Lymphatic diagnostic equipment

Abstract

The present disclosure relates to a diagnostic device for diagnosing lymphedema that may have a sensor array that may include at least a durometer, a temperature sensor, and a dielectric sensor to measure tissue parameters that can be used to develop a tissue health score for diagnosing lymphedema and monitoring tissue health.

Description

[Technical field]

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 215,396, filed June 25, 2021, which is incorporated by reference in its entirety. All applications identified as having foreign or domestic priority in an Application Data Sheet filed with this application are incorporated by reference herein pursuant to 37 CFR 1.57.

[0002] The present disclosure relates to diagnostic devices, and more particularly to lymphatic diagnostic devices for diagnosing lymphedema. [Background technology]

[0003] Lymphedema is a medical condition in which excess fluid, such as lymph, builds up in the body. In some cases, this excess fluid can build up in certain areas of the body, such as the hands and feet, causing swelling (edema). If left untreated, a number of additional symptoms can occur, including infection, fatigue, limited range of motion, and skin / tissue hardening. Summary of the Invention [Means for solving the problem]

[0004] Lymphedema and other skin conditions can be difficult to diagnose. Even experienced physicians with years of training, experience, and education often have difficulty identifying the severity of skin and / or lymphatic deterioration. Disclosed herein are diagnostic devices, systems, and associated components that may be used to diagnose lymphedema and / or other skin conditions. The diagnostic devices may provide real-time indications to aid in diagnosis. The diagnostic devices may measure one or more parameters such as temperature, moisture content, bioimpedance, hardness or elasticity, oxygen content, pulse, electromagnetic reflectance in the visual and non-visual spectrum, and / or others. The data obtained for one or more parameters may be cleaned or filtered. The cleaned or filtered data may be used as input to an algorithm to generate a tissue health score. The tissue health score may be an indication used by patients and medical personnel to aid in diagnosis and treatment. Integrating multiple parameters to generate a tissue health score may provide a more reliable indication of subcutaneous tissue health for a variety of conditions including, but not limited to, lymphedema, edema, circulatory insufficiency, tissue health, ulceration, cellulitis, fibrosis, venous insufficiency, and others.

[0005] In some variations, diagnostic devices are disclosed herein that measure two or more parameters. The diagnostic devices may include one or more sensors capable of measuring the two or more parameters. The diagnostic devices may include a display capable of displaying the two or more measured parameters and / or the tissue health score.

[0006] In some variations, the two or more parameters may include temperature, moisture content, bioimpedance, and / or hardness or elasticity.

[0007] In some variations, the two or more parameters may include oxygen content, pulse rate, and / or electromagnetic reflectance in the visual and / or non-visual spectrum.

[0008] In some variations, the temperature may be measured at the user's skin.

[0009] In some variations, the temperature may be measured subcutaneously.

[0010] In some variations, two or more sensors may measure two or more parameters simultaneously.

[0011] In some variations, two or more sensors may measure two or more parameters sequentially.

[0012] In some variations, two or more sensors may measure two or more parameters at approximately the same location on the user's body.

[0013] In some variations, two or more sensors may measure two or more parameters at multiple locations on the user's body.

[0014] In some variations, more than one parameter can be used to generate the tissue score.

[0015] In some variations, measurements of two or more parameters can be taken at any location on a human or animal.

[0016] In some variations, measurements of two or more parameters can be taken at a site on the human or animal body and associated with a map to facilitate tracking of measurements at the same site across multiple measurements.

[0017] In some variations, measurements of more than one parameter can be tracked over time.

[0018] In some variations, measurements of more than one parameter may be stored in the diagnostic device.

[0019] In some variations, the diagnostic device is capable of communicating with a remote device and can transmit measurements of two or more parameters and / or a tissue health score to the remote device.

[0020] In some variations, the display of the diagnostic device can prompt the user to measure two or more parameters at a human or animal site.

[0021] In some variations, a display on a remote device in communication with the diagnostic device can prompt a user to measure two or more parameters at a human or animal site.

[0022] In some variations, the diagnostic device can be used by trained or untrained users in a hospital, clinic, or home environment.

[0023] In some variations, the tissue health score can be generated by an algorithm that uses measurements of two or more parameters as input.

[0024] In some variations, measurement data for more than one parameter can be cleaned.

[0025] In some variations, two or more parameters may be weighted equally by the algorithm.

[0026] In some variations, measurement data for two or more parameters may be weighted unequally by the algorithm.

[0027] In some variations, measurements of two or more parameters and / or tissue health scores can be used to determine tissue health trends, disease diagnoses, and / or recommended treatments.

[0028] In some variations, the display can output information regarding tissue health trends, disease diagnoses, and / or recommended treatments.

[0029] In some variations, the tissue health score, or a derivative thereof, can be used to guide the treatment of one or more diseases.

[0030] In some variations, the one or more conditions may include edema, ulceration, cellulitis, fibrosis, and / or venous insufficiency.

[0031] In some variations, a tissue health score may be generated from a comparison of measurements of two or more parameters and / or tissue health scores to measurement data of two or more parameters and / or tissue health scores related to healthy tissue and / or unhealthy tissue.

[0032] In some variations, the diagnostic device can be used to measure edema, lymphedema, circulatory insufficiency, and tissue health.

[0033] In some variations, the diagnostic device can automatically take measurements of two or more parameters when pressed against the skin, or can receive user input to manually take measurements.

[0034] In some variations, the two or more parameters may include temperature, which may be measured using a thermocouple, a resistance temperature detector, a thermistor, a semiconductor-based integrated circuit, and / or an infrared thermometer.

[0035] In some variations, the two or more parameters may include hydration / bioimpedance, which may be measured using multi-frequency bioimpedance analysis (MFBIA), spectroscopic imaging, differential spectroscopic visible, infrared, and ultraviolet spectra, and / or open-ended coaxial probes.

[0036] In some variations, the two or more parameters may include hardness, which may be measured using a durometer, single or multiple force transducers, strain transducers, pressure transducers, and / or suction with an optical displacement sensor.

[0037] In some variations, the two or more parameters can include oxygen content, which can be measured using spectroscopic imaging, differential spectroscopic visible, infrared, and / or ultraviolet spectroscopy.

[0038] In some variations, the two or more parameters may include pulse, which may be measured using spectroscopic imaging, differential spectroscopic visible, infrared, and ultraviolet spectra, and / or near-field coherent sensing.

[0039] In some variations, the two or more parameters may include electromagnetic reflectance, which may be measured using a digital camera sensor and / or a photodiode.

[0040] In some variations, the diagnostic device can include a head assembly that can have a durometer probe, a temperature sensor, a dielectric conductor, and a ground conductor.In some variations, the diagnostic device can include a head assembly that can have a durometer probe, a temperature sensor, a dielectric conductor, and a ground conductor.

[0041] In some variations, the ground conductor may include a ring shape and the dielectric conductor may be centrally located within the ring shape.

[0042] In some variations, the durometer probe may be positioned inside the periphery of the ground conductor.

[0043] In some variations, the temperature sensor may be located inside the periphery of the ground conductor.

[0044] In some variations, the durometer probe may be positioned outside the periphery of the ground conductor.

[0045] In some variations, the temperature sensor may be positioned outside the periphery of the ground conductor.

[0046] In some variations, the diagnostic device can include an electrical insulator that can be disposed between the dielectric conductor and the ground conductor.

[0047] In some variations, the diagnostic device can include a head assembly that can include a probe, a ground conductor, and a temperature sensor. The probe can be used to obtain the dielectric constant measurements and to measure hardness. In some variations, the diagnostic device can include a head assembly that can include a probe, a ground conductor, and / or a temperature sensor.

