Bilateral symmetric comparison of subcutaneous humidity values

Abstract

The present disclosure provides devices and methods for measuring subepidermal wetness at bilaterally symmetrical locations on a patient to identify damaged tissue for clinical intervention.

Description

[0001] This application is a divisional application of an invention application with an application date of February 2, 2018, application number 201880004142.1 (international application number PCT / US2018 / 016731), and invention name “Bilaterally symmetrical comparison of subcutaneous humidity values”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 454,455, filed on February 3, 2017, and U.S. Provisional Application No. 62 / 521,871, filed on June 19, 2017, both of which are incorporated herein by reference in their entirety. Technical Field

[0004] The present disclosure provides an apparatus and a computer readable medium for measuring subcutaneous wetness of a patient to identify damaged tissue for clinical intervention. The present disclosure also provides a method for determining damaged tissue. Background Art

[0005] The skin is the largest organ of the human body. It is easily exposed to different kinds of insults and damage. Ulcers may form when the skin and its surrounding tissues are unable to redistribute external pressure and mechanical forces. Continuous exposure to even moderate pressure over a long period of time, such as the pressure exerted by a supine patient's weight on their posterior skin surface, may lead to pressure ulcers. In the presence of other insults, such as neuropathy and peripheral tissue weakening that may be induced by diabetes, even periodic exposure to mild levels of pressure and stress may lead to ulcers, such as foot ulcers.

[0006] In the United States, approximately 2.5 million people develop pressure ulcers each year and a similar number in Europe. In long-term and acute care settings, up to 25% of elderly and immobile patients develop pressure ulcers. In the United States, approximately 60,000 patients die each year from infections and other complications caused by pressure ulcers.

[0007] Detecting tissue damage before the skin breaks down and intervening with appropriate therapy to prevent further deterioration of the underlying tissue is desirable not only to the patient but also to society. The average cost of treating pressure-induced damage at the earliest sign of overtness (stage 1 ulcer) is only $2,000, but rises to $129,000 when the ulcer is deep enough to expose muscle or bone (stage 4 ulcer). The current standard for detecting pressure ulcers is by visual inspection, which is subjective, unreliable, untimely, and lacks specificity. Summary of the invention

[0008] In one aspect, the present disclosure provides and includes a device for identifying damaged tissue, the device comprising: a first sensor and a second sensor, wherein the sensors each include a first electrode and a second electrode, and wherein each of the sensors is configured to be placed against the skin of a patient; a circuit, electronically coupled to the first and second electrodes, and configured to measure an electrical characteristic between the first and second electrodes of each of the sensors and provide information about the electrical characteristic; a processor, electronically coupled to the circuit and configured to receive information from the circuit and convert the information into a skin moisture (SEM) value; and a non-transitory computer readable medium, electronically coupled to the processor and including instructions stored thereon, which, when executed on the processor, perform the following steps: determining a difference between a first SEM value corresponding to the electrical characteristic measured by the first sensor at a first location on the patient's skin and a second SEM value corresponding to the electrical characteristic measured by the second sensor at a second location on the patient's skin, wherein the second location is bilaterally symmetrical relative to the first location.

[0009] In one aspect, the present disclosure provides a device for identifying damaged tissue, the device comprising: a substrate configured to be placed against the surface of a patient's skin; a plurality of sensors disposed on the substrate at corresponding plurality of locations, wherein each sensor comprises a pair of electrodes; a circuit electronically coupled to a pair of electrodes of each of the plurality of sensors and configured to measure electrical characteristics between paired electrodes of a portion of the plurality of sensors and provide information about the measured electrical characteristics; a processor electronically coupled to the circuit and configured to receive information about the electrical characteristics from the circuit and convert the plurality of electrical characteristics into corresponding plurality of subepidermal moisture (SEM) values; and a non-transitory computer-readable medium electronically coupled to the processor and comprising instructions stored thereon, which, when executed on the processor, perform the following steps: identifying a first sensor and a second sensor located at first and second locations that are bilaterally symmetrical relative to the patient's skin through a plurality of SEM values, and comparing a first SEM value associated with the first sensor with a second SEM value associated with the second sensor.

[0010] In one aspect, the present disclosure provides a device for identifying damaged tissue, the device comprising: a device body; two sensors, including a first sensor and a second sensor, wherein the two sensors are arranged on the device body to allow the first sensor to be simultaneously positioned at a first position on the patient's skin and the second sensor to be positioned at a second position symmetrically relative to the first position; a circuit, electronically coupled to each of the two sensors and configured to measure an electrical characteristic from each of the two sensors; a processor, electronically coupled to the circuit and configured to receive a first electrical characteristic measurement value from the first position and a second electrical characteristic measurement value from the second position, and convert the first electrical characteristic measurement value into a first SEM value and convert the second electrical characteristic measurement value into a second SEM value; a non-transitory computer readable medium, electronically coupled to the processor and containing instructions, which, when executed on the processor, perform the step of determining the difference between the first SEM value and the second SEM value.

[0011] In one aspect, the present disclosure provides a method for identifying damaged tissue, the method comprising: obtaining a first subcutaneous moisture (SEM) value from a first location on the skin of a patient; obtaining a second SEM value from a second location that is symmetrical on both sides of the first location; and determining a difference between the first SEM value and the second SEM value. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Aspects of the present disclosure are described herein by way of example only with reference to the accompanying drawings. Reference is now made in detail to the accompanying drawings, which show specific details by way of example and for the purpose of illustrative discussion of aspects of the present disclosure. In this regard, when the description and the drawings are considered individually and together, it will be apparent to those skilled in the art how to practice aspects of the present disclosure.

[0013] Figure 1A A plan view of a ring sensor is shown.

[0014] Figure 1B Shows Figure 1A Cross section of a ring sensor in .

[0015] Figure 1C Shows when activated by Figure 1A Idealized field diagram formed by the ring sensor in .

[0016] Figure 2A An example of a pair of bilaterally symmetrical locations on the sacral region according to the present disclosure is provided.

[0017] Figure 2B An example of a pair of bilaterally symmetrical locations on the bottom side of both feet according to the present disclosure is provided.

[0018] Figure 2CExamples of a pair of bilaterally symmetrical locations on the lateral sides and soles of both feet according to the present disclosure are provided.

[0019] Figure 3 An arrangement comprising a coaxial sensor is shown.

[0020] Figure 4A is a first exemplary device according to the present disclosure including two sensors.

[0021] Figure 4B is a second exemplary apparatus according to the present disclosure comprising two sensors and configured to determine SEM values ​​at bilaterally symmetrical positions.

[0022] Figure 5 is an exemplary device including a plurality of sensors according to the present disclosure.

[0023] Figure 6 is a first exemplary array of electrodes.

