Method and system for detecting electrophysiological changes in pre-cancerous and cancerous breast tissue and epithelium

• US 8,275,453 B2
• Filed: 10/23/2009
• Issued: 09/25/2012
• Est. Priority Date: 05/20/2002
• Status: Expired due to Fees

• Current Assignee: Epi-Sci, LLC
• Original Assignee: Epi-Sci, LLC
• Inventors: Davies, Richard J.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/589,434
• Publication Number:
  US 20100049079A1
• Time in Patent Office: 1,068 Days
• Field of Search: 600/382, 600/386, 600/442, 600/506, 600/536, 600/547, 600/554, 600/562, 600/573, 600/511, 600/376, 600/439, 600/483, 600/549, 600/513, 606/32, 606/34, 606/41, 324/600, 601/2, 604/20, 424/764, 514/2, 514/53, 514/23, 514/54, 514/58, 514/60, 435/183, 435/69.1, 435/320.1, 435/325
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/2415 Measuring direct current [DC] or slowly varying biopotentials
• CPC Class Codes: A61B 5/252 by suction
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery

Abstract

A method and system are provided for determining a condition of a selected region of epithelial and stromal tissue in the human breast. A plurality of measuring electrodes are used to measure the tissue and transepithelial electropotential of breast tissue. Surface electropotential and impedance are also measured at one or more locations. An agent may be introduced into the region of tissue to enhance electrophysiological characteristics. The condition of the tissue is determined based on the electropotential and impedance profile at different depths of the epithelium, stroma, tissue, or organ, together with an estimate of the functional changes in the epithelium due to altered ion transport and electrophysiological properties of the tissue. Devices for practicing the disclosed methods are also provided.

Claims

1. A method for determining a condition of a region of ductal epithelial breast tissue comprising:

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

(1) placing over the nipple of a breast a cup having an interior volume, first and second openings, and a current-passing first electrode disposed within the interior volume;

(2) placing a source of suction in communication with the first opening;

(3) introducing an electroconductive medium within the interior of the cup; and

(4) applying suction to the first opening;

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

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

(D) measuring an electrical property between the first and second electrode; and

(E) determining the condition of the ductal epithelial tissue based on the measured electrical property between the first and second electrode.

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

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

4. The method of claim 1, wherein the electroconductive media comprises physiologic saline.

5. The method of claim 4, wherein the physiologic saline further comprises an agent suitable for inducing a challenge test of the epithelial tissue.

6. The method of claim 5, wherein the agent is selected from the group consisting of agonists, antagonists, ionic substitutions, hormones, growth factors and mixtures thereof.

7. The method of claim 6, wherein the agent is a hormone.

8. An apparatus for determining a condition of a region of ductal epithelial breast tissue comprising:

(A) a cup having an interior volume, first and second openings, and a current-passing first electrode disposed within the interior volume;

(B) a source of suction suitable for communication with the first opening;

(C) the cup adapted to receive an electroconductive medium within the interior of the cup;

(D) a second electrode adapted for contact with the surface of the breast;

wherein;

(1) the first electrode is operable for electrical communication with the ductal epithelial tissue; and

(2) the second electrode can be placed at a location spaced from said first electrode; and

wherein the apparatus is adapted to;

(3) establish a signal between the first and second electrodes; and

(4) measure at least one electrical property between the first and second electrode so as to determine the condition of the ductal epithelial tissue based on the measured electrical property between the first and second electrode.

9. The apparatus of claim 8, wherein the electrical property is impedance.

10. The apparatus of claim 8, wherein the electrical property is DC potential.

11. The apparatus of claim 8, wherein the electroconductive media comprises physiologic saline.

12. The apparatus of claim 11, wherein the physiologic saline further comprises an agent suitable for inducing a challenge test of the epithelial tissue, said agent selected from the group consisting of agonists, antagonists, ionic substitutions, hormones, growth factors and mixtures thereof.

13. The apparatus of claim 8, wherein the at least one electrical property comprises a plurality of properties, including impedance and DC potential.

14. The apparatus of claim 8, wherein the at least one electrical property comprises a plurality of properties, including impedance measured at least two different frequencies.

15. The apparatus of claim 13, wherein the plurality of electrical properties are used to determine an electrical profile of the ductal epithelial breast tissue.

16. The apparatus of claim 15, wherein the electrical profile is displayed on a computer monitor.