Units, kits, and systems for identifying abnormalities in a subject's tissue.

Abstract

This disclosure provides units, kits, systems, and methods for identifying abnormalities in a subject's tissue, particularly those associated with cancer. This disclosure utilizes a unit configured to be attached to a portion of the breast and, optionally, to the armpit. The unit includes a sensing unit or sensing spot configured to sense a temperature or electrical profile response, or both, from an associated skin portion, i.e., a skin portion in contact with or adjacent to the sensing unit or sensing spot, after the unit has been attached. The unit further comprises at least one current electrode configured to apply a current profile to the subject's skin, with the response to this current profile being identified by the sensing spot. That is, the application of current can be done through a first location in the subject's skin, and a sensing spot associated with a second location in the subject's skin is configured to sense the response to the current profile. A processing circuit incorporated into the unit is configured to (i) control the current profile to perform a selected current profile, (ii) operate the sensing spot to perform a measurement, and (iii) transmit the sensing data measured by the sensing spot. Based on the measurements of the sensing unit, a map of temporal temperature and electrical profile responses of various portions of the breast can be generated. Next, the temporal profiles of temperature and electrical profile-related parameters are analyzed to identify signatures of tissue abnormalities.

Description

Technical Field

[0001] The present disclosure is in the field of medical examination units, particularly units for examining a subject's body part or tissue of a body part to identify abnormalities.

Background Art

[0002] The following are listed references considered relevant as background to the presently disclosed subject matter. CN108576952 US2019357774 KR200406517

[0003] The citation of the above references in this specification is not to be construed as an admission that they are in any way relevant to the patentability of the presently disclosed subject matter.

Summary of the Invention

[0004] This disclosure provides units, kits, systems, and methods for identifying abnormalities in a subject's tissue, particularly those associated with cancer. This disclosure utilizes a unit configured to be attached to a portion of the breast and, optionally, to the armpit. Thus, in one embodiment, the unit is configured to be attached integrally to the breast and the armpit, and in a second embodiment, there are two subunits, each independently attached to the breast and the armpit, respectively, and configured to communicate with each other to transfer data. The unit includes a sensing unit or sensing spot configured to sense a temperature or electrical profile response, or both, from an associated skin portion, i.e., a skin portion in contact with or adjacent to the sensing unit or sensing spot, after the unit has been attached. The unit further comprises at least one current electrode configured to apply an electrical profile to the subject's skin, and the response to this electrical profile is identified by the sensing spot. That is, the application of current can be done through a first location in the subject's skin, and a sensing spot associated with a second location in the subject's skin is configured to sense the response to the electrical profile. The processing circuitry incorporated into the unit is configured to (i) control the current profile to execute the selected current profile, (ii) operate the sensing spot to perform measurements, and (iii) transmit the sensing data measured by the sensing spot. Based on the measurements of the sensing unit, it is possible to generate maps of the temporal temperature profile and electrical profile response of various parts of the breast. Then, the temporal profiles of temperature and electrical profile-related parameters are analyzed to identify signatures of tissue abnormalities.

[0005] Accordingly, a first aspect of the present disclosure provides an examination unit for examining a subject's breast and, optionally, the subject's axilla to identify tissue abnormalities, such as potential cancerous tumors. The examination unit comprises at least one attachable sheet configured to be attached to a first selected portion and, optionally, a second selected portion, corresponding to at least one breast and, optionally, one axilla, respectively. That is, the examination unit can be configured to measure only the breast, or the breast and axilla simultaneously. The attachable sheet comprises a plurality of measuring electrodes and a plurality of first sensing spots, each sensing spot configured to sense from the tissue portion associated therewith (i) an electrical profile from each of the plurality of measuring electrodes, (ii) an IR radiation profile or a thermal profile, or (iii) either (i) an electrical profile or (ii) an IR radiation profile or a thermal profile, and generate a first sensing data thereon, and at least one current electrode configured to apply current to at least the tissue portion associated with each of the first sensing spots, wherein the current electrode and the measuring electrode may have the same structure. The inspection unit further comprises a processing circuit and one or more memories coupled to the processing circuit that store programming instructions to be executed by the processing circuit for (1) operating the first and second sensing spots and receiving each of the respective first and second sensing data, (2) controlling the at least one current electrode to execute a selected current profile, and (3) transmitting each of the respective first and second sensing data.

[0006] It should be noted that any combination of the embodiments described may apply to any aspect of this disclosure. In other words, any aspect of this disclosure can be defined by any combination of the embodiments described.

[0007] In some embodiments of the inspection unit, the at least one attachable sheet comprises a skin-facing surface, the skin-facing surface comprising an adhesive layer for enabling attachment to the first and second selected portions.

[0008] In some embodiments of the inspection unit, the skin-facing surface is provided with a removable cover that covers the adhesive layer and is configured to be removable before installation.

[0009] In some embodiments of the inspection unit, the at least one attachable sheet has a closed shape.

[0010] In some embodiments of the examination unit, the first selected portion includes the majority of the breast area of ​​the breast. The breast area is defined as the area spanning between the clavicle and the inframammary fold.

[0011] In some embodiments of the examination unit, the second selected portion includes a large portion of the axillary surface of the axilla. The anatomical boundaries of the axillary surface in which the examination unit is positioned are as follows: (1) anterior - pectoralis major muscle (known as the axillary fold), (2) posterior - latissimus dorsi muscle, (3) superior - intertubercular groove of the humerus, and (4) inferior - lateral inframammary groove.

[0012] In some embodiments of the inspection unit, the first selected portion and the second selected portion form a physical continuum that can be attached to at least one attachable sheet.

[0013] In some embodiments of the inspection unit, the at least one attachable sheet comprises a first attachable sheet attachable to the first selected portion and a second attachable sheet attachable to the second selected portion, wherein the first and second attachable sheets are physically separate. That is, the two sheets are physically separated and can communicate with each other for the exchange of sensing data, sensing profile execution data, or both.

[0014] In some embodiments of the examination unit, at least one attachable sheet is configured to be attached to a first selected area and a second selected area. That is, the attachable sheet is attached to both the axilla and breast of the subject, allowing measurements to be taken from these areas. At least one attachable sheet is a single unit that covers both areas.

[0015] In some embodiments, the inspection unit further comprises a plurality of second sensing spots, each second sensing spot configured to sense an IR radiation profile or thermal profile (both can be called thermal profiles) from the tissue portion associated with it and generate each second sensing data based thereon.

[0016] In some embodiments of the inspection unit, at least a portion of the measuring electrodes constitutes at least one current electrode. That is, the measuring electrode can perform a desired current profile applied to the skin portion to which it is associated, and can measure an electrical profile in response to the performance of the current profile.

[0017] In some embodiments, the inspection unit further includes ratio (1:1) measuring electrodes and thermal sensors to create an overlap map for analysis.

[0018] In some embodiments of the inspection unit, the electrical profile is determined by the impedance, conductivity, potential, and dielectric constant of at least the tissue portion associated with each first sensing spot, or a combination thereof.

[0019] In some embodiments of the inspection unit, the first sensing spot comprises a measuring electrode and a thermal sensor, so that the electrode and the sensor are physically adjacent to each other at each sensing spot. That is, the thermal sensor and the measuring electrode are positioned substantially in the same location such that their data maps overlap.

[0020] In some embodiments of the inspection unit, each of a plurality of first sensing spots comprises a measuring electrode and a thermal sensor, and the first sensing spot is configured to sense both (i) an electrical profile and (ii) an IR radiation profile or thermal profile of the respective tissue portion associated therewith. It should be noted that each sensing spot is defined by a specific area containing at least one thermal sensor and at least one measuring electrode. By arranging the sensors in this manner, maps of electrical and thermal profiles can be generated and easily correlated.

[0021] In some embodiments of the inspection unit, the at least one attachable sheet comprises a first sensing array having a plurality of first sensing spots, each sensing spot being arranged opposite to one another along at least one first continuous line. In some embodiments, the distance between sensors is 5 mm or less in a constant, even distribution.

[0022] In some embodiments of the inspection unit, the at least one first continuous line is configured to correspond to the shape and dimensions of the first selected portion.

[0023] In some embodiments of the inspection unit, at least one of the continuous lines defines a left - or right - hand spiral with the first sensing spots arranged sequentially and orderly and configured to enable sensing of most of the selected first portion. The spiral is made to order based on a universal bust cup size so as to fit surely onto any type of breast. Also, the spiral shape is cut from a breast 3D scan or a breast shape database. By cutting the shape into a spiral, a demo formed of a spiral structure that fits onto the breast is created. The spiral shape can be geometrically defined as a curve starting from a central point (nipple) and gradually moving outward or inward in a circular or spiral pattern. A decisive feature of the spiral is that it continuously expands and contracts while keeping the distance between consecutive turns constant. By arranging the sensors in a spiral, the sheet, and the PCB carrying the sensors become flexible enough to conform to the shape of the breast.

[0024] In some embodiments of the inspection unit, the continuous line forms a closed shape.

[0025] In some embodiments of the inspection unit, the first sensing array comprises a plurality of the closed shapes arranged concentrically. For example, the centers of these concentric circles can be near the nipple - placement position of the attachable sheet.

[0026] In some embodiments of the inspection unit, the distance between each pair of concentric circles defined as R1 - R2 is such that O1>O2, which may or may not be equal, but maintains a constant ratio throughout.

[0027] In some embodiments, the inspection unit further comprises an optical sensor configured to identify anatomical marks of the breast and generate optical sensing data, and the optical sensing data is generated by a processor of the optical sensor itself or by a processing circuit of the inspection unit that receives the optical measurements of the optical sensor and analyzes them to identify anatomical marks such as the nipple of the subject. The processing circuit is configured to identify a misplacement of the inspection unit based on the optical sensing data and output a warning if a misplacement is identified.

[0028] <( In some embodiments, the inspection unit further comprises one or more optical sensors configured to sense optical parameters indicating the intensity profile of light in one or more selected wavelength ranges sensed by each optical sensor and generate optical sensing data based thereon, and the optical sensing data is generated by a processor of the optical sensor itself or by a processing circuit of the inspection unit that receives the optical measurements of the optical sensor. At least one processing circuit is configured to analyze the optical sensing data to identify (1) insufficient adhesion of the attachable sheet and / or insufficient stability throughout the inspection process (including the initial steps of attaching the inspection unit), and (2) at least one of the misplacements of the inspection unit. The processing circuit is further configured to output a warning if (1) or (2), or both, are identified.

[0029] In some embodiments of the inspection unit, the one or more optical sensors are arranged along different portions of the periphery of at least one attachable sheet.

[0030] In some embodiments of the inspection unit, at least one of the continuous lines defines an open shape configuration configured to sense most of the selected second portion.

[0031] In some embodiments of the inspection unit, the at least one current electrode includes one or more pairs of electrodes positioned opposite each other on a mountable sheet, i.e., spaced apart from each other, and each member of the pair or more electrodes is associated with each fat-measuring electrode included in the plurality of measuring electrodes, i.e., the fat-measuring electrode can also function as a standard measuring electrode. The processing circuit is configured to operate one or more electrode pairs to apply a selected current profile so that it flows from a first member of the electrode pair to a second member of the pair. The electrical profile sensed by each fat-measuring electrode indicates the fat percentage in the tissue. Typically, the current and voltage between two fat-measuring electrodes are sensed and analyzed to extract the fat percentage of breast tissue. This measurement may be used to analyze the generated map and contribute to concluding whether an abnormality is identified in the breast or axilla.

[0032] In some embodiments of the inspection unit, the first sensing spot comprises a second sensing spot, which can perform not only placement verification but also substantial measurement.

[0033] In some embodiments, the inspection unit further comprises a second sensing array having a plurality of second sensing spots, which may be part of or distinct from the first array. Each second sensing spot is positioned relative to one another along at least one second continuous line, and a processing circuit is further configured to analyze the second sensing data and identify thermal signatures of one or more anatomical landmarks for verifying good placement of the attachable sheet, and if no thermal signatures are identified, the processing circuit is configured to perform a misplacement warning. The landmarks are typically one or both of the internal mammary artery and the lateral thoracic artery of each breast. Note that if at least one attachable sheet is a single sheet, verification of good placement by one of these arteries may also indicate good placement to the axillary portion. In some embodiments, further, a simple verification may be required to determine whether the axillary portion of the attachable sheet is actually attached to the subject's skin.

[0034] In some embodiments of the inspection unit, the at least one second continuous line is oriented substantially vertically when inspected with the attachable sheet properly attached to the breast.

[0035] In some embodiments of the inspection unit, the at least one second continuous line is positioned outside the first selected portion. To verify that the breast unit is properly positioned, the outer and inner boundaries of the device include a longitudinal row of thermal sensors and optionally optical sensors, intended for detecting the lateral thoracic artery, nipple, and internal mammary artery, thereby ensuring that the device is in place.

[0036] In some embodiments of the inspection unit, the at least one second continuous line is located inward relative to the first selected portion.

[0037] In some embodiments of the inspection unit, the attachable sheet comprises a first layer and a second layer, the first layer comprising the first and second sensing arrays and at least one current electrode, and the second layer comprising the processing circuit.

[0038] In some embodiments of the inspection unit, the electrical profile is characterized by applying a current containing the current profile continuously or discontinuously, i.e., in pulses, or any combination thereof.

[0039] In some embodiments of the examination unit, the at least one current electrode is configured to transmit pulses of current having a frequency in the range of about 1 kHz to about 10 MHz, a peak-to-peak voltage of about 0 to about 5 volts, and a peak-to-peak current of about 40 to 70 microamperes. The pulses may follow a sinusoidal pattern / wave or other pulse type. The frequency of the current is determined individually depending on the subject's characteristics, such as age, breast size (dimensions), volume, and tissue type.

[0040] Throughout this specification, the term "approximately" shall be understood as a deviation of ±20% from the nominal value. For example, if the nominal value is approximately 10 MHz, it defines a range of 8 to 12 MHz.

[0041] In some embodiments of the examination unit, at least one attachable sheet is made of a flexible and / or stretchable material, having the flexibility to accommodate different anatomically diverse subjects, and is at least partially flexible and / or stretchable, so that the examination unit is flexible enough to be attached to a large portion of a selected first and second part.

