediator, about 2.5 wt % of said stabilizer, about 1 wt % of said binder, and about 0.03 wt % of said surfactant in said buffer.

10. The biosensor of claim 9 wherein said citrate buffer is about 0.05M.

11. The biosensor of claim 5 wherein said at least one redox mediator is potassium ferricyanide and other inorganic and organic redox mediators.

12. The biosensor of claim 9 wherein said first reagent is made of a mixture having starting components comprising about 1 wt % of said potassium ferricyanide, about 2.5 wt % of said polyethylene glycol, about 1 wt % of said methyl cellulose, about 0.03 wt % of said t-octylphenoxypolyethoxyethanol, and said citrate buffer is about 0.05M.

13. The biosensor of claim 9 wherein said second reagent is made of a mixture having starting components comprising about 6.5 wt % of said potassium ferricyanide, about 2.5 wt % of said polyethylene glycol, about 1 wt % of said methyl cellulose, about 0.03 wt % of said t-octylphenoxypolyethoxyethanol, and said pH buffer is about a 0.05M citrate buffer, and about 1 wt % of said enzyme.

14. The biosensor of claim 13 wherein said enzyme is glucose oxidase.

15. The biosensor of claim 1 wherein said base layer has a conductive coating disposed thereon for forming said at least three electrodes.

16. The biosensor of claim 15 wherein said conductive coating is gold.

17. The biosensor of claim 15 wherein said conductive coating comprising gold and tin oxide.

18. The biosensor of claim 15 wherein said base layer, said reagent holding layer, said channel forming layer, and said cover are made of a plastic dielectric material.

19. The biosensor of claim 18 wherein said plastic material is selected from the group consisting of polyvinyl chloride, polycarbonate, polysulfone, nylon, polyurethane, cellulose nitrate, cellulose propionate, cellulose acetate, cellulose acetate butyrate, polyester, acrylic, and polystyrene.

20. The biosensor of claim 1 wherein said enclosed channel is hydrophilic.

21. The biosensor of claim 1 wherein said cover has a hydrophilic coating on at least one side.

22. The biosensor of claim 1 wherein said channel forming layer has a thickness sufficient to optimize the flow of said fluid sample along said open path.

23. The biosensor of claim 22 wherein said thickness is about 0.007 inches (0.1778 mm).

24. The biosensor of claim 1 wherein the surface area of said first working electrode is substantially same as the surface area of said second working electrode.

25. A disposable electrode strip for detecting or measuring the concentration of at least one analyte in a fluid sample, said electrode strip comprising:

an insulating base layer having a first base end and a second base end;

a conductive layer disposed on one side of said base layer delineating at least three electrically-distinct conductive paths insulated from each other;

a reagent holding layer sized smaller than said base layer and overlaying a substantial portion of said conductive layer, said reagent holding layer having at least a first cutout portion and a second cutout portion spaced from said first base end, said first cutout portion exposing a limited area of a first of said at least three conductive paths and said second cutout portion exposing a limited area of a second and a third of said at least three conductive paths;

at least two electrode materials wherein a first electrode material is a reagent for measuring the concentration of said at least one analyte and wherein a second electrode material is a material suitable for use as a reference material, each of said at least two electrode materials contains at least a polyalkylene glycol as a stabilizer, said first material being disposed in said first cutout potion and said second material being disposed in said second cutout portion;

a channel forming layer sized to fit over and coextensive with said reagent holding layer, said channel forming layer having an opening configured to expose an area of said reagent holding layer a limited distance from said first base and, said area including said at least two cutout portions of said reagent holding layer; and

a top layer sized to fit over and coextensive with said channel forming layer creating a sample fluid channel, said top layer having an inlet notch at a first top layer end, said first top layer end being coextensive with said first base end, and a top layer vent spaced from said first base end and configured to expose at least a small portion of said opening of said channel forming layer.

26. The strip of claim 25 wherein said sample fluid channel is hydrophillic.

27. The device of claim 25 wherein said first material and said second material further include a redox mediator, a binder, a surfactant, and a buffer.

28. The strip of claim 27 wherein said redox mediator is at least one metal complex selected from the group consisting of ferrocene, ferrocene derivatives and potassium ferricyanide, said binder is a cellulose material, said surfactant is a polyoxyethylene ether, and said buffer has a pH of about 5 to about 6.

29. The strip of claim 28 wherein said mediator is potassium ferricyanide, said stabilizer is polyethylene glycol, said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.

30. The strip of claim 29 wherein said first reagent is made of a mixture having starting components comprising about 1 wt % of said potassium ferricyanide, about 2.5 wt % of said polyethylene glycol, about 1 wt % of said methyl cellulose, and about 0.03 wt % of said t-octylphenoxypolyethoxyethanol in said citrate buffer.

