Method of performing a guided self-examination of a subject's tissue

Abstract

A method for performing guided self-examination of a subject's tissues is described. The method includes: positioning a handheld device comprising multiple electrodes and a certain amount of flexible material in general contact with a region of the subject's body; measuring the capacitance between two of the electrodes; calculating tissue parameters based on the capacitance; determining instructions for the subject in a controller based on the tissue parameters; and issuing instructions to the subject to guide the subject in manipulating the handheld device.

Description

[0001] This application is a divisional application of the Chinese national phase application, filed on July 16, 2020, with international application number PCT / US2020 / 042298 and entitled "System and method for measuring tissue parameters by using a capacitive tactile sensor". The Chinese national phase application entered the national phase on March 17, 2022, with application number 202080065319.6 and entitled "System and method for measuring tissue parameters by using a capacitive tactile sensor".

[0002] Cross-citation of related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 875,485, filed July 17, 2019, the entire contents of which are incorporated herein by reference. Background Technology

[0004] Early detection is crucial for the successful treatment of many forms of cancer. Consequently, the early detection and identification of cancerous growths largely depends on the availability, relative cost, effectiveness, and associated risks of existing sensors and screening technologies. Currently, a variety of sensors and tools exist for studying the mechanical properties of soft tissues and for imaging them.

[0005] One type of conventional soft tissue sensor uses an external force applicator to guide the displacement and an external displacement gauge to measure the resistance. The external force applicator can be hydraulic or piezoelectric, and the external displacement gauge can be optical or piezoelectric.

[0006] Exemplary soft tissue imaging tools include computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), T-scan (TS), and ultrasound elastography (UE). CT scans capture 360-degree X-ray images and use computer software to reconstruct 3D tissue structures. MRI scans use strong magnetic fields and radio waves to form diagnostic images of the tissue. US scans send high-frequency waves through the tissue and capture the echoes to image the tissue structure. TS measures low-level bioelectric currents to generate real-time images of the tissue's electrical impedance properties. UE scans evaluate the echo time through the tissue under constant mechanical stress and compare it to the echo time of the same tissue under no stress. A tissue strain map is then obtained, from which a 2D image of the elastic modulus distribution is formed using conventional inversion techniques.

[0007] Tactile imaging tools such as mammography use arrayed pressure sensors to detect changes in the stiffness of spatial tissue. Currently, mammography is used in breast cancer screening to detect abnormal tissue through contrast in tissue density. Mammography is the only FDA-approved breast cancer screening technology with a typical sensitivity of 85%, decreasing to 65% in radio-dense breasts. However, a high false-positive rate exists in these screening procedures. In fact, only about 15%–30% of breast biopsies yield a malignant diagnosis. While effective for screening over 40% of women, mammography is less effective for screening women with dense breast tissue.

[0008] Because many tissues with abnormal growths are harder than the surrounding normal tissue under compression, detecting changes in tissue stiffness is increasingly becoming an important factor when detecting potential abnormal tissue. For example, breast cancer is known to be calcified tissue that is more than seven times harder than normal breast tissue. Similarly, blood vessels arranged in plaques are also harder than normal healthy blood vessels.

[0009] U.S. Patent No. 7,497,133, incorporated herein by reference, discloses a piezoelectric finger sensor that can detect tumors by measuring tissue stiffness. Tumor migration is assessed by the ratio of the tumor's shear modulus to its elastic modulus (G / E) or by a sensitive direct tumor migration measurement using two piezoelectric finger sensors, one for pushing and the other for measuring the tumor movement caused by pushing. The patent infers that a higher G / E ratio in the tumor region than in the surrounding normal tissue, and a much higher G / E ratio in the cancer region compared to the surrounding normal tissue, indicates that the tumor moves less under shear than under compression. The patent infers that these measurements could potentially provide potential for non-invasive screening of breast cancer malignancies; however, it does not disclose methods for determining malignancy, invasiveness, or tumor type.

[0010] U.S. Patent No. 8,562,546, incorporated herein by reference, discloses a piezoelectric sensor system for evaluating tissue, including determining whether the tissue contains abnormal growths. The described system uses an array of piezoelectric elements actuated toward the tissue in a first direction, after which their relative positions are recorded to approximate tissue stiffness. This sensor is very difficult to calibrate and cannot be calibrated after continuous use or even upon accidental touch. Therefore, it is unsuitable for use by non-professionals.

[0011] Therefore, there remains a clear need for an accurate, non-invasive, portable, and easy-to-use system for detecting, recording, measuring, and mapping the size, shape, and location of lesions beneath the surface of skin or other soft tissue. This invention addresses that need. Summary of the Invention

[0012] In one embodiment, a device for measuring tissue parameters of a subject includes: a housing having at least one exposure window; a substrate including a plurality of electrodes disposed within the window; an insulating layer positioned on the electrodes; a flexible membrane positioned on the insulating layer, wherein at least a portion of the flexible membrane is accessible via the exposure window; and a controller disposed within the housing, configured to calculate at least one parameter of the subject's tissue based on capacitance measured between the electrodes. In one embodiment, the flexible membrane comprises foam. In one embodiment, the foam has a stiffness in the range of 00-0 to 00-20. In one embodiment, the plurality of electrodes includes at least two electrodes. In one embodiment, each of the plurality of electrodes has a thickness of 1 mm. 2 With 16mm 2 The surface area between. In one embodiment, the device includes a visualization device communicatively connected to the controller, the visualization device including a display. In one embodiment, the controller is connected to the visualization device via Bluetooth. In one embodiment, the device includes a conductive element configured to deliver a reference voltage to a surface in contact with the flexible membrane. In one embodiment, the conductive element is positioned to substantially surround the exposure window. In one embodiment, at least one parameter includes tissue stiffness. In one embodiment, the subject's tissue includes breast tissue.

[0013] In one embodiment, a method for measuring tissue parameters of a subject includes the steps of: positioning a handheld device comprising a plurality of electrodes and a quantity of flexible material substantially in contact with a region of the subject's body; measuring the capacitance between two of the plurality of electrodes; determining the thickness of the flexible material based on the capacitance; and calculating the tissue parameters based on the thickness of the flexible material. In one embodiment, the method includes sending data selected from a group consisting of capacitance, thickness, and tissue parameters to a visualization system. In one embodiment, the method includes measuring multiple capacitance values ​​between a set of electrode pairs and displaying a graph of the parameter values ​​on a tissue surface on the visualization system. In one embodiment, the tissue parameter refers to stiffness. In one embodiment, the method includes the step of making a provisional diagnosis based on the tissue parameters.