[0024] Figure 7 is an exemplary array of electrodes according to the present disclosure.

[0025] Fig. 8A It shows that according to the present disclosure Figure 7 A first example of how the electrode array disclosed in can be configured to form a sensor.

[0026] Figure 8B It shows that according to the present disclosure Figure 7 A second example of how the electrode array disclosed in can be configured to form a sensor.

[0027] Fig.9A An example of a first sensor formed in an array of electrodes according to the present disclosure is shown.

[0028] Fig. 9B It shows how to form and Fig.9A Example of a first sensor overlapping a second sensor.

[0029] Fig.10 shows how a portion of the patient's skin can be formed by an electrode array that is larger than the patient's skin portion according to the present disclosure. Fig. 8A An example of a sensor is shown in , where the patient's skin portion is positioned against the array.

[0030] Fig.11A Shown are locations on the left and right feet for SEM measurements in accordance with the present disclosure.

[0031] Fig. 11B is a graph of SEM values ​​associated with known relative positions for identifying bilaterally symmetrical locations in accordance with the present disclosure.

[0032] Fig. 12A An exemplary configuration of a substrate configured to be positioned at a known location on a patient's skin in accordance with the present disclosure is shown.

[0033] Fig. 12B It shows that according to the present disclosure Fig. 12A Front view of an exemplary configuration.

[0034] Fig.13 An integrated system for measuring, evaluating, storing and transmitting SEM values ​​according to the present disclosure is shown. DETAILED DESCRIPTION

[0035] This description is not intended to be a detailed catalog of all the different ways in which the present disclosure can be implemented or all the features that can be added to the current disclosure. For example, the features shown in one embodiment can be incorporated into other embodiments, and the features shown in a specific embodiment can be deleted from the embodiment. Therefore, the present disclosure contemplates that in some embodiments of the present disclosure, any feature or combination of features set forth herein can be excluded or omitted. In addition, according to the current disclosure, various modifications and additions to the various embodiments suggested herein will be obvious to those skilled in the art, and they do not depart from the current disclosure. In other cases, in order to unnecessarily obscure the present invention, known structures, interfaces and processes are not shown in detail. It is expected that any part of this specification should not be interpreted as realizing a denial of any part of the full scope of the present invention. Therefore, the following description is intended only to exemplify some specific embodiments of the present disclosure, rather than to thoroughly and exhaustively specify all its arrangements, combinations and variations.

[0036] Unless otherwise defined, all technical terms and scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the present disclosure belongs. The terms used in the description of the present disclosure are only for describing specific aspects and embodiments and are not intended to limit the present disclosure.

[0037] All publications, patent applications and other references cited herein are incorporated by reference in their entirety to provide teachings related to the sentences and / or paragraphs in which the references are given. References to the techniques used herein are intended to relate to techniques commonly understood in the art, including variations of these techniques or equivalent replacements of the techniques that are obvious to those skilled in the art.

[0038] U.S. Patent Application No. 14 / 827,375 discloses a device that uses radio frequency (RF) energy to measure subcutaneous capacitance corresponding to moisture content of a target area of ​​a patient's skin by utilizing a bipolar sensor similar to sensor 90 shown in FIG1. ​​The '375 application also discloses arrays of these bipolar sensors having various sizes.

[0039] U.S. Patent Application Serial No. 15 / 134,110 discloses a method for measuring subepidermal moisture (SEM) similar to Figure 3 The device shown in , wherein the device transmits and receives RF signals at a frequency of 32 kHz through a single coaxial sensor and generates a bioimpedance signal, which is then converted into a SEM value.

[0040] Both U.S. Application Serial Nos. 14 / 827,375 and 15 / 134,110 are incorporated herein by reference in their entirety.

[0041] Unless otherwise indicated in the context, it is specifically contemplated that the various features of the present disclosure described herein may be used in any combination. In addition, the present disclosure also contemplates that in some embodiments of the present disclosure, any feature or combination of features set forth herein may be excluded or omitted.

[0042] The method described herein includes and comprises one or more steps or actions for realizing the method. Method steps and / or actions can be interchanged with each other without departing from the scope of the present invention. In other words, unless a specific order of steps or actions is required for the correct operation of the embodiment, the order and / or use of specific steps and / or actions can be modified without departing from the scope of the present invention.

[0043] As used in this disclosure and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0044] As used herein, "and / or" refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as no combination when interpreted in the alternative form ("or").

[0045] As used herein, the terms "about" and "approximately" when referring to a measurable value such as a length, frequency or SEM value, are meant to encompass variations of ±20 / %, ±10%, ±5 / %, ±1 / %, ±0.5 / % or even ±0.10 / % of the particular amount.

[0046] As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y" and phrases such as "from about X to Y" mean "from about X to about Y."

[0047] As used herein, the term "subepidermal moisture" or "SEM" refers to the increase in tissue fluid and local edema caused by vascular leakage and other changes that modify the underlying structure of damaged tissue when there is sustained pressure on the tissue, apoptosis, necrosis, inflammatory processes.

[0048] As used herein, a "system" may be a collection of devices that communicate with each other in wired or wireless communications.

[0049] As used herein, "interrogation" refers to the use of radio frequency energy to penetrate the skin of a patient.

[0050] As used herein, a "patient" can be a human or animal subject.

[0051] As used herein, "bilaterally symmetrical" refers to a pair of locations that are approximately equidistant from a line of symmetry.

[0052] As used herein, "delta" refers to the calculated difference between two SEM values.

[0053] Figure 1A FIG. 1 is a plan view of an annular sensor 90, which includes a central electrode 110 and an annular electrode 120. In one aspect, electrodes 110 and 120 are disposed on a common surface of substrate 100, such as Figure 1B . In one aspect, the substrate 100 is rigid, for example, a sheet of FR4 printed circuit board (PCB). In one aspect, the substrate 100 is flexible, for example, a sheet of polyimide. In one aspect, the substrate 100 is a combination of rigid and flexible elements. In one aspect, the electrodes 110 and 120 are covered with a non-conductive cover layer 130 so as to isolate the electrodes 110 and 120 from each other and / or from external contacts. In one aspect, portions of the cover layer 130 are directionally conductive, so that the electrodes 110 and 120 can be electrically contacted with an object disposed on the cover layer 130 while being electrically isolated from adjacent electrodes. In one aspect, the cover layer 130 is rigid and planar, thereby providing a flat outer surface. In one aspect, the cover layer 130 is conformal to the underlying electrodes 110 and 120 and the substrate 100 so that there is no gap or air space between the substrate 100 and the cover layer 130. When a voltage is applied across electrodes 110 and 120, an electric field 140 is generated between electrodes 110 and 120 that extends outward from the plane of electrodes 110 and 120 by a distance 150, which is also referred to as the depth of the field. Figure 1C The diameter of the center electrode 110, the inner and outer diameters of the ring electrode 120, and the gap between the electrodes 110 and 120 may be varied to change the characteristics of the field 140, such as the depth 150 of the field.