[0048] In some variations, the diagnostic device may include a head assembly that may include a probe, a ground conductor, and a temperature sensor. The probe may be used to obtain dielectric measurements and to measure elasticity.

[0049] In some variations, the ground conductor may include a ring shape.

[0050] In some variations, the probes may be positioned inside the periphery of the ground conductor.

[0051] In some variations, the probe may be positioned concentrically with the ground conductor.

[0052] In some variations, the head assembly may include a force transducer body, a force transducer tip, and a spring disposed between the force transducer body and the force transducer tip. The probe moves the force transducer tip toward the force transducer body to measure hardness by being pushed by tissue.

[0053] In some variations, the head assembly may include a force transducer body, a force transducer tip, and a spring disposed between the force transducer body and the force transducer tip, and the probe moves the force transducer tip toward the force transducer body to measure elasticity of the tissue by being pushed by the tissue.

[0054] In some variations, the diagnostic device can include an insulator that can be disposed between the probe and the ground conductor.

[0055] In some variations, the diagnostic device can include an insulator that can be disposed between the probe and the ground conductor. The insulator can be spaced from the tip of the ground conductor such that an air gap is disposed between the probe and the ground conductor.

[0056] In some variations, disclosed herein are diagnostic devices for measuring two or more parameters of tissue. The diagnostic device can include one or more sensors that can measure the two or more parameters to generate a tissue health score for the tissue.

[0057] In some variations, disclosed herein is a diagnostic device for measuring tissue stiffness and bioimpedance. The diagnostic device may include a ground conductor. The diagnostic device may include a probe capable of measuring tissue bioimpedance and obtaining dielectric constant measurements to measure tissue stiffness.

[0058] In some variations, the dielectric constant and hardness measurements can be used to generate a tissue health score for the tissue.

[0059] In some variations, the diagnostic device includes a temperature sensor configured to measure a temperature of the tissue.

[0060] In some variations, the dielectric constant, hardness, and temperature measurements can be used to generate a tissue health score for the tissue.

[0061] In some variations, the diagnostic device can include an insulator that can be disposed between the probe and the ground conductor.

[0062] In some variations, the probes may be positioned inside the periphery of the ground conductor.

[0063] In some variations, the ground conductor may include a ring shape.

[0064] In some variations, the diagnostic device may have a force transducer body, a force transducer tip, and a spring disposed between the force transducer body and the force transducer tip, and the probe is pushed by the tissue to move the force transducer tip toward the force transducer body to measure hardness.

[0065] In some variations, the diagnostic device may include an insulator that may be disposed between the probe and the ground conductor. The insulator may be spaced from the tip of the ground conductor such that an air gap is disposed between the probe and the ground conductor.

[0066] In some variations, the probe can be used to measure the bioimpedance of tissue and simultaneously obtain dielectric constant measurements to measure tissue stiffness.

[0067] In some variations, the diagnostic device may include a transducer to which the probe may apply a force to measure tissue hardness.

[0068] In some variations, the diagnostic device may prompt the user to take measurements at parts of the user's body.

[0069] In some variations, a computing device in communication with the diagnostic device may prompt the user to take measurements at parts of the user's body.

[0070] Neither the above summary nor the following detailed description is intended to limit or define the scope of protection. The scope of protection is defined by the claims. Furthermore, reference is made herein to the diagnosis of lymphedema. However, a person skilled in the art will understand, after reviewing the entire disclosure, that the diagnostic devices, methods, systems, components, etc. described herein may be used for other purposes besides diagnosing and / or monitoring lymphedema. For example, the diagnostic devices, methods, systems, components, etc. described herein may be used to diagnose and / or monitor edema, lymphedema, circulatory insufficiency, tissue health. Furthermore, the diagnostic devices, methods, systems, components, etc. may be used in both humans and animals. [Brief description of the drawings]

[0071] The above-mentioned and other features of the embodiments disclosed herein are described below with reference to the drawings of the embodiments. The illustrated embodiments are intended to illustrate, but not to limit, the scope of protection. Various features of the different disclosed embodiments can be combined to form further embodiments that are part of this disclosure. [Figure 1] FIG. 1 shows the lymphatic system of the human body. [Diagram 2] FIG. 2 shows a diagnostic device. [Diagram 3] FIG. 3 shows a diagnostic device and multiple test sites on a user's arm. [Figure 4] FIG. 4 shows a head assembly for a diagnostic device. [Figure 5A] FIG. 5A shows the contact surface of the nose portion of the head assembly. [Figure 5B] FIG. 5B shows a cross section of the nose portion of the head assembly of FIG. 5A. [Figure 6A] FIG. 6A shows a side view of the head assembly. [Figure 6B] FIG. 6B shows a view of the connecting portion of the head assembly of FIG. 6A. [Figure 6C] FIG. 6C shows a perspective view of the head assembly of FIG. 6A. [Figure 6D]FIG. 6D shows a cross-sectional view of the head assembly of FIG. 6A. [Figure 7] FIG. 7 is a schematic diagram of the diagnostic device and the computing device. [Figure 8] FIG. 8 is a schematic diagram of a handheld diagnostic device. [Figure 9] FIG. 9 is a schematic diagram of a benchtop diagnostic device. [Figure 10] FIG. 10 shows a display of a diagnostic device showing test sites on a user's arm. [Figure 11] FIG. 11 shows various sensor measurements (water content / bioimpedance, hardness, and temperature) across multiple stages of tissue health in lymphedema. [Figure 12] FIG. 12 illustrates a process for generating tissue health scores and other information based on tissue health scores and / or sensor measurements. [Figure 13] FIG. 13 shows a graph of the tissue scores generated over time. [Figure 14] FIG. 14 shows a graph of standing wave ratio measurements versus moisture content. [Figure 15] FIG. 15 shows a graph of the tip to body force transducer. [Figure 16A] FIG. 16A shows an alternative head assembly of a diagnostic device. [Figure 16B] FIG. 16B shows a cross-sectional side view of the head assembly of FIG. 16A. [Figure 17A] FIG. 17A illustrates an alternative head assembly for a diagnostic device. [Figure 17B] FIG. 17B shows a cross-sectional side view of the head assembly of FIG. 17A. [Figure 18A] FIG. 18A illustrates an alternative head assembly for a diagnostic device. [Figure 18B] FIG. 18B shows a cross-sectional side view of the head assembly of FIG. 18A. [Figure 18C] FIG. 18C shows a cross-sectional side view of the head assembly of FIG. 18B contacting tissue. [Figure 19A] FIG. 19A illustrates an alternative head assembly for a diagnostic device. [Figure 19B] FIG. 19B shows a cross-sectional side view of the head assembly of FIG. 19A. [Figure 20A] FIG. 20A shows another head assembly of a diagnostic device. [Figure 20B] FIG. 20B shows a cross-sectional side view of the head assembly of FIG. 20A. [Figure 21A] FIG. 21A shows a perspective view of the head assembly of FIG. 19A. [Figure 21B] FIG. 21B shows a side cross-sectional view of the head assembly of FIG. 21A. [Figure 22A] FIG. 22A shows the simulated electric field for a head assembly similar to the one shown in FIG. 16A. [Figure 22B] FIG. 22B shows the simulated electric field for a head assembly similar to the one shown in FIG. 19A. [Figure 23A] FIG. 23A shows a graph of the clinical data for the real part of the permittivity measurements. [Figure 23B] FIG. 23B shows a graph of the clinical data for the imaginary part of the permittivity measurement. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0072] Although specific embodiments and examples are described below, the disclosure extends beyond the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. Additionally, although this disclosure describes many embodiments with reference to treating lymphedema, as described herein, none of the embodiments and their modifications or equivalents should be limited to treating lymphedema.

