# US 8,417,328 B2 · Electrical systems for detection and characterization of abnormal tissue and cells > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,417,328 B2 - Document ID: US8417328B2 - Status: Granted - Kind: B2 - Application number: 12/524,973 - Filed: 2008-01-31 - Published: 2010-05-13 - Granted: 2013-04-09 - Earliest claimed: 2007-02-01 - Assignees: LS Biopath, Inc. - Applicants: Moshe Sarfaty; Amir Lev - Inventors: Moshe Sarfaty; Amir Lev - Web page: https://patentgrep.com/patent/US8417328B2 ## CPC - A61B 5/418: {lymph vessels, ducts or nodes} - A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24) - A61B 5/053: Measuring electrical impedance or conductance of a portion of the body - A61B 5/0536: Impedance imaging, e.g. by tomography - A61B 5/0538: invasively, e.g. using a catheter - A61B 5/415: {the glands, e.g. tonsils, adenoids or thymus} - A61B 2562/046: in a matrix array - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract An apparatus for the diagnosis of a biological sample is disclosed. An embodiments of the apparatus includes a probe, a probe head distally connectable to the probe, the probe head further comprising a plurality of electrode elements thereby forming an electrode array where each electrode element is variably actuatable to apply an electrical signal to the biological sample; an RF signal source for applying the electrical signal to the electrode array; an electrode selector adapted and configured to switch the electrical signal from the RF signal source between the plurality of electrode elements; and a detection circuit for analyzing a dielectric property received from the biological sample. Methods and kits for diagnosing a biological sample are also disclosed. ## Claims ### Claim 1 An apparatus for diagnosis of a biological sample, comprising: a probe, a probe head distally connectable to the probe, the probe head further comprising a fixed plate having a plurality of electrode elements forming an electrode array extending therefrom, wherein each electrode element comprises a tip and a shaft and is adapted to be separately actuatable to apply an electrical signal to the biological sample between selected pairs of electrode elements on the electrode array forming an electrical circuit through the biological tissue; a moveable plate adjacent the fixed plate wherein the moveable plate controls a depth of penetration of the electrode elements; an RF signal source for applying the electrical signal respective electrode elements within the electrode array forming a respective selected pair of electrode elements; an electrode selector adapted and configured to switch a signal pulse from the RF signal source to one of the selected electrode elements forming the respective selected one or more pairs of electrode elements; and a detection circuit configured to detect the effect on the signal pulse of a dielectric property of the biological sample intermediate the respective selected pair of electrode elements and to generate a tissue map of normal and abnormal cells. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the electrode selector is a multiplexer. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the detection circuit is configured to obtain a plurality of measurements in response to a signal pulse. ### Claim 4 (depends on 1) The apparatus of claim 1, further comprising a processor for analyzing a group of parameters with reference to a stored parameter. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the probe head is configured to collect successive groups of signal pulses over time. ### Claim 6 (depends on 1) The apparatus of claim 1, configured to derive at least two parameter values from a target signal pulse. ### Claim 7 (depends on 1) The apparatus of claim 1, wherein the probe head has an electrode array area of less than or equal to 100 mm2. ### Claim 8 (depends on 1) The apparatus of claim 1, wherein the apparatus is adapted and configured for use in vivo. ### Claim 9 (depends on 1) The apparatus of claim 1, wherein the apparatus is configured to analyze at least one dielectric property received by the detection circuit from the biological sample in real-time. ### Claim 10 (depends on 1) The apparatus of claim 1, further comprising a plurality of serially deployable probe heads each probe head comprising one or more electrode elements. ### Claim 11 (depends on 1) The apparatus of claim 1 wherein the dielectric property received by the detection circuit is a function of at least one of voltage, current or frequency. ### Claim 12 (depends on 1) The apparatus of claim 1 wherein the probe head measures the dielectric property locally. ### Claim 13 (depends on 1) The apparatus of claim 1, wherein the apparatus is adapted to measure a near-field response in the sample. ### Claim 14 (depends on 1) The apparatus of claim 1, wherein the apparatus is adapted to measure a far-field response in the sample. ### Claim 15 (depends on 1) The apparatus of claim 1 wherein a near-field electrical response and a far-field electrical response are measured from the same biological sample. ### Claim 16 (depends on 1) The apparatus of claim 1, wherein the apparatus is adapted and configured to be handheld. ### Claim 17 (depends on 1) The apparatus of claim 1, wherein the apparatus is adapted and configured for use with an endoscope. ### Claim 18 (depends on 1) The apparatus of claim 1, further comprising a metrology unit. ### Claim 19 (depends on 18) The apparatus of claim 18, wherein the metrology unit scans an extracted biological sample ex vivo in three dimensions at different locations. ### Claim 20 (depends on 19) The apparatus of claim 19, further comprising a motorized stage adapted and configured to receive a mounted biological sample. ### Claim 21 (depends on 1) The apparatus of claim 1 further comprising a source of backside suction whereby the backside suction enhances the contact between the sample and the electrode elements of the electrode array. ### Claim 22 An apparatus for determination of surgical efficacy, comprising: a probe adapted and configured to engage a target tissue of a mammal at a surgical site at a distal end of the probe; a probe head distally connectable to the probe, the probe head further comprising a fixed plate having an electrode array of electrode elements wherein each electrode element comprises a tip and a shaft and is adapted to apply an electrical signal to the target tissue sample between separately selected one or more pairs of electrode elements on the electrode array forming an electrical circuit through the target tissue; a moveable plate adjacent the fixed plate wherein the moveable plate controls a depth of penetration of the electrode elements; an electrode selector adapted and configured to switch the electrical signal to one of the selected electrode