Operating an infusion pump system

• US 9,878,097 B2
• Filed: 04/29/2015
• Issued: 01/30/2018
• Est. Priority Date: 04/29/2015
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US14/699,341
• Publication Number:
  US 20160317743A1
• Time in Patent Office: 1,007 Days
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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: G16H 20/17 delivered via infusion or injection

Abstract

Some embodiments an infusion pump system can be configured to control dispensation of medicine according to a closed-loop delivery mode that is responsive to feedback information provided from a monitoring device, and the infusion pump system permits a user to interrupt the closed-loop delivery mode for purposes of dispensing a user-selected manual bolus dosage.

Claims

1. A method of operating a portable insulin infusion pump system, comprising:

while operating an infusion pump system to dispense insulin according to a closed-loop delivery mode, detecting a trigger event to initiate a user-selected manual bolus dosage;

temporarily interrupting the closed-loop delivery mode by dispensing from the infusion pump system the user-selected manual bolus dosage, wherein a calculated dosage amount of the user-selected manual bolus dosage is calculated by the infusion pump system based upon both user input and an amount of insulin dispensed during the closed-loop delivery mode over a time period immediately prior to said interrupting; and

automatically returning to the closed-loop delivery mode after dispensation of the user-selected manual bolus dosage;

wherein said amount of insulin dispensed during the closed-loop delivery mode over the time period comprises an effective-insulin-on-board amount calculated as follows;

Effective Insulin-on-Board=[Σ

(Dosage_n*Duration Factor(t)_n)]−

Estimated Basal Rate,

where n is any positive whole number, and where Duration Factor(t)_n, represents a factor discounting the dosage based on an amount of time (t) since its delivery;

wherein the Estimated Basal Rate is an estimate of a background insulin need of a user of the insulin pump system over the time period.

2. The method of claim 1, wherein the closed-loop delivery mode causes the infusion pump system to dispense insulin in response to feedback information of a user'"'"'s blood glucose level.

3. The method of claim 1, wherein the infusion pump system comprises a controller including:

a user interface display device, control circuitry arranged in a controller housing and being programmed to perform said calculation of the suggested bolus dosage.

4. The method of claim 3, wherein the infusion pump system comprises a pump device including:

a pump housing that houses a drive system and an insulin reservoir, the controller housing being removably mountable to the pump housing so that the controller is electrically connected to the drive system.

5. The method of claim 1, further comprising outputting an alert from the infusion pump system in response to a calculated stacking value exceeding a predetermined stacking threshold, wherein the calculated stacking value comprises the calculated dosage amount of the user-selected manual bolus dosage plus the Effective Insulin-on-board.

6. The method of claim 1, wherein the calculated dosage amount of the user-selected manual bolus dosage comprises comprise a calculation of a suggested bolus dosage according to the following function:

Suggested Bolus Dosage=(Food Offsetting Component)+(Blood Glucose Correction Component)−

(Effective Insulin-on-board Component).

7. The method of claim 1, wherein the Estimated Basal Rate is calculated according to the following function:

Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where T is a unit of time;

wherein the Scale Down Factor is a multiplier selected to scale down the total dose to a fractional value that only accounts for insulin delivered to meet the user'"'"'s background insulin needs.

8. The method of claim 1, wherein the trigger event comprises actuation of a user interface button while the infusion pump system is in a powered on state, actuation of the user interface button indicating a user'"'"'s request to initiate calculation of a suggested bolus dosage by the infusion pump system;

the method further comprising;

calculating, by the infusion pump system, a suggested bolus dosage;

presenting, by the infusion pump system, the suggested bolus dosage to the user of the infusion pump system;

receiving user input indicating that the suggested bolus dosage should be administered as the user-selected manual bolus dosage.

9. A medical infusion pump system, comprising:

a portable pump housing configured to receive medicine for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the medicine through a flow path to the user; and

a controller that controls the pump drive system to dispense the medicine from the portable pump housing according to a closed-loop delivery mode in which the controller autonomously provides insulin dosages to the user in response to feedback information of a user'"'"'s blood glucose level, wherein the controller is configured to, in response to receiving input indicative of a user-prompted bolus dosage, temporarily interrupt the closed-loop delivery mode by dispensing from the infusion pump system the user-prompted bolus dosage, wherein a calculated dosage amount of the user-prompted bolus dosage is calculated by the infusion pump system based upon both user input and an amount of insulin dispensed during the closed-loop delivery mode over a time period prior to the user-prompted bolus dosage;

wherein said amount of insulin dispensed during the closed-loop delivery mode over the time period comprises an effective-insulin-on-board amount calculated as follows;

Effective Insulin-on-Board=[Σ

(Dosage_n*Duration Factor(t)_n)]−

Estimated Basal Rate,

where n is any positive whole number, and where Duration Factor(t)_n, represents a factor discounting the dosage based on an amount of time (t) since its delivery;

wherein the Estimated Basal Rate is an estimate of a background insulin need of a user of the insulin pump system over the time period.

10. The system of claim 9, wherein the input indicative of the user-prompted bolus dosage comprises actuation of a user interface button indicating a user request to manually enter a bolus dosage amount.

