Model predictive method and system for controlling and supervising insulin infusion

• US 10,154,804 B2
• Filed: 01/31/2007
• Issued: 12/18/2018
• Est. Priority Date: 01/31/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Steil, Garry M., Kanderian, Jr., Sami S., Cantwell, Martin T., Hoss, Udo
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US11/700,666
• Publication Number:
  US 20080183060A1
• Time in Patent Office: 4,339 Days
• Field of Search: 600345, 600347, 600365
• 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 controller contained within the housing, wherein the controller optimizes delivery of insulin into the body of the user to cover a planned meal by, prior to consumption of the meal by the user, (a) obtaining from the user a carbohydrate count for the meal, a meal-type indicator for the meal, an insulin amount to cover the meal, and a plurality of insulin delivery patterns for delivery of said insulin amount to cover the meal, (b) generating a respective predicted post-prandial glucose concentration profile for each one of said plurality of insulin delivery patterns based on the carbohydrate count, the meal-type indicator, the insulin amount, and a meal appearance rate, and (c) determining whether any one of said respective predicted post-prandial glucose concentration profiles is acceptable, wherein said determination is made solely by the controller and independently of the user,

wherein the controller determines acceptability of the respective predicted post-prandial glucose concentration profiles by comparing each of said respective predicted post-prandial glucose concentration profiles to a predetermined glucose profile and selecting one of the respective predicted post-prandial glucose concentration profiles that is closest to the predetermined glucose profile within an acceptable range of deviation,

wherein the carbohydrate count is equal to the total amount of carbohydrates contained in the meal, wherein said total amount of carbohydrates appear as glucose in the user'"'"'s blood plasma in accordance with a predetermined meal appearance rate curve having a peak, wherein the meal-type indicator corresponds to a predetermined amount of time calculated as a difference between a first point in time when the meal is to be consumed and a second point in time when said peak is reached, wherein said meal appearance rate curve is defined by the relation

2. The infusion pump of claim 1, wherein each of said plurality of insulin delivery patterns is selected from the group consisting of a basal pattern, a single-bolus pattern, and an extended-bolus pattern.

3. The infusion pump of claim 1, wherein at least one of said plurality of insulin delivery patterns is an extended-bolus pattern.

4. The infusion pump of claim 3, wherein the at least one insulin delivery pattern is a 2-hour extended bolus pattern.

5. The infusion pump of claim 3, wherein the at least one insulin delivery pattern is a 4-hour extended bolus pattern.

6. The infusion pump of claim 1, wherein, if the controller determines that none of the respective predicted post-prandial glucose concentration profiles is acceptable, the controller further receives from the user a modified value for at least one of the carbohydrate count for the meal, the meal-type indicator for the meal, the insulin amount to cover the meal, and the plurality of insulin delivery patterns, and then repeats steps (b) and (c).

7. 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 controller contained within the housing, wherein the controller optimizes delivery of insulin into the body of the user to cover a planned meal by, prior to consumption of the meal by the user, (a) obtaining from the user a carbohydrate count for the meal, a meal-type indicator for the meal, an insulin amount to cover the meal, and at least one insulin delivery pattern for delivery of said insulin amount to cover the meal, (b) generating a predicted post-prandial glucose concentration profile based on the carbohydrate count, the meal-type indicator, the insulin amount, a meal appearance rate, and the at least one insulin delivery pattern, (c) displaying said predicted post-prandial glucose concentration profile to the user, and (d) prompting the user to either accept or decline said generated post-prandial glucose concentration profile,

wherein the carbohydrate count is equal to the total amount of carbohydrates contained in the meal, wherein said total amount of carbohydrates appear as glucose in the user'"'"'s blood plasma in accordance with a predetermined meal appearance rate curve having a peak, and wherein the meal-type indicator corresponds to a predetermined amount of time calculated as a difference between a first point in time when the meal is to be consumed and a second point in time when said peak is reached, wherein said meal appearance rate curve is defined by the relation

8. The infusion pump of claim 7, wherein, if the user declines said displayed post-prandial glucose concentration profile, the controller further receives from the user a modified value for at least one of the carbohydrate count for the meal, the meal-type indicator for the meal, the insulin amount to cover the meal, and the at least one insulin delivery pattern.

9. The infusion pump of claim 8, wherein, after receipt of said modified value, the controller repeats steps (a)-(d), thereby generating and displaying to the user at least one additional predicted, post-prandial glucose concentration profile.

10. The infusion pump of claim 7, wherein said at least one insulin delivery pattern is selected from the group consisting of a basal pattern, a single-bolus pattern, and an extended-bolus pattern.