Non-invasive wearables for physiological assessment of physical and cognitive readiness for military missions

Abstract

The disclosed device includes a band wearable by a user and configured to be worn in substantially complete cross-sectional contact with the user's biological compartment, a tensioning mechanism connected to the band configured to allow a circumference of the band to (i) expand to allow fluid to enter the biological compartment or (ii) contract to allow fluid to exit the biological compartment so that the band maintains substantially complete cross-sectional contact with the user's biological compartment, and a sensor connected to the band, the sensor configured to collect a plurality of patient data. The device is suitable for use in assessing military readiness of an individual or a group.

Description

[Technical Field]

[0001] The disclosed technology generally relates to systems, wearable devices, and methods for obtaining measurements of emergent properties of complex adaptive systems, such as biological, living (e.g., human), or non-living systems. More specifically, the disclosed technology relates to non-invasive wearable devices for physiological assessment of physical and cognitive readiness for military missions. The disclosed technology also generally relates to automatically or manually adjustable bands. [Background technology]

[0002] From a historical perspective, various advantages of the disclosed technology become apparent. Known devices and methods for monitoring biological systems, as well as known systems for maintaining or improving health, are inadequate. For example, known wearable devices generally exist in the off-the-shelf market, but many patients and users are excluded from that market. As a further example, known wearable devices generally are "one size fits all," but many patients and users cannot accommodate such devices. In addition, wearable devices generally perform their intended functions only when worn as intended, and perform little or no function unless worn substantially continuously. While there are typically critical moments when a wearable device should be worn, off-the-shelf and one-size-fits-all devices have characteristics that may not be worn at those moments, often motivating patients and users to remove the wearable device. Summary of the Invention

[0003] Methods for designing, manufacturing, adjusting for basic and extended use, and improving an adjustable wearable device are disclosed. The disclosed technology provides a user-wearable device, the device comprising: a band configured to be worn in substantially complete cross-sectional contact with the user's biological compartment; a tensioning mechanism connected to the band, the tensioning mechanism configured to allow the circumference of the band to (i) expand to allow fluid to enter the biological compartment or (ii) contract to allow fluid to exit the biological compartment, such that the band maintains substantially complete cross-sectional contact with the user's biological compartment; and a sensor connected to the band, the sensor configured to collect a plurality of patient data. Methods for collecting and distributing data collected via the device are also disclosed. In certain embodiments of the disclosed devices and methods, the data relates to a user's fitness performance. In certain embodiments of the disclosed devices and methods, the data relates to a user's heat flux. In certain embodiments of the disclosed devices and methods, the data relates to a user's heat flux over a plurality of circadian cycles.

[0004] The present disclosure provides methods for designing and manufacturing a device that continuously and contextually characterizes an individual's metabolic state by measuring their thermal signature to assess what is referred to as their thermoregulatory phenotype. Changes associated with this phenotype are sensitive indicators of changes in health status. The device is designed and configured for human use to provide a rough correlation between an individual's thermal signature and physiological reserve. The thermal signature contains additional information for practical assessment of readiness. Clinical studies are designed to gather data that will serve as a novel vital sign of homeostasis and a comprehensive health signature applicable to the early detection of many disease states and the management of individual health and readiness.

[0005] In certain embodiments, the disclosed technology provides a device in which the tensioning mechanism is directly connected to the sensor.

[0006] In certain embodiments, the disclosed technology provides a device in which the tensioning mechanism is directly connected to the band.

[0007] In certain embodiments, the disclosed technology provides a device in which the tensioning mechanism is located within a clasp that is directly connected to the band.

[0008] In certain embodiments, the disclosed technology provides a device in which the tensioning mechanism includes first and second mechanisms that are positioned in parallel when the band is in a closed position.

[0009] In certain embodiments, the disclosed technology provides a device in which the clasp is positioned parallel to the sensor when the band is in a closed position.

[0010] In certain embodiments, the disclosed technology provides a device in which a first end of the band is configured to be wound around a first band adapter located within the tensioning mechanism, and a second end of the band is configured to be wound around a second band adapter located within the tensioning mechanism, the first band adapter and the second band adapter configured to stabilize the first end of the band and the second end of the band.

[0011] In certain embodiments, the disclosed technology provides a device wherein the tensioning mechanism comprises a spring.

[0012] In certain embodiments, the disclosed technology provides a device in which the spring is embedded within the band.

[0013] In certain embodiments, the disclosed technology provides a device wherein the tensioning mechanism comprises a slider.

[0014] In certain embodiments, the disclosed technology provides a device in which a first end of the band overlaps a second end of the band.

[0015] In certain embodiments, the disclosed technology provides a device in which the tensioning mechanism is circular.

[0016] In certain embodiments, the disclosed technology provides a device wherein the tensioning mechanism is knurled.

[0017] In certain embodiments, the disclosed technology provides a device wherein the tensioning mechanism is configured to move the first end of the band and the second end of the band closer together or further apart.

[0018] In certain embodiments, the disclosed technology provides a device wherein the clasp further includes at least two pulleys, the at least two pulleys configured to transmit tension from the band.

[0019] In certain embodiments, the disclosed technology provides a device, wherein a first connector is disposed on a first pulley of the at least two pulleys and includes a first connector end and a second connector end, the first connector end being fixed and the second connector end being connected to the tensioning mechanism, and the first connector is parallel to the second connector.

[0020] In certain embodiments, the disclosed technology provides a device in which a second connector is disposed on a second pulley of the at least two pulleys and includes a first connector end and a second connector end, the first connector end being fixed and the second connector end being connected to the tensioning mechanism, and the second connector being parallel to the first connector.

[0021] In certain embodiments, the disclosed technology provides a device wherein the tensioning mechanism is configured to adjust based on the circumference of the user's biological compartment.

[0022] In certain embodiments, the disclosed technology provides a device in which the tensioning mechanism is configured to automatically adjust based on the circumference of the user's biological compartment.

[0023] In certain embodiments, the disclosed technology provides a device wherein the biological compartment is at least one of a wrist and an ankle.

[0024] In certain embodiments, the disclosed technology provides a device wherein the biological compartment is at least one of a finger and a toe.

[0025] In certain embodiments, the disclosed technology provides devices wherein the biological compartment is at least one of a lower leg and a forearm.

[0026] In certain embodiments, the disclosed technology provides devices wherein the biological compartment is at least one of the thigh and the upper arm.

[0027] In certain embodiments, the disclosed technology provides a device wherein the biological compartment is the abdomen.

[0028] In certain embodiments, the disclosed technology provides a device wherein the sensor is configured to dynamically measure pressure in the biological compartment.

[0029] In certain embodiments, the disclosed technology provides a device wherein the sensor is configured to dynamically measure the circumference of the band.

