Analyte monitoring device and methods of use

• US 8,480,580 B2
• Filed: 04/19/2007
• Issued: 07/09/2013
• Est. Priority Date: 04/30/1998
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wolpert, Howard, Heller, Adam
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/737,671
• Publication Number:
  US 20080021436A1
• Time in Patent Office: 2,273 Days
• Field of Search: 600/309, 600345-365
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• 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 5/1118 Determining activity level
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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: 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

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 medication management device, comprising:

a communication interface configured to receive one or more data associated with a monitored analyte level; and

a processor coupled to the communication interface, the processor configured to detect or predict a predetermined rate of change or level based on the received one or more data associated with the monitored analyte level, wherein the processor is configured to prompt a user to disable one or more medication related functions when the detected predetermined rate of change deviates from a predefined threshold level, to receive a request to disable the one or more, medication related functions, and to disable the one or more, medication related functions upon receipt of the request.

2. The device of claim 1 wherein the predetermined rate of change includes a decrease in the analyte level of the user.

3. The device of claim 1 wherein the one or more medication related functions includes one or more medication or carbohydrate administration functions.

4. The device of claim 1 wherein the processor is configured to temporarily disable the one or more medication related functions until the predicted or detected predetermined rate of change or level substantially falls within the predefined threshold level.

5. The device of claim 1 wherein the predefined threshold level includes a hypoglycemic condition, an impending hypoglycemic condition, a hyperglycemic condition or an impending hyperglycemic condition.

6. The device of claim 1 wherein the processor is further configured to determine an increase in the risk of an adverse physiological condition, and to modify the predefined threshold level when the increase in the risk of the adverse physiological condition is determined.

7. The device of claim 6 wherein the increase in the risk of the adverse physiological condition is determined based on a retrospective analysis using a determined blood glucose index.

8. A method, comprising:

predicting or detecting, using one or more processors, a predetermined rate of change or level based on one or more data associated with a monitored analyte level;

prompting, using the one or more processors, a user to disable one or more medication related functions of a medical device when the detected predetermined rate of change deviates from a predefined threshold level;

receiving, using the one or more processors, a request to disable the one or more medication related functions; and

disabling, using the one or more processors, the one or more medication related functions upon receipt of the request.

9. The method of claim 8 wherein disabling includes temporarily disabling one or more executable functions of the medical device related to an infusion of a medication.

10. The method of claim 8 wherein the disabling includes temporarily disabling the one or more medication related functions of the medical device until the predicted or detected predetermined rate of change or level substantially falls within the predefined threshold level.

11. The device of claim 8 wherein the predefined threshold level includes a hypoglycemic condition, an impending hypoglycemic condition, a hyperglycemic condition or an impending hyperglycemic condition.

12. The method of claim 8 further comprising:

determining an increase in the risk of an adverse physiological condition; and

modifying the predefined threshold level when the increase in the risk of the adverse physiological condition is determined.

13. The method of claim 12 wherein the increase in the risk of the adverse physiological condition is determined based on a retrospective analysis using a determined blood glucose index.