System for monitoring and delivering medication to a patient and method of using the same to minimize the risks associated with automated therapy

• US 10,314,974 B2
• Filed: 07/31/2017
• Issued: 06/11/2019
• Est. Priority Date: 06/16/2014
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Day, William Kenneth, Ruchti, Timothy L.
• Primary Examiner(s): Blount, Eric
• Application Number:
  US15/664,785
• Publication Number:
  US 20180043094A1
• Time in Patent Office: 680 Days
• Field of Search: 340540, 604506
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/16 with back-up system in case of failure
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• 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

Abstract

A system and method for monitoring and delivering medication to a patient. The system includes a controller that has a control algorithm and a closed loop control that monitors the control algorithm. A sensor is in communication with the controller and monitors a medical condition. A rule based application in the controller receives data from the sensor and the closed loop control and compares the data to predetermined medical information to determine the risk of automation of therapy to the patient. A system monitor is also in communication with the controller to monitor system, remote system, and network activity and conditions. The controller then provides a predetermined risk threshold where below the predetermined risk threshold automated closed loop medication therapy is provided. If the predetermined risk threshold is met or exceeded, automated therapy adjustments may not occur and user/clinician intervention is requested.

Claims

1. A system for controlling an automation of insulin therapy, the system comprising:

a sensor connected with a controller, the sensor configured to detect measurements responsive to a glucose level in a patient; and

one or more hardware processors configured to;

determine a change in glucose level from the measurements;

determine an insulin volume for delivery to the patient based on the change in glucose level;

apply a predetermined risk assessment matrix to the change in glucose level and the determined insulin volume;

estimate a risk in automatically delivering the insulin volume to the patient based on the application of the predetermined risk assessment matrix; and

control pump for the delivery of the insulin volume to the patient based on the estimated risk in automatically delivering the insulin volume,

wherein the one or more hardware processors are further configured to detect failure in an infusion system and stop the automated delivery of the insulin based on the detected failure.

2. The system of claim 1, wherein the failure comprises a network failure.

3. The system of claim 1, wherein the failure comprises air in an infusion line.

4. The system of claim 1, wherein the failure comprises occlusion of an infusion line.

5. The system of claim 1, wherein the one or more hardware processors are configured to deliver insulin at a predetermined rate after the detected failure.

6. The system of claim 1, wherein the one or more hardware processors are configured to notify a clinician system when the estimated risk is high.

7. The system of claim 1, wherein the estimation of risk is determined on a supervisory computing system that is independent from a closed loop control system.

8. The system of claim 1, wherein the one or more hardware processors are configured to pause the automated delivery when the estimated risk is high.

9. A method for controlling an automation of insulin therapy, the method comprising:

determining a change in glucose level from measurement received from a sensor;

determining an insulin volume for delivery to the patient based on the change in glucose level;

applying a predetermined risk assessment matrix to the change in glucose level and the determined insulin volume;

estimating a risk in automatically delivering the insulin volume to the patient based on the application of the predetermined risk assessment matrix;

controlling pump for the delivery of the insulin volume to the patient based on the estimated risk in automatically delivering the insulin volume; and

detecting failure in an infusion system and stop the automated delivery of the insulin based on the detected failure.

10. The method of claim 9, wherein the failure comprises a network failure.

11. The method of claim 9, wherein the failure comprises air in an infusion line.

12. The method of claim 9, wherein the failure comprises occlusion of an infusion line.

13. The method of claim 9, further comprising delivering insulin at a predetermined rate after the detected failure.

14. The method of claim 9, further comprising transmitting a notification message to a clinician system when the estimated risk is high.

15. The method of claim 9, wherein the estimation of risk is determined on a supervisory computing system that is independent from a closed loop control system.

16. The method of claim 9, further comprising pausing the automated delivery when the estimated risk is high.

17. A system for controlling an automation of insulin therapy, the system comprising:

a sensor connected with a controller, the sensor configured to detect measurements responsive to a glucose level in a patient; and

one or more hardware processors configured to;

determine a change in glucose level from the measurements;

determine an insulin volume for delivery to the patient based on the change in glucose level;

apply a predetermined risk assessment matrix to the change in glucose level and the determined insulin volume;

estimate a risk in automatically delivering the insulin volume to the patient based on the application of the predetermined risk assessment matrix; and

control pump for the delivery of the insulin volume to the patient based on the estimated risk in automatically delivering the insulin volume,

wherein the estimation of risk is determined on a supervisory computing system that is independent from a closed loop control system.