[0014] In one embodiment, a method for performing guided self-examination of a subject's tissue includes the following steps: positioning a handheld device comprising a plurality of electrodes and a quantity of flexible material in general contact with a region of the subject's body; measuring the capacitance between two of the electrodes; calculating tissue parameters based on the capacitance; determining instructions for the subject in a controller based on the tissue parameters; and issuing instructions to the subject to guide the subject in manipulating the handheld device. In one embodiment, the instructions refer to auditory instructions issued via a speaker. In one embodiment, the instructions are configured to guide the subject to move the device to a new location on the tissue. In one embodiment, the instructions include visual cues presented on a display.

[0015] In one embodiment, a capacitive tactile sensor device is used to detect, record, measure, and map the size, shape, and location of lesions beneath the surface of skin or other soft tissue by measuring changes in tactile pressure on the skin or other tissue surface of a subject. The capacitive tactile sensor device includes: a housing having at least one exposure window and an exposed conductive surface positioned such that an operator or device is always in contact with the conductive surface during operation; a substrate located within the housing, comprising multiple pairs of separate coplanar and co-located electrodes arranged in a Cartesian grid on a non-conductive material, configured such that any two adjacent electrodes are electrically independent and can be independently stimulated by an externally generated stimulation voltage or current signal, thereby forming a capacitor between each electrode pair, and the space above the outer surface of the electrode grid serves as a dielectric; an insulating material layer positioned on the outward-facing surface of the electrode grid; and a homogeneous, compressible, non-ferrite, and non-conductive membrane covering the insulating layer positioned on the outward-facing surface of the electrode grid, the membrane: (a (a) The entire surface region spanning each pair of adjacent electrodes constituting the capacitor and the entire surface region spanning the Cartesian grid of the electrodes has a uniform thickness; (b) The entire surface region spanning the Cartesian grid of the electrodes has a fixed, uniform, and known compressibility ratio and stiffness; and (c) It has a steady-state equilibrium shape such that the volume of the membrane remains constant when not subjected to external forces; with a non-conductive covering material positioned on the outward-facing surface of the homogeneous, compressible, non-ferrite, and compressible membrane, at least a portion of the non-conductive covering material being accessible through an exposure window of the housing, the exposure window serving as the outward-facing surface of the sensor and, together with the membrane, effectively replacing air with the dielectric for the capacitor formed by each pair of adjacent electrodes, one electrode serving as a transmitting electrode and the other as a receiving electrode; wherein the sensor surface is configured to be placed in complete and firm contact with the surface of the subject's tissue. The electromechanical properties disrupt the electric field in the dielectric composed of a compressible membrane and interfere with the capacitive coupling between the coplanar electrodes of the associated pair, the electromechanical properties including conducting the normal surface pressure of the tissue; wherein, the sensor input device, in response to pressure applied to the sensor surface by contact with the skin or other soft tissue surface, compression generated by the compressible membrane, and interference with the capacitive coupling between the associated coplanar electrode pairs, guides and generates at least one signal as an indicator of the location, dynamics, and specific characteristics of a local area of ​​hard tissue beneath the surface area of ​​the skin or other tissue being studied; and a controller, disposed within the housing, includes: (a) one or more commercially available IC capacitive sensor chips configured to: (i) generate signals for stimulating electrode pairs located in a substrate;(ii) receiving and processing signals subsequently guided, generated, and transmitted by the capacitive tactile sensor input device in response to pressure applied to the sensor surface by contact with skin or other soft tissue surfaces; and (iii) guiding, generating, and transmitting to the device signals derived from the processing of signals guided, generated, and transmitted to the IC capacitive sensor chip by the capacitive tactile sensor input device; and (b) one or more integrated circuits and processors configured to: (i) receive and process signals guided, generated, and transmitted by the IC capacitive sensor chip to calculate one or more parameters of the underlying tissue structure based on changes in the sensing capacitance between adjacent related electrode pairs caused by pressure applied to the sensor surface by contact with skin or other soft tissue surfaces; and (ii) communicatively connect to a visualization device including a display and integrated storage devices. In one embodiment, the homogeneous, compressible, non-ferrite, and non-conductive membrane comprises polyurethane, silicone, or thermoplastic elastomer foam. In one embodiment, the foam has a hardness in the range of 00-0 to 00-20. In one embodiment, the plurality of electrodes comprises at least two electrodes. In one embodiment, each of the plurality of electrodes has a hardness of 1 mm; 2 With 16mm 2 The surface area between. In one embodiment, the device includes a visualization device communicatively connected to the controller, the visualization device including a display. In one embodiment, the controller is connected to the visualization device via Bluetooth. In one embodiment, it includes: a conductive element located outside the housing, configured to transmit the reference voltage used for all subsequent capacitance calculations. In one embodiment, the device includes: a grounding pad or grounding strip providing conductive contact between a non-insulated portion of the electronic plane and the outer surface of the capacitive sensor, configured to transmit the reference voltage to be used for all subsequent capacitance calculations. In one embodiment, at least one parameter includes tissue stiffness. In one embodiment, the subject's tissue includes breast tissue.

[0016] In one embodiment, a method for recording, measuring, and mapping the size, shape, and location of a palpable lesion beneath the surface of a subject's skin or other soft tissue by using capacitive tactile sensing to measure changes in normal tactile pressure on the surface of other soft tissue areas of the skin or tissue surface includes the following steps: positioning a handheld device comprising a plurality of electrodes and a quantity of non-conductive compressible material and covering it to substantially contact a surface area of ​​the subject's skin or tissue; determining a baseline reference capacitance of the subject using measurement data obtained by an operator from an undamaged area of ​​the tissue; determining a baseline reference voltage potential by the operator through conductive contact between the operator and the handheld device; positioning the handheld device to substantially contact the surface area of ​​the skin or tissue under study; measuring the capacitance generated between two of the plurality of electrodes due to contact with the surface area of ​​the skin or tissue under study; measuring, with reference to the baseline reference voltage potential, the change in sensed capacitance between adjacent related electrode pairs caused by pressure applied to a sensor surface (compressible membrane and covering) due to disruption of capacitive coupling between adjacent related electrode pairs caused by contact with the surface of the skin or tissue under study; and calculating one or more tissue parameters from the baseline reference voltage potential based on the change in sensed capacitance. In one embodiment, the method includes the steps of sending data selected from a group consisting of sensing capacitance, thickness, and tissue parameters to a visualization system. In another embodiment, the method includes the steps of measuring multiple capacitance values ​​between a set of electrode pairs and displaying a graph of the parameter values ​​on the tissue surface on the visualization system. In one embodiment, the tissue parameter refers to stiffness.

