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

• US 9,724,470 B2
• Filed: 06/15/2015
• Issued: 08/08/2017
• 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 M
• Application Number:
  US14/739,840
• Publication Number:
  US 20150359966A1
• Time in Patent Office: 785 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 delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient;

a network; and

a supervisory system monitor in communication with a remote system, the network, the controller and the automation risk monitor.

2. The system of claim 1 wherein the system monitor detects occlusion pressure levels.

3. The system of claim 1 wherein the system monitor detects air in line levels.

6. The system of claim 1 wherein the controller controls a medication delivery device to deliver medication to the patient based on a comparison of the risk to predetermined risk threshold.

13. The system of claim 1 A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient; and

a system monitor in communication with a remote system, the controller and the automation risk monitor;

wherein the system monitor monitors remote system activity.

4. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient; and

a system monitor in communication with a network, the controller and the automation risk monitor;

wherein the system monitor detects network failures.

5. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient; and

a system monitor in communication with a remote system, the controller and the automation risk monitor;

wherein the system monitor detects remote system failures.

7. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient; and

a system monitor in communication with the controller and the automation risk monitor;

wherein the controller transitions a medication delivery device to a backup system to deliver medication to the patient based on a comparison of the risk to predetermined risk threshold.

8. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient;

a multi-channel infusion system; and

a system monitor in communication with the controller and the automation risk monitor;

wherein when the system monitor detects a system failure the controller transitions medication delivery to a different channel of the multi-channel infusion system.

9. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient;

a multi-channel infusion system; and

a system monitor in communication with the controller and the automation risk monitor;

wherein when the system monitor detects a system failure the controller adjusts a concurrently administered infusion to compensate for the failure.

10. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient; and

a system monitor in communication with the controller and the automation risk monitor;

wherein the system monitor detects a failure of a clinician to respond.

11. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient; and

a system monitor in communication with the controller and the automation risk monitor; and

an alarm system that escalates alarms based on the risk to the patient.

12. The system of claim 11 wherein the risk to the patient is determined by the automation risk monitor based on data from the sensor and the system monitor.

14. A system for delivering medication to a patient, the system comprising:

a controller having a control algorithm and an automation risk monitor that monitors the control algorithm;

a sensor in communication with the controller and the automation risk monitor and monitoring a medical condition;

a rule based application in the automation risk monitor that receives data from the sensor and a closed loop control and compares the data to predetermined medical information to determine risk to a patient; and

a system monitor in communication with a network, the controller and the automation risk monitor;

wherein the system monitor monitors network activity.