Method of manufacturing electrochemical sensors

• US 7,225,535 B2
• Filed: 09/12/2003
• Issued: 06/05/2007
• Est. Priority Date: 10/08/1998
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Krishnan, Rajesh, Heller, Ephraim, Heller, Adam, Colman, Fredric C., Feldman, Benjamin J., Mao, Fei, Funderburk, Jeffery V., Vivolo, Joseph A.
• Primary Examiner(s): Trinh; Minh
• Assistant Examiner(s): Nguyen; Donghai D.
• Application Number:
  US10/662,081
• Publication Number:
  US 20040060818A1
• Time in Patent Office: 1,362 Days
• Field of Search: 29593-595, 298/30, 298/74, 298/76, 298/77, 298/84, 294/15, 298/31, 204/403.01, 204/403.03, 204/403.04, 204/409, 204/416, 205/777.5, 427/2.13, 435/287.5, 435/287.8, 435/287.9, 600/345, 600/347
• US Class Current: 29/831
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• 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 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49004 including measuring or testing of device or component part
• CPC Class Codes: Y10T 29/49007 Indicating transducer
• CPC Class Codes: Y10T 29/49126 Assembling bases
• CPC Class Codes: Y10T 29/49128 Assembling formed circuit to base
• CPC Class Codes: Y10T 29/4913 Assembling to base an electrical component, e.g., capacitor, etc.
• CPC Class Codes: Y10T 29/49147 Assembling terminal to base
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing
• CPC Class Codes: Y10T 29/49208 by assembling plural parts
• CPC Class Codes: Y10T 29/4921 with bonding
• CPC Class Codes: Y10T 29/49794 Dividing on common outline

Abstract

Methods for manufacturing electrochemical sensors are described. The sensors have a working electrode and a counter electrode, which are planar, and optionally an indicator electrode. The sensor includes a sample chamber to hold a sample of no more than 1 μL in electrolytic contact with the working electrode. The methods provide sensors that can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry.

Claims

1. A method of manufacturing electrochemical sensors, the method comprising steps of:

(a) applying a plurality of working electrodes on a substrate;

(b) applying a plurality of counter electrodes on the substrate;

(c) positioning a spacer layer over the substrate and the working electrodes and the counter electrodes;

(d) overlaying the spacer layer with a second substrate;

(e) creating a sample chamber region within the spacer layer comprising a plurality of connected sample chambers between the substrate and the second substrate; and

(f) separating a plurality of electrochemical sensors, each electrochemical sensor comprising at least one working electrode planar with at least one counter electrode on the substrate, the substrate and second substrate having generally a similar length and width, and at least one sample chamber between the substrate and the second substrate, the sample chamber having a volume of no more than about 1 microliter and continuous with the at least one sample chamber of an adjacent electrochemical sensor.

2. The method according to claim 1, wherein the step of positioning a spacer layer comprises:

(a) positioning an adhesive layer over the substrate having the electrodes.

3. The method according to claim 2, further comprising:

(a) applying a plurality of indicator electrodes on the substrate; and

(b) wherein the step of separating a plurality of electrochemical sensors comprises;

(i) separating a plurality of electrochemical sensors, each electrochemical sensor comprising at least one working electrode, at least one counter electrode, at least one indicator electrode, and at least one sample chamber.

4. The method according to claim 2, wherein the step of positioning an adhesive layer over the substrate having the electrodes is done before the step of creating a sample chamber region between the substrate having the electrodes and the second substrate.

5. The method according to claim 1, wherein the step of applying a plurality of working electrodes on a substrate comprises:

(a) applying a plurality of working electrodes on a substrate by printing.

6. The method according to claim 5, wherein the step of applying a plurality of working electrodes on a substrate by printing comprises:

(a) applying a plurality of working electrodes on a substrate by screen printing or ink jet printing.

7. The method according to claim 1, wherein the step of creating a sample chamber region between the substrate having the electrodes and the second substrate comprises:

(a) removing a portion of the spacer layer; and

then

(b) positioning the spacer layer between the substrate having the electrodes and the second substrate to create the sample chamber region.

8. The method according to claim 1, wherein the step of creating a sample chamber region between the substrate having the electrodes and the second substrate comprises:

(a) positioning the spacer layer over the substrate having the electrodes; and

then

(b) removing a portion of the spacer layer to create the sample chamber region.

9. The method according to claim 1, wherein the step of creating a sample chamber region comprising a plurality of connected sample chambers comprises:

(a) creating a sample chamber region having a plurality of connected sample chambers each having a volume of no more than about 0.5 microliter.

10. The method according to claim 9, wherein the step of creating a sample chamber region comprising a plurality of connected sample chambers comprises:

(a) creating a sample chamber region having a plurality of connected sample chambers each having a volume of no more than about 0.25 microliter.

11. A method of manufacturing electrochemical sensors, the method comprising steps of:

(a) applying a plurality of working electrodes on a substrate;

(b) applying a plurality of counter electrodes on the substrate;

(c) forming a plurality of indicator electrodes on one of the substrate and a second substrate;

(d) overlaying the working electrodes and the counter electrodes with a spacer layer;

(e) creating a sample chamber region within the spacer layer comprising a plurality of connected sample chambers between the substrate;

(f) overlaying the second substrate over the spacer layer; and

(g) separating a plurality of electrochemical sensors, each electrochemical sensor comprising at least one working electrode planar with at least one counter electrode on the substrate, the substrate and second substrate having generally a similar length and width, at least one indicator electrode, and at least one sample chamber between the substrate and the second substrate, the sample chamber having a volume of no more than about 1 microliter and continuous with the at least one sample chamber of an adjacent electrochemical sensor.

12. The method according to claim 11, wherein the step of creating a sample chamber region between the substrate having the electrodes and the second substrate comprises:

(a) removing a portion of the spacer layer; and

then

(b) positioning the spacer layer over the substrate having the electrodes to create the sample chamber region.

13. The method according to claim 11, wherein the step of creating a sample chamber region between the substrate having the electrodes and the second substrate comprises:

(a) positioning the spacer layer over the substrate having the electrodes; and

then

(b) removing a portion of the spacer layer to create the sample chamber region.

14. The method according to claim 11, wherein the step of creating a sample chamber region comprising a plurality of connected sample chambers comprises:

(a) creating a sample chamber region having a plurality of connected sample chambers each having a volume of no more than about 0.5 microliter.

15. The method according to claim 14, wherein the step of creating a sample chamber region comprising a plurality of connected sample chambers comprises:

(a) creating a sample chamber region having a plurality of connected sample chambers each having a volume of no more than about 0.25 microliter.