WO2020113204A1

WO2020113204A1 - Systems and methods for detection and evaluation of changes in dimension of a body or appendage

Info

Publication number: WO2020113204A1
Application number: PCT/US2019/063929
Authority: WO
Inventors: Farshad SHIRAZI; Marvin J. Slepian
Original assignee: Arizona Board Of Regents On Behalf Of The University Of Arizona
Priority date: 2018-11-30
Filing date: 2019-12-02
Publication date: 2020-06-04

Abstract

Injection or deposition of venom, poisons, toxins, or even tissue disruption due to trauma, and defined edema-forming disease states, leads to swelling and edema of the afflicted body or extremity. Systems and methods are described herein to detect the onset, progression, or halting of venom-related edema and inflammatory effects; as well as edema and swelling associated with edema-forming disease states, by measuring dimensional changes of the afflicted body or extremity. The invention can further determine if additional intervention is required.

Description

SYSTEMS AND METHODS FOR DETECTION AND EVALUATION OF CHANGES IN

DIMENSION OF A BODY OR APPENDAGE

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 62/773,467 filed November 30, 2018, the specification(s) of which is/are incorporated herein in their entirety by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to systems and methods of use for determining dimension changes of a body or appendage.

BACKGROUND OF THE INVENTION

[0003] Animals, including man, living in complex environmental conditions may be exposed to various exogenous agents such as insects, snakes, infectious microbes, predators and other environmental toxins and trauma, which may lead to acute alteration in body elements such as limbs and appendages. Injection or deposition of venom, poisons, toxins, or even tissue disruption due to trauma, leads to swelling and edema of the afflicted body or body part (e.g. at the bite zone). A specific example occurs in the case of snake bite and the deposition of toxin known as envenomation. As a result of venom injection into the tissue, the local tissue responds with swelling and edema that is progressive, which is defined as changes in tissue girth and volume. This progression could be acute (e.g. within minutes), or subacute (e.g. within hours), e.g., as in the case of infections.

[0004] The conventional method of managing snake bite includes correction or reversal of any of the following abnormalities: vital signs, progression of edema, or laboratory derangements. Medications and biologies such as anti-venom may be utilized. The need for anti-venom may be determined by evaluation of patient's vital signs, laboratory derangements, or by assessment of local effects, including the progression of edema and its leading-edge. For example, in an emergency room, a physician visually evaluates the extent of tissue response (e.g. swelling, redness and inflammation) and demarcates a border zone. The patient receives a dose of anti-venom with the intention that it will halt the effect of the venom as well as limit its further progression proximally up the limb. The progression of edema, or lack thereof, is observed over a short period of time, which is traditionally set to be an hour. A progression of the leading edge could indicate a need for more anti-venom in either a bolus or continuous infusion form. The halt in progression of the leading edge is traditionally used to convey initial control in a victim of a snake bite.

[0005] Anti-venom is costly and can carry certain risks of allergic reaction, serum sickness and other potential derangements. The current practice of anti-venom administration, dosing and monitoring is filled with errors and subjective assessment since the treating physician or physicians might have disagreements on the time of treatment and where the real leading-edge lies. Furthermore, other personnel may be involved in this observation and could impact the treatment of the patient, especially when subspecialists are not always available to assess such a tissue derangement. There is no reliable device or system to accurately evaluate the extent of venom response, edema progression, and the location and movement of the border zone or leading edge, and the need for additional anti-venom dosing. Limitations of such subjective assessments are either overtreatment of the patient with anti-venom, which can be expensive and can expose the patient to more risk; or under-treatment of the patient, which could lead to increased tissue compromise, overall morbidity and mortality.

[0006] Therefore, there is a need for systems and methods that would allow for assessment in change of dimension (e.g., perimeter, circumference, area, volume, etc.) and progression of the leading-edge to objectively describe disease progression or indicate its control. The present invention offers a solution to detect the onset, progression or halting of venom-related edema and inflammatory effects of afflicted tissue and the need for additional therapy. The present invention may be used in emergency locations that deal with insect or snake bites, toxin injection, and trauma.

