System for providing blood glucose measurements to an infusion device

• US 9,636,456 B2
• Filed: 07/17/2013
• Issued: 05/02/2017
• Est. Priority Date: 07/24/2002
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Talbot, Cary D., Estes, Mark C., Mastrototaro, John J., Moberg, Sheldon B., Tolle, Mike Charles Vallet, Williams, Gary L., Mueller, Jr., John C.
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US13/944,630
• Publication Number:
  US 20130303980A1
• Time in Patent Office: 1,385 Days
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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

Abstract

An infusion system includes an infusion device and a sensing device. The infusion system may further include a characteristic determining device. The infusion device also includes a communication system for transmitting to and receiving communications from the sensing device or a computer. The sensing device may sense an analyte of a bodily fluid of the user. The analyte may be calibrated using data from the infusion device and from a characteristic determining device. The system may be set up to automatically call for assistance when analytes reach a certain level.

Claims

1. An infusion system for infusing insulin into a body of a user, the infusion system comprising:

a sensing device including;

a sensor configured to continuously measure glucose levels in the user;

a sensing device processor coupled to the sensor and configured to process sensor values indicative of the glucose levels in the user measured by the sensor; and

a sensing device transmitter coupled to the sensing device processor and configured to transmit a communication including the sensor values indicative of the glucose levels in the user measured by the sensor;

an external hand-held characteristic determining device including;

a determining device housing configured to be carried by the user;

a receptacle coupled to the determining device housing and configured to receive and test a blood sample from the user to obtain a blood glucose measurement;

a determining device processor contained in the determining device housing and coupled to the receptacle and configured to process the obtained blood glucose measurement; and

a determining device transmitter contained in the determining device housing and coupled to the determining device processor and configured to transmit a communication including the obtained blood glucose measurement; and

an infusion device including;

an infusion device housing configured to be carried by a user;

a drive mechanism contained in the infusion device housing and operatively coupled with a reservoir containing insulin for infusing the insulin into the body of the user;

an infusion device receiver contained in the infusion device housing and configured to receive the communication from the sensing device transmitter and the communication from the determining device transmitter;

an infusion device processor contained in the infusion device housing and coupled to the infusion device receiver and configured to process the sensor values received from the sensing device transmitter and the obtained blood glucose measurement received from the determining device transmitter;

an infusion device indicator coupled to the infusion device processor and configured to indicate the sensor values and the blood glucose measurement; and

a bolus estimator used in conjunction with the infusion device processor for calculating an estimated amount of insulin to be infused into the body of the user based upon the obtained blood glucose measurement received from the determining device transmitter and a target blood glucose level for the user, wherein the infusion device processor determines an amount of time that has elapsed since the obtained glucose measurement was received from the determining device transmitter, and prevents the bolus estimator from calculating the estimated amount of insulin to be infused based upon the obtained blood glucose measurement if the elapsed amount of time exceeds a predetermined amount of time, and causes the bolus estimator to calculate the estimated amount of insulin to be infused based upon the obtained blood glucose measurement if the elapsed amount of time does not exceed the predetermined amount of time, and wherein the infusion device indicator further indicates when the estimated amount of insulin to be infused has been calculated.

2. The infusion system according to claim 1, wherein the sensing device transmitter continuously transmits the sensor values to the infusion device receiver.

3. The infusion system according to claim 1, wherein the sensing device processor is further configured to calibrate the sensor values, and the sensing device transmitter transmits the calibrated sensor values to the infusion device receiver.

4. The infusion system according to claim 3, wherein the sensing device further includes a sensing device receiver coupled to the sensing device processor and configured to receive said communication including the obtained blood glucose measurement from the determining device transmitter, and the sensing device processor is further configured to calibrate the sensor values based on the obtained blood glucose measurement received from the determining device transmitter.

5. The infusion system according to claim 1, wherein the sensing device transmitter transmits the communication including the sensor values to the infusion device receiver using wireless communication.

6. The infusion system according to claim 1, wherein the infusion device receiver receives uncalibrated sensor values from the sensing device transmitter, and the infusion device processor is further configured to calibrate the received sensor values.

7. The infusion system according to claim 6, wherein the infusion device processor is configured to calibrate the received sensor values based on the obtained blood glucose measurement received from the determining device transmitter.

8. The infusion system according to claim 6, wherein the infusion device indicator is configured to display the calibrated sensor values.

9. The infusion system according to claim 8, wherein the infusion device indicator is configured to display the calibrated sensor values in response to input from the user.