31. The strip of claim 29 wherein said second reagent is made of a mixture having starting components comprising about 6.5 wt % of said potassium ferricyanide, about 2.5 wt % of said polyethylene glycol, about 1 wt % of said methyl cellulose, about 0.03 wt % of said t-octylphenoxypolyethoxyethanol, and about 1 wt % of an enzyme in said citrate buffer.

32. The strip of claim 31 wherein said enzyme is glucose oxidase.

33. The strip of claim 25 wherein said insulating base layer, said reagent holding layer, said channel forming lawyer, and said top layer are made from a plastic material selected from the group consisting of polyvinyl chloride, polycarbonate, polysulfone, nylon, polyurethane, cellulose nitrate, cellulose propionate, cellulose acetate, cellulose acetate butyrate, polyester, acrylic, and polystyrene.

34. A laminated biosensor strip comprising:

a bass layer with an electrode end and an electrical contact end, said base layer having an electrically conductive coating on one side wherein said conductive coating has a plurality of scribed lines delineating a first conductive path having an L-shape, a second conductive path having a mirror-image L-shape wherein the L-shape ends of said first and second conduit conductive paths are adjacent to each other, and a third conductive path which is shorter than either of said first and second conductive paths and having a linear, elongated shape wherein said L-shaped ends of said first and second conductive paths and the end of said third conductive path are aligned with each other along the central axis of said base layer;

a reagent holding layer sized smaller than said base layer and overlaying a substantial portion of said conductive coating, said reagent holding layer having at least a first cutout portion and a second cutout portion, said first cutout portion exposing a limited area of said first conductive path and said second cutout portion exposing a limited area of at least said second conductive path;

at least two electrode materials wherein a first electrode material is a reagent for measuring the concentration of at least one analyte and wherein a second electrode material is a material suitable for use as a reference material, said first material being disposed in said first cutout portion and said second material being disposed in said second cutout portion;

a channel forming layer sized to fit over and coextensive with said reagent holding layer, said channel forming layer having an opening configured to expose an area of said reagent holding layer that includes said at least two cutout portions of said reagent holding layer; and

a cover with a vent, said cover disposed on and coextensive with said channel forming layer, said cover, said channel forming layer, said reagent holding layer, and said base layer forming a capillary channel with an inlet at one end and communicating with said vent at the other end.

35. The biosensor strip of claim 34 further comprising an inlet notch in said cover.

36. A disposable biosensor comprising:

a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer with at least two electrodes delineated thereon, a reagent holding layer carried on said base layer, said reagent holding layer having at least two cutouts, a channel forming layer carried on said reagent holding layer, and a cover having a notch at said first strip end;

an enclosed channel between said first strip end and said vent opening, said enclosed channel containing said at least two cutouts;

a reagent disposed in said at least two cutouts forming a first working electrode and a reference electrode, said reagent containing an enzyme; and

conductive contacts at said second strip end and insulated from said enclosed channel.

37. The biosensor of claim 36 wherein said enzyme is selected from the group consisting of glucose oxidase, lactate oxidase, cholesterol oxidase, and creatinine amidohydrolase.

38. The biosensor of claim 37 wherein said reagent further contains at least one of a redox mediator, a stabilizer, a binder, a surfactant, and a buffer.

39. The biosensor of claim 38 wherein said stabilizer is a polyalkylene glycol, said binder is a cellulose material, and said surfactant is a polyoxyethylene ether.

40. The biosensor of claim 39 wherein said stabilizer is polyethylene glycol, said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.

41. The biosensor of claim 40 wherein said reagent is made from a mixture having starting components comprising about 1 wt % to about 6.5 wt % of said redox mediator, about 2.5 wt % of said stabilizer, about 1 wt % of said binder, and about 0.03 wt % of said surfactant in said buffer.

42. The biosensor of claim 38 wherein said reagent is made from a mixture having starting components comprising about 6.5 wt % of said redox mediator, about 2.5 wt % of said stabilizer, about 1 wt % of said binder, about 0.03 wt % of said surfactant, about 1 wt % of said enzyme dissolved in a buffered solvent.

43. The biosensor of claim 42 wherein said enzyme is glucose oxidase.

44. The biosensor of claim 38 wherein said reagent is made of a mixture having stating components comprising about 6.5 wt % of potassium ferricyanide, about 2.5 wt % of polyethylene glycol, about 1 wt % of methyl cellulose, about 0.03 wt % of t-octylphenoxypolyethoxyethanol, about 1 wt % of said enzyme dissolved in said buffer wherein said buffer is about a 0.05M citrate buffer.

45. The biosensor of claim 36 wherein said reagent holding layer has a third cutout.