[0042] In some embodiments of the inspection unit, either the first layer or the second layer, or both, are made of a flexible and / or stretchable material.

[0043] In some embodiments of the inspection unit, the flexible material is selected from polyurethane, polyester nonwoven tape, and one of the following: non-tacking acrylic adhesive, adhesive hydrogel, silica gel, or silicone adhesive.

[0044] In some embodiments, the inspection unit further comprises a plurality of first pressure applicators associated with at least one attachable sheet, each configured to controllly apply pressure to an associated breast or axillary area when the at least one attachable sheet is attached to the breast. The first sensing spot is further configured to sense at least one of a deformation profile, a pressure profile, or a pressure change profile from the associated skin portion in response to the controlled pressure application and to generate the respective data to be included in the first sensing data. A processing circuit is further configured to control the first pressure applicators to execute a selected first pressure plan for the breast and / or axilla and measure the skin's response to the pressure applied thereby.

[0045] In some embodiments of the inspection unit, the first sensing spot comprises a plurality of first pressure sensors.

[0046] In some embodiments of the inspection unit, each first sensing spot, which includes a first pressure sensor, is associated with a first pressure applicator, each first pressure applicator is configured to apply pressure to at least the breast area associated with the respective first sensing spot.

[0047] In some embodiments of the inspection unit, the selected first pressure plan includes simultaneously applying pressure to a selected perimammary portion of the breast for a selected duration, and then coordinating the release of the pressure from the perimammary portion. The processing circuit is configured to operate the first sensing unit to sense at least a temperature profile in response to the selected first pressure plan.

[0048] In some embodiments of the inspection unit, the coordinated release includes simultaneously releasing pressure from the breast area.

[0049] In some embodiments of the examination unit, the breast area forms a continuum.

[0050] In some embodiments of the inspection unit, the application of pressure to the selected peripheral portion results in a continuous pressure application along the force application line.

[0051] In some embodiments of the inspection unit, the selected first pressure plan includes applying pressure in at least one first early pressure applicator, releasing the pressure application in the at least one first early pressure applicator, applying pressure in at least one first subsequent pressure applicator following the release of pressure in the at least one first early pressure applicator, and releasing the pressure application in the at least one first subsequent pressure applicator. The at least one first subsequent pressure applicator is spatially contiguous with the at least one first early pressure applicator, and the processing circuit is configured to operate the first sensing spot to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the selected first pressure plan.

[0052] In some embodiments of the inspection unit, the plurality of measuring electrodes each include at least one current electrode. That is, some of the measuring electrodes can also function as current electrodes.

[0053] In some embodiments of the inspection unit, each of the plurality of measuring electrodes also functions as a current electrode. That is, each measuring electrode has two optional functions: (i) to apply current to at least the tissue portion associated with each of the first sensing spots, and (ii) to measure an electrical profile, whether it be voltage, impedance, or current.

[0054] In some embodiments of the inspection unit, the multiple measuring electrodes are clustered into multiple groups, each group comprising multiple measuring electrode members. The processing circuit is configured to operate the multiple measuring electrodes to measure the electrical profile between each measuring electrode member in a group and any other measuring electrode member in the same group, i.e., the electrical profile between each member and any other member is measured. The electrical profile is selected from one or more of impedance, voltage, and current. In certain embodiments, the electrical profile is the impedance between each pair of measuring electrodes in the same group.

[0055] In some embodiments of the testing unit, some of the measuring electrodes are common to two or more groups. Such overlap of measuring electrodes between different groups typically occurs in areas that are statistically most likely to contain abnormalities, such as cancerous tissue. This can result in repeated measurements being taken with the same measuring electrodes in such areas, or at least different measurements being taken in different groups with common measuring electrodes.

[0056] In some embodiments of the inspection unit, each measuring electrode is also a current electrode capable of applying current to the associated tissue. The processing circuit is configured to control each measuring electrode such that, for each measurement of the electrical profile between each measuring electrode member in a group and any of the other measuring electrode members, a selected current profile is applied from one member participating in the measurement to another participating in the measurement. That is, in each measurement between a first member in a group and a second member in a group, current is applied from the first member in the group to the second member in the group.

[0057] In some embodiments of the testing unit, the electrical profile between each measuring electrode member of a group and any of the other measuring electrode members of the group is measured without the application of current in order to measure the natural electrical profile of the breast, i.e., to map the natural electrical profile such as the voltage of the breast. This is done to identify tumors in the breast that transmit electrical signals to increase their growth rate. Such tumor cells contain a larger charge than non-tumor cells and can be identified by this technique.

[0058] In some embodiments of the inspection unit, the first sensing spot comprises the second sensing spot.

[0059] In some embodiments of the examination unit, the at least one attachable sheet comprises a first portion, a second portion, and a third portion, the first and second portions being formed to fit over the subject's shoulders from opposite sides, respectively, to ensure that the at least one attachable sheet is properly positioned over the subject's armpit and breast, and the third portion providing a degree of freedom relative to the first and second portions to allow for adjustment of the at least one attachable sheet to breasts of different sizes and shapes.

[0060] In some embodiments of the inspection unit, each part extends circumferentially from the central portion of at least one attachable sheet.

[0061] In some embodiments of the inspection unit, at least one attachable sheet defines a varying perimeter length from the center point of the at least one attachable sheet to any point along the perimeter of the at least one attachable sheet, and the perimeter length between two adjacent portions decreases to a certain minimum value that defines the boundary between the two adjacent portions.

[0062] In some embodiments of the inspection unit, each of the three parts is a flap-shaped or wing-shaped portion.

[0063] In some embodiments of the examination unit, at least one attachable sheet comprises two similar surfaces, each equipped with all sensing spots and electrodes, and each surface is intended to be attached to a different breast of the subject.

[0064] In some embodiments of the inspection unit, the multiple measuring electrodes are clustered into multiple circular groups, where each measuring electrode within a circular group is at the same level as at least one other measuring electrode within the same group. The level is to be understood as a topographical map; that is, the topographical height of such a pair of electrodes is the same with respect to the breast. The purpose of such clustering is to enable measurement of the deeper tissues of the breast by allowing the current from one measuring electrode to pass through the deeper tissues of the breast before reaching the other electrode. The term “circular” means that the electrodes are arranged in a circle along the shape of the breast and are positioned at approximately the same height or level with respect to the breast. However, it should be noted that these circular groups may include electrodes that are not arranged in a perfect circle and may deviate from a circular arrangement as long as they are positioned at approximately the same level or height with respect to the breast. At least one processing circuit is configured to operate the measuring electrodes to measure the electrical profile between one measuring electrode in a circular group and at least one other measuring electrode within the group.

[0065] In some embodiments of the inspection unit, at least one processing circuit is configured to operate a measuring electrode to measure the electrical profile between one measuring electrode in a circular group and another measuring electrode on the opposite side of the group, located on the opposite side of the circle defining the arrangement of the circular group. That is, the measurement is performed between one electrode in the group and another measuring electrode located on the opposite side of the diameter of the circle defining the group.

[0066] Another aspect of the present disclosure provides a system for examining at least one breast and at least one axilla of a subject to identify tissue abnormalities. The system comprises an examination unit as described in any one of the embodiments described above, or a combination thereof, and an analysis module configured to receive and analyze the at least first sensing data, thereby identifying a signature indicating an abnormality in at least one of the selected first and second portions of the subject, and generating abnormality data thereon, and an output module configured to output the abnormality data.

[0067] In some embodiments of the system, the analysis module is further configured to receive one or more user-related parameters indicating at least one of the following: the subject's medical-related data, age, body mass index (BMI), the subject's demographic data, the subject's genetic data, the subject's family history showing abnormalities of the breast, ovaries, and / or uterus, the subject's family or personal history showing cancer and / or cancer-related pathology, ethnicity, the subject's objective data, and the subject's subjective data, and such identification is further based on the one or more user-related parameters.

[0068] In some embodiments of the system, the analysis module is configured to receive bra size, breast volume, or both bra size and breast volume. The analysis module is configured to apply adjustment conditions to the first sensing data based on the bra size or breast volume. The adjustment conditions may further depend on breast tissue density and fat versus glandular components.

[0069] In some embodiments of the system, the analysis includes, based on the respective first sensing data, generating an electrical profile including at least (i) impedance, dielectric constant, or conductance, or any combination thereof, and (ii) a sensing map of an IR profile or thermal profile.

[0070] In some embodiments of the system, the analysis includes analyzing the second sensing data to identify thermal signatures of one or more anatomical landmarks to verify the proper placement of the mountable sheet, and if no thermal signatures are identified, the processing circuit is configured to perform a misplacement warning.

[0071] In some embodiments of the system, the analysis further includes generating at least one sensing map, which is a deformation profile, a pressure profile, or a pressure change profile, based on the respective first data in response to a controlled pressure application.

[0072] In some embodiments of the system, the analysis includes comparing each of the first sensing data to the baseline data in order to identify deviations from the baseline that indicate anomalies.

[0073] In some embodiments of the system, the baseline is selected from one of the following: perceptual data from the contralateral breast and / or axilla, subjective tissue density of the breast being examined, pre-acquired perceptual data from subjects with some similarity to one or more of the user-related parameters, and other subjective and / or objective medical-related data adjusted for demographic data such as age, BMI, and ethnicity.

[0074] In some embodiments of the system, the analysis includes analyzing the fat percentage of the first selected portion to determine the subjective tissue density. The fat percentage of the breast tissue is calculated according to impedance data recorded by electrodes placed at the upper and lower edges of the breast. Using these parameters, the density and structure of the breast are calculated and used for analysis.

[0075] In some embodiments of the system, the analysis module is configured to compare first sensing data from two identical groups of first sensing spots, each measured on a different breast of the subject. In some embodiments, the comparison is made between two similar groups of measuring electrodes, each of which is measured on a different breast of the subject. The measurements may include multiple groups, each group containing multiple measuring electrodes. The electrical profile measurements are made between two electrodes within the same group; that is, each group on one side of the breast has a corresponding group on the opposite side for comparison. Since this type of measurement is performed identically on both breasts, comparison is possible. If a significant difference is observed between the two breasts, it is included in the anomaly data. This can also be processed together with the IR profiles of the same suspicious area to increase the reliability of the identified anomaly.

[0076] Another aspect of the present disclosure provides a method for examining a subject's breast and, optionally, the subject's axilla. The method includes attaching a plurality of measuring electrodes and a plurality of first sensing spots and at least one current electrode to a first selected portion and an optionally second selected portion, each corresponding to at least one breast and optionally one axilla, for sensing from the associated tissue portion (i) an electrical profile from each of the plurality of measuring electrodes, (ii) an IR radiation profile or a thermal profile, or (iii) either (i) an electrical profile or (ii) an IR radiation profile, and generating a first sensing data therefrom; the at least one current electrode is configured to apply current to at least the tissue portion associated with each of the first sensing spots; the method further includes controlling the at least one current electrode to perform a selected current profile; the method further includes operating the first and second sensing spots, receiving each of the respective first and second sensing data; and transmitting each of the respective first sensing data.

[0077] In some embodiments of the method, the first selected portion includes the majority of the breast area of ​​the breast, defined as the area spanning between the clavicle and the inframammary fold.

[0078] In some embodiments of the method, the second selected portion includes a large portion of the axillary surface of the axilla.

[0079] In some embodiments of the method, the first selected portion and the second selected portion form a physical continuum that can be attached to at least one attachable sheet.

[0080] In some embodiments, the method further includes attaching a plurality of second sensing spots to a first selected portion and an optional second selected portion, each corresponding to at least one breast and one optional axilla. Each second sensing spot is configured to sense an IR radiation profile or thermal profile from the tissue portion associated with it and generate its respective second sensing data therefrom.

[0081] In some embodiments of the method, at least a portion of the measuring electrodes constitutes at least one current electrode. That is, the measuring electrode can perform a desired current profile applied to the skin portion to which it is associated, and can measure an electrical profile in response to the performance of the current profile.

[0082] In some embodiments of the method, the electrical profile is determined by the impedance, conductivity, potential, and dielectric constant of at least the tissue portion associated with each first sensing spot, or a combination thereof.

[0083] In some embodiments of the method, the first sensing spot comprises a measuring electrode and a thermal sensor, so that the electrode and the sensor are physically adjacent to each other at each sensing spot. That is, the thermal sensor and the measuring electrode are positioned substantially in the same location such that their data maps overlap.

[0084] In some embodiments of the method, each of a plurality of first sensing spots comprises a measuring electrode and a thermal sensor, and the first sensing spot is configured to sense both (i) an electrical profile and (ii) an IR radiation profile or thermal profile of the respective tissue portion associated therewith. It should be noted that each sensing spot is defined by a specific area containing at least one thermal sensor and at least one measuring electrode. By arranging the sensors in this manner, the generated electrical and thermal profiles can be easily correlated.

[0085] In some embodiments of the method, the plurality of first sensing spots are arranged in a first sensing array, and each sensing spot is positioned relative to one another along at least one first continuous line. The distance between the sensors may be 5 mm or less in a constant, even distribution.

[0086] In some embodiments of the method, the at least one first continuous line is configured to correspond to the shape and dimensions of the first selected portion.

[0087] In some embodiments of the method, at least one of the continuous lines defines a left-handed or right-handed spiral having first sensing spots arranged sequentially and in an orderly manner, configured to enable sensing of a large portion of the selected first portion.

[0088] In some embodiments of the method, the continuous line forms a closed shape.

[0089] In some embodiments, the method further includes optically sensing the breast to identify anatomical landmarks of the breast and generate optical sensing data, identifying misplacement of the inspection unit based on the optical sensing data, and outputting a warning if misplacement is identified.

[0090] In some embodiments, the method further includes optically sensing optical parameters representing the intensity profile of light in one or more selected wavelength ranges from portions of an attachable sheet, including first or second sensing spots, adjacent to these spots, and generating optical sensing data thereon. The method further includes analyzing the optical sensing data and identifying at least one of the following: (1) insufficient adhesion of the attachable sheet and / or stability throughout the inspection process (including the first step of attaching the inspection unit); and (2) mispositioning of the inspection unit. The method further includes outputting a warning if (1) or (2), or both, are identified.

