Patent ID: 8376947
Filing Date: 2013-02-19
Classification: A61B,G01S

Abstract:
1. A non-invasive method of identifying microcalcification in a breast of a human body comprising: a. positioning a disposable biocompatible, circular and compliant ring on the breast (ring) which contains four housings spaced approximately 90 degrees apart on the ring and each housing retaining an acoustic receiving sensor which is positioned within the ring; b. each respective breast-facing surface of each respective sensor housing is open and retains a thin and acoustically transparent biocompatible plastic film which separates the receiving sensor from directly contacting skin on the breast; c. each respective breast-facing surface of the ring around the location of the receiving sensors is covered with biocompatible adhesive material coupled with a removable protective material selected from the group consisting of paper or plastic material; d. the biocompatible adhesive material is exposed by removing the protective paper or plastic material; e. positioning the disposable ring on and around a human breast and adhering the ring onto the breast so that the sensor housings and the thin film are firmly coupled with the skin of the breast and located at positions approximately 90 degrees apart; f. utilizing a bi-modal Image-based Dynamic Ultrasound Spectrography system with “Imaging Mode” and “Stimulation Mode”; g. the Image-based Dynamic Ultrasound Spectrography system is switched to its “Imaging Mode”; h. an ultrasound imaging transducer is utilized to scan different segments of the breast and impact the breast with ultrasound imaging frequencies in the range of 1 megahertz (MHz) to 14 MHz to image the breast at each given time; i. an ultrasound B-mode gray scale image is created in real-time whereby ultrasound frequencies are transmitted towards specific segments of the breast and subsequently reflected from the specific segments of the breast towards the transducer; j. while the transducer is still in the imaging mode, the Image-based Dynamic Ultrasound Spectrography system is switched to its “Stimulation Mode”; k. the selected segment of the breast is stimulated by an ultrasound modulated scheme of non-invasive stimulation sequence in the form of a fixed band of frequencies or a derivative of which, as a swept band of frequencies, delivered by said ultrasound imaging transducer; l. when the stimulation sequence is delivered as a swept band of frequency, one signal generator provides incremented frequency ranges while another signal generator provides a fixed frequency so that due to instantaneous differences in the frequencies from the signal generator, certain acoustic radiation forces are generated proportional to the characteristic response frequencies of targeted microcalcifications that stimulate and vibrate the targeted microcalcifications; m. a single stimulation sequence is broken down into different segments so that the frequency scan occurs in a particular and controlled sequence called “one presentation” so that the swept band of frequencies can be applied over the desired frequency spans, thereby exerting the intended radiation force and in turn, creating the response in the targeted microcalcifications while minimizing the time for which each frequency span is introduced, which in turn increases the signal-to-noise ratio (S/N); n. when the stimulation sequence is delivered as modulated fixed band of frequencies, the data is acquired over a time interval wherein a fixed megahertz frequency is applied to the targeted microcalcifications and another variable and swept band of megahertz frequencies is incremented; o. in detection of stationary breast microcalcification, said modulated fixed band of stimulation frequencies is preferred wherein a first-hand estimate of the response is obtained and then a subsequent derivative of a swept band of megahertz frequencies is applied; p. in either the fixed band of frequency scheme of the swept band of frequency scheme, the stimulating signal is swept over a band of Hertz or kilohertz range frequencies and the frequencies are modulated on the megahertz ultrasound carrier frequency; q. as a result of stimulation, the microcalcifications produce response frequencies in the form of acoustic signals corresponding and specific to their mass density and structure and that are received by the receiving sensors positioned on the ring around the breast; r. utilizing an acoustic readout apparatus whereby certain frequencies are received by one or more of the acoustic receiving sensors positioned on the disposable ring; s. the detected frequencies received by each receiving sensor are compared and correlated with a predetermined map of peak frequencies corresponding to different microcalcification sizes, mass densities and structures; t. if a detected (received) frequency received by sensor/s correlates with a predetermined frequency in a the predetermined frequency signature map, the targeted site on the B-mode image is color-coded using a predetermined color scheme and the exact coordinates of the site within the breast is determined and co-registered with the B-mode image based on the readout from each sensor using certain triangulation techniques; and u. incorporating a fifth sensor within the ultrasound transducer in the Image-based Dynamic Ultrasound Spectrography system, the fifth sensor creating a reference axis in conjunction with the four acoustic receiving sensors, the fifth sensor used to create a reference axis so that the relative location of a detected site can be marked and co-registered to determine an exact three-dimensional location.