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

• US 7,630,759 B2
• Filed: 11/19/2003
• Issued: 12/08/2009
• 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): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/717,074
• Publication Number:
  US 20040253652A1
• Time in Patent Office: 2,211 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, 606/41, 324/600, 601/2, 604/20
• 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. An apparatus for determining the condition of a region of tissue comprising:

(A) a cup having an interior, and first and second openings;

(B) a current-passing electrode disposed within the interior; and

(C) a source of suction connectable to the first opening; and

wherein when the second opening is placed over a region of tissue, an electroconductive medium is disposed within the interior for facilitating an electrical connection between the region of tissue to be examined and the electrode and suction is applied to the first opening, an electrical connection is made between the region of tissue to be examined and the electrode via the electroconductive medium; and

wherein;

(1) the tissue is epithelium containing tissue;

(2) the electroconductive medium is in combination with at least one pharmacological agent; and

the pharmacological agent induces a challenge test of the epithelium containing tissue.

2. The apparatus of claim 1 wherein the pharmacological agent is selected from the group consisting of agonists, antagonists, hormones and mixtures thereof.

3. The apparatus of claim 2 wherein the hormone is selected from the group consisting of prolactin, estradiol and mixtures thereof.