Method of making an electrochemical sensor

• US 7,797,825 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): PHAN, THIEM D
• Application Number:
  US11/929,994
• Publication Number:
  US 20080047129A1
• Time in Patent Office: 1,057 Days
• Field of Search: 298/46, 295/921, 295/95, 298/31, 204/403.09, 204/403.11, 204/412, 204/415
• US Class Current: 29/846
• 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 one or more sensors for the in vivo determination of the level of glucose in a sample, the method comprising:

determining a pattern of conducting material to be disposed on a web of material;

disposing conductive material on the web to form the pattern for one or more in vivo glucose sensors;

disposing sensing layer material on the web; and

cutting the web to produce one or more in vivo glucose sensors, each sensor comprising conductive material, wherein each of the one or more in vivo glucose sensors include a code applied to each sensor, and wherein each applied code is associated with information related to the respective sensor.

2. The method of claim 1 wherein the code applied to each sensor includes a batch code.

3. The method of claim 1 wherein the code is associated with one or more of a manufacturing batch number, a type of chemistry applied to the sensor, a quantity of chemistry applied to the sensor, or a calibration data associated with the sensor.

4. The method of claim 1 wherein the code for each of the produced one or more in vivo glucose sensors in a sensor batch is associated with one sensor calibration data.

5. A method of manufacturing one or more sensors for the in vivo determination of the level of glucose in a sample, the method comprising:

determining a pattern of conducting material to be disposed on a web of material;

disposing conductive material on the web to form the pattern for one or more in vivo glucose sensors;

disposing sensing layer material on the web;

disposing anticlotting agent on the web; and

cutting the web to produce one or more in vivo glucose sensors, each sensor comprising conductive material and anticlotting agent, wherein each of the one or more in vivo glucose sensors include a code applied to each sensor, wherein the code applied to each sensor is associated with information related to the respective sensor.

6. The method of claim 5, wherein the anticlotting agent reduces or eliminates the clotting of a biological fluid.

7. The method of claim 6, wherein the biological fluid is blood.

8. The method of claim 5, wherein the anticlotting agent is heparin.

9. The method of claim 5, wherein the anticlotting agent is tissue plasminogen activator.

10. The method of claim 6 wherein the anticlotting agent is immobilized on a surface of the one or more sensors.

11. The method of claim 5 wherein the anticlotting agent diffuses away from the surface of the one or more sensors.

12. The method of claim 5, wherein each sensor operates for at least three days.

13. The method of claim 12, wherein each sensor operates for at least one week.

14. The method of claim 5, wherein the flexibility of the one or more in vivo sensors is variable.

15. The method of claim 5, wherein the cutting comprises cutting the web to produce one or more in vivo sensors, each having a width that ranges from about 0.5 mm to about 15 mm.

16. The method of claim 15, wherein the cutting comprises cutting the web to produce one or more in vivo sensors each having a width that ranges from about 1 mm to about 10 mm.

17. The method of claim 16, wherein the cutting comprises cutting the web to produce one or more in vivo sensors each having a width that ranges from about 3 mm to about 7 mm.

18. The method of claim 5 wherein the code for each sensor includes information associated with one or more of a type and/or quantity of chemistry applied to the sensor, or calibration data associated with the sensor.

19. The method of claim 5 wherein the code for each sensor includes a batch number.

20. The method of claim 5 wherein the web of material includes a substrate, and further, wherein the code for each sensor is provided on the substrate of each sensor.