[0054] Figure 2A The sacral region of the back of the patient 10 is shown. A symmetry line 12 can be drawn down from the center of the back, dividing the back into a left mirror image and a right mirror image. Position 14 is approximately the same distance from the symmetry line 12 and is approximately at the same height, and is therefore considered to be a bilaterally symmetrical position on the back of the patient 10.

[0055] Figure 2B The left foot 20L and the right foot 20R of the patient 10 are shown, and it is seen as if the patient 10 is lying on his back on a bed (not shown) and the observer is standing at the foot of the bed. For the soles 22L and 22R of the feet 20L and 20R, the positions 24L and 24 are located at approximately equivalent positions, for example, the same distance from the rear surface (i.e., the heel), and the same distance from the inner side of the corresponding foot 20L or 20R, and are considered to be bilaterally symmetrical positions.

[0056] Figure 2C Other exemplary bilaterally symmetrical locations 26L and 26R are shown on lateral sides of feet 20L and 20R, as well as bilaterally symmetrical locations 28L and 28R located on the soles 22L and 22R of feet 20L and 20R, respectively. In one aspect, locations 26R and 30R are considered to be bilaterally symmetrical about foot 20R when considered alone without reference to foot 20L.

[0057] Without being limited to a particular theory, comparing SEM measurements taken at bilaterally symmetrical locations can compensate for deviations in readings for a particular patient from a patient population. For example, a patient may be dehydrated on a particular day when the measurement is taken. A comparison of SEM values ​​for healthy tissue from the same patient in a dehydrated condition may differ from the SEM values ​​for the same tissue at the same location when the patient is fully hydrated. If tissue at one location is healthy and tissue at a bilaterally symmetrical location is damaged, a comparison of readings taken at bilaterally symmetrical locations can exclude the effects of a "common pattern" of dehydration on both locations and provide a more robust indication that the tissue is damaged at one location.

[0058] Figure 3An exemplary SEM measurement device 170 is shown, which includes an annular sensor 174 disposed on the underside 172 of the device body. The device 170 can be used to collect measurements at multiple locations, such as a first measurement at a first location and a second measurement at a second location that is bilaterally symmetrical relative to the first location. In one aspect, the device 170 includes a processor that can be configured by instructions stored on a non-transitory computer readable medium to determine characteristics of the measurements collected at the multiple locations or parameters associated with or derived from the measurements, such as one or more of the differences between, their averages, or differences from a common average of SEM values ​​derived from the multiple measurements, respectively. In one aspect, the device 170 includes a display that is configured to display one or more parameters associated with the measurements, such as the amount of change between SEM values ​​derived from the measurements collected at two bilaterally symmetrical locations.

[0059] Figure 4A An exemplary SEM measurement device 180 according to the present disclosure is shown, which includes two sensors 184A and 184B located at separate locations on a device body 182. One exemplary use may be to place the device 180 against a patient's body (not shown) so as to simultaneously position a first sensor 184 at a first location and a second sensor 184B at a second location, both on the surface of the patient's skin. In one aspect, the device body 182 is rigid and holds the sensors 184A and 184B at a fixed spacing distance and fixed orientation relative to each other. In one aspect, the sensors 184A and 184B are aligned on a common plane, such as Figure 4A In one aspect, device body 182 is flexible so that sensors 184A and 184B can be oriented at an angle relative to each other. In one aspect, one or more of sensors 184A and 184B can be moved so that the angle between the movable sensor and the other sensor can be changed.

[0060] In use, the device 180 can utilize one or more sensors 184A and 184B to measure electrical characteristics or parameters, including one or more electrical characteristics selected from the group consisting of resistance, capacitance, inductance, impedance, and magnetoresistance, as well as other electrical characteristics. In one aspect, the sensors 184A and 184B are configured as follows: Figure 1A, and has a central electrode 110 and an annular electrode 120. In one aspect, sensors 184A and 184B are provided in accordance with other configurations discussed in this application. In one aspect, sensors 184A and 184B include an electrical ground plane (not shown) adjacent to and separated from a portion of electrodes 110 and 120. In one aspect, the ground plane shields electrodes 110 and 120 from interfering with or modifying the fields of sensors 184A and 184B (conceptually similar to Figure 1C In one aspect, the ground plane is disposed on the side of the substrate opposite to the side on which the electrodes 110 and 120 are disposed. In one aspect, the device 180 includes a circuit (not shown) that is electronically coupled to the electrodes 110 and 120 of each sensor 184A and 184B and is configured to measure an electrical characteristic between the electrodes 110 and 120. In one aspect, the ground plane is coupled to ground or an equivalent floating reference of the circuit. In one aspect, the circuit is configured to determine and provide information about the measured electrical characteristic. In one aspect, the device 180 collects measurements using sensors 184A and 184B substantially simultaneously. In one aspect, the device 180 collects measurements sequentially with time intervals ranging from zero to one second or longer between measurements. In one aspect, measurements made by the device 180 are performed by buttons ( Figure 4A In one aspect, the measurement performed by the device 180 is based on a switch element ( Figure 4A 184A and 184B are automatically triggered by an input (not shown) of a switch element, such as a contact sensor, pressure sensor, optical sensor, or other type of proximity detection device, which in one aspect is located adjacent to one or more of sensors 184A and 184B. In one aspect, multiple switch elements need to be activated simultaneously to provide input to collect measurement values.

[0061] In one aspect, the device 180 includes a processor (not shown) that is coupled to the circuit and receives information related to the measured electrical characteristic from the circuit. In one aspect, the information is in the form of an analog signal, such as a voltage, or in the form of a digital signal. In one aspect, the processor is directly coupled to the sensors 184A and 184B and is configured to directly measure the electrical characteristic. In one aspect, the processor is configured to convert the received electrical characteristic into a SEM value. In one aspect, the processor is configured by machine-readable instructions stored on a non-transitory computer-readable medium electronically coupled to the processor. In one aspect, the instructions are loaded into the processor from the medium when the device 180 is powered on.

