Infusion pump system and methods

• US 9,901,677 B2
• Filed: 10/16/2012
• Issued: 02/27/2018
• Est. Priority Date: 10/16/2012
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Swanson, Leah
• Application Number:
  US13/652,905
• Publication Number:
  US 20140107607A1
• Time in Patent Office: 1,960 Days
• Field of Search: 604131, 604 66, 604 67
• CPC Class Codes: A61M 2205/27 preventing use
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• 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: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Some embodiments an infusion pump system can be configured to activate an alarm in response to a calculated prediction of the user'"'"'s future blood glucose levels. Optionally, the predictive calculation of the user'"'"'s future blood glucose levels can be based at least in part upon a recent blood glucose level, a trend of blood glucose levels over time, and an insulin load of the user.

Claims

1. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing; and

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user, wherein the controller is configured to;

predict a future blood glucose level of the user based at least in part upon a recent blood glucose level, a trend of blood glucose levels over time, and an insulin load of the user, operate in a low glucose recovery mode in which a basal rate is reduced as compared to a normal operational mode in response to the predicted future blood glucose level being less than a lower threshold value, and in response to the activation of the controller to operate in the low glucose recovery mode, automatically exit from the low glucose recovery mode and return to the normal operational mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to the lower threshold value, wherein the controller is further configured to operate in a high glucose recovery mode in which a basal rate is temporarily increased in response to the predicted future blood glucose level being greater than an upper threshold level; and

wherein in response to the controller calculating the predicted future blood glucose level being less than the lower threshold value, the controller automatically cancels any previously scheduled bolus amount of insulin to be dispensed from the portable pump housing and informs the user of how much bolus was missed.

2. The system of claim 1, wherein the controller calculates the predicted future blood glucose level of the user based at least in part upon the recent blood glucose level, the trend of blood glucose levels over time, and the insulin load of the user, the insulin load of the user being an estimated value of previously dispensed insulin that has not yet acted in the user.

3. The system of claim 2, wherein the insulin load is an insulin-on-board estimate indicative of bolus insulin dosages that have been dispensed but not yet acted in the user.

4. The system of claim 2, wherein the insulin load is total-insulin-load estimate indicative of both bolus and basal insulin dosages that have been dispensed but not yet acted in the user.

5. The system of claim 1, wherein the controller calculates the predicted future blood glucose level of the user based at least in part upon the recent blood glucose level, the trend of blood glucose levels over time, the insulin load of the user, and a food-on-board value, the food-on-board value being indicative of previous food intake by the user that has not yet metabolized in the user.

6. The system of claim 1, further comprising one or more computer-readable memory device of the controller that store the glucose information received from the monitoring device and time values associated with the glucose information.

7. The system of claim 6, wherein the one or more computer-readable memory devices of the controller store computer-readable instructions for a blood glucose prediction process that, when executed by a processor of the controller, cause the controller to:

calculate the predicted future blood glucose level of the user based at least in part upon the recent blood glucose level, the trend of blood glucose levels over time, and the insulin load of the user;

output an alarm in response to the predicted future blood glucose level being less than the lower threshold value; and

operate in the low glucose recovery mode in response to user input that confirms an operational change for the controller.

8. The system of claim 1, further comprising a user interface coupled to the controller, the user interface including (i) a display device that is configured to provide a visual indication of an alarm and (ii) a user input device that is configured to receive user input to activate the controller to operate in the low glucose recovery mode.

9. The system of claim 8, wherein in response to the activation of the controller to operate in the low glucose recovery mode, the controller communicates with the pump drive system to reduce, but not stop, a basal rate amount of insulin to be dispensed the from the portable pump housing.

10. The system of claim 1, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing, wherein the controller is a reusable device while at least one of the pump housing and the pump drive system include a structure to prevent reuse of the pump housing and the pump drive system.

11. The system of claim 1, wherein the portable pump housing defines an opening that slidably receives a prefilled cartridge of the insulin, further comprising a cap device configured to cover the opening and pierce the prefilled cartridge of insulin when the portable pump housing receives the prefilled cartridge of insulin.

12. The system of claim 1, wherein the monitoring device comprises a portable housing wearable on the user'"'"'s skin, a sensor shaft that penetrates into the user'"'"'s skin, and a wireless communication device to transmit the glucose information to a wireless communication device of the controller.

13. A controller for an insulin infusion pump system, comprising:

a processor;

one or more computer-readable memory devices that store glucose information received from a monitoring device and time values associated with the glucose information, wherein the one or more computer-readable memory devices store computer-readable instructions for a blood glucose prediction process that, when executed by the processor, cause the controller to;

calculate a predicted future blood glucose level of the user based at least in part upon a recent blood glucose level of a user, a trend of blood glucose levels over time, and an insulin load of the user;

output an alarm in response to the predicted future blood glucose level being less than a lower threshold value; and

operate in a low glucose recovery mode in response to user input that accepts activation of the low glucose recovery mode; and

in response to the activation of the controller to operate in the low glucose recovery mode, automatically exit from the low glucose recovery mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to the lower threshold value and return to a normal operational mode;

wherein a basal rate is reduced in the low glucose recovery mode as compared to the normal operational mode;

wherein a previously scheduled bolus amount of insulin is canceled in the low glucose recovery mode and the alarm informs the user of how much bolus was missed; and

output an alarm in response to the predicted future blood glucose level being greater than an upper threshold level; and

operate in a high glucose recovery mode in response to user input that accepts activation of the high glucose recovery mode, wherein a basal rate is temporarily increased in the high glucose recovery mode as compared to the normal operational mode.