[0017] In one embodiment, a method for performing guided self-examination of a subject's tissue includes the following steps: positioning a handheld device comprising a plurality of electrodes and a quantity of flexible material substantially in contact with a region of the subject's body; measuring the capacitance between two of the electrodes; calculating tissue parameters based on the capacitance; determining instructions for the subject in a controller based on the tissue parameters; and issuing instructions to the subject to guide the subject in manipulating the handheld device. In one embodiment, the instructions refer to auditory instructions issued via a speaker. In one embodiment, the instructions are configured to guide the subject to move the device to a new location on the tissue. In one embodiment, the instructions include visual cues presented on a display.

[0018] On one hand, a method for dynamically calibrating data received from at least one sensor includes: acquiring multiple data values ​​from the at least one sensor; calculating a first mean and a first standard deviation of the multiple data values; obtaining a subset of the multiple data values, the subset values ​​being within one standard deviation of the first mean; calculating a second mean from the subset of multiple data values ​​as a baseline value; and subtracting the baseline value from the multiple data values ​​to generate a calibration dataset.

[0019] In one embodiment, the method further includes: acquiring a second plurality of data values; calculating a third mean and a third standard deviation of the first and second plurality of data values; obtaining a second subset of the first and second plurality of data values, the values ​​of the second subset being within one standard deviation of the third mean; calculating a fourth mean from the second subset of the plurality of data values ​​as a second baseline value; and subtracting the second baseline value from the first plurality of data values ​​and the second plurality of data values ​​to generate a calibration dataset.

[0020] In one embodiment, the method further includes: displaying a three-dimensional surface plot of the calibration dataset; displaying baseline values; and providing visual feedback when the baseline values ​​are within an optimal range. In one embodiment, the visual feedback includes: changing the color of a region of the three-dimensional surface plot. In one embodiment, the method further includes: calculating a moving average of multiple data values ​​and calculating a first mean and a first standard deviation from the moving average.

[0021] In one embodiment, the method further includes: comparing a moving average with a maximum threshold and a minimum threshold; capturing multiple data values ​​or a moving average when the moving average is between the maximum threshold and the minimum threshold; and storing the captured data values ​​on a non-volatile computer-readable medium when the moving average remains between the maximum threshold and the minimum threshold for a specified time period. In one embodiment, the specified time period is at least three seconds. Attached Figure Description

[0022] The above-described objects and features, as well as other objects and features, will become apparent from the following description and the accompanying drawings, which are provided to give an understanding of the invention and which form part of this specification, wherein similar reference numerals denote similar elements, and wherein: Figure 1 This is a diagram of a capacitor sheet according to one embodiment; Figure 2 This is a diagram of a capacitor sheet according to one embodiment; Figure 3A It is a cross-section of an electrode pair on a substrate according to one embodiment; Figure 3B It is a cross-section of a portion of a capacitive tactile sensor device according to one embodiment; Figure 3CThis is an exemplary illustration of normal pressure applied to the surface of a tissue that is part of a capacitive tactile sensor device according to one embodiment; Figure 3D An exemplary cross-section is a portion of a capacitive tactile sensor input device in contact with a non-uniform surface according to one embodiment; Figure 4A and Figure 4B The first and second embodiments are housings having an operator grounding contact. Figure 5 It is a visual display graphic according to one implementation method; Figure 6A , Figure 6B ,as well as Figure 6C It is a visual display graphic according to one implementation method; Figure 7 This is a method of the present invention according to one embodiment; and Figure 8 This is an illustration comparing sample data from piezoelectric and capacitive sensors based on experimental examples. Detailed Implementation

[0023] It should be understood that the figures and descriptions in this invention have been simplified to illustrate the relevant elements and to provide a clear understanding of the invention, while many other elements found in the relevant systems and methods have been omitted for clarity. Those skilled in the art will recognize that other elements and / or steps are desired and / or required in carrying out this invention. However, because such elements and steps are well known in the art and because they do not necessarily contribute to a better understanding of the invention, a discussion of these elements and steps is not provided herein. This disclosure is directed to all such variations and modifications of the elements and methods known to those skilled in the art.

[0024] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein can be used in carrying out or testing this invention, exemplary methods and materials have been described.

[0025] As used herein, each of the following terms has the meaning associated with that section.

[0026] The articles “a” and “an” used here refer to one or more (i.e., at least one) grammatical objects of the article. For example, “element” refers to one or more elements.

[0027] When referring to measurable values ​​such as quantity, time interval, etc., since such variation is appropriate, the term “approximately” used here means including variations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value.

[0028] Throughout this disclosure, various aspects of the invention can be presented in a scope format. It should be understood that the scope format is for convenience and brevity only and should not be considered an inflexible limitation on the scope of the invention. Accordingly, the scope description should be considered to have all possible sub-scopes of the specified disclosure and the individual numerical values ​​within those scopes. For example, a description of a scope such as from 1 to 6 should be considered to have specified sub-scopes of the disclosure such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and the individual numbers within those scopes, such as 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any whole and partial increments therein. This applies regardless of the width of the scope.

[0029] In some aspects of the invention, software that executes the instructions provided herein may be stored on a non-volatile computer-readable medium, wherein, when executed on a processor, the software performs some or all of the steps of the invention.

[0030] Various aspects of this invention relate to algorithms executed in computer software. While specific implementations may be described as being written in a particular programming language or executed on a particular operating system or computing platform, it should be understood that the systems and methods of this invention are not limited to any particular computing language, platform, or combination thereof. Software that executes the algorithms described herein can be written, compiled, or interpreted in any programming language known in the art, including but not limited to C, C++, C#, Objective-C, Java, JavaScript, Python, PHP, Perl, Ruby, or Visual Basic. It should be further understood that elements of this invention can run on any acceptable computing platform, including but not limited to servers, cloud instances, workstations, thin clients, mobile devices, embedded microcontrollers, televisions, or any other suitable computing devices known in the art.

[0031] Various parts of this invention are described as software running on a computing device. While the software described herein may be disclosed as operating on a specific computing device (e.g., a dedicated server or workstation), those skilled in the art will understand that the software is inherently portable and can also run on any wide range of devices for the purposes of this invention. This includes desktop or mobile devices, laptop computers, tablet computers, smartphones, watches, wearable electronic devices or other wireless digital / cellular phones, televisions, cloud instances, embedded microcontrollers, thin client devices, or any other suitable computing device known in the art.

[0032] Similarly, various parts of the invention are described as communicating via various wireless or wired computer networks. For the purposes of this invention, the terms "network," "networked," and "networking" should be understood to include wired Ethernet, fiber optic connections, wireless connections including any of the various 802.11 standards, cellular WAN infrastructure such as 3G or 4G / LTE networks, Bluetooth®, Bluetooth® Low Energy (BLE), or Zigbee® communication links, or any other method by which an electronic device can communicate with another. In some embodiments, elements in the networking portion of the invention may be implemented via a Virtual Private Network (VPN).

