Discriminant function analysis method and apparatus for disease diagnosis and screening

• US 4,955,383 A
• Filed: 12/22/1988
• Issued: 09/11/1990
• Est. Priority Date: 12/22/1988
• Status: Expired due to Term

• Current Assignee: Biofield Corporation
• Original Assignee: Biofield Corporation
• Inventors: Faupel, Mark L.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Pfaffle, K. M.
• Application Number:
  US07/288,572
• Time in Patent Office: 628 Days
• Field of Search: 128/733, 128/734, 128/736, 128/630, 128/653, 128/639
• US Class Current: 600/407
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/2415 Measuring direct current [DC] or slowly varying biopotentials
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287

Abstract

A method and apparatus for determining the presence or absence of a disease condition at a test site on a human or animal subject by detecting during a test period the respective electrical potentials of the electromagnetic field present in the subject between each of a plurality of measurement locations in the area of the test site and at least one reference location. A representative potential is separately obtained for each measurement location during the test period, and these representative potentials are compared at the end of the test period to obtain relationships therebetween which are indicative of either the presence or absence of a disease condition.

Claims

1. A method for determining the presence or absence of a disease condition at a test site on a human or animal subject as a function of the potential of the electromagnetic field present in the subject which includes:

detecting respective electrical potentials of the electromagnetic field present in said subject between each of a plurality of measurement locations located in an area of the test site and at least one reference location on the subject,

comparing the respective electrical potentials so obtained to identify a high and low level potential,

obtaining a differential value indicative of the difference between said high and low level potentials,

comparing said differential value to a predetermined reference value to determine a relationship therebetween, and

obtaining an indication of the presence or absence of a disease condition from said relationship of the differential value to the reference value.

2. The method of claim 1 which includes taking a plurality of electrical potential measurements at each said measurement location during a measurement period,

obtaining an average measurement value for each said measurement location from the electrical potential measurements taken from said locations during the measurement period,

and comparing said average measurement values to identify therefrom said high and low level potentials.

3. The method of claim 1 which includes obtaining an identification of the presence or absence of a disease condition based upon whether said differential value exceeds or is less than said predetermined reference value,

if the absence of a disease indication is indicated, comparing said low level potential to a second predetermined reference value to determine a second relationship therebetween,

and obtaining a second indication of the presence or absence of said disease condition from the second relationship of said low level potential to said second reference value.

4. The method of claim 3 which includes taking a plurality of electrical potential measurements at each measurement location during a measurement period,

obtaining an average measurement value for each said measurement location from the electrical potential measurements taken from each said location during the measurement period,

and comparing said average measurement values to identify therefrom said high and low level potentials.

5. The method of claim 3 which includes detecting the electrical potentials of the electromagnetic field present in said subject between at least one auxiliary location and said reference location to obtain auxiliary potentials, and comparing the relationship between the auxiliary potentials and the potentials obtained from said plurality of measurement locations to obtain an auxiliary indication of the presence or absence of said disease condition if an indication of the presence of said disease condition is obtained from the relationship of said low level potential to said second reference value.

6. The method of claim 1, wherein said low level potential is the lowest potential detected and said high level potential is the highest level detected.

7. The method of claim 6 which includes taking a plurality of electrical potential measurements at each measurement location during a measurement period,

obtaining an average measurement value for each said measurement location from the electrical potential measurements taken from each said location during the measurement period,

and comparing said average measurement values to identify therefrom said high and low level potentials.

8. The method of claim 7 which includes obtaining an indication of the presence or absence of a disease condition based upon whether said differential value exceeds or is less than said predetermined reference value,

if the absence of said disease condition is indicated, comparing said low level potential to a second predetermined reference value to determine a second relationship therebetween,

and obtaining a second indication of the presence or absence of said disease condition from the second relationship of said low level potential to said second reference value.

9. The method of claim 8, wherein said disease condition is indicated if said differential value exceeds said reference value.

10. The method of claim 9, wherein said disease condition is indicated if said low level potential is less than said second reference value.

11. The method of claim 10 which includes detecting the electrical potentials of the electromagnetic field present in said subject between at least one auxiliary location and said reference location to obtain auxiliary potentials and comparing the relationship between the auxiliary potentials and the potentials obtained from said plurality of measurement locations to obtain an auxiliary indication of the presence or absence of said disease condition if the presence of said disease condition is obtained from either the relationship of said low level potential to said second reference value or from the relationship of the differential value to the reference value.

12. The method of claim 11, wherein said auxiliary location is spaced from the area of said test site.

13. The method of claim 11, wherein said test site includes a known lesion having a core, said auxiliary potentials including potentials of the electromagnetic field present in said subject between said reference location and an auxiliary location in an area over said core.

14. The method of claim 13, wherein additional auxiliary locations are spaced from the area of said test site.

15. The method of claim 7 which includes taking electrical potential measurements sequentially from said measurement locations during the measurement period.

16. The method of claim 7 which includes taking each of the plurality of electrical potential measurements at each said measurement location concurrently with the taking of an electrical potential measurement at remaining measurement locations.

17. The method of claim 1 which includes detecting the electrical potentials of the electromagnetic field present in said subject between at least one auxiliary location and said reference location to obtain auxiliary potentials, and comparing a relationship between the auxiliary potentials and the differential value to obtain an auxiliary indication of the presence or absence of said disease condition if an indication of the presence of said disease condition is obtained from the relationship of the differential value to the reference value.

