Analyte monitoring device and methods of use

• US 8,226,557 B2
• Filed: 12/28/2009
• Issued: 07/24/2012
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Say, James, Tomasco, Michael F., Heller, Adam, Gal, Yoram, Aria, Behrad, Heller, Ephraim, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Colman, Fredric C.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/648,143
• Publication Number:
  US 20100099969A1
• Time in Patent Office: 939 Days
• Field of Search: 600/309, 600345-366
• 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 glucose monitoring system comprising:

an in vivo glucose sensor that produces one or more signals indicative of a glucose concentration in a subject; and

a portable analyte monitoring device comprising

a housing,

a port for receiving an electrochemical test strip that produces one or more signals indicative of a glucose concentration in a sample from a subject,

a touch screen display unit coupled to the housing,

a receiver unit coupled to the housing and in communication with the touch screen display unit, and

a processor coupled to the housing and in communication with the receiver unit and the touch screen display unit

wherein the receiver unit wirelessly receives the one or more signals generated by the in vivo glucose sensor,

the processor analyzes the one or more signals produced by the electrochemical test strip and the one or more signals produced by the in vivo glucose sensor to;

determine a drug administration protocol based on the glucose concentration,

determine a rate of increase or decrease of the glucose concentration in the subject, and

adjust the determined drug administration protocol based on the rate of increase or decrease in the glucose concentration to provide an adjusted drug administration protocol, and

wherein the display is configured to display the adjusted drug administration protocol and provide an indicator of the rate of increase or decrease in the glucose concentration in the subject.

2. The system of claim 1, wherein the receiver unit is configured for periodic monitoring of the in vivo glucose sensor.

3. The system of claim 1, wherein the receiver unit is configured for continuous monitoring of the in vivo glucose sensor.

4. The system of claim 1, wherein the display unit comprises a light emitting diode (LED) display or liquid crystal display (LCD).

5. The system of claim 1, wherein the portable analyte monitoring device further comprises an input device configured for numeric or alphanumeric input.

6. The system of claim 1, wherein the portable analyte monitoring device further comprises a data storage unit in communication with the processor, wherein the data storage unit is configured to store the results of the analysis.

7. The system of claim 1, wherein the portable analyte monitoring device further comprises a transmitter in communication with the processor, wherein the transmitter is configured to transmit the results of the analysis to an external computer.

8. The system of claim 1, wherein the portable analyte monitoring device further comprises a transmitter in communication with the processor, wherein the transmitter is configured to send or receive messages from a health care professional.

9. The system of claim 1, wherein the portable analyte monitoring device further comprises a transmitter in communication with the processor, wherein the transmitter is configured to communicate with an external communications device.

10. The system of claim 1, wherein the portable analyte monitoring device further comprises a transmitter in communication with the processor, wherein the transmitter is configured to send and receive messages from a health care professional.