Analyte Monitoring Device and Methods of Use

• US 20090292189A1
• Filed: 07/31/2009
• Published: 11/26/2009
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• 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, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Granted Patent: US 8,473,021 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 sensing system, comprising:

a substrate;

at least one electrode disposed on a first surface of the substrate; and

at least one electrode disposed on an opposite surface of the substrate;

wherein at least a portion of the at least one electrode on each of the opposing surfaces of the substrate are subcutaneously positionable in a patient.

2. The system of claim 1 wherein the at least one electrode disposed on the first surface is made of a first material and the at least one electrode disposed on the opposite surface is made of a second material.

3. The system of claim 1 further comprising at least one other electrode disposed on a surface of the substrate that is not subcutaneously positionable.

4. The system of claim 3 wherein at least one electrode disposed on the subcutaneously positionable surfaces of the substrate is a working electrode and the least one other electrode disposed on the surface that is not subcutaneously positionable is a reference or counter electrode.

5. The system of claim 4 wherein at least two electrodes disposed on the subcutaneously positionable surfaces of the substrate are working electrodes.

6. The system of claim 1 wherein the at least one electrode disposed on the first surface is a working electrode and the at least one electrode disposed on the opposite surface is a reference or counter electrode.

7. The system of claim 6 wherein at least a second electrode disposed on the first surface is a working electrode.

8. The system of claim 1 wherein the at least one electrode disposed on the first surface and the at least one electrode disposed on the opposite surface are working electrodes.

9. The system of claim 1 further comprising at least one other electrode that is positionable on the skin of the patient.

10. The system of claim 9 wherein the at least one other electrode that is positionable on the skin is a reference electrode, a counter electrode or a counter/reference electrode.

11. The system of claim 1 wherein an electrode disposed on the substrate includes a temperature probe.

12. The system of claim 1 wherein the substrate has an implantable distal portion and a nonimplanted proximal portion.

13. The system of claim 1 configured for sensing glucose.

14. The system of claim 1 configured for sensing an analyte in interstitial fluid or blood.

15. The system of claim 1 further including a transmitter unit configured to establish electrical contact with one or more electrodes.

16. An analyte sensing system, comprising:

a substrate having at least one electrode disposed thereon wherein at least a portion of the electrode is implantable within the skin; and

at least one other electrode positionable on the skin of the patient.

17. The system of claim 16 wherein the at least one electrode disposed on the substrate is a working electrode and the on-skin electrode is a counter electrode, a reference electrode or a counter/reference electrode.

18. The system of claim 16 wherein at least one electrode is disposed on a first surface of the substrate and at least a second electrode is disposed on an opposite surface of the substrate.

19. The system of claim 18 wherein the electrode disposed on the first substrate surface is a working electrode, the electrode disposed on the opposite substrate surface is a reference electrode and the on-skin electrode is a counter electrode.

20. The system of claim 16 further comprising a plurality of electrodes disposed on the substrate wherein at least one of the plurality of electrodes is a working electrode.

21. The system of claim 20 wherein each of the plurality of electrodes disposed on the substrate is a working electrode.

22. The system of claim 20 wherein one of the plurality of electrodes disposed on the substrate includes a temperature probe.

23. The system of claim 16 wherein the substrate has an implantable distal portion and a nonimplanted proximal portion.

24. The system of claim 16 configured for sensing glucose.

25. The system of claim 16 configured for sensing an analyte in interstitial fluid or blood.

26. The system of claim 18 wherein the at least one electrode disposed on the first surface is made of a first material and the at least one electrode disposed on the opposite surface is made of a second material.

27. The system of claim 16 further including a transmitter unit configured to establish electrical contact with one or more electrodes.