Systems approach to disease state and health assessment

• US 8,951,192 B2
• Filed: 06/15/2010
• Issued: 02/10/2015
• Est. Priority Date: 06/15/2010
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): SANDS, DAVIN K
• Application Number:
  US12/816,357
• Publication Number:
  US 20110306846A1
• Time in Patent Office: 1,701 Days
• Field of Search: None
• US Class Current: 600/301
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• 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 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Methods, systems, and apparatus for assessing a state of an epilepsy disease or a comorbidity thereof are provided. The methods comprise receiving at least one autonomic index, neurologic index, stress marker index, psychiatric index, endocrine index, adverse effect of therapy index, physical fitness index, or quality of life index of a patient; comparing the at least one index to at least one reference value; and assessing a state of an epilepsy disease or a body system of the patient based on the comparison. A computer readable program storage device encoded with instructions that, when executed by a computer, perform the method described above is also provided. A medical device system capable of implementing the method described above is also provided.

Claims

1. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for assessing an epilepsy disease state, comprising:

receiving at least one autonomic index;

receiving at least one neurologic index;

first comparing the at least one autonomic index to at least a first reference value associated with the at least one autonomic index;

second comparing the at least one neurologic index to at least a second reference value associated with the at least one neurologic index;

assessing a state of an epilepsy disease of a patient based on an output of the first comparing and an output of the second comparing, wherein assessing comprises determining a change in at least one of a seizure severity value or an interseizure interval; and

providing an output relating to the assessment, the output comprising at least one of disease stability, disease progression, disease regression, or a finding that the assessment could not determine a disease state.

2. The non-transitory computer readable program storage unit of claim 1, wherein the output comprises at least one of a magnitude of a change of a progression, a magnitude of a change of a regression, a rate of change of a progression, or a rate of change of a regression.

3. The non-transitory computer readable program storage unit of claim 1, wherein the at least one autonomic index comprises a cardiovascular parameter, a respiration parameter, a body temperature parameter, a skin resistance parameter, or two or more thereof;

and

the at least one neurologic index comprises an attention aptitude parameter, a responsiveness parameter, a memory parameter, a kinetic parameter, a cognitive aptitude parameter, or two or more thereof.

4. The non-transitory computer readable program storage unit of claim 3, wherein the at least one autonomic index comprises at least one cardiovascular parameter selected from a heart rate parameter or a heart rate variability parameter, and the at least one neurologic index comprises at least one of a responsiveness parameter or a kinetic parameter selected from an electromyogram signal, an accelerometer signal, an inclinometer signal, or a parameter derived from one of the foregoing signals.

5. The non-transitory computer readable program storage unit of claim 1, wherein the method further comprises providing a warning signal to the patient, a physician, or a caregiver if said assessing indicates disease progression.

6. The non-transitory computer readable program storage unit of claim 5, wherein the warning signal is proportional to at least one of a magnitude of a change of a progression, a rate of change of a disease progression, or a correlation of the index value to life span.

7. The non-transitory computer readable program storage unit of claim 1, wherein the method further comprises assessing a state of at least one body system of a patient based on the comparing, wherein the body system is selected from an autonomic system, a neurological system, a psychiatric system, an endocrine system, or subsystems of the foregoing, and wherein the output comprises at least one of body system stability, body system improvement, body system decline, or a finding that a state of the body system cannot be determined.

8. The non-transitory computer readable program storage unit of claim 7, wherein a subsystem of the autonomic system is selected from a cardiovascular subsystem or a respiratory subsystem, and a subsystem of the neurologic system is a body kinetic subsystem.

9. The non-transitory computer readable program storage unit of claim 1, wherein the output comprises identifying one or more comorbidities associated with the disease.

10. The non-transitory computer readable program storage unit of claim 1, wherein the method further comprises forecasting a state of the disease, wherein the forecast comprises a disease stability, a disease progression, a disease regression, or a finding that no forecast can be made.

11. The non-transitory computer readable program storage unit of claim 10, wherein the forecast is of disease progression and the forecast comprises at least one of a risk of an increased magnitude of change of progression, a risk of an increased rate of change of progression, or a risk of emergence of one or more comorbidities associated with the disease.

