Method of making an electrochemical sensor

• US 7,797,814 B2
• Filed: 10/30/2007
• Issued: 09/21/2010
• Est. Priority Date: 03/04/1998
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Tomasco, Michael F.
• Primary Examiner(s): Kim; Paul D
• Application Number:
  US11/929,964
• Publication Number:
  US 20080295324A1
• Time in Patent Office: 1,057 Days
• Field of Search: 29/253.5, 294/17, 295/921, 295/95, 298/31, 298/46, 156/73.1, 216/65, 361/283, 361/301, 427/79, 427/80, 347/54, 347 68- 72
• US Class Current: 29/595
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• 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 1/001 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
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 156/1064 Partial cutting [e.g., grooving or incising]
• CPC Class Codes: Y10T 156/1082 Partial cutting bonded sandwich [e.g., grooving or incising]
• CPC Class Codes: Y10T 29/42 Piezoelectric device making
• 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 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49128 Assembling formed circuit to base
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base
• CPC Class Codes: Y10T 29/49208 by assembling plural parts
• CPC Class Codes: Y10T 29/49798 : Dividing sequentially from leading end, e.g., by cutting or breaking

Abstract

A process for the manufacture of small sensors with reproducible surfaces, including electrochemical sensors. One process includes forming channels in the surface of a substrate and disposing a conductive material in the channels to form an electrode. The conductive material can also be formed on the substrate by other impact and non-impact methods. In a preferred embodiment, the method includes cutting the substrate to form a sensor having a connector portion and a transcutaneous portion, the two portions having edges that define one continuous straight line.

Claims

1. A method of manufacturing in vitro sensors for the determination of the presence and/or level of glucose in a sample, the method comprising:

positioning a substrate in opposition to a fluid ejection printer;

ejecting a conductive material from the fluid ejection printer onto the substrate to form a pattern on the substrate, the pattern corresponding to the production of one or more sensors; and

cutting, if the pattern corresponds to a plurality of sensors, the substrate to produce the plurality of in vitro glucose sensors, each sensor configured to determine the presence and/or level of glucose in a volume sample of about 1 microliter or less.

2. The method of claim 1, wherein the pattern comprises one or more traces.

3. The method of claim 2, wherein the pattern comprises one or more electrodes.

4. The method of claim 2, wherein the one or more traces comprise at least one trace having a width of about 25 microns to about 250 microns.

5. The method of claim 2, wherein the one or more traces comprise at least two traces having a distance of separation of about 25 microns to about 250 microns.

6. The method of claim 1, wherein the conductive material comprises carbon.

7. The method of claim 1, wherein the conductive material comprises a polymer.

8. The method of claim 1, wherein the conductive material comprises a metal or alloy or metallic compound.

9. The method of claim 8, wherein the conductive material comprises silver/silver chloride.

10. The method of claim 1, wherein the conductive material comprises conductive ink.

11. The method of claim 1, wherein the printer is an ink jet printer.

12. The method of claim 1, wherein the conductive material comprises a redox couple.

13. The method of claim 12, wherein the redox couple comprises a redox polymer.

14. The method of claim 1, wherein the pattern comprises a contact pad.

15. The method of claim 1, wherein the printer is a piezo jet printer.

16. The method of claim 1, wherein the cutting step comprises cutting the substrate so that each sensor has a variable width.

17. The method of claim 16, wherein the variable width sensors comprise a first end and a second end having different widths.

18. The method of claim 1, wherein the cutting step comprises cutting the substrate so that each sensor comprises a tapered end.

19. The method of claim 1, further comprising coupling a skin piercer to each sensor.

20. The method of claim 1, further comprising printing a sensor code on each sensor.