Method of making a transcutaneous electrochemical sensor

• US 6,973,706 B2
• Filed: 03/31/2003
• Issued: 12/13/2005
• Est. Priority Date: 03/04/1998
• Status: Expired due to Term

• Current Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense 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:
  US10/405,765
• Publication Number:
  US 20030188427A1
• Time in Patent Office: 988 Days
• Field of Search: 294/17, 295/921, 295/95, 298/31, 298/46, 156/73.1, 361/283, 361/301, 427/79, 427/80, 216/65
• 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 fanning 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 a transcutaneous electrochemical sensor, the method comprising the steps of:

providing a substrate having a sensor planform, the sensor planform having a connector portion and a transcutaneous portion, the transcutaneous portion being adjacent to the connector portion and extending therefrom;

applying at least one contact pad to the connector portion;

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

removing the sensor planform of the substrate by cutting through the substrate to form a removed sensor, wherein the connector portion of the removed sensor has first and second opposite edges and the transcutaneous portion has third and fourth opposite edges, wherein the first and third edges together form a continuous straight edge, and wherein the second and fourth edges do not form a continuous straight edge.

2. The method of claim 1 wherein a distance between the first and second edges formed in the removing step is at least about three times greater than a distance between the third and fourth edges.

3. The method of claim 1 wherein a distance between the first and second edges formed in the removing step is at least about six times greater than a distance between the third and fourth edges.

4. The method of claim 1 wherein the connector portion has a width between the first and second edges formed in the removing step and also a length, the width being substantially greater than the length.

5. The method of claim 1 wherein the connector portion has a width between the first and second edges formed in the removing step and also a length, the width being at least about twenty percent greater than the length.

6. The method of claim 1 wherein the connector and transcutaneous portions each have a length, the length of the connector portion being at least about ninety percent of the length of the transcutaneous portion.

7. The method of claim 1 wherein the removing step further includes cutting at least one of the third and fourth opposite edges of the transcutaneous portion such that it has a barb.

8. The method of claim 1 wherein the connector portion has a width between the first and second edges formed in the removing step of 0.5-15 mm.

9. The method of claim 8 wherein the connector portion has a width between the first and second edges formed in the removing step of 1-10 mm.

10. The method of claim 1 wherein the transcutaneous portion has a width between the third and fourth edges formed in the removing step of 2 mm or less.

11. The method of claim 10 wherein the transcutaneous portion has a width between the third and fourth edges formed in the removing step of 1 mm or less.

12. The method of claim 1 wherein after the step of applying at least one conductive trace to the transcutaneous portion and the connector portion, applying a sensing layer over at least a portion of the conductive trace.