Use of impedance techniques in breast-mass detection

• US 9,037,227 B2
• Filed: 09/01/2010
• Issued: 05/19/2015
• Est. Priority Date: 09/01/2009
• Status: Active Grant

• Current Assignee: David J. Mishelevich, Roman A. Slizynski
• Original Assignee: David J. Mishelevich, Roman A. Slizynski
• Inventors: Slizynski, Roman A., Mishelevich, David J.
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/874,192
• Publication Number:
  US 20110054344A1
• Time in Patent Office: 1,721 Days
• Field of Search: 600/382, 600/407, 600/442, 600/547, 606/34
• 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 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence

Abstract

A device is described for measuring electrical characteristics of biological tissues with plurality of electrodes and a processor controlling the stimulation and measurement in order to detect the presence of abnormal tissue masses in the breast and determine probability of tumors containing malignant cancer cells being present in a breast. The device has the capability of providing the location of the abnormality, at least to the quadrant. The method for measuring electrical characteristics includes placing electrodes and applying a voltage waveform in conjunction with a current detector. A mathematical analysis method is then applied to the collected data, which computes spectrum of frequencies and correlates magnitudes and phases with given algebraic conditions to determine mass presence and type.

Claims

1. A device for testing presence and tracking of benign or malignant breast masses, the device including comprising:

a. signal generator configured to deliver simultaneous stimuli at multiple frequencies with one or a plurality of source electrodes configured for attachment where a breast joins the chest wall of a patient,

b. a receiving electrode adapted for configured for attachment to the nipple of the same breast;

c. a computer program stored on a non-transient medium executed by a control system,

d. the control system configured to use the simultaneously occurring multi-frequencies coherent signals applied in a sequence to each source electrode to stimulate tissue through;

e. the control system configured to use ratio-metric measurements and coherent sampling across simultaneously occurring signals in returning current from the tissue;

f. the control system configured to determine ratio measurements where the measurements examines the interaction between multiple-frequencies amplitudes and phases, not the absolute values;

g. the control system configured to use derived ratios created in clinical studies of tissue to determine a classification result of the determined ratio measurements of tissue selected from the group consisting of healthy, benign, and malignant tissue; and

h. the control system configured to use an indicator that indicates the results to the user.

2. The device of claim 1 where a wide spectral band is used from 20 kHz to 1 MHz with even and odd harmonics coherently sampled between the output stage and wide-band current input measurement input.

3. The device of claim 1 where a wide spectral band is used from 1 MHz to 100 MHz with even and odd harmonics coherently sampled between the output stage and wide-band current input measurement input.

4. The device of claim 1 where a wide spectral band is used from 100 MHz to 10 GHz with even and odd harmonics coherently sampled between the output stage and wide-band current input measurement input.

5. The device of claim 1 where the excitation wave form is selected from the group consisting of square wave, sine wave, and triangle wave.

6. The system of claim 1 where the receiving electrode is a wire inserted into one of the milk ducts.

7. The device in claim 1 in which the number source electrodes is selected from the group consisting of 4, 6, 8, 12, and 16.

8. The device in claim 1 in which the electrodes are incorporated into a brassiere.

9. The device in claim 1 where the presence of an abnormality is indicated by a non-visual feedback selected from the group consisting of auditory cue and vibratory cue.

10. The device in claim 1 where the presence of an abnormality is a simple visual cue such as an LED display, either binary or relative magnitude, including level of probability.

11. The device in claim 1 where the presence of an abnormality is an intermediate visual display presenting text or graphical results, including level of probability.

12. The device in claim 1 where the presence of an abnormality is a complex visual cue display presenting raw data and processed graphical information, including level of probability.

13. The device in claim 1 used in screening where if a result is positive, confirmation is sought by use of a technique selected from the group consisting of mammography, Magnetic Resonance Imaging, Positron Emission Tomography, and ultrasound.

14. The device in claim 1 where tissue in one breast is compared to a potential lesion in the other breast in the same patient.

15. The device in claim 1 where adjustments are made in specificity and sensitivity.

16. The device in claim 1 where adjustments are made in parameters selected from the group consisting of true positives, false positives, true negatives, and false negatives.

17. The device in claim 1 where the presence of an abnormality is stored and accessed by medical professional through computer or internet.