SUMMARY OF THE INVENTION

[0007] It is an objective of the present invention to provide for system and methods for determining dimension change (e.g., perimeter, circumference, girth, area, volume, etc.) of a body or appendage of a subject, as specified herein. Embodiments of the present invention can be freely combined with each other if they are not mutually exclusive. [0008] For example, the present invention features a system for detecting (e.g., measuring) a dimension change in a body or extremity of a subject. In certain embodiments, the system comprises at least one sensor device that can be applied to a specific location of the body or extremity, wherein the sensor device is for detecting a dimension change at the specific location of the body or extremity; a processor operatively connected to the sensor device; a memory operatively connected to the processor storing computer-readable instructions that, when executed by the processor, cause the processor to perform operations comprising recording readings from the sensor device, and calculating a dimension change of the specific location based on the sensor readings. The system is capable of detecting an onset and/or a change in dimensional changes at the specific location of the body or extremity. In certain embodiments, the system can monitor progression or cessation thereof.

[0009] The body part, extremity, or body area being tested or monitored may have a regular or irregular contour. Thus, the dimension measured or monitored may, for example, be described as the perimeter. Other non-limiting examples of dimension change includes circumference, length, girth, area, volume, etc. In certain embodiments, the systems herein utilize one or a combination of sensors to measure area and volume of the body part.

[0010] In certain embodiments, the system detects an increase in dimension (e.g., perimeter, circumference, length, girth) of the body location. In certain embodiments, the system detects a decrease in dimension (e.g., perimeter, circumference, length, girth) of the body location. In certain embodiments, the system detects when there is no change in dimension (e.g., perimeter, circumference, length, girth) of the body location.

[0011] The sensor devices herein include active and passive sensors. For example, an active sensor may be one that has contained electrical or chemical element for detecting the dimension change. A passive sensor may be one that senses the dimension change based on an intrinsic material property (e.g., a band with a known stress-strain curve and a defined tensile point) wherein if the dimension exceeds its tensile point it breaks). Non-limiting examples of sensors include strain sensors, stress sensors, swell sensors, bands (e.g., stretchable or elastic bands) for measuring girth, etc. [0012] In certain embodiments, the sensor device comprises a sensor mounted to a band for wrapping around the dimension (e.g., the perimeter, circumference) of the specific location of the body or extremity, wherein the band expands or contracts in conjunction with the onset, change, or cessation of the dimensional changes at the specific location of the body or extremity. The sensor detects and reads said expansion and contraction (and/or lack of change in dimension) of the band.

[0013] In certain embodiments, the sensor device comprises a sensor mounted to a band that for attaching to the specific location of the body or extremity (e.g., attaching to a first point on the body/ extremity and to a second point on the body/ extremity a certain distance from the first point), wherein the band expands or contracts in conjunction with the onset, change, or cessation of the dimensional changes at the specific location of the body or extremity. The sensor detects and reads said expansion and contraction (and/or lack of change in dimension) of the band.

[0014] In certain embodiments, the sensor device comprises two sensors having a modulus link mounted there between, wherein the sensor device is attached to the specific location of the body or extremity, wherein the modulus link expands or contracts in conjunction with the onset, change, or cessation of the dimensional changes at the specific location of the body or extremity. The sensor detects and reads said expansion and contraction of (and/or lack of change in) the modulus link. In certain embodiments, the modulus link breaks when the dimensional changes exceed a physical limitation (e.g., tensile strength) of the modulus link.

[0015] The systems herein are not limited to a single sensor device and/or sensor. In certain embodiments, the system comprises two or more sensor devices, e.g. a chain of sensors, a series of sensors, etc. In certain embodiments, the system comprises a sensor device with two or more sensors. In certain embodiments, the system comprises two or more sensor devices with at least one having two or more sensors. In certain embodiments, the system comprises a plurality of the sensor devices disposed in series on the body or extremity, wherein the plurality of the sensor devices is configured to detect the dimension changes at multiple locations.

[0016] The dimension changes detected and/or monitored by the systems herein may include those that are a result of venom or trauma-related edema and inflammatory effects. However, the present invention is not limited to the aforementioned applications and uses. For example, in certain embodiments, the dimension changes are a result of one or more diseases including but not limited to nephrosis, cirrhosis, cardiosis (heart failure), and/or hypoalbuminemia. In certain embodiments, the dimension changes are a result of a disease state causing edema, inflammatory effects, or both edema and inflammatory effects.