[0030] In certain embodiments, the disclosed technology provides a device wherein the sensor is configured to dynamically measure heat flux in the biological compartment.

[0031] In certain embodiments, the disclosed technology provides a device wherein the sensor is configured to dynamically measure the volume of the biological compartment.

[0032] In certain embodiments, the disclosed technology provides a device that includes an additional sensor configured to dynamically measure tension in the band.

[0033] In certain embodiments, the disclosed technology provides a device that includes an additional sensor configured to dynamically measure tension in the tensioning mechanism.

[0034] In certain embodiments, the sensor is configured to remain flush with the biological compartment of the user as the tensioning mechanism expands or contracts the circumference of the band.

[0035] In certain embodiments, the disclosed technology provides a method of adjusting a user-wearable device, the method comprising: placing a band on a biological compartment of a user, the band configured to be worn in substantially full cross-sectional contact with the biological compartment of the user; and winding a tensioning mechanism configured to receive a first end of the band and a second end of the band, the tensioning mechanism configured to move the first end of the band and the second end of the band closer together or further apart.

[0036] In certain embodiments, the disclosed technology provides a method wherein the band is further configured to be worn in substantially full cross-sectional contact with the user's biological compartment based on the user's comfort level.

[0037] In certain embodiments, the disclosed technology provides a method, wherein winding the tensioning mechanism compresses a sensor connected to the band into the biological compartment of the user, the sensor being configured to collect a plurality of user data.

[0038] In certain embodiments, the disclosed technology provides a method whereby the step of winding the tensioning mechanism occurs automatically based on the circumference of the biological compartment.

[0039] In certain embodiments, the disclosed technology provides a method for collecting data from a user-wearable device, the method comprising: dynamically adjusting a tensioning mechanism connected to a wearable based on a circumference of a biological compartment of the user; dynamically sensing at least one emergent factor of the user's biological system; and generating a plurality of data related to the at least one emergent factor.

[0040] In certain embodiments, the disclosed technology provides a method, wherein the plurality of data comprises surface temperature and physical activity of the biological system over time.

[0041] In certain embodiments, the disclosed technology provides a method further comprising the steps of: estimating heat removal of the biological system over time based on surface temperature differentials; estimating heat production of the biological system over time based on physical activity; and estimating a basal metabolic state of the biological system based on the temporal alignment of heat removal and heat production.

[0042] In certain embodiments, the disclosed technology provides a method further comprising the step of obtaining a quasi-periodic rhythm of the biological system based on the plurality of data, wherein the quasi-periodic rhythm is on a second-by-second, minute-by-minute, ultradian, circadian, circalunar or yearly basis.

[0043] In certain embodiments, the disclosed technology provides a method further comprising the steps of obtaining a variability in the quasi-periodic rhythm over a predetermined time period; and identifying health performance based on the variability in the quasi-periodic rhythm.

[0044] In certain embodiments, the disclosed technology provides a method further comprising the steps of: estimating heat removal over time of the biological system based on surface temperature differentials; estimating heat production over time of the biological system based on physical activity; estimating a basal metabolic state of the biological system based on the temporal alignment of heat removal and heat production; and determining health capacity by applying a time-dependent function to the estimated basal metabolic state, wherein the time-dependent function is calculated from the quasi-periodic rhythm of the biological system.

[0045] In certain embodiments, the disclosed technology provides a method, wherein the plurality of data comprises heat flux data.

[0046] In certain embodiments, the disclosed technology provides a method wherein the at least one health capacity is a basal metabolic state and the at least one emergent factor is the temporal alignment of heat production and heat removal.

[0047] In certain embodiments, the disclosed technology provides a method, wherein the temporal alignment relates to at least one quasi-periodic rhythm of the biological system.

[0048] In certain embodiments, the disclosed technology provides methods wherein the at least one quasi-periodic rhythm is a circadian rhythm. [Brief explanation of the drawings]

[0049] [Figure 1A] FIG. 1 illustrates a particular wearable device known in the art. [Figure 1B] FIG. 1 illustrates a particular wearable device known in the art. [Figure 1C] FIG. 1 illustrates a particular wearable device known in the art. [Figure 2A] FIG. 1 illustrates a particular wearable device known in the art. [Figure 2B] FIG. 1 illustrates a particular wearable device known in the art. [Figure 2C]FIG. 1 illustrates a particular wearable device known in the art. [Figure 3A] 1A-1C illustrate an exemplary embodiment of a tensioning mechanism. [Figure 3B] 1A-1C illustrate an exemplary embodiment of a tensioning mechanism. [Figure 4] 1A-1C illustrate an exemplary embodiment of a tensioning mechanism. [Figure 5A] 10A-10C illustrate an exemplary embodiment of a tensioning mechanism within a holder. [Figure 5B] 10A-10C illustrate an exemplary embodiment of a tensioning mechanism within a holder. [Figure 6A] 1A-1C illustrate an exemplary embodiment of the internal structure of a tensioning mechanism. [Figure 6B] 1A-1C illustrate an exemplary embodiment of the internal structure of a tensioning mechanism. [Figure 7] 1A-1C illustrate an exemplary embodiment of a tensioning mechanism. [Figure 8] 1A-1C illustrate an exemplary embodiment of a band with a clasp. [Figure 9A] 1A-1C illustrate an exemplary embodiment of a tensioning mechanism. [Figure 9B] 1A-1C illustrate an exemplary embodiment of a tensioning mechanism. [Figure 10] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 11] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 12] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 13] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 14] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 15] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 16] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 17] FIG. 1 illustrates an exemplary embodiment of a wearable device. [Figure 18] FIG. 1 illustrates an exemplary embodiment of a sensor. [Figure 19] FIG. 1 illustrates an exemplary embodiment of a sensor. [Figure 20] FIG. 1 illustrates an exemplary embodiment of a sensor. [Figure 21] FIG. 1 illustrates an exemplary embodiment of a sensor. [Figure 22] FIG. 1 illustrates an exemplary embodiment of a battery. [Figure 23] FIG. 1 illustrates an exemplary embodiment of a battery. [Figure 24] 1 illustrates an exemplary embodiment of a thermal disk. [Figure 25] 1 illustrates an exemplary embodiment of a thermal disk. DETAILED DESCRIPTION OF THE INVENTION

[0050] All patents, patent applications, and other publications referenced herein, including all sequences disclosed in these references, are expressly incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. All cited documents are, in relevant part, incorporated herein by reference in their entirety for the purposes indicated by the context of the citation herein. However, the citation of any document should not be construed as an admission that it is prior art with respect to the present disclosure.

