System for developing patient specific therapies based on dynamic modeling of patient physiology and method thereof

• US 8,818,782 B2
• Filed: 05/12/2008
• Issued: 08/26/2014
• Est. Priority Date: 06/27/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Thukral, Ajay, Galley, Paul, Chittajallu, Siva, Weinert, Stefan
• Primary Examiner(s): HARWARD, SOREN T
• Application Number:
  US12/119,143
• Publication Number:
  US 20090006061A1
• Time in Patent Office: 2,297 Days
• Field of Search: None
• US Class Current: 703/11
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• 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 10/20 for electronic clinical trials or questionnaires
• 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
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A system for developing patient-specific therapies based on dynamic modeling of patient-specific physiology and method thereof are disclosed. The system includes software modules configured to provide access via a computer to one or more data collection protocols defining at least a type of patient-specific data to be collected and a manner in which the patient-specific data is to be collected, and to information from which one or more patient-specific models, configured to simulate one or more aspects of the patient'"'"'s physiology, is developed. Another software module of the system is configured to provide access via the computer to one or more software tools that apply patient-specific data, collected according to the one or more data collection protocols, to the one or more patient specific models to determine therefrom one or more patient-specific therapies.

Claims

1. A computerized system used by a user(s) to developing patient specific therapies for chronic disease management of a patient(s) with a known disease, the system comprising:

a collection device;

a server computer having a database; and

a client computer operably connected to the collection device and the server computer, the client computer having a monitor, memory, and an input device operably connect to a processor, said processor running;

a data collection protocols module which collects patient specific data via the monitor, the input device, or the collection device according to a data collection protocol specialized to identify or determine a particular aspect of the known disease of the patient, stores collected patient specific data in the database or the memory performs integrity and quality checks on the collected patient specific data stored in the database or the memory and provides to the user for selection therapy assessments/recommendations each with a relevance rating that is based on the integrity and quality of the collected patient specific data,

a patient models module which enables the user to select via a user interface a patient model from a plurality of patient models provided by at least one of the server computer and the client computer and provides to the user for selection options each with a relevance rating indicating relevance of therapy parameters based on a selected one of the therapy assessments/recommendations so that the relevance rating makes clear if the collected data is not good enough to generate a new therapy,

a model validation module which validates the selected patient model and provides results to the user for review and acceptance of the selected patient model, an analyses module which applies the patient specific data to the selected,

accepted patient model to extract patient specific physiological information, and to use the extracted patient specific physiological information to develop one or more patient specific therapies for treating the chronic disease of the patient based on parameters generated from the selected model, and

a result validation and presentation module which validates the one or more patient specific therapies and presents validated ones of the one or more patient specific therapies each with the confidence interval on the monitor for approval by the user.

2. The computerized system according to claim 1 wherein the data collection protocol dictates specific data to be collected, manner to be collected, and compliancy procedure.

3. The computerized system according to claim 1 wherein for the integrity and quality checks the data collection module enables the system to check for inconsistencies between collected patient specific data and the data collection protocol and time stamps, to determine whether collection performed over a required time period, and to determine for the collected patient data whether data values are in predefined ranges and provide a predetermined number of samples within a certain time window.

4. The computerized system according to claim 1 wherein the system provides the plurality of patient models from at least one of a client computer, a computer server, a portable memory device, computer storage, and a computer readable medium.

5. The computerized system according to claim 1 wherein the plurality of patient models each mathematically represents at least one aspect of human physiology, and provides mapping to different physiological states, conditions or parameters.

6. The computerized system according to claim 1 wherein the module validation module enables the system to perform on the selected patient model at least one of a Bayesian analysis, a cost function analysis, parameter estimation, statistical analysis, numeric analysis, range analysis, gain values analysis, test scenarios analysis, simulations, and modeling.

7. The computerized system according to claim 1 wherein the model validation module enables the system to determine model parameters which are then used to validate the selected patient model.

8. The computerized system according to claim 1 wherein the analyses module provides analysis tools which enables the system to perform at least one of simulations, statistical analysis, sensitivity analysis, visualizations, information extraction, optimizations, and to provide recommendations which include at least one of type, amount, and timing for dosing, exercise, and meals.

9. The computerized system according to claim 1 further comprising a rule/guideline sets module which governs the system in collection of the patient specific data according to the data collection protocol.

10. The computerized system according to claim 1 wherein the result validation and presentation module provides simulation tools which enable the system to test the one or more patient specific therapies for at least one of robustness, stability, sensitivity to parameter variation, and effectiveness, and to generate confidence intervals.