[0073] FIG. 1 illustrates the lymphatic system of a user's body. The lymphatic system is an organ system and may be a separate and complete body system that serves a unique functional role to the human body. The lymphatic system includes a network of lymphatic vessels or channels and lymph nodes, among other functions that help recirculate blood and / or lymphatic fluid throughout the body. As described herein, lymphedema is a medical condition in which excess fluid, such as lymphatic fluid, accumulates in areas of the body, such as the hands and feet, causing swelling (i.e., edema), hardening of the skin, skin discoloration (e.g., redness), and / or warmth of the skin. If left untreated, many more adverse symptoms may result.

[0074] FIG. 2 illustrates a diagnostic device 100. The diagnostic device 100 can be used to diagnose, monitor, and / or predict lymphedema, edema, circulatory insufficiency, tissue health, ulceration, cellulitis, fibrosis, venous insufficiency, and other medical conditions. The diagnostic device 100 can be a handheld device, or in some variations, a tabletop device. The diagnostic device 100 can be used by a patient and / or administrator, allowing the diagnostic device 100 to be used on the go and / or at home, in a hospital, in a clinic, and the like. The diagnostic device 100 can communicate with computing devices, such as portable electronic devices (e.g., smartphones), tablets, laptops, desktops, remote computing environments, servers, storage devices, and the like. In some variations, diagnostic data and / or usage data generated from the diagnostic device 100 can be transmitted to a remote device for review and / or analysis by the patient and / or administrator associated with the system.

[0075] The diagnostic device 100 may include a housing 102 in which various components of the diagnostic device 100 may be housed. The housing 102 may be gripped by a user to handle the diagnostic device 100. The housing 102 may be of various sizes and / or shapes. For example, the housing 102 may be an elongated prism with rounded edges, which may increase user comfort.

[0076] The diagnostic device 100 may include a head 104, also referred to as a head assembly, a tip, and / or an end. The head 104 may extend from an end of the housing 102.

[0077] The diagnostic device 100 may include one or more sensors 108, e.g., a sensor array, for measuring one or more parameters. The one or more sensors 108 may be located on the head 104. The one or more sensors 108 may be used to measure one or more parameters of the user, such as temperature (measured cutaneously or subcutaneously), water content, bioimpedance, hardness or elasticity, oxygen content, tissue dielectric constant, pulse rate, electromagnetic reflectance in the visible and non-visible spectrum, and / or others. Temperature (measured at the skin or subcutaneously) may be measured using at least one or more sensors, such as a thermocouple, a resistance temperature detector (RDT), a thermistor, a semiconductor-based integrated circuit, and / or an infrared thermometer. The hydration or bioimpedance may be measured by at least one or more sensors using at least multi-frequency bioimpedance analysis (MFBIA), spectroscopic imaging, differential spectroscopic visible, infrared and / or ultraviolet spectrum, open-ended coaxial probes. Hardness or elasticity may be measured using at least one or more sensors such as a durometer, single or multiple force transducers, strain transducers, pressure transducers, and / or suction with optical displacement sensors. The oxygen content may be measured using at least one or more sensors using at least spectroscopic imaging and / or differential spectroscopy in the visible, infrared and / or ultraviolet spectrum. The pulse may be measured by at least one or more sensors using at least spectroscopic imaging, differential spectroscopic visible, infrared and ultraviolet spectra, and / or near-field coherent sensing. Electromagnetic reflection (images) in the visible and non-visible spectrum can be measured using at least a digital camera sensor and / or a photodiode. One or more sensors 108 may measure one or more parameters simultaneously or sequentially at one or more substantially the same locations on a user (eg, a human or animal). In some variations, the diagnostic device 100 can automatically take one or more measurements when one or more sensors 108 and / or head 104 are pressed against the skin, and / or can take one or more measurements based on user input via a user interface as described herein. Measurements can be taken at any location on the user. In some variations, measurements can be tracked over time. In some variations, measurements can be correlated to a map, allowing a user to track measurements at the same location over a period of time, which can be useful for monitoring progress or regression.

[0078] The measured data and / or tissue scores for one or more parameters described herein can be used to diagnose, monitor, and / or predict a medical condition. The diagnostic device 100 and / or a computing device in communication (wirelessly or wired) with the diagnostic device 100 (such as a portable electronic device, e.g., a smartphone, a tablet, a laptop, a desktop, a remote computing environment, a server, a storage device, etc.) can generate tissue scores based on the measured data for one or more parameters. The diagnostic device 100 and / or a computing device in communication (wirelessly or wired) with the diagnostic device 100 can clean or filter the measured data. The algorithm can use measurement data for one or more parameters as input to generate a tissue score. In some variations, the measurement data for one or more parameters can have equal or unequal weighting. For example, in some medical conditions, one or more parameters can be weighted more heavily than another to better diagnose, monitor, and / or predict the condition. The input of multiple parameters can provide a more complete picture of the health of the skin and / or subcutaneous tissue. In some variations, a tissue score can be generated based on a comparison to a healthy limb or part of the body. The measurements and / or tissue scores for one or more parameters can be stored in the diagnostic device 100 and / or a computing device in communication with the diagnostic device 100. The measurements and / or tissue scores for one or more parameters can be used to derive a treatment regimen.

[0079] The diagnostic device 100 may include a user interface 106. The user interface 106 may receive user input and / or display information to a user. The user interface 106 may include one or more toggles, buttons, switches, etc. for receiving user input, including turning the diagnostic device 100 on or off, instructing the diagnostic device 100 to take one or more measurements, navigating through information (e.g., past measurements and / or tissue scores) and / or pages displayed on the display, changing one or more settings, etc. The display may show measurement data (past and / or current) and / or tissue scores, settings, messages, instructions (eg, prompting the user to take measurements on specific parts of a human or animal), graphics, and the like. In some variations, a computing device and / or display in communication with the diagnostic device 100 can display measurement data (past and / or current) and / or tissue scores, settings, messages, instructions (e.g., prompting a user to take measurements of specific parts of a human or animal), graphics, etc.

[0080] 3 illustrates a diagnostic device 100 and various test sites 302 on a user's arm 300. The diagnostic device 100 may include a housing 102, a head 104, and / or sensors 108 for measuring one or more parameters as described herein. The sensors 108 include at least a bioimpedance sensor 110 for measuring water content, a durometer for measuring hardness and / or elasticity, and a temperature sensor 114 for measuring temperature. The above parameters may be used to diagnose, monitor, and / or predict the course of lymphedema and / or other medical conditions. The diagnostic device 100 can be manipulated by a patient and / or medical personnel to obtain one or more measurements, such as moisture content, hardness and / or elasticity, and / or temperature, at various test sites 302 on the user's body, such as the user's arm 300 shown. The measurement data may be cleaned or filtered by diagnostic device 100 and / or another computing device in communication with diagnostic device 100. The measurement data may be input into an algorithm, as described herein, that generates a tissue health score at a particular test site 302, such that each test site 302 has measurement data and / or tissue health score associated with it. By being able to track the measurement data and / or tissue health score over time, the condition of the tissue (e.g., skin) at the test site 302 may be monitored for diagnosis, treatment, etc.