10. The infusion system according to claim 1, wherein the infusion device indicator is configured to provide at least one of a visual indication, an audible indication, or a tactile indication, to indicate when the sensor values are below or above predetermined levels.

11. The infusion system according to claim 1, wherein the infusion device is configured to automatically contact an emergency response system if the sensor values are below or above predetermined levels.

12. The infusion system according to claim 11, wherein the infusion device is configured to transmit a global positioning signal to the emergency response system.

13. The infusion system according to claim 1, wherein the characteristic determining device is a blood glucose meter.

14. The infusion system according to claim 1, wherein the determining device transmitter transmits the communication including the obtained blood glucose measurement to the infusion device receiver using wireless communication.

15. The infusion system according to claim 1, wherein the determining device processor has identification information, and wherein the communication transmitted from the determining device transmitter to the infusion device receiver further includes the identification information of the determining device processor such that the infusion device is capable of deciding whether to accept the communication from the determining device transmitter.

16. The infusion system according to claim 15, wherein the identification information of the determining device processor is unique.

17. The infusion system according to claim 1, wherein the infusion device processor has identification information, and wherein the communication transmitted from the determining device transmitter to the infusion device receiver further includes the identification information of the infusion device processor such that the infusion device is capable of deciding whether to accept the communication from the determining device transmitter.

18. The infusion system according to claim 17, wherein the identification information of the infusion device processor is unique.

19. The infusion system according to claim 1, wherein the sensing device processor has identification information, and wherein the communication transmitted from the sensing device transmitter to the infusion device receiver further includes the identification information of the sensing device processor such that the infusion device is capable of deciding whether to accept the communication from the sensing device transmitter.

20. The infusion system according to claim 19, wherein the identification information of the sensing device processor is unique.

21. The infusion system according to claim 1, wherein the infusion device processor has identification information, and wherein the communication transmitted from the sensing device transmitter to the infusion device receiver further includes the identification information of the infusion device processor such that the infusion device is capable of deciding whether to accept the communication from the sensing device transmitter.

22. The infusion system according to claim 21, wherein the identification information of the infusion device processor is unique.

23. The infusion system according to claim 1, wherein the infusion device further includes a memory for storing data including the sensor values received from the sensing device and the obtained blood glucose measurement received from the characteristic determining device.

24. The infusion system according to claim 23, wherein the data stored in the memory of the infusion device is downloaded from the infusion device to a computer.

25. The infusion system according to claim 24, wherein the infusion device further includes an infusion device transmitter for transmitting the data to be downloaded from the infusion device to the computer.

26. The infusion system according to claim 25, wherein the infusion device transmitter is configured to transmit the data to be downloaded from the infusion device to the computer automatically at predetermined times.

27. The infusion system according to claim 25, wherein the infusion device receiver is configured to receive a signal from the computer, and the infusion device transmitter is configured to transmit the data to be downloaded from the infusion device to the computer automatically in response to the signal received from the computer.

28. The infusion system according to claim 25, wherein the characteristic determining device further includes a determining device receiver configured to receive the data to be downloaded from the infusion device transmitter to the computer, and the determining device transmitter is configured to transmit the received data to be downloaded to the computer.

29. The infusion system according to claim 1, wherein the sensing device transmitter is configured to transmit data to be downloaded from the sensing device, wherein the infusion device further includes an infusion device transmitter configured to transmit data to be downloaded from the infusion device, and wherein the characteristic determining device further includes:

a determining device receiver configured to receive the data to be downloaded from the sensing device transmitter and the infusion device transmitter; and

a memory for storing the data received from the sensing device and the infusion device.

30. The infusion system according to claim 29, wherein the data stored in the memory of the characteristic determining device is downloaded from the characteristic determining device to a computer.

31. The infusion system according to claim 30, wherein the determining device transmitter is configured to transmit the data to be downloaded from the characteristic determining device to the computer.

32. The infusion system according to claim 31, wherein the determining device transmitter is configured to transmit the data to be downloaded from the characteristic determining device to the computer automatically at predetermined times.

33. The infusion system according to claim 31, wherein the determining device receiver is configured to receive a signal from the computer, and the determining device transmitter is configured to transmit the data to be downloaded from the characteristic determining device to the computer automatically in response to the signal received from the computer.

34. The infusion system according to claim 1, wherein the infusion device receiver uses one of radio frequency, infrared, Bluetooth, and spread spectrum communication.