System for monitoring physiological characteristics

• US 7,766,830 B2
• Filed: 11/30/2004
• Issued: 08/03/2010
• Est. Priority Date: 12/27/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Rebrin, Kerstin, Saidara, Frank, Fox, James Kelly, Estes, Mark C., Steil, Garry M.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US10/999,491
• Publication Number:
  US 20050113653A1
• Time in Patent Office: 2,072 Days
• Field of Search: 600/481, 600483-485, 600/300, 600/301, 600500-503, 600345-366, 600/529, 600/531, 600/309
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Apparatuses and methods for medical monitoring physiological characteristics values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide dynamic glucose monitoring functions that perform predictive analysis to anticipate harmful conditions, such as glucose crash and hyperglycemic incidents for a patient. The dynamic functions can also be used to maximize athletic performance and warn of inadequate nocturnal basal rate. Other aspects include advanced alarm and reminder functions, as well as advanced data presentation tools to further facilitate convenient and efficient management of various physiological conditions.

Claims

1. A physiological characteristic monitor, comprising:

an input device capable of receiving a signal from a sensor, the signal being based on a physiological characteristic value of a user;

a processor for analyzing the received signal; and

a memory for storing data and instructions used by the processor;

wherein;

the physiological characteristic is blood glucose;

the processor initiates a timer based upon a condition associated with the blood glucose value of the user, wherein an initiating condition comprises hyperglycemia or hypoglycemia and a duration of the timer is preset based upon the initiating condition; and

the processor provides a reminder to the user following expiration of the timer, wherein the reminder;

prevents an alarm from being initiated for a first period of time; and

initiates an alarm that reminds the user to monitor blood glucose when the first period of time has expired.

2. The physiological characteristic monitor of claim 1, wherein the reminder includes an alarm signal selected from the group consisting of an audible signal, a visual signal, a tactile signal and a display.

3. The physiological characteristic monitor of claim 1, wherein the condition is that an event marker is entered into the monitor.

4. The physiological characteristic monitor of claim 3, wherein the event marker is selected from the group consisting of a meal marker, an exercise marker, a high blood glucose marker and a low blood glucose marker.

5. The physiological characteristic monitor of claim 1, wherein the condition is that a reference value is entered into the monitor and the reminder indicates that a new reference value should be entered.

6. The physiological characteristic monitor of claim 1, wherein the processor determines a physiological characteristic value from the received signal and the condition based upon the physiological characteristic value.

7. The physiological characteristic monitor of claim 1, wherein the condition is that the physiological characteristic value exceeds a threshold value.

8. The physiological characteristic monitor of claim 1, wherein the condition is that the physiological characteristic value is below a threshold value.

9. The physiological characteristic monitor of claim 1, wherein the sensor is placed in subcutaneous tissue.

10. The physiological characteristic monitor of claim 1, wherein the sensor is placed in interstitial fluid.

11. A method of triggering a reminder to a user of a physiological characteristic monitor, comprising the steps of:

receiving a signal from a sensor, the signal being based on a physiological characteristic value of a user, wherein the physiological characteristic is blood glucose;

using a processor and a memory that stores data and instructions used by the processor to analyze the received signal and to initiate a timer based upon a condition associated with the blood glucose value of the user, wherein an initiating condition comprises hyperglycemia or hypoglycemia and a duration of the timer is preset based upon the initiating condition; and

using the processor to provide a reminder to the user following expiration of the timer, wherein the reminder;

prevents an alarm from being initiated for a first period of time; and

initiates an alarm that reminds the user to monitor blood glucose when the first period of time has expired,

so as to provide a reminder to the user following expiration of the timer.

12. The method of claim 11, wherein the reminder includes an alarm signal selected from the group consisting of an audible signal, a visual signal, a tactile signal and a display.

13. The method of claim 11, wherein the condition is that an event marker is entered into the monitor.

14. The method of claim 13, wherein the event marker is selected from the group consisting of a meal marker, an exercise marker, a high blood glucose marker and a low blood glucose marker.

15. The method of claim 11, wherein the condition is that a reference value is entered into the monitor and the reminder indicates that a new reference value should be entered.

16. The method of claim 11, wherein the processor determines a physiological characteristic value from the received signal and the condition based upon the physiological characteristic value.

17. The method of claim 11, wherein the condition is that the physiological characteristic value exceeds a threshold value.

18. The method of claim 11, wherein the condition is that the physiological characteristic value is below a threshold value.

19. The method of claim 11, wherein the processor provides an alarm based upon the condition associated with the physiological characteristic value of the user before initiating the timer.

20. A physiological characteristic monitor, comprising:

an input device capable of receiving a signal from a sensor placed in subcutaneous tissue, the signal being based on a blood glucose value of a user;

a processor for analyzing the received signal; and

a memory for storing data and instructions used by the processor;

wherein;

the processor initiates a timer based upon a condition associated with the blood glucose value of the user, wherein an initiating condition comprises hyperglycemia or hypoglycemia and a duration of the timer is preset based upon the initiating condition; and

the processor provides a reminder to the user following expiration of the timer,

wherein the reminder;

prevents an alarm from being initiated for a first period of time; and

initiates an alarm that reminds the user to monitor blood glucose when the first period of time has expired.

21. The physiological characteristic monitor of claim 20, wherein:

the sensor comprises an electrode; and

the electrode is exposed for direct contact with blood or another body fluid when the sensor is subcutaneously placed at an insertion site.

22. A method of triggering a reminder to a user of a monitor, comprising the steps of:

receiving a signal from a sensor placed in subcutaneous tissue, the signal being based on a value of a user;

using a processor and a memory that stores data and instructions used by the processor to analyze the received signal and to initiate a timer based upon a condition associated with the value of the user, wherein an initiating condition comprises hyperglycemia or hypoglycemia and a duration of the timer is preset based upon the initiating condition; and

using the processor to provide a reminder to the user following expiration of the timer,

wherein the reminder;

prevents an alarm from being initiated for a first period of time; and

initiates an alarm that reminds the user to monitor blood glucose when the first period of time has expired,

so as to provide a reminder to the user following expiration of the timer.

23. The method of claim 22, wherein:

the sensor comprises an electrode; and

the electrode is exposed for direct contact with blood or another body fluid, when the sensor is subcutaneously placed at an insertion site.