Assessment of medical conditions

• US 8,103,065 B2
• Filed: 01/05/2006
• Issued: 01/24/2012
• Est. Priority Date: 01/05/2006
• Status: Active Grant

• Current Assignee: Complete Medical Solutions LLC
• Original Assignee: Lifesciences Solutions LLC
• Inventors: Richardson, Charles
• Primary Examiner(s): Repko, Jason M
• Assistant Examiner(s): Edwards, Patrick
• Application Number:
  US11/326,091
• Publication Number:
  US 20070156030A1
• Time in Patent Office: 2,210 Days
• Field of Search: 382/100, 382/128, 128/920, 600/509, 600/516, 600/517
• US Class Current: 382/128
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/338 Recording by printing on paper
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• 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 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• 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: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

The present invention is directed to methods for analyzing electrical signals generated by biological tissues, such as muscles (e.g., cardiac or skeletal muscle) and tissue within the nervous system (e.g., neurons within the central and peripheral nervous systems). The tissue may be a patient'"'"'s own, or it may have been transplanted into the patient from a donor organism or from a tissue or cell culture. The result of the analysis indicates the condition of the tissue, and results obtained over time can alert a patient or health care professional to changes in that condition.

Claims

1. A method for assessing a medical condition, the method comprising:

obtaining a first baseline template corresponding to an average of results of a first calculation performed on multiple segments of a first electrical signal acquired at a first time;

obtaining a first captured template corresponding to an average of results of the first calculation performed on multiple segments of a second electrical signal acquired a second time later than the first time;

obtaining a second baseline template corresponding to an average of results of a second calculation performed on multiple segments of the first electrical signal;

obtaining a second captured template corresponding to an average of results of the second calculation performed on multiple segments of the second electrical signal;

calculating a first variance between the first baseline and captured templates;

calculating a second variance between the second baseline and captured templates, the first and second variances providing unequal indications of the medical condition;

scaling the first and second variances by first and second weighting factors, respectively, to produce first and second scaled variances indicative of the relative importance of the variances; and

calculating a first sum of the first and second scaled variances.

2. The method of claim 1, further comprising comparing the first sum to a threshold value indicative of the medical condition.

3. The method of claim 1, wherein the first and second electrical signals are acquired from first and second electrocardiograms;

first and second electromyograms;

or first and second electroencephalograms.

4. The method of claim 1, wherein the medical condition comprises heart failure;

a neurodegenerative disease;

or brain damage.

5. The method of claim 1, wherein obtaining a first baseline template comprises excluding results of the first calculation that are greater than a first predetermined value and that are less than a second predetermined value from the average of results of the first calculation.

6. The method of claim 5, wherein the first predetermined value is the sum of a mean and a standard deviation of the results of the first calculation and the second predetermined value is the difference between the mean and the standard deviation.

7. The method of claim 2, wherein comparing the first sum to a threshold further comprises determining that the medical condition exists if the first sum is greater than the threshold.

8. The method of claim 1, wherein the first and second calculations are, independently, calculations of an area under a curve, a frequency difference between first and second points each within consecutive segments, an ascending slope from a nadir to an apex, a descending slope from an apex to a nadir, or an amplitude difference between an apex and a nadir.

9. The method of claim 1, further comprising obtaining a third baseline template corresponding to an average of results of a third calculation performed on multiple segments of the first electrical signal, wherein the first calculation characterizes an area under a curve, the second calculation characterizes a frequency difference between first and second points each within consecutive segments, and the third calculation characterizes an ascending slope from a nadir to an apex;

obtaining a third captured template corresponding to an average of results of the third calculation performed on multiple segments of the second electrical signal;

obtaining a fourth baseline template corresponding to an average of results of a fourth calculation performed on multiple segments of the first electrical signal, wherein the fourth calculation characterizes a descending slope from an apex to a nadir;

obtaining a fourth captured template corresponding to an average of results of the fourth calculation performed on multiple segments of the second electrical signal;