[0091] In some embodiments of the method, at least one of the continuous lines defines an open shape configuration configured to sense a large portion of the selected second portion.

[0092] In some embodiments of the method, the first sensing spot comprises a second sensing spot, which can perform not only placement verification but also substantial measurements.

[0093] In some embodiments, the method includes arranging the second sensing spots in a second array, which may be part of or separate from the first array, and each second sensing spot is arranged opposite to one another along at least one second continuous line; the method further includes analyzing the second sensing data to identify thermal signatures of one or more anatomical landmarks for verifying good placement of the attachable sheet; if no thermal signatures are identified, the method further includes outputting a misplacement alarm. The landmarks are typically one or both of the internal and lateral mammary arteries of each breast. It should be noted that if at least one attachable sheet is a single sheet, verification of good placement by one of these arteries may also indicate good placement in the axillary portion. In some embodiments, it may further be necessary to verify whether the axillary portion of the attachable sheet is actually attached to the subject's skin.

[0094] In some embodiments of the method, the at least one second continuous line is positioned outside the first selected portion. To verify that the breast unit is properly positioned, the outer and inner boundaries of the device include a longitudinal row of thermal sensors and optionally optical sensors, for the purpose of detecting the lateral thoracic artery, nipple, and internal mammary artery, thereby ensuring that the device is in place.

[0095] In some embodiments of the method, the at least one second continuous line lies inward relative to the first selected portion.

[0096] In some embodiments of the method, the electrical profile is characterized by applying a current containing the current profile continuously or discontinuously, i.e., in pulses, or any combination thereof.

[0097] In some embodiments of the method, the at least one current electrode is configured to transmit pulses of current having a frequency in the range of about 1 kHz to about 10 MHz, a peak-to-peak voltage of about 0 to about 5 volts, and a peak-to-peak current of about 40 to 70 microamperes.

[0098] In some embodiments, the method further includes: attaching a plurality of first pressure applicators, each configured to apply controllable pressure to an associated area of ​​the breast or axilla; controlling the first pressure applicators to execute a first pressure plan selected for the breast and / or axilla and measure the skin's response to the pressure applied thereby; and sensing at least one of a deformation profile, a pressure profile, or a pressure change profile from the skin portion associated with a first sensing spot in response to the controlled pressure application and generating the respective data to be included in the first sensing data.

[0099] In some embodiments of the method, the first sensing spot comprises a plurality of first pressure sensors.

[0100] In some embodiments of the method, the selected first pressure plan includes simultaneously applying pressure to a selected perimammary portion of the breast for a selected duration, and then coordinating the release of the pressure from the perimammary portion, and operating the first sensing unit to sense at least a temperature profile in response to the selected first pressure plan.

[0101] In some embodiments of the method, the coordinated release includes simultaneously releasing pressure from the area surrounding the breast.

[0102] In some embodiments of the method, the area around the breast forms a continuum.

[0103] In some embodiments of the method, the application of the pressure to the selected peripheral portion results in a continuous pressure application along the force application line.

[0104] In some embodiments of the method, the selected first pressure plan is The method includes applying pressure with at least one first early pressure applicator, releasing the pressure application from the at least one first early pressure applicator, applying pressure with at least one first subsequent pressure applicator following the release of pressure from the at least one first early pressure applicator, and releasing the pressure application from the at least one first subsequent pressure applicator, wherein the at least one first subsequent pressure applicator is spatially contiguous with the at least one first early pressure applicator, and the method further includes operating the first sensing unit to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the selected first pressure plan.

[0105] In some embodiments, the method further includes analyzing the at least first sensing data, identifying therein signatures indicating anomalies in at least one of the selected first and second portions of the subject, generating anomaly data thereon, and outputting the anomaly data.

[0106] In some embodiments, the method further includes receiving one or more user-related parameters indicating at least one of the following: the subject's medical-related data, the subject's demographic data, BMI, age, the subject's genetic data, the subject's family history showing abnormalities of the breast, ovaries, and / or uterus, the subject's family or personal history showing cancer and / or cancer-related pathology, ethnicity, the subject's objective data, and the subject's subjective data, and such identification is further based on such one or more user-related parameters.

[0107] In some embodiments of the method, the analysis further includes generating at least one sensing map, which is a deformation profile, a pressure profile, or a pressure change profile, based on the respective first data in response to a controlled pressure application.

[0108] In some embodiments of the method, the analysis includes comparing each of the first sensing data to the baseline data in order to identify deviations from the baseline that indicate anomalies.

[0109] In some embodiments of the method, the baseline is selected from one of the following: perceptual data from the contralateral breast and / or axilla, subjective tissue density of the breast examined, pre-acquired perceptual data from subjects with some similarity to one or more of the user-related parameters, and other subjective and / or objective medical-related data adjusted for demographic data such as age, BMI, and ethnicity.

[0110] In some embodiments, the method further includes applying a selected current profile between one or more pairs of current electrodes positioned on both sides of the breast, i.e., spaced apart from one another. Each member of the one or more pairs of electrodes is associated with a respective fat-measuring electrode included in the plurality of measuring electrodes. The method further includes measuring an electrical profile by each fat-measuring electrode, the electrical profile measured by the fat-measuring electrode indicating the fat percentage in the tissue. Typically, the current and voltage between two fat-measuring electrodes are sensed and analyzed to extract the fat percentage of the breast tissue. This measurement may be used to analyze the generated map and contribute to concluding whether an abnormality is identified in the breast or axilla.

[0111] In some embodiments of the method, the analysis includes analyzing the fat percentage of the first selected portion in order to determine the subjective tissue density.

[0112] In some embodiments, the method further includes receiving bra size, breast volume, or breast size data indicating both bra size and breast volume. The analysis further includes applying adjustment conditions to the first sensing data based on bra size or breast volume. The adjustment conditions may further depend on breast tissue density and fat versus glandular components.

[0113] Another aspect of the present disclosure provides a breast unit for performing an examination of a subject's breast to identify abnormalities of the breast. The unit comprises a flexible, attachable first sheet formed to be attached to a desired portion of the breast via one of its surfaces. Note that throughout this application the term “desired” is interchangeable with the term “selected.” The first sheet comprises a plurality of first sensing units, each first sensing unit configured to sense from an associated skin portion (i) a deformation profile, pressure profile, or pressure change profile, and (ii) at least one of an IR radiation profile or temperature profile of the respective skin portion, and to generate respective first sensing data therefrom. Note that sensing from a skin portion includes sensing parameters of skin or behavior via skin, such as temperature. The breast unit further comprises a plurality of first pressure applicators associated with the first sheet, each configured to controllably apply pressure to an associated area of ​​the breast when the first sheet is attached to the breast. The breast unit comprises a processing circuit, i.e., a processor or controller, coupled to the processing circuit, (1) Operate the first sensing unit and receive each of the first sensing data, (2) Control the first pressure applicator to perform a desired first pressure plan on the breast, (3) To analyze the first sensing data and identify whether or not there is an anomaly, each of the first sensing data from each of the first sensing units is transmitted to an external computing device. It further comprises one or more memories for storing programming instructions to be executed by a processing circuit.

[0114] It should be noted that any combination of the embodiments described may apply to any aspect of this disclosure. In other words, any aspect of this disclosure can be defined by any combination of the embodiments described.

[0115] In some embodiments of the breast unit, the attachable first sheet includes a skin-facing surface. The skin-facing surface includes an adhesive layer to enable attachment to the desired site.

[0116] In some embodiments of the breast unit, the skin-facing surface is provided with a removable cover that covers the adhesive layer and is configured to be removable before installation.

[0117] In some embodiments of the breast unit, the desired portion includes the majority of the breast area, including the nipple and areola.

[0118] In some embodiments of the breast unit, the desired portion includes most of the breast area excluding the nipple and areola.

[0119] In some embodiments of the breast unit, the first sheet has a closed shape, i.e., a sheet shape that encloses the nipple or includes the nipple in its area.

[0120] In some embodiments of the breast unit, the first sheet has a shape that completely surrounds the subject's nipple when attached to the desired area.

[0121] In some embodiments of the breast unit, the first sensing unit includes a first pressure sensor. The pressure sensor may include one of the following: a tactile sensor, a piezoelectric sensor, a magnetoresistive sensor, a force-sensitive resistor, etc.

[0122] In some embodiments of the breast unit, the first sensing unit further comprises a temperature sensor. The temperature sensor may include one of the following: an IR sensor, a resistance temperature detector (RTD), a thermocouple, a semiconductor IC, etc.

[0123] In some embodiments of the breast unit, each first sensing unit comprises a first pressure sensor and a temperature sensor, and each first sensing unit is configured to sense (i) a deformation profile, pressure profile, or pressure change profile and (ii) both an IR emission profile or temperature profile of the respective skin portion associated therewith.

[0124] In some embodiments of the breast unit, the first sheet comprises a first layer and a second layer, the first layer comprising the first sensing unit and an adhesive, and the second layer comprising the first pressure applicator.

[0125] In some embodiments of the breast unit, the second layer comprises the processing circuit.

[0126] In some embodiments of the breast unit, the first sheet includes the processing circuit.

[0127] In some embodiments of the breast unit, each first sensing unit is associated with a first pressure applicator, each first pressure applicator is configured to apply pressure to the breast area associated with the first sensing unit.

[0128] In some embodiments, the first pressure applicators are arranged in a mesh. Each pressure sensor in the mesh is coupled to a plurality of its own elastic wires or elements, i.e., elastic wires or elements coupled only to a specific pressure sensor, and each pressure applicator of each first pressure sensor is configured to apply pressure that causes elastic deformation of the elastic wire coupled to the respective pressure sensor. This configuration allows pressure to be applied to isolated breast portions and, in response to that pressure, pressure indication parameters of the isolated breast portions to be measured.

[0129] In some embodiments of the breast unit, the desired first pressure plan includes simultaneously applying pressure to a selected peripheral portion of the breast, or a selected peripheral portion of a sheet that will apply pressure to the breast, for a selected duration, and then coordinating the release of the pressure from the peripheral portion. The application of peripheral pressure reduces blood flow to the internal regions of breast tissue surrounded by the selected peripheral portion, thereby cooling these internal regions. After the pressure is released, the sensing unit senses the temperature profile of each skin portion, which may indicate a signature of abnormality in that skin portion. The processing circuit is further configured to operate the first sensing unit to sense at least the temperature profile in response to the desired first pressure plan.

[0130] In some embodiments of the breast unit, the coordinated release includes simultaneously releasing pressure from the surrounding portion of the breast.

[0131] In some embodiments of the breast unit, the peripheral portion of the breast forms a continuum, such as a spatial continuum. It should be noted that this continuum appears due to a given pressure applied along the peripheral circle surrounding the nipple.

[0132] In some embodiments of the breast unit, the application of pressure to the selected peripheral portion results in a continuous pressure application along a force application line, which may not be equal at any point along the line, but is at least greater than the passive state when no force is applied. It should be noted that the application line is not specific, but merely intended to define the geometric shape of the pressure application.

[0133] In some embodiments of the breast unit, the desired first pressure plan is (a) Apply pressure with at least one first early (or primary) pressure applicator, and release the pressure application from the at least one first early pressure applicator. (b) After releasing the pressure from at least one first early pressure applicator, pressure is applied in at least one first subsequent pressure applicator, and the pressure application of the at least one first subsequent pressure applicator is released. This includes the following.

[0134] The at least one first subsequent pressure applicator is spatially contiguous to the at least one first early pressure applicator, thereby enabling measurement of pressure change or deformation profile of a continuous portion of the breast and creating a continuous map of the breast's pressure change or deformation profile behavior in response to the application of pressure. The processing circuit is further configured to operate the first sensing unit to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the desired first pressure plan.

[0135] In some embodiments of the breast unit, the processing circuit is electrically connected to each of the first sensing units, thereby controlling their operation and receiving the respective first sensing data.

[0136] In some embodiments of the breast unit, the processing circuit is electrically connected to each of the first pressure applicators, thereby controlling their operation.

[0137] In some embodiments, the breast unit is disposable.

[0138] In some embodiments of the breast unit, the sheet is formed at least partially from one of the following: silicone, plastic TPU, or PDMS.

[0139] Another aspect of the present disclosure provides a kit for examining one or more body parts of a subject in order to identify abnormalities in such body parts. The kit comprises a breast unit as described in any one of the embodiments described above, or any combination thereof. The kit comprises (i) an attachable second sheet formed to be attached to a desired portion of the armpit of a subject, the second sheet comprising a plurality of second sensing units, each second sensing unit configured to sense a deformation profile, pressure profile, or pressure change profile from the skin portion associated therewith and to generate a respective second sensing data therewith; (ii) a plurality of second pressure applicators associated with the second sheet, each second pressure applicator configured to apply controllable pressure to the armpit area associated therewith when the second sheet is attached to the armpit; and (iii) a transmitting unit for transmitting each of the respective second sensing data. It further includes an axillary unit equipped with [a specific feature].

[0140] In some embodiments of the kit, the processing circuit is: (1) Operate the second sensing unit, (2) Control the second pressure applicator to execute the desired second pressure plan under the armpit. It is structured in this way.

[0141] In some embodiments of the kit, the processing circuit is further configured to receive each of the respective second sensing data and to transmit each of the respective second sensing data.

[0142] In some embodiments of the kit, the attachable second sheet comprises a second skin-facing surface, the second skin-facing surface comprising an adhesive layer for enabling attachment to the desired portion.

[0143] In some embodiments of the kit, the second skin-facing surface includes a second removable cover that covers the adhesive layer and is configured to be removable before installation.

[0144] In some embodiments of the kit, the second sensing unit comprises a second pressure sensor configured to sense the deformation profile, pressure profile, or pressure change profile of each associated skin portion.

[0145] In some embodiments of the kit, the second sheet comprises a first layer and a second layer, the first layer comprising the second sensing unit and the second layer comprising the second pressure applicator.

