Systems approach to comorbidity assessment

• US 8,951,189 B2
• Filed: 02/18/2014
• 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:
  US14/183,342
• Publication Number:
  US 20140200414A1
• Time in Patent Office: 357 Days
• Field of Search: None
• US Class Current: 600/300
• 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 5/11 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 5/16 Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• 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 5/417 the bone marrow
• 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 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• 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 5/746 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 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• 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

Abstract

Methods, systems, and apparatus for assessing a state of a comorbidity associated with a primary disease 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 a body system of the patient that is a site of the comorbidity, 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 a body system for an amplification of a comorbidity by a primary disease, comprising:

receiving at least one of an autonomic index, a neurologic index, a stress marker index, a psychiatric index, an endocrine index, a metabolic index or a quality of life index of a patient;

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

assessing the body system for the amplification of the comorbidity by the primary disease based on the comparing, wherein the body system comprises at least one of an autonomic system, a neurologic system, a psychiatric system, a metabolic system, an endocrine system, or subsystems of the foregoing; and

providing an output relating to the assessing, wherein the output comprises at least one of amplification, deamplification, neither amplification nor deamplification, or a determination that amplification and deamplification cannot be determined.

2. The non-transitory computer readable program storage unit of claim 1, wherein the method further comprises assessing a second body system for the amplification of the comorbidity associated with the primary disease based on the comparing, wherein the second body system comprises at least one of an autonomic system, a neurologic system, a psychiatric system, a metabolic system, an endocrine system, or subsystems of the foregoing, and the output comprises at least one of second amplification, second deamplification, second neither amplification nor deamplification, or a determination that second amplification and second deamplification cannot be determined.

3. The non-transitory computer readable program storage unit of claim 1, wherein the output further comprises at least one of a magnitude of the amplification, a magnitude of the deamplification, a rate of change of the amplification, or a rate of change of the deamplification, or a determination that the magnitude or rate of amplification or deamplification cannot be determined.

4. 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 the output comprises secondary disease amplification, secondary disease deamplification, or a finding that secondary disease state amplification and deamplification cannot be determined.

5. The non-transitory computer readable program storage unit of claim 1, wherein the method further comprises assessing an amplification of the primary disease by a comorbidity of the patient based on comparing at least one second index to at least one second reference value, wherein the output further comprises primary disease amplification, primary disease deamplification, neither primary disease amplification nor deamplification, or a finding that primary disease amplification and deamplification cannot be determined.

6. The non-transitory computer readable program storage unit of claim 5, wherein the output further comprises assessing an amplification of the primary disease by at least a second comorbidity associated with said primary disease.

7. The non-transitory computer readable program storage unit of claim 1, wherein the output further comprises determination of at least one of a magnitude of the amplification, a magnitude of the deamplification, a rate of the amplification, or a rate of deamplification of the primary disease by at least one comorbidity associated with said primary disease, or a determination that the magnitude or rate of amplification or deamplification of the primary disease by at least one comorbidity associated with it, cannot be determined.

8. The non-transitory computer readable program storage unit of claim 5, wherein the method further comprises providing a warning signal to the patient, a physician, or a caregiver if the output comprises primary disease amplification, primary disease deamplification, or a finding that primary disease state amplification and deamplification cannot be determined.

9. The non-transitory computer readable program storage unit of claim 8, wherein the warning signal is proportional to at least one of a magnitude of a change of the amplification, a rate of change of the amplification of either the secondary or the primary disease, or a role of the body system in the overall health of the patient.

10. The non-transitory computer readable program storage unit of claim 1, wherein the primary disease is epilepsy;

and

receiving comprises receiving at least one autonomic index selected from a cardiovascular signal, a respiratory signal, a metabolic signal, a stress marker signal, an endocrine signal, body temperature signal, a skin activity signal , or two or more thereof; and

at least one neurologic index selected from an attention aptitude parameter, a responsiveness signal, a memory signal, a kinetic signal, a cognitive signal , a quality of life signal, or two or more thereof.

11. The non-transitory computer readable program storage unit of claim 10, wherein determination of at least one of a magnitude of the amplification of epilepsy, a magnitude of the deamplification of epilepsy, a rate of the amplification of epilepsy, a rate of deamplification of epilepsy or a determination the magnitude or rate of amplication or deamplification of epilepsy cannot be made, is based on a comparison of seizure severity between at least two consecutive or non-consecutive seizures and/or of interseizure intervals between at least two consecutive or non-consecutive sets each, with at least two seizures.