14. The controller of claim 13, wherein the one or more computer-readable memory devices store computer-readable instructions for the blood glucose prediction process that, when executed by the processor, cause the controller to:

in response to the activation of the controller to operate in the low glucose recovery mode, reduce but not stop a basal rate amount of insulin to be dispensed while operating in the low glucose recovery mode.

15. A method of operating an insulin infusion pump system, comprising:

receiving, at a controller of an insulin infusion pump system, glucose information indicative of a glucose level of a user;

determining an insulin load value indicative of an estimated value of previously dispensed insulin that has not yet acted in the user;

calculating, at the controller of the insulin infusion pump system, a predicted future blood glucose level of the user based at least in part upon a recent glucose level of the user, a trend of blood glucose levels over time, and the insulin load of the user;

in response to the predicted future blood glucose level being less than a lower threshold value or greater than a higher threshold value, outputting an alarm from the insulin infusion pump system;

operating in a low glucose recovery mode in which a basal rate is reduced as compared to a normal operational mode in response to the predicted future blood glucose level being less than a lower threshold value; and

automatically exiting from the low glucose recovery mode and returning to the normal operational mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to the lower threshold value, in response to the activation of the controller to operate in the low glucose recovery mode; and

canceling any previously scheduled bolus amount of insulin to be dispensed from the portable pump housing and informing the user of how much bolus was missed in response to the controller calculating the predicted future blood glucose level being less than the lower threshold value;

operating in a high glucose recovery mode in which a basal rate is temporarily increased as compared to a normal operational mode in response to the predicted future blood glucose level being greater than an upper threshold level.

16. The method of claim 15, further comprising, in response to the predicted future blood glucose level being less than the lower threshold value or greater than the higher threshold value, prompting the user to confirm a change to an operational mode of the insulin infusion pump system.

17. The method of claim 16, further comprising, in response to the predicted future blood glucose level being less than the lower threshold value, prompting the user to confirm activation of the low glucose recovery mode for the insulin infusion pump system.

18. The method of claim 15, further comprising, in response to the predicted future blood glucose level being less than the lower threshold value, stopping any previously scheduled bolus amount of insulin to be dispensed from the insulin infusion pump system.

19. The method of claim 15, wherein, the determined predicted future blood glucose level is further based on a food on board component, in addition to the glucose information and the dispensed insulin amount, and wherein the food on board component is based on previous food intake by the user that has not yet metabolized in the user.

20. The method of claim 15, further comprising activating a pump drive system of the insulin infusion pump system to dispense the insulin through a flow path.

21. The method of claim 15, wherein receiving the glucose information comprises receiving at the controller of the insulin infusion pump system a wireless signal from a wireless glucose monitoring device wearable on the user'"'"'s body.

22. A method of operating an insulin infusion pump system, comprising:

receiving, at a controller of an insulin infusion pump system, glucose information indicative of a glucose level of a user;

determining an insulin load value indicative of an estimated value of previously dispensed insulin that has not yet acted in the user;

calculating, at the controller of the insulin infusion pump system, a predicted future blood glucose level of the user based at least in part upon a recent glucose level of the user, a trend of blood glucose levels over time, and the insulin load of the user; and

in response to the predicted future blood glucose level being less than a lower threshold value or greater than a higher threshold value, outputting an alarm from the insulin infusion pump system;

further comprising, in response to the predicted future blood glucose level being less than the lower threshold value, prompting the user to confirm activation of a low glucose recovery mode for the insulin infusion pump system;

wherein in response to user input confirming the activation of the low glucose recovery mode for the insulin infusion pump system, the method further comprises;

reducing but not stopping a basal rate amount of insulin to be dispensed from the insulin infusion pump system;

canceling any previously scheduled bolus amount of insulin to be dispensed from the portable pump housing in response to the controller calculating the predicted future blood glucose level being less than the lower threshold value and informing the user of how much bolus was missed

subsequently predicting the future blood glucose level of the user based upon updated glucose information indicative of the glucose level of a user, an updated trend of blood glucose levels over time, and an updated insulin load of the user; and

activating the insulin infusion pump system to return to a normal operational mode in response to the subsequently predicted future blood glucose level being greater than or equal to the lower threshold level; and

operating in a high glucose recovery mode in which a basal rate is temporarily increased as compared to a normal operational mode in response to the predicted future blood glucose level being greater than an upper threshold level.

23. The method of claim 22, wherein a bolus programming function is disabled during the low glucose recovery mode.