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

• US 10,022,498 B2
• Filed: 12/14/2012
• Issued: 07/17/2018
• 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.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Legette-Thompson, Tiffany
• Application Number:
  US13/714,545
• Publication Number:
  US 20130158504A1
• Time in Patent Office: 2,041 Days
• Field of Search: 604 66, 604503, 604504
• 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 configured to control an electronic medication delivery device and determine a risk of automatically making therapy decision;

the electronic medication delivery device configured to deliver insulin;

a sensor in communication with the controller, the sensor configured to monitor a glucose readings;

wherein the controller is configured to;

retrieve a user customizable risk matrix wherein the user customizable risk matrix includes;

a first user-defined risk level for a first range of glucose readings where a change in glucose readings is increasing and a calculated change in insulin is increasing;

a second user-defined risk level for the first range of glucose readings where the change in glucose readings is decreasing and the calculated change in insulin is increasing;

a third user-defined risk level for the first range of glucose readings where the change in glucose readings is increasing and the calculated change in insulin is decreasing; and

a fourth user-defined risk level for the first range of glucose readings where the change in glucose readings is decreasing and the calculated change in insulin is decreasing; and

configured to determine a first glucose reading from the sensor;

determine a first insulin amount for injection to the patient;

determine a first change in glucose based on the first glucose reading;

determine a first change in insulin injection based on the first insulin amount; and

determine the risk of automatically making therapy decision based on the first glucose reading, the first change in glucose, the first change in insulin injection, and the user customizable risk matrix;

wherein the controller is configured to control the electronic medication delivery device to deliver medication to the patient based on the determined risk of automatically making therapy decision.

2. The system of claim 1 wherein the controller is further configured to trigger a request for user intervention causes a closed loop control to function as an open loop.

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

4. The system of claim 3 wherein the messaging system is remote from the controller.

5. The system of claim 3 wherein the user intervention requires authentication.

6. A method for delivering medication to a patient, the method comprising:

controlling an electronic medication delivery device that is configured to deliver insulin;

receiving glucose readings responsive to measurements from a sensor;

retrieving a user customizable risk matrix, wherein the user customizable risk matrix includes;

a first user-defined risk level for a first range of glucose readings where a change in glucose readings is increasing and a calculated change in insulin is increasing;

a second user-defined risk level for the first range of glucose readings where the change in glucose readings is decreasing and the calculated change in insulin is increasing;

a third user-defined risk level for the first range of glucose readings where the change in glucose readings is increasing and the calculated change in insulin is decreasing; and

a fourth user-defined risk level for the first range of glucose readings where the change in glucose readings is decreasing and the calculated change in insulin is decreasing;

determining a first glucose reading responsive to a first measurement from the sensor;

determining a first insulin amount for injection to the patient;

determining a first change in glucose based on the first glucose reading;

determining a first change in insulin injection based on the first insulin amount;

determining a risk of automatically making therapy decision based on the first glucose reading, the first change in glucose, the first change in insulin injection, and the user customizable risk matrix; and

controlling the electronic medication delivery device based on the determined risk of automatically making therapy decision.