[0062] In one aspect, the measured electrical parameter is related to the moisture content of the patient's epidermis at a depth determined by the geometry of the electrodes of sensors 184A and 184B, the reference Figure 1C The moisture content is determined by the frequency and intensity of the electric field 140 formed by sensors 184A and 184B and other operating characteristics of device 180. In one aspect, the moisture content is equivalent to the SEM content having a value on a predetermined scale. In one aspect, the predetermined scale range can be from 0 to 20, such as from 0 to 1, from 0 to 2, from 0 to 3, from 0 to 4, from 0 to 5, from 0 to 6, from 0 to 7, from 0 to 8, from 0 to 9, from 0 to 10, from 0 to 11, from 0 to 12, from 0 to 13, from 0 to 14, from 0 to 15, from 0 to 16, from 0 to 17, from 0 to 18, from 0 to 19. In one aspect, the predetermined scale can be proportionally adjusted by a factor or multiple based on the values ​​provided herein. In one aspect, multiple measurements are measured while changing one or more of the operating characteristics between readings, thereby providing information related to the moisture content at various depths of the skin.

[0063] In one aspect, when the contact sensor ( Figure 4A When sensors 184A and 184B are properly in contact with two bilaterally symmetrical locations on the patient's skin (not visible in the figure), capacitance measurements are collected simultaneously using sensors 184A and 184B. In one aspect, the simultaneous capacitance measurements are compared to each other to determine whether the tissue beneath one of the bilaterally symmetrical locations is damaged. In one aspect, the capacitance measurements are individually converted to SEM values ​​that correspond to the moisture content of the tissue adjacent to the respective sensors 184A and 184B and the SEM values ​​are compared. In one aspect, the comparison is made using equivalent voltages, capacitance values, or other intermediate signals.

[0064] In one aspect, a difference between SEM values ​​is determined, wherein a difference exceeding a predetermined threshold indicates tissue damage at one of the locations where the corresponding capacitance measurements were collected. In one aspect, a mean of the SEM values ​​obtained at each bilaterally symmetrical location is determined and compared. In one aspect, a median or mode of the SEM values ​​obtained at each bilaterally symmetrical location is determined and compared. In one aspect, damage is indicated at a location associated with a larger of the SEM values. In one aspect, damage is indicated at a location associated with a smaller of the SEM values. In one aspect, determining whether tissue damage is present includes one or more of comparing individual SEM values ​​to one or more predetermined ranges or thresholds and comparing the difference to one or more predetermined ranges or thresholds. In one aspect, the predetermined range can be from 0.1 to 8.0, for example, from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to 7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0, or from 4.0 to 4.5. In one aspect, the predetermined range can be from 0.1 to 4.0, such as from 0.5 to 4.0, from 0.1 to 3.5, from 1.0 to 3.5, from 1.5 to 4.0, from 1.5 to 3.5, from 2.0 to 4.0, from 2.5 to 3.5, from 2.0 to 3.0, from 2.0 to 2.5, or from 2.5 to 3.0. In one aspect, the predetermined range can be from 4.1 to 8.0, such as from 4.5 to 8.0, from 4.1 to 7.5, from 5.0 to 7.5, from 5.5 to 7.0, from 5.5 to 7.5, from 6.0 to 8.0, from 6.5 to 7.5, from 6.0 to 7.0, from 6.0 to 6.5, or from 6.5 to 7.0. In one aspect, the predetermined threshold can be about 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1 3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4 or 7.5.In one aspect, the predetermined threshold value can be from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to 7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0, or from 4.0 to 4.5. In one aspect, the predetermined range or threshold value can be scaled by a factor or multiple based on the values ​​provided herein. It should be understood that the predetermined value is not limited by design, but rather, one skilled in the art can select the predetermined value based on a given unit of SEM. In one aspect, the ranges and thresholds of the present disclosure vary depending on the specific bilaterally symmetrical location, the part of the patient's body on which the measurement is made, or one or more characteristics of the patient, such as age, height, weight, family history, ethnic group, and other physical characteristics or medical conditions.

[0065] One or more parts can be defined on the body. In one aspect, measurements taken within a part are considered comparable to each other. A part can be defined as an area on the skin of the body, where measurements can be collected at any point within the area. In one aspect, a part corresponds to an anatomical part (e.g., heel, ankle, lower back). In one aspect, a part can be defined as a group of two or more specific points relative to an anatomical feature, where measurements are collected only at the specific point. In one aspect, a part can include multiple non-adjacent areas on the body. In one aspect, the group of specific locations can include points in multiple non-adjacent areas.

[0066] In one aspect, a site is defined by surface area. In one aspect, a site can be, for example, 5 cm 2 Up to 200cm 2 Between, within 5cm 2 Up to 100cm 2 Between, within 5cm 2 Up to 50cm 2 Between or within 10cm 2 Up to 50cm 2 Between, within 10cm 2 Up to 25cm 2 Between, or within 5cm 2 Up to 25cm 2 between.

[0067] In one aspect, measurements can be taken in a specific pattern or portion thereof. In one aspect, the pattern that makes the reading is a pattern with the target area of ​​interest at the center. In one aspect, measurements are taken in one or more circular patterns that gradually increase or decrease in size, a T-shaped pattern, a set of specific locations, or randomly on the tissue or part. In one aspect, a pattern can be positioned on the body by defining a first measurement location of the pattern relative to an anatomical feature, while the remaining measurement locations of the pattern are defined as offsets from the first measurement location.

[0068] In one aspect, multiple measurements are collected on a tissue or site, and the difference between the lowest measurement and the highest measurement in the multiple measurements is recorded as the delta value of the multiple measurements. In one aspect, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more measurements are collected on a tissue or site.

[0069] In one aspect, a threshold value may be established for at least one site. In one aspect, a threshold value may be established for at least one site as 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 or other values. In one aspect, a delta value is identified as significant when a delta value of a plurality of measurements collected within a site meets or exceeds a threshold value associated with the site. In one aspect, each of a plurality of sites has a different threshold value. In one aspect, two or more sites have a common threshold value.

[0070] In one aspect, the threshold has both a delta value component and a time order component, wherein the delta value is identified as significant when the delta value is greater than a predetermined value for a predetermined portion of the time interval. In one aspect, the predetermined portion of the time interval is defined as at least X days where a plurality of measurements collected on that day produced a delta value greater than or equal to a predetermined value out of a total of Y consecutive days of measurement. In one aspect, the predetermined portion of the time interval can be defined as 1, 2, 3, 4, or 5 consecutive days where a plurality of measurements collected on that day produced a delta change value greater than or equal to a predetermined value. In one aspect, the predetermined portion of the time interval can be defined as a portion of different specific time periods (weeks, months, hours, etc.).

[0071] In one aspect, the threshold has a trend aspect, wherein changes in delta values ​​of consecutive multiple measurements are compared to one another. In one aspect, the trend threshold is positioned as a predetermined change in delta values ​​over a predetermined length of time, wherein a determination that the threshold has been met or exceeded is significant. In one aspect, a determination of significance will cause a warning to be issued. In one aspect, a trend line can be calculated over a portion of each of the consecutive multiple measurements. In one aspect, a trend line can be calculated over a portion of the delta values ​​of the consecutive multiple measurements.