[0146] In some embodiments of the kit, the second layer of the second sheet comprises the transmitting unit.

[0147] In some embodiments of the kit, each second sensing unit is associated with a second pressure applicator, and each second pressure applicator is configured to apply pressure to the axillary area associated with the second sensing unit.

[0148] In some embodiments, the second pressure applicators are arranged in a mesh. Each pressure sensor in the mesh is coupled to a plurality of its own elastic wires, i.e., elastic wires or elements coupled only to a specific pressure sensor, and each pressure applicator of each second pressure sensor is configured to apply pressure that causes elastic deformation of the elastic wire coupled to the respective pressure sensor. This configuration allows pressure to be applied to isolated breast tissue and, in response to that pressure, to measure pressure indication parameters of the isolated breast tissue.

[0149] In some embodiments of the kit, the desired second pressure scheme is The process includes applying pressure with at least one second early pressure applicator, releasing the pressure application from the at least one second early pressure applicator, and, following the release of pressure from the at least one second early pressure applicator, applying pressure with at least one second subsequent pressure applicator and releasing the pressure application from the at least one second subsequent pressure applicator, wherein the at least one second subsequent pressure applicator is spatially contiguous with the at least one second early pressure applicator. The processing circuit is further configured to operate the second sensing unit to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the desired second pressure plan.

[0150] In some embodiments of the kit, the transmitting unit is configured to transmit the second sensing data to either a processing circuit or an external computing unit.

[0151] In some embodiments of the kit, the axillary unit is disposable.

[0152] In some embodiments of the kit, the second sheet is formed at least partially from one of silicone, plastic TPU, or PDMS.

[0153] Another aspect of the present disclosure provides a system for examining a subject's breast to identify abnormalities therein. The system includes a breast unit or kit of any one or any combination thereof of the embodiments described above, and an analysis module configured to receive and analyze the respective first sensing data, second sensing data, or first and second data, and to therein identify a signature indicating an abnormality in the subject's breast or armpit.

[0154] In some embodiments of the system, the analysis module is further configured to receive one or more user-related parameters indicating at least one of the following: the subject's medical-related data, the subject's demographic data, the subject's genetic data, objective data of the subject such as family history of breast abnormalities, ethnicity, and age, and subjective data of the subject such as clinical symptoms, and the identification is further based on the one or more user-related parameters.

[0155] In some embodiments of the system, the analysis includes generating a map of (i) a deformation profile, a pressure profile, or a pressure change profile, or (ii) an IR radiation profile or a temperature profile, based on each of the first sensing data, the second sensing data, or the first and second sensing data.

[0156] In some embodiments of the system, the analysis includes comparing each of the first sensing data, the second sensing data, or each of the first and second sensing data to baseline data in order to identify deviations from the baseline that indicate anomalies.

[0157] In some embodiments of the system, the baseline is selected from one of the following: sensory data from different skin regions, pre-acquired sensory data from subjects with a certain degree of similarity to one or more user-related parameters, data from other women adjusted for age, ethnicity, and breast density, or sensory data from different breasts of the subject.

[0158] Another aspect of the present disclosure provides a method for examining a subject's breast to identify abnormalities in the breast. The method includes: attaching a plurality of first sensing units to the breast, each first sensing unit configured to sense from an associated skin portion (i) a deformation profile, a pressure profile, or a pressure change profile, and (ii) at least one of an IR radiation profile or a temperature profile of the respective skin portion, and to generate respective first sensing data thereon; attaching a plurality of first pressure applicators to the breast, each configured to apply controllable pressure to an associated area of ​​the breast; operating the first sensing units to receive each of the respective first sensing data; controlling the first pressure applicators to perform a desired first pressure plan on the breast; and transmitting each of the respective first sensing data from all the first sensing units to an external computing device for analysis of the first sensing data and identification of abnormalities.

[0159] In some embodiments of the method, the first sensing unit comprises a first pressure sensor. The pressure sensor may include one of a tactile sensor, a piezoelectric sensor, a magnetoresistive sensor, or a force-sensitive resistor.

[0160] In some embodiments of the method, the first sensing unit further comprises a temperature sensor. The temperature sensor may include any one of the following: an IR sensor, a resistance temperature detector (RTD), a thermocouple, a semiconductor IC, etc.

[0161] In some embodiments of the method, each first sensing unit comprises a first pressure sensor and a temperature sensor, and each first sensing unit is configured to sense (i) a deformation profile, a pressure profile, or a pressure change profile, and (ii) both an IR radiation profile or a temperature profile of the respective skin portion associated therewith.

[0162] In some embodiments of the method, the desired first pressure plan includes simultaneously applying pressure to selected peripheral portions of the breast for a selected duration, and then coordinating the release of the pressure from those peripheral portions. The application of peripheral pressure reduces blood flow to the internal regions of breast tissue surrounded by the selected peripheral portions, thereby cooling these internal regions. After the pressure release, a sensing unit senses the temperature profile of each skin portion, which may indicate a signature of abnormality in that skin portion. The method further includes operating the first sensing unit to sense at least the temperature profile in response to the desired first pressure plan.

[0163] In some embodiments of the method, the coordinated release includes simultaneously releasing pressure from the area surrounding the breast.

[0164] In some embodiments of the method, the area around the breast forms a continuum, such as a spatial continuum. It should be noted that this continuum appears due to a given pressure applied along the peripheral circle surrounding the nipple.

[0165] In some embodiments of the method, the application of pressure to the selected peripheral portion results in a continuous pressure application along a force application line, which may not be equal at any point along the line, but is at least greater than the passive state when no force is applied. It should be noted that the application line is not concrete and is merely intended to define the geometric shape of the pressure application.

[0166] In some embodiments of the method, the desired first pressure scheme is The method includes applying pressure with at least one first early / primary pressure applicator, releasing the pressure application from the at least one first early pressure applicator, applying pressure with at least one first subsequent pressure applicator following the release of pressure from the at least one first early pressure applicator, and releasing the pressure application from the at least one first subsequent pressure applicator, wherein the at least one first subsequent pressure applicator is spatially continuous with the at least one first early pressure applicator, thereby enabling measurement of pressure change or deformation profile of a continuous portion of the breast and creating a continuous map of the breast's pressure change or deformation profile behavior in response to the application of pressure. The method further includes operating the first sensing unit to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the desired first pressure plan.

[0167] In some embodiments, the method further includes attaching a plurality of second sensing units to the armpit of a subject, each second sensing unit configured to sense a deformation profile, pressure profile, or pressure change profile from a skin portion associated therewith and to generate its respective second sensing data; attaching a plurality of second pressure applicators to the armpit, each configured to apply controllable pressure to an associated area of ​​the armpit; operating the second sensing unit; controlling the second pressure applicators to perform a desired second pressure plan on the armpit; and transmitting each of the respective second sensing data.

[0168] In some embodiments of the method, the second sensing unit comprises a second pressure sensor configured to sense the deformation profile, pressure profile, or pressure change profile of each associated skin portion.

[0169] In some embodiments of the method, each second sensing unit is associated with a second pressure applicator, each second pressure applicator is configured to apply pressure to the axillary area associated with the second sensing unit.

[0170] In some embodiments of the method, the desired second pressure plan includes applying pressure in at least one second early pressure applicator, releasing the pressure application in the at least one second early pressure applicator, applying pressure in at least one second subsequent pressure applicator following the release of pressure in the at least one second early pressure applicator, and releasing the pressure application in the at least one second subsequent pressure applicator, wherein the at least one second subsequent pressure applicator is spatially contiguous with the at least one second early pressure applicator. The method further includes operating the second sensing unit to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the desired second pressure plan.

[0171] In some embodiments, the method further includes analyzing the respective first sensing data, second sensing data, or first and second sensing data, and identifying signatures indicating abnormalities in the subject's breast or armpit.

[0172] In some embodiments, the method further includes receiving one or more user-related parameters indicating at least one of the subject's medical-related data, subject's demographic data, subject's genetic data, objective data of the subject such as family history of breast abnormalities, ethnicity, age, and subjective data of the subject such as clinical symptoms, and such identification is further based on such one or more user-related parameters.

[0173] In some embodiments of the method, the analysis includes generating a map of (i) a deformation profile, a pressure profile, or a pressure change profile, or (ii) an IR emission profile or a temperature profile, based on each of the first sensing data, the second sensing data, or the first and second sensing data.

[0174] In some embodiments of the method, the analysis includes comparing each of the first sensing data, the second sensing data, or each of the first and second sensing data to baseline data in order to identify deviations from the baseline that indicate anomalies.

[0175] In some embodiments of the method, the baseline is selected from one of the following: sensory data from different skin regions, pre-acquired sensory data from subjects with a certain similarity to one or more user-related parameters, data from other women adjusted for age, ethnicity, and breast density, or sensory data from different breasts of a subject.

[0176] In some embodiments of the method, the plurality of measuring electrodes comprises at least one current electrode. That is, some of the measuring electrodes can also function as current electrodes.

[0177] In some embodiments of the method, each of the plurality of measuring electrodes also functions as a current electrode. That is, each measuring electrode has two optional functions: (i) to apply current to at least the tissue portion associated with each of the first sensing spots, and (ii) to measure an electrical profile, whether it be voltage, impedance, or current.

[0178] In some embodiments of the method, the plurality of measuring electrodes are clustered into a plurality of groups, each group comprising a plurality of measuring electrode members, and the method further comprises measuring the electrical profile between each measuring electrode member of a group and any other measuring electrode member of the same group, i.e., the electrical profile between each member and any other member is measured, and the electrical profile is selected from one or more of impedance, voltage, and current. In certain embodiments, the electrical profile is the impedance between each pair of measuring electrodes in the same group.

[0179] In some embodiments of the method, each measuring electrode is also a current electrode capable of applying current to the associated tissue, and for each measurement of the electrical profile between each measuring electrode member in a group and any of the other measuring electrode members, a selected current profile is applied from one member participating in the measurement to another participating in the measurement. That is, in each measurement between a first member in a group and a second member in a group, current is applied from the first member in the group to the second member in the group.

[0180] In some embodiments of the method, in order to measure the natural electrical profile of the breast, i.e., to map the natural electrical profile such as the voltage of the breast, the electrical profile between each measuring electrode member of a group and any of the other measuring electrode members of the group is measured without the application of current.

[0181] In some embodiments of the method, the first sensing spot comprises the second sensing spot.

[0182] In some embodiments of the method, the multiple measuring electrodes are clustered into multiple circular groups, where each measuring electrode within a circular group is at the same level as at least one other measuring electrode within the same group. Levels are to be understood as on a topographic map; that is, the topographical height of such a pair of electrodes is the same with respect to the breast. The purpose of such clustering is to enable measurement of the deeper tissues of the breast by allowing the current from one measuring electrode to pass through the deeper tissues of the breast before reaching the other electrode. The term “circular” means that the electrodes are arranged in a circle along the shape of the breast and are positioned at approximately the same height or level with respect to the breast. It should be noted, however, that these circular groups may include electrodes that are not arranged in a perfect circle and may deviate from a circular arrangement as long as they are positioned at approximately the same level or height with respect to the breast. The method further includes measuring the electrical profile between one measuring electrode in a circular group and at least one other measuring electrode within the group.

[0183] In some embodiments, the method further includes measuring the electrical profile between one measuring electrode in a circular group and a measuring electrode on the opposite side of the group, which is located on the opposite side of the circle defining the arrangement of the circular group. That is, the measurement is performed between one electrode in the group and another measuring electrode located on the opposite side of the diameter of the circle defining the group. Embodiment