12. The non-transitory computer readable program storage unit of claim 10, wherein the comorbidities associated with epilepsy are cardiac diseases, increased risk of sudden death, attention deficits, memory deficits, dereased or depression.

13. The non-transitory computer readable program storage unit of claim 1, wherein the method further comprises forecasting a state of comorbidity associated with the primary disease, wherein the forecast comprises amplification of the comorbidity, deamplification of the comorbidity, neither amplification nor deamplification of the comorbidity, or a finding that no forecast can be made.

14. The non-transitory computer readable program storage unit of claim 1, wherein receiving comprises receiving a plurality of autonomic indices, neurologic indices, stress marker indices, psychiatric indices, metabolic indices, endocrine indices, physical fitness indices, quality of life indices, or two or more thereof;

and

the at least one index comprises a weighted composite of the plurality of autonomic indices, neurologic indices, stress marker indices, psychiatric indices, metabolic indices, endocrine indices, physical fitness indices, quality of life indices, or two or more thereof.

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

16. The non-transitory computer readable program storage unit of claim 1, wherein the change in the values of at least one index is determined based on at least 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.

17. The non-transitory computer readable program storage unit of claim 1, wherein the output of amplification is indicative of a deterioration of the patient'"'"'s health, the output of deamplification is indicative of an improvement of the patient'"'"'s health, the output of neither amplification nor deamplification is indicative of a stability of the patient'"'"'s health, an output of deterioration in quality of life is indicative of a deterioration of the patient'"'"'s mental health, an output of improvement in quality of life is indicative of an improvement of the patient'"'"'s mental health, or an output of indeterminability of amplification and deamplification is indicative of indeterminability of the patient'"'"'s health.

18. The non-transitory computer readable program storage unit of claim 5, wherein an output of primary disease deterioration is indicative of a deterioration of the patient'"'"'s health, an output of primary disease improvement is indicative of an improvement of the patient'"'"'s health, an output of primary disease stability is indicative of a stability of the patient'"'"'s health, or an output of indeterminability of a primary disease is indicative of indeterminability of the patient'"'"'s health.

19. The non-transitory computer readable program storage unit of claim 14, further comprising determining the state of health of a patient using said weighted composite index.

23. 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 the output comprises amplification or the determination that amplification and deamplification cannot be determined.

20. A computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for assessing an amplification of a comorbidity by a primary disease, comprising:

receiving a first index selected from the group consisting of an autonomic index, a neurologic index, a stress marker index, a psychiatric index, a metabolic index, an endocrine index, a physical fitness index, and a quality of life index of a patient;

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

assessing an amplification of the comorbidity by the primary disease based on the comparing;

assessing a state of the patient'"'"'s health based on the assessing the amplification of the comorbidity; and

providing an output relating to at least one of the assessment of amplification or the assessment of the state of the patient'"'"'s health, wherein the output comprises at least one of amplification, deamplification, neither amplification nor deamplification, a determination that amplification and deamplification cannot be determined, a stable health state, a poorer health state, an improved health state, or a finding that the state of the patient'"'"'s health cannot be determined.

21. A medical system, comprising:

a body index determination unit capable of determining at least one of an autonomic index, at least one neurologic index, at least one stress marker index, at least one psychiatric index, a metabolic index, at least one endocrine index, at least one adverse effect of therapy index, at least one physical fitness index, or at least one quality of life index;

an index comparison unit capable of comparing at least one said index with at least one reference value;

a comorbidity amplification assessment unit capable of assessing;

an amplification of a comorbidity by the primary disease of a patient;

a deamplification of the comorbidity by the primary disease of the patient; and

a determination that an amplification or deamplification of the comorbidity by the primary disease cannot be made, and;

an output unit capable of providing an output relating to the assessing, wherein the output comprises at least one of amplification, deamplification, neither amplification nor deamplification, or a determination that amplification and deamplification cannot be determined.

22. The medical device system of claim 21, wherein the output provided by the output unit comprises at least one of amplification of the primary disease, deamplification of the primary disease, neither amplification nor deamplification, or a determination that amplification and deamplification cannot be determined.