[0072] In one aspect, the number of measurements collected in a single region may be less than the number of measurement locations defined in the pattern. In one aspect, a delta value is calculated after a predetermined initial number of readings have been collected in a region, the predetermined initial number being less than the number of measurement locations defined in the pattern, and after each additional reading in the same region, wherein no additional readings are collected once the delta value meets or exceeds a threshold associated with the region.

[0073] In one aspect, the number of measurements collected in a single location may exceed the number of measurement locations defined in the pattern. In one aspect, a delta value will be calculated after each additional reading.

[0074] In one aspect, a quality metric may be generated for each of the multiple measurements.

[0075] In one aspect, the quality metric is selected to evaluate the reproducibility of the measurement. In one aspect, the quality metric is selected to evaluate the skills of the clinician performing the measurement. In one aspect, the quality metric may include one or more statistical parameters, such as an average value, mean, or standard deviation. In one aspect, the quality metric may include one or more comparisons of individual measurements with a predetermined range. In one aspect, the quality metric may include a comparison of individual measurements with a pattern of values, such as a comparison of measurements at predefined locations with a range associated with each predefined location. In one aspect, the quality metric may include determining which measurements are based on healthy tissue and one or more assessments of consistency within this subset of "healthy" measurements, such as a range, standard deviation, or other parameter.

[0076] In one aspect, the measurement (eg, threshold value) is determined by a SEM Scanner Model 200 [Bruin Biometrics, LLC, Los Angeles, CA]. In another aspect, the measurement is determined by another SEM scanner.

[0077] In one aspect, measured value is based on the capacitance measurement value by reference to reference device. In one aspect, capacitance measurement value can be according to the position of any electrode in the equipment and other aspects. Such modification can be compared with reference SEM equipment, for example SEM Scanner Model 200 [Bruin Bioassay Co., Ltd., Los Angeles, California]. It will be appreciated by those of ordinary skill in the art that the measurement set forth herein can be adjusted to adapt to different capacitance ranges by reference to reference device.

[0078] In one aspect, the device 180 is capable of storing multiple measurements and calculations. In one aspect, the device according to the present disclosure may also include other components, such as a camera or a barcode scanner ( Figure 4A In one aspect, the device 180 includes a component for transmitting the stored data ( Figure 4A ), for example, via a Bluetooth, WiFi or Ethernet connection to another device, such as a personal computer, server, tablet computer or smartphone, such as Fig.13 as shown in .

[0079] Figure 4B Another aspect of the device 186 configured to determine SEM values ​​at bilaterally symmetrical locations is shown. In one aspect, the device 186 includes a hinge 188 so that the separation distance between sensors 187A and 187B can be changed. In one aspect, sensors 184A and 184B are aligned with respect to the device body elements 186A and 186B to obtain a desired relative orientation, such as parallel to each other at a predetermined separation distance. In one aspect, one or more of the sensors 187A and 187B can be moved so that the angle between the movable sensor and the other sensor can be changed, for example, in order to position the position sensors 187A and 187B when the device 185 is tightly around the ankle. Figure 2C When above the positions 26R and 30R shown in , this matches the orientation of the skin beneath each sensor 187A and 187B.

[0080] Figure 5 An exemplary pad assembly 190 is shown that includes an array 92 that includes a plurality of sensors 90 in accordance with the present disclosure. In one aspect, the pad assembly 192 includes a pad 200 on which the sensors 90 are disposed. In one aspect, the sensors 90 are embedded within the pad 200. In one aspect, the sensors 90 are located on an upper surface of the pad 200. In one aspect, the sensors 90 have a cover layer above them (on the Figure 5 In one aspect, the sensors 90 include conductive electrodes exposed on their upper surfaces so as to make electrical contact with an object adjacent to the top of the mat, such as the foot of a patient standing on the mat. In one aspect, the sensors 90 are Figure 1A In one aspect, sensors 90 are of a single type and configuration. In one aspect, sensors 90 are of different sizes and types within array 92. In one aspect, sensors 90 are of one or more alternative configurations, such as those related to Figure 6 , Figure 7 , Fig. 8A as well as Figure 8B In one aspect, pad assembly 190 is coupled to electronic assembly 192, either directly or via cable 194. In one aspect, electronic assembly 192 includes circuitry (in Figure 4A ) and a processor coupled to the circuit ( Figure 4A ), as previously discussed with respect to device 180.

[0081] In one aspect, the pad assembly 190 includes a pressure sensor, a temperature sensor, an optical sensor, and a contact sensor ( Figure 5 In one aspect, one or more measurements using sensor 90 are triggered by input from one or more of pressure, temperature, optical, and contact sensors.

[0082] In one aspect, mat assembly 190 is configured as a floor mat, and actuation of one or more of the pressure, temperature, optical, and contact sensors, such as detection of a person standing on mat assembly 190 due to detection of the person's weight by the pressure sensor, initiates a measurement by one or more of sensors 90. In one aspect, sensor 90 operates in a "detection mode" that is capable of detecting when a person steps on mat assembly 190 and transitions to a "measurement mode" when it is determined that a person is standing on mat assembly 190.

[0083] In one aspect, the pad assembly 190 is configured as a portable device that can be placed against a surface of a patient's skin, such as against the patient's back or against the soles of one or both of the patient's feet when the patient is lying in bed. In one aspect, the pad assembly 190 includes a support tray, a reinforcement element, and a conformable pad ( Figure 5 One or more of the foregoing (not shown) may be used to assist in placing sensor 90 against the surface of the patient's skin.

[0084] Figure 6 An exemplary electrode array 290 according to the present disclosure is shown. In this example, the array 290 is composed of individual electrodes 300 arranged in a regular pattern on a substrate 292. In one aspect, each electrode 300 (via Figures 6 to 8B Conductive elements (not shown) are separately coupled to the circuit, such as Figure 4AAs described, a circuit configured to measure an electrical parameter. In one aspect, a "virtual sensor" is formed by selectively connecting a predetermined subset of electrodes 300 to a common element of the circuit. In this example, a particular electrode 310 is connected as a central electrode, similar to Figure 1A The electrode 110 in FIG. 1 and the six electrodes 320A to 320F are connected together as a "virtual ring" electrode, similar to Figure 1A In one aspect, two separate electrodes are individually connected to a circuit to form a virtual sensor, for example, electrodes 310 and 320A are connected as two electrodes of a sensor, respectively. In one aspect, one or more electrodes 300 are connected together to form one or the other of the electrodes of a dual-electrode sensor.