[0033] When used in the context of organisms, tissues, cells, or their composition, the term "abnormal" refers to organisms, tissues, cells, or their composition that differ from those exhibiting a "normal" (expected) corresponding characteristic in at least one observable or detectable feature (e.g., age, treatment, date and time). For different cell or tissue types, a characteristic that is normal or expected for one cell or tissue type may be abnormal.

[0034] As used herein, the term "diagnosis" refers to the determination of the existence of a disease or disorder. In some embodiments of the invention, methods for determining the existence of a particular disease or disorder and for making a diagnosis are provided.

[0035] As used herein, the term “screening” refers to the detection, recording, measurement, and / or mapping of the size, shape, and location of abnormal features of a subject’s tissues that indicate the potential presence of a disease or disorder in order to warrant further investigation.

[0036] In this context, according to the methods described herein, the terms "patient," "subject," "individual," etc., are used interchangeably and refer to any animal, its cells in vitro or in situ. In a particular non-limiting embodiment, patient, subject, or individual refers to a human being.

[0037] One aspect of the invention relates to an apparatus for detecting features of a tissue surface, comprising: a normal surface pressure and a change in the surface pressure over the area under study, which can indicate the presence of underlying tissue abnormalities, such as masses, lesions, cysts, or tumors. Exemplary apparatuses of the invention may be handheld or compact in form. In some embodiments, the apparatus of the invention comprises multiple parts, while in other embodiments, the apparatus is a self-contained and powered diagnostic device.

[0038] The device of the present invention may include Figure 1 The capacitor sheet shown is a composite sheet. The capacitor sheet 101 can be rigid, flexible, or conformable, and can be made of any suitable material, such as Capton resin, glass fiber reinforced (glass fiber) epoxy resin, or reinforced phenolic resin. The depicted exemplary capacitor sheet includes a plurality of capacitor elements 102, 103. The depicted sheet includes nine capacitor elements or electrodes arranged in a 3x3 Cartesian grid; however, it should be understood that the capacitor sheet of the present invention can include any number of individual capacitor elements, for example, in a matrix ranging from 2 to 20x20 or more.

[0039] The depicted capacitor element is square; however, it should be understood that the capacitor element can be of any shape, including but not limited to circular, triangular, hexagonal, or square. Each capacitor element can be made of any conductive material, including but not limited to copper, gold, silver, steel, aluminum, carbon nanotubes, stainless steel, or platinum.

[0040] For example, the capacitor element in a capacitor sheet can be from 1mm 2 Up to 16mm 2 The capacitor sheet can be of any size within the range of [specific dimensions] and can typically have a thickness ranging from 0.5 mils to 3 mils. In some embodiments, all capacitor elements in the capacitor sheet are substantially the same size; however, in other embodiments, the capacitor sheet of the present invention may include multiple capacitor elements of different sizes. Similarly, different capacitor elements located on the same sheet may be made of the same or different materials, or may have the same or different shapes.

[0041] For reference Figure 2 An alternative capacitor sheet 201 is shown. Exemplary sheet 201 includes generally square capacitor elements 202 and 203 and generally circular capacitor elements, such as 204.

[0042] In some embodiments, the individual capacitor elements can be interconnected and arranged such that any two adjacent electrodes are electrically independent and can be independently activated. In this configuration, each pair of electrodes can be used as an independent capacitor, and the space above the surface of the capacitor sheet (including any material placed or disposed thereon) serves as a dielectric.

[0043] For reference Figures 3A to 3D An exemplary device of the present invention is shown in a cross-sectional view. Figure 3A In this device, the substrate includes a substrate 301 having multiple capacitive elements (including 303 and 304) and an insulating surface 302 disposed above the elements. Elements 303 and 304 are electrically isolated from each other, and an electric field 305 is formed between the two elements when element 303 is held at a first potential and element 304 is held at a second potential. Figure 3A In this embodiment, the dielectric of the capacitor formed between elements 303 and 304 is air. The insulating surface 302 can be made of any insulating material, including but not limited to epoxy resin laminates such as FR-4 or standard solder mask materials. The insulating surface 302 can have a thickness up to 80 micrometers.

[0044] refer to Figure 3B Alternative designs include a membrane 306 placed over an insulating surface 302. Membrane 306 can be a homogeneous, mechanically compressible, non-ferrite, and non-conductive membrane that effectively replaces air with the dielectric for a capacitor formed by two adjacent electrodes. In some embodiments, although the thickness can be varied—for example, to allow the device to fit more precisely against curved or irregular body regions—the membrane can have a generally uniform thickness. The membrane provides mechanical separation between the electrode surfaces and any outer surfaces adjacent to the opposing surfaces of the membrane on parallel surfaces facing the electrode plane. The membrane can be covered with a loosely fitted non-conductive material, such as a nitrile.

[0045] Membrane 306 can be configured to have a substantially fixed and uniform density, compression ratio, and hardness across the entire substrate or an exposed subset of the substrate. Suitable materials used in the membrane of the device of the present invention include silicone, compressible foam, or brine encapsulant. The Shore hardness of the material can be in the range of 0.0-20. The dielectric constant of the material can be in the range of 1.0 to about 5.0. The membrane material can be configured to return to a steady-state equilibrium shape when not exposed to any external force.

[0046] like Figure 3CAs shown, for example, when an external force is applied with finger 307, membrane 306 deforms, thereby altering the characteristics of electric field 305 and thus changing the capacitance of the capacitor generated between capacitive elements 303 and 304. In the exemplary device, the external force is supplied by the normal pressure of the surface of the subject's skin or other tissue in the area under study. This change in capacitance can be measured using any suitable means in the art (e.g., utilizing series or parallel resistive / inductive elements) or by combining other fixed or variable resistive, inductive, or capacitive elements to measure the capacitor itself or the impedance response of the capacitor. Thus, the location and extent of the force applied by the external force can be measured and tracked over time.

