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

• US 7,853,319 B2
• Filed: 04/21/2006
• Issued: 12/14/2010
• Est. Priority Date: 04/21/2005
• 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): DANEGA, RENEE A
• Application Number:
  US11/409,144
• Publication Number:
  US 20060241514A1
• Time in Patent Office: 1,698 Days
• Field of Search: 600/546, 600/407
• US Class Current: 600/547
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/6834 using vacuum

Abstract

A method and system for determining a condition of a selected region of epithelial and stromal tissue, for example in the human breast. A plurality of electrodes are used to measure surface and transepithelial electropotential of breast tissue as well as surface electropotential and impedance at one or more locations and at several defined frequencies, particularly very low frequencies. An agent may be introduced into the region of tissue to enhance electrophysiological characteristics. Measurements made at ambient and varying suction and/or positive pressure applied to the epithelial tissue and/or positive pressure conditions applied to the breast are also used as a diagnostic tool. Tissue condition 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 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 a 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 the DC potential and impedance measurements between the first and second electrode.

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

(A) placing over the nipple of a breast 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;

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

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

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

(E) 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 (E) (3) is substantially unchanged in order to confirm that the ducts are open;

(F) measuring a DC potential between the first and second electrode;

(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 DC potential, and the impedance measurements under varying pressure conditions.