[0085] Figure 7 Another exemplary array 400 of electrodes 410 according to the present disclosure is shown. In this example, each of the electrodes 410 is approximately hexagonal and is separated from each of the surrounding electrodes 410 by a gap 420. In one aspect, the electrodes 410 are one of a circle, a square, a pentagon, or other regular or irregular shape. In one aspect, the gap 420 is consistent between all electrodes 410. In one aspect, the gap 420 is different between each electrode. In one aspect, the gap 420 has a width that is narrower than the cross-section of each electrode 410. In one aspect, the electrodes 410 can be interconnected to form the following about Fig. 8A and Figure 8B The virtual sensor.

[0086] Fig. 8A An array 400 of electrodes 410 in accordance with the present disclosure is shown, which are configured, e.g., connected to a measurement circuit, to form an exemplary sensor 430. In one aspect, a single hexagonal electrode 410 labeled "1" forms a center electrode, and a ring of electrodes 410 labeled "2" are interconnected to form a ring electrode. In one aspect, the electrodes 410 between the center and ring electrodes are electrically "floating." In one aspect, the electrodes 410 between the center and ring electrodes are grounded or connected to a floating ground. In one aspect, the electrodes 410 outside the ring electrodes are electrically "floating." In one aspect, the electrodes 410 outside the virtual ring electrodes are grounded or connected to a floating ground.

[0087] Figure 8BAn alternative aspect according to the present disclosure is shown in which an array 400 of electrodes 410 has been configured to form a virtual sensor 440. In one aspect, multiple electrodes 410, designated as "1", are interconnected to form a central electrode, while double-width electrode rings, designated as "2", are interconnected to form a ring electrode. In one aspect, various numbers and locations of electrodes 410 are interconnected to form virtual electrodes of various sizes and shapes.

[0088] Fig.9A and Fig. 9B An exemplary configuration of an electrode array 400 according to the present disclosure is shown, which can form sensors 430 in multiple overlapping positions. Fig.9A In FIG. 4 , a virtual sensor 430A has been formed with a central electrode 432 formed by a single electrode 410 indicated by “1” and a ring electrode 434 formed by a plurality of electrodes 410 indicated by “2”. Fig. 9B 4 shows this same array 400, where a new virtual sensor 430B has been formed using a central electrode 436, designated "3", and a ring electrode 438, designated "4". The location of virtual sensor 430A is shown by a dark outline. As can be seen, virtual sensor 430B overlaps the location of virtual sensor 430A, allowing measurements to be made with a resolution finer than the diameter of sensor 430.

[0089] Fig.10 4 shows how a sensor 430 can be formed from an electrode array 400 that is larger than a portion of a patient's skin that is positioned against the array in accordance with the present disclosure. In this example, an outline of a contact area 450 of the sole 22R of the right foot 20R of the patient 10, as viewed from below the foot 20R and with reference to FIG. 2A to FIG. 2C As can be seen, sensor 430 is shown overlaid on array 400. In this example, sensor 430C has been formed in a position where a portion of sensor 430C extends beyond the edge of contact area 450. In such a position, the capacitance or other electrical parameter measured by sensor 430C is lower than the capacitance measured by sensor 430D positioned completely within contact area 450. As can be seen, sensor 430 can be formed at any point within array 400 and can overlap the contact area at any level ranging from 0% to 100% depending on the position of sensor 430.

[0090] In one aspect, the two sensors can overlap by 0% to 50%, such as 0% to 10%, 5% to 15%, 10% to 20%, 15% to 25%, 20% to 30%, 25% to 35%, 30% to 40%, 35% to 45%, 40% to 50%, 0% to 25%, 15% to 35%, or 25% to 50%. In one aspect, the two sensors can overlap by 25% to 75%, such as 25% to 35%, 30% to 40%, 35% to 45%, 40% to 50%, 45% to 55%, 50% to 60%, 55% to 65%, 60% to 70%, 65% to 75%, 25% to 50%, 40% to 55%, or 50% to 75%. In one aspect, the two sensors can overlap by 50% to 100%, such as 50% to 60%, 55% to 65%, 60% to 70%, 65% to 75%, 70% to 80%, 75% to 85%, 80% to 90%, 85% to 95%, 90% to 100%, 50% to 75%, 65% to 85%, or 75% to 100%.

[0091] In one aspect, the sensor array 400 can further include a plurality of contact sensors ( Fig.10 The plurality of contact sensors may be a plurality of pressure sensors, a plurality of light sensors, a plurality of temperature sensors, a plurality of pH sensors, a plurality of sweat sensors, a plurality of ultrasound sensors, a plurality of bone growth stimulator sensors, or a plurality of combinations of these sensors. In some embodiments, the plurality of contact sensors may include four, five, six, seven, eight, nine, or ten or more contact sensors surrounding each electrode.

[0092] Fig.11A and Fig. 11B 20R, the sensor 430 is formed at a non-overlapping position on the contact area 450R of the right foot 20R. Fig.11A The non-overlapping positions are labeled "A" to "H". Fig. 11BThe SEM values ​​measured at each location are plotted in a graph of FIG. In this example, the SEM values ​​for locations “A” and “H” are low or zero, reflecting that in those locations the sensor 430 does not overlap the contact area 450. The SEM values ​​associated with locations “B” and “G” are higher because the sensor 430 overlaps a portion of the contact area 450 in those locations. The SEM values ​​for locations CDEF are higher, and in this example, are approximately the same, indicating that in those locations the sensor 430 is completely within the contact area 450. In one aspect, a SEM measurement device such as device 180 can determine that certain locations, such as locations “C” and “F” are bilaterally symmetrical about the centerline 452R of the right foot 20R. In one aspect, where a similar set of measurements are made at locations A′-H′ of the left foot 20L, locations on each foot 20L and 20R, such as locations E and E′, can be determined to be approximately bilaterally symmetrical.

[0093] Fig. 12A and Fig. 12B 20L and the right foot 20R. In one aspect, the sensor assembly 500 includes one or more sensors 520 disposed on an inner surface of the shaped substrate 510. In this example, the sensor assembly 500 is configured to conform to the posterior and bottom surfaces of the heel of the foot 20. In one aspect, the shaped substrate 510 can be suitable for use with both the left foot 20L and the right foot 20R. In one aspect, the sensor assembly 500 includes one or more sensors 520 disposed on an inner surface of the shaped substrate 510. In this example, the sensors 520 are configured as Figure 1A In one aspect, the inner surface of the forming substrate 510 is lined with an array 400 of electrodes 410, as shown in FIG. Figure 7 , so that virtual sensors can be formed at any location. In one aspect, sensors having other shapes and configurations are disposed on the inner surface of the forming substrate 510. In one aspect, the forming substrate 510 is a flexible panel (on Fig. 12A ), which can conform to the patient's skin, for example, wrapped around the back of the ankle. In one aspect, the sensor assembly 500 includes a cable 530 for connecting the sensor 520 to one or more power sources, a circuit configured to measure one or more of capacitance or other electrical characteristics, a processor, a communication subsystem, or other types of electronic components ( Fig. 12A not shown).

