Analyte Monitoring Device and Methods of Use

• US 20100168658A1
• Filed: 12/21/2009
• Published: 07/01/2010
• 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 8,641,619 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• 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 system for communicating with an external infusion pump, comprising:

a housing including an in vitro glucose monitor and a processor operatively coupled to the in vitro glucose monitor and disposed in the housing, the processor configured to generate a reading associated with an analyte concentration based on a blood sample from an in vitro test strip; and

a drug administration system configured to receive the generated reading from the processor and to execute a drug administration protocol.

2. The system of claim 1 wherein the housing includes a data communication port.

3. The system of claim 1 further including an RF transmitter operatively coupled to the housing.

4. The system of claim 1 wherein the generated reading is transmitted using one or more of an RF transmission, an optical transmission, or a wired transmission.

5. The system of claim 1 wherein the in vitro glucose monitor includes a calibration unit.

6. The system of claim 1 including a display operatively coupled to the housing and configured to output one or more of a visual, auditory or vibratory output associated with the generated reading.

7. The system of claim 1 wherein the generated reading includes blood glucose level information.

8. The system of claim 1 including a data storage unit operatively coupled to the housing and configured to store one or more of the generated reading, the associated analyte concentration, information related to the blood sample or information related to the drug administration protocol.

9. The system of claim 8 wherein the information related to the blood sample includes one or more of a time stamp, a date stamp, or a calibration code associated with the in vitro glucose monitor.

10. The system of claim 8 wherein the information related to the drug administration protocol includes one or more of a drug sensitivity curve, a duration of the drug administration protocol, a patient profile, food intake information, exercise information, fasting information, body temperature information, drug sensitivity feedback information or one or more subsequent drug administration protocols.

11. The system of claim 1 including an input unit operatively coupled to the housing, the processor configured to detect one or more input signals generated by the input unit.

12. The system of claim 11 wherein the one or more input signals includes an event marker.

13. The system of claim 1 including an alarm system operatively coupled to the housing and configured to generate one or more notifications.

14. The system of claim 13 wherein the alarm system is triggered when a predetermined condition is detected by the processor.

15. The system of claim 1 wherein the drug administration system includes one or more of an external infusion pump, an internal infusion pump, a syringe injector, a transdermal delivery system, or an inhalation system.

16. The system of claim 1 wherein the drug administration system is configured to determine the drug administration protocol based at least on the generated reading associated with the analyte concentration.

17. The system of claim 1 wherein the analyte concentration includes glucose concentration.

18. The system of claim 1 wherein the processor is further configured to process data received from a sensor control unit.

19. The system of claim 18 wherein the data received from the sensor control unit includes analyte sensor data.

20. The system of claim 18 wherein the data from the sensor control unit is wirelessly received by the processor.