12. The non-transitory computer readable program storage unit of claim 1, wherein the autonomic index comprises a weighted composite of a plurality of autonomic indices, the neurologic index comprises a weighted composite of a plurality of neurologic indices, or both.

13. The non-transitory computer readable program storage unit of claim 1, wherein at least one of the first reference value or the second reference value is based on the patient'"'"'s index value history or on normative data.

14. The non-transitory computer readable program storage unit of claim 1, wherein the at least one autonomic index, the at least one neurologic index, or both comprises a measure of central tendency, a measure of dimensionality, a measure of fractality, a measure of stationarity, a measure of long-range dependency, a measure of clustering, a distribution of measures of central tendency, a distribution of measures of dimensionality, a distribution of measures of fractality, a distribution of measures of stationarity, a distribution of measures of long-range dependency, a distribution of measures of clustering, or two or more thereof.

15. The non-transitory computer readable program storage unit of claim 1, wherein the method further comprises assessing the patient'"'"'s overall health.

16. The non-transitory computer readable program storage unit of claim 15, wherein the method further comprises using the assessment of the patient'"'"'s overall health and an assessment of the patient'"'"'s quality of life to assess the patient'"'"'s well being.

22. The non-transitory computer readable program storage unit of claim 1, wherein the disease state is a non-acute disease state.

17. A medical device system, comprising:

an autonomic index determination unit capable of determining at least one autonomic index;

a neurologic index determination unit capable of determining at least one neurologic index;

an index comparison unit capable of first comparing the at least one autonomic index with at least one first reference value and second comparing the at least one neurologic index with at least one second reference value;

an epilepsy disease state assessment unit capable of assessing a state of an epilepsy disease based on an output by the index comparison unit of the first comparing and an output by the index comparison unit of the second comparing, wherein assessing comprises determining a change in at least one of a seizure severity value or an interseizure interval; and

an output unit capable of providing an output relating to the assessment, wherein the output comprises at least one of disease stability, disease progression, disease regression, or a finding that the epilepsy disease state assessment unit could not determine a disease state.

18. The medical device system of claim 17, further comprising:

a warning unit adapted to provide a warning if the epilepsy disease state assessment unit yields an assessment of disease progression.

19. The medical device system of claim 17, wherein the autonomic index determination unit comprises at least one of:

a cardiovascular indication processing unit, a respiration indication processing unit,

a blood parameter indication processing unit,

a pupillary response indication processing unit,

a body temperature indication processing unit, or

a skin resistance indication processing unit; and

the neurologic index determination unit comprises at least one of;

an attention aptitude indication processing unit,

a responsiveness indication processing unit,

a memory indication processing unit,

a kinetic indication processing unit, or

a cognitive aptitude indication processing unit.

20. The medical device system of claim 17, further comprising:

a forecast unit capable of forecasting a state of the disease, wherein the forecast comprises a disease stability, a disease progression, a disease regression, or a finding that no forecast can be made.

23. The medical device of claim 17, wherein the epilepsy disease state assessment unit is capable of assessing a non-acute state of the epilepsy disease.

21. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for assessing an epilepsy disease state, comprising:

receiving at least one autonomic index;

receiving at least one neurologic index;

first comparing the at least one autonomic index to at least a first reference value associated with the at least one autonomic index, wherein the at least one autonomic index comprises at least one cardiovascular parameter selected from a heart rate parameter or a heart rate variability parameter;

second comparing the at least one neurologic index to at least a second reference value associated with the at least one neurologic index, wherein the at least one neurologic index comprises at least one of a responsiveness parameter or a kinetic parameter selected from an electromyogram signal, an accelerometer signal, an inclinometer signal, or a parameter derived from one of the foregoing signals;

assessing a state of an epilepsy disease of a patient based on an output of the first comparing and an output of the second comparing, wherein assessing comprises determining a change in at least one of a seizure severity value or an interseizure interval; and

providing an output relating to the assessment, the output comprising at least one of disease stability, disease progression, disease regression, or a finding that the assessment could not determine a disease state.

24. The non-transitory computer readable program storage unit of claim 21, wherein said assessment comprises determining a change in a mean, a median, or a percentile of said seizure severity value or said interseizure interval.