OPERATING MULTI-MODAL MEDICINE DELIVERY SYSTEMS

• US 20170189614A1
• Filed: 12/20/2016
• Published: 07/06/2017
• Est. Priority Date: 01/05/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc. (Abbott Laboratories)
• Inventors: Mazlish, Bryan, Desborough, Lane
• Granted Patent: US 10,987,468 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• 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 2205/502 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 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/702 automatically during use
• 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 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Some embodiments a multi-modal medicine delivery system can be configured to control dispensation of medicine according to any of a plurality of delivery modes, such as closed-loop delivery modes and open-loop delivery modes, and according to a secondary feedback loop to determine user-specific settings related to dosage delivery.

Claims

1. A method, comprising:

selecting a first delivery mode from among a plurality of delivery modes to use for operating a multi-modal medicine delivery system to dispense one or more medications adapted to alter a blood analyte level;

delivering the one or more medications to the user according to the first delivery mode, the first delivery mode providing a schedule of medication delivery based upon user-specific dosage parameters and a primary feedback loop corresponding to the first delivery mode;

obtaining, while the multi-modal medicine delivery system is operating according to and without exiting the first delivery mode, (i) analyte sensor data and (ii) medicine delivery data or food intake data, the analyte sensor data being generated by an analyte sensor and indicating the blood analyte level for the user at one or more specific times, the medicine delivery data identifying amounts and times at which the one or more medications were delivered to the user, the food intake data identifying amounts and times at which one or more foods were consumed by the user;

determining, using a secondary feedback loop, one or more updates to the user-specific dosage parameters based on (i) the analyte sensor data and (ii) the medicine delivery data or the food intake data;

delivering the one or more medications to the user according to the first delivery mode based upon the updated user-specific dosage parameters; and

switching to a second delivery mode and delivering the one or more medications to the user according to the second delivery mode and the updated user-specific dosage parameters.

2. The method of claim 1, wherein the multi-modal medicine delivery system comprises a portable insulin infusion pump system, the analyte sensor data comprises data describing blood glucose readings, and the medicine delivery data identifies insulin dosages delivered to the user from the portable insulin infusion pump system.

3. The method of claim 2, wherein switching to the second delivery mode comprises:

determining whether to transition out of operating the multi-modal medicine delivery system according to the first delivery mode;

selecting, in response to a determination to transition out of operating according to the first delivery mode, the second delivery mode to use for operating the multi-modal medicine delivery system from among the plurality of delivery modes; and

operating the multi-modal medicine delivery system to dispense the one or more medications according to the second delivery mode and the updated user-specific dosage parameters.

4. The method of claim 3, further comprising:

while the multi-modal medicine delivery system is operating according to and without exiting the second delivery mode, performing the following;

obtaining additional analyte sensor data and additional medicine delivery data from operation of the multi-modal medicine delivery system according to the second delivery mode and the updated user-specific dosage parameters;

determining, using the secondary feedback loop, one or more additional updates to the user-specific dosage parameters based on (i) the additional analyte sensor data and (ii) the additional medicine delivery data;

delivering the one or more medications to the user according to the second delivery mode based upon the additional updates to the user-specific dosage parameters.

5. The method of claim 4, wherein the secondary feedback loop determines the additional updates to the user-specific dosage parameters based on both (i) the analyte sensor data and the medicine delivery data generated during the first delivery mode, and (ii) the additional analyte sensor data and the additional medicine delivery data generated during the second delivery mode.

6. The method of claim 3, wherein the determination to transition out of operating according to the first delivery mode is based on detection of a transition trigger event.

7. The method of claim 6, wherein the transition trigger event is detected automatically without user input.

8. The method of claim 7, wherein the transition trigger event comprises a signal to the analyte sensor being lost or acquired.

9. The method of claim 7, wherein the transition trigger event comprises expiration of a period of time for operating the multi-modal medicine delivery system according to the first delivery mode.

10. The method of claim 7, wherein the transition trigger event comprises one or more calibrations for components of the multi-modal medicine delivery system being incomplete after a threshold period of time.

11. The method of claim 7, wherein the transition trigger event comprises a time-based schedule for a patient using the multi-modal medicine delivery system indicating that a scheduled transition is to occur at the current time.

12. The method of claim 7, wherein the transition trigger event comprises one or more components of the multi-modal medicine delivery system failing one or more safety checks.

13. The method of claim 6, wherein the transition trigger event is detected based on user input provided to the multi-modal medicine delivery system.

14. The method of claim 1, wherein:

the plurality of delivery modes include, at least, a closed-loop delivery mode and an open-loop delivery mode, and

the first delivery mode comprises the closed-loop delivery mode.

15. A method, comprising:

receiving, as part of a secondary feedback loop that is running in parallel with operation of a multi-modal medicine delivery system according to a first delivery mode from among a plurality of delivery modes, (i) analyte sensor data and (ii) medicine delivery data or food intake data, the analyte sensor data being generated by an analyte sensor and indicating the blood analyte level for the user at one or more specific times, the medicine delivery data identifying amounts and times at which the one or more medications were delivered to the user, the food intake data identifying amounts and times at which one or more foods were consumed by the user;

determining, by the secondary feedback loop and based, at least in part, on (i) the analyte sensor data and (ii) the medicine delivery data or the food intake data, whether to update one or more user-specific dosage parameters that are used to operate multi-modal medicine delivery system according to the selected delivery mode;

generating, by the secondary feedback loop and in response to determining to update the user-specific dosage parameters, one or more updates to the user-specific dosage parameters; and

providing the one or more updates for use with the operation of the multi-modal medicine delivery system according to the first delivery mode, wherein the one or more updates are incorporated into the operation of the multi-modal medicine delivery system without interrupting the first delivery mode.

16. The method of claim 15, wherein the one or more updates are determined based on both (i) the analyte sensor data and the medicine delivery data generated during the first delivery mode, and (ii) additional analyte sensor data and additional medicine delivery data generated during a second delivery mode.

17. The method of claim 15, wherein the secondary feedback loop repeatedly performs the receiving, determining, generating, and providing steps across the plurality of delivery modes.

18. The method of claim 15, wherein the multi-modal medicine delivery system comprises a portable insulin infusion pump system and wherein the secondary feedback loop is implemented on a mobile computing device that is in wireless communication with a controller device of the portable insulin infusion pump system that (i) controls delivery of one or more medications to a patient by portable insulin infusion pump system and (ii) operates the portable insulin infusion pump system according to the first delivery mode.

19. The method of claim 15, wherein:

the plurality of delivery modes include, at least, a closed-loop delivery mode and an open-loop delivery mode, and

the first delivery mode comprises the closed-loop delivery mode.

20. A portable medical multi-modal medicine delivery system, comprising:

a medicine delivery system that receives one or more medications for dispensation to a user, the medicine delivery system at least partially containing a mechanism to dispense the one or more medications to the user;

a controller configured to control dispensation of the medicine from the mechanism to dispense the one or more medications; and

wherein the controller is configured to control the dispensation of the one or more medications according to (i) a plurality of delivery modes and (ii) one or more user-specific settings that are determined by a secondary feedback loop that is independent of the plurality of delivery modes,

wherein the plurality of delivery modes include, at least, a closed-loop delivery mode and an open-loop delivery mode that both operate based, at least in part, on the one or more user-specific settings that are determined by the secondary feedback loop.