[0051] The generation, analysis, and utilization of data related to the health performance of biological systems have been explored. More specifically, the use of sensors and combinations of sensors to obtain data related to the health performance of biological systems has also been explored. Health performance may refer to the resilience (adaptability) of a system, primarily expressed in terms of its ability to sustain or achieve its core functions. To assess the health performance of a system, one may interpret the emergent factors of the system. Emergent factors may refer to properties of water, aquatic systems, biological systems, or complex adaptive systems that relate to and can form the basis for assessing the health performance of the system. Emergent factors may also refer to events, deviations from norms, or other time-dependent patterns in some measurable parameters of the system that can be observed directly or indirectly. Emergent factors or characteristics may also refer to properties of a biological system that cannot be easily predicted from the function of the system's components. Examples of emergent properties may include amphotericity, conductivity, solvation capacity, ion mobility, redox potential, ligand binding, hydration, electrolysis, thermal conductivity, heat capacity, heat absorption, adhesion, cohesion, transparency, turbidity, incompressibility, polarity, dipolarity, dipole motion, diamagnetism, liquid phase voltage range, liquid phase temperature range, abundance, and flux of chemical species, energy, momentum, particles, and other substances, heat removal as an absolute static value, or heat removal as a periodic function (e.g., circadian period of heat removal).

[0052] Water is central to the functioning of all chemical or physical processes in all biological systems at any scale (e.g., whole body, cells, tissues, organs, etc.), and therefore the availability of sufficient relevant water and any of the aforementioned water-related properties (alone or in combination) is critical to the functioning of biological systems. It is therefore useful to select and utilize sensors that directly and / or indirectly measure water and any of the aforementioned water-related properties, alone or in combination, to quantify and learn at least the following operational characteristics of biological systems, for example:

[0053] High heat capacity: The relatively high heat capacity of water and aqueous systems provides thermal stability within the environment of biological systems. In contrast, the heat capacity of other typical or abundant solvents is significantly less than half that of water.

[0054] Incompressibility: The relatively high incompressibility of water and water-based systems results in very high thermal diffusivities comparable to those of solids. In contrast, other typical or abundant solvents are much more compressible and therefore more susceptible to structural damage.

[0055] High thermal diffusivity: Water and aqueous systems have very high thermal diffusivities comparable to solids. This minimizes detrimental internal temperature changes around active organelles. In contrast, other typical or abundant solvents are much less efficient at distributing energy, leading to very large temperature gradients around metabolic centers that can lead to structural degradation.

[0056] Wide infrared absorption band: Metabolism builds organic structures by creating and breaking carbon bonds in specific ways. Waste heat from these processes is efficiently recovered by the infrared absorption band of water. In contrast, other typical or abundant solvents recover heat much less efficiently. Furthermore, efficient heat recovery is essential for rapid enzymatic reactions.

[0057] Currently, there is no agreed upon measurement of health. Health is often defined as the absence of disease (symptoms). Disease indicators are lagging indicators of declining health and therefore do not reflect health in a positive sense, and as such, cannot be optimized for actual health (rather than disease) outcomes. Advances in understanding disease have revealed that early changes in inflammation can be predictive of disease, but inflammation is also a later sign of pathogenesis.

[0058] Inflammation is a common pathway that can affect all organ systems in the body. Inflammatory responses can be triggered by numerous stimuli and stresses, ranging from normal responses to exercise and training, to mechanisms now associated with carcinogenesis and neurodegeneration. Clinical signs of inflammation have classically been defined as five components: increased heat, pain, redness, swelling, and loss of function, and early inflammation (so-called pre-inflammation) is now considered a risk factor for disease. We focus on the relationship between changes in water and emerging parameters of inflammation (e.g., temperature and swelling).

[0059] Edema is an example of inflammation. Edema can occur when fluid accumulates in a patient's tissues and can affect anyone by causing a part of the patient's body to enlarge. For example, the circumference of a biological compartment of the patient may increase. As described above, edema can be a symptom of an underlying health condition. The underlying health condition can be monitored or assessed through the use of a wearable device capable of collecting and / or monitoring the health capacity of a biological system. This can include at least one wearable thermodynamic sensor configured to measure a human emergent factor (the emergent factor being the time alignment of heat production and heat removal in the human, the time alignment being related to the human circadian rhythm) and generate measurement data comprising heat flux data over time based on the emergent factor. The wearable device can also acquire the heat flux data, where the at least one health capacity is the basal metabolic state and the at least one emergent factor is the time alignment of heat production and heat removal in the biological system. The wearable device can include a number of sensors that record health indicators and acquire data. The wearable device may continuously record selected "energy signature" indicators, or indicators of a subject's health. In some embodiments, the wearable device allows real-time access and continuous data acquisition at low cost and low power. In some embodiments, the wearable device is equipped with a multimodal sensor system that measures electrochemical, mechanical, structural, thermal, and / or energetic properties that reflect homeostasis and cellular physiology. The wearable device may include any number of sensors.

[0060] Mild or severe edema may prevent a patient from wearing a wearable device capable of monitoring and / or assessing the health performance of the patient's biological compartments. The patient may remove the wearable device because it is too tight, constricting the patient's biological compartments. In some cases, severe edema may prevent a patient from using any existing wearable device because the device is not sized to accommodate the patient's edema. Data regarding the health performance of a biological system cannot be obtained or assessed unless the patient continuously wears a wearable device that allows for data acquisition and assessment. In other words, the data stream collected by the wearable device is interrupted when the user removes the wearable device.

[0061] As shown in FIGS. 1A, 1B, 1C, 2A, 2B, and 2C, certain wearable devices known in the art include a variety of passively and actively adjustable wearable devices that offer "off-the-shelf" solutions. Actively adjustable wearable devices include band-type devices that require the user to manually adjust the size of the band. These adjustments can be macro or micro adjustments. For example, bands can be manufactured in different sizes with flexible materials. For example, a "small" band may fit a user with a wrist circumference between 5.5 inches and 7 inches, or a "large" band may fit a user with a wrist circumference between 7.1 inches and 8.7 inches. The limited range of adjustment can result in discomfort for the user and can lead to the user removing the device, which can cause an interruption in the data stream.

[0062] Thus, a need exists for a device that enables optimal monitoring of health performance and heat flux. Such a device is disclosed herein. In some embodiments, a wearable device may include a band, a tensioning mechanism, and a sensor. The wearable device may be worn around a biological compartment to measure emergent factors. As used herein, a biological compartment may refer to a wrist, ankle, a finger, a toe, a lower leg, a forearm, a thigh, an upper arm, and / or an abdomen. In a biological compartment, changes in homeostasis may cause the size or shape of the biological compartment to change or fluctuate. In a biological compartment, homeostasis may change such that water flow is quite different from normal. For example, a patient with some disease component may experience or undergo a dramatic change in the diameter of the biological compartment. While the homeostasis of a biological compartment changes, it may not be optimal for monitoring the patient's health performance. In some embodiments, the wearable device may adapt to changes in homeostasis indicated by the biological compartment measured by the wearable device.

