Electrical impedance method and apparatus for detecting and diagnosing diseases

• US 6,122,544 A
• Filed: 04/29/1999
• Issued: 09/19/2000
• Est. Priority Date: 05/01/1998
• Status: Active Grant

• Current Assignee: ImpediMed Limited
• Original Assignee: Z-Tech Incorporated
• Inventors: Organ, Leslie William
• Primary Examiner(s): Jeffery, John A.
• Application Number:
  US09/301,355
• Time in Patent Office: 509 Days
• Field of Search: 600/547
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0531 Measuring skin impedance

Abstract

A method and apparatus for screening, sensing, or diagnosing disease states by obtaining a plurality of electrical impedance data measurements in organized patterns from two anatomically homologous body regions, one of which may be affected by disease. One subset of the data so obtained is processed and analyzed after structuring the data values as elements of an n×n impedance matrix, and deriving from these matrices their eigenvalues and eigenvectors. The matrices and their derivatives are then related by their characteristics to normal or disease states.

Claims

1. A method of diagnosing the possibility of a disease state in one of first and second substantially similar parts of a living organism, said method comprising:

(a) obtaining a plurality of impedance measurements across each of said parts and thereby producing first and second sets of impedance measurements, said first set for said first part, and said second set for said second part,

(b) said measurements of said first set being taken across predetermined portions of said first part, and each measurement of said first set having a corresponding measurement in said second set taken across a corresponding portion of said second part,

(c) comparing said sets to determine differences therebetween, and where there is a substantial difference, diagnosing the possibility of a disease state.

2. A method according to claim 1 wherein said parts of said living organism are the breasts of a person, and said disease state is a cancer.

3. A method according to claim 2 wherein said impedance measurements for each breast are taken between a plurality of pairs of points encircling each breast.

4. A method according to claim 3 wherein said measurements are taken using an electrode array having two electrodes for each point, one electrode to inject or receive electrical current, and the other electrode for measuring voltage.

5. A method according to claim 4 wherein electrical current is injected and withdrawn between successive pairs of points, and while current is being injected between each pair of points, voltage measurements are taken between the points of such pairs and also between a plurality of pairs of other points of said electrode array.

6. A method according to claim 5 wherein impedance values are determined from said respective pairs of points and said method comprising arranging said values in a mathematical matrix and performing matrix analysis for said diagnosis.

7. A method according to claim 4 wherein electrical current is injected and withdrawn between successive pairs of points, and while current is being injected between each pair of points, a voltage measurement is taken between such pair of points.

8. A method according to claim 5, 6 or 7 wherein impedance values are determined from said respective pairs of points and the difference between said impedance values are analyzed for said diagnosis.

9. A method according to claim 5 wherein said points define a plurality of chords extending between respective pairs of points, said method including the step of graphically depicting the impedance measurements for each said first and second sets on two chord diagrams, and then analysing the two chord diagrams for said diagnosis.

10. A method according to claim 7 wherein said points define a plurality of chords extending between respective pairs of points, said method including the step of graphically depicting the impedance measurements for each said first and second sets on two chord diagrams, and then analysing the two chord diagrams for said diagnosis.

11. A method according to claim 9 or 10 in which chords of said diagrams that have impedances which are the same or within a selected difference from each other are removed, and then the remaining chords are compared for said diagnosis.

12. A method according to claim 2, wherein said points are arranged in a variety of geometrical patterns on each breast.

13. A method according to claim 2 wherein said points are arranged in a substantially circular pattern around a nipple of each of said breasts.

19. A method according to claim 13 wherein said disease state is a cancer.

14. An electrode array for diagnosing the presence of a disease state in a living organism, said electrode array comprising a flexible backing material, and a plurality of pairs of electrodes spaced around said backing material, said electrodes being connected to terminals and being adapted to obtain impedance measurements between respective said electrodes.

15. An electrode array according to claim 14, wherein said electrodes include adhesive for fixation to the skin.

16. An electrode array according to claim 15 and including a positioning formation thereon to align and reproducibly position said electrode array over a selected part of said organism.

17. An electrode array according to claim 15 and including a separate positioning formation to align and reproducibly position said electrode array over a selected part of said organism.

18. A method of diagnosing the possibility of a disease state in one of first and second parts of a living organism, said parts being similar but having impedances which differ by consistent and known amounts, said method comprising:

(a) obtaining a plurality of impedance measurements across each of said parts and thereby producing first and second sets of impedance measurements, said first set for said first part, and said second set for said second part,

(b) said measurements of said first set being taken across predetermined portions of said first part, and each measurement of said first set having a corresponding measurement in said second set taken across a corresponding portion of said second part,

(c) comparing said sets to determine differences therebetween which are additional to said known amounts, and where there is a substantial difference other than said known amounts, diagnosing the possibility of a disease state.