[0094] Fig. 12BAn exemplary configuration of a sensor assembly 500 is shown in which a plurality of sensors 520 are disposed on a shaped substrate 510 such that, for example, when the sensor assembly 500 is placed against the patient's skin around the back and bottom of the right heel, the sensors 520 may be positioned at locations 26R, 28R, and 30R, with reference to FIG. Figure 2C , and positioned on the central rear portion of the heel. This enables the acquisition of multiple SEM measurements at repeatable locations on the heel using the sensor assembly 500 in a single location. In one aspect ( Fig. 12A and 12B In one aspect, the sensor assembly 500 is configured to be placed on a portion of the patient's back, thereby providing the ability to measure at bilaterally symmetrical locations on the back. In one aspect, the shaped substrate 510 is configured to match the anatomical features of the patient's target area. In one aspect, the shaped substrate 510 includes markings or other indications that can be aligned with features of the patient's body so as to collect multiple measurements at the same location at multiple time intervals over a period of time generally ranging from hours to weeks. In one aspect, the sensor assembly 500 is integrated into the lining of clothing or shoes or other clothing items. In one aspect, the sensor assembly 500 is integrated into a sheet, blanket, pad, or other type of bedding. In one aspect, the sensor assembly 500 includes wireless communication capabilities, such as passive radio frequency identification (RFID) or inductive coupling, to allow the sensor 520 to be activated without being physically connected to the sensor assembly 500.

[0095] Fig.13 A schematic diagram of an integrated system 600 for measuring, evaluating, storing, and transmitting SEM values ​​according to the present disclosure is shown. In this example, the system 600 includes a SEM measurement device 180, such as Figure 4A As discussed, it includes the ability to communicate wirelessly with a WiFi access point 610. The device 180 communicates with one or more of a SEM application running on a server 640, an application running on a laptop 620, a smartphone 630, or other digital device, in one aspect, the laptop 620 and smartphone 630 are carried by a user of the device 180, such as a nurse, and the application provides feedback and information to the user. In one aspect, information received from the device 180 for the patient is stored in a database 650. In one aspect, the information received from the device 180 is transmitted over a network 645 to another server 660, which stores a portion of the information in the patient's electronic medical record (EMR) 670. In one aspect, the information from the device 180 or the information retrieved from the database 650 or the EMR 670 is transmitted to an external server 680 and then transmitted to a computer 685, such as a computer at a doctor's office providing care to the patient.

[0096] From the foregoing, it should be understood that the present invention can be embodied in various ways, including but not limited to the following:

[0097] Embodiment 1. A device for identifying damaged tissue, the device comprising: a first sensor and a second sensor, wherein the first and second sensors each comprise a first electrode and a second electrode, and wherein each of the sensors is configured to be placed against the skin of a patient; a circuit electronically coupled to the first and second electrodes and configured to measure an electrical characteristic between the first and second electrodes of each of the sensors and to provide information about the electrical characteristic; a processor electronically coupled to the circuit and configured to receive information from the circuit and convert the information into a skin moisture (SEM) value; and a non-transitory computer-readable medium electronically coupled to the processor and comprising instructions stored thereon, which, when executed on the processor, perform the following steps: determining a difference between a first SEM value corresponding to an electrical characteristic measured by the first sensor at a first position on the skin of the patient and a second SEM value corresponding to an electrical characteristic measured by the second sensor at a second position on the skin of the patient, wherein the second position is bilaterally symmetrical relative to the first position.

[0098] Embodiment 2. The device of embodiment 1, wherein a difference greater than a predetermined threshold indicates tissue damage at one of the first and second locations.

[0099] Embodiment 3. A device according to embodiment 1, wherein: the circuit is electronically coupled to the first and second electrodes of each of the first and second sensors, and the circuit is configured to convert the first electrical characteristic measured using the first sensor into a first SEM value and convert the second electrical characteristic measured using the second sensor into a second SEM value.

[0100] Embodiment 4. The device according to embodiment 2 further comprises: a substrate configured to be placed at a known position on the patient's skin, and the first and second sensors are arranged on the substrate so that when the substrate is placed at the known position on the patient's skin, the first and second sensors are positioned at bilaterally symmetrical positions on the patient's skin.

[0101] Embodiment 5. The device of embodiment 1, further comprising a gap between the first and second electrodes.

[0102] Embodiment 6. The apparatus of embodiment 1, wherein the electrical characteristic comprises one or more electrical components selected from the group consisting of: resistance, capacitance, inductance, impedance, and magnetoresistance.

[0103] Embodiment 7. A device for identifying damaged tissue, the device comprising: a substrate configured to be placed against the surface of a patient's skin; a plurality of sensors arranged on the substrate at corresponding plurality of positions, wherein each sensor comprises a pair of electrodes; a circuit electronically coupled to a pair of electrodes of each of the plurality of sensors and configured to measure electrical characteristics between paired electrodes of a portion of the plurality of sensors and provide information about the measured electrical characteristics; a processor electronically coupled to the circuit and configured to receive information about the electrical characteristics from the circuit and convert the plurality of electrical characteristics into corresponding plurality of subepidermal moisture (SEM) values; and a non-transitory computer-readable medium electronically coupled to the processor and comprising instructions stored thereon, which, when executed on the processor, perform the following steps: identifying a first sensor and a second sensor located at first and second positions that are bilaterally symmetrical relative to the patient's skin through a plurality of SEM values, and comparing a first SEM value associated with the first sensor with a second SEM value associated with the second sensor.

[0104] Embodiment 8. The apparatus of embodiment 7, wherein the instructions further comprise the steps of determining a difference between the first and second SEM values ​​and providing an indication that tissue is damaged at one of the first and second locations if the difference is greater than a predetermined threshold.

[0105] Embodiment 9. An apparatus according to embodiment 7, wherein the instructions further include the steps of determining a difference between the first and second SEM values, determining which of the first and second SEM values ​​is greater than the other, and providing an indication that tissue is damaged at a location associated with the larger SEM value if the difference is greater than a predetermined threshold.

[0106] Embodiment 10. The apparatus of Embodiment 7, wherein the electrical characteristic comprises one or more electrical components selected from the group consisting of: resistance, capacitance, inductance, impedance, and magnetoresistance.

[0107] Embodiment 11. A device for identifying damaged tissue, the device comprising: a device body; two sensors, including a first sensor and a second sensor, wherein the two sensors are arranged on the device body to allow the first sensor to be simultaneously positioned at a first position on the patient's skin and the second sensor to be positioned at a second position symmetrically relative to the first position; a circuit, electronically coupled to each of the two sensors and configured to measure electrical characteristics from each of the two sensors; a processor, electronically coupled to the circuit and configured to receive a first electrical characteristic measurement value from the first position and a second electrical characteristic measurement value from the second position, and convert the first electrical characteristic measurement value into a first subepidermal moisture (SEM) value and convert the second electrical characteristic measurement value into a second SEM value; a non-transitory computer readable medium, electronically coupled to the processor and containing instructions, which, when executed on the processor, perform the step of determining the difference between the first SEM value and the second SEM value.