obtaining a fifth baseline template corresponding to an average of results of a fifth calculation performed on multiple segments of the first electrical signal, wherein the fifth calculation characterizes an amplitude difference between an apex and a nadir;

obtaining a fifth captured template corresponding to an average of results of the fifth calculation performed on multiple segments of the second electrical signal;

calculating a third variance between the third baseline and captured templates;

calculating a fourth variance between the fourth baseline and captured templates;

calculating a fifth variance between the fifth baseline and captured templates;

scaling the third, fourth, and fifth variances by third, fourth, and fifth weighting factors, respectively, to produce third, fourth, and fifth scaled variances;

calculating a second sum of the third, fourth, and fifth scaled variances;

calculating a third sum of the first sum and second sums; and

comparing the third sum to a threshold value indicative of the medical condition.

10. A system for assessing a medical condition, the system comprising:

a registering unit for capturing a first electrical signal at a first time and a second electrical signal at a second time later than the first time; and

a controller configured to;

obtain a first baseline template corresponding to an average of results of a first calculation performed on multiple segments of a first electrical signal acquired at a first time;

obtain a first captured template corresponding to an average of results of the first calculation performed on multiple segments of a second electrical signal acquired at a second time later than the first time;

obtain a second baseline template corresponding to an average of results of a second calculation performed on multiple segments of the first electrical signal;

obtain a second captured template corresponding to an average of results of the second calculation performed on multiple segments of the second electrical signal;

calculate a first variance between the first baseline and captured templates;

calculate a second variance between the second baseline and captured templates, the first and second variances providing unequal indications of the medical condition;

scale the first and second variances by first and second weighting factors, respectively, to produce first and second scaled variances indicative of the relative importance of the variances; and

calculate a first sum of the first and second scaled variances.

11. The system of claim 10, wherein the controller is further configured to comparing the first sum to a threshold value indicative of the medical condition.

12. The system of claim 10, wherein the first and second electrical signals are acquired from first and second electrocardiograms;

first and second electromyograms;

or first and second electroencephalograms.

13. The system of claim 10, wherein the medical condition comprises heart failure;

a neurodegenerative disease;

or brain damage.

14. The system of claim 10, wherein the controller is further configured to exclude results of the first calculation that are greater than a first predetermined value and that are less than a second predetermined value from the average of results of the first calculation.

15. The system of claim 14, wherein the first predetermined value is the sum of a mean and a standard deviation of the results of the first calculation and the second predetermined value is the difference between the mean and the standard deviation.

16. The method of claim 11, wherein the controller is further configured to determine that the medical condition exists if the first sum is greater than the threshold.

17. The system of claim 11, wherein the first and second calculations are, independently, calculations of an area under a curve, a frequency difference between first and second points each within consecutive segments, an ascending slope from a nadir to an apex, a descending slope from an apex to a nadir, or an amplitude difference between an apex and a nadir.

18. The system of claim 11, wherein the controller is further configured to:

obtain a third baseline template corresponding to an average of results of a third calculation performed on multiple segments of the first electrical signal, wherein the first calculation characterizes an area under a curve, the second calculation characterizes a frequency difference between first and second points each within consecutive segments, and the third calculation characterizes an ascending slope from a nadir to an apex;

obtain a third captured template corresponding to an average of results of the third calculation performed on multiple segments of the second electrical signal;

obtain a fourth baseline template corresponding to an average of results of a fourth calculation performed on multiple segments of the first electrical signal, wherein the fourth calculation characterizes a descending slope from an apex to a nadir;

obtain a fourth captured template corresponding to an average of results of the fourth calculation performed on multiple segments of the second electrical signal;

obtain a fifth baseline template corresponding to an average of results of a fifth calculation performed on multiple segments of the first electrical signal, wherein the fifth calculation characterizes an amplitude difference between an apex and a nadir;

obtain a fifth captured template corresponding to an average of results of the fifth calculation performed on multiple segments of the second electrical signal;

calculate a third variance between the third baseline and captured templates;

calculate a fourth variance between the fourth baseline and captured templates;

calculate a fifth variance between the fifth baseline and captured templates;

scale the third, fourth, and fifth variances by third, fourth, and fifth weighting factors, respectively, to produce third, fourth, and fifth scaled variances;

calculate a second sum of the third, fourth, and fifth scaled variances;

calculate a third sum of the first sum and second sums; and

compare the third sum to a threshold value indicative of the medical condition.

