ELECTROCHEMICAL BIOSENSORS AND ARRAYS

• US 20080302659A1
• Filed: 06/06/2008
• Published: 12/11/2008
• Est. Priority Date: 06/07/2007
• Status: Active Grant

• Current Assignee: DARE MB Incorporated, Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Santini, John T. JR., Sheppard, Norman F. JR.
• Granted Patent: US 8,649,840 B2
• Time in Patent Office: Days
• US Class Current: 204/403.01
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Electrochemical sensor devices are provided, in various amperometric, potentiometric, and conductometric sensor device configurations. An amperometric sensor device may include a structural body which has at least one reservoir that has at least one opening; a working electrode located within the reservoir; analyte sensor chemistry located within the reservoir and deposited on at least the working electrode; an auxiliary electrode located outside of the reservoir; a reference electrode; at least one reservoir cap closing the opening to isolate the working electrode and analyte sensor chemistry within the reservoir and to prevent an analyte outside of the reservoir from contacting the analyte sensor chemistry; and means for rupturing or displacing the reservoir cap to permit the analyte from outside of the reservoir to contact the analyte sensor chemistry.

Claims

1. An amperometric sensor device comprising:

a structural body which comprises at least one reservoir that has at least one opening in the structural body;

a working electrode located within the reservoir;

analyte sensor chemistry located within the reservoir and deposited on at least the working electrode;

an auxiliary electrode located outside of the reservoir;

a reference electrode;

at least one reservoir cap closing the at least one opening to isolate the working electrode and analyte sensor chemistry within the reservoir and to prevent an analyte outside of the reservoir from contacting the analyte sensor chemistry; and

means for rupturing or displacing the reservoir cap to permit the analyte from outside of the reservoir to contact the analyte sensor chemistry.

2. The amperometric sensor device of claim 1, wherein the reference electrode is located in the reservoir.

3. The amperometric sensor device of claim 2, wherein the analyte sensor chemistry is further deposited on the reference electrode.

4. The amperometric sensor device of claim 1, wherein the reference electrode is located in a second reservoir which is separate from the reservoir containing the working electrode.

5. The amperometric sensor device of claim 1, wherein the reference electrode is located outside of the reservoir.

6. The amperometric sensor device of claim 1, wherein the analyte sensor chemistry comprises an enzyme-containing layer and at least one polymer layer.

7. The amperometric sensor device of claim 1, wherein the enzyme is selected from the group consisting of glucose oxidase, glucose dehydrogenase, NADH oxidase, uricase, urease, creatininase, sarcosine oxidase, creatinase, creatine kinase, creatine amidohydrolase, cholesterol esterase, cholesterol oxidase, glycerol kinase, hexokinase, glycerol-3-phosphate oxidase, lactate oxidase, lactate dehydrogenase, alkaline phosphatase, alanine transaminase, aspartate transaminase, amylase, lipase, esterase, gamma-glutamyl transpeptidase, L-glutamate oxidase, pyruvate oxidase, diaphorase, bilirubin oxidase, and mixtures thereof.

8. The amperometric sensor device of claim 1, which comprises a plurality of the reservoirs, a plurality of the working electrodes and the analyte sensor chemistries located correspondingly therein, and a plurality of the at least one reservoir caps closing openings in the reservoirs, wherein the reference electrode, the auxiliary electrode, or both, are adapted to be operatively coupled with two or more of the plurality of the working electrodes.

9. The amperometric sensor device of claim 1, wherein the reservoir has two or more openings and two or more discrete reservoir caps, each reservoir cap closing at least one of the reservoir openings, and wherein the structural body further comprises at least one reservoir cap support extending over the reservoir, wherein the two or more reservoir caps are in part supported by the at least one reservoir cap support.

10. The amperometric sensor device of claim 1, wherein the area of the auxiliary electrode is equal to or larger than the area of the working electrode.

11. The amperometric sensor device of claim 1, wherein the means for rupturing or displacing comprises:

a pair of conductive leads electrically connected to the reservoir cap, the reservoir cap comprising an electrically conductive material; and

a power source for applying an electrical current through the reservoir cap via the pair of conductive leads,

wherein the pair of conductive leads and power source are adapted to rupture the reservoir cap by electrothermal ablation.

12. The amperometric sensor device of claim 11, wherein the pair of conductive leads, the reservoir cap, or both, serve as the auxiliary electrode.

13. The amperometric sensor device of claim 1, wherein the means for rupturing or displacing comprises a cathode and a source of electrical power, the at least one reservoir cap serves as an anode, and the reservoir cap disintegrates upon application of an electric potential between the anode and the cathode.