[0184] The following are optional embodiments and combinations thereof according to the embodiments of this disclosure. 1. An examination unit for examining the subject's breast and, optionally, the subject's armpit, in order to identify tissue abnormalities, At least one attachable sheet configured to be attached to a first selected portion and an optional second selected portion, each corresponding to at least one breast and optionally one axilla, wherein the attachable sheet Multiple measuring electrodes, A plurality of first sensing spots, each sensing spot is configured to sense from the tissue portion associated therewith (i) an electrical profile from each of the plurality of measuring electrodes, (ii) an IR radiation profile or a thermal profile, or (iii) either (i) or (ii), and to generate a first sensing data therefor, Optionally, a plurality of second sensing spots, each second sensing spot configured to sense an IR radiation profile or thermal profile from the tissue portion associated with it and generate each second sensing data based thereon (i.e., understand that the broadest definition of the inspection unit does not include a plurality of second sensing spots, while the more specific optional definition includes a plurality of second sensing spots), Each of the first sensing spots comprises at least one current electrode configured to apply current to at least the tissue portion associated with it, The inspection unit consists of a processing circuit and a unit coupled to the processing circuit. (i) Activate the first and second sensing spots and receive the respective first and second sensing data: (ii) Control the at least one current electrode to perform the selected current profile, (iii) Transmit each of the first and second sensing data. It further comprises one or more memories for storing programming instructions to be executed by a processing circuit, Inspection unit. 2. The inspection unit according to Embodiment 1, wherein at least one attachable sheet comprises a skin-facing surface, the skin-facing surface comprising an adhesive layer for enabling attachment to the first and second selected portions. 3. The inspection unit according to Embodiment 2, wherein the skin-facing surface is provided with a removable cover that covers the adhesive layer and is configured to be removable before installation. 4. The inspection unit according to any one of embodiments 1 to 3, wherein the at least one attachable sheet has a closed shape. 5. The inspection unit according to any one of Embodiments 1 to 4, wherein the first selected portion includes the majority of the breast area of ​​the breast. 6. The inspection unit according to any one of Embodiments 1 to 5, wherein the second selected portion includes most of the axillary surface of the axilla. 7. The inspection unit according to any one of embodiments 1 to 6, wherein the first selected portion and the second selected portion form a physical continuum that can be attached to at least one attachable sheet. 8. The inspection unit according to any one of embodiments 1 to 7, wherein the at least one attachable sheet comprises a first attachable sheet attachable to the first selected portion and a second attachable sheet attachable to the second selected portion, the first and second attachable sheets being physically separate. 9. An inspection unit according to any one of embodiments 1 to 8, wherein at least a portion of the measuring electrodes constitutes the at least one current electrode. 10. An inspection unit according to any one of embodiments 1 to 9, including a ratio of measuring electrode to thermal sensor (1:1). 11. The inspection unit according to any one of embodiments 1 to 10, wherein the electrical profile is determined by the impedance, conductivity, and dielectric constant of at least the tissue portion associated with each first sensing spot, or any combination thereof. 12. The inspection unit according to any one of embodiments 1 to 11, wherein the first sensing spot comprises a measuring electrode and a thermal sensor, so that the electrode and the sensor are physically adjacent to each other at each sensing spot. 13. An inspection unit according to any one of embodiments 1 to 12, wherein each of a plurality of first sensing spots comprises a measuring electrode and a thermal sensor, and the first sensing spot is configured to sense (i) an electrical profile and (ii) both an IR radiation profile or a thermal profile of the respective tissue portion associated therewith. 14. The inspection unit according to any one of embodiments 1 to 13, wherein the at least one attachable sheet comprises a first sensing array having a plurality of first sensing spots, each sensing spot being arranged opposite to one another along at least one first continuous line. 15. The inspection unit according to Embodiment 14, wherein the at least one first continuous line is configured to correspond to the shape and dimensions of the first selected portion. 16. The inspection unit according to Embodiment 15, wherein at least one of the continuous lines defines a left-handed or right-handed helix having first sensing spots arranged sequentially and in an orderly manner to enable sensing of a large portion of the selected first portion. 17. The inspection unit according to embodiment 16, wherein the continuous line forms a closed shape. 18. The inspection unit according to Embodiment 17, wherein the first sensing array comprises a plurality of such closed shapes arranged concentrically. 19. The inspection unit according to Embodiment 18, wherein the distance between each concentric circle is equal. 20. comprising one or more optical sensors positioned in different parts around at least one mountable sheet and configured to sense optical parameters indicating light intensity in one or more selected wavelength ranges and to generate optical sensing data thereon, The processing circuit is configured to analyze the optical sensing data to identify an insufficient level of adhesion or bonding of the at least one attachable sheet to the subject's skin, and to output a warning if such insufficient level of adhesion is identified. An inspection unit according to any one of Embodiments 1 to 19. 21. The inspection unit according to embodiment 13, wherein at least one of the continuous lines defines an open shape configuration configured to sense a large portion of the selected second portion. 22. The inspection unit according to any one of embodiments 1 to 21, wherein the first sensing spot is the second sensing spot. 23. An inspection unit according to any one of embodiments 1 to 22, comprising a second sensing array having a plurality of the second sensing spots, each second sensing spot being arranged opposite to one another along at least one second continuous line, and a processing circuit further configured to analyze the second sensing data and identify one or more thermal signatures of anatomical landmarks for verifying good placement of the mountable sheet, and if no thermal signature is identified, the processing circuit is configured to perform a misplacement warning. 24. The inspection unit according to Embodiment 23, wherein the at least one second continuous line is located outside the first selected portion. 25. The inspection unit according to any one of embodiments 23 to 24, wherein the at least one second continuous line is located inside the first selected portion. 26. The inspection unit according to any one of embodiments 1 to 25, wherein the attachable sheet comprises a first layer and a second layer, the first layer comprising the first and second sensing arrays and at least one current electrode, and the second layer comprising the processing circuit. 27. The test unit according to any one of embodiments 1 to 26, characterized by applying a current including the current profile continuously, discontinuously, or in any combination thereof. 28. The inspection unit according to any one of embodiments 1 to 27, wherein the at least one current electrode is configured to transmit pulses of current having a frequency in the range of about 1 kHz to about 10 MHz, a peak-to-peak voltage of about 0 to about 5 volts, and a peak-to-peak current of about 40 to 70 microamperes. 29. The examination unit according to any one of embodiments 1 to 28, wherein at least one attachable sheet has flexibility to accommodate different anatomically diverse subjects and is made of at least partially flexible and / or stretchable material, so that the examination unit is flexible enough to be attached to a large portion of a selected first and second part. 30. The inspection unit according to any one of embodiments 1 to 29, wherein either the first layer or the second layer, or both, are made of a flexible and / or stretchable material. 31. The inspection unit according to any one of embodiments 29 to 30, wherein the flexible material is selected from polyurethane, polyester nonwoven tape, and one of non-tacking acrylic adhesives, adhesive hydrogels, silica gels, or silicone adhesives. 32. A plurality of first pressure applicators associated with at least one attachable sheet, each configured to apply controllable pressure to an area of ​​the breast or axilla associated with the at least one attachable sheet when it is attached to the breast, The first sensing spot is further configured to sense at least one of a deformation profile, a pressure profile, or a pressure change profile from the associated skin portion in response to a controlled pressure application, and to generate the respective data included in the first sensing data. The processing circuit is further configured to control the first pressure applicator to execute a first pressure plan selected for the breast and / or axilla. An inspection unit according to any one of Embodiments 1 to 31. 33. The inspection unit according to any one of embodiments 1 to 32, wherein the first sensing spot comprises a plurality of first pressure sensors. 34. An inspection unit according to any one of embodiments 1 to 33, wherein each first sensing spot, which includes a first pressure sensor, is associated with a first pressure applicator, and each first pressure applicator is configured to apply pressure to at least the breast area associated with each first sensing spot. 35. The selected first pressure plan includes simultaneously applying pressure to a selected perimammary portion of the breast for a selected duration, and then coordinating the release of the pressure from the perimammary portion. The processing circuit is configured to operate the first sensing unit to sense at least a temperature profile in response to the selected first pressure plan. An inspection unit according to any one of Embodiments 1 to 34. 36. The inspection unit according to embodiment 35, wherein the coordinated release includes simultaneously releasing pressure from the breast area. 37. The inspection unit according to embodiment 35 or 36, wherein the portion surrounding the breast forms a continuum. 38. The inspection unit according to any one of embodiments 35 to 37, wherein the application of the pressure to the selected peripheral portion results in a continuous pressure application along the force application line. 39. The selected first pressure plan is: Apply pressure with at least one first early pressure applicator, and release the pressure application from said at least one first early pressure applicator. The process includes releasing the pressure from at least one first early pressure applicator, followed by applying pressure from at least one first subsequent pressure applicator, and then releasing the pressure application from the at least one first subsequent pressure applicator. The at least one first subsequent pressure applicator is spatially continuous with the at least one first early pressure applicator. The processing circuit is configured to operate the first sensing spot to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the selected first pressure plan. An inspection unit according to any one of embodiments 31 to 38. 40. The inspection unit according to any one of embodiments 1 to 39, wherein the plurality of measuring electrodes comprises at least one current electrode. 41. An inspection unit according to any one of embodiments 1 to 40, wherein each of the plurality of measuring electrodes also functions as a current electrode. 42. The inspection unit according to any one of embodiments 1 to 41, wherein the plurality of measuring electrodes are clustered into a plurality of groups, each group comprising a plurality of measuring electrode members, and the processing circuit is configured to operate the plurality of measuring electrodes to measure an electrical profile between each measuring electrode member of a group and any other measuring electrode member of the same group, the electrical profile being selected from one or more of impedance, voltage, and current. 43. The inspection unit according to Embodiment 42, wherein each measuring electrode is also a current electrode capable of applying current to the associated tissue, and the processing circuit is configured to control each measuring electrode such that, for each measurement of the electrical profile between each measuring electrode member of the group and any of the other measuring electrode members, a selected current profile is applied from one member participating in the measurement to another member participating in the measurement. 44. The inspection unit according to Embodiment 42, wherein, in order to measure the natural electrical profile of the breast, the electrical profile between each measuring electrode member of the group and any of the other measuring electrode members of the group is measured without the application of current. 45. The inspection unit according to any one of embodiments 1 to 44, wherein the first sensing spot is the second sensing spot. 46. ​​The examination unit according to any one of embodiments 1 to 45, wherein the at least one attachable sheet comprises a first part, a second part, and a third part, the first and second parts being formed to fit over the subject's shoulder from one shoulder to the other, respectively, to ensure that the at least one attachable sheet is properly positioned over the subject's armpit and breast, and the third part providing a degree of freedom to the first and second parts to allow the at least one attachable sheet to be adjusted to breasts of different sizes and shapes. 47. The inspection unit according to embodiment 46, wherein each part extends circumferentially from the central part of at least one mountable sheet. 48. The inspection unit according to Embodiment 47, wherein at least one attachable sheet defines a varying perimeter length from the center point of the at least one attachable sheet to any point along the perimeter of the at least one attachable sheet, and the perimeter length between two adjacent portions decreases to a specific minimum value that defines the boundary between the two adjacent portions. 49. An inspection unit according to any one of embodiments 46 to 48, wherein each of the three parts is a flap-shaped part. 50. An examination unit according to any one of embodiments 1 to 49, wherein at least one attachable sheet comprises two similar surfaces, each surface intended to be attached to a different breast of a subject. 51. The inspection unit according to any one of embodiments 1 to 50, wherein the plurality of measuring electrodes are clustered into a plurality of circular groups such that each measuring electrode in a circular group is at the same level as at least one other measuring electrode in the same group, and at least one processing circuit is configured to operate the measuring electrodes to measure the electrical profile between one measuring electrode in a circular group and at least one other measuring electrode in the group. 52. The inspection unit according to Embodiment 51, wherein at least one processing circuit is configured to operate a measuring electrode to measure an electrical profile between one measuring electrode of a circular group and a measuring electrode on the opposite side of the group, located on the opposite side of the circle defining the arrangement of the circular group. 53. A system for examining at least one breast and at least one armpit of a subject in order to identify tissue abnormalities, An inspection unit according to any one of Embodiments 1 to 52, An analysis module configured to receive and analyze the at least first sensing data, identify therea signatures indicating anomalies in at least one of the selected first and second parts of a subject, and generate anomaly data based thereon, An output module configured to output the abnormal data and A system equipped with these features. 54. The analysis module is further configured to receive one or more user-related parameters indicating at least one of the following: the subject's medical-related data, age, BMI, the subject's demographic data, the subject's genetic data, the subject's family or personal history indicating abnormalities of the breast, ovaries, and / or uterus, the subject's family history indicating cancer and / or cancer-related pathology, ethnicity, the subject's objective data, and the subject's subjective data, and such identification is further based on the one or more user-related parameters, as described in Embodiment 53. 55. The system according to any one of embodiments 53 to 54, wherein the analysis includes generating, based on each of the first sensing data, an electrical profile including at least (i) impedance, dielectric constant, tissue potential, or conductance, or any combination thereof, and (ii) a sensing map of an IR profile or thermal profile. 56. The system according to any one of embodiments 53 to 55, wherein the analysis includes analyzing the second sensing data to identify thermal signatures of one or more anatomical landmarks for verifying good placement of the attachable sheet, and if no thermal signatures are identified, the processing circuit is configured to perform a misplacement warning. 57. The system according to Embodiment 56, further comprising, based on the respective first data, generating a sensing map of at least one of deformation profiles, pressure profiles, or pressure change profiles in response to a controlled pressure application. 58. The system according to embodiments 53 to 57, wherein the analysis includes comparing each of the respective first sensing data with the baseline data in order to identify deviations from a baseline that indicate an anomaly. 59. The system according to Embodiment 58, wherein the baseline is selected from one of the following: perceptual data from the contralateral breast and / or axilla, subjective tissue density of the breast examined, pre-acquired perceptual data from subjects having some degree of similarity to one or more of the user-related parameters, and other subjective and / or objective medical-related data adjusted for demographic data such as age and ethnicity. 60. The system according to embodiments 53 to 59, wherein the analysis includes analyzing the fat percentage of the first selected portion in order to determine the subjective tissue density. 61. The system according to embodiments 53-60, wherein the analysis module is configured to compare first sensing data from two identical groups of first sensing spots, each measured in a different breast of the subject. 62. A method for examining the breasts of a subject and, optionally, the armpits of a subject, Attaching multiple measuring electrodes, The method includes attaching a plurality of first sensing spots, at least one current electrode, and optionally a plurality of second sensing spots (i.e., the broadest definition of the method does not include a plurality of second sensing spots, but the more specific and optional definition does include a plurality of second sensing spots) to a first selected portion and an optionally second selected portion, each corresponding to at least one breast and optionally one axilla, respectively. From the associated tissue portion, (i) the electrical profile from each of the multiple measuring electrodes, and (ii) the IR radiation profile or thermal profile are sensed, and each sensing spot generates its respective first sensing data based thereon. Each second sensing spot is configured to sense an IR radiation profile or thermal profile from the associated tissue portion and generate its own second sensing data based thereon, At least one current electrode is configured to apply current to at least the tissue portion associated with each of the first sensing spots, The method involves controlling the at least one current electrode to perform a selected current profile, Activating the first and second sensing spots and receiving the respective first and second sensing data, Further including transmitting each of the respective first sensing data, method. 63. The method according to Embodiment 62, wherein the first selected portion includes the majority of the breast area of ​​the breast. 64. The method according to embodiment 62 or 63, wherein the second selected portion includes most of the axillary surface of the axilla. 65. The method according to any one of embodiments 62 to 64, wherein the first selected portion and the second selected portion form a physical continuum that can be attached to at least one attachable sheet. 66. An inspection unit according to any one of embodiments 62 to 65, wherein at least a portion of the measuring electrodes constitutes the at least one current electrode. 67. The method according to any one of embodiments 62 to 66, wherein the electrical profile is determined by the impedance, potential, conductivity, and dielectric constant of at least the tissue portion associated with each first sensing spot, or any combination thereof. 68. The method according to any one of embodiments 62 to 67, wherein the first sensing spot comprises a measuring electrode and a thermal sensor, so that the electrode and the sensor are physically adjacent to each other at each sensing spot. 69. The method according to any one of embodiments 62 to 68, wherein each of a plurality of first sensing spots comprises a measuring electrode and a thermal sensor, and the first sensing spot is configured to sense (i) an electrical profile and (ii) both an IR radiation profile or a thermal profile of the respective tissue portion associated therewith. 70. The method according to any one of embodiments 62 to 69, wherein the plurality of first sensing spots are arranged in a first sensing array, and each sensing spot is arranged opposite to one another along at least one first continuous line. 71. The method according to embodiment 70, wherein the at least one first continuous line is configured to correspond to the shape and dimensions of the first selected portion. 72. The method according to embodiment 71, wherein at least one of the continuous lines defines a left-handed or right-handed spiral having first sensing spots arranged sequentially and in an orderly manner, and configured to enable sensing of a large portion of the selected first portion. 73. The method according to embodiment 71, wherein the continuous line forms a closed shape. 74. Optical sensing of the breast to identify anatomical landmarks and generate optically sensing data, Based on optical sensing data, the system identifies misplacement of inspection units and outputs a warning when misplacement is detected. A method according to any one of embodiments 62 to 73, including the method described above. 75. The method according to embodiment 70, wherein at least one of the continuous lines defines an open shape configuration configured to sense a large portion of the selected second portion. 76. The method according to any one of embodiments 62 to 75, wherein the first sensing spot comprises the second sensing spot. 77. The method according to any one of embodiments 62 to 76, comprising arranging the second sensing spots in a second array, each second sensing spot being arranged opposite to one another along at least one second continuous line, the method further comprising analyzing the second sensing data to identify one or more thermal signatures of anatomical landmarks for verifying good placement of the attachable sheet, and if no thermal signature is identified, the method further comprises outputting a misplacement alarm. 78. The method according to embodiment 77, wherein the at least one second continuous line is located outside the first selected portion. 79. The method according to embodiment 77 or 78, wherein the at least one second continuous line is located inward relative to the first selected portion. 80. The method according to any one of embodiments 62 to 79, wherein the electrical profile is characterized by applying a current including the current profile continuously, discontinuously, or in any combination thereof. 81. The method according to any one of embodiments 62 to 80, wherein the at least one current electrode is configured to transmit pulses of current having a frequency in the range of about 1 kHz to about 10 MHz, a peak-to-peak voltage of about 0 to about 5 volts, and a peak-to-peak current of about 40 to 70 microamperes. 82. Attaching a plurality of first pressure applicators, each configured to apply controllable pressure to the associated breast or axillary area, Controlling the first pressure applicator to perform a first pressure plan selected for the breast and / or axilla, In response to the application of controlled pressure, at least one of a deformation profile, a pressure profile, or a pressure change profile is sensed from the skin portion associated with a first sensing spot, and the respective data included in the first sensing data is generated. The method according to any one of embodiments 62 to 81, including the method described above. 83. The method according to embodiment 82, wherein the first sensing spot comprises a plurality of first pressure sensors. 84. The selected first pressure plan involves simultaneously applying pressure to a selected area of ​​the breast surrounding the breast for a selected duration, and then coordinating the release of the pressure from that area of ​​the breast. In response to the selected first pressure plan, the first sensing unit is operated to sense at least a temperature profile. The method according to embodiment 82 or 83, including the method described in embodiment 82 or 83. 85. The method according to Embodiment 84, wherein the coordinated release includes simultaneously releasing pressure from the area surrounding the breast. 86. The method according to embodiment 84 or 85, wherein the portion of the breast area forms a continuum. 87. The method according to any one of embodiments 84 to 86, wherein the application of the pressure to the selected peripheral portion results in a continuous pressure application along the force application line. 88. The selected first pressure plan is: Apply pressure with at least one first early pressure applicator, and release the pressure application from said at least one first early pressure applicator. The process includes releasing the pressure from at least one first early pressure applicator, followed by applying pressure from at least one first subsequent pressure applicator, and then releasing the pressure application from the at least one first subsequent pressure applicator. The at least one first subsequent pressure applicator is spatially continuous with the at least one first early pressure applicator. The method further includes operating the first sensing unit to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the selected first pressure plan. The method according to any one of embodiments 84 to 87. 89. Analyze the at least first sensing data, identify therein a signature indicating an anomaly in at least one of the selected first part and the selected second part of the subject, and generate anomaly data based thereon. Output the abnormal data The method according to any one of embodiments 84 to 88, including the method described above. 90. The system according to Embodiment 89, further comprising receiving one or more user-related parameters indicating at least one of the following: medical-related data of the subject, demographic data of the subject, genetic data of the subject, age, BMI, family history of the subject showing abnormalities of the breast, ovaries, and / or uterus, family or personal history of the subject showing cancer and / or cancer-related pathology, ethnicity, objective data of the subject, and subjective data of the subject, wherein such identification is further based on such one or more user-related parameters. 91. The method according to Embodiment 89 or 90, further comprising, based on the respective first data, generating a sensing map of at least one of deformation profiles, pressure profiles, or pressure change profiles in response to a controlled pressure application. 92. The method according to any one of embodiments 89 to 91, wherein the analysis includes comparing each of the respective first sensing data with the baseline data in order to identify deviations from a baseline that indicate an anomaly. 93. The method according to Embodiment 92, wherein the baseline is selected from one of the following: respective sensory data of the contralateral breast and / or axilla; subjective tissue density of the breast examined; pre-acquired sensory data of subjects having some similarity to one or more such user-related parameters; and other subjective and / or objective medical-related data adjusted for demographic data such as age, BMI, and ethnicity. 94. The method according to embodiments 89-93, wherein the analysis includes analyzing the fat percentage of the first selected portion in order to determine the subjective tissue density. 95. The method includes applying a selected current profile between one or more pairs of current electrodes positioned on both sides of the breast, wherein each component of the one or more pairs of electrodes is associated with each fat measurement electrode included in the plurality of measurement electrodes. The method further includes measuring an electrical profile using each fat-measuring electrode, wherein the electrical profile measured by the fat-measuring electrode indicates the fat percentage within the tissue. The method according to any one of embodiments 62 to 94. 96. The method according to any one of embodiments 62 to 95, wherein the plurality of measuring electrodes comprises at least one current electrode. 97. The method according to any one of embodiments 62 to 96, wherein each of the plurality of measuring electrodes also functions as a current electrode. 98. The method according to any one of embodiments 62 to 97, wherein the plurality of measuring electrodes are clustered into a plurality of groups, each group comprising a plurality of measuring electrode members, and the method further comprises measuring an electrical profile between each measuring electrode member of a group and any of the other measuring electrode members of the same group, wherein the electrical profile is selected from one or more of impedance, voltage, and current. 99. The method according to Embodiment 98, wherein each measuring electrode is also a current electrode capable of applying current to the associated tissue, and for each measurement of the electrical profile between each measuring electrode member of the group and any of the other measuring electrode members, a selected current profile is applied from one member participating in the measurement to another member participating in the measurement. 100. An inspection unit according to Embodiment 98, wherein, in order to measure the natural electrical profile of the breast, the electrical profile between each measuring electrode member of a group and any of the other measuring electrode members of the group is measured without the application of current. 101. The method according to any one of embodiments 62 to 100, wherein the first sensing spot comprises the second sensing spot. 102. The method according to any one of embodiments 62 to 101, wherein the plurality of measuring electrodes are clustered into a plurality of circular groups such that each measuring electrode in a circular group is at the same level as at least one other measuring electrode in the same group, and the method further comprises measuring the electrical profile between one measuring electrode in a circular group and at least one other measuring electrode in the group. 103. The method according to Embodiment 102, further comprising measuring the electrical profile between one measuring electrode of a circular group and a measuring electrode on the opposite side of the group, which is located on the opposite side of the circle defining the arrangement of the circular group. 104. The at least one current electrode includes one or more pairs of electrodes arranged on opposite sides of the mountable sheet, and each member of the one or more pairs of electrodes is associated with each fat-measuring electrode included in the plurality of measuring electrodes. The processing circuit is configured to operate one or more electrode pairs to apply a selected current profile so that it flows from a first member of the electrode pair to a second member of the pair, and the electrical profile sensed by each fat-measuring electrode indicates the fat percentage in the tissue. An inspection unit according to any one of Embodiments 1 to 52.