19. A computer program product for assessing a medical condition, the computer program product being tangibly stored on machine readable media, comprising instructions operable to cause one or more processors to:

obtain a first baseline template corresponding to an average of results of a first calculation performed on multiple segments of a first electrical signal acquired at a first time;

obtain a first captured template corresponding to an average of results of the first calculation performed on multiple segments of a second electrical signal acquired a second time later than the first time;

obtain a second baseline template corresponding to an average of results of a second calculation performed on multiple segments of the first electrical signal;

obtain a second captured template corresponding to an average of results of the second calculation performed on multiple segments of the second electrical signal;

calculate a first variance between the first baseline and captured templates;

calculate a second variance between the second baseline and captured templates, the first and second variances providing unequal indications of the medical condition;

scaling the first and second variances by first and second weighting factors, respectively, to produce first and second scaled variances indicative of the relative importance of the variances; and

calculate a first sum of the first and second scaled variances.

20. The product of claim 19, further comprising instructions to compare the first sum to a threshold value indicative of the medical condition.

21. The product of claim 19, wherein the first and second electrical signals are acquired from first and second electrocardiograms;

first and second electromyograms;

or first and second electroencephalograms.

22. The product of claim 19, wherein the medical condition comprises heart failure;

a neurodegenerative disease;

or brain damage.

23. The product of claim 19, further comprising instructions to obtain a first baseline template comprises excluding results of the first calculation that are greater than

a first predetermined value and that are less than a second predetermined value from the average of results of the first calculation.

24. The product of claim 23, wherein the first predetermined value is the sum of a mean and a standard deviation of the results of the first calculation and the second predetermined value is the difference between the mean and the standard deviation.

25. The product of claim 20, further comprising instructions to determine that the medical condition exists if the first sum is greater than the threshold.

26. The product of claim 19, wherein the first and second calculations are, independently, calculations of an area under a curve, a frequency difference between first and second points each within consecutive segments, an ascending slope from a nadir to an apex, a descending slope from an apex to a nadir, or an amplitude difference between an apex and a nadir.

27. The product of claim 19, further comprising instructions to:

obtain a third baseline template corresponding to an average of results of a third calculation performed on multiple segments of the first electrical signal, wherein the first calculation characterizes an area under a curve, the second calculation characterizes a frequency difference between first and second points each within consecutive segments, and the third calculation characterizes an ascending slope from a nadir to an apex;

obtain a third captured template corresponding to an average of results of the third calculation performed on multiple segments of the second electrical signal;

obtain a fourth baseline template corresponding to an average of results of a fourth calculation performed on multiple segments of the first electrical signal, wherein the fourth calculation characterizes a descending slope from an apex to a nadir;

obtain a fourth captured template corresponding to an average of results of the fourth calculation performed on multiple segments of the second electrical signal;

obtain a fifth baseline template corresponding to an average of results of a fifth calculation performed on multiple segments of the first electrical signal, wherein the fifth calculation characterizes an amplitude difference between an apex and a nadir;

obtain a fifth captured template corresponding to an average of results of the fifth calculation performed on multiple segments of the second electrical signal;

calculate a third variance between the third baseline and captured templates;

calculate a fourth variance between the fourth baseline and captured templates;

calculate a fifth variance between the fifth baseline and captured templates;

scaling the third, fourth, and fifth variances by third, fourth, and fifth weighting factors, respectively, to produce third, fourth, and fifth scaled variances;

calculate a second sum of the third, fourth, and fifth scaled variances;

calculate a third sum of the first sum and second sums; and

compare the third sum to a threshold value indicative of the medical condition.