Glucagon Administration System and Methods

• US 20160000998A1
• Filed: 07/01/2014
• Published: 01/07/2016
• Est. Priority Date: 07/01/2014
• Status: Active Grant

• Current Assignee: Bigfoot Biomedical, Inc.
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Granted Patent: US 9,629,901 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61M 2202/0486 Glucose
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• 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 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Some embodiments a glucagon administration system can provide a suggested glucagon dosage based on one or more particular parameters (e.g., the user'"'"'s recent blood glucose characteristics, a glucagon sensitivity value of the user, and other parameters). In some circumstances, the glucagon administration system can receive information indicative of the user'"'"'s blood glucose level and suggest a glucagon dosage that is at least partially dependent upon a previously stored glucagon sensitivity for the user.

Claims

1. A glucagon administration system, comprising:

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

a controller that communicates with the pump drive system to dispense the medicinal fluid from the portable pump housing, wherein the controller is configured to activate a glucagon dosage calculator that calculates a suggested glucagon dosage value based at least in part on a glucagon sensitivity parameter stored in a computer-readable memory device of the controller.

2. The system of claim 1, wherein the controller activates the glucagon dosage calculator to determine the suggested glucagon dosage value in response to receiving blood glucose data indicative of a user'"'"'s blood glucose level being below a predetermined threshold.

3. The system of claim 2, further comprising a monitoring device that communicates glucose information to the controller, the glucose information being indicative of the user'"'"'s blood glucose level.

4. The system of claim 3, wherein the monitoring device wirelessly communicates the glucose information to a wireless communication device coupled to the controller.

5. The system of claim 1, wherein the glucagon dosage calculator is executed by the controller to determine the suggested glucagon dosage value based at least in part on three or more of the following components:

the glucose sensitivity parameter, a blood glucose level of the user, a rate of change to the blood glucose level of the user, target glucose level(s), user input of food intake information, an estimate of an amount of insulin already delivered to the user which has not yet acted on the user, and an estimate of glucagon already delivered to the user which has not yet acted on the user.

6. The system of claim 1, wherein the controller comprises a user interface including a display device, wherein the display device contemporaneously displays the suggested glucagon dosage value, a blood glucose level of the user, and an indication that the rate of change in the blood glucose level in increasing or decreasing.

7. The system of claim 6, wherein said medicinal fluid is glucagon, and wherein the controller the communicates with the pump drive system to dispense glucagon in an amount equal to the suggested glucagon dosage value in response to user acceptance of the suggested glucagon dosage value via the user interface.

8. The system of claim 6, wherein said medicinal fluid is insulin, and the system further comprises a separate glucagon delivery device configured to dispense glucagon in an amount equal to the suggested glucagon dosage value that is displayed by the user interface.

9. A method of operating glucagon administration system, comprising:

receiving, by a controller of an infusion pump system, glucose information indicative of a blood glucose level of a user;

detecting, by the controller of an infusion pump system, that the blood glucose level of the user is less than a threshold value stored by the controller of the infusion pump system;

activating a glucagon dosage calculator configured to determine a suggested glucagon dosage according to a function that is at least partially dependent upon (i) a glucagon sensitivity parameter stored by the controller of the infusion pump system, (ii) the blood glucose level of the user, and (iii) a targeted blood glucose level of the user;

displaying on a display screen the suggested glucagon dosage, the blood glucose level of the user, and an indication that the rate of change in the blood glucose level in increasing or decreasing.

10. The method of claim 9, further comprising dispensing glucagon to the user in an amount equal to the suggested glucagon dosage displayed on the display screen.

11. The method of claim 10, further comprising prompting the user to initiate dispensation of the glucagon from the infusion pump system in the amount of the suggested glucagon dosage displayed on the display screen.

12. The method of claim 10, wherein the glucagon is dispensed from a glucagon delivery device that is different from the infusion pump system.

13. The method of claim 9, wherein the target blood glucose level for the user is stored by the controller of the infusion pump system, wherein the suggested glucagon dosage provides an estimated amount of glucagon to be dispensed so as to increase the blood glucose level of the user to the target blood glucose level for the user.

14. A method of determining a suggested glucagon dosage comprising:

storing, at a portable computing system, a parameter value indicative of a glucagon sensitivity of a user;

receiving, by the portable computing system, glucose information indicative of a blood glucose level of the user;

comparing, by the portable computing system, the blood glucose level of the user to threshold level to determine that the blood glucose level of the user is below the threshold level;

in response to determining that the blood glucose level of the user is below the threshold level, calculating a suggested glucagon dosage for the user using at least the parameter value indicative of the glucagon sensitivity of the user;

displaying on a display screen the suggested glucagon dosage.

15. The method of claim 14, further comprising storing, by the portable computing system, a target blood glucose level for the user, wherein the suggested glucagon dosage provides an estimated amount of glucagon to be dispensed so as to increase the blood glucose level of the user to the target blood glucose level for the user.

16. The method of claim 14, wherein the portable computing device is selected from the group consisting of:

a portable infusion pump system, a mobile phone, a tablet computing device, and a glucagon injector device.

17. The method of claim 14, wherein the portable computing device is an insulin infusion pump system and the display screen is part of the insulin infusion pump system, the method further comprising prompting the user to dispense glucagon from a glucagon delivery device that is different from the infusion pump system in an amount that is equal to the suggested glucagon dosage displayed on the display screen.

18. A medicine administration 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 that is removably attachable to the pump housing in a fixed relationship 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 displays a suggested glucagon dosage in response to user input to the user interface, the suggested glucagon dosage being at least partially dependent upon a glucose sensitivity value stored by the controller device, a target blood glucose level stored by the controller device, and the blood glucose level of the user.

19. The system of claim 18, wherein the controller device is configured to activate a glucagon dosage calculator that calculates the suggested glucagon dosage based at least in part on the glucose sensitivity value stored by the controller device, the target blood glucose level stored by the controller device, and the blood glucose level of the user.

20. The system of claim 18, further comprising a glucagon injector device that is separate from the pump device and the controller device, the glucagon injector device being configured to dispense glucagon in an amount equal to the suggested glucagon dosage that is displayed by the controller device.