Electrochemical Analyte Sensor

• US 20100305422A1
• Filed: 08/06/2010
• Published: 12/02/2010
• Est. Priority Date: 03/04/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care 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 8,463,351 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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: C12Q 1/006 for glucose

Abstract

An electrochemical analyte sensor formed using conductive traces on a substrate can be used for determining and/or monitoring a level of analyte in in vitro or in vivo analyte-containing fluids. For example, an implantable sensor may be used for the continuous or automatic monitoring of a level of an analyte, such as glucose, lactate, or oxygen, in a patient. The electrochemical analyte sensor includes a substrate and conductive material disposed on the substrate, the conductive material forming a working electrode. In some sensors, the conductive material is disposed in recessed channels formed in a surface of the sensor. An electron transfer agent and/or catalyst may be provided to facilitate the electrolysis of the analyte or of a second compound whose level depends on the level of the analyte. A potential is formed between the working electrode and a reference electrode or counter/reference electrode and the resulting current is a function of the concentration of the analyte in the body fluid.

Claims

1. An in vivo glucose sensor, comprising:

one or more working electrodes;

a sensing layer proximate to at least one of the one or more working electrodes; and

a mass transport limiting layer proximate to at least one of the one or more working electrodes;

wherein the flexibility of the sensor is varied along a continuum of the sensor.

2. The glucose sensor of claim 1, further comprising a substrate, wherein the varied flexibility of the sensor is based at least in part on the composition of the substrate.

3. The glucose sensor of claim 1, further comprising a substrate, wherein the varied flexibility of the sensor is based at least in part on the thickness of the substrate.

4. The glucose sensor of claim 1, further comprising a substrate, wherein the varied flexibility of the sensor is based at least in part on the composition and the thickness of the substrate.

5. The glucose sensor of claim 1, wherein the sensor is a planar sensor.

6. The glucose sensor of claim 1, wherein the sensor is a wire sensor.

7. An in vivo glucose sensor, comprising:

one or more working electrodes; and

a sensing layer proximate to at least one of the one or more working electrodes;

wherein the length of the sensor is between 0.3 cm and 5 cm, and the flexibility of the sensor is varied along a continuum of the sensor.

8. The glucose sensor of claim 7, further comprising a subcutaneous portion, wherein the length of the subcutaneous portion is between 0.25 cm and 2 cm.

9. The glucose sensor of claim 7, further comprising a subcutaneous portion, wherein the length of the subcutaneous portion is 0.25 cm or less.

10. The glucose sensor of claim 7, further comprising a substrate, wherein the varied flexibility of the sensor is based at least in part on the composition of the substrate.

11. The glucose sensor of claim 7, further comprising a substrate, wherein the varied flexibility of the sensor is based at least in part on the thickness of the substrate.

12. The glucose sensor of claim 7, further comprising a substrate, wherein the varied flexibility of the sensor is based at least in part on the composition and the thickness of the substrate.

13. The glucose sensor of claim 7, wherein the sensor is a planar sensor.

14. The glucose sensor of claim 7, wherein the sensor is a wire sensor.

15. An in vivo glucose sensor, comprising:

a substrate having a thickness of 50 μ

m to 500 μ

m;

one or more working electrodes disposed on the substrate; and

a sensing layer proximate to at least one of the one or more working electrodes;

wherein the flexibility of the sensor is varied along a continuum of the sensor; and

further

wherein the sensor has a period of operation of at least one week.

16. The glucose sensor of claim 15, wherein the substrate has a thickness of 100 μ

m to 300 μ

m.

17. The glucose sensor of claim 15, wherein the varied flexibility of the sensor is based at least in part on the composition of the substrate.

18. The glucose sensor of claim 15, wherein the varied flexibility of the sensor is based at least in part on the thickness of the substrate.

19. The glucose sensor of claim 15, wherein the varied flexibility of the sensor is based at least in part on the composition and the thickness of the substrate.

20. The glucose sensor of claim 15, wherein the sensor is a planar sensor.

21. The glucose sensor of claim 15, wherein the sensor is a wire sensor.