[0017] The systems herein may further comprise a therapeutic delivery component that when activated is capable of administering a therapeutic treatment to the body or extremity so as to modulate the dimensional change. The therapeutic treatment may be, for example, a pharmacological treatment (e.g., one or a combination of anti-venom, a diuretic, a corticosteroid, an anti-inflammatory, a coagulant, a hypotonic fluid, an electrolyte, an anti-coagulant, an anabolic steroid, etc.). In certain embodiments, the therapeutic treatment may be a mechanical treatment. In certain embodiments, the processor causes activation of the therapeutic delivery component when a detected dimension change varies from a pre-determ ined reference value.

[0018] The present invention also features a method of monitoring dimension changes in a body or extremity of a subject. In certain embodiments, the method comprises applying a system according to the present invention to a specific location of the body or extremity (e.g., at least one sensor device may be attached or applied to the specific location of the body or extremity); detecting, via the sensor device, dimension changes at the specific location; recording readings of the dimension changes from the sensor device; and calculating the dimension changes of the specific location based on the sensor readings. In certain embodiments, the system that monitors dimension changes comprises a radio or telemetry mechanism. The radio or telemetry mechanism may utilize Bluetooth or near field communication, or other appropriate communication mechanism.

[0019] The present invention also features methods of monitoring and treating venom or trauma-related edema that causes dimension changes in a body or extremity of a subject. In certain embodiments, the method comprises applying a system according to the present invention to a specific location of the body or extremity affected by venom or trauma. For example, at least one sensor device may be attached or applied to the specific location of the body or extremity affected by venom or trauma. The method may further comprise detecting, via the sensor device(s) of the system(s), the dimension changes at the specific location; recording readings of the dimension changes from the sensor device; calculating the dimension changes of the specific location based on the sensor readings; and administering a therapeutic treatment to the affected body or extremity if the calculated dimension change exceeds a pre-determ ined reference threshold. As previously discussed, the therapeutic treatment may be a pharmacological treatment. For example, the pharmacological treatment may be one or a combination of: anti-venom, a diuretic, a corticosteroid, an anti-inflammatory, a coagulant, a hypotonic fluid, an electrolyte, an anti-coagulant, or an anabolic steroid. In certain embodiments, the therapeutic treatment is mechanical.

[0020] With respect to the systems herein, somatic quantitative measurements may be made, as well as component measurements such as that of the dimension (e.g., perimeter, circumference, girth, length, area, volume, etc.) of an arm, forearm, hand, neck, torso, leg, or foot. Devices of the present invention include but are not limited to enveloping systems with contained means, such as sensors, strain gauges, stress sensors, strain sensors, swell sensors, or other elements capable of reacting to underlying pressure, tension, or other expansible forces leading to dimension changes. In addition, non-contact and wireless systems, which can accomplish similar measurements with limited or no contact to the underlying body components, may be featured in the systems and devices herein. In certain embodiments, the systems herein are capable of interrogating and/or storing and/or telemetering and/or sending and/or downloading data to a storage and processing means, which may also provide a closed- loop capability indicating the need to or actually effectuating means for delivering additional intervention, such as pharmacologic or mechanical intervention.

[0021] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:

[0023] FIG. 1 A shows a non-limiting embodiment of the present invention.

[0024] FIG. 1 B shows the embodiment of FIG. 1A in an expanded configuration from increasing band stress.

[0025] FIG. 2A shows another non-limiting embodiment of the present invention.

[0026] FIG. 2B shows the embodiment of FIG. 2A in an expanded configuration from increasing stress to a modulus link.

[0027] FIG. 3A shows another non-limiting embodiment with multiple sensor devices in series.

[0028] FIG. 3B shows the sensor devices of FIG. 3A in expanded configurations from increasing stress to each link.

[0029] FIG. 4 shows multiple sensor devices in series, wherein the sensors are constructed from different materials (e.g., materials with different tensile strengths).

[0030] FIG. 5 shows multiple sensor devices in series, wherein the sensors are constructed from different lengths of the same material (e.g., material with the same tensile strength).

[0031] FIG. 6 shows a system comprising multiple sensor devices in series, wherein the sensors are attached to bands that encircle the body part. This series (or stacking) configuration could allow for a measurement of a change in volume.