[0047] exist Figure 3D Another embodiment is illustrated, and an exemplary device for use with an outer surface 308 is shown, having dielectric properties such that when placed on a membrane, it disrupts the dielectric constant between a pair of adjacent electrodes and thus disrupts the electric field mode. This causes a change in capacitance, for example, measured using the methods summarized above. Suitable outer surfaces used with the device of the invention include, but are not limited to, human or other animal skin, human or other animal organs, or any ferrous or conductive or semi-conductive material. As shown, when normal pressure from the surface of the tissue under study is applied between the outer surface 308 and the capacitor elements 303 and 304, the membrane 306 deforms. When the pressure is non-uniform, for example, if the outer surface 308 is a tissue with variable stiffness on the surface to which the membrane 306 is applied, the membrane 306 will deform non-uniformly. For example, the membrane can deform in such a way that it reflects the underlying tissue structure, for example, hard or soft damage. Non-uniform deformation on a surface with multiple capacitor elements will cause a measurable change in the distance between the outer surface and the electrode surfaces on the electrode array. The varying distance will affect the overall dielectric sensed by any adjacent capacitor pair (e.g., adjacent pairs 303 and 304). This will affect the dielectric constant of each capacitor, which can be used to calculate the distance between the outer surface and the electrode surfaces on the array, and in turn, to calculate the normal force per square millimeter (mm) on the electrode surfaces. The change in capacitance is related to the change in sensed permittivity, i.e., linearly proportional to the measured capacitance.

[0048] exist Figure 3DThe diagram also shows a conductive element 309. Element 309 is configured to provide a stable reference potential to the outer surface 308. For example, element 309 may reference a ground potential within the device, designed to provide a ground reference to the subject's skin in the estimated body region. Alternatively, a ground reference can be obtained through conductive contact with the operator's skin. In some embodiments, a fixed reference potential on the outer surface can significantly improve the measurement quality on the electrode pair. As envisioned herein, element 309 may be made of any conductive material, including but not limited to copper, gold, silver, or platinum. In some embodiments, element 309 is made generally of a first material, such as a metal, and coated with a second conductive or semi-conductive material at one end near the outer surface 308 to provide greater user comfort. In one embodiment, membrane 306 defines a treatment area, such as a circular, oval, square, rectangular, or elliptical treatment area. The conductive element 309 may extend generally around the perimeter or edge of the treatment area to maximize the probability of good electrical contact between the conductive element 309 and the outer surface 308 (e.g., the subject's skin).

[0049] The device of the present invention may further include a controller, comprising dedicated circuitry for reading capacitance values ​​from each electrode pair. The controller may include any computing device, such as an integrated microcontroller or processor, and may also include a quantity of volatile and / or non-volatile memory storing instructions to perform the method steps of the present invention. In some embodiments, the controller includes instructions configured to iterate through some or all of the possible electrode pairs arranged sequentially in an array grid to provide continuous measurements of capacitance and thus to provide characteristics of the outer surface 308 in contact with the membrane 306. In some embodiments, the controller may utilize any of a number of commercially available chips or modules suitable for capacitance sensing and related calculations.

[0050] As described herein, the system is configured to detect and estimate subcutaneous soft tissue injury by measuring and quantifying changes in tactile pressure at the surface of tissue through capacitive sensing and the measurement of multiple pairs (including at least one pair) of individual coplanar electrodes arranged in a Cartesian grid on a substrate disposed within a housing. The system is configured such that any two adjacent electrodes are electrically independent and can be independently activated, thereby forming a capacitor between the electrode pairs. Therefore, the system can be used as a capacitive sensor. In a particular embodiment comprising a loose, non-conductive covering material, the sensor surface is placed on the outward-facing surface of a compressible, non-ferrite, and non-conductive membrane, positioned on the outward-facing surface of the electrode grid, which serves as the dielectric of the capacitor formed by any two adjacent electrodes (one serving as a transmitting electrode and the other as a receiving electrode). The sensor surface is configured to contact the tissue with sufficient pressure to slightly compress the compressible dielectric. In a particular instance, the term "slight compression" can be the minimum amount of pressure applied sufficient to ensure complete and fixed contact between the entire sensor surface and the tissue. At this point, the electromagnetic properties of the tissue will disrupt the electric field in the dielectric and interfere with the capacitive coupling between the coplanar electrodes of the relevant pairs. The interference of capacitance is measured using a set of calibration baseline measurements obtained by the operator from a non-damaged area of ​​the tissue and then by determining the difference between these baseline measurements and capacitance measurements obtained from each pair of electrodes facing the surface area of ​​the tissue under study in the set. According to one embodiment, it is assumed that the potential of the tissue (i.e., the patient) disconnected from the sensor remains constant throughout a complete set of measurements (including the baseline) and is not necessarily 0 volts. It is also assumed that the potential of the tissue (i.e., the operator holding the device) in contact with the device housing (i.e., the operator holding the device) also remains constant throughout a complete set of measurements (including the baseline) and again, is not necessarily 0 volts. Tissue stiffness is classified by measuring the difference in tactile pressure on the tissue surface on the sensor surface. These pressures are then quantified by measuring the capacitance between the coplanar electrodes. The measuring capacitance is compared to the set of baseline measurements defined above, and then the relative measurements for each pair of electrodes are quantified. For consistent relative measurements, it must be determined that the baseline is exactly the same as the reference voltage potential used in the measuring capacitance. As described above, this constant voltage potential can be obtained from (1) the patient tissue or (2) the operator tissue. The grounding option already described can be utilized with option (1). Option (2) requires a conductive surface to be placed on the housing of the device, the conductive surface being configured such that it is always in contact with the operator, including when performing baseline capacitance measurements and when the measured capacitance is used for relative tissue stiffness. See now. Figure 4A and Figure 4B Conductive surfaces are integrated into the surfaces of various parts of the housing (e.g., the handheld portion) and configured to provide a reference voltage from the operator. Figure 4AAn exemplary housing includes a gripping surface 401 connected to two housing portions 402 and 403. In the depicted embodiment, housing portion 402 includes a top gripping surface 413. In some embodiments, gripping surface 413 includes one or more buttons or other controls that allow an operator to control the sensor assembly, for example, to start or stop a measurement or to zero the sensor for calibration purposes. In the depicted embodiment, gripping surface 401 is held in place by two pins 411 that mate with two corresponding holes 412 on housing portions 402 and 403 (a second pin is located on the opposing inner surface of 401). In some embodiments, one or both gripping surfaces 401 and 413 include conductive elements or terminals that allow the sensor assembly to measure a reference voltage from the operator's skin during use.

[0051] refer to Figure 4B An exemplary housing includes a top handle surface 404 and a bottom ring 405. In various embodiments, one or both of the handle 404 and the ring 405 may include a conductive element or terminal configured to measure a reference voltage from the skin of an operator (in the case of the handle 404) or from the skin of a subject (ring 405). In some embodiments, for example, during a self-examination, the user and the subject are the same.

[0052] The implementation of the device can be integrated into a housing designed for self-checking. The integrated device may include: a power source, such as a battery or power management hardware; and one or more communication devices, such as wired or wireless communication devices for sending or receiving data, configuration information, or issuing instructions to and from a remote computing device. In one embodiment, the integrated device includes a Bluetooth transceiver, and a remote computing device can be paired with the integrated device to transmit and receive data.

