Analyte Monitoring Device and Methods of Use

• US 20100234709A1
• Filed: 12/21/2009
• Published: 09/16/2010
• 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 8,235,896 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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. A device, comprising:

a housing;

a glucose test strip port coupled to the housing and configured to receive a test strip having a fluid sample thereon;

a processor operatively coupled to the housing and configured to determine a glucose level information from the fluid sample on the test strip; and

a communication component operatively coupled to the processor and configured to receive a plurality of time spaced analyte related signals from a remote location;

wherein the processor is configured to generate output data based on the determined glucose level from the fluid sample, the received plurality of time spaced analyte related signals or both.

2. The device of claim 1 including a data storage device disposed in the housing and operatively coupled to the processor and configured to store the determined glucose level information, the plurality of time spaced analyte related signals, the generated output data, or one or more combinations thereof.

3. The device of claim 1 wherein the housing is sized to be portable.

4. The device of claim 1 wherein the processor includes an analyzer configured to evaluate one or more of the received plurality of time spaced analyte related signals or the determined glucose level information.

5. The device of claim 1 including a power supply disposed in the housing and operatively coupled to the processor and the communication component.

6. The device of claim 1 wherein the communication component includes an RF transceiver.

7. The device of claim 1 wherein the communication component includes an RF transmitter and an RF receiver.

8. The device of claim 1 wherein the communication component includes a bi-directional communication unit configured to transmit and to receive data.

9. The device of claim 1 wherein the communication component is configured to transmit or receive data using one or more of a wireless communication protocol or a wired connection.

10. The device of claim 1 wherein the remote location is associated with a subcutaneously positioned analyte sensor.

11. The device of claim 10 wherein the subcutaneously positioned analyte sensor is configured to generate the plurality of time spaced analyte related signals.

12. The device of claim 1 wherein the remote location includes a sensor control unit in signal communication with a subcutaneously positioned analyte sensor.

13. The device of claim 12 wherein the analyte sensor includes a glucose sensor.

14. The device of claim 12 wherein the analyte sensor is in fluid contact with an interstitial fluid under a skin layer.

15. The device of claim 1 further including a display unit operatively coupled to the housing and configured to output trend information corresponding to the received plurality of time spaced analyte related signals.

16. The device of claim 1 further including an output unit configured to output a notification related to a predetermined condition.

17. The device of claim 16 wherein the notification related to the predetermined condition includes the received plurality of time spaced analyte related signals reaching or exceeding a predetermined threshold level.

18. The device of claim 17 wherein the predetermined threshold level is associated with one or more of an impending hyperglycemic condition, an impending hypoglycemic condition, a hyperglycemic condition, or a hypoglycemic condition.