[0032] FIG. 7 shows an example of how multiple sensor devices in series could be used to calculate an increase in volume, wherein an increase in dimension (e.g., perimeter, circumference, radius, etc.) can be used to calculate an increase in volume, and a series of sensors can be used to calculate an increase in volume of a particular area.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0033] The present invention features systems for detecting, measuring, and/or monitoring dimension changes in a body, body component or extremity of a subject. In some embodiments, the dimension changes may be a result of venom or trauma-related edema and inflammatory effects, however the present invention is not limited to use in connection with trauma or venom -associated edema or inflammation. As used herein, the term“extremity” may refer to a limb, arm, or leg, ankle, wrist, hand, foot, head, neck or any appendage or body component protruding from a body. Since the body part, extremity, or body area being tested or monitored may have a regular or irregular contour, the dimension measured or monitored may, for example, be described as the perimeter, circumference, length, girth, area, volume, etc.

System

[0034] The system comprises a sensor device that can be applied (e.g., attached to, wrapped around, etc.) to a specific location of the body or extremity. The sensor device features a sensor for detecting a dimension change at the specific location of the body or extremity.

[0035] In certain embodiments, the sensor device may be enveloping. Referring to FIG. 1A and FIG. 1 B, the system (100) comprises a sensor device (110) that can be wrapped around the specific location of the body or extremity, in this example, a user’s leg near a snake bite (105). The sensor device (110) in FIG. 1A and FIG. 1 B comprises a band (130) to which the sensor (120) is attached or mounted (or integrated into). The band (130) can expand or contract in conjunction with the change in dimension (e.g., the onset, change, or cessation of the dimensional change). The band (130) is circumferentially wrapped around the subject’s leg near the snake bite (105). The sensor (120) detects a change in dimension (e.g., perimeter) of the location of the body or extremity (e.g., around the area of the leg near the snake bite (105)). Note the change in dimension (e.g., perimeter) of the area of the leg near the snake bite (105) from FIG. 1A to FIG. 1 B. The sensor (120) can detect (and/or read) the expansion and contraction (or lack of change) of the band (130). In FIG. 1A and FIG. 1 B, the swelling caused by the snake bite (105) causes the dimension (e.g., perimeter, circumference) of the band (130) to expand.

[0036] In certain embodiments, the sensor is non-enveloping. For example, the sensor device may be attached to the specific location of the body (or near the specific location of the body), or to two or more places at or near the specific location of the body. Attachment may include an adhesive or other appropriate attachment mechanism. Referring to FIG. 2A and FIG. 2B, the system (200) comprises a sensor device (210) attachable to the specific location of the body or extremity, in this example, a user’s leg near a snake bite (105). The sensor device (210) in FIG. 2A and FIG. 2B comprises a first sensor (220a) and a second sensor (220b) connected by a modulus link (230). The modulus link (230) can expand or contract in conjunction with the change in dimension e.g., the onset, change, or cessation of the dimensional change). The sensor device (210) is attached to the subject’s leg near the snake bite (105). For example, the first sensor (220a) is attached to a first site near the snake bite and the second sensor (220b) is attached to a second site near the snake bite a certain distance from the first sensor (220a). Note, in certain embodiments, the sensors (220a, 220b) are merely attachment points and do not necessarily function as active (e.g., electrical, chemical, etc.) sensors. Flowever, the term“sensor” for these embodiments may be used for either at attachment point or a real sensor.

[0037] In FIG. 2A and FIG. 2B, the sensor device (210) detects a change in dimension (e.g., perimeter, length) of the location of the body or extremity (e.g., around the area of the leg near the snake bite (105)) by detecting a change (e.g., change in length) of the modulus link (230). Note the change in dimension of the area of the leg near the snake bite (105) from FIG. 2A to FIG. 2B. The swelling caused by the snake bite (105) causes the length of the modulus link (230) to expand. In certain embodiments, the modulus link (230) may tear, rip, or yield with increasing expansion caused by edema. In certain embodiments, the system comprises active elements that can provide a read out of the expansion or contraction (or lack of change) of the modulus link (230). In some embodiments, the sensor device can measure regional dimension changes using embedded strain gauge, visual or other markers, ultrasonic systems or other means for detecting creep.

[0038] In some embodiments, the system may comprise a plurality of sensor devices. For example, the system may comprise two or more (e.g., a plurality) of sensor devices in series on the body or extremity. The two or more sensor devices may be the same type of sensor devices. In certain embodiments, the two or more sensor devices may be different sensor devices, or some that are the same and some that are different. In certain embodiments, the system comprises two or more sensor devices like those shown in FIG. 1 A and FIG. 1 B. In FIG. 3A and FIG. 3B, the system (300) comprise three sensor devices (310) like those of FIG. 2A and FIG. 2B. The multiple sensor devices (310) in series can be used to detect a dimension change at multiple locations, such as a location near a snake bite (105) on a subject’s leg. Note the change in dimension of the area near the snake bite (105) from FIG. 3A to FIG. 3B. The modulus links (330) of the sensor devices (310) become stretched by the edema. The bottommost modulus link (330) in FIG. 3B breaks when it exceeds its tensile strength.