[0081] 4 shows an example of a head assembly 104, also referred to as a head, tip, and / or end. The head 104 may include a first retainer 120 and / or a second retainer 122 used to house the functional elements of the head 104. The first retainer 120 and the second retainer 122 may be rings having holes therethrough with internal threads configured to thread into the body 118, for example, the head 104 may have a threaded portion 154 on one side and a threaded portion 155 on the other side. The first retainer 120 may be engageable with the threaded portion 154 to couple with the body 118 and may retain one or more functional elements and related components, such as a nose 124 and / or a probe 132, to the body 118. The nose 124 may be retained in the body 118 while extending through the hole in the first retainer 120. The second retainer 122 is engageable with the threaded portion 155 for coupling with the body 118 and can retain one or more functional elements to the body 118 .

[0082] As described herein, the head 104 may include a durometer. The durometer may include a force transducer. For example, the body 118 may include a cavity 136. The cavity 136 houses a spring 138 therein. The spring 138 may be disposed between the force transducer body 142 and the force transducer tip 140 to transmit a force to facilitate measuring hardness or elasticity. For example, a probe 132, also referred to as a pin or signal probe, may extend through a hole 128 in the nose portion 124 to contact the user's skin. The probe 132 may be pressed against the skin, and applying a force against the force transducer tip 140 transmits the force through the spring 138 to the force transducer body 142, thereby measuring hardness or elasticity. The probe 132 is translatable within the hole 128.

[0083] The nose portion 124 may include a contact surface 126. The contact surface 126 may contact the user's skin when the probe 132 is pressed against the skin to measure hardness or elasticity. In some variations, the nose portion 124 may include a ground ring 130 that may be positioned on the contact surface 126 and that contacts the user's skin during measurement. In some variations, the head 104 may include a temperature sensor 134 that may be positioned on the contact surface 126 to enable temperature measurements when the contact surface 126 is pressed against the skin. In some variations, the probe 132 and / or other functional elements of the head 104 or nose portion 124 can measure the bioimpedance / water content of the user. In use, the probe 132 and contact surface 126 are pressed against the skin while simultaneously obtaining temperature, hardness or elasticity, and / or bioimpedance. In some variations, temperature, hardness or elasticity, and / or bio-impedance may be obtained sequentially and / or in part (eg, temperature and bio-impedance together, etc.).

[0084] 5A and 5B show the nose portion 124 of the head 104 from various perspectives. As described herein, the ground ring 130 can be disposed within the contact surface 126 of the nose portion 124. The nose portion 124 can include a hole 128 through which the probe 132 can extend. The ground ring 130 can surround the hole 128 and the probe 132. The diagnostic device 100 can include a coaxial cable 146. A wire can connect the coaxial cable 146 to the ground ring 130. A wire can connect the coaxial cable 146 to a washer 152, which in some variations is simply a contact configured to form an electrical connection between the coaxial cable 146 and the pressure sensor 148. In use, when the probe 132 presses against the skin, a force is applied to the pressure sensor 148 by the washer 152 disposed therebetween to measure hardness or elasticity. The diagnostic device 100 can include a ring 144 disposed around the probe 132. The ring 144 may be disposed inside the nose portion 124 .

[0085] As described herein, nose portion 124 can include a temperature sensor 134 positionable within contact surface 126 such that temperature sensor 134 contacts the user's skin when probe 132 and contact surface 126 contact the skin. Diagnostic device 100 can include a printed circuit board 150 operably connectable to temperature sensor 134 and / or other functional elements. Printed circuit board 150 can be a flexible printed circuit board.

[0086] 6A-6D show head 104 from various perspectives. Head 104 may include a sensor as described herein. Head 104 may include a body 118 as described herein. Head 104 may include a first retainer 120 to retain one or more functional elements in body 118. Body 118 may include threaded portion 154 and threaded portion 155. First retainer 120 may be threaded onto threaded portion 155 of body 118 to retain nose 124 and probe 132. As described herein, the head 104 may include a durometer that may include a force transducer. For example, the body 118 may include a cavity 136. The cavity 136 may house a spring 138 therein. The spring 138 may be disposed between the force transducer body 142 and the force transducer tip 140 to transmit a force to facilitate measuring hardness or elasticity. The head 104 may include a hole 156 that may be located on an opposite side of the head 104 from the probe 132. The hole 156 may include a notch 158. The head 104 may include a stopper 160 that may extend into the hole 156, and the stop 160 may be configured to stop or limit the movement of the probe 132. For example, the stop 160 may limit the amount of force that may be applied to the transducer.

[0087] 7 illustrates a schematic of a diagnostic device 100 and a computing device 172, which may include a computer, tablet, smartphone, remote computing environment, etc. The diagnostic device 100 may include a sensor 108, a battery 162, a controller 164, a processor 166, data storage 168, a wired or wireless communication interface 170, and / or any other functional elements to perform the functions described herein. As described herein, the diagnostic device 100 may obtain measurements and / or compute tissue health scores. The diagnostic device 100 may communicate with the computing device 172 via the wired or wireless communication interface 170 (e.g., wireless, WI-FI, Bluetooth, cellular networks such as 3G, 4G and 5G, etc.). In some variations, diagnostic device 100 can take measurements and transmit the measurement data to computing device 172 for processing, storage, and / or generation of a tissue health score. In some variations, diagnostic device 100 can take measurements, process the measurement data, generate a tissue health score, store the data, etc., and transmit the measurement data, tissue health score, etc. to computing device 172 for storage, further processing, and / or display on a display of computing device 172. For example, in some variations, the computing device 172 may have a display to allow a user and / or administrator to review and / or analyze the measurement data, the organizational health score, record messages, etc. The computing device 172 may be at least a portable electronic device (e.g., a smartphone), a tablet, a laptop, a desktop, a remote computing environment, a server, a storage device, etc.

[0088] 8 illustrates a schematic of a handheld diagnostic device 174. Diagnostic device 174 may include any of the functional elements of diagnostic device 100 or other diagnostic devices described herein. Diagnostic device 174 may have a printed circuit board 176 that may include a display 192, one or more buttons 188, one or more LEDs 190, and / or other functional elements, which may be integrated into a top layer 178. Display 192 may communicate instructions, measurement data of one or more parameters, a tissue health score, and / or other information to a user. In some variations, display 192 may be a touch screen. The top layer 178 can be in communication with one or more functional elements of the bottom layer 180. The diagnostic device 174 can include a head 104, also referred to as a probe head assembly, which communicates with a vector network analyzer 184 via a connector 182. The head 104 can include any of the sensors described herein and is configured to contact the skin of a patient. The diagnostic device 174, the connector 182, the vector network analyzer 184, and / or the battery 186 can be incorporated into the bottom layer 180 of the diagnostic device 174.

[0089] 9 illustrates a schematic of a benchtop diagnostic device 196. The diagnostic device 196 may include any of the functional elements of the diagnostic device 100 or other diagnostic devices described herein. The benchtop diagnostic device 196 may include a printed circuit board 176 that may include a display 192, one or more buttons 188, one or more LEDs 190, and / or other functional elements that may be incorporated into a top layer 178. The benchtop diagnostic device 196 may include a connector 182 that is operably connected to a vector network analyzer 184 that may be installed in the bottom layer 180. The benchtop diagnostic device 196 may include a battery 186 that may be installed in the bottom layer 180 and / or a power connection for power. The benchtop diagnostic device 196 may include a head 104, also referred to as a probe head assembly. The head 104 may include any of the sensors described herein and configured to contact the patient's skin. The head 104 may be operably connected to a top layer 178 and a bottom layer 180 via a coaxial cable 146. For example, the coaxial cable 146 may connect the head 104 and the bottom layer 180 via a connector 182. A wired connection, which may be a coaxial cable, may connect the head 104 to the top layer 178. One or more wired connections from the head 104 to the top layer 178 and the bottom layer 180 may be coupled together by a cable harness 194.

