Device and method for therapy calibration and safety response

• US 8,454,576 B2
• Filed: 02/06/2012
• Issued: 06/04/2013
• Est. Priority Date: 04/25/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Mastrototaro, John J., Yoon, Richard K.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US13/366,368
• Publication Number:
  US 20120136336A1
• Time in Patent Office: 484 Days
• Field of Search: 6048901-8911, 604/28, 604/31, 604/504, 604 65- 67, 604/246
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1582 Double lumen needles
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A closed loop/semi-closed loop infusion system provides therapy modification and safeguards against the over-delivery or under-delivery of insulin. A glucose sensor system is configured to obtain a measured blood glucose value. A controller is operationally connected with the glucose sensor system and configured to trigger an alarm based on a measured blood glucose value or amount of insulin delivered, selectively perform calibration of the glucose sensor system when the alarm is triggered, and adjust a therapy delivery parameter when the alarm is triggered, wherein the adjusted therapy delivery parameter is limited to be within a boundary. Thereafter, a delivery system delivers therapy at the adjusted therapy delivery parameter.

Claims

1. A method for providing therapy modification in an infusion system, the method comprising:

delivering insulin at a current basal rate in an existing basal pattern for a user;

obtaining a plurality of measured blood glucose values including a current measured blood glucose value and historical measured blood glucose values;

triggering an alarm when the current measured blood glucose value is higher or lower than a target blood glucose value;

informing the user that calibration of a glucose sensor system needs to be performed when the alarm is triggered;

prompting the user to decide whether the calibration is to be performed;

performing the calibration if the user decides to perform the calibration;

determining a basal rate adjustment from the current basal rate to an adjusted basal rate if the user decides not to perform the calibration in order to bring the current measured blood glucose value to be consistent with the target blood glucose value, wherein the basal rate adjustment is limited to be within a boundary based on the current basal rate; and

delivering insulin at the adjusted basal rate if the basal rate adjustment is within the boundary.

2. The method of claim 1, further comprising:

prior to delivering insulin at the adjusted basal rate, evaluating whether a condition is safe to deliver insulin at the adjusted basal rate.

3. The method of claim 2, wherein evaluating whether a condition is safe to deliver insulin at the adjusted basal rate comprises determining that the condition is unsafe if the basal rate adjustment exceeds the boundary, and the method further comprises:

prompting the user to accept the adjusted basal rate; and

delivering insulin at the adjusted basal rate.

4. The method of claim 2, wherein evaluating whether a condition is safe to deliver insulin at the adjusted basal rate comprises determining that the condition is unsafe if the plurality of measured blood glucose values do not follow a consistent pattern, and the method further comprises:

continuing delivery of insulin at the current basal rate if the condition is unsafe.

5. The method of claim 2, further comprising:

suspending closed-loop delivery of insulin if the condition is unsafe; and

reverting to open-loop delivery of insulin using a default basal pattern.

6. The method of claim 5, further comprising:

resuming closed-loop delivery of insulin if the unsafe condition is corrected; and

continuing open-loop delivery of insulin if the unsafe condition is not corrected.

7. The method of claim 1, wherein the boundary comprises a percentage of the current basal rate above or below the current basal rate.

8. The method of claim 1, wherein the boundary comprises a maximum allowed increase or decrease of the current basal rate.

9. The method of claim 1, further comprising:

after performing the calibration, obtaining a new measured blood glucose value;

comparing the new measured blood glucose value to the target blood glucose value;

determining whether the new measured blood glucose value is higher or lower than the target blood glucose value;

determining a second basal rate adjustment from the current basal rate to a second adjusted basal rate if the new measured blood glucose value is higher or lower than the target blood glucose value in order to bring the new measured blood glucose value to be consistent with the target blood glucose value, wherein the second basal rate adjustment is limited to be within the boundary based on the current basal rate; and

delivering insulin at the second adjusted basal rate if the second basal rate adjustment is within the boundary.

10. The method of claim 1, further comprising logging the adjusted basal rate.

11. An infusion system for providing therapy modification, the system comprising:

a glucose sensor system;

a delivery system configured to deliver insulin into a user; and

a controller operationally connected with the glucose sensor system and the delivery system, wherein the controller causes the delivery system to deliver insulin at a current basal rate in an existing basal pattern for the user, obtains a plurality of measured blood glucose values including a current measured blood glucose value and historical measured blood glucose values, triggers an alarm when the current measured blood glucose value is higher or lower than a target blood glucose value, informs the user that calibration of the glucose sensor system needs to be performed when the alarm is triggered, prompts the user to decide whether the calibration is to be performed, performs the calibration if the user decides to perform the calibration, determines a basal rate adjustment from the current basal rate to an adjusted basal rate if the user decides not to perform the calibration in order to bring the current measured blood glucose value to be consistent with the target blood glucose value, wherein the basal rate adjustment is limited to be within a boundary based on the current basal rate, and causes the delivery system to deliver insulin at the adjusted basal rate if the basal rate adjustment is within the boundary.

12. The system of claim 11, wherein the controller further evaluates whether a condition is safe to deliver insulin at the adjusted basal rate prior to the delivery system delivering insulin at the adjusted basal rate.

13. The system of claim 12, wherein the controller evaluates whether a condition is safe to deliver insulin at the adjusted basal rate by determining that the condition is unsafe if the basal rate adjustment exceeds the boundary, and the controller further prompts the user to accept the adjusted basal rate, and causes the delivery system to deliver insulin at the adjusted basal rate.

14. The system of claim 12, wherein the controller evaluates whether a condition is safe to deliver insulin at the adjusted basal rate by determining that the condition is unsafe if the plurality of measured blood glucose values do not follow a consistent pattern, and the controller further causes the delivery system to continue delivery of insulin at the current basal rate if the condition is unsafe.

15. The system of claim 12, wherein the controller further causes the delivery system to suspend closed-loop delivery of insulin if the condition is unsafe, and revert to open-loop delivery of insulin using a default basal pattern.

16. The system of claim 15, wherein the controller further causes the delivery system to resume closed-loop delivery of insulin if the unsafe condition is corrected, and continue open-loop delivery of insulin if the unsafe condition is not corrected.

17. The system of claim 11, wherein the boundary comprises a percentage of the current basal rate above or below the current basal rate.

18. The system of claim 11, wherein the boundary comprises a maximum allowed increase or decrease of the current basal rate.

19. The system of claim 11, wherein after performing the calibration, the controller further obtains a new measured blood glucose value, compares the new measured blood glucose value to the target blood glucose value, determines whether the new measured blood glucose value is higher or lower than the target blood glucose value, determines a second basal rate adjustment from the current basal rate to a second adjusted basal rate if the new measured blood glucose value is higher or lower than the target blood glucose value in order to bring the new measured blood glucose value to be consistent with the target blood glucose value, wherein the second basal rate adjustment is limited to be within the boundary based on the current basal rate, and causes the delivery system to deliver insulin at the second adjusted basal rate if the second basal rate adjustment is within the boundary.

20. The system of claim 11, wherein the controller further logs the adjusted basal rate.