Analyte Monitoring Device And Methods Of Use

• US 20100056891A1
• Filed: 11/09/2009
• Published: 03/04/2010
• Est. Priority Date: 04/30/1998
• 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, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Granted Patent: US 8,306,598 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• 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 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• 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: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: H01L 23/3107 : the device being completely enclosed
• CPC Class Codes: H01L 23/49548 : Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 : Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Claims

1. An analyte monitoring system comprising, comprising:

an electrochemical sensor comprising

a working electrode;

a first conductive contact in electrical communication with the working electrode; and

a sensing layer comprising a catalyst disposed proximate to the working electrode; and

a control unit comprising a second conductive contact comprising carbon,

wherein the first conductive contact and the second conductive contact are coupled.

2. The analyte monitoring system of claim 1, wherein the sensor is capable of operation for a period of at least three days.

3. The analyte monitoring system of claim 1, wherein the sensor is capable of operation for a period of at least seven days.

4. The analyte monitoring system of claim 1, wherein the sensor is configured for at least partial implantation in the tissue of an animal.

5. The analyte monitoring system of claim 1, wherein the first conductive contact comprises gold.

6. The analyte monitoring system of claim 1, wherein the first conductive contact comprises platinum.

7. The analyte monitoring system of claim 1, wherein the first conductive contact comprises palladium.

8. The analyte monitoring system of claim 1, wherein the catalyst comprises an enzyme.

9. The analyte monitoring system of claim 8, wherein the enzyme comprises glucose oxidase.

10. The analyte monitoring system of claim 9, wherein the glucose oxidase is non-leachably disposed proximate to the working electrode.

11. The electrochemical sensor of claim 1, wherein the sensing layer comprises an electron transfer agent.

12. The electrochemical sensor of claim 11, wherein the electron transfer agent is non-leachably disposed proximate to the working electrode.

13. An analyte responsive electrochemical sensor, comprising:

a substrate having a narrow distal region for implantation into an animal and a wider proximal region;

at least one working electrode disposed on the narrow distal region of the substrate;

at least one contact pad disposed on the wider proximal region of the substrate and in electrical communication with the working electrode; and

a biocompatible layer disposed proximate the working electrode.

14. The electrochemical sensor of claim 13, wherein the narrow distal region has a width of about 0.5 mm or less.

15. The electrochemical sensor of claim 13, wherein the working electrode has a width on at least a portion thereof of about 150 μ

m or less.

16. The electrochemical sensor of claim 13, wherein the working electrode has a width on at least a portion thereof between 150 μ

m and 25 μ

m.

17. The electrochemical sensor of claim 13, further comprising a first conductive material disposed on a surface of the substrate to form a first trace coupled to the working electrode, a second conductive material disposed on a surface of the substrate to form a second trace coupled to a second electrode, the first and second traces being disposed 250 μ

m or less apart.

18. The electrochemical sensor of claim 17, wherein the first and second traces are disposed between 250 μ

m and 25 μ

m apart.

19. The electrochemical sensor of claim 17, wherein the first and second traces are disposed 150 μ

m or less apart.

20. The electrochemical sensor of claim 17, wherein the first and second traces are disposed between 150 μ

m and 25 μ

m apart.

21. The electrochemical sensor of claim 17, wherein the wider proximal region extends in a lateral direction from the longitudinal axis.

22. The electrochemical sensor of claim 17, wherein the wherein the wider proximal region extends in a single lateral direction from the longitudinal axis.

23. The electrochemical sensor of claim 17, wherein the sensor is capable of operation for a period of at least three days.

24. The electrochemical sensor of claim 17, wherein the sensor is capable of operation for a period of at least seven days.