[0090] 10 shows a display 192 of the diagnostic device 100. The diagnostic device 100 may include a user interface 106 that may include the display 192. The display 192 may provide instructions to a user, such as where to measure. The display 192 may depict a representation of a part of the user's body, such as a representation 301 of an arm, and may show a representation 303 of an examination site on the representation 301 of the arm where a measurement should be taken. Based on the instructions, the user may contact the sensor 108 on the head 104 of the diagnostic device 100 with the user's skin at an examination site 302 on the user's arm 300 that corresponds to the representation 303 of the examination site on the representation 301 of the arm displayed on the user interface 106. This can assist a user in obtaining one or more measurements for one or more parameters at a particular site, which can assist in easily tracking one or more parameters and / or tissue health scores for a particular site over time. In some variations, diagnostic device 100 is capable of communicating with a remote device. The remote device may include a display that can instruct a user to take one or more measurements at a particular location on the user's body, as described herein. Diagnostic device 100 and / or the remote device can instruct a user to take one or more measurements at any location on the body. In some variations, measurements may be taken on the body and correlated with a map of the body, allowing the same area to be tracked over time (e.g., multiple measurements). For example, in some variations, a user may take a measurement at a test site 302 on the arm 300, and the diagnostic device 100 and / or an associated remote device may record the test site 302 and associated data and / or correlate the test site 302 and / or data with a map of the user's body, allowing the same area to be tracked over multiple measurements.

[0091] As described herein, one or more measurements of one or more parameters can be used to generate a tissue health score for a user. The use of multiple parameters to generate a tissue health score can provide a more complete picture of the health of a patient's skin and / or subcutaneous tissue. FIG. 11 is a graph showing sensor measurements of three parameters at four stages of tissue health (e.g., tissue health score) for a patient with lymphedema. The three parameters in the graph are water content / bioimpedance, hardness, and temperature. The stages may progress in severity from stage 1, which corresponds to an early stage of lymphedema, to stage 4, which corresponds to an advanced stage of lymphedema with more severe symptoms. Because the measurements for the three parameters may change over the four stages of lymphedema, they may help create a tissue health score (e.g., advanced stages) that more fully captures the health of the skin and / or subcutaneous tissue.

[0092] Measurements of the three parameters may be obtained by a diagnostic device. The measurement data of the three parameters may be used to determine whether the patient's lymphedema is at stage 1, 2, 3, or 4, thereby providing a quantifiable indicator for diagnosis, treatment, and / or monitoring. In some variations, less than three or more than three parameters may be measured to create the tissue health score. In some variations, other parameters may be used to create the tissue health score. In some variations, the measurements are compared to data related to healthy or unhealthy skin to create the tissue health score. In some variations, the measurements are input into an algorithm, which compares the measurement data to data associated with healthy or unhealthy skin to create the tissue health score.

[0093] 12 illustrates a process for generating tissue health scores and other information based on the tissue health scores and / or sensor measurements. Using a diagnostic device as described herein, the process may obtain measurement data for one or more parameters of a patient. For example, a diagnostic device may be pressed against and / or in close proximity to a user's skin via one or more sensors to obtain measurement data such as bioimpedance data 202, hardness data 204, and / or temperature data 206 of a user at a site on the user's body. In some variations, measurement data of other parameters of the user may be obtained. The process may proceed to a data cleaning step 208. The measured data may be cleaned (e.g., filtered) using one or more techniques. In some variations, the measured data is not cleaned. The process continues to algorithm step 210 where the cleaned measurement data may be input to one or more algorithms to generate a tissue score 216 and / or other information. For example, in some variations, the cleaned measurement data may be input to a sensor weighting algorithm 212, which may weight one or more parameters over one or more other parameters to generate a tissue score 216 and / or other information. In some variations, the cleaned measurement data can be input into a comparison algorithm 214, which can compare the cleaned measurement data with data relating to healthy or diseased skin or tissue to generate a tissue score 216 and / or other information. In some variations, the combined weighted measurement data or weighted data of measurements between healthy and diseased tissue and / or skin can be used as variables in a predictive algorithm to generate a tissue score. The measurement data, previous data, and / or tissue score can be tracked over time. The algorithm can perform variable weighting depending on the stage of the disease.

[0094] As described herein, the algorithm can generate a tissue score 216 that can provide a quantifiable index that gives a more complete indication of skin or tissue health. In some variations, the algorithm and / or related functional components can output an indication and / or description of the current tissue health state 218, tissue health trends 220, disease diagnosis 222, and / or recommended treatment 224, which can be displayed to a user using at least the techniques described herein. The tissue health trends 220 can be based on measurement data over time and / or the tissue health score.

[0095] Figure 13 shows a graph of the tissue scores generated herein over time, which can be used to determine tissue health trends over time, which can be useful for treatment. Figure 14 shows a graph of water content versus standing wave ratio measurements. Figure 15 shows a graph of tip versus force transducer body.

[0096] 16A and 16B show a head 304, which may be a head assembly, a tip, and / or an end of a diagnostic device 100. The head 304 may be located at the end of the diagnostic device 100. The head 304 may have at least any of the functional elements, including one or more sensors, described with reference to any of the other heads and / or diagnostic devices described herein. The head 304 may include one or more functional elements for measuring the bioimpedance / water content of tissue. For example, the head 304 may include a dielectric probe 331 (e.g., a dielectric conductor) and a ground ring 330 to obtain dielectric measurements for measuring the bioimpedance / water content of tissue. The dielectric probe 331 may be arranged coaxially with respect to the ground ring 330. The dielectric probe 331 may be centrally located within the ground ring 330. A contact surface 326, which may be an insert, may be disposed between the dielectric probe 331 and the ground ring 330. The contact surface 326 may be an insulator such as polytetrafluoroethylene (PTFE) (e.g., Teflon) to electrically insulate the dielectric probe 331 from the ground ring 330. The contact surface 326 may be part of a ring-shaped insulator. In some variations, the dielectric probe 331, contact surface 326, and ground ring 330 may be pressed against tissue to obtain dielectric measurements to measure the bioimpedance / water content of the tissue. 16B, the dielectric probe 331, the contact surface 326, and the ground ring 330 may be flush. In some variations, the dielectric probe 331, the contact surface 326, and the ground ring 330 may not be flush. The ground ring 330 may be a continuous ring. In some variations, the ground ring 330 may not be continuous. In some variations, the ground ring 330 may not be ring-shaped, but may be at least a polygonal (e.g., square, rectangular, etc.) irregular shape, or other shape.

[0097] The head 304 may include a durometer 333 (e.g., a durometer sensor, a durometer probe) to measure tissue hardness and / or elasticity. The durometer sensor 333 may be located on the outside (e.g., radially outward) of the ground ring 330. In some variations, the durometer sensor 333 may be located on the inside (e.g., radially inward) of the ground ring 330. The head 304 may include a temperature sensor 134 to measure the temperature of tissue (at the skin and / or subcutaneously). The temperature sensor 134 may be located on the outside (e.g., radially outward) of the ground ring 330. In some variations, the temperature sensor 134 may be located on the inside (e.g., radially inward) of the ground ring 330.