[0185] To better understand the subject matter disclosed herein and to illustrate how it can be put into practice, embodiments will now be described with reference only to the accompanying drawings, as non-limiting examples. [Brief explanation of the drawing]

[0186] [Figure 1] This is a schematic diagram illustrating a non-limiting example of some of the components of a system according to one aspect of this disclosure. [Figure 2A-B] This is a schematic cross-sectional view showing a non-limiting example of the structure of the breast unit and underarm unit of the present disclosure. [Figure 3] This is a schematic cross-sectional view showing a non-limiting example of the configuration of the breast unit and underarm unit pressure applicators of the present disclosure. [Figure 4] This is a schematic diagram showing a non-specific example of pressure sensor placement. [Figure 5] This is a schematic diagram illustrating a non-limiting example of an embodiment of an inspection unit according to one aspect of the present disclosure. [Figure 6] Figure 5 is a schematic diagram showing a non-limiting example of the measurement scheme using the inspection unit. [Figure 7] This is a schematic diagram illustrating a non-limiting example of the structure of an inspection unit consisting of a flexible or stretchable PCT connected to a rigid PCB. [Figure 8] This is a schematic diagram of a non-limiting example of a system according to one aspect of this disclosure. [Figure 9A-B] This is a schematic diagram of a non-limiting example of electrical profile measurement by an inspection unit according to one aspect of the present disclosure. [Figure 10] This is a schematic diagram of a non-limiting example of electrical profile measurement by an inspection unit according to one aspect of the present disclosure. [Figure 11] This figure illustrates, in a non-limiting manner, the shape of a sheet to which an inspection unit according to one aspect of the present disclosure can be attached. [Modes for carrying out the invention]

[0187] The following figures are provided to illustrate embodiments and realizations of the inventions of this disclosure.

[0188] Figures 1 to 3 are schematic diagrams illustrating non-limiting examples of different components of a system for performing an examination of a subject's breast, armpit, or both, and identifying abnormalities in said breast, armpit, or both, according to one aspect of the present disclosure. The system 100 comprises a first breast unit 102 configured to be attached to a portion of the subject's breast. The first unit 102 comprises a first sheet 104 comprising a plurality of first sensing units 106, each positioned at different locations on the sheet, so as to sense different areas of the breast when the first unit 102 is attached to the breast. Each first sensing unit 106 may include one or more types of sensors that, after the first unit 102 has been attached to the breast, enable sensing from the associated skin portion of the breast, at least one of the following: (i) deformation profile, pressure profile, or pressure change profile, and (ii) IR radiation profile or temperature profile of each skin portion. Each first sensing unit 106 is configured to sense from each skin portion of the breast and generate its respective first sensing data FSD based thereon. The first sensing data FSD includes a time profile of the measurement taken by each sensing unit 106 and is transmitted to a processing circuit 108 or a microcontroller (the two terms are interchangeable herein). The processing circuit 108 is configured to control the operation of the sensing units 106 and to receive the first sensing data FSD generated by each of the first sensing units 106. The processing circuit 108 is further configured to communicate with an analysis module 110, which may take the form of an application installed in a mobile unit or a computing module in a server. The processing circuit 108 is configured to transmit each of the first sensing data FSDs to the analysis module 110, which is configured to analyze each of the first sensing data FSDs and identify signatures indicating abnormalities in the subject's breast, such as tumors or other suspicious tissue structures / masses.

[0189] Each first sensing unit 106 may include a temperature sensor, a pressure sensor, or a temperature sensor and a pressure sensor. Each first sensing unit 106 is associated with a different breast area of ​​the subject, and the sensing data collected in a particular sensing unit is associated with the particular breast area to which it is associated.

[0190] The system further comprises a second underarm unit 112 configured to be attached to a portion of the subject's underarm. Although the system is described to include the second unit 112, it should be noted that the system may omit the second unit 112 if the examination is performed only on the breast and not on the underarm. The second unit 112 comprises a second sheet 114 having a plurality of second sensing units 116, each positioned at different locations on the sheet, so as to sense different areas of the underarm when the second unit 112 is attached to the underarm. Each second sensing unit 116 includes at least a pressure sensor and, after the second unit 112 has been attached to the underarm, enables sensing from the associated underarm skin portion at least one of at least a deformation profile, pressure profile, or pressure change profile of each skin portion. Each second sensing unit 116 is configured to sense from each underarm skin portion and generate its own second sensing data SSD based on that. The second sensing data SSD contains the time profile of the measurements from each sensing unit 116 and is transmitted to the processing circuit 108, where it is processed in the same way as the first sensing data FSD. The processing circuit 108 is further configured to control the operation of the second sensing unit 116.

[0191] Each of the first and second units 102 and 112 further comprises arrays of first and second pressure applicators 118 and 120, respectively. The processing circuit 108 is further configured to control the operation of the first and second arrays of pressure applicators 118 and 120 to execute selected first and second pressure plans, respectively. Each of the first and second sensing units 102 and 112, capable of sensing at least a deformation profile, pressure profile, or pressure change profile, is associated with one or more pressure applicators configured to apply pressure to a portion of the subject's skin, such as the breast or armpit, so that the effect of the pressure application is sensed by each sensing unit. In other words, the pressure sensors of either the first and second sensing units 102 and 112 are configured to sense the result of the pressure application performed by the pressure applicators on the portion of skin to which they are associated.

[0192] The first and second units may have a two-layer or three-layer structure. A two-layer structure is illustrated in Figure 2A, and a three-layer structure in Figure 2B. The examples in Figures 2A and 2B apply to both the first and second units. Referring here to Figure 2A, unit 102 / 112 comprises a sheet 104 / 114 that constitutes the first layer and includes sensing units 106 / 116 (not specifically shown in Figures 2A and 2B). The sensing units 106 / 116 are arranged such that there is at least one sensing unit in each selected area portion of the sheet. For example, each 1 cm 2There may be at least one sensing unit below. The second layer 124 comprises a processing circuit 108 and pressure applicators 118 / 120 configured to apply pressure to the skin portion via the first layer. Figure 3 shows an example of pressure applicators 118 / 120 formed on the second layer and applying pressure to the first layer. The pressure applicators shown in Figure 3 are each in different states. That is, Figure 3 shows that each pressure applicator may be controlled independently, and the pressure applicators may be in different states simultaneously, each applying a different degree of pressure to the first layer, resulting in different degrees of pressure on the breast portion associated with the pressure applicator. Furthermore, Figure 4 illustrates a specific non-limiting example of the arrangement of pressure sensors in sensing units 106 / 116. Each pressure sensor is coupled to multiple elastic wires 119 or elastic elements, and each pressure sensor 107 / 117 is associated with a respective pressure applicator (not shown in Figure 4) such that the pressure applied by the respective pressure applicator results in isolated deformation of the elastic wires coupled to the respective pressure sensor, resulting in isolated pressure application to a specific breast or underarm area. To understand this, all elastic wires coupled to each pressure sensor are coupled to only one pressure sensor, enabling the isolation of pressure application to a specific breast or underarm area and sensing the response to that isolated pressure application. This makes it possible to isolate a specific breast area and measure its response to pressure application.

