Analyte monitoring device and methods of use

• US 7,860,544 B2
• Filed: 03/07/2007
• Issued: 12/28/2010
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Behrad, Aria, Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Colman, Fredric C., Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US11/683,408
• Publication Number:
  US 20070149874A1
• Time in Patent Office: 1,392 Days
• Field of Search: 600345-366, 600/309
• 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 monitoring system, comprising:

a first sensor, at least a portion of which is positionable in the body of a person, and including at least one electrode with an analyte-responsive enzyme associated therewith;

a second sensor, at least a portion of which is positionable in the body of the person, and including at least one electrode with an analyte-responsive enzyme associated therewith;

a data processing unit to receive data from the first and second sensors and programmed to verify the data validity; and

a medication delivery unit in communication with the data processing unit;

wherein when a predetermined physiological condition is detected, the data processing unit is configured to analyze data from the first or second sensor over a predetermined time period, and to determine one or more patterns associated with the detected predetermined physiological condition based on the stored data, and to predict an occurrence of a future episode associated with the physiological condition based on the determined one or more patterns; and

further

wherein the data processing unit is trainable to modify medication delivery based on the predicted occurrence of the future episode associated with the physiological condition.

4. The system of claim 1 wherein the analyte response enzyme associated with the at least one electrode of the first and second sensors are different.

5. The system of claim 4 wherein the analyte response enzyme is responsive to glucose.

6. The system of claim 4 wherein the analyte response enzyme is responsive to lactate.

7. The system of claim 1 wherein the data processing unit is configured to confirm validity of at least one data from the first or second sensors when the data from the first and the second sensor are within a predetermined parameter.

8. The system of claim 1 wherein the data from at least one of the first or the second sensors is calibrated using a blood sample.

9. The system of claim 1 wherein the data from at least one of the first or the second sensors is calibrated at the factory.

10. The system of claim 1 further including an output unit operatively coupled to the medication delivery unit to output one or more of the data from the first or the second sensor.

11. The system of claim 10 wherein the output unit presents the data visually, audibly, vibratorily, or any combination thereof.

12. The system of claim 1 wherein at least a portion of the at least one electrode of the first sensor or of the at least one electrode of the second sensor is in fluid contact with an analyte of the person.

13. The system of claim 12 wherein the at least the portion of the at least one electrode of the first sensor and the at least one electrode of the second sensor are in fluid contact simultaneously for a predetermined time period.

14. The system of claim 1 wherein the medication delivery unit includes one of an internal infusion pump, an external infusion pump, a syringe injector, a transdermal delivery system, an inhalation system, or one or more combinations thereof.

15. The system of claim 1 wherein the data processing unit is configured to determine a drug administration protocol based on the verified data validity.

16. The system of claim 1 wherein the medication delivery unit is configured to deliver a drug to a patient based at least in part on the data from the first or second sensors.

17. The system of claim 16 wherein the medication delivery unit is configured to deliver insulin.

18. The system of claim 1 wherein the predetermined physiological condition includes one of a hypoglycemic condition, a hyperglycemic condition, an impending hyperglycemic condition, or an impending hypoglycemic condition.

19. The system of claim 1 wherein the data processing unit is configured to provide drug sensitivity feedback.

20. The system of claim 1 including a memory operatively coupled to the data processing unit configured to store data from the first or second sensor.

21. The system of claim 1 wherein the data processing unit initiates a deactivation mode disabling output of at least a portion of information associated with the data from the first or second sensors when the data validity is not verified.

22. The system of claim 1 wherein the one or more patterns include responses to a similar external or internal stimulus.

23. The system of claim 22 wherein the external or internal stimulus includes a period of hypoglycemia, a period of hyperglycemia, a non-glucose analyte condition, a treatment of a condition, medication level, food intake, exercise level, or temperature level.

24. The system of claim 1 wherein the medication delivery unit is configured to deliver a medication based on the determined one or more patterns by the data processing unit.

25. The system of claim 24 wherein the medication includes insulin.

26. The system of claim 19 wherein the data processing unit is configured to provide on-going drug sensitivity feedback.

27. The system of claim 19 wherein the medication delivery unit or the data processing unit is configured to modify a current drug administration protocol based on the drug sensitivity feedback and/or the determined one or more patterns.

28. The system of claim 27 wherein the medication delivery unit or the data processing unit is configured to provide a current drug administration protocol based on the drug sensitivity feedback and/or the predicted occurrence of the future episode associated with the physiological condition.

29. The system of claim 1 wherein the first sensor and the second sensor are the same.

2. The system of 1 wherein the analyte-response enzyme associated with the at least one electrode of the first and second sensors are the same.

3. The system of 2 wherein the analyte response enzyme is responsive to glucose.