[0098] 17A and 17B show a head 404, which may be a head assembly, tip, and / or end of a diagnostic device 100. The head 404 may be located at the end of the diagnostic device 100. The head 404 may have at least any of the functional elements described with reference to any of the other heads and / or diagnostic devices described herein, including one or more sensors. The head 404 may include one or more functional elements for measuring water content of tissue. For example, the head 404 may include a probe 432, which may be the same as or similar to the probe 132. The probe 432 may be for at least two purposes and may be used to measure the hardness and / or elasticity of tissue and / or to obtain a permittivity measurement to measure the bioimpedance / water content of tissue. The head 404 may include a ground ring 430. The probe 432 may be coaxially located with respect to the ground ring 430. The probe 432 may be centered within the ground ring 430. Contact surface 426, which may be an insert, may be disposed between probe 432 and ground ring 430. Contact surface 426 may be an insulator such as polytetrafluoroethylene (PTFE) (e.g., Teflon) and electrically insulates probe 432 from ground ring 430. Contact surface 426 may be part of a ring-shaped insulator. In some variations, the probe 432, contact surface 426, and ground ring 430 may be pressed against tissue to obtain measurements of tissue hardness and / or elasticity and / or bio-impedance / water content. As shown in FIG. 17B, the probes 432 may extend away from the ground ring 430 and / or the contact surface 426.

[0099] The head 404 may include a temperature sensor 134 for measuring tissue temperature (measured at the skin and / or subcutaneously). The temperature sensor 134 may be disposed inside (e.g., radially inward) of the ground ring 430. The temperature sensor 134 may be disposed on and / or at least a portion of the contact surface 426. In some variations, the temperature sensor 134 may be disposed outside (e.g., radially outward) of the ground ring 430.

[0100] 18A and 18B show a head 504, which may be a head assembly, a tip, and / or an end of a diagnostic device 100. The head 504 may be located at the end of the diagnostic device 100. The head 504 may have at least any of the functional elements, including one or more sensors, described with reference to any of the other heads and / or diagnostic devices described herein. The head 504 may include one or more functional elements for measuring tissue bioimpedance / water content. For example, the head 504 may include a dielectric probe 531 (e.g., a dielectric conductor) and a ground ring 530 to obtain dielectric measurements to measure tissue bioimpedance / water content. The dielectric probe 531 may be a ring structure. The dielectric probe 531 may be coaxially disposed with respect to the ground ring 330. The dielectric probe 531 may be centered within the ground ring 530. A contact surface 526, which may be an insert, may be disposed between the dielectric probe 531 and the ground ring 530. The contact surface 526 may be an insulator such as polytetrafluoroethylene (PTFE) (e.g., Teflon) and electrically insulates the dielectric probe 531 from the ground ring 530. The contact surface 526 may be part of a ring-shaped insulator. In some variations, the dielectric probe 531, contact surface 526, and ground ring 530 may be pressed against tissue to obtain a dielectric measurement to measure the bioimpedance / water content of the tissue.

[0101] The head 504 may include a durometer sensor 533 (e.g., durometer, durometer probe) that can measure the hardness and / or elasticity of tissue. The durometer sensor 533 may be located inward (e.g., radially inward) relative to the dielectric probe 531 and the ground ring 530. As shown in FIG. 18B, the durometer sensor 533 may extend away from the ground ring 530, the contact surface 526, and / or the dielectric probe 531. The ground ring 530, the contact surface 526, and / or the dielectric probe 531 may be flush with one another, as shown in FIG. 18B. The head 504 may include a temperature sensor for measuring the temperature of the tissue (measured cutaneously and / or subcutaneously). In some variations, the dielectric probe 531 may be biased outward by a spring, but may be pressed against the tissue to be flush with the dielectric probe 531, the contact surface 526, and / or the ground ring 530.

[0102] 18C, when the head 504 is pressed against tissue 550, a gap 505 (e.g., an air gap) may be placed between the tissue 550 and a portion of the dielectric probe 531. The gap 505 may be problematic when obtaining dielectric constant measurements.

[0103] 19A and 19B show a head 604, which may be a head assembly, tip, and / or end of a diagnostic device 100. The head 604 may be located at the end of the diagnostic device 100. The head 604 may have at least any of the functional elements described with reference to any of the other heads and / or diagnostic devices described herein, including one or more sensors. The head 604 may include one or more functional elements for measuring water content of tissue. For example, the head 604 may include a probe 632, which may be the same as or similar to the probe 132. The probe 632 may be for at least two purposes and may be used to measure the hardness and / or elasticity of tissue and / or to obtain a dielectric constant measurement to measure the bioimpedance / water content of tissue. The head 604 may include a ground ring 630. The probe 632 may be coaxially located with respect to the ground ring 630. The probe 632 may be centered within the ground ring 630. An insulator 627, which may be an insert, may be placed between the probe 632 and the ground ring 630. The insulator 627 may be an insulator such as polytetrafluoroethylene (PTFE) (e.g., Teflon) and electrically insulates the probe 632 from the ground ring 630. The insulator 627 may be ring shaped. In some variations, the probe 632 and ground ring 630 may be pressed against tissue to obtain measurements of tissue hardness and / or elasticity and / or to obtain dielectric measurements to measure bioimpedance / water content.

[0104] 19B, the probe 632 may extend away from the tip of the ground ring 630 and / or the insulator 627. A gap 629, which may be an annular gap, may be disposed between the probe 632 and the ground ring 630. The insulator 627 may be recessed relative to the tip of the ground ring 630 and the end of the probe 632, such that the gap 629 is disposed inward relative to the tip of the ground ring 630. When processing the permittivity measurements, the gap 629 can be taken into account and the permittivity measurements can be shifted accordingly, which may help to mitigate issues caused by the gap 505 described with reference to FIG. 18C.

[0105] The head 604 may include a temperature sensor 134 for measuring tissue temperature (measured at the skin and / or subcutaneously). The temperature sensor 134 may be located outside (e.g., radially outside) the ground ring 630.

[0106] 20A and 20B show a head 704, which may be a head assembly, tip, and / or end of a diagnostic device 100. The head 704 may be located at the end of the diagnostic device 100. The head 704 may have at least any of the functional elements described with reference to any of the other heads and / or diagnostic devices described herein, including one or more sensors. The head 704 may include one or more functional elements for measuring water content of tissue. For example, the head 704 may include a dielectric probe 731 and a ground conductor 730 to obtain a dielectric constant measurement for measuring the bioimpedance / water content of tissue when pressed against the tissue. The dielectric conductor 731 may have a periphery of different shapes, which may include at least a polygon (e.g., square, rectangle, etc.), a circle, an ellipse, etc. The dielectric conductor 731 and the ground conductor 730 may be the same or similar in shape and / or size. The dielectric conductor 731 and the ground conductor 730 may be spaced apart from each other. The dielectric conductor 731 and the ground conductor 730 may be parallel to each other. The head 704 may include a contact surface 726 that may be disposed between the dielectric conductor 731 and the ground conductor 730. The contact surface 726 may be a part of an electrical insulator as described herein. The contact surface 726 may have a periphery with a different shape that may include at least a polygon (e.g., a square, a rectangle, etc.). The ground conductor 730, the dielectric conductor 731, and the contact surface 726 may be pressed against tissue to obtain a permittivity measurement. The ground conductor 730, the dielectric conductor 731, and the contact surface 726 may be flush with each other as shown in FIG. 20B.

[0107] The head 704 may include a durometer sensor 733 (e.g., a durometer probe) that may be used to measure tissue hardness and / or elasticity. The head 704 may include a temperature sensor 134 for measuring tissue temperature (measured at the skin and / or subcutaneously). The durometer sensor 733 and / or the temperature sensor 134 may be located at a location that is not between the ground conductor 730 and the dielectric conductor 731. In some variations, the durometer sensor 733 and / or the temperature sensor 134 may be located between the ground conductor 730 and the dielectric conductor 731.