[0193] Figure 2B shows an example where unit 102 / 112 has a three-layer structure. The first layer is a sheet 104 / 114 containing sensing units 106 / 116, similar to Figure 2A. The second layer 124 contains pressure applicators 118 / 120, and the third layer 126 contains a processing circuit and wires connecting the processing circuit to different components of the first and second layers.

[0194] The system may include multiple unique inspection schemes.

[0195] The first unique testing scheme aims to measure the temporal temperature profile of a breast area after reducing blood exchange to or from the tissue associated with the breast. The first unique testing scheme begins by reducing blood exchange to a portion of the breast area by applying a peripheral pressure profile using selected peripheral pressure applicators of a first array of first pressure applicators 118. For example, most or all of the first pressure applicators 118 positioned around the periphery of the first unit 102 are activated to simultaneously apply peripheral pressure to the breast area associated with the periphery of the first unit 102. This simultaneous application of peripheral pressure reduces blood exchange to or from the internal area of ​​the breast. After a selected duration of such simultaneous peripheral pressure application, the pressure is released and the restriction on blood exchange is lifted. A first sensing unit 106, positioned to sense the temperature of the internal area, senses the temporal temperature profile following the release of the peripheral pressure. Abnormal breast tissue is expected to exhibit a temporal temperature profile with at least one unique signature, and these abnormal tissues can be identified by identifying the signature of such a temporal temperature profile.

[0196] The second unique inspection scheme aims to generate a continuous map of multiple areas of the breast or armpit of pressure-related parameters, i.e., parameters derived from deformation profiles, pressure profiles, or pressure change profiles measured by sensing units associated with each breast area or portion. The second unique inspection scheme includes continuous measurement of the effect of pressure application on the skin portion associated with the sensing unit by successive sensing units. In other words, the first and second pressure applicators are operated to apply pressure according to the pressure application plan such that each session of the pressure application plan includes application to a subsequent area of ​​the breast or armpit shifted from the area where pressure was applied. Note that the subsequent area may include a portion of the previous area. Thus, the second scheme includes operating at least one early pressure applicator and releasing the pressure application of that at least one first early pressure applicator. The system applies pressure to at least one subsequent pressure applicator, followed by the release of pressure from at least one initial pressure applicator, and then release of pressure from the at least one first subsequent pressure applicator. The at least one subsequent pressure applicator is spatially contiguous with the at least one initial pressure applicator. A sensing unit is activated to sense the response of the skin portion pressured by the initial and subsequent pressure applicators, thereby enabling the generation of a continuous map of pressure-related parameters. It should be noted that the second inspection scheme is applicable to the first unit, the second unit, or both, i.e., the breast, the armpit, or both.

[0197] Each of the first and second inspection schemes is operated and controlled by the system's processing circuitry.

[0198] Next, we refer to Figures 5 to 8, which are schematic diagrams of different components of non-limiting examples of embodiments of the inspection unit and system according to one aspect of the present disclosure. The inspection unit 500 is configured as a patch intended to be attached to the breast portion of the subject by a first part 502 and to the axillary portion of the subject (i.e., underarm) by a second part 504. The first part 502 and the second part 504 together form a single inspection unit 500 that is attached to the subject's skin. The inspection unit 500 is configured to cover the entire breast (from the clavicle to the inframammary fold) and the axilla, whether as a single patch or as two patches. The inspection unit 500 comprises a plurality of first sensing spots 506, each sensing spot configured to sense from the tissue portion associated with it either (i) an electrical profile, (ii) an IR radiation profile or a thermal profile, or (iii) both an electrical profile and an IR radiation profile or a thermal profile, and to generate the respective first sensing data therefrom. Measurement of the electrical profile and thermal profile is performed by a thermal sensor 508 and a measuring electrode 510, respectively. The thermal sensor 508 can be any type of thermal sensor known in the art, such as an IR sensor or thermocouple. The measuring electrode is configured to measure one or more electrical parameters, such as current, voltage, impedance, dielectric constant, or any other electrical parameter. Based on the measurements of the thermal and electrical profiles, a map of parameters is generated. Each map contains parameter information for all measurement locations on the subject's skin along a selected time frame. That is, each map contains parameter measurements from a specific location at each point in time over the measurement period. Based on these maps, abnormalities in the breast or axilla can be identified in post-processing analysis that can be performed remotely from the examination device, for example, via the cloud or a mobile device. Typically, each sensing spot 506 includes both the thermal sensor 508 and the measuring electrode 510 such that the ratio of thermal sensor to measuring electrode is 1:1 or approximately 1:1, thereby simplifying the correlation of different maps.The first sensing spots 506 are arranged on one or more flexible PCBs and can be arranged in various ways. For example, some of the first sensing spots 506 can be arranged along concentric circles or arranged to form a helical shape. A helical configuration (not shown) is very advantageous because it allows for a relatively close relationship between adjacent sensing spots, can be attached relatively easily to concave shapes such as the shape of the breast, and can adapt the device to various different shapes of the chest. Current electrodes 512 are arranged at different locations on the examination unit 500 and are configured to execute a current profile on the subject's skin by the operation of a processing circuit, and the response to this current profile can be identified and measured by at least some of the multiple first sensing spots 506, or in some embodiments all of them. Typically, the current electrodes 512 are arranged in pairs on opposing sides of the examination unit 500. Note that the current electrodes 512 may be included in the first sensing spots 506, i.e., some of the measuring electrodes may also serve as current electrodes. In some embodiments of the inspection unit, one or two pairs of electrodes are arranged such that each component of each pair is positioned separately from one another at two opposing positions on the inspection unit. For example, two electrodes may be placed in the inframammary fold, and two electrodes may be placed at the upper edge of the breast (2 cm below the clavicle). The inspection unit is configured to measure the fat percentage in the tissue by passing an electric current between the electrodes (from the upper to the lower part of the breast). The fat percentage of the breast tissue is calculated according to impedance data recorded on electrodes positioned in the upper and lower parts of the breast, close to the current electrodes through which the current flows. By using these parameters, the density and structure of the breast can be calculated and used in the analytical models performed in this disclosure.

[0199] The inspection unit 500 further comprises a plurality of second sensing spots 514, each equipped with a thermal sensor 516 for measuring the thermal profile of the associated skin portion. The second sensing spots 514 are arranged in one or more arrays along the anatomical structure of the major arteries in the breast, namely the lateral thoracic artery and the internal mammary artery. The arrays of the second sensing spots 514 are arranged roughly vertically along the anatomical structure of these arteries, particularly the distribution of the mammary ducts and lobes. The second sensing spots 514 are configured to detect thermal signatures of these arteries to verify that the inspection unit is properly mounted on the breast and axilla. If no thermal signature of the arteries is detected, a warning of misplacement of the inspection unit 500 is output to the user, and the user is prompted to remount the inspection unit 500 in the correct position. This is repeated until a thermal signature is detected in each array.

[0200] The first measurement performed by the testing unit is an electrical profile measurement, followed by a thermal profile measurement. This is rational because the flow of current within the breast tissue can widen blood vessels, thus potentially affecting and improving thermal sensing. Typically, the electrical profile measurement is performed between any two measuring electrodes of the first sensing spot 506; that is, after the current electrode 512 applies a selected current profile, the current and voltage are measured between any two pairs of measuring electrodes. This is illustrated in Figure 6. Based on these electrical measurements, impedance, conductance, and dielectric constant are extracted. The frequency of the current wave flowing through the electrodes, i.e., the current profile, is 1 kHz to 10 MHz, with a peak-to-peak voltage of 0 to 5 V in the form of a square wave, sine wave, or other pulse, and a peak-to-peak current of approximately 40 to 70 microamperes. The current frequency can be individually determined and adapted according to the subject's characteristics, i.e., age, breast size and volume, and tissue type. Both bra size and breast volume (calculated using breast length and width measurements) may be used to determine impedance adjustments depending on breast tissue density and fat versus glandular components.

[0201] Breast tissue can be treated as tissue with substantial impedance because its volume component is considerably smaller than its substantial impedance. The following formula can be used to calculate the substantial impedance portion within breast tissue: ρ / 4π[1 / R1-1 / R2], where R1 is the nipple diameter ÷ 2, R2 is the breast base diameter ÷ 2, and ρ is the breast tissue density calculated using breast volumetric measurement.

[0202] The processing circuit 518, as illustrated in Figure 8, is contained within the examination unit 500 and is configured to control the operation of the current electrodes and sensing spot sensors and to transmit the collected sensing data to a remote device such as a cloud or mobile device, or to a processor 520. Note that each side of the breast may have its own examination unit, each having its own processing circuit that operates the entire measurement. Alternatively, one processing circuit in one of the examination units may operate both examination units (the other receiving commands wirelessly). Figure 7 illustrates the integration of the processing circuit 518 into a flexible or stretchable PCB with first and second sensing spots and current electrodes. A rigid PCB connects the processing circuit, sensing spots, current electrodes, and a communication module (not shown). The communication module may be part of the processing circuit or independent and is configured to transmit the sensing data, either raw or processed, to a remote device 520, for example, a cloud or mobile device, where it is subjected to further analysis to generate maps, which are correlated and used to identify the presence or absence of abnormalities. For example, malignant tissue may show variability in the volume component compared to healthy tissue. By analyzing the generated map, such fluctuations can be identified.

[0203] Next, refer to Figures 9A-9B, schematic diagrams of a non-limiting example of electrical profile measurement by an inspection unit according to one aspect of the present disclosure. The figures show a similar concept of a PCB having multiple branches, each branch comprising a winding, and the measuring electrodes 910 are arranged along these windings. The measuring electrodes 910 are grouped into electrode groups. In these examples, the groups include seven measuring electrodes arranged in a hexagon, as shown in the figure for ease of explanation. Note that the groups can contain different numbers of sensors and can be arranged in different shapes. The groups are selected to have some overlap, with the measuring electrodes associated with areas prone to breast cancer being in the largest group. During measurement, the electrical profile is measured between each measuring electrode in a group and any other measuring electrode member in the same group. For example, in the figure, the electrical profile is measured between electrode 910A and any other electrode in the hexagon. The electrical profile is either voltage, current, impedance, or any combination thereof. The difference between Figure 9A and Figure 9B is the current source applied to the tissue during measurement. In Figure 9A, a current is applied from the measuring electrode, from which the electrical profile is being measured, to any other electrode in the group. In the example in Figure 9A, measuring electrode 910A functions as a current electrode, applying a current profile toward the electrodes participating in the measurement. For example, when the electrical profile between electrode 910A and electrode 910B is being measured, a current profile is applied from electrode 510A toward electrode 910B. In Figure 9B, the current profile is always applied to the subject's hand and spreads evenly across the breast depending on the tissue resistance.

[0204] Refer to Figure 10, which illustrates a different measurement method, but with a similar arrangement of measurement electrodes as in Figures 9A and 9B. Figure 10 illustrates clustering of measurement electrodes along a circle, in this example, with lines defining a constant level for each of the measurement electrodes on the breast profile. In other words, each line defines a specific height difference from the apex of the breast, i.e., the nipple. Therefore, the shortest distance between each pair of measurement electrodes passes through the deeper parts of the breast tissue, which is particularly important when the measurement is performed between two opposing measurement electrodes on a circle. This allows for the identification of potential abnormalities found in the deep tissues of the breast. For example, the measurement is performed between electrode 1010A and any other electrode on the innermost circle. This measurement can be performed by any of the methods described in Figures 9A and 9B, i.e., by applying current from the measurement electrodes or by applying current from the hand.

[0205] Next, we refer to Figure 11, which non-limitingly illustrates the shape of an attachable sheet for an inspection unit according to one aspect of the present disclosure. The attachable sheet 1104 comprises a plurality of sensing spots 1106, each sensing spot comprising either (1) an IR or temperature sensor, a measuring electrode configured to measure the electrical profile of the associated skin portion, or (3) both an IR or temperature sensor and a measuring electrode. The attachable sheet 1104 is formed from three flap-like or wing-like portions, a first portion 1130, a second portion 1132, and a third portion 1134. The first portion 1130 and the second portion 1132 are formed to fit the shoulder or upper arm of a subject, such that the first portion 1130 partially surrounds the shoulder or upper arm from one side and the second portion 1132 partially surrounds it from the other side, with portions of their respective distal portions 1130A, 1132A overlapping or in close proximity when properly attached to the body. The third portion 1134 has some degree of freedom relative to the first and second portions 1130 and 1132, allowing the attachable sheet 1104 to be adjusted to fit breasts of different shapes and sizes. For example, the third portion can be positioned close to or overlapping either the first or second portion 1130 or 1132 to fit the shape of a relatively small breast. Note that there is no clear, identifiable distinction between the three portions, but they can be distinguished by the peripheral profile of the attachable sheet 1104. The peripheral profile is defined by various distances from the nipple portion 1136 of the attachable sheet 1104, which is located approximately in the center of the attachable sheet 1104. The transition between one portion and another can be defined by a line connecting the nipple portion 1136 to the peripheral portion closest to the nipple portion 1136, i.e., the portion having at least a local minimum distance from the nipple portion 1136. These lines are illustrated in the figure by dashed lines L1, L2, and L3.

[0206] Note that the embodiments shown in Figures 1 to 4 can be combined with the embodiments shown in Figures 5 to 11 to obtain an inspection unit capable of measuring thermal profiles, electrical profiles, and pressure response profiles.