[0063] In some embodiments, the band may be adjustable to the user. For example, the band may be available in various sizes (e.g., small, medium, large) so that the band can be worn by users with biological compartments of various sizes. In some embodiments, the band may be adjustable and comprise a flexible material. Such flexible materials may include nylon, rubber, silicone, fabric, etc. In some embodiments, the adjustability of the band allows the patient to continue wearing the wearable device while the biological compartment is undergoing or experiencing a homeostatic change. For example, the circumference or length of the band may increase or decrease. In other words, the circumference or length of the band may be adjusted to accommodate or fit the circumference of the biological compartment. This allows the patient to remain comfortable (e.g., without feeling constricted) while wearing the device and experiencing a homeostatic change. Similarly, this may allow the patient to wear the wearable device at all times, thereby allowing the wearable device to collect a constant stream of data. An adjustable band allows patients prone to irregular biological compartment homeostasis to wear the wearable device and monitor their health performance. Furthermore, in some embodiments, the adjustability of the band allows sensors measuring or assessing various emergent factors to maintain substantially full connectivity with the biological compartments they are intended to measure or assess, thereby allowing the sensors to maintain a continuous, constant collection of data streams, since without substantially full connectivity between the sensor and the biological compartment being measured, the sensor cannot assess or monitor the biological compartment.

[0064] Military applications, including military readiness assessments.

[0065] Physicists have faced problems of emergent order before (e.g., magnetism) and concluded that it may be advantageous to identify thermodynamic parameters that summarize order rather than attempting to directly measure the molecular details of that order. Indeed, all order is associated with lost energy (see, e.g., https: / / en.wikipedia.org / wiki / Latent_heat). For example, when studying complex materials, physicists look for anomalous specific heats as a sign of hidden organization. Landau defined the order parameter (see, e.g., https: / / en.wikipedia.org / wiki / Landau_theory): a useful mathematical device to quantify the thermodynamic properties and robustness of latent order.

[0066] Our insight is based, in part, on the notion that the organization of living systems has associated thermodynamic signatures analogous to order parameters. Only these biological order parameters can be learned with high accuracy using small sample sizes. Furthermore, such thermal signatures likely inform the robustness of biological order, i.e., its physiological reserve and readiness.

[0067] Energy TM The wearable device, also known as a 'physical energy monitor' (EMT), is designed and configured to quantify physiological energy output (e.g., peripheral heat and physical activity). The device has been benchmarked against gold-standard physiological endpoints in multiple IRB-approved human studies. These benchmark metrics include highly accurate signals with training sets as small as 25 samples.

[0068] "A robust structure has been identified in the human thermal signature, which serves as a direct measure of the autonomous processes underlying homeostasis (i.e., biological organization). Specifically, the device provides a means to noninvasively detect the thermal signature of the inflammatory cascade before changes in core temperature occur. This observation has implications in terms of thermal physics and transformative biological applications."

[0069] Despite fundamental differences in the hypothalamic-adrenal-pituitary axis between men and women, there are no readily available metrics that characterize the functional capacity of neuroendocrine responses essential for trauma prevention and survival (REF). Instead, physiological responses to trauma are often assumed to be similar between men and women, leading to the default of standard metrics for men and potentially suboptimal treatment of trauma in women. The wearable device described herein utilizes a physical model of thermal homeostasis, inspired by hypothalamic function, to interpret the health significance of an individual's thermal signature (see References 1-5). By measuring the key data streams integrated by the hypothalamus (heat and body temperature), the device enables characterization of the foundations of homeostasis and physiological reserve, including gender differences (see References 4 and 5), and defines gender-specific metrics relevant to trauma treatment (see Reference 6). Wearable devices provide continuous and contextual measurement of these key data streams regulated by the hypothalamus, providing a means to characterize both individuals and gender groups by measuring thermal signatures to assess what is termed thermoregulatory phenotypes.

[0070] The disclosed technology is based, in part, on utilizing a novel physical model of thermal homeostasis to provide a means to understand and / or interpret the health significance of an individual's thermal signature (thermal phenotype) and act in various ways based on that interpretation. The non-invasive wearable device goes beyond simple skin temperature measurements by continuously sensing the thermal signature of body temperature and can last for up to several months without requiring charging or battery replacement.

[0071] The disclosed technology relates to a non-invasive wearable device for physiological assessment of physical and cognitive readiness for military missions. The disclosure provides methods for designing and manufacturing a device that continuously and contextually characterizes an individual's metabolic state by measuring a thermal signature to assess what is referred to as a thermoregulatory phenotype. Changes associated with this phenotype are sensitive indicators of changes in health status. The device is designed and configured to provide a rough correlation between an individual's thermal signature and physiological reserve in human use. Additional information is contained within the thermal signature for practical assessment of readiness. Clinical studies are designed to gather data that can serve as a novel vital sign of homeostasis and a comprehensive health signature applicable to the early detection of many disease states and the management of individual health and readiness.

[0072] A warfighter's readiness is determined by their physiological reserve, or their ability to adapt and perform under stress (e.g., maintain homeostasis). This "reserve" can be assessed clinically through various stress tests, but has not yet been simplified into an accurate physical measurement that can be passively measured by a wearable device. Our goal is to automate the measurement of physiological reserve using a wearable device so that readiness can be continuously assessed at individual and population scales.

[0073] Currently, when stress testing is not possible, readiness is quantified by manual assessment of vital signs and other physiological markers / tests by medical professionals. Currently available physiological data panels only weakly correlate with physiological reserve in young, healthy subjects, forcing medical professionals to exercise difficult clinical judgment when assessing each patient. As a result, this approach is highly subjective and limited in both accuracy and scalability. Our approach assumes that readiness and physiological reserve are determined by the organization of biological energy resources, which underpin homeostasis. While some consumer wearables measure skin temperature, none measure actual energy. Energy TMUsing a novel sensor configuration, the device can estimate peripheral heat removal, a rich new indicator of physiological energy fundamentally related to homeostasis and hypothalamic regulation. By continuously compiling this signature, we identified and quantified previously unobserved patterns, termed thermoregulatory phenotypes. Our hypothesis is that these structures are directly determined by autonomic control of thermoregulation and therefore may reveal homeostatic stress in real time, thereby enabling prediction of responsiveness.

