Discriminant function analysis method and apparatus for disease diagnosis and screening with biopsy needle sensor

• US 5,320,101 A
• Filed: 03/27/1992
• Issued: 06/14/1994
• Est. Priority Date: 12/22/1988
• Status: Expired due to Fees

• Current Assignee: Biofield Corporation
• Original Assignee: Biofield Corporation
• Inventors: Ganepola, G. A. P., Faupel, Mark L.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): ZELE, KRISTA MICHELLE
• Application Number:
  US07/859,170
• Time in Patent Office: 809 Days
• Field of Search: 128/653.1, 128/639, 128/642, 128/734, 128/749, 128/753, 128/754, 128/763, 128/635
• 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 biopsy method and apparatus for determining and locating the presence or absence of a neoplastic and other disease condition within 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 neoplasm and at least one reference location while a combination biopsy instrument and electrode is inserted into the subject at the location of suspected neoplasm. Electrical potential differences are compared during this period to obtain relationships therebetween which are indicative of either the presence or absence of neoplastic tissue. Once the neoplastic tissue is located and identified, the biopsy instrument is manipulated to remove a tissue sample for further study.

Claims

1. An apparatus for precisely locating suspected neoplastic tissue in a living subject by measuring the electrical potentials which are a function of the electromagnetic fields present within the tissues of the subject in an area where the presence of the neoplastic tissue is suspected consisting essentially of;

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

tissue locator electrode means adapted for insertion into the subject'"'"'s tissues in the area where the presence of the neoplastic tissue is suspected and operative with said reference electrode means to detect the electrical potentials of the electromagnetic fields present between said reference electrode means and said tissue locator electrode means while said tissue locator electrode means is being inserted internally toward and into said suspected neoplastic tissue and to provide test potentials as a function of each of said electrical potentials detected;

said tissue locator electrode means including biopsy means for removing a sample of said suspected neoplastic tissue, and

processing means connected to said reference electrode means and said tissue locator electrode means and operative to receive said test potentials, said processing means operating to sample a plurality of said test potentials to provide indications which are a function of said test potentials.

2. The apparatus of claim 1 wherein said tissue locator electrode means is a biopsy needle having a pointed end and includes an electrical potential sensing electrode mounted at said pointed end.

3. The apparatus of claim 2 wherein said biopsy needle includes a hollow shaft having a first end and a second end, said electrical potential sensing electrode being formed to provide a point at the first end of said hollow shaft, insulating means mounted on the first end of said hollow shaft between said electrical potential sensing electrode and said hollow shaft to electrically insulate said electrical potential sensing electrode from said hollow shaft, and an opening formed in said hollow shaft at the first end thereof for receiving a sample of the suspected neoplastic tissue.

4. A method of locating suspected neoplastic tissue in a human subject by comparing the differences in electrical potential between the tissues in an area where the presence of neoplastic tissue is suspected including the steps of:

(a) providing a locator electrode for insertion into the tissue of the human subject in the area of the suspected neoplastic tissue;

(b) attaching a reference electrode to a reference area of normal tissue sufficiently proximate to the suspected neoplastic tissue to permit said locator electrode to detect the electrical potentials of the electromagnetic fields present between sad reference and locator electrodes as said locator electrode passes through the tissue of the human subject,

(c) inserting said locator electrode and detecting the electrical potentials between said locator electrode and the reference electrode while said locator electrode is being inserted through the tissue into said area of suspected neoplastic tissue; and

(d) processing the detected electrical potentials during said locator electrode insertion to determine when the detected electrical potentials reach a value indicative of contact by said locator electrode with neoplastic tissue.

5. The method of claim 4 wherein said locator electrode is mounted on a biopsy needle and includes removing a sample of said neoplastic tissue with said biopsy needle when said locator electrode has contacted said neoplastic tissue.

6. The method of claim 4 which includes detecting the potentials between said locator electrode and reference electrode at a plurality of measurement locations as said locator electrode is inserted through the tissue,

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

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

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

obtaining average potential values for each said measurement location from the measurements taken,

comparing said average potential values to identify therefrom high and low level average potentials, and obtaining said differential value from the difference between said high and low level average potentials.

8. The method of claim 4 which includes detecting a plurality of electrical potentials between said reference electrode and said locator electrode after contact by said locator electrode with the neoplastic tissue while maintaining said locator electrode in contact with said neoplastic tissue,

comparing the electrical potentials obtained during contact of said locator electrode with said neoplastic tissue to identify a high and low level potential,

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

and using said differential value to determine the presence or absence of a disease condition.