18. An apparatus for disease screening or diagnosis at a potential disease site on a human or animal subject by measuring the electrical potentials which are a function of the electromagnetic field present in the subject on the skin surface of the subject in an area of said potential disease site comprising

reference electrode means adapted for contacting the skin surface of the subject at a reference location,

a plurality of test electrode means adapted for contact with the skin surface of the subject at spaced locations in the area of the potential disease site, each said test electrode means operating with said reference electrode means define a test-reference electrode means combination for to detecting electrical potential of the electromagnetic field present between said reference electrode means and said test electrode means during a test period and to provide a test potential as a function thereof,

analog-to-digital converter means connected to separately receive each said test potential and to provide a separate digital test signal indicative of each said test potential obtained during said test period,

and processing means connected to separately receive each said separate digital test signal, said processing means operating to compare said digital test signals obtained during said test period to identify potential relationships therebetween indicative of the presence of a disease condition.

19. The apparatus for disease screening or diagnosis of claim 18, wherein said processing means operates to sample and receive a plurality of said digital test signals from each of said test-reference electrode means combinations during said test period and to average the digital test signals for each said test-reference electrode means combination to obtain an average digital signal therefore at the end of the teat period, said processing means operating to compare said average digital signals obtained for said test period to identify potential difference relationships therebetween.

20. The apparatus for disease screening or diagnosis of claim 19, wherein said processing means operates to sample said digital test signals concurrently.

21. The apparatus for disease screening or diagnosis of claim 19, wherein said processing means operates to sample said digital test signals sequentially.

22. The apparatus for disease screening or diagnosis of claim 19, wherein said processing means compares said average digital signals to obtain a maximum voltage differential, said processing means operating to provide said maximum voltage differential by obtaining from the average digital signals for said measurement period the maximum and minimum average digital signals and subsequently obtaining a differential value signal indicative of the difference between said maximum and minimum average digital signals.

23. The apparatus for disease screening or diagnosis of claim 22, wherein said processing means operates to compare said differential value signal to a first reference value, said processing means operating to provide an output signal indicative of the presence of a disease condition in accordance with a relationship between said first reference value and said differential value signal.

24. The apparatus for disease screening or diagnosis of claim 23, wherein said processing means operates when the relationship between said first reference value and said differential value signal is not indicate of the presence of said disease condition to compare said minimum average digital signal to a second reference value, said processing means operating to provide an output signal indicative of the presence of said disease condition in accordance with a second relationship between said second reference value and said minimum average digital signal.

25. The apparatus for disease screening or diagnosis of claim 24, wherein said processing means provides an output signal indicative of the presence of said disease condition if said differential value signal is of a greater value than said first reference value and if said minimum average digital signal is of a lesser value than said second reference value.

26. The apparatus for disease screening or diagnosis of claim 24 which includes auxiliary electrode means adapted for contact with the skin surface of said subject at an auxiliary site, said auxiliary electrode means operating with said reference electrode means during a test period to detect the potential of the electromagnetic field present between said reference electrode means and said auxiliary electrode means and to provide an auxiliary potential as a function thereof, said analog-to-digital converter means being connected to receive said auxiliary potential and to provide digital auxiliary signals indicative of said auxiliary potential to said processing means, said processing means operating when the second relationship between said second reference value and said minimum average digital signal is indicative of the presence of said disease condition and said auxiliary signals are present to initiate a subroutine with said auxiliary signals and said test digital signals to identify said potential difference relationships therebetween indicative of the presence of said disease condition.

27. The apparatus for disease screening or diagnosis of claim 26, wherein said potential disease site includes a known lesion having a core, said auxiliary electrode means including an electrode to be positioned over said core.

28. The apparatus for disease screening or diagnosis of claim 26, wherein said auxiliary electrode means includes an electrode array to be positioned remotely from said potential disease site.

29. The apparatus for disease screening or diagnosis of claim 26, wherein said processing means operates when the relationship between said first reference value and said differential value signal is indicative of the presence of said disease condition and said auxiliary signals are present to initiate said subroutine.

30. A method for determining the presence or absence of a disease condition at a test site on a human or animal subject as a function of the potential of the electromagnetic field present in the subject which includes,

detecting during a test period respective electrical potentials of the electromagnetic field present in said subject between each of a plurality of measurement locations in an area of the test site and at least one reference location on the subject to obtain a separate representative potential for each said measurement location during the test period, detecting the electrical potentials of the electromagnetic field present in said subject between at least one auxiliary location remote from said test site and said reference location to obtain auxiliary potentials during said test period, comparing said separate representative potentials at the end of the test period to obtain therefrom relationships which are indicative of either the presence or absence of a disease condition, and comparing said auxiliary potentials with said separate representative potentials to obtain therefrom auxiliary relationships which are indicative of either the presence or absence of a disease condition if the relationship between said representative potentials has first indicated the presence of a disease condition.

31. The method of claim 30 which includes detecting said electrical potentials sequentially during said test period.

32. The method of claim 30 which includes detecting said electrical potentials concurrently during said test period.

33. The method of claim 30, wherein said auxiliary location is spaced from the area of said test site.

34. The method of claim 30, wherein said test site includes a known lesion having a core, said auxiliary potentials including potentials of the electromagnetic field present in said subject between said reference location and an auxiliary location in the area over said core.

35. The method of claim 34, wherein at least one additional auxiliary location is spaced from the area of said test site.