[0074] Energy TM The device can meet the hardware requirements of this BAA. Initial IRB-approved human trials have demonstrated a rough correlation between our signals and physiological reserve. The challenge remains to translate the general information in our data stream into an actionable assessment of readiness. Current trials are gathering data toward this goal. If successful, we will have discovered a new vital sign of homeostasis that serves as an individual's comprehensive health signature, applicable to assessing readiness and early detection of many disease states, as well as personal health management.

[0075] In certain embodiments, the present invention utilizes a physical model of thermal homeostasis inspired by the function of the hypothalamus to interpret the health significance of an individual's thermal signature (References 1-4). Measuring the key data streams (heat and body temperature) integrated by the hypothalamus reveals the theoretical basis for homeostasis and physiological reserve. Therefore, instead of using "molecular biomarkers" to determine health, our approach uses a homeostatic thermal energy marker. Our prototype wearable device senses this signature continuously and does not require charging or battery replacement for several months. In military environments, we envision a closed, secure wireless ecosystem that enables timely data collection and analysis, delivering readiness results within hours of deployment (Figure A). With physiological sensors and prototypes already partially developed, the main technical challenge lies in collecting relevant data that allows for the establishment of robust thresholds linking indicators of an individual warfighter's thermoregulatory phenotype to physical and cognitive readiness ratings.

[0076] JPEG2025528192000002.jpg48114 (Figure A) Energy TM 1 is a diagram of a proposed solution using wearables.

[0077] A robust model of readiness will be developed based on both (1) physical links to homeostasis and hypothalamic function and (2) previously collected human research data, as described below.

[0078] The disclosed technology has the ability to noninvasively detect inflammation, a common cause of disease. Specifically, in a yet-to-be-published, IRB-approved human study, healthy subjects were injected with lipopolysaccharide (LPS) to stimulate inflammation and serial biomarkers of inflammation were measured (see Reference 5). In parallel, the subjects' thermoregulatory signatures were noninvasively recorded. The plot below shows the baseline (in blue) joint distribution of thermal and skin temperature over approximately 30 days for three subjects (one per column) from a recent study. Triangular frames are included to highlight inter-subject variability. The study protocol included two LPS injections, one week apart. JPEG2025528192000003.jpg73157Sensor recordings after the first and second LPS injections are shown in red and green, respectively, as a time course over 4 hours post-injection. The data shown are raw measurements without any preprocessing and are intended only to illustrate the structured relationship between skin temperature and body temperature as regulated by the hypothalamus.

[0079] Despite inter-subject variability, the results show a common pattern of pre-fever fever responses, and a readily observable post-symptom fever response. The results are consistent with known physiology—the hypothalamic control of core temperature (6). The pre-fever response includes an outlier point in the lower left quadrant (low fever, low skin temperature), which is a vasoconstriction state that precedes and promotes an increase in core temperature. This is followed by an outlier point in the upper right quadrant (high fever, high skin temperature), which corresponds to a defervescent state.

[0080] These data suggest that pre-symptomatic signals of inflammatory stress may contribute to Enerji TMThis demonstrates that the device can detect stress levels. By measuring combatants in typical stress states, this technology can map the heat response to a readiness rating. The disclosed technology can identify stress patterns from a single subject by measuring the core temperature parameter of the hypothalamic system. In fact, the inflammatory response shown in Figure 2 is seen independently in each individual. Obtaining inter-subject variability allows for statistical optimization, but is not strictly necessary for the signal to be useful.

[0081] Models are being developed to build representative cohorts of warfighters, expose them to typical stressors, and then observe and set thresholds around their characteristic stress responses. This type of study will be similar in structure and complexity to those already underway. Basic statistical methods and visualizations similar to Figure 2 will be used to isolate and grade outlier records related to stress conditions in preparation for an internal V&V demonstration at the end of Phase 1.

[0082] Similar experiments using tests of cognitive readiness will be conducted. These experiments demonstrate how stressed thermoregulatory phenotypes relate to cognitive performance. A strong relationship between cognitive function and thermoregulation has been shown (see references 7-10). The device is also suitable for assessing cognitive readiness.

[0083] The challenge with molecular biomarkers is establishing their significance to known physiology and homeostasis. The disclosed technology circumvents the challenges of typical molecular biomarkers because it measures body temperature, which is fundamentally related to temperature homeostasis.

[0084] Appropriate computing and readout capabilities will be developed. Wearable devices may be highly durable. The data analysis platform described above may be deployable on a public cloud and use commodity computer, network, and storage services. The architecture may be redesigned to meet SWaP requirements for military use on the battlefield.

[0085] Clinical Research: Conducting studies to develop models for stratifying the readiness states of "healthy" individuals under various stress loads.

[0086] Data Analytics: Enhance data analytics to develop military-specific readiness models based on sensor data and clinical research results.

[0087] Hardware: Select and / or develop device ruggedization in accordance with military specification requirements and data collection and display hardware that meets operational and SWaP requirements.

[0088] Software: Enhance the software to integrate wearable sensor devices, portable computers and readout capabilities, and converged functions specific to DoD operational requirements (e.g., data storage, remote upgrade capabilities, etc.).

[0089] In some embodiments, the band may include at least one strap. In some embodiments, the band may include two straps parallel to one another. In some embodiments, the band may include a casing. In some embodiments, the band or the casing may be textured. In some embodiments, the patient may insert a portion of the biological compartment into an opening formed by the band when the band is in a closed position. In some embodiments, the band may include a first portion and a second portion. In some embodiments, the first portion may include a receiving portion capable of receiving the second portion of the band.

[0090] In some embodiments, the band can be connected to a tensioning mechanism. In some embodiments, the tensioning mechanism can accept the band. The tensioning mechanism can include a first slot capable of accepting a first portion of the band and a second slot capable of accepting a second portion of the band. In some embodiments, the tensioning mechanism can implement a winding function to adjust the band. For example, the tensioning mechanism can be rotated to wrap around the band, thereby tightening the band or shortening its length. Similarly, the tensioning mechanism can be rotated in the opposite direction to unwind the band from the tensioning mechanism, thereby loosening the band or lengthening its length. In some embodiments, the tensioning mechanism can be controlled automatically or manually. In some embodiments, the tensioning mechanism can be rounded. In some embodiments, the tensioning mechanism can be knurled to allow the patient to more firmly grip the tensioning mechanism.

[0091] In some embodiments, the tensioning mechanism can include a spring. In some embodiments, the spring can be embedded within the band to allow the band to stretch. For example, a patient can pull on the band, thereby stretching the spring and adjusting the length of the band. The band can be at its shortest length or circumference when the spring is at its shortest length.