elements forming the respective selected pair of electrode elements; and an analyzer configured to compare a signal received through the target tissue at the surgical site by another of the selected electrode elements forming the respective selected pair of electrode elements comprising a collection electrode elements with a reference signal and to generate a tissue map of normal and abnormal cells. ### Claim 23 (depends on 22) The apparatus of claim 22 further comprising an RF signal source for applying the electrical signal to the electrode array. ### Claim 24 (depends on 22) The apparatus of claim 22 wherein the electrode selector is a multiplexer. ### Claim 25 (depends on 22) The apparatus of claim 22 further comprising a detection circuit for detecting a dielectric property received from the target tissue. ### Claim 26 (depends on 25) The apparatus of claim 25, wherein the detection circuit is configured to obtain a plurality of measurements in response to a pulsed signal. ### Claim 27 (depends on 22) The apparatus of claim 22, wherein the analyzer is a processor for analyzing a group of parameters with reference to a stored parameter. ### Claim 28 (depends on 22) The apparatus of claim 22, wherein the probe head is configured to collect collects successive groups of pulsed signals over time. ### Claim 29 (depends on 22) The apparatus of claim 22, configured to derive at least two parameter values from a target signal pulse. ### Claim 30 (depends on 22) The apparatus of claim 22 wherein the probe head has an electrode array area of less than or equal to 100 mm2. ### Claim 31 (depends on 22) The apparatus of claim 22, wherein the apparatus is adapted and configured for use in vivo. ### Claim 32 (depends on 22) The apparatus of claim 22, wherein the apparatus is configured to analyzes at least one dielectric property received by the detection circuit from the biological sample in real-time. ### Claim 33 (depends on 22) The apparatus of claim 22, further comprising a plurality of serially deployable probe heads each probe head comprising one or more electrode elements. ### Claim 34 (depends on 25) The apparatus of claim 25, wherein the dielectric property received by the detection circuit is a function of at least one of voltage, current or frequency. ### Claim 35 (depends on 25) The apparatus of claim 25, wherein the analyzer measures the dielectric property locally. ### Claim 36 (depends on 22) The apparatus of claim 22, wherein the apparatus is adapted to measure a near-field response in the sample. ### Claim 37 (depends on 22) The apparatus of claim 22, wherein the apparatus is adapted to measure a far-field response in the sample. ### Claim 38 (depends on 22) The apparatus of claim 22 wherein a near-field electrical response and a far-field electrical response are measured from the same biological sample. ### Claim 39 (depends on 22) The apparatus of claim 22, wherein a near-field electrical response and a far-field electrical response is measured from the same target tissue. ### Claim 40 (depends on 22) The apparatus of claim 22, wherein the apparatus is adapted and configured to be handheld. ### Claim 41 (depends on 22) The apparatus of claim 22, wherein the apparatus is adapted and configured for use with an endoscope. ### Claim 42 (depends on 22) The apparatus of claim 22, further comprising a metrology unit. ### Claim 43 (depends on 42) The apparatus of claim 42, wherein the metrology unit scans an extracted biological sample ex vivo in three dimensions at different locations. ### Claim 44 (depends on 43) The apparatus of claim 43, further comprising a motorized stage adapted and configured to receive a mounted biological sample. ### Claim 45 A kit for diagnosing a biological tissue comprising: a probe; and a probe head adapted and configured for use with the probe, the probe head comprising a fixed plate having at least a plurality of electrode elements in an array extending therefrom adapted to apply an electrical signal to a biological tissue, a moveable plate adapted to control a depth of penetration of the electrode elements, and a detection circuit configured to detect the effect on the signal pulse of a dielectric property of the biological sample elements and to generate a tissue map of normal and abnormal cells; the array comprising a plurality of electrode elements forming the array, each electrode element further comprises a tip and a shaft and is separately actuatable to apply an electrical signal to the biological sample between selected pairs of electrode elements on the electrode array forming an electrical circuit through the biological tissue. ### Claim 46 (depends on 45) The kit of claim 45 further comprising an electrode selector adapted to select at least one active electrode element. ### Claim 47 (depends on 45) The kit of claim 45, further comprising a plurality of probe heads connectable to the probe. ### Claim 48 (depends on 45) The kit of claim 45 further comprising a console. ### Claim 49 (depends on 48) The kit of claim 48 wherein the console further comprises a base. ### Claim 50 (depends on 49) The kit of claim 49 wherein the probe is adapted to be connected the base through a connection. ### Claim 51 (depends on 50) The kit of claim 50 wherein the connection is a wired connection. ### Claim 52 (depends on 50) The kit of claim 50 wherein the connection is a wireless connection. ### Claim 53 (depends on 52) The kit of claim 52 wherein the wireless connection is an operating room approved wireless connection. ### Claim 54 (depends on 48) The kit of claim 48 wherein the console displays a result. ### Claim 55 (depends on 1) The apparatus of claim 1 wherein the plurality of electrode elements forming the electrode array are selectively actuatable to apply an electrical signal to the biological sample. ### Claim 56 (depends on 1) The apparatus of claim 1 wherein the detection circuit is configured to receive a signal from a set of electrodes different from a set of electrodes actuated to apply an electrical signal. ### Claim 57 (depends on 22) The apparatus of claim 22 wherein the electrode array further comprises a plurality of electrode elements forming the electrode array which are selectively actuable to apply an electrical signal to the biological sample. ### Claim 58 (depends on 1) The apparatus of claim 1 wherein the moveable plate functions as a stopper to prevent the electrodes from being inserted into the tissue further than desired. ### Claim 59 (depends on 22) The apparatus of claim 22 wherein the moveable plate functions as a stopper to prevent the electrodes from being inserted into the tissue further than desired. ### Claim 60 (depends on 45) The kit of claim 45 wherein the moveable plate functions as a stopper to prevent the electrodes from being inserted into the tissue further than desired.