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

• US 10,646,651 B2
• Filed: 06/07/2019
• Issued: 05/12/2020
• 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:
  US16/435,206
• Publication Number:
  US 20200061291A1
• Time in Patent Office: 340 Days
• Field of Search: 340540
• 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 drug delivery, the system comprising one or more hardware processors configured to:

control a pump that is configured to deliver a drug to a patient using a closed loop control system;

detect failure in an infusion system that includes the pump and stop the delivery of the drug using the closed loop control system based on the detected failure;

assess a first risk of stopping further delivery of the drug versus a second risk corresponding to the detected failure; and

determine whether to continue delivery of the drug using a protocol that is different than the closed loop control system delivery based on the assessment of the first risk with the second risk.

2. The system of claim 1, wherein the drug is insulin.

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

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

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

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

7. The system of claim 1, wherein the one or more hardware processors are configured to notify a clinician system based on the detected failure.

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

9. The system of claim 1, wherein the one or more hardware processors are configured to completely stop delivery of the drug based on the assessment indicating that the first risk of stopping is lower than the second risk corresponding to the detected failure.

10. A method for controlling an automation of drug delivery, the method comprising:

controlling a pump that is configured to deliver a drug to a patient using a closed loop control system;

detecting failure in an infusion system that includes the pump and stop the delivery of the drug using the closed loop control system based on the detected failure;

assessing a first risk of stopping further delivery of the drug versus a second risk corresponding to the detected failure; and

determining whether to continue delivery of the drug using a protocol that is different than the closed loop control system delivery based on the assessment of the first risk with the second risk.

11. The method of claim 10, wherein the drug is insulin.

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

13. The method of claim 10, wherein the failure comprises air in an infusion line.

14. The method of claim 10, wherein the failure comprises occlusion of an infusion line.

15. The method of claim 10, further comprising delivering the drug at a predetermined rate after the detected failure.

16. The method of claim 10, further comprising notifying a clinician system based on the detected failure.

17. The method of claim 10, wherein the estimation of first risk is determined on a supervisory computing system that is independent from a closed loop control system.

18. The method of claim 10, further comprising completely stopping delivery of the drug based on the assessment indicating that the first risk of stopping is lower than the second risk corresponding to the detected failure.