Analytical instruments, biosensors and methods thereof

• US 6,652,720 B1
• Filed: 05/31/2001
• Issued: 11/25/2003
• Est. Priority Date: 05/31/2001
• Status: Expired due to Term

• Current Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Original Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Inventors: Mansouri, Sohrab, Cosofret, Vasile, Xu, Clarke
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/872,247
• Time in Patent Office: 908 Days
• Field of Search: 204/402, 204/403.03, 204/403.05, 204/403.1, 204/403.11, 204/403.12, 204/403.14, 204/409, 204/411, 204/415
• US Class Current: 204/403.11
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

An electrochemical sensor system and membrane and method thereof for increased accuracy and effective life of electrochemical and enzyme sensors.

Claims

1. An electrochemical sensor, comprising:

at least one electrode; and

,

a composite membrane, the composite membrane comprising an outer layer comprising a polyurethane-based compound, an enzyme layer, and a restorable inner layer in contact with at least one electrode and comprising a polymerizable membrane, wherein the enzyme layer is disposed next to the inner layer.

2. An electrochemical sensor, comprising:

at least one electrode; and

,

a composite membrane, the composite membrane comprising an outer layer, an enzyme layer, and a restorable inner layer, wherein the inner layer is in contact with at least one electrode and comprises benzothiophene.

3. An electrochemical sensor cartridge, comprising:

an electrochemical sensor card comprising at least one electrochemical sensor and a reservoir containing an electropolymerizable monomer solution in fluid communication with the electrochemical sensor card.

4. The electrochemical sensor cartridge of claim 3, wherein the electrochemical sensor card comprises at least one composite membrane.

5. The electrochemical sensor cartridge of claim 4, wherein the composite membrane comprises a restorable inner layer.

6. The electrochemical sensor cartridge of claim 3, further comprising at least one calibration solution combined with the electropolymerizable monomer in a reservoir in fluid communication with the electrochemical sensor card.

7. The electrochemical sensor cartridge of claim 3, wherein the concentration of said electropolymerizable monomer solution is in the range of about 1 mM to 100 mM.

8. The electrochemical sensor cartridge of claim 3, wherein at least one of the electrochemical sensors comprises an enzyme electrode sensor.

9. The electrochemical sensor cartridge of claim 3, wherein the electropolymerizable monomer is selected from the group consisting of benzothiophene, phenylenediamine, and dihydroxybenzene.

10. The electrochemical sensor cartridge of claim 3, wherein said electropolymerizable monomer comprises benzothiophene.

11. The electrochemical sensor cartridge of claim 3, wherein said electropolymerizable monomer comprises phenylenediamine.

12. The electrochemical sensor cartridge of claim 3, wherein said electropolymerizable monomer comprises dihydroxybenzene.

13. The electrochemical sensor cartridge of claim 3, wherein the electrochemical sensor is selective for a compound selected from a group consisting of hydrogen ion, carbon dioxide, oxygen, sodium ion, potassium ion, ionized calcium, chloride, hematocrit, glucose, lactate, creatine, creatinine or urea.

14. The electrochemical sensor cartridge of claim 3, wherein the electropolymerizable monomer is at least one phenylenediamine derivative.

15. An electrochemical sensor system, comprising:

an electrochemical sensor card comprising at least one electrochemical sensor, said electrochemical sensor comprising at least one polymerc membrane;

an electrochemical sensor apparatus in electrical contact with the electrochemical sensor card, the electrochemical sensor apparatus configured to measure electrical signals from the electrochemical sensor card and capable of providing an electrical potential to the electrochemical sensor for the polymerization of an electropolymerizable monomer to the polymeric membrane; and

a reservoir containing a solution comprising the electropolymerizable monomer in fluid communication with the electrochemical sensor card, said electropolymerizable monomer solution polymerized to said polymeric membrane by the electrical potential provided by said electrochemical sensor apparatus.

16. The electrochemical sensor system of claim 15, wherein the electrochemical sensor card comprises at least one composite membrane.

17. The electrochemical sensor cartridge of claim 16, wherein the composite membrane comprises a restorable inner layer.

18. The electrochemical sensor system of claim 15, wherein at least one of the electrochemical sensors comprises an enzyme electrode sensor.

19. The electrochemical sensor system of claim 15, wherein the electrochemical sensor is selective for a compound selected from a group consisting of hydrogen ion, carbon dioxide, oxygen, sodium ion, potassium ion, ionized calcium, chloride, hematocrit, glucose, lactate, creatine, creatinine or urea.

20. The electrochemical sensor system of claim 15, wherein the electropolymerizable monomer is selected from a group consisting of benzothiophene, phenylenediamine, and dihydroxybenzene.

21. The electrochemical sensor system of claim 15, wherein the electropolymerizable monomer comprises phenylenediamine.

22. The electrochemical sensor system according to claim 15, wherein said electrochemical sensor apparatus is further capable of providing a change in electrical potential for at least the partial removal of interfering agents in the polymeric membrane.