9. The method of claim 4 which includes detecting a plurality of electrical potentials between said reference electrode and said locator electrode after contact by said locator electrode with the neoplastic tissue while maintaining said locator electrode in contact with said neoplastic tissue, and

using said electrical potentials obtained during contact of said locator electrode with said neoplastic tissue to determine the presence or absence of a disease condition.

10. A method for determining the presence of absence of an internal disease condition present at an internal disease site in the area of a test site on a living subject which includes,

detecting during a first test period the respective electrical potentials of the electromagnetic field present in said subject between each of a plurality of measurement locations in the area of the test site and at least one reference location on the subject to obtain a representative potential for each measurement for each measurement location during the test period,

comparing such representative potentials at the end of the first test period to obtain therefrom relationships which are indicative of either the presence or the absence of the internal disease condition in the area of the test site,

inserting a locator electrode into the tissue of the subject in the area of the test site when the presence of the internal disease condition is sensed,

detecting the electrical potentials between said reference location and said locator electrode while said locator electrode is being inserted through the tissue toward the internal disease site, and

processing the detected electrical potentials during said locator electrode insertion to guide said locator electrode to said internal disease site and to determine when the detected electrical potential is indicative of contact by said locator electrode with said internal disease site.

11. The method of claim 10 wherein said locator electrode is mounted on a biopsy needle and includes removing a sample of neoplastic tissue from said disease site with said biopsy needle when said locator electrode has contacted said neoplastic tissue.

12. An apparatus for precisely locating neoplastic tissue in a living subject by measuring the electrical potentials which are a function of the electromagnetic fields which originate from within and are present on the skin surface of the subject in an area of a potential disease site and are present within the tissues of the subject comprising:

reference electrode means adapted for contacting the subject at one or more reference locations,

a plurality of screening electrode means adapted for contact with the skin surface of the subject at spaced locations in the area of the potential disease site and operative with said reference electrode means to detect the potentials of said electromagnetic fields which are present in the area of said potential disease site during a first test period and to provide test signals as a function of the potentials detected,

processing means connected to receive said test signals and operative to compare the test signals obtained during said first test period to identify potential relationships indicative of the presence of the neoplastic tissue; and

tissue locator electrode means for insertion into the subject'"'"'s tissues in the area of the potential disease site and operative with said reference electrode means during a second test period to detect electrical potentials of the electromagnetic fields present between said reference electrode means and said tissue locator electrode means while said tissue locator electrode means is being inserted internally toward and into said neoplastic tissue and to provide locator potentials as a function of each of said electrical potentials detected;

said processing means being connected to receive said locator potentials and operating to provide indications which are a functions of said locator potentials.

13. The apparatus of claim 12 wherein said processing means operates during said second test period to detect potential changes in said locator potentials as an indicator of when said tissue locator electrode means has reached the neoplastic tissue.

14. The apparatus of claim 12 wherein said processing means is operative during said first test period to receive a plurality of said test signals from a combination of said reference electrode means and said screening electrode means, said processing means being further operative to compare the test signals so obtained to identify a high and low level signal and to obtain a differential value indicative of the difference between said high and low level signals.

15. The apparatus of claim 12 wherein said processing means operates to sample and receive a plurality of said test signals from a combination of each of said screening electrode means and said reference electrode means during said first test period and to average the test signals for each said screening electrode means reference electrode means combinations to obtain an average signal value therefrom, said processing means operating to compare said average signal values obtained for said first test period to identify differential relationships therebetween.

16. The apparatus of claim 15 wherein said processing means operates to compare said average signal values obtained for said first test period and obtain therefrom the maximum and minimum average signal values and subsequently obtaining a differential value indicative of the difference between said maximum and minimum average signal values.

17. The apparatus of claim 16 wherein said processing means operates to compare said differential value to a first reference value, said processing means operating to provide an output indicative of the presence or absence of the neoplastic tissue in accordance with a relationship between said first reference value and said differential value.

18. The apparatus of claim 12 wherein said processing means operates during said second test period to detect the electrical potentials between said locator electrode means and said reference electrode means at a plurality of measurement locations as said location electrode means is inserted toward said neoplastic tissue, said processor means operating to compare the electrical potentials obtained during the second test period to identify therefrom high and low level potential values and to obtain differential values indicative of the difference between said high and low potential values.