[0053] The system of the present invention includes the aforementioned sensor device for detecting, recording, measuring, and mapping the size, shape, and location of lesions beneath the surface of a subject's skin or other soft tissue by measuring changes in tactile pressure on the surface of tissue in a body region via a wired or wireless connection incorporated into a visualization computing device including software. The software is used to visualize the results and, in some embodiments, to interpret the results to provide ad-hoc analysis. The visualization computing device may include a wired or wireless transceiver for receiving, processing, displaying, and storing data from a diagnostic device configured to use any wired or wireless communication protocol known in the art. In some embodiments, the data connection between the visualization device and the sensor device is encrypted.

[0054] In some embodiments, the system of the present invention is configured for a subject to perform a self-guided examination or estimation. For example, the system includes a guidance element integrated into any one or both of the aforementioned sensor devices and visualization devices. The guidance element can be configured to receive information from one or both of the sensor devices and visualization devices and, based on that information, transmit instructions or prompts to the subject. Instructions or prompts may include visual, auditory, or tactile feedback. In one embodiment, the sensor device can be positioned on the subject's tissue to detect structures of interest along the top edge of the device. The guidance element can then instruct the subject to reposition the device, for example, to move the device further upward so that the structure of interest is better centered in the detection area of ​​the device. For example, the guidance element may also instruct the user to reposition the device across the entire breast. In some cases, the guidance may instruct switching from one breast to the other.

[0055] Another aspect of the invention includes a method for visualizing structures of interest in the tissue of a subject. Using the system described above, the subject can position a sensor device with a detection surface on a body region, with the detection surface in direct, general contact with the skin of the body region. Although not mandatory, the subject can then press a button or actuate some other control to initiate detection processing. The device then collects data from the tissue region in contact with the detection surface and performs calculations based on that data. The processing may include denoising algorithms and basic smoothing algorithms. The processed data and / or the original data are then transmitted via a wired or wireless connection to the visualization device, which can then perform further calculations based on the received data. A visualization of the body region is then generated using the final processed data for viewing by the subject or another person (e.g., a clinician).

[0056] calibration

[0057] In one embodiment, the systems and methods disclosed herein may include components and methods for performing dynamic, real-time baseline, or calibration on array data obtained from a sensor array, such as a Cartesian array of capacitive and / or pressure sensors disclosed herein. In one embodiment, the system includes a set of capacitive and / or pressure sensors positioned on a surface and arranged, for example, in a Cartesian arrangement. The method may include periodically acquiring capacitive and / or pressure data from the set of sensors, for example, at a rate between 1 Hz and 1 kHz, or between 1 Hz and 500 Hz, or between 1 Hz and 100 Hz, or between 1 Hz and 30 Hz, or any suitable range. In one embodiment, the data obtained from the sensors is stored as a DC-shifted sparse matrix, wherein a portion of the data lies within 1.5 standard deviations of the mean. In one embodiment, a majority or most of the measurement data lies within 1.5 standard deviations of the mean.

[0058] The calibration method may include: first, acquiring a certain amount of data; then, calculating a baseline calibration point or "zero" point from the data, wherein all data falling outside one standard deviation of the data mean is considered, and a second mean is calculated from a subset of data falling within one standard deviation (SD) of the first mean. Although previous embodiments used one standard deviation of the mean as an exemplary threshold, it should be understood that in other implementations, any suitable threshold may be used, including but not limited to 0.3SD, 0.5SD, 0.75SD, 0.8SD, 0.9SD, 1.1SD, 1.25SD, 1.5SD, 2SD, etc. The second mean can then be used as the baseline or zero point for the remaining data. The second mean is then considered as the deviation from all the remaining data, and for each measured data point, the second mean is subtracted, resulting in most data points being at or near the new zero point (i.e., the second mean), thereby allowing outliers in the entire measurement dataset to be appropriately highlighted.

[0059] In some implementations, multiple measurements are performed by all sensors before the initial calibration step, while in other implementations, calibration is performed sequentially, i.e., by performing calibration on the first dataset measured and repeating the calibration after each new dataset measured. This novel approach eliminates the need for conventional, single, static calibration, which can be inaccurate due to the tissue stiffness difference between the tissue region used for calibration and the tissue in the measurement region. The method also prevents operator-to-operator and operator-to-operator errors when a single calibration is performed incorrectly. For example, in some implementations, the operator may apply variable pressure to the tissue between measurements or during a single measurement, which could produce skewed data if static calibration is used. By dynamically calibrating the measured data, the overall bias applied to the data can be adapted to properly distinguish true outliers by varying the skew produced by the operator's pressure.

[0060] In one implementation, a calculated baseline level is used to validate and store a quantity of measurement data. In one embodiment, a quantity of data points are measured from at least one pressure or capacitive sensor arranged in an array, such as a Cartesian array. In one implementation, a moving average of the measured data points is calculated to smooth the data over time. The moving average can be calculated within a window of at least three samples, at least five samples, at least ten samples, at least twenty samples, or any suitable number of samples. The smoothed moving average data can then be monitored, and when the moving average moves into a specific range, a capture trigger can be activated to indicate that the captured data is now valid for measurement. In some implementations, the specific range may be between 40% and 60% of the sensor's dynamic measurement range, or between 45% and 55%, between 47% and 53%, between 49% and 51%, or approximately 50% of the sensor's dynamic measurement range. In some implementations, once the capture trigger is activated, the data is monitored to see if it remains valid for a certain period of time, such as two seconds, three seconds, or five seconds. When data remains valid for a specified time period, the smoothed and / or original data measured during that interval will be stored as valid data measurements.

[0061] Sample data visualization

[0062] In some implementations and now referenced Figure 5 In addition to visualizing body areas, the visualization device can display perimeter or other indicators that are actually screened. In some implementations, the diagnostic device performs all data collection and processing, and transmits the results via wired or wireless connections to a remote computing system or cloud system for further processing and visualization.

[0063] In some embodiments, the method of the present invention may include one or more guidance steps, such as instructions or prompts transmitted by a visualization device or sensor device to a subject or clinician, including steps to guide a subject through self-screening. The method may include processing some or all of the data measured by the sensor device via a processor integrated into the device, a processor integrated into the visualization device, or another device located near or far from a diagnostic system including both the diagnostic device and the visualization device. The guidance steps may also include instructing the subject or clinician, based on the processed data, to perform one or more manipulation steps on or using the device, such as moving up, down, left, right, pressing harder, or pressing lighter. Using this self-screening system, subjects with little or no medical or device training can perform guided self-screening to collect data for review by a clinician.