23. The electrochemical sensor system according to claim 15, further comprising an outer membrane, and an enzyme layer, said enzyme layer in contact with said outer membrane and said polymeric membrane.

24. An electrochemical sensor system, comprising:

an electrochemical sensor card comprising at least one electrochemical sensor, said electrochemical sensor comprising at least one polymeric membrane;

an electrochemical sensor apparatus in electrical contact with the electrochemical sensor card, the electrochemical sensor apparatus configured to measure electrical signals from the electrochemical sensor card and capable of providing an electrical potential to the electrochemical sensor for the polymerization of an electropolymerizable monomer to the polymeric membrane;

a reservoir containing a solution comprising the electropolymerizable monomer in fluid communication with the electrochemical sensor card, said electropolymerizable monomer solution polymerized to said polymeric membrane by the electrical potential provided by said electrochemical sensor apparatus; and

a calibration solution in said reservoir containing an electropolymerizable monomer solution.

25. The electrochemical sensor system of claim 24, wherein the concentration of said electropolymerizable monomer solution in said calibration solution comprises the range of about 1 to 100 mM.

26. The electrochemical sensor system according to claim 24 wherein the concentration of said electropolymerizable monomer solution in said calibration solution is 1 to 100 mM.

27. An electrochemical sensor system, comprising:

an electrochemical sensor card comprising at least one electrochemical sensor, said electrochemical sensor comprising at least one polymeric membrane;

an electrochemical sensor apparatus in electrical contact with the electrochemical sensor card, the electrochemical sensor apparatus configured to measure electrical signals from the electrochemical sensor card and capable of providing an electrical potential to the electrochemical sensor for the polymerization of an electropolymerizable monomer to the polymeric membrane; and

a reservoir containing a solution comprising the electropolymerizable monomer in fluid communication with the electrochemical sensor card, said electropolymerizable monomer solution polymerized to said polymeric membrane by the electrical potential provided by said electrochemical sensor apparatus, wherein the electropolymerizable monomer comprises benzothiophene.

28. An electrochemical sensor system, comprising:

an electrochemical sensor card comprising at least one electrochemical sensor, said electrochemical sensor comprising at least one polymeric membrane;

an electrochemical sensor apparatus in electrical contact with the electrochemical sensor card, the electrochemical sensor apparatus configured to measure electrical signals from the electrochemical sensor card and capable of providing an electrical potential to the electrochemical sensor for the polymerization of an electropolymerizable monomer to the polymeric membrane; and

a reservoir containing a solution comprising the electropolymerizable monomer in fluid communication with the electrochemical sensor card, said electropolymerizable monomer solution polymerized to said polymeric membrane by the electrical potential provided by said electrochemical sensor apparatus, wherein the electropolymerizable monomer comprises dihydroxybenzene.

29. An electrochemical sensor comprising:

at least one electrode; and

a composite membrane, the composite membrane comprising an outer layer comprising a compound selected from the group consisting of polyvinyl-based compounds, silicone elastomer-based compounds, and polycarbonate-based compounds, an enzyme layer, and a restorable inner layer in contact with at least one electrode and comprising a polymerizable membrane, wherein the enzyme layer is disposed next to the inner layer.

30. The electrochemical sensor of claim 29, wherein said enzyme layer comprises a H₂O₂ generating enzyme.

31. The electrochemical sensor of claim 29, wherein said enzyme layer comprises one or more enzymes selected from the group consisting of glucose oxidase, lactate oxidase, creatininase, creatinase, and sarcosine oxidase.

32. The electrochemical sensor of claim 29, wherein said enzyme layer comprises glucose oxidase.

33. The electrochemical sensor of claim 29, wherein said enzyme layer comprises lactate oxidase.

34. The electrochemical sensor of claim 29, wherein said enzyme layer comprises creatinase.

35. The electrochemical sensor of claim 29, wherein said enzyme layer comprises creatininase.

36. The electrochemical sensor of claim 29, wherein said enzyme layer comprises sarcosine oxidase.

37. The electrochemical sensor of claim 29, further comprising a restored surface on said inner layer wherein said surface is restored by polymerized monomer.

38. The electrochemical sensor of claim 29, wherein said inner layer comprises an electropolymerizable compound selected from the group consisting of benzothiophene, phenylenediamine, and dihydroxybenzene.

39. The electrochemical sensor of claim 29, wherein said inner layer comprises phenylenediamine.

40. The electrochemical sensor of claim 29, wherein said inner layer comprises dihydroxybenzene.

41. The electrochemical sensor of claim 29, wherein the outer layer comprises a polyvinyl-based compound.

42. The electrochemical sensor of claim 29, wherein the outer layer comprises a silicone elastomer-based compound.

43. The electrochemical sensor of claim 29, wherein the outer layer comprises a polycarbonate-based compound.