Electrochemical biosensors and arrays

• US 8,649,840 B2
• Filed: 06/06/2008
• Issued: 02/11/2014
• Est. Priority Date: 06/07/2007
• Status: Active Grant

• Current Assignee: DARE MB Incorporated, Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Sheppard, Norman F. Jr., Santini, John T. Jr.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Tcherkasskaya, Olga V
• Application Number:
  US12/134,966
• Publication Number:
  US 20080302659A1
• Time in Patent Office: 2,076 Days
• Field of Search: None
• US Class Current: 600/345
• 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 a first plurality of reservoirs, each of the first plurality of reservoirs having at least one opening in the structural body and a working electrode located in said reservoir;

analyte sensor chemistry located within each of the first plurality of reservoirs and deposited on at least the working electrode;

one or more auxiliary electrodes located on the structural body outside of the first plurality of reservoirs and a reference electrode located inside each reservoir, or one or more auxiliary electrodes located on the structural body outside of the first plurality of reservoirs and one or more reference electrodes located outside of the first plurality of reservoirs;

at least one reservoir cap closing the at least one opening of each of the first plurality of reservoirs to isolate the working electrode and analyte sensor chemistry within the reservoir from an analyte outside of the reservoir to prevent contact with the analyte sensor chemistry; and

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

wherein the one or more reference electrodes, the one or more auxiliary electrodes, or both, are adapted to be operatively coupled with two or more of the working electrodes.

2. The amperometric sensor device of claim 1, wherein the analyte sensor chemistry is further deposited on the reference electrode.

3. The amperometric sensor device of claim 1, wherein the one or more reference electrodes are located outside of the first plurality of reservoirs and in one or more of a second plurality of reservoirs separate from the first plurality of reservoirs containing the working electrodes.

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

5. The amperometric sensor device of claim 4, wherein an enzyme of the enzyme-containing layer 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.

6. The amperometric sensor device of claim 1, wherein each of the first plurality of reservoirs 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 each reservoir, wherein the two or more reservoir caps are in part supported by the at least one reservoir cap support.

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

8. The amperometric sensor device of claim 1, wherein each 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.

9. The amperometric sensor device of claim 8, wherein the pair of conductive leads, the reservoir cap, or both, serve as the auxiliary electrode.

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

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

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

13. 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 a first reservoir of the plurality of reservoirs;

at least one reference electrode located within a second reservoir of the plurality of reservoirs, wherein the first reservoir is different from the second reservoir and the at least one indicator electrode and the at least one reference electrode forms an operable pair of electrodes;

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 first and second reservoirs and to prevent an analyte outside of the first and second 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 independently 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.

14. The potentiometric sensor device of claim 13, which comprises a plurality of the indicator electrodes, each one being located in a separate reservoir.

15. An implantable medical device comprising the potentiometric sensor device of claim 13.

16. A potentiometric sensor device comprising:

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

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

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

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

means for rupturing or displacing each of the at least one reservoir cap independently 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.

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

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

25. The potentiometric sensor device of claim 16, wherein:

each of the at least one reference electrodes is located within a reservoir of a second plurality of reservoirs, each reservoir of the second plurality of reservoirs having at least one opening in the structural body and at least one reservoir cap closing the at least one opening, to isolate the at least one reference electrode within the reservoir it is located within and to prevent an analyte outside of the reservoir from contacting the at least one reference electrode, and

the device further comprises means for rupturing or displacing the at least one reservoir cap of the second plurality of reservoirs independently to permit the analyte from outside of the reservoir to contact the at least one reference electrode.

19. A conductometric sensor device comprising:

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

an electrode pair located within each reservoir, each electrode pair being co-planar and having an interdigitated or serpentine configuration and at least one reference electrode located outside of the plurality of reservoirs;

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

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

means for rupturing or displacing each reservoir cap independently to permit the analyte from outside of the reservoir to contact the corresponding biological recognition element.

20. The conductometric sensor device of claim 19, wherein the biological recognition element comprises an enzyme, an antibody, a nucleic acid, a receptor protein, or a combination thereof.

21. The conductometric sensor device of claim 19, wherein the other selectively sensitive material comprises a polyimide for moisture sensing.

22. The conductometric sensor device of claim 19, wherein the other selectively sensitive material comprises a polymeric coating material for organic vapor sensing.

23. An implantable medical device comprising the conductometric sensor device of claim 19.

24. The conductometric sensor device of claim 19, further comprising a control electrode pair.