# US 8,275,453 B2 · Method and system for detecting electrophysiological changes in pre-cancerous and cancerous breast tissue and epithelium > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,275,453 B2 - Document ID: US8275453B2 - Status: Granted - Kind: B2 - Application number: 12/589,434 - Filed: 2009-10-23 - Published: 2010-02-25 - Granted: 2012-09-25 - Earliest claimed: 2002-05-20 - Assignees: Epi-Sci, LLC - Inventors: Richard J. Davies - Web page: https://patentgrep.com/patent/US8275453B2 ## CPC - A61B 5/0531: Measuring skin impedance - A61B 5/2415: {Measuring direct current [DC] or slowly varying biopotentials} - A61B 5/252: by suction - A61B 5/4312: {Breast evaluation or disorder diagnosis (optical mammography A61B5/0091)} - A61B 5/4839: {combined with drug delivery} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## 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 ### Claim 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. ### Claim 2 (depends on 1) The method of claim 1, wherein the electrical property is impedance. ### Claim 3 (depends on 1) The method of claim 1, wherein the electrical property is a DC potential. ### Claim 4 (depends on 1) The method of claim 1, wherein the electroconductive media comprises physiologic saline. ### Claim 5 (depends on 4) The method of claim 4, wherein the physiologic saline further comprises an agent suitable for inducing a challenge test of the epithelial tissue. ### Claim 6 (depends on 5) 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. ### Claim 7 (depends on 6) The method of claim 6, wherein the agent is a hormone. ### Claim 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. ### Claim 9 (depends on 8) The apparatus of claim 8, wherein the electrical property is impedance. ### Claim 10 (depends on 8) The apparatus of claim 8, wherein the electrical property is DC potential. ### Claim 11 (depends on 8) The apparatus of claim 8, wherein the electroconductive media comprises physiologic saline. ### Claim 12 (depends on 11) 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. ### Claim 13 (depends on 8) The apparatus of claim 8, wherein the at least one electrical property comprises a plurality of properties, including impedance and DC potential. ### Claim 14 (depends on 8) 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. ### Claim 15 (depends on 13) The apparatus of claim 13, wherein the plurality of electrical properties are used to determine an electrical profile of the ductal epithelial breast tissue. ### Claim 16 (depends on 15) The apparatus of claim 15, wherein the electrical profile is displayed on a computer monitor.