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

• US 9,042,977 B2
• Filed: 08/31/2012
• Issued: 05/26/2015
• 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:
  US13/600,526
• Publication Number:
  US 20120323137A1
• Time in Patent Office: 998 Days
• Field of Search: 600/547, 600/382, 600/386, 600/442, 600/506, 600/536, 600/554, 600/562, 600/573, 600/511, 600/376, 600/439, 600/483, 600/549, 600/513, 606/32, 606/34, 606/41, 601/2, 324/600, 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. An apparatus for determining the condition of an epithelial region of tissue comprising:

(A) a cup having an interior adapted to receive a volume of fluid, 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;

(i) the first opening is adapted for connection to a source of fluid for introducing the fluid to the cup and alternatively to a source of suction; and

(ii) the second opening is adapted for placement over a region of tissue;

wherein the apparatus is adapted to make an electrical connection between the epithelial region of tissue to be examined and the electrode;

(a) upon the application of suction to the first opening to seal the apparatus to a tissue surface; and

(b) introduction of fluid to the interior of the cup through the first opening.

2. The apparatus of claim 1, wherein said fluid is physiologic saline solution.

3. The apparatus of claim 1, wherein said source of suction is an aspirator.

4. The apparatus of claim 1, said fluid comprising an electroconductive medium for facilitating an electrical connection between the region of tissue to be examined and the electrode.

5. The apparatus of claim 4, said electroconductive medium comprising a pharmacological challenge agent.

6. The apparatus of claim 1 suitable for measuring impedance of the epithelial region of the tissue.

7. A device adapted to measure electrical properties useful in determining the condition of a region of tissue comprising:

(A) a housing having an interior space adapted to receive a volume of fluid;

(B) an electrode positioned within the interior space of the housing;

(C) said housing including a first opening communicating with the interior space of the housing and adapted to be placed proximate to the surface of a region of tissue; and

(D) said housing including a second opening adapted to receive suction and communicating with the interior space of the housing.

8. The device of claim 7, further comprising a flange surrounding said first opening.

9. The device of claim 7, wherein the region of tissue comprises ducts.

10. The device of claim 7, wherein the region of tissue is selected from the tissue group consisting of breast, prostate, liver, uterus, pancreas and salivary gland tissue.

11. The device of claim 7 suitable for measuring impedance of the region of tissue.