[0092] In some embodiments, a portion of the tensioning mechanism may be disposed within a clasp that may be directly connected to the band. The clasp allows the band to remain in a closed position when the patient is wearing the wearable device. In some embodiments, the clasp may include at least one pulley. The pulley may include a channel portion that receives an intermediate portion of the band. For example, a first pulley may include a first channel portion that can receive a first intermediate portion of the first portion of the band. Similarly, a second pulley may include a second channel portion that can receive a second intermediate portion of the second portion of the band. The first and second intermediate portions of the band may be disposed within the first and second channel portions of the pulley, respectively. The second portion of the tensioning mechanism may be disposed parallel to the first portion of the tensioning mechanism. This parallel configuration may form an opening for the patient to insert the biological compartment. The second portion of the tensioning mechanism may include a first connection portion and a second connection portion. The first connection portion may be disposed on a first side of the tensioning mechanism, and the second connection portion may be disposed on a second side of the tensioning mechanism. The connector may function to connect the band to the tensioning mechanism. The tensioning mechanism may further include an anchor point for stabilizing the band within the tensioning mechanism. For example, a first end of a first portion of the band may be connected to a first connector, and a second end of the first portion of the band may be connected to a first anchor point located on the opposite side of the tensioning mechanism from the first connector. Similarly, a first end of a second portion of the band may be connected to a second connector, and a second end of the second portion of the band may be connected to a second anchor point located on the opposite side of the tensioning mechanism from the second connector. The tensioning mechanism may further include a knob that can be rotated to tighten or loosen the band, thereby increasing or decreasing the circumference of the band.

[0093] In some embodiments, the wearable device may include numerous sensors. In some embodiments, the sensors may record health indicators. In some embodiments, the wearable device continuously records selected energy signature indicators or user health indicators. In some embodiments, the wearable device captures emergent complexity at the scale of cellular physiology. In some embodiments, the wearable device allows real-time access and continuous data acquisition at low cost and low power. In some embodiments, the wearable device includes a multimodal sensor system that measures electrochemical, mechanical, structural, thermal, and / or energetic properties that reflect homeostasis and cellular physiology. In some embodiments, the wearable device includes sensors that control and / or measure tension in the tensioning mechanism. In some embodiments, the sensors may be connected to the band and / or the tensioning mechanism. In some embodiments, the first sensor may be based on a circumference measurement where the sensor may dynamically measure tension in the band and / or tension in the tensioning mechanism. In some embodiments, the second sensor may dynamically measure various emergent factors of the biological compartment. For example, the second sensor may dynamically measure the pressure, heat flux, volume, etc. of the biological compartment. In some embodiments, the sensor may non-invasively or minimally invasively measure various emergent factors. In some embodiments, the sensor may dynamically measure tension in the band and dynamically equalize the tension to the internal pressure of the biological compartment. In some embodiments, the sensor may include an implantable microneedle that dynamically measures interstitial pressure minimally invasively. In some embodiments, the sensor may include a controller that can dynamically alter the tension mechanism and / or tension in the band based on measurements measured by the sensor.

[0094] As shown in FIG. 3A, the wearable device 300 may include a band 310, a tensioning mechanism 320, a first sensor 330, and a second sensor 340. FIG. 3B shows that the tensioning mechanism 320 may be square, round, or knurled. The tensioning mechanism 320 may be mechanically or automatically controlled. The first sensor 330 may dynamically measure various emergent factors of the user. The second sensor 340 may measure and / or control the tension within the tensioning mechanism 320. The first sensor 330 may include a thermal disk that may be flush with the user's skin while the wearable device 300 is being worn.

[0095] The tensioning mechanism 320 is designed to receive the band and may include a first channel portion 350 and a second channel portion 360. The tensioning mechanism 320 is designed to increase or decrease the amount of band 310 received by the first channel portion 350 and the second channel portion 360 depending on whether the tensioning mechanism 320 is tightened or loosened. The tensioning mechanism 320 may use frictional rotational feedback to maintain the desired tension on the band 310 and tensioning mechanism 320. Each frictional rotation can reel in the band 310 by wrapping it further around the first channel portion 350 and the second channel portion 360, or release the band 310 by unwinding it from the channels. The band 310 may resemble a cord bracelet. The band 310 may be made of a biocompatible silicone elongated cord of various diameters for increased user comfort. The band 310 may have a diameter of approximately 0.5 mm to approximately 2 mm.

[0096] 4, the diameter of the tensioning mechanism 420 can be from about 10 mm to about 30 mm. The diameter of the tensioning mechanism 420 can be proportional to the length of the band and the allowable range of band length adjustment. The height of the tensioning mechanism 420 can be from about 8 mm to about 15 mm.

[0097] As shown in FIGS. 5A-5B, the tensioning mechanism 520 can be inserted into the ring slot 530. The width of the ring slot 530 can range from about 1 inch to about 2 inches. The height of the ring slot 530 can range from about 0.1 inch to about 0.4 inch. The diameter of the tensioning mechanism 520 can be about 0.5 inches to 1.5 inches and is inserted into the opening of the ring slot 520. As shown in FIGS. 5A-5B, the opening of the ring slot can extend from the top of the ring slot 520 to the bottom of the ring slot 520. The diameter of the opening at the top of the ring slot 520 can be larger than the diameter of the opening at the bottom of the ring slot 520. In other words, the diameter of the opening can decrease throughout the depth of the ring slot. The diameter of the opening of the ring slot can be constant over a portion of the ring slot, forming a ledge where the opening diameter decreases. The ledge allows the tensioning mechanism 520 to seat in the ring slot. An opening at the bottom of ring slot 520 allows the sensor to contact the user's skin.

[0098] As shown in Figure 6, scale fit studies indicate that the components of the tension mechanism fit within the internal compartment of the tension mechanism.

[0099] 7, band 710 can include spring 720. Spring 720 allows the length of band 710 to expand to accommodate the user's biological compartment.

[0100] 8, the wearable device may include a band 810 and a clasp 820. The clasp 820 may be connected to the band 810. The clasp 820 may also connect a first end of the band 810 to a second end of the band 810, thereby forming a closed loop or bracelet worn by a user. A tensioning mechanism may be located within the clasp.

