# US 2013/0158503 A1 · Apparatus and method for controlling insulin infusion with state variable feedback

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- Number: US 2013/0158503 A1
- Document ID: US20130158503A1
- Status: Published application
- Kind: A1
- Application number: 13/692,510
- Filed: 2012-12-03
- Published: 2013-06-20
- Earliest claimed: 1999-06-03
- Assignees: Medtronic MiniMed, Inc.
- Inventors: SAMI S. KANDERIAN, JR.; GARRY M. STEIL
- Web page: https://patentgrep.com/patent/US20130158503A1

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14539: {for measuring pH}
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/6849: {in combination with a needle set}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/1582: {Multi-lumen needles}
- A61M 2005/14296: {Pharmacokinetic models}
- A61M 2005/1581: {Right-angle needle-type devices}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2230/201: Glucose concentration
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An infusion system, which may be a closed loop, or “semi-closed-loop”, infusion system, uses state variable feedback to control the rate at which fluid is infused into a user's body. The closed loop system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user and produces a sensor signal which is representative of the user's condition. 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, e.g., subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused with a bolus and to be removed from the basal delivery of the fluid.

## Claims

### Claim 1

A method of infusing insulin into a body of a user, the method comprising:
delivering a basal amount of insulin to the body of the user at a predetermined basal rate;
determining at least one state variable;
determining, based on the at least one state variable, an additional amount of insulin to be delivered to the body of the user; and
reducing the basal rate by said additional amount of insulin to be delivered to the body of the user.

### Claim 2 (depends on 1)

The method of claim 1, wherein the at least one state variable is selected from the group consisting of subcutaneous insulin concentration, plasma insulin concentration, and insulin effect.

### Claim 3 (depends on 1)

The method of claim 1, wherein the determining at least one state variable includes determining subcutaneous insulin concentration, plasma insulin concentration, and insulin effect.

### Claim 4 (depends on 1)

The method of claim 1, wherein the determining the additional amount of insulin is further based on at least one gain corresponding to one of the at least one state variables.

### Claim 5 (depends on 1)

The method of claim 1, further comprising repeating, after a predetermined period of time, the determining at least one state variable, determining an additional amount of insulin to be delivered to the body of the user, and reducing the basal rate by said additional amount of insulin to be delivered to the body of the user.

### Claim 6 (depends on 1)

The method of claim 1, further including determining a bolus amount of insulin and infusing said bolus amount of insulin and said additional amount of insulin to the body of the user.

### Claim 7 (depends on 6)

The method of claim 6, wherein the bolus amount of insulin is determined based on an obtained blood glucose concentration of the user.

### Claim 8 (depends on 7)

The method of claim 7, wherein the determining the bolus amount of insulin includes:
generating a controller input based on the blood glucose concentration;
generating commands by a proportional plus, integral plus, derivative (PID) controller from the controller input; and
determining, based on the commands from the PID controller, the bolus amount of insulin to be delivered to the body of the user.

### Claim 9 (depends on 8)

The method of claim 8, wherein the determining a bolus amount of insulin to be delivered to the body of the user is further based on at least one preset PID controller gain selected such that the commands generated by the PID controller cause insulin to be infused into the body of the user in response to a glucose concentration at a rate substantially equal to the rate that beta cells would release insulin in an individual with a healthy normally functioning pancreas.

### Claim 10 (depends on 9)

The method of claim 9, wherein the at least one preset controller gain is selected by a method that includes measuring an insulin response of at least one individual with a healthy normally functioning pancreas and calculating the at least one controller gain that causes the commands to substantially match the insulin response of the at least one individual.

### Claim 11 (depends on 7)

The method of claim 7, wherein the at least one state variable is selected from the group consisting of subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and wherein the determining the additional amount of insulin is further based on at least one gain corresponding to one of the at least one state variables.

### Claim 12 (depends on 6)

The method of claim 6, further including providing a prompt to indicate that the bolus amount of insulin has been determined and receiving an input to indicate that the bolus amount of insulin should be infused to the user.

### Claim 13 (depends on 6)

The method of claim 6, further comprising repeating, after a predetermined period of time, the determining at least one state variable, determining the additional amount of insulin to be delivered to the body of the user, infusing the determined bolus amount of insulin and the determined additional amount of insulin to the body of the user, and reducing the basal rate by said additional amount of insulin.