[0108] Embodiment 12. The device of embodiment 11, wherein each of the two sensors is disposed on both ends of the device body while being aligned on a common plane.

[0109] Embodiment 13. A device according to embodiment 11, wherein the device body is rigid and holds the two sensors at a fixed separation distance and fixed orientation relative to each other.

[0110] Embodiment 14. The device of embodiment 11, wherein the device body is flexible and allows the two sensors to be oriented at an angle relative to each other.

[0111] Embodiment 15. The device of embodiment 14, wherein the device body comprises a hinge.

[0112] Embodiment 16. The device of Embodiment 11, wherein each of the two sensors comprises a first electrode and a second electrode separated by a gap.

[0113] Embodiment 17. The device of Embodiment 16, wherein the electrical characteristic is measured between the first electrode and the second electrode.

[0114] Embodiment 18. The device of Embodiment 11, wherein each of the two sensors comprises a plurality of electrodes separated by gaps.

[0115] Embodiment 19. The device of embodiment 18, wherein a plurality of electrodes are selectively activated to form a virtual ring electrode and a virtual center electrode.

[0116] Embodiment 20. The apparatus of Embodiment 11, wherein the electrical characteristic comprises one or more electrical characteristics selected from the group consisting of: resistance, capacitance, inductance, impedance, and magnetoresistance.

[0117] Embodiment 21. The apparatus of Embodiment 11, wherein the first electrical characteristic measurement and the second electrical characteristic measurement are measured simultaneously.

[0118] Embodiment 22. The device of Embodiment 21, wherein the device further comprises a contact sensor positioned adjacent to one of the two sensors, and wherein the simultaneous measurement is triggered by actuation of the contact sensor.

[0119] Embodiment 23. The device according to embodiment 22, wherein the contact sensor is a pressure sensor or an optical sensor.

[0120] Embodiment 24. The apparatus of Embodiment 11, wherein the instructions further comprise the step of providing an indication that tissue is damaged at one of the first and second locations if the difference is greater than a predetermined threshold.

[0121] Embodiment 25. The apparatus of Embodiment 11, wherein the instructions further comprise the steps of determining the larger of the first and second SEM values ​​and providing an indication that tissue is damaged at a location associated with the larger SEM value if the difference exceeds a predetermined threshold.

[0122] Embodiment 26. A method for identifying damaged tissue, the method comprising: obtaining a first subepidermal moisture (SEM) value from a first location on the skin of a patient; obtaining a second SEM value from a second location symmetrically relative to the first location; and determining a difference between the first SEM value and the second SEM value.

[0123] Embodiment 27. The method of Embodiment 26, further comprising providing an indication that tissue is damaged at one of the first and second locations if the difference is greater than a predetermined threshold.

[0124] Embodiment 28. The method of Embodiment 26, further comprising: determining the larger of the first and second SEM values, and providing an indication that tissue is damaged at a location associated with the larger SEM value if the difference exceeds a predetermined threshold.

[0125] Although the present invention has been described with reference to specific aspects, it will be appreciated by those skilled in the art that various changes may be made and equivalent replacements may be made to its elements without departing from the scope of the present invention. In addition, many modifications may be made to specific situations or materials according to the teachings of the present invention without departing from the scope of the present invention. Therefore, it is not intended that the present invention be limited to the specific aspects disclosed, but that the present invention may include all aspects falling within the scope and spirit of the appended claims.

Claims

1. An apparatus for determining tissue damage, comprising means for performing the following steps: a) obtaining a first plurality of biocapacitive measurements at a first location on the patient's skin; b) obtaining a second plurality of biocapacitive measurements at a second location on the patient's skin that is bilaterally symmetrical with respect to the first location; c) converting the first plurality of biocapacitance measurements into a first plurality of subcutaneous moisture SEM values; d) converting the second plurality of biocapacitive measurements into a second plurality of SEM values; e) determining a first average SEM value from the first plurality of SEM values; f) determining a second average SEM value from the second plurality of SEM values; g) determining a difference between the first average SEM value and the second average SEM value; and h) If the difference is greater than a predetermined threshold, it is determined that the tissue is damaged at the location having the larger mean SEM value.

2. The apparatus of claim 1 , wherein the first plurality and the second plurality of biocapacitance measurements are obtained simultaneously.

3. The apparatus of claim 1, wherein the first plurality and the second plurality of biocapacitive measurements are obtained sequentially.

4. The device according to claim 1, characterized in that The first position and the second position are located at a left heel and a right heel, respectively.

5. The device according to claim 1, wherein: The first position and the second position are located at the left foot and the right foot respectively.

6. The device according to claim 1, wherein: The first position and the second position are located on the left side and the right side of the lower back, respectively.

7. The device according to claim 1, wherein: The first position and the second position are located in the left and right sacral regions, respectively.

8. The device according to claim 1, wherein: The first location is a first anatomical site, and the second location is a second anatomical site that is bilaterally symmetric relative to the first anatomical site.

9. An apparatus for determining tissue damage, comprising means for performing the following steps: a) obtaining a first measurement of an electrical property at a first location on the patient's skin; b) obtaining a second measurement of the electrical characteristic at a second location on the patient's skin that is bilaterally symmetrical with respect to the first location; c) converting the first measured value and the second measured value of the electrical characteristic into a first subcutaneous moisture SEM value and a second SEM value, respectively; d) determining a difference between the first SEM value and the second SEM value; and e) If the difference is greater than a predetermined threshold, it is determined that the tissue is damaged at the location having the larger SEM value.

10. The device according to claim 9, wherein: The first measurement of the electrical characteristic is a first biocapacitance measurement and the second measurement of the electrical characteristic is a second biocapacitance measurement.

11. The device according to claim 10, wherein: The first biocapacitance measurement and the second biocapacitance measurement are obtained simultaneously.

12. The apparatus of claim 10, wherein the first biocapacitance measurement and the second biocapacitance measurement are obtained sequentially.

13. The device according to claim 10, wherein: The first position and the second position are located at a left heel and a right heel, respectively.

14. The device according to claim 10, wherein: The first position and the second position are located at the left foot and the right foot respectively.

15. The device according to claim 10, wherein: The first position and the second position are located on the left side and the right side of the lower back, respectively.

16. The device according to claim 10, wherein: The first position and the second position are located in the left and right sacral regions, respectively.

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