Claims

1. A testing unit for examining a subject's breast and, optionally, the subject's armpit, in order to identify tissue abnormalities, At least one attachable sheet configured to be attached to a first selected portion and an optional second selected portion, each corresponding to at least one breast and optionally one axilla, wherein the attachable sheet Multiple measuring electrodes, A plurality of first sensing spots, each sensing spot is configured to sense from the tissue portion associated therewith (1) an electrical profile from each of the plurality of measuring electrodes, (2) an IR radiation profile or a thermal profile, or (3) either (1) or (2), and to generate a first sensing data therefor, A plurality of second sensing spots, each second sensing spot configured to sense an IR radiation profile or thermal profile from the tissue portion associated with it and to generate its own second sensing data based thereon, Each of the first sensing spots comprises at least one current electrode configured to apply current to at least a portion of the tissue associated with it, The inspection unit comprises a processing circuit and a unit coupled to the processing circuit. (i) Operate the first and second sensing spots and receive each of the first and second sensing data respectively. (ii) Control the at least one current electrode to execute the selected current profile, (iii) Transmit each of the first and second sensing data. It further comprises one or more memories for storing programming instructions to be executed by the processing circuit, Inspection unit.

2. The at least one attachable sheet comprises a skin-facing surface, the skin-facing surface comprising an adhesive layer for enabling attachment to the first and second selected portions, The skin-facing surface is provided with a removable cover that covers the adhesive layer and is configured to be removable before installation. The inspection unit according to claim 1.

3. The inspection unit according to claim 1, wherein at least a portion of the measuring electrode constitutes the at least one current electrode.

4. The inspection unit according to claim 1, wherein the electrical profile is determined by the impedance, conductivity, voltage, current, dielectric constant, or any combination thereof of at least the tissue portion associated with each first sensing spot.

5. The inspection unit according to claim 1, wherein each of the plurality of first sensing spots comprises a measuring electrode and a thermal sensor, and the first sensing spot is configured to sense both (i) an electrical profile and (ii) an IR radiation profile or thermal profile of the respective tissue portion associated therewith.

6. The system comprises one or more optical sensors positioned in different parts of the periphery of the at least one attachable sheet, and configured to sense optical parameters indicating light intensity in one or more selected wavelength ranges and to generate optical sensing data based thereon, The processing circuit is configured to analyze the optical sensing data to identify an insufficient level of adhesion or bonding of the at least one attachable sheet to the subject's skin, and to output a warning if such an insufficient level of adhesion is identified. The inspection unit according to claim 1.

7. The inspection unit according to claim 1, comprising a plurality of second sensing spots, each second sensing spot configured to sense an IR radiation profile or thermal profile from a tissue portion associated therewith and to generate a second sensing data thereon.

8. The inspection unit according to claim 7, wherein the first sensing spot comprises the second sensing spot.

9. The inspection unit according to claim 8, comprising a second sensing array having a plurality of the second sensing spots, each second sensing spot being arranged opposite to one another along at least one second continuous line, the processing circuit further configured to analyze the second sensing data and identify one or more thermal signatures of anatomical landmarks for verifying good placement of the mountable sheet, and if no thermal signature is identified, the processing circuit configured to perform a misplacement warning.

10. The inspection unit according to claim 9, wherein the at least one second continuous line is located outside or inside the first selected portion.

11. A plurality of first pressure applicators associated with the at least one attachable sheet, each configured to controllly apply pressure to the breast or axillary area associated with the at least one attachable sheet when it is attached to the breast, The first sensing spot is further configured to sense at least one of a deformation profile, a pressure profile, or a pressure change profile from the associated skin portion in response to a controlled pressure application, and to generate the respective data included in the first sensing data. The processing circuit is further configured to control the first pressure applicator to execute a first pressure plan selected for the breast and / or axilla, The first sensing spot comprises a plurality of first pressure sensors, Each first sensing spot, equipped with a first pressure sensor, is associated with a first pressure applicator, each of which is configured to apply pressure to at least the breast area associated with each of the first sensing spots. The inspection unit according to claim 1.

12. The selected first pressure plan includes simultaneously applying pressure to a selected perimammary portion of the breast for a selected duration, and then coordinating the release of the pressure from the perimammary portion. The processing circuit is configured to operate the first sensing unit to sense at least the temperature profile in response to the selected first pressure plan, The aforementioned coordinated release includes simultaneously releasing pressure from the breast area, The breast area forms a continuum. The application of the pressure to the selected peripheral portion results in a continuous pressure application along the force application line. The selected first pressure plan is Apply pressure with at least one first early pressure applicator, and release the pressure application from the at least one first early pressure applicator. The procedure includes releasing the pressure from at least one first early pressure applicator, followed by applying pressure from at least one first subsequent pressure applicator, and then releasing the pressure from the at least one first subsequent pressure applicator. The at least one first subsequent pressure applicator is spatially continuous with the at least one first early pressure applicator. The processing circuit is configured to operate the first sensing spot to sense at least a deformation profile, a pressure profile, or a pressure change profile in response to the selected first pressure plan. The inspection unit according to claim 11.

13. The inspection unit according to claim 1, wherein each of the plurality of measuring electrodes also functions as a current electrode.

14. The inspection unit according to claim 1, wherein the plurality of measuring electrodes are clustered into a plurality of groups, each group comprising a plurality of measuring electrode members, and the processing circuit is configured to operate the plurality of measuring electrodes to measure an electrical profile between each measuring electrode member of a group and any other measuring electrode member of the same group, the electrical profile being selected from one or more of impedance, voltage, and current.

15. The inspection unit according to claim 14, wherein each measuring electrode is also a current electrode capable of applying current to the tissue to which it is associated, and the processing circuit is configured to control each measuring electrode such that, for each measurement of the electrical profile between each measuring electrode member of the group and any of the other measuring electrode members, a selected current profile is applied from one member participating in the measurement to another member participating in the measurement.

16. The inspection unit according to claim 15, wherein, in order to measure the natural electrical profile of the breast, the electrical profile between each measuring electrode member of the group and any of the other measuring electrode members of the group is measured without the application of current.

17. The examination unit according to claim 1, wherein the at least one attachable sheet comprises a first portion, a second portion, and a third portion, the first portion and the second portion being formed to fit over the shoulder of the subject from different shoulders, respectively, to ensure that the at least one attachable sheet is properly positioned over the subject's armpit and breast, and the third portion providing a degree of freedom to the first portion and the second portion to allow the at least one attachable sheet to be adjusted to breasts of different sizes and shapes.

18. The inspection unit according to claim 17, wherein each of the aforementioned parts extends circumferentially from the central portion of the at least one attachable sheet.

19. The inspection unit according to claim 18, wherein the at least one attachable sheet defines a varying peripheral length from the center point of the at least one attachable sheet to any point along the periphery of the at least one attachable sheet, and the peripheral length between two adjacent portions decreases to a specific minimum value that defines the boundary between the two adjacent portions.

20. The examination unit according to claim 1, wherein the at least one attachable sheet comprises two similar surfaces, each surface intended to be attached to a different breast of the subject.

21. The inspection unit according to claim 1, wherein the plurality of measuring electrodes are clustered into a plurality of circular groups such that each measuring electrode in a circular group is at the same level as at least one other measuring electrode in the same group, and the at least one processing circuit is configured to operate the measuring electrodes to measure the electrical profile between one measuring electrode in the circular group and at least one other measuring electrode in the group.

22. The inspection unit according to claim 21, wherein the at least one processing circuit is configured to operate the measuring electrode to measure an electrical profile between one measuring electrode of the circular group and a measuring electrode on the opposite side of the group, which is located on the opposite side of the circle defining the arrangement of the circular group.

23. A system for examining at least one breast and at least one armpit of a subject in order to identify tissue abnormalities, The inspection unit according to claim 1, An analysis module configured to receive and analyze the at least first sensing data, identify a signature therein indicating an anomaly in at least one of the selected first part and the selected second part of the subject, and generate anomaly data based thereon, An output module configured to output the aforementioned abnormal data and A system equipped with these features.

24. The analysis module is further configured to receive one or more user-related parameters indicating at least one of the following: the subject's medical-related data, the subject's demographic data, age, body mass index (BMI), the subject's genetic data, the subject's family history indicating abnormalities of the breast, ovaries, and / or uterus, the subject's family or personal history indicating cancer and / or cancer-related pathology, ethnicity, the subject's objective data, and the subject's subjective data, and the identification is further based on the one or more user-related parameters, according to claim 23.

25. The system according to claim 23, wherein the analysis comprises generating, based on each of the first sensing data, (i) an electrical profile including impedance, dielectric constant, or conductance, or any combination thereof, and (ii) an IR profile or thermal profile, or at least one sensing map of (i) and (ii).

26. The system according to claim 23, wherein the analysis includes analyzing the second sensing data to identify thermal signatures of one or more anatomical landmarks for verifying good placement of the attachable sheet, and if no thermal signatures are identified, the processing circuit is configured to perform a misplacement warning.

27. The system according to claim 26, wherein the analysis further comprises generating a sensing map of at least one of a deformation profile, a pressure profile, or a pressure change profile in response to a controlled pressure application, based on each of the first data.

28. The system according to claim 23, wherein the analysis includes comparing each of the first sensing data to the baseline data in order to identify deviations from a baseline that indicate an anomaly.

29. The system according to claim 28, wherein the baseline is selected from one of the following: sensory data of the contralateral breast and / or axilla, subjective tissue density of the breast being examined, pre-acquired sensory data of subjects having some similarity to one or more of the user-related parameters, and other subjective and / or objective medical-related data adjusted for demographic data such as age and ethnicity.

30. The system according to claim 23, wherein the analysis includes analyzing the fat percentage of the first selected portion in order to determine the subjective tissue density.

31. The system according to claim 23, wherein the analysis module is configured to compare first sensing data from two identical groups of first sensing spots, each measured in a different breast of the subject.

32. A method for examining the breasts of a subject and, optionally, the armpits of the subject, This includes attaching a plurality of first sensing spots, a plurality of measuring electrodes, and at least one current electrode to a first selected portion and an optional second selected portion, each corresponding to at least one breast and optionally one armpit, respectively. Each sensing spot is for sensing (1) an electrical profile from each of the multiple measuring electrodes, (2) an IR radiation profile or a thermal profile, or (3) either (1) or (2) from the associated tissue portion, and for generating each first sensing data based thereon. The at least one current electrode is configured to apply current to at least the tissue portion associated with each of the first detection spots, The method involves controlling the at least one current electrode to execute the selected current profile, Activating the first and second sensing spots and receiving the respective first and second sensing data, Further comprising transmitting each of the aforementioned first sensing data, method.

33. The method according to claim 32, wherein at least a portion of the measuring electrode constitutes the at least one current electrode.

34. The method according to claim 32, wherein the electrical profile is determined by the impedance, conductivity, dielectric constant, current, voltage, or any combination thereof of at least the tissue portion associated with each first sensing spot.

35. The method according to claim 32, wherein each of the plurality of first sensing spots comprises a measuring electrode and a thermal sensor, and the first sensing spot is configured to sense (i) an electrical profile and (ii) both an IR radiation profile or a thermal profile of the respective tissue portion associated therewith.

36. The method according to claim 32, comprising attaching a plurality of second sensing spots to a first selected portion and an optional second selected portion, each second sensing spot configured to sense an IR radiation profile or thermal profile from the associated tissue portion and generate a respective second sensing data thereon.

37. (1) Optically sensing optical parameters representing the light intensity in one or more wavelength ranges between the plurality of first sensing spots, (2) the plurality of second sensing spots, or (3) any of the plurality of first sensing spots and the plurality of second sensing spots and the subject's skin, and generating optical sensing data; In the sensing data, the system identifies insufficient adhesion or bonding of the plurality of first sensing spots or the plurality of second sensing spots to the skin, and outputs a warning when insufficient adhesion or bonding is identified. The method according to claim 36, including the method described in claim 36.

38. The method according to claim 36, comprising arranging the second sensing spots in a second array, each second sensing spot being arranged opposite to one another along at least one second continuous line, the method further comprising analyzing the second sensing data to identify thermal signatures of one or more anatomical landmarks for verifying good placement of the first sensing spots, and if no thermal signatures are identified, the method further comprises outputting a misplacement alarm.

39. Analyzing the aforementioned first sensing data, identifying a signature therein indicating an anomaly in at least one of the selected first part and the selected second part of the subject, and generating anomaly data based thereon, Outputting the aforementioned abnormal data The method according to claim 32, which includes the following:

40. The process involves applying a selected current profile between one or more pairs of current electrodes positioned on both sides of the breast, wherein each member of the one or more pairs of electrodes is associated with each fat measurement electrode included in the plurality of measurement electrodes. The method further includes measuring an electrical profile using each of the fat-measuring electrodes, wherein the electrical profile measured by the fat-measuring electrodes indicates the fat percentage within the tissue. The method according to claim 32.

41. The method according to claim 32, wherein the plurality of measuring electrodes are clustered into a plurality of groups, each group comprising a plurality of measuring electrode members, and the method further comprises measuring an electrical profile between each measuring electrode member of a group and any of the other measuring electrode members of the same group, wherein the electrical profile is selected from one or more of impedance, voltage, and current.

42. The method according to claim 41, wherein each measuring electrode is also a current electrode capable of applying current to the tissue to which it is associated, and for each measurement of the electrical profile between each measuring electrode member of the group and any of the other measuring electrode members, a selected current profile is applied from one member participating in the measurement to another member participating in the measurement.

43. The method according to claim 32, wherein the plurality of measuring electrodes are clustered into a plurality of circular groups such that each measuring electrode in a circular group is at the same level as at least one other measuring electrode in the same group, and the method further comprises measuring an electrical profile between one measuring electrode in the circular group and at least one other measuring electrode in the group.

44. The method according to claim 43, further comprising measuring an electrical profile between one measuring electrode of the circular group and a measuring electrode on the opposite side of the group, which is located on the opposite side of the circle defining the arrangement of the circular group.

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