11. The system of claim 9, wherein the input indicative of the user-prompted bolus dosage comprises actuation of a user interface button indicating a user request to initiate a calculation, by the infusion pump system, of a suggested bolus dosage.

12. The system of claim 9, wherein the controller comprises a user interface including a display device and a plurality of buttons.

13. The system of claim 12, wherein the controller comprises a controller housing that removably attaches to the pump housing.

14. The system of claim 13, wherein the controller is electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

15. The system of claim 14, wherein the controller is a reusable device and the pump housing and pump drive system are disposable and nonreusable.

16. The system of claim 9, further comprising a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user.

17. A method of operating a portable insulin infusion pump system, comprising:

while operating an infusion pump system to dispense insulin according to a closed-loop delivery mode, detecting a trigger event to initiate a user-selected manual bolus dosage;

determining, at the infusion pump system, that the bolus dosage is permissible based on an amount of the bolus dosage and an amount of insulin dispensed during the closed-loop delivery mode over a time period immediately prior to the trigger event; and

initiating delivery of the permissible bolus dosage;

wherein said amount of insulin dispensed during the closed-loop delivery mode over the time period comprises an Effective-Insulin-on-Board amount calculated as follows;

Effective Insulin-on-Board=[Σ

(Dosage_n*Duration Factor(t)_n)]−

Estimated Basal Rate,

where n is any positive whole number, and where Duration Factor(t)_n, represents a factor discounting the dosage based on an amount of time (t) since its delivery;

wherein the Estimated Basal Rate is an estimate of a background insulin need of a user of the insulin pump system over the time period.

18. The method of claim 17, wherein the closed-loop delivery mode causes the infusion pump system to dispense insulin in response to feedback information of a user'"'"'s blood glucose level, and wherein the trigger event comprises actuation of a user interface button indicating a user'"'"'s request to manually initiate a bolus dispensation that is independent from said feedback information of the user'"'"'s blood glucose characteristic.

19. The method of claim 17, wherein the trigger event comprises actuation of a user interface button indicating a user'"'"'s request to initiate calculation of a suggested bolus dosage by the infusion pump system.

20. The method of claim 17, wherein determining whether the bolus dosage is permissible comprises comparing a calculated stacking value to a predetermined stacking threshold, and wherein the calculated stacking value comprises the bolus dosage plus the Effective Insulin-on-Board.

21. The method of claim 17, wherein determining whether the bolus dosage is permissible comprises comparing a calculated future blood glucose level to a predetermined threshold, and wherein the calculated future blood glucose level is a function of the Effective Insulin-on-Board.

22. The method of claim 17, wherein the Estimated Basal Rate is calculated according to the following function:

Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where T is a unit of time;

wherein the Scale Down Factor is a multiplier selected to scale down the total dose to a fractional value that only accounts for insulin delivered to meet the user'"'"'s background insulin needs.

23. A portable infusion pump system, comprising:

a portable pump housing configured to receive medicine for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the medicine through a flow path to the user;

control circuitry that controls the pump drive system to dispense the medicine from the portable pump housing according to a closed-loop delivery mode in which insulin is dispensed in response to feedback information of a user'"'"'s blood glucose characteristic; and

a user interface in communication with the control circuitry and being configured to receive user input to interrupt said closed-loop delivery mode,

wherein the control circuitry is configured to perform operations comprising;

detecting, while the infusion pump system is in a powered on state, actuation of a user interface control of the user interface indicating a user'"'"'s request to initiate calculation of a suggested bolus dosage by the infusion pump system;

in response to detecting the actuation of the user interface control indicating a user'"'"'s request to initiate calculation of a suggested bolus dosage, calculating a suggested bolus dosage;

causing the user interface to present the suggested bolus dosage to the user of the infusion pump system;

detecting user input received at the user interface indicating that the suggested bolus dosage should be administered as a user-selected manual bolus dosage;

temporarily interrupting the closed-loop delivery mode by dispensing from the infusion pump system the user-selected manual bolus dosage;

automatically returning to the closed-loop delivery mode after dispensation of the user-selected manual bolus dosage

wherein a calculated dosage amount of the user-selected manual bolus dosage is calculated by the infusion pump system based upon both user input and an amount of insulin dispensed during the closed-loop delivery mode over a time period prior to the user-prompted bolus dosage;

wherein said amount of insulin dispensed during the closed-loop delivery mode over the time period comprises an effective-insulin-on-board amount calculated as follows;

Effective Insulin-on-Board=[Σ

(Dosage_n*Duration Factor(t)_n)]−

Estimated Basal Rate,

where n is any positive whole number, and where Duration Factor(t)_n, represents a factor discounting the dosage based on an amount of time (t) since its delivery;

wherein the Estimated Basal Rate is an estimate of a background insulin need of a user of the insulin pump system over the time period.

24. The system of claim 23, wherein the Estimated Basal Rate is calculated according to the following function:

Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where T is a unit of time;

wherein the Scale Down Factor is a multiplier selected to scale down the total dose to a fractional value that only accounts for insulin delivered to meet the user'"'"'s background insulin needs.