[0039] FIG. 4 shows another embodiment wherein a system (400) comprises multiple sensor devices (410) in series attached to a subject’s leg near a snake bite (105). The sensor devices (410) feature modulus links (430) made from different materials with different tensile strengths. FIG. 5 shows another embodiment wherein a system (500) comprises multiple sensor devices (410) in series attached to a subject’s leg near a snake bite (105). The sensor devices (510) feature modulus links (530) made from the same material but in different lengths.

[0040] The systems herein are not limited to a single sensor device and/or sensor. In certain embodiments, the system comprises two or more sensor devices. In certain embodiments, the system comprises a sensor device with two or more sensors. In certain embodiments, the system comprises two or more sensor devices with at least one having two or more sensors. In certain embodiments, the system comprises a plurality of the sensor devices disposed in series on the body or extremity, wherein the plurality of the sensor devices is configured to detect the dimension changes at multiple locations.

[0041] In certain embodiments, the use of two or more sensors allows for calculations of volume of particular area of the body or extremity. For example, as shown in FIG. 6, the system (600) may comprise three or more sensor devices (610) (bands) that wrap around an area of the body part or extremity. This series (or stacking) configuration, or other configurations, may allow for a measurement of a change in volume. For example, the top (first) sensor detects an increase in dimension (e.g., perimeter, radius, etc.) of X units, the middle (second) sensor detects an increase in dimension (e.g., perimeter, radius, etc.) of Y units, and the bottom (third) sensor detects an increase in dimension (e.g., perimeter, radius, etc.) of Z units. The increase in area could be calculated for each sensor based on the detected increase in dimension (e.g., perimeter, radius, etc.) (e.g., the increase in area sweep of the encircled sensor can be calculated). Using a height distance between the sensors, the system can calculate an increase in volume within a particular region, e.g., from the top sensor to the bottom sensor. FIG. 7 shows a schematic view of how multiple sensor devices in series could be used to calculate an increase in volume, wherein an increase in dimension (e.g., perimeter, circumference, radius) is used to calculate an increase in area, and the series of sensors is used to calculate an increase in volume.

[0042] The present invention is not limited to calculating increases in dimension, area, and/or volume. In some embodiments, the systems of the present invention calculate decreases in dimension, area, and/or volume. In some embodiments, the systems of the present invention detect a lack of change in dimension, area, and/or volume.

Processor and Memory

[0043] The system may further comprise a processor operatively connected to the sensor device (e.g., to the sensor(s) of the sensor device). The system may further comprise a memory operatively connected to the processor. The memory stores computer-readable instructions that, when executed by the processor, cause the processor to perform operations such as operations comprising detecting readings from the sensor device, recording readings from the sensor device, calculating the dimension changes of the specific location based on the sensor readings, etc.

[0044] The systems herein may be configured to detect an onset and/or a change and/or a cessation and/or progression of dimensional changes at the specific location of interest. In certain embodiments, the system detects an increase in dimension (e.g., perimeter, circumference, length, girth) of the body location. In certain embodiments, the system detects a decrease in dimension (e.g., perimeter, circumference, length, girth) of the body location. In certain embodiments, the system detects when there is no change in dimension (e.g., perimeter, circumference, length, girth) of the body location.

Sensors

[0045] As previously discussed, the sensor devices comprise one or more sensors for detecting the change in dimension of the body part or extremity.

[0046] Sensors may include active and/or passive sensors. For example, an active sensor may be defined as a sensor that has contained electrical or chemical elements for detecting the dimension change. A passive sensor may be defined as a sensor that senses the dimension change based on an intrinsic material property, e.g., a material with a known stress-strain curve (e.g., tensile point) wherein if the dimension exceeds its tensile point it breaks. Non-limiting examples of sensors include strain sensors, pressure sensors, stress sensors, swell sensors, bands (e.g., stretchable or elastic bands) for measuring girth, etc. Other non-limiting examples of sensors include temperature sensors, pH sensors, colorimetric means for looking at tissue color change. Sensors may also encompass other means of detecting and measuring dimension changes, include plethysmographic means, which involves displacement of fluids, such as liquids and gases. Sensors or other components of the system may feature gauges or markers to indicate a dimensional change.