[0064] In some embodiments, graphical visualization may include the dynamic calibration method disclosed above or updates based on the dynamic calibration method disclosed above. In some embodiments, a 3D surface plot can be displayed through the interface of the present invention, wherein the tissue surface being measured is displayed in the XY plane and the data is represented on the Z-axis. Due to baseline updates, the XY surface of the data plot shifts vertically along the Z-axis by subtracting the calculated baseline amount. The surface is color-coded to indicate deviation from the optimal baseline. When the baseline is within the optimal range, the surface appears green, except for aberrations that gradually turn yellow and red. As the baseline deviates from the optimal value, the surface turns yellow and eventually red, thus indicating approximate deviation from the optimal baseline. Furthermore, in some embodiments, the calibration display may graphically display the calculated baseline itself on the screen, thereby providing further feedback to the operator to allow the operator to adjust, for example, the applied pressure to move the baseline within the optimal range. This novel visualization scheme optimizes user training by facilitating the capture of a consistent baseline and maximizing measurement integrity.

[0065] refer to Figure 6A , Figure 6B ,as well as Figure 6C An embodiment is shown. Figure 6A As shown, the uncalibrated surface map can display most points in red, i.e., the aberrations from the fixed "zero" value. In the depicted embodiment, most points in the measured surface map are approximately 22%, i.e., significantly lower than the fixed zero value of 50%. Therefore, all points are highlighted in red as aberrations from the zero value.

[0066] Figure 6B A visualization of the dynamic calibration data is shown. Figure 6BThe data graph shown depicts the entire surface in green, representing normal. The data has been calibrated to remove bias, and therefore, most of it falls within the green window, i.e., between 55% and 65% in the depicted embodiment.

[0067] Figure 6C A visualization of the data used to achieve optimal real-time calibration is shown. Most of the graph is shown in green; however, some areas are yellowish-green, indicating that some data still fall outside the zero window. The mean of the depicted data is approximately 44%, meaning it falls just outside the optimal window of 45% to 55%.

[0068] exist Figure 7 An exemplary method for measuring tissue parameters of a subject is illustrated. The method includes the following steps: at step 701, positioning a handheld device comprising a plurality of electrodes and a quantity of non-conductive compressible material and covering it to substantially contact a region of the subject's body; at step 702, measuring the capacitance between two of the plurality of electrodes; at step 703, determining the thickness of the flexible material based on the capacitance; and at step 704, calculating tissue parameters based on the thickness of the flexible material.

[0069] According to one embodiment, a capacitive tactile sensor device is used to detect, record, measure, and map the size, shape, and location of lesions beneath the surface of a subject's skin or other soft tissue by measuring changes in tactile pressure on the skin or other tissue surface. The capacitive tactile sensor device includes: a housing having at least one exposure window and an exposed conductive surface positioned such that an operator or device is always in contact with the conductive surface during operation. A substrate located within the housing includes multiple pairs of separate, coplanar, co-located electrodes arranged in a Cartesian grid on a non-conductive material, configured such that any two adjacent electrodes are electrically independent and can be independently stimulated by an externally generated stimulation voltage or current signal, thereby forming a capacitor between each electrode pair, and the space above the outer surface of the electrode grid serves as a dielectric. An insulating material layer is positioned above the outward-facing surface of the electrode grid. A homogeneous, compressible, non-ferrite, and non-conductive membrane covers an insulating layer positioned above the outward-facing surface of an electrode grid. The membrane: (a) has a uniform thickness over the entire surface area of ​​each pair of adjacent electrodes constituting the capacitor and over the entire surface area of ​​the Cartesian grid of the electrodes; (b) has a fixed, uniform, and known compressibility ratio and stiffness over the entire surface area of ​​the Cartesian grid of the electrodes; and (c) has a steady-state equilibrium shape such that the membrane volume remains constant when no external force is applied. A non-conductive covering material is positioned above the outward-facing surface of the homogeneous, compressible, non-ferrite, and compressible membrane. At least a portion of the non-conductive covering material is accessible through an exposure window of the housing, which serves as the outward-facing surface of the sensor and, together with the membrane, effectively displaces air as a dielectric for the capacitor formed by each pair of adjacent electrodes, one serving as a transmitting electrode and the other as a receiving electrode. The sensor surface is configured to be in complete and firm contact with the surface of the subject's tissue, such that the electromechanical properties, including the conduction of normal surface pressure of the tissue, disrupt the electric field in the dielectric composed of the compressible membrane and interfere with the capacitive coupling between the coplanar electrodes of the relevant pair; wherein, in response to the pressure applied to the sensor surface through contact with the skin or other soft tissue surface, the compression generated by the compressible membrane, and the interference with the capacitive coupling between the coplanar electrodes of the relevant pair, the sensor input device guides and generates at least one signal as an indication of the location, dynamics, and specific characteristics of a local area of ​​hard tissue beneath the surface region of the skin or other tissue being studied.The controller is housed within the housing and includes: (a) one or more commercially available IC capacitive sensor chips configured to: (i) generate signals for stimulating electrode pairs located in a substrate; (ii) receive and process signals subsequently guided, generated, and transmitted by a capacitive tactile sensor input device in response to pressure applied to a sensor surface by contact with skin or other soft tissue surfaces; and (iii) guide, generate, and transmit to a device signals derived from the processing of signals guided, generated, and transmitted to the IC capacitive sensor chips by the capacitive tactile sensor input device; and (b) one or more integrated circuits and a processor configured to: (i) receive and process signals guided, generated, and transmitted by the IC capacitive sensor chips to calculate one or more parameters of the underlying tissue structure based on changes in the sensed capacitance between adjacent related electrode pairs caused by pressure applied to the sensor surface by contact with skin or other soft tissue surfaces; and (ii) communicatively connect to a visualization device including a display and integrated storage devices.

[0070] In one embodiment, the homogeneous, compressible, non-ferrite, and non-conductive membrane comprises polyurethane, silicone, or thermoplastic elastomer foam. In one embodiment, the foam has a hardness in the range of 00-0 to 00-20. In one embodiment, the plurality of electrodes comprises at least two electrodes. In one embodiment, each of the plurality of electrodes has a surface area between 1 mm² and 16 mm². In one embodiment, the device includes a visualization device communicatively connected to a controller, the visualization device including a display. In one embodiment, the controller is connected to the visualization device via Bluetooth. In one embodiment, the device includes a conductive element located outside the housing, configured to transmit the reference voltage used for all subsequent capacitance calculations. In one embodiment, the device includes a grounding pad or grounding strip providing conductive contact between a non-insulated portion of the electronic plane and the outer surface of the capacitive sensor, configured to transmit the reference voltage used for all subsequent capacitance calculations. In one embodiment, at least one parameter includes tissue stiffness. In one embodiment, the subject's tissue includes breast tissue.

