Infusion systems and related personalized bolusing methods

• US 10,854,323 B2
• Filed: 12/19/2017
• Issued: 12/01/2020
• Est. Priority Date: 12/21/2016
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Grosman, Benyamin, Roy, Anirban, Weydt, Patrick E., Parikh, Neha J., Lintereur, Louis J., Wu, Di
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/847,755
• Publication Number:
  US 20180169334A1
• Time in Patent Office: 1,078 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• 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 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/145 : using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/16804 : Flow controllers
• 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 5/16877 : Adjusting flow; Devices for setting a flow rate
• 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 10/20 : for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 : relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a patient involves obtaining, by a control system associated with the infusion device, an input meal indication, obtaining historical data for the patient associated with the input meal indication, determining an estimated carbohydrate amount corresponding to the input meal indication based at least in part on the historical data, determining a bolus dosage of the insulin based at least in part on the estimated carbohydrate amount, and operating an actuation arrangement of the infusion device to deliver the bolus dosage of the insulin to the patient.

Claims

1. A method of operating an infusion device capable of delivering insulin to a patient, the method comprising:

obtaining, by a control system associated with the infusion device, an input qualitative meal size;

obtaining historical carbohydrate amounts associated with historical meal events for the patient associated with the input qualitative meal size;

determining an estimated carbohydrate amount corresponding to the input qualitative meal size based at least in part on the historical carbohydrate amounts;

determining, by the control system, a bolus dosage of the insulin based at least in part on the estimated carbohydrate amount; and

operating, by the control system, an actuation arrangement of the infusion device to deliver the bolus dosage of the insulin to the patient.

2. The method of claim 1, further comprising:

obtaining an indication of nutritional content of a meal via a user interface, wherein;

obtaining the historical carbohydrate amounts comprises obtaining the historical meal carbohydrate amounts corresponding to historical meal events including the nutritional content; and

determining the estimated carbohydrate amount comprises determining the estimated carbohydrate amount based at least in part on the historical carbohydrate amounts associated with the historical meal events including the nutritional content.

3. The method of claim 2, wherein determining the bolus dosage comprises determining the bolus dosage based at least in part on the estimated carbohydrate amount and the nutritional content.

4. The method of claim 3, wherein determining the bolus dosage comprises:

calculating an initial bolus dosage based at least in part on the estimated carbohydrate amount; and

adjusting the initial bolus dosage based on the nutritional content to obtain the bolus dosage.

5. The method of claim 4, wherein adjusting the initial bolus dosage comprises decreasing the initial bolus dosage when the nutritional content indicates a relatively high fat meal.

6. The method of claim 4, wherein adjusting the initial bolus dosage comprises increasing the initial bolus dosage when the nutritional content indicates a relatively high carbohydrate meal.

7. The method of claim 2, further comprising adjusting a closed-loop control parameter based on the nutritional content.

8. The method of claim 2, further comprising temporarily suspending delivery of the insulin by a closed-loop control system of the infusion device based on the nutritional content.

9. The method of claim 1, further comprising determining an estimated carbohydrate ratio corresponding to the input qualitative meal size based at least in part on the historical data and a current time of day, wherein determining the bolus dosage comprises determining the bolus dosage based on the estimated carbohydrate amount and the estimated carbohydrate ratio.

10. The method of claim 9, wherein:

determining the estimated carbohydrate amount comprises determining the estimated carbohydrate amount for the qualitative meal size based at least in part on historical carbohydrate amounts associated with the historical meal events associated with the qualitative meal size and the current time of day.

11. A computer-readable medium having instructions stored thereon that are executable by the control system associated with the infusion device to perform the method of claim 1.

12. The method of claim 1, wherein the input qualitative meal size comprises small, medium or large.

13. A method of operating an infusion device capable of delivering fluid influencing a physiological condition to a patient, the method comprising:

obtaining, by a control system associated with the infusion device, an indication of an event via a user interface, wherein the indication comprises a qualitative size for a meal;

obtaining historical data for the patient associated with previous instances of the event;

determining, by the control system, a delivery adjustment based at least in part on a subset of the historical data for the patient associated with the previous instances of the event having the qualitative size for the meal associated therewith; and

operating, by the control system, an actuation arrangement of the infusion device to deliver the fluid to the patient in accordance with the delivery adjustment.

14. The method of claim 13, the fluid comprising insulin and the historical data including historical sensor glucose measurement data for the patient corresponding to the previous instances of the event, and the method further comprising determining an estimated glycemic response to the event based at least in part on the historical sensor glucose measurement data corresponding to the previous instances of the event, wherein the delivery adjustment is influenced by the estimated glycemic response.

15. The method of claim 14, wherein:

determining the estimated glycemic response comprises an estimated carbohydrate ratio based on the historical sensor glucose measurement data corresponding to the previous instances of the event; and

determining the delivery adjustment comprises determining a bolus dosage based at least in part on the estimated carbohydrate ratio.

16. The method of claim 13, wherein:

the fluid comprises insulin;

the historical data comprises historical meal data for the patient;

determining the delivery adjustment comprises;

correlating the qualitative size to an estimated carbohydrate amount for the patient based at least in part on a subset of the historical meal data for the patient associated with previous meals having the qualitative size associated therewith; and

determining a meal bolus amount based at least in part on the estimated carbohydrate amount; and

operating the actuation arrangement comprises operating the actuation arrangement to deliver the meal bolus amount of the insulin.

17. The method of claim 13, wherein:

the fluid comprises insulin;

the indication comprises a nutritional content for a meal;

the historical data comprises historical meal data for the patient;

determining the delivery adjustment comprises;

correlating the nutritional content to an estimated carbohydrate amount for the patient based at least in part on a subset of the historical meal data for the patient associated with previous meals having the nutritional content associated therewith; and

determining a meal bolus amount based at least in part on the estimated carbohydrate amount; and

operating the actuation arrangement comprises operating the actuation arrangement to deliver the meal bolus amount of the insulin.

18. The method of claim 13, wherein:

the fluid comprises insulin;

the indication comprises a nutritional content for a meal;

the historical data comprises historical meal data for the patient;

determining the delivery adjustment comprises;

determining an estimated glycemic response to the meal based at least in part on a subset of the historical meal data for the patient associated with previous meals having the nutritional content associated therewith; and

adjusting a closed-loop control parameter based at least in part on the estimated glycemic response; and

operating the actuation arrangement comprises operating the actuation arrangement to deliver the fluid based at least in part on a sensor glucose measurement for the patient and the adjusted closed-loop control parameter.

19. An infusion system comprising:

an actuation arrangement operable to deliver insulin to a patient;

a user interface to receive an input qualitative meal size indication;

a data storage element to maintain historical meal data for the patient; and

a control system coupled to the actuation arrangement, the user interface, and the data storage element to determine a meal bolus dosage of the insulin based at least in part on a subset of the historical meal data for the patient corresponding to previous meals corresponding to the input qualitative meal size indication and operate the actuation arrangement to deliver the meal bolus dosage of the insulin to the patient.

20. The infusion system of claim 19, wherein the control system determines an estimated carbohydrate amount corresponding to the input qualitative meal size indication based at least in part on the subset of the historical meal data and determines the meal bolus dosage based at least in part on the estimated carbohydrate amount.