Additional Features

[0047] In some embodiments, the system may further comprise a therapeutic delivery component that when activated is capable of administering a therapeutic treatment. For example, if the detected dimension change is different from a reference threshold (e.g., if the detected dimension change is greater than the threshold, less than the threshold, if no change in dimension is detected and the “threshold” is a particular change in dimension, etc.) the processor can activate the therapeutic delivery component, which administers the therapeutic treatment to the body or extremity so as to effect a modulation in dimension. The therapeutic treatment may be, for example, a pharmacological treatment (e.g., one or a combination of anti-venom, a diuretic, a corticosteroid, an anti-inflammatory, a coagulant, a hypotonic fluid, an electrolyte, an anti-coagulant, an anabolic steroid, etc.). In certain embodiments, the therapeutic treatment may be a mechanical treatment. In certain embodiments, the processor causes activation of the therapeutic delivery component when a detected dimension change varies from a pre-determ ined reference value. The reference threshold or pre determined reference value may be a laboratory standard, an institutional standard, an industry standard, etc.

[0048] In certain embodiments, the sensor device may comprise a non-contacting component. The non-contacting component may comprise a laser as a means of looking at angle changes. As an example, the laser has an incident beam targeted at the specific location with a reflectance means affixed to a tissue site where the reflected beam is normalized as a baseline. Any alteration of said reflected wave is an indication of underlying baseline geographic tissue shifts. Other examples of non-contacting component include, but are not limited to, optical, ultrasonic, temperature, or other electromagnetic means.

[0049] In certain embodiments, the systems may also comprise a telemeter or communication system. The telemeter or communication system may be configured to transmit the readings and measurements to a receiver or server for additional processing.

Methods

[0050] For example, the present invention also features a method of monitoring dimension changes in a body or extremity of a subject. In certain embodiments, the method comprises applying a system according to the present invention (or at least one system according to the present invention) to a specific location of the body or extremity. For example, at least one sensor device may be attached or applied to the specific location of the body or extremity. The method may further comprise detecting, via the sensor device, dimension changes at the specific location. The method may further comprise recording readings of the dimension changes from the sensor device. The method may further comprise calculating the dimension changes of the specific location based on the sensor readings.

[0051] The present invention also features methods of monitoring and treating venom or trauma-related edema that causes dimension changes in a body or extremity of a subject. In certain embodiments, the method comprises applying a system (or two or more systems) according to the present invention to a specific location of the body or extremity affected by venom or trauma. For example, at least one sensor device may be attached or applied to the specific location of the body or extremity affected by venom or trauma. The method may further comprise detecting, via the sensor device(s) of the system(s), the dimension changes at the specific location. The method may further comprise recording readings of the dimension changes from the sensor device. The may further comprise calculating the dimension changes of the specific location based on the sensor readings. The method may further comprise administering a therapeutic treatment to the affected body or extremity if the calculated dimension change exceeds a pre-determ ined reference threshold. As previously discussed, the therapeutic treatment may be a pharmacological treatment. For example, the pharmacological treatment may be one or a combination of: anti-venom, a diuretic, a corticosteroid, an anti-inflammatory, a coagulant, a hypotonic fluid, an electrolyte, an anti-coagulant, or an anabolic steroid. In certain embodiments, the therapeutic treatment is mechanical.

[0052] The disclosures of the following U.S. Patents are incorporated in their entirety by reference herein: US3853118, US6196231 , US20080307874, and US20140088461.

[0053] Various modifications of the invention, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims. Each reference cited in the present application is incorporated herein by reference in its entirety.

[0054] Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. Reference numbers recited in the claims are exemplary and for ease of review by the patent office only, and are not limiting in any way. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase“comprising” includes embodiments that could be described as “consisting of”, and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase“consisting of” is met.

[0055] The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.

Claims

WHAT IS CLAIMED IS:

1. A system for monitoring a dimension change in a body, body component or extremity of a subject, said system comprising:

a. at least one sensor device for detecting a dimension change at a specific location of the body or extremity when said sensor is applied to said location;

b. a processor operatively connected to the sensor device;

c. a memory operatively connected to the processor storing computer- readable instructions that, when executed by the processor, cause the processor to perform operations comprising recording readings from the sensor device, and calculating the dimension change of the specific location based on the sensor readings;

wherein the system detects an onset of dimensional changes at the specific location of the body or extremity and monitor progression or cessation thereof.