[0108] 21A and 21B show the head 604. As shown in FIG. 21A, the head 604 can include a main body 118. The ground ring 630, the insulator 627, and the probe 632 can be coupled to the main body 118. For example, the head 604 can include a housing 624 (e.g., annular structure) that can be disposed circumferentially around the ground ring 630. The housing 624 can extend along at least a portion of the length of the ground ring 630. The housing 624 can be an annular structure. The housing 624, the ground ring 630, the insulator 627, and the probe 632 can be secured directly or indirectly to the main body 118 by a first retainer 120. The head 604 may include an annular structure 690 and / or a second retainer 122 capable of holding the fastener 692 directly or indirectly to the main body 110. The annular structure 690 may include a notch 691. The second retainer 122 may be located on an opposite side of the main body 118 from the first retainer 120. The main body 118 may be a cylindrical structure. The first retainer 120 and / or the second retainer 122 may be annular structures. The first retainer 120 and the second retainer 122 may be securable to the main body 118 with threaded portions 154, 155 as described herein.

[0109] As described herein, the head 604 may include a probe 632, which may be a probe for at least a durometer and / or a dielectric sensor. The probe 632 may cooperate with a force transducer to sense the hardness and / or elasticity of tissue. For example, as shown in FIG. 21B, the main body 110 may include a cavity 136. The cavity 136 may house a spring 138. The spring 138 may be disposed between the force transducer body 142 and the force transducer tip 140 to transmit a force to facilitate measuring the hardness and / or elasticity. When the probe 632, which may be a pin or a signal probe, is pressed against tissue and a force is applied to the force transducer tip 140, the force may be transmitted by the spring 138 to the force transducer body 142 to measure the hardness and / or elasticity. In some variations, the probe 632 is movable and the spring 138 may be compressed until the end of the probe 632 is at least flush with the tip of the ground ring 30.

[0110] The main body 118 may include a number of holes therethrough. The number of holes may include longitudinal holes 676, 677 oriented parallel to the longitudinal axis of the main body 118. The number of holes may include transverse holes 672, 674 oriented perpendicular to the longitudinal axis of the main body 118.

[0111] Figure 22A shows the simulated electric field in a head assembly similar to head 304 as described with reference to Figures 16A and 16B when in contact with tissue. Figure 22B shows the simulated electric field in a head assembly similar to head 604 as described with reference to Figures 19A, 19B, 21A, and 21B when in contact with tissue. As shown, skin 551 extends across gap 629 from the tip of probe 632 to the tip of ground ring 630.

[0112] Figure 23A shows a graph of clinical data for the real part of the permittivity measurements, and Figure 23B shows a graph of clinical data for the imaginary part of the permittivity measurements.

[0113] ·term Although the systems and methods have been disclosed in terms of certain embodiments and example concepts, it will be understood by those skilled in the art that the systems and methods extend beyond the specifically disclosed embodiments to the use of other alternative embodiments and / or implementations, as well as certain modifications and their equivalents. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form various modes. The scope of the present disclosure should not be limited by the specific disclosed embodiments described herein.

[0114] Included are methods of using the system(s) described above (including device(s), apparatus(es), assembly(es), structure(s), etc.), which may include using or assembling any one or more of the features disclosed herein to achieve the functions and / or features of the system(s) as discussed in this disclosure. Included are methods of manufacturing the system(s) described above, which may include providing, making, connecting, assembling, and / or installing any one or more of the features of the system(s) as discussed in this disclosure.

[0115] Certain features that are described in the disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. In addition, although features may be described as acting in a particular combination, one or more features from a claimed combination may, in some cases, be removed from the combination, and the combination may be claimed as any subcombination or variation of the subcombination.

[0116] Additionally, although operations may be illustrated in the figures or described in the specification in a particular order, such operations need not be performed in the particular order illustrated, or in sequential order, nor need all operations be performed, to achieve desirable results. Other operations not illustrated or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Additionally, in other implementations, operations may be rearranged or reordered. It should also be understood that the separation of the various system components in the implementations described above is not to be understood as requiring such separation in all implementations, and that the components and systems described may generally be integrated together in a single product or packaged together in multiple products. Additionally, other implementations are within the scope of this disclosure.

[0117] Conditional language such as "can," "could," "might," or "may" is generally intended to convey that a particular embodiment includes or does not include certain features, elements, and / or steps, unless specifically stated otherwise or understood otherwise within the context in which it is used. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments.

[0118] Conjunctive language such as the phrase "at least one of X, Y, Z," unless otherwise specified, is understood in the context in which it is generally used to convey that an item, term, etc., can be either X, Y, or Z. Thus, such conjunctive language is generally not intended to suggest that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0119] Several embodiments have been described with reference to the accompanying drawings. Components may be added, removed, or rearranged. For example, directional references such as "top" and "bottom" are for ease of description and may be rearranged such that top features are proximate the bottom and bottom features are proximate the top. Furthermore, disclosure of any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. associated with various embodiments may be used in all other embodiments described. Furthermore, it will be recognized that any method described herein may be implemented using any apparatus suitable for performing the recited steps.

[0120] In summary, various embodiments and examples of diagnostic devices and methods have been disclosed. Although the systems and methods have been disclosed with reference to these embodiments and examples, those skilled in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, including certain modifications and equivalents thereof. The disclosure expressly contemplates that various features and aspects of the disclosed embodiments may be combined with each other or substituted for each other. Thus, the scope of the disclosure should not be limited by the specific embodiments described above, but should be determined solely by a proper reading of the claims.

Claims

1. 1. A diagnostic device for measuring two or more parameters of tissue, the diagnostic device comprising: one or more sensors configured to measure the two or more parameters; and a display configured to display the two or more measured parameters and / or the tissue health score.

2. The diagnostic device of claim 1 , wherein the two or more parameters include temperature, water content, bioimpedance, and / or hardness or elasticity.

3. The diagnostic device of claim 1 , wherein the two or more parameters include oxygen content, pulse rate, and / or electromagnetic reflectance in the visible and / or non-visible spectrum.

4. The diagnostic device of claim 2 , wherein the temperature is measured at the user's skin.

5. The diagnostic device of claim 2 , wherein the temperature is measured subcutaneously.

6. The diagnostic device of claim 1 , wherein the one or more sensors are configured to measure the two or more parameters simultaneously.

7. The diagnostic device of claim 1 , wherein the one or more sensors are configured to measure the two or more parameters sequentially.

8. The diagnostic device of claim 1 , wherein the one or more sensors are configured to measure the two or more parameters at approximately the same location on the user's body.

9. The diagnostic device of claim 1 , wherein the one or more sensors are configured to measure the two or more parameters at multiple locations on the user's body.

10. The diagnostic device of claim 1 , wherein the two or more parameters are used to generate the tissue health score.

11. The diagnostic device of claim 1 , wherein measurements of the two or more parameters are obtainable at any location on a human or animal.

12. 2. The diagnostic device of claim 1, wherein measurements of the two or more parameters are taken at sites on a human or animal body and are associated with a map that facilitates tracking of measurements at the same site across multiple measurements.

13. The diagnostic device of claim 1 , wherein measurements of the two or more parameters are tracked over time.

14. The diagnostic device of claim 1 , wherein the measurements of the two or more parameters are stored in the diagnostic device.

15. The diagnostic device of claim 1 , wherein the diagnostic device is configured to communicate with a remote device, the diagnostic device being configured to transmit the measurements of the two or more parameters and / or the tissue health score to the remote device.

16. The diagnostic device of claim 1 , wherein the display of the diagnostic device is configured to prompt a user to measure two or more parameters at a site on a human or animal body.

17. The diagnostic device of claim 1 , wherein a display of a remote device in communication with the diagnostic device is configured to prompt a user to measure two or more parameters at a site on a human or animal body.

18. The diagnostic device of claim 1 , wherein the diagnostic device is configured for use by trained or untrained users in a hospital, clinic, or home environment.

