MODEL PREDICTIVE METHOD AND SYSTEM FOR CONTROLLING AND SUPERVISING INSULIN INFUSION

• US 20110282321A1
• Filed: 06/27/2011
• Published: 11/17/2011
• Est. Priority Date: 01/31/2007
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Kanderian, Sami S. JR., Cantwell, Martin T., STEIL, GARRY M., Hoss, Udo
• Application Number:
  US13/169,933
• Publication Number:
  US 20110282321A1
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• 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 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1582 Double lumen needles
• 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: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 5/48 of the pancreatic hormones
• CPC Class Codes: C12Y 301/01003 Triacylglycerol lipase (3.1.1.3)
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

A system and method for controlling and monitoring a diabetes-management system through the use of a model that predicts or estimates future dynamic states of glucose and insulin from variables such as insulin delivery or exogenous glucose appearance as well as inherent physiological parameters. The model predictive estimator can be used as an insulin bolus advisor to give an apriori estimate of postprandial glucose for a given insulin delivery profile administered with a known meal to optimize insulin delivery; as a supervisor to monitor the operation of the diabetes-management system; and as a model predictive controller to optimize the automated delivery of insulin into a user'"'"'s body to achieve a desired blood glucose profile or concentration. Open loop, closed-loop, and semi-closed loop embodiments of the invention utilize a mathematical metabolic model that includes a Minimal Model, a Pump Delivery to Plasma Insulin Model, and a Meal Appearance Rate Model.

Claims

1. An infusion pump for infusing insulin from a reservoir into a body of a user, the infusion pump comprising:

a housing;

a drive mechanism contained within the housing and operatively coupled to the reservoir to deliver insulin from the reservoir through a fluid path into the body of the user; and

a model predictive controller contained within the housing, wherein the controller optimizes the delivery of insulin into the user'"'"'s body so as to achieve a desired blood glucose concentration by measuring the user'"'"'s current blood glucose concentration, generating a pre-defined desired glucose concentration profile based on the current blood glucose concentration, generating an insulin-delivery profile to achieve said desired concentration over a predetermined time period, generating a predicted glucose concentration profile for said time period based on the current glucose concentration and the generated insulin-delivery profile, calculating a difference between the generated glucose concentration profile and the pre-defined glucose concentration profile, iteratively identifying an optimal insulin-delivery profile as the profile that minimizes said difference, and generating commands for the drive mechanism to deliver insulin to the user according to the optimal insulin-delivery profile for a pre-set period of time defining a time step.

2. The infusion pump of claim 1, wherein the controller re-optimizes the delivery of insulin into the user'"'"'s body every time step for the duration of the predetermined time period.

3. The infusion pump of claim 1, wherein the pre-defined glucose concentration profile is defined per American Diabetes Association (ADA) guidelines.

4. The infusion pump of claim 1, wherein said predetermined time period is at least one hour long, and each said time step is at most five minutes long.

5. A method for optimizing the delivery of insulin into a body of a user so as to achieve a desired blood glucose concentration, the method comprising:

(a) measuring the user'"'"'s current blood glucose concentration;

(b) generating a pre-defined desired glucose concentration profile based on the current blood glucose concentration;

(c) generating an insulin-delivery profile to achieve said desired concentration over a predetermined time period;

(d) generating a predicted glucose concentration profile for said time period by a model predictive controller using the current glucose concentration and the generated insulin-delivery profile as inputs;

(e) calculating a difference between the generated glucose concentration profile and the pre-defined glucose concentration profile;

(f) iteratively repeating steps (a)-(e) and identifying an optimal insulin-delivery profile as the delivery profile that produces the minimal difference calculated in step (e);

(g) delivering insulin to the user according to the optimal insulin-delivery profile for a pre-set period of time defining a time step; and

(h) for the duration of the predetermined time period, repeating steps (a)-(g) every time step.

6. The method of claim 5, wherein the pre-defined glucose concentration profile is defined per American Diabetes Association (ADA) guidelines.

7. The method of claim 5, wherein said predetermined time period is at least one hour long, and each said time step is at most five minutes long.

8. The method of claim 5, wherein the controller is in communication with an insulin delivery system in a closed loop and, at each time step, generates commands that instruct the insulin delivery system to infuse insulin into the body of the user according to the optimal insulin-delivery profile.