2. The system of claim 1 , wherein the dimension change is a change in perimeter.

3. The system of claim 1 , wherein the dimension change is a change in circumference.

4. The system of any of claims 1 -3, wherein the sensor is an active sensor.

5. The system of any of claims 1 -3, wherein the sensor is a passive sensor.

6. The system of claim 1 , wherein the sensor device comprises a sensor mounted to a band that is configured to be wrapped around a perimeter of the specific location of the body or extremity, wherein the band expands or contracts in conjunction with the onset, progression or cessation of the dimensional changes at the specific location of the body or extremity, wherein the sensor detects and reads said expansion and contraction of the band.

7. The system of claim 1 , wherein the sensor device comprises two sensors having a modulus link mounted there between, wherein the sensor device is attached to the specific location of the body or extremity, wherein the modulus link expands or contracts in conjunction with the onset, progression or cessation of the dimensional changes at the specific location of the body or extremity, wherein the sensors detect and read said expansion and contraction of the modulus link.

8. The system of claim of claim 7, wherein the modulus link breaks when the dimensional changes exceed a physical limitation of the modulus link.

9. The system of claim 8, wherein the physical limitation is tensile strength of the modulus link.

10. The system of any of claims 1 -9, wherein the system comprises a plurality of the sensor devices disposed in series on the body or extremity, wherein the plurality of the sensor devices is configured to detect the volume and dimension changes at multiple locations.

11. The system of any one of claims 1 -10, wherein the dimension changes are a result of venom or trauma-related edema and inflammatory effects.

12. The system of any one of claims 1 -11 , wherein the dimension changes are a result of one or more diseases including or related to: nephrosis, cirrhosis, cardiosis, or hypoalbuminemia.

13. The system of any one of claims 1 -11 , wherein the dimension changes are a result of a disease state causing edema, inflammatory effects, or both edema and inflammatory effects.

14. The system of any one of claims 1 -13 further comprising a therapeutic delivery component that when activated is capable of administering a therapeutic treatment to the body or extremity so as to modulate the dimensional changes.

15. The system of claim 14, wherein the processor causes activation of the therapeutic delivery component when a detected dimension change varies from a pre-determ ined reference value.

16. The system of claim 14, wherein the therapeutic treatment is a pharmacological treatment.

17. The system of claim 16, wherein the pharmacological treatment is one or a combination of: anti-venom, a diuretic, a corticosteroid, an anti-inflammatory, a coagulant, a hypotonic fluid, an electrolyte, an anti-coagulant, or an anabolic steroid.

18. The system of claim 14, wherein the therapeutic treatment is mechanical.

19. A method of monitoring and treating venom or trauma-related edema, said edema causing dimension changes in a body or extremity of a subject, said method comprising:

a. applying at least one sensor device of a system for monitoring dimension changes according to any of claims 1 -18 to a specific location of the body or extremity affected by venom or trauma;

b. detecting, via the sensor device, the dimension changes at the specific location;

c. recording readings of the dimension changes from the sensor device;

d. calculating the dimension changes of the specific location based on the sensor readings; and

e. administering a therapeutic treatment to the affected body or extremity if the calculated dimension change in (d) exceeds a pre-determ ined reference threshold.

20. The system of claim 19, wherein the therapeutic treatment is a pharmacological treatment.

21. The system of claim 20, wherein the pharmacological treatment is one or a combination of: anti-venom, a diuretic, a corticosteroid, an anti-inflammatory, a coagulant, a hypotonic fluid, an electrolyte, an anti-coagulant, or an anabolic steroid.

22. The system of claim 15, wherein the therapeutic treatment is mechanical.

23. A method of monitoring dimension changes in a body or extremity of a subject, said method comprising:

a. applying at least one sensor device of a system for monitoring dimension changes according to any of claims 1 -18 to a specific location of the body or extremity;

b. detecting, via the sensor device, dimension changes at the specific location;

c. recording readings of the dimension changes from the sensor device; and d. calculating the dimension changes of the specific location based on the sensor readings.

24. The method of claim 23, wherein the system that monitors dimension changes comprises a radio or telemetry mechanism.

25. The method of claim 24, wherein the radio or telemetry mechanism utilizes near field or Bluetooth communication.