Method and System for Detecting Electrophysiological Changes in Pre-Cancerous and Cancerous Tissue and Epithelium

• US 20090306535A1
• Filed: 12/06/2006
• Published: 12/10/2009
• Est. Priority Date: 12/06/2005
• Status: Active Grant

• Current Assignee: Epi-Sci, LLC
• Original Assignee: Epi-Sci, LLC
• Inventors: Davies, Mary K., Davies, Richard J.
• Granted Patent: US 8,332,025 B2
• Time in Patent Office: Days
• US Class Current: 600/547
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body

Abstract

Methods and apparatus are provided for determining the condition of selected regions of epithelial and stromal tissue. A plurality of electrodes are used to measure surface and transepithelial electropotential of tissue, especially breast tissue, as well as surface electropotential and impedance at one or more locations and at several defined frequencies, particularly low frequencies. An agent may be introduced into the region of tissue to enhance electrophysiological response characteristics. Measured and derived electrical properties facilitating diagnosis include DC potential, impedance, subepithelial resistance, epithelial resistance, capacitance, characteristic frequency, depression angle and transepithelial potential. Ambient and varying pressure measurements applied to epithelial tissue are also used for diagnosis. Improved diagnosis of tissue condition can be made based on the electrical properties and tissue electrophysiological response to altered ion transport and pressure. Devices for practicing the disclosed methods are also provided.

Claims

1. A method, for determining a condition of a region of epithelial or stromal tissue comprising:

(A) establishing a connection between a first electrode and the tissue;

(B) placing a second electrode in electrical contact on an outer tissue surface proximate the epithelial tissue;

(C) establishing at least one electrical signal between the first and second electrodes;

(D) measuring or deriving at least one electrical property between the first and second electrode, the property selected from the group consisting of impedance, DC potential, subepithelial resistance, epithelial resistance, capacitance, characteristic frequency, depression angle and transepithelial potential; and

(E) determining the condition of a region of epithelial tissue based on the at least, one property.

2. The method of claim 1, wherein the electrical property is impedance.

3. The method of claim 1 wherein said electrical signal is at a frequency of about 0.1 Hz to about 60,000 Hz.

4. The method of claim 2, wherein at least two response curves are obtained from the impedance data.

5. The method claim 4 wherein the curves include:

(a) a high frequency curve at a frequency of about 60,000 Hz to about 100 Hz;

(b) a intermediate, frequency curve at a frequency of about 100 Hz to about 10 Hz; and

(c) a low frequency curve at a frequency of about 0.1 to about 6 Hz.

6. The method of claim 1, wherein the electrical property is a DC potential.

7. The method of, claim 1, wherein the epithelial or stromal tissue is associated with the breast.

8. The method of claim 7, wherein the method of establishing a connection between the first electrode and the epithelial tissue is by a cannula.

9. The method of claim 8, wherein the cannula is a ductal probe.

10. The method of claim 1, wherein the method of establishing a connection between the first electrode and the epithelial tissue is by an electroconductive media.

11. The method of claim 10, wherein the electroconductive media is a physiologic saline.

12. The method of claim 10, further comprising introducing an agent into the electroconductive media.

13. The method of claim 12, wherein the agent is a hormone.

14. The method of claim 7 for determining a condition of, a region of epithelial breast tissue comprising:

(A) establishing a connection between a first electrode and the epithelial tissue of the nipple of a breast with a ductal probe, an electroconductive media or both;

(B) placing a second electrode in contact with the surface of the breast;

(C) establishing an electrical signal between the first and second electrodes;

(D) establishing that the nipple ducts of the breast are open by;

(1) measuring the impedance between the first and second electrode at about 5 different frequencies in the range of about 200 Hz to about 60,000 Hz sufficient to establish an impedance curve;

(2) treating the nipple using at least one method selected from the group consisting of (a) applying suction and release of suction to the nipple;

(b) applying alcohol; and

(c) applying a dekeratinizing agent;

(3) again measuring the impedance between the first and second electrode at about 5 different frequencies in the range of about 200 Hz to about 60,000 Hz sufficient to establish an impedance curve and comparing the impedance curve obtained to that obtained in (D)(1) above;

(4) repeating steps (2) and (3) until the impedance curve obtained in step (D)(3) is substantially unchanged, in order to confirm that the ducts are open;

(E) measuring between the first and second electrode;

(1) a DC potential; and

(2) impedance at about 5 different frequencies in the range of about 10 Hz to about 200 Hz and impedance at from about 5 to about 50 different frequencies in the range of about 0.1 Hz to about 10 Hz; and

(F) determining the condition of the region of epithelial tissue based on one or more electrical properties measured between the first and second electrodes or electrical properties derived therefrom, said electrical properties selected from the group consisting of DC potential, impedance, subepithelial resistance, epithelial resistance, capacitance, characteristic frequency, depression angle and transepithelial potential.

15. The method of claim 14, wherein the electrical connection between the first electrode and the epithelial tissue of the nipple, of a breast is facilitated by placing over the nipple a cup having an interior, and first and second openings, and an electrode disposed within the interior, the cup having a source of suction in communication with the first opening, the second, opening having been placed over the nipple;

and further comprising the steps of;

(G) applying suction to the cup sufficient to effect ductal collapse in a normal or non-malignant duct; and

measuring impedance at about 5 different frequencies in the range of about 10 Hz to about 200 Hz and impedance at from about 5 to about 50 different frequencies in the range of about 0.1 Hz to about 10 Hz; and

(H) altering the suction level and again measuring impedance at about 5 different frequencies in the range of about 10 Hz to about 200 Hz and impedance at from about 5 to about 50 different frequencies in the range of about 0.1 Hz to about 10 Hz; and

(J) determining the condition of the region of epithelial tissue based on the one or more measured or derived electrical properties and the affect on the properties of varying pressure conditions.

16. A method for determining the location of a tumor in a body comprising:

establishing a connection between a first, electrode and the epithelial tissue of the duct of an organ;

placing a second electrode at a second location on the body;

establishing an electrical signal between the first and second electrodes;

measuring an electrical property between the first and second electrodes; and

determining the condition of the selected region of epithelial tissue based on the signal between the first and second electrode.

17. The method of claim 16, wherein the second location is on the surface of the body.

18. The method of claim 16, wherein the epithelial tissue is located within the breast.

19. The method of claim 16, wherein the epithelial tissue is located within the prostate.

20. A computer-readable medium having computer-executable, instructions, for performing a method for determining the presence of a tumor in the human breast comprising:

establishing a connection between a first electrode and a region of epithelial tissue within the duct of a breast;

establishing a connection between, a second electrode on the surface of the breast;

establishing an electrical signal between the first and second electrodes;

measuring an electrical property between the first and second electrode or deriving an electrical property from the measured electrical property, the measured or derived property selected from the group consisting of impedance, DC potential, subepithelial resistance, epithelial resistance, capacitance, characteristic frequency, depression angle and transepithelial potential; and

determining the presence of a tumor based on the signal between the first and second electrode.