SYSTEM FOR MONITORING AND DELIVERING MEDICATION TO A PATIENT AND METHOD OF USING THE SAME TO MINIMIZE THE RISKS ASSOCIATED WITH AUTOMATED THERAPY

• US 20130158504A1
• Filed: 12/14/2012
• Published: 06/20/2013
• Est. Priority Date: 12/16/2011
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Ruchti, Timothy L., Khair, Mohammad M.
• Granted Patent: US 10,022,498 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system and method for monitoring and delivering medication to a patient 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 base 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. 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;

an electronic medication delivery device controlled by the controller;

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 the closed loop control and compares the data to predetermined medical information to determine a risk of therapy automation to the patient; and

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

2. The system of claim 1 wherein when the risk is below the predetermined risk threshold additional automated medication delivery therapy is provided and when the risk at or above the predetermined risk threshold the controller triggers a request for user intervention.

3. The system of claim 2 wherein triggering a request for user intervention causes the closed loop control to function as an open loop.

4. The system of claim 2 wherein the additional automated medication delivery therapy includes delivering insulin.

5. The system of claim 1 wherein the medical condition is a glucose level of the patient.

6. The system of claim 1 wherein the predetermined medical information includes a risk matrix.

7. The system of claim 6 wherein the risk matrix includes information pertaining to glucose ranges, glucose change, insulin change and risk level.

8. The system of claim 1 wherein the predetermined medical information includes information determined using continuous mapping functions, fuzzy logic or probability calculations.

9. The system of claim 1 wherein the predetermined medical information includes information determined using a mathematical model.

10. The system of claim 9 wherein the mathematical model is defined by one of a pharmacokinetic and a pharmacodynamic model.

11. The system of claim 2 wherein the request for user intervention is sent to the user through a messaging system.

12. The system of claim 6 wherein a portion of the risk matrix is user customizable.

13. The system of claim 12 wherein the user customizable portion of the risk matrix includes a plurality of user-defined risk levels and respective actions are associated with the risk levels and wherein at least two of the respective actions are different.

14. The system of claim 13 wherein the plurality of user-defined risk levels includes at least three risk levels comprising high, medium and low risk levels.

15. A method for monitoring and delivering medication to a patient comprising:

monitoring a control algorithm of a controller for delivering medication from an electronic medication delivery device with an automation risk monitor;

receiving data at the controller from a sensor regarding a medical condition;

comparing the data from the control algorithm and sensor to predetermined medical information to determine a risk of therapy automation to the patient;

comparing the risk of therapy automation to a predetermined risk threshold; and

delivering medication to the patient as automated medication therapy based on the comparison of the risk of therapy automation to the predetermined risk threshold.

16. The method of claim 15 further comprising the step of providing additional automated medication delivery therapy when the risk is below the predetermined risk threshold.

17. The method of claim 16 wherein the automated medication delivery therapy includes delivering insulin.

18. The method of claim 15 further comprising the step of triggering a request for user intervention when the risk is at or above the predetermined threshold to cause a closed loop control to function as an open loop.

19. The method of claim 15 wherein the medical condition is a glucose level of the patient.

20. The method of claim 15 wherein the predetermined medical information includes a risk matrix.

21. The method of claim 20 wherein the risk matrix includes information pertaining to glucose ranges, glucose change, insulin change and risk level.

22. The method of claim 15 wherein the predetermined medical information includes information determined using continuous mapping functions, fuzzy logic or probability calculations.

23. The method of claim 15 wherein the predetermined medical information includes information determined using a mathematical model.

24. The method of claim 23 wherein the mathematical model is defined by one of a pharmacokinetic and a pharmacodynamic model.

25. The method of claim 15 wherein the request for user intervention is sent to the user through a messaging system.

26. The method of claim 20 wherein a portion of the risk matrix is user customizable and includes at least three risk levels comprising high, medium and low risk levels with respective actions associated therewith and at least two of the respective actions are different.