Apparatus and method for controlling insulin infusion with state variable feedback

• US 8,348,886 B2
• Filed: 05/01/2009
• Issued: 01/08/2013
• Est. Priority Date: 06/03/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Kanderian, Sami S. Jr., Steil, Garry M.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/387,420
• Publication Number:
  US 20100114015A1
• Time in Patent Office: 1,348 Days
• Field of Search: 604 65- 67, 6048901-8911, 604/131, 604 65- 67, 6048901-8911, 604502-504, 600/345, 600/347, 600/316
• US Class Current: 604/66
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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

Abstract

An infusion system, which may be a closed loop infusion system or “semi-closed-loop” system, uses state variable feedback to control the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that are displayed or sounded or otherwise provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The delivery system infuses a fluid into the user at a rate dictated by the commands from the controller. The system may use three state variables, subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused as a bolus and to be removed from the basal delivery of the fluid.

Claims

1. An apparatus for infusing a fluid into a body of a user, the apparatus comprising:

a housing;

a pump inside the housing for delivering a fluid into the body of the user; and

at least one controller to control delivery of the fluid from the housing by the pump,

wherein the at least one controller;

controls delivery of a basal amount of fluid to the body of the user at a predetermined basal rate;

determines a bolus amount of fluid to be delivered to the body of the user;

determines at least one state variable including a state variable for each of subcutaneous insulin concentration, plasma insulin concentration, and insulin effect;

determines, based on the at least one state variable, an additional amount of fluid to be delivered to the body of the user with the bolus amount of fluid;

controls delivery of the determined bolus amount of fluid and the determined additional amount of fluid to the user; and

reduces the basal rate by the additional amount of fluid delivered with the bolus amount of fluid.

2. The apparatus according to claim 1, wherein, to determine the additional amount of fluid, the at least one controller uses at least one gain, wherein each of the at least one gains corresponds to one of the at least one state variables.

3. The apparatus according to claim 1, wherein, to determine the bolus amount of fluid, the at least one controller uses an obtained blood glucose concentration of the user.

4. The apparatus according to claim 3, wherein the at least one controller includes a proportional plus, integral plus, derivative (PID) controller operable to generate a controller input based on the blood glucose concentration, generate commands from the controller input, and determine, based on the commands, the bolus amount of fluid to be delivered to the body of the user.

5. The apparatus according to claim 4, wherein, to determine the bolus amount of fluid to be delivered to the body of the user, the PID controller further uses at least one preset PID controller gain selected such that the commands generated by the PID controller infuse fluid into the body of the user in response to a glucose concentration at a rate similar to the rate that beta cells would release insulin in an individual with a healthy normally functioning pancreas.

6. The apparatus of claim 1, wherein the fluid is insulin.

7. The apparatus of claim 1, further including one or more input devices in the housing, wherein the at least one controller provides a prompt to indicate that the bolus amount of fluid has been determined and receives an input from the one or more input devices to indicate that the bolus amount of fluid should be infused to the user.