Analyte monitoring device and methods of use

• US 20050121322A1
• Filed: 01/24/2005
• Published: 06/09/2005
• Est. Priority Date: 04/30/1998
• Status: Abandoned Application

• Current Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense 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.
• Application Number:
  US11/041,404
• Publication Number:
  US 20050121322A1
• Time in Patent Office: Days
• US Class Current: 204/403.100
• 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 sensor control unit, comprising:

a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin and having at least one contact pad;

at least one conductive contact configured for coupling to the at least one contact pad on the electrochemical sensor; and

an rf transmitter disposed in the housing and coupled to the at least one conductive contact for transmitting data obtained using the electrochemical sensor.

2. The sensor control unit of claim 1, further comprising adhesive for adhering the sensor control unit to skin.

3. The sensor control unit of claim 1 wherein the housing is substantially water resistant.

4. The sensor control unit of claim 1, further comprising an alarm to indicate a physiological condition including one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia, and a medication protocol alert.

5. The sensor control unit of claim 1, further comprising a switch for deactivating the alarm.

6. The sensor control unit of claim 1, wherein the alarm produces an audible signal when activated.

7. The sensor control unit of claim 6, wherein a loudness of the alarm increases over time when the alarm is activated.

8. The sensor control unit of claim 4, wherein the alarm produces a vibration when activated.

9. The sensor control unit of claim 4 wherein the alarm is configured to indicate at least two of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.

10. The sensor control unit of claim 1, further comprising a receiver disposed in the housing.

11. The sensor control unit of claim 1, further comprising a receiver operatively coupled to the rf transmitter in the housing, the receiver configured to receive the transmitted data from the rf transmitter.

12. A glucose monitoring system, comprising, comprising:

a sensor control unit, the sensor control unit including;

a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin and having at least one contact pad;

at least one conductive contact configured for coupling to the at least one contact pad on the electrochemical sensor; and

an rf transmitter disposed in the housing and coupled to the at least one conductive contact for transmitting data obtained using the electrochemical sensor;

and

a receiver operatively coupled to the rf transmitter in the housing, the receiver configured to receive the transmitted data from the rf transmitter.

13. The system of claim 12 wherein the rf transmitter is configured to transmit a data signal associated with each data obtained using the electrochemical sensor at a predetermined interval.

14. The system of claim 12 wherein the sensor control unit further includes a medication dispensing unit, said medication dispending unit configured to administer a medication protocol in accordance with the data obtained using the electrochemical sensor.

15. The system of claim 14 wherein the medication dispensing unit includes an insulin pump.

16. The system of claim 14 wherein the medication dispensing unit is disposed substantially within the housing.

17. The system of claim 14 wherein the medication dispensing unit is disposable.

18. A method of providing a sensor control unit, comprising the steps of:

providing a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin and having at least one contact pad;

configuring at least one conductive contact for coupling to the at least one contact pad on the electrochemical sensor;

disposing an rf transmitter in the housing; and

coupling the rf transmitter to the at least one conductive contact for transmitting data obtained using the electrochemical sensor.

19. The method of claim 18 further including the step of adhering the sensor control unit to skin.

20. The method if claim 18 further including the step of providing an alarm to indicate a physiological condition including one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia, and a medication protocol alert.