[0101] As shown in FIGS. 9A-9B, the tensioning mechanism 920 includes at least two clasps 930, 940. The clasps 930, 940 may be a pulley system that assists in tightening or loosening the wearable device. The pulleys may include a channel portion that receives an intermediate portion of the band. As shown in FIGS. 9A-9B, the first pulley 930 has a first channel portion that receives a first intermediate portion 910 of the first portion of the band. The second pulley 940 includes a second channel portion that receives a second intermediate portion 915 of the second portion of the band. The first and second intermediate portions of the band may be disposed within the first and second channel portions of the pulleys, respectively. The tensioning mechanism 920 may include a first connector portion 950 and a second connector portion 960. As shown in FIG. 9A, the first connector portion 950 is disposed on a first side of the tensioning mechanism 920, and the second connector portion 960 is disposed on a second side of the tensioning mechanism 920. The connector may function to connect the band to the tensioning mechanism 920. The tensioning mechanism 920 further includes anchor points 970a and 970b for stabilizing the band within the tensioning mechanism. As shown in FIG. 9A, a first end 972 of a first portion of the band is connected to the first connector 950, and a second end 974 of the first portion of the band is connected to the first anchor point 970a, located on the opposite side of the tensioning mechanism from the first connector 950. Similarly, a first end 976 of a second portion of the band is connected to the second connector 960, and a second end 978 of the second portion of the band is connected to the second anchor point 970b, located on the opposite side of the tensioning mechanism from the second connector 960. The tensioning mechanism further includes a knob 980 that can be rotated to tighten or loosen the band, thereby increasing or decreasing the circumference of the band. As shown in FIG. 9B, clasps 930 and 940 are connected to secure the wearable device around a user's biological compartment.

[0102] 10, the tensioning mechanism includes a first portion 1020 and a second portion 1030 that are parallel to one another during use of the wearable device 1000. The first portion 1020 and the second portion 1030 remain connected by a band 1050 that changes length based on the variable size of the user's biological compartment.

[0103] 11-12 illustrate various ways in which pulley systems can be used within a tensioning mechanism. As shown in FIG. 11, the tensioning mechanism includes a single pulley 1110 for dynamically adjusting the size of the wearable device 1100. The wearable device 1100 includes a strap 1120 in which the pulley 1110 is embedded to improve comfort for the portion of the wearable device that contacts the user's skin. The strap can be a flexible material to further enhance the wearable device's ability to adjust to various sizes of the user's biological compartments. The flexible material of the strap can increase or decrease the size of the wearable device by approximately 1 inch to approximately 4 inches. As shown in FIG. 12, the tensioning mechanism includes two pulleys 1210 embedded in a strap 1220, which can increase or decrease the size of the wearable device by approximately 1 inch to approximately 6 inches.

[0104] 13-17 show various wearable devices with the tensioning mechanism described above. As shown in FIG. 13, the tensioning mechanism is on the outer surface of the wearable device. This embodiment provides easy user access to the tensioning mechanism. As shown in FIG. 14, the tensioning mechanism is located within an internal compartment of the wearable device. This embodiment protects the tensioning mechanism from unintentional adjustment.

[0105] As shown in FIG. 15 , the tensioning mechanism is also internal to the wearable device. This embodiment allows for macro- and micro-adjustment of the size of the wearable device. As described above, macro-adjustment can be controlled by the length at which the user connects the first portion of the strap and the second portion of the strap. Micro-adjustment can be controlled by the tensioning mechanism. The band of the tensioning mechanism is connected to the strap to allow for macro- and micro-adjustment in both increasing and decreasing the size of the wearable device. In other words, the macro- and micro-adjustments complement each other to ultimately maximize the user's comfort and extend the wearing period of the wearable device.

[0106] A flexible material or cloth-like scrunchie can wrap or flex over the tensioning mechanism band, as shown in Figure 16. As shown in Figure 17, the tensioning mechanism band can be exposed to reduce the overall weight of the wearable device.

[0107] Figures 18-25 show sensors used within the tensioning mechanism. As shown in Figures 18-21, the sensor is used to convert signals controlling the tensioning mechanism. This sensor controls the tightening and loosening of the tensioning mechanism as well as the overall size of the wearable device. The sensor includes an embedded magnet so that the rotation signal results from the orientation of the magnetic field. The magnet can be a ceramic or ferrite donut magnet with a cross-field orientation. Figures 19-20 show examples of commercially available magnets. As shown in Figures 22-23, a battery can be included within the tensioning mechanism to increase the use of the wearable device.

[0108] As shown in Figures 24-25, the sensor is used to measure any number of emergent factors of a user. The sensor includes a thermal disk that fits inside the ring magnet described above. The thermal disk contacts the user's skin when the user is wearing the wearable device.

[0109] The described embodiments are examples. Various changes can be made to the above-described devices and methods without departing from the scope of the invention. All matter set forth in this disclosure, including the accompanying figures, is illustrative and not limiting.

[0110] References

[0111] Reference 1: Osilla EV, Marsidi JL, Sharma S. Physiology, Temperature Regulation. [Updated May 8, 2022]. In: StatPearls. Treasure Island (FL): StatPearls Publishing; January 2022. Available from: https: / / www.ncbi.nlm.nih.gov / books / NBK507838 / .

[0112] Reference 2: Schieber AM, Ayres JS. Thermoregulation as a disease tolerance defense strategy. Pathog Dis. 2016 Dec;74(9):ftw106. DOI: 10.1093 / femspd / ftw106. E-published November 3, 2016. PMID: 27815313; PMC ID: PMC5975229.

[0113] Reference 3: Drewry AM, Fuller BM, Bailey TC, Hotchkiss RS. Body temperature patterns as a predictor of hospital-acquired sepsis in afebrile adult intensive care unit patients: a case-control study. Crit Care. 2013 Sep 12;17(5):R200. DOI: 10.1186 / cc12894. PMID: 24028682; PMC ID: PMC3906745.

[0114] Reference 4: Kenny GP, Sigal RJ, McGinn R. Body temperature regulation in diabetes. Temperature (Austin). 2016 Jan 4;3(1):119-45. DOI: 10.1080 / 23328940.2015.1131506. PMID: 27227101; PMC ID: PMC4861190.

[0115] Reference 5: van Lier D, Geven C, Leijte GP, Pickkers P. Experimental human endotoxemia as a model of systemic inflammation. Biochimie. 2019 Apr;159:99-106. DOI: 10.1016 / j.biochi.2018.06.014. E-published June 22, 2018. PMID: 29936295.

[0116] Reference 6: Romanovsky AA. Skin temperature: its role in thermoregulation. Acta Physiol (Oxf). 2014 Mar;210(3):498-507. DOI: 10.1111 / apha.12231. PMID: 24716231; PMC ID: PMC4159593.

[0117] Reference 7: Altered Experienced Thermoregulation in Depression—No Evidence for an Effect of Early Life Stress - PubMed (nih.gov), Front Psychiatry. 2021 Jul 21;12:620656. DOI: 10.3389 / fpsyt.2021.620656. PMID: 34366905; PMC ID: PMC8333702.

[0118] Reference 8: Hanusch, K., Janssen, CH, Billheimer, D, Jenkins, I., Spurgeon, E., Lowry, CA, Raison, CL Whole Body Hyperthermia (WBH) for the Treatment of Major Depression: Associations with Thermoregulatory Cooling. American Journal of Psychiatry 2013; 170: 802-804.