14. A catheter comprising the amperometric sensor device of claim 1.

15. An implantable medical device comprising the amperometric sensor device of claim 1.

16. A potentiometric sensor device comprising:

a structural body which comprises a plurality of reservoirs that each have at least one opening in the structural body;

at least one indicator electrode located within the plurality of reservoirs;

at least one reference electrode located within the plurality of reservoirs;

at least one reservoir cap closing the at least one opening of each of the plurality of reservoirs, to isolate the at least one indicator electrode and the at least one reference electrode within the plurality of reservoirs and to prevent an analyte outside of the reservoirs from contacting the at least one indicator electrode and the at least one reference electrode; and

means for rupturing or displacing the reservoir caps to permit the analyte from outside of the reservoir to contact the at least one indicator electrode and the at least one reference electrode,

wherein an electrical potential which can be developed between the at least one indicator electrode and the at least one reference electrode provides a sensor signal indicative of a concentration of the analyte.

17. The potentiometric sensor device of claim 16, wherein the at least one indicator electrode is located in the same reservoir as the at least one reference electrode, forming an operable pair of electrodes.

18. The potentiometric sensor device of claim 16, wherein the at least one indicator electrode and the at least one reference electrode are located in different reservoirs from one another, forming an operable pair of electrodes.

19. The potentiometric sensor device of claim 16, which comprises a plurality of the indicator electrodes, each one being located in a separate reservoir.

20. An implantable medical device comprising the potentiometric sensor device of claim 16.

21. A potentiometric sensor device comprising:

a structural body which comprises a plurality of reservoirs that each have at least one opening in the structural body;

at least one indicator electrode located within the plurality of reservoirs;

at least one reference electrode located outside of the plurality of reservoirs;

at least one reservoir cap closing the at least one opening of each of the plurality of reservoirs, to isolate the at least one indicator electrode within the plurality of reservoirs and to prevent an analyte outside of the reservoirs from contacting the at least one indicator electrode; and

means for rupturing or displacing the at least one reservoir cap to permit the analyte from outside of the reservoir to contact the at least one indicator electrode,

wherein a potential which can be developed between the at least one indicator electrode and the at least one reference electrode provides a sensor signal indicative of a concentration of the analyte.

22. The potentiometric sensor device of claim 21, which comprises a plurality of the indicator electrodes, each one being located in a separate reservoir.

23. An implantable medical device comprising the potentiometric sensor device of claim 21.

24. A potentiometric sensor device comprising:

a structural body which comprises a plurality of reservoirs that each have at least one opening in the structural body;

at least one indicator electrode;

at least one reference electrode located within the plurality of reservoirs;

at least one reservoir cap closing the at least one opening of each of the plurality of reservoirs, to isolate the at least one reference electrode within the plurality of reservoirs and to prevent an analyte outside of the reservoirs from contacting the at least one reference electrode; and

means for rupturing or displacing the at least one reservoir cap to permit the analyte from outside of the reservoir to contact the at least one reference electrode,

wherein a potential which can be developed between the at least one indicator electrode and the at least one reference electrode provides a sensor signal indicative of a concentration of the analyte.

25. An implantable medical device comprising the potentiometric sensor device of claim 24.

26. A conductometric sensor device comprising:

a structural body which comprises at least one reservoir that has at least one opening in the structural body;

an electrode pair located within the reservoir;

a biological recognition element or other selectively sensitive material located within the reservoir and deposited on the electrode pair;

at least one reservoir cap closing the at least one opening to isolate the electrode pair and the biological recognition element within the reservoir and to prevent an analyte outside of the reservoir from contacting the biological recognition element; and

means for rupturing or displacing the at least one reservoir cap to permit the analyte from outside of the reservoir to contact the biological recognition element.

27. The conductometric sensor device of claim 26, wherein the electrode pair are co-planar and have an interdigitated or serpentine configuration.

28. The conductometric sensor device of claim 26, wherein the biological recognition element comprises an enzyme, an antibody, a nucleic acid, a receptor protein, or a combination thereof.

29. The conductometric sensor device of claim 26, wherein the other selectively sensitive material comprises a polyimide for moisture sensing.

30. The conductometric sensor device of claim 26, wherein the other selectively sensitive material comprises a polymeric coating material for organic vapor sensing.

31. An implantable medical device comprising the conductometric sensor device of claim 26.

32. The conductometric sensor device of claim 26, further comprising a control electrode pair.