Medical Diagnosis, Therapy, And Prognosis System For Invoked Events And Methods Thereof

• US 20090006129A1
• Filed: 05/12/2008
• Published: 01/01/2009
• 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: Weinert, Stefan, Galley, Paul, Chittajallu, Siva, Thukral, Ajay
• Granted Patent: US 8,712,748 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 for remote operation
• 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 diagnosis, therapy and prognosis system (DTPS) and method thereof to help either the healthcare provider or the patient in diagnosing, treating and interpreting data are disclosed. The apparatus provides data collection based on protocols, and mechanism for testing data integrity and accuracy. The data is then driven through an analysis engine to characterize in a quantitative sense the metabolic state of the patient'"'"'s body. The characterization is then used in diagnosing the patient, determining therapy, evaluating algorithm strategies and offering prognosis of potential use case scenarios.

Claims

1. A computerized method for providing medical diagnosis, therapy and prognosis of a patient with a chronic disease on a computer, the method comprising:

specifying on the computer one or more protocols that address specific diagnosis and therapy needs of the patient;

specifying on the computer a patient model;

performing analysis on the computer to determine parameters of the patient model;

performing model verification of the parameters on the computer to further ensure that the patient model has captured appropriate dynamics that address the specific diagnosis and therapy needs of the patient;

applying data collected per the one or more protocols to perform analysis on the computer using the patient model to provide at least one recommended patient-specific therapy; and

providing on the computer the recommended patient-specific therapy for approval.

2. The computerized method according to claim 1 further comprises tuning the recommended patient-specific therapy.

3. The computerized method according to claim 1 further comprises defining and implementing test scenarios on the computer that help in testing the recommended patient-specific therapy and quantifying the quality of therapy potentially achievable using the recommended patient-specific therapy.

4. The computerized method according to claim 1 further comprises defining and implementing test scenarios on the computer that help in performing the model verification of the parameters.

5. The computerized method according to claim 1 further comprises providing a plurality of recommended patient-specific therapies, and testing the recommended patient-specific therapies against several critical test scenarios and evaluating expected therapy outcomes to provide a prognosis based on a selected one of the recommended patient-specific therapies.

6. The computerized method according to claim 1 further comprises performing mathematical analysis to evaluate stability, sensitivity, robustness, and provided an indication of confidence for the recommended patient-specific therapy.

7. The computerized method according to claim 1 further comprises confirming that the dynamics of the patient model by simulating special test cases to evaluate dynamic response against at least one of literature data and clinical data.

8. The computerized method according to claim 1 further comprises providing mathematical analysis tools, visualization tools, and data presentation tools to help perform the analysis on the computer.

9. The computerized method according to claim 1 further comprises providing a simulated environment to defining and implementing test scenarios on the computer that help in performing the model verification of the parameters.

10. The computerized method according to claim 1 further comprises implementing the recommended patient-specific therapy on a portable unit.

11. The computerized method according to claim 1 further comprises collecting the data per the one or more protocols from a patient data collection device.

12. The computerized method according to claim 1 further comprises using an algorithm on the computer to govern the collection of the data, the performing of analysis on the data, the applying of the data to the patient model, and the providing of the recommended patient-specific therapy.

13. The computerized method according to claim 1 wherein the data collected includes at least one of event activities and physiological measurements which update the analysis for provided the recommended patient-specific therapy.

14. The computerized method according to claim 1 further comprises approving the recommended patient-specific therapy as a prescription, and using an algorithm on the computer to govern scheduling, controlling, and monitoring of the prescription.

15. The computerized method according to claim 1 further comprises approving the recommended patient-specific therapy as a prescription, and using an algorithm on the computer to control implementation of the prescription open loop with a portable device providing administration of the prescription directly to the patient.

16. The computerized method according to claim 1 further comprises approving the recommended patient-specific therapy as a prescription, and using an algorithm on the computer to control implementation of the prescription closed loop with a portable device providing administration of the prescription directly to the patient.

17. The computerized method according to claim 15 further comprises the algorithm commanding the portable unit to dispense medication and perform a measurement task according to the prescription.

18. The computerized method according to claim 16 further comprises the algorithm commanding the portable unit to dispense medication and perform a measurement task each with a given input characteristics, and using the input characteristics to update the algorithm.

19. The computerized method of claim 1 further comprises the claim 1 being provided in a client-server computer system environment.

20. A computerized method to evaluate pharmacokinetic effects and therapy efficacy in a specific patient on a computer, the method comprising:

providing patient data to the computer, the patient data include metabolic, physiological, and lifestyle information on the patient;

performing a validity check on the patient data on the computer to provided validated data;

analysis the validated data on the computer using one or more patient models to quantify disease progression, to determine therapy tailored to the patient by considering the metabolic, physiological, and lifestyle information, and to determine therapy prognosis; and

providing the tailored therapy and therapy prognosis.

21. The method of claim 20 wherein the one or more patient models includes physiological models, metabolic models, and mathematics for determining a drug dose based on the pharmacokinetics and pharmacodynamics of the drug.

22. The method of claim 20 wherein the therapy prognosis includes whether a particular action will have an effect that is either adverse or desired.

23. A computerized system for providing medical diagnosis, therapy and prognosis of a patient with a chronic disease, the system comprising:

a data collection of collection protocols and patient models;

a first software module for testing integrity and accuracy of data collected per one of the collection protocols;

a second software module for analyzing the collected data with at least one of the patient models to characterize specific metabolic needs of the patient; and

a third software module which uses the characterized specific metabolic needs of the patient in diagnosing the patient to determine a patient-specific therapy and to offer prognosis of the patient-specific therapy.

24. The computerized system according to claim 23 further comprises a fourth software module which provides tools to define a prescription that is consistent with the characterized specific metabolic needs of the patient, and to assess critical scenarios which ensure stability and robustness of the patient-specific therapy.

25. The computerized system according to claim 23 further comprises a test stand program providing a simulation environment for defining and implementing test scenarios that help in testing recommended patient-specific therapy and quantifying quality of therapy potentially achievable using the recommended patient-specific therapy.

26. The computerized system according to claim 23 further comprises a test stand program providing a simulation environment for defining and implementing test scenarios that help in performing model verification of parameters.

27. The computerized system according to claim 23 further comprises a test stand program providing a simulation environment for simulating special test cases to evaluate dynamic response of the patient models against at least one of literature data and clinical data.

28. The computerized system according to claim 23 further comprises a portable unit which implements the patient-specific therapy.

29. The computerized system according to claim 23 further comprises a patient data collection device which collects the data per one or more of the collection protocols.

30. The computerized system according to claim 23 wherein the data collected includes at least one of event activities and physiological measurements which an algorithm uses to update the analysis for provided the patient-specific therapy.

31. The computerized system according to claim 23 further comprises an algorithm which governs scheduling, controlling, and monitoring of the patient-specific therapy.

32. The computerized system according to claim 23 further comprises an algorithm which controls implementation of the patient-specific therapy open loop with a portable device providing administration of patient-specific therapy directly to the patient.

33. The computerized system according to claim 23 further comprises an algorithm which controls implementation of the prescription closed loop with a portable device providing administration of the patient-specific therapy directly to the patient.

34. The computerized method according to claim 23 further comprises a portable unit for dispensing medication and performing a measurement when commanded by an algorithm following the patient-specific therapy.

35. The computerized method according to claim 23 further comprises a portable unit for performing actions which include dispensing medication and performing a measurement when commanded by an algorithm following the patient-specific therapy, each actions when performed provides a given input characteristics to update an algorithm in the system used to control and monitor application of the patient-specific therapy.