[0071] In one embodiment, a method for recording, measuring, and mapping the size, shape, and location of a palpable lesion beneath the surface of a subject's skin or other soft tissue by using capacitive tactile sensing to measure changes in normal tactile pressure on the surface of a tissue surface, the method comprising the steps of: positioning a handheld device comprising a plurality of electrodes and a quantity of non-conductive compressible material and covering it to substantially contact a surface area of ​​the subject's skin or tissue; determining a baseline reference capacitance of the subject by measurement obtained by an operator from an undamaged area of ​​the tissue; determining a baseline reference voltage potential by the operator through conductive contact between the operator and the handheld device; positioning the handheld device to substantially contact the surface area of ​​the skin or tissue under study; measuring the capacitance generated between two of the plurality of electrodes due to contact with the surface area of ​​the skin or tissue under study; measuring, with reference to the baseline reference voltage potential, the change in sensed capacitance between adjacent related electrode pairs caused by pressure applied to a sensor surface (compressible membrane and covering) due to disruption of capacitive coupling between adjacent related electrode pairs caused by contact with the surface of the skin or tissue under study; and calculating one or more tissue parameters from the baseline reference voltage potential based on the change in sensed capacitance. In one embodiment, the method includes the steps of sending data selected from a group consisting of sensing capacitance, thickness, and tissue parameters to a visualization system. In another embodiment, the method includes the steps of measuring multiple capacitance values ​​between a set of electrode pairs and displaying a graph of the parameter values ​​on the tissue surface on the visualization system. In one embodiment, the tissue parameter refers to stiffness.

[0072] In one embodiment, a method for performing guided self-examination of a subject's tissue includes the following steps: positioning a handheld device comprising a plurality of electrodes and a quantity of flexible material substantially in contact with a region of the subject's body; measuring the capacitance between two of the electrodes; calculating tissue parameters based on the capacitance; determining instructions for the subject in a controller based on the tissue parameters; and issuing instructions to the subject to guide the subject in manipulating the handheld device. In one embodiment, the instructions refer to auditory instructions issued via a speaker. In one embodiment, the instructions are configured to guide the subject to move the device to a new location on the tissue. In one embodiment, the instructions include visual cues presented on a display.

[0073] Experimental Example

[0074] The invention will be described in further detail with reference to the following experimental examples. These embodiments are provided for illustrative purposes only and are not intended to be limiting unless otherwise specified. Therefore, the invention should not be construed in any way as being limited to the following embodiments, but should be considered to include any and all modifications that become apparent from the teachings provided herein.

[0075] Unless further described, it is assumed that those skilled in the art can manufacture and utilize the systems and methods of the present invention using the foregoing description and the following illustrative embodiments. Therefore, the following working examples clearly indicate exemplary embodiments of the invention and should not be construed as limiting the remainder of this disclosure in any way.

[0076] According to one implementation method, reference Figure 8 Provides simple comparison data for piezoelectric and capacitive sensors.

[0077] The entire contents of each and every patent, patent application, and published disclosure are hereby incorporated by reference. Although the invention has been disclosed with reference to specific embodiments, it will be apparent to those skilled in the art that other embodiments and modifications of the invention will be conceived without departing from its true spirit and scope. The appended claims are intended to be regarded as encompassing all such embodiments and equivalent modifications.

Claims

1. A method for administering guided self-examination to a subject, comprising: A positioning handheld device, the handheld device comprising multiple electrodes and a certain amount of flexible material that substantially contacts a body area of ​​the subject; Measure the capacitance between two of the plurality of electrodes; Calculate tissue parameters based on the capacitance; The controller determines instructions for the subject based on the tissue parameters; and The instructions are issued to the subject in order to guide the subject in operating the handheld device.

2. The method according to claim 1, wherein, The instruction is an auditory instruction delivered via a loudspeaker.

3. The method according to claim 1, wherein, The instructions are configured to guide the subject to move the device to a new location on the tissue.

4. The method according to claim 1, wherein, The instructions include visual cues presented on the display.

5. A method for recording, measuring, and mapping the size, shape, and location of a tactile lesion in the subsurface layer of a subject's skin or other soft tissue by using capacitive tactile sensing to measure changes in normal tactile pressure on the surface of other soft tissue areas of the skin or tissue surface, the method comprising: A positioning handheld device, the handheld device comprising multiple electrodes and a certain amount of non-conductive compressible material, and covered to substantially contact the surface area of ​​the subject's skin or tissue; The baseline reference capacitance of the subject is determined by measurement data obtained by the operator from a non-damaged area of ​​the tissue; The baseline reference voltage potential is determined by the operator through conductive contact between the operator and the handheld device; Position the handheld device so that it is in general contact with the surface area of ​​the skin or tissue being studied; The capacitance generated between two of the plurality of electrodes due to contact with the surface region of the skin or tissue under study is measured. The change in sensing capacitance between adjacent related electrode pairs caused by pressure applied to the sensor surface due to the disruption of capacitive coupling between adjacent related electrode pairs caused by contact with the surface of the skin or tissue under study is measured with reference to the baseline reference voltage potential. and One or more tissue parameters are calculated based on the changes in the sensed capacitance and the baseline reference voltage potential.

6. The method according to claim 5, further comprising: Data selected from the group consisting of the sensed capacitance, thickness, and tissue parameters is sent to the visualization system.

7. The method according to claim 6, further comprising: Multiple capacitance values ​​between a set of electrode pairs are measured, and a graph of the parameter values ​​across the tissue surface is displayed on the visualization system.

8. A method for dynamically calibrating data received from at least one sensor, comprising: Multiple data values ​​are acquired from the at least one sensor; Calculate the first mean and the first standard deviation of the plurality of data values; Obtain a subset of the plurality of data values, wherein the values ​​of the subset are within one standard deviation of the first mean; A second mean is calculated from the subset of the plurality of data values ​​as a baseline value; and The baseline value is subtracted from the plurality of data values ​​to generate a calibration dataset.

9. The method according to claim 8, further comprising: Get a second or more data values; Calculate the third mean and third standard deviation of the first and second sets of data values; Obtain a second subset of the first and second plurality of data values, wherein the values ​​of the second subset are within one standard deviation of the third mean; A fourth mean is calculated from the second subset of multiple data values ​​as the second baseline value; and The second baseline value is subtracted from the first and second plurality of data values ​​to generate the calibration dataset.

10. The method of claim 8, further comprising: Display a three-dimensional surface map of the calibration dataset; Display the baseline value; and Visual feedback is provided when the baseline value is within the optimal range.

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