19. The diagnostic device of claim 1 , wherein the tissue health score is generated by an algorithm that uses the measurements of the two or more parameters as inputs.

20. The diagnostic device of claim 19 , wherein the measurement data of the two or more parameters is cleaned.

21. 20. The diagnostic device of claim 19, wherein the measurement data of the two or more parameters are weighted equally by an algorithm.

22. 20. The diagnostic device of claim 19, wherein the measurement data of the two or more parameters are weighted unequally by an algorithm.

23. The diagnostic device of claim 1 , wherein the measurements of the two or more parameters and / or the tissue health score are usable to determine tissue health trends, disease diagnoses, and / or recommended treatments.

24. The diagnostic device of claim 1 , wherein the display is capable of outputting information regarding tissue health trends, disease diagnosis, and / or recommended treatments.

25. The diagnostic device of claim 1 , wherein the tissue health score, or a derivative thereof, is used to guide the treatment of one or more diseases.

26. 26. The diagnostic device of claim 25, wherein the one or more conditions include edema, ulcers, cellulite, fibrosis, and / or venous insufficiency.

27. The diagnostic device of claim 1 , wherein the tissue health score is generateable by comparison of the measured values ​​of the two or more parameters and / or the tissue health score with measured data of the two or more parameters and / or tissue health scores relating to healthy tissue and / or unhealthy tissue.

28. The diagnostic device of claim 1 , wherein the diagnostic device is configured to be used to measure edema, lymphedema, circulatory insufficiency, and tissue health.

29. 10. The diagnostic device of claim 1, wherein the diagnostic device automatically obtains measurements of the two or more parameters when pressed against the skin or obtains measurements manually in response to receiving user input.

30. The diagnostic device of claim 1 , wherein the two or more parameters include temperature, and the temperature is measured by a thermocouple, a resistance temperature detector, a thermistor, a semiconductor-based integrated circuit, and / or an infrared thermometer.

31. 2. The diagnostic device of claim 1, wherein the two or more parameters include hydration and / or bioimpedance, and the hydration and / or bioimpedance are measured using multi-frequency bioimpedance analysis (MFBIA), spectroscopic imaging, differential spectroscopic visible, infrared and ultraviolet spectra, and / or an open-ended coaxial probe.

32. 10. The diagnostic device of claim 1, wherein the two or more parameters include hardness, and hardness is measured using a durometer, single or multiple force transducers, strain transducers, pressure transducers, and / or suction with an optical displacement sensor.

33. 10. The diagnostic device of claim 1, wherein the two or more parameters include oxygen content, and the oxygen content is measured using spectroscopic imaging, differential spectroscopic visible, infrared, and / or ultraviolet spectroscopy.

34. 10. The diagnostic device of claim 1, wherein the two or more parameters include pulse, and pulse is measured using spectroscopic imaging, differential spectroscopic visible, infrared, and ultraviolet spectra, and / or near-field coherent sensing.

35. The diagnostic device of claim 1 , wherein the two or more parameters include electromagnetic reflectance, and the electromagnetic reflectance is measured using a digital camera center and / or a photodiode.

36. The diagnostic device of claim 1 further comprising a head assembly including a durometer probe, a temperature sensor, a dielectric conductor, and a ground conductor.

37. 37. The diagnostic device of claim 36, wherein the ground conductor comprises a ring shape and the dielectric conductor is centrally located within the ring shape.

38. 37. The diagnostic device of claim 36, wherein the durometer probe is disposed inside a periphery of the ground conductor.

39. 37. The diagnostic device of claim 36, wherein the temperature sensor is disposed inside a periphery of the ground conductor.

40. 37. The diagnostic device of claim 36, wherein the durometer probe is disposed outside a periphery of the ground conductor.

41. 37. The diagnostic device of claim 36, wherein the temperature sensor is disposed outside a periphery of the ground conductor.

42. 37. The diagnostic device of claim 36, further comprising an electrical insulator disposed between the dielectric conductor and the ground conductor.

43. The diagnostic device of claim 1 further comprising a head assembly including a probe, a ground conductor, and a temperature sensor, the probe configured for use in obtaining dielectric measurements and measuring hardness.

44. The diagnostic device of claim 1 further comprising a head assembly including a probe, a ground conductor, and a temperature sensor, the probe configured for use in obtaining dielectric measurements and measuring elasticity.

45. 45. The diagnostic device of claim 43 or 44, wherein the ground conductor comprises a ring shape.

46. 45. The diagnostic device of claim 43 or 44, wherein the probe is disposed inside a periphery of the ground conductor.

47. 45. The diagnostic device of claim 43 or 44, wherein the probe is positioned concentrically with the ground conductor.

48. 44. The diagnostic device of claim 43, wherein the head assembly includes a force transducer body, a force transducer tip, and a spring disposed between the force transducer body and the force transducer tip, and the probe is configured to be pushed by tissue to move the force transducer tip toward the force transducer body to measure hardness.

49. 45. The diagnostic device of claim 44, wherein the head assembly includes a force transducer body, a force transducer tip, and a spring disposed between the force transducer body and the force transducer tip, and the probe is configured to be pushed by tissue to move the force transducer tip toward the force transducer body to measure tissue elasticity.

50. 46. ​​The diagnostic device of claim 45, further comprising an insulator disposed between the probe and the ground conductor.

51. 46. ​​The diagnostic device of claim 45, further comprising an insulator disposed between the probe and the ground conductor, the insulator being spaced from a tip of the ground conductor such that an air gap is disposed between the probe and the ground conductor.

52. 1. A diagnostic device for measuring two or more parameters of tissue, the diagnostic device comprising: A diagnostic device having one or more sensors configured to measure the two or more parameters to generate a tissue health score for the tissue.

53. 1. A diagnostic device for measuring tissue stiffness and bioimpedance, the diagnostic device comprising: A ground conductor; and a probe configured to obtain dielectric measurements to measure tissue bioimpedance and tissue hardness.

54. 54. The diagnostic device of claim 53, wherein the dielectric constant and hardness measurements are used to generate a tissue health score for the tissue.

55. 54. The diagnostic device of claim 53, further comprising a temperature sensor configured to measure a temperature of tissue.

56. 56. The diagnostic device of claim 55, wherein the measurements of dielectric constant, hardness, and temperature are used to generate a tissue health score for the tissue.

57. 54. The diagnostic device of claim 53, further comprising an insulator disposed between the probe and the ground conductor.

58. 58. The diagnostic device of any of claims 53 to 57, wherein the probe is disposed inside the periphery of the ground conductor.

59. 54. The diagnostic device of claim 53, wherein the ground conductor comprises a ring shape.

60. 54. The diagnostic device of claim 53, further comprising a force transducer body, a force transducer tip, and a spring disposed between the force transducer body and the force transducer tip, and wherein the probe is configured to be pushed by tissue to move the force transducer tip toward the force transducer body to measure hardness.

61. 54. The diagnostic device of claim 53, further comprising an insulator disposed between the probe and the ground conductor, the insulator being spaced from a tip of the ground conductor such that an air gap is disposed between the probe and the ground conductor.

62. 54. The diagnostic device of claim 53, wherein the probe is adapted to be used to measure the bioimpedance of tissue and simultaneously obtain permittivity measurements to measure tissue stiffness.

63. 54. The diagnostic device of claim 53, wherein the probe is configured to apply a force to the transducer to measure tissue hardness.

64. 54. The diagnostic device of claim 53, wherein the diagnostic device prompts a user to take measurements at sites on the user's body.

65. 54. The diagnostic device of claim 53, wherein a computing device in communication with the diagnostic device prompts a user to take measurements at sites on the user's body.

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