[0119] Reference 9: Byrne J, Ludington-Hoe SM, Voss JG. Occupational Heat Stress, Thermal Comfort, and Cognitive Performance in the OR: An Integrative Review. AORN J. May 2020;111(5):536-545. DOI: 10.1002 / aorn.13009. PM Identification Number: 32343372.

[0120] Reference 10: Hancock, Peter A. and Ioannis Vasmatzidis. “Effects of heat stress on cognitive performance: the current state of knowledge.” International Journal of Hyperthermia 19 (2003): 355–372.

Claims

1. A user-wearable device, comprising: a band configured to be worn in substantially complete cross-sectional contact with the user's biological compartment; a tensioning mechanism connected to the band, the tensioning mechanism configured to allow a circumference of the band to (i) expand to allow fluid to enter the biological compartment, or (ii) contract to allow fluid to exit the biological compartment, such that the band maintains substantially full cross-sectional contact with the biological compartment of the user; and a sensor connected to the band, the sensor configured to collect a plurality of patient data.

2. 10. The device of claim 1, The tensioning mechanism is directly connected to the sensor.

3. 10. The device of claim 1, The tensioning mechanism is connected directly to the band.

4. 10. The device of claim 1, The tensioning mechanism is located in a clasp that is directly connected to the band.

5. 10. The device of claim 1, The tensioning mechanism includes a first mechanism and a second mechanism that are positioned in parallel when the band is in a closed position.

6. 5. The device of claim 4, The clasp is positioned parallel to the sensor when the band is in the closed position.

7. 10. The device of claim 1, a first end of the band configured to be wound around a first band adapter located within the tensioning mechanism, and a second end of the band configured to be wound around a second band adapter located within the tensioning mechanism; The first band adapter and the second band adapter are configured to stabilize the first end of the band and the second end of the band.

8. 10. The device of claim 1, The tensioning mechanism includes a spring.

9. 9. The device of claim 8, The spring is embedded within the band.

10. 10. The device of claim 1, The tensioning mechanism includes a slider.

11. 11. The device of claim 10, The first end of the band overlaps the second end of the band.

12. 10. The device of claim 1, The tensioning mechanism is circular.

13. 10. The device of claim 1, The tensioning mechanism is knurled.

14. 8. The device of claim 7, The tensioning mechanism is configured to move the first end of the band and the second end of the band closer together or further apart.

15. 5. The device of claim 4, The clasp further includes at least two pulleys; The at least two pulleys are configured to transmit tension from the band.

16. 16. The device of claim 15, a first connector disposed on a first of the at least two pulleys, the first connector including a first connector end and a second connector end; The first connector end is fixed and the second connector end is connected to the tensioning mechanism, with the first connector being parallel to the second connector.

17. 16. The device of claim 15, a second connector disposed on a second of the at least two pulleys, the second connector including a first connector end and a second connector end; The first connector end is fixed and the second connector end is connected to the tensioning mechanism, the second connector being parallel to the first connector.

18. 10. The device of claim 1, The tensioning mechanism is configured to adjust based on the circumference of the user's biological compartment.

19. 20. The device of claim 18, The tensioning mechanism is configured to automatically adjust based on the circumference of the user's biological compartment.

20. 10. The device of claim 1, The biological compartment is at least one of a wrist and an ankle.

21. 10. The device of claim 1, The biological compartment is at least one of a finger and a toe.

22. 10. The device of claim 1, The biological compartment is at least one of a lower leg and a forearm.

23. 10. The device of claim 1, The biological compartment is at least one of the thigh and the upper arm.

24. 10. The device of claim 1, The biological compartment is the abdomen.

25. 10. The device of claim 1, The sensor is configured to dynamically measure pressure in the biological compartment.

26. 10. The device of claim 1, The sensor is configured to dynamically measure the circumference of the band.

27. 10. The device of claim 1, The sensor is configured to dynamically measure heat flux in the biological compartment.

28. 10. The device of claim 1, The sensor is configured to dynamically measure the volume of the biological compartment.

29. 10. The device of claim 1, An additional sensor is provided that is configured to dynamically measure tension in the band.

30. 10. The device of claim 1, An additional sensor configured to dynamically measure tension in the tensioning mechanism is provided.

31. 10. The device of claim 1, The sensor is configured to remain flush with the biological compartment of the user as the tensioning mechanism expands or contracts the circumference of the band.

32. 1. A method for adjusting a user wearable device, comprising: placing a band on a biological compartment of the user, the band configured to be placed in substantially full cross-sectional contact with the biological compartment of the user; and winding a tensioning mechanism configured to receive a first end of the band and a second end of the band, the tensioning mechanism configured to move the first end of the band and the second end of the band closer together or further apart.

33. 33. The method of claim 32, The band is further configured to be worn in substantially full cross-sectional contact with the user's biological compartment based on the user's comfort level.

34. 33. The method of claim 32, Winding the tensioning mechanism compresses a sensor connected to the band into the biological compartment of the user, the sensor configured to collect a plurality of user data.

35. 33. The method of claim 32, The step of winding the tensioning mechanism occurs automatically based on the circumference of the biological compartment.

36. 1. A method for collecting data from a user-wearable device, comprising: dynamically adjusting a tensioning mechanism connected to the wearable based on a circumference of the user's biological compartment; dynamically sensing at least one emergent factor of the user's biological system; and generating a plurality of data related to the at least one emergent factor.

37. 37. The method of claim 36, The plurality of data comprises surface temperature and physical activity of the biological system over time.

38. 38. The method of claim 37, estimating heat removal over time of the biological system based on surface temperature differentials; estimating heat production over time of said biological system based on physical activity; and estimating a basal metabolic state of the biological system based on the temporal alignment of heat removal and heat production.

39. 38. The method of claim 37, The method further comprises a step of obtaining a quasi-periodic rhythm of the biological system based on the plurality of data, the quasi-periodic rhythm being on a second-by-second, minute-by-minute, ultradian, circadian, circalunar or yearly basis.

40. 40. The method of claim 39, obtaining the variability of the quasi-periodic rhythm over a predetermined time period; and determining health performance based on the variability of the quasi-periodic rhythm.

41. 40. The method of claim 39, estimating heat removal over time of the biological system based on surface temperature differentials; estimating heat production over time of said biological system based on physical activity; estimating a basal metabolic state of the biological system based on the temporal alignment of heat removal and heat production; and determining health potential by applying a time-dependent function to the estimated basal metabolic state; The time-dependent function is calculated from the quasi-periodic rhythm of the biological system.

42. 38. The method of claim 37, The plurality of data comprises heat flux data.

43. 43. The method of claim 42, At least one health capability