Operating an infusion pump system

• US 10,449,294 B1
• Filed: 01/05/2016
• Issued: 10/22/2019
• Est. Priority Date: 01/05/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc. (Abbott Laboratories)
• Inventors: Estes, Mark
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US14/988,697
• Time in Patent Office: 1,386 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An infusion pump system can operate to control dispensation of medicine according to a closed-loop delivery mode and according to an open-loop delivery mode. In the closed-loop delivery mode, the system can determine user-specific settings. In the open-loop delivery mode, the system can determine insulin dosages for dispensation based at least in part on the user-specific settings that were determined during the closed-loop delivery mode.

Claims

1. A medical infusion pump system, comprising:

a 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;

a controller configured to control the pump drive system to dispense the medicine from the pump housing; and

wherein the controller is configured to control the dispensation of the medicine according to a closed-loop delivery mode in which the controller controls the pump drive system to dispense the medicine, receives feedback data in response to the dispensation of the medicine, automatically delivers a corrected dosage of the medicine determined based at least in part on the feedback data, and determines one or more user-specific settings based at least in part on the feedback data and according to an open-loop delivery mode in which one or more insulin dosages for dispensation are based at least in part on the one or more user-specific settings that were determined during the closed-loop delivery mode, wherein said one or more insulin dosages for dispensation during the open-loop delivery mode include a suggested bolus dosage calculated and displayed by the controller during the open-loop delivery mode, wherein the controller determines the suggested bolus dosage during the open-loop delivery mode based at least in part on the one or more user-specific settings of any of the user'"'"'s insulin sensitivity and the user'"'"'s carbohydrate ratio, the one or more user-specific settings being determined and stored by the controller during the closed-loop delivery mode.

2. The system of claim 1, wherein the controller is configured to transition from the closed-loop delivery mode to the open-loop delivery mode in response to detecting a transition trigger event.

3. The system of claim 2, wherein the transition trigger event comprises actuation of a user interface button indicating the user'"'"'s acknowledgement to exit the closed-loop delivery mode.

4. The system of claim 1, wherein the controller determines the suggested bolus dosage according to the function:

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

(Insulin Load Correction Component),

wherein each of the Food Offsetting Component, the Blood Glucose Correction Component, and the Insulin Load Correction Component are dependent upon one of the one or more user-specific settings that were determined during the closed-loop delivery mode.

5. The system of claim 1, wherein the controller comprises a user interface including a display device and a plurality of user-actuatable buttons.

6. The system of claim 5, wherein the controller comprises a controller housing configured to removably attach to the pump housing.

7. The system of claim 6, wherein the controller is electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

8. The system of claim 7, wherein the controller is a reusable device and the pump housing and pump drive system are disposable and nonreusable.

9. The system of claim 1, wherein the one or more user-specific settings that were determined during the closed-loop delivery mode comprise values for the user'"'"'s personal dosage parameters.

10. The system of claim 1, further comprising a monitoring device configured to communicate glucose information to the controller, the glucose information being indicative of a blood glucose level of the user.

11. A portable insulin pump system, comprising:

a disposable and non-reusable pump device including;

a pump housing that defines a space to receive an insulin cartridge; and

a drive system to dispense insulin when the insulin cartridge is received by the pump housing, the drive system including a piston rod that is incrementally movable to apply a dispensing force; and

a removable controller device including;

a controller housing configured to removably attach to the pump housing to provide an electrical connection between the controller device and the pump device;

control circuitry arranged in the controller housing to electrically communicate with the drive system in the pump housing;

a user interface connected to the control circuitry, the user interface including a display and one or more user-selectable buttons; and

a wireless communication device to receive glucose information from a wearable monitoring device, the glucose information being indicative of a blood glucose level of the user,

wherein the removable controller device is configured to control dispensation of medicine to a user according to a closed-loop delivery mode in which the controller controls the drive system to dispense the medicine, receives feedback data in response to the dispensation of the medicine, automatically delivers a corrected dosage of the medicine determined based at least in part on the feedback data, and determines customized dosage parameters that are specific to the user based at least in part on the feedback data and according to an open-loop delivery mode in which insulin dosages for dispensation to the user are based at least in part on the customized dosage parameters that were determined during the closed-loop delivery mode, wherein the insulin dosages include a suggested bolus dosage calculated during the open-loop delivery mode, wherein the customized dosage parameters include a customized insulin sensitivity and a customized carbohydrate ratio that are used in the open-loop delivery mode to determine the suggested bolus dosage.