Method and system for detecting electrophysiological changes in pre-cancerous and cancerous tissue and epithelium
First Claim
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.
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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.
89 Citations
4 Claims
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1. A method for determining a condition of a region of epithelial breast tissue comprising:
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(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.
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2. A method for determining a condition of a region of epithelial breast tissue comprising:
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(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.
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3. A method for determining a condition of a region of epithelial or stromal tissue comprising:
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A. measurement of an impedance spectrum over a region of tissue where an abnormality is suspected (suspicious region);
B. measurement of an impedance spectrum over a region of tissue where no abnormality is suspected (control region);
C. application of mechanical pressure or compression over the suspicious region;
D. measurement of the impedance spectrum in the suspicious region following the application of mechanical pressure;
E. application of mechanical pressure or compression over the control region;
F. comparison of the impedance profile before and after compression in the suspicious region;
G. comparison of the impedance profile before and after compression in the control region; and
H. comparison of the impedance profile of the suspicious region to the control region.
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4. A computer-readable medium having computer-executable instructions for performing a method for determining the presence of a tumor in the human breast comprising:
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establishing a connection between a first electrode and a region of epithelial tissue within the duct of a breast;
establishing a connection between a second electrode on the surface of the breast;
establishing a signal between the first and second electrodes;
measuring an electrical property between the first and second electrode;
applying at least one form of pressure to at least one region of the breast, the form pressure selected from the group consisting of positive pressure, negative pressure and a combination of positive and negative pressure;
measuring an electrical property between the first and second electrode in response to the pressure; and
determining the presence of a tumor based on the signal, or the change in the signal in response to the pressure, between the first and second electrode.
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Specification