Method of making an electrochemical sensor

• US 20060042080A1
• Filed: 08/16/2005
• Published: 03/02/2006
• Est. Priority Date: 03/04/1998
• Status: Active Grant

• Current Assignee: Therasense Incorporated (Abbott Laboratories)
• Original Assignee: Therasense Incorporated (Abbott Laboratories)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Tomasco, Michael F.
• Granted Patent: US 7,721,412 B2
• Time in Patent Office: Days
• US Class Current: 29/876
• 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 making an electrochemical sensor, the method comprising:

providing a substrate having a sensor planform having a first portion and an adjacent second portion;

applying at least one contact pad to the first portion;

applying at least one conductive trace to the first portion and to the second portion such that the at least one conductive trace electrically communicates with the at least one contact pad; and

removing the sensor planform from the substrate to form a removed sensor.

2. The method of claim 1, wherein the first portion is a major portion and the second portion is a minor portion.

3. The method of claim 2, wherein the major portion has a greater surface area than the minor portion.

4. The method of claim 2, wherein the major portion has a width greater than the minor portion.

5. The method of claim 1, wherein the first portion is a connector portion and the second portion is a transcutaneous portion.

6. The method of claim 1, wherein the step of applying a conductive trace to the first portion and the second portion comprises forming at least one electrode on a surface of the first portion and a surface of the second portion.

7. The method of claim 1, wherein the step of applying at least one conductive trace utilizes non-impact printing.

8. The method of claim 7, wherein the non-impact printing is selected from the group of piezo jet, electrographic, magnetographic and ionographic printing.

9. The method of claim 1, wherein the method further comprises, after the step of applying at least one conductive trace, applying a sensing layer over at least a portion of the conductive trace.

10. The method of claim 9, wherein the step of applying a sensing layer comprises providing an electron transfer agent disposed in or on the sensing layer.

11. The method of claim 9, wherein the step of applying a sensing layer comprises providing a catalyst disposed in or on the sensing layer.

12. The method of claim 1, further comprising the step of applying at least one membrane layer over the at least one conductive trace.

13. The method of claim 12, wherein the membrane layer comprises a mass transport limiting layer.

14. An electrochemical sensor made according to the method of claim 1.

15. A method of making an electrochemical sensor, the method comprising:

providing a substrate having a sensor planform, the sensor planform comprising a first portion and a second portion, at least a portion of the first portion adapted for positioning external to a subject and at least a portion of the second portion adapted for positioning within the subject;

forming at least one electrode on said planform, the at least one electrode present at the first portion and the second portion; and

separating the planform from the substrate to form a removed sensor comprising at least one electrode.

16. The method of claim 15, wherein the first portion is a major portion and the second portion is a minor portion.

17. The method of claim 16, wherein the major portion has a width greater than the minor portion.

18. The method of claim 15, wherein the step of forming at least one electrode comprises applying a conductive material on a surface of the substrate.

19. The method of claim 15, further comprising providing a sensing layer over at least a portion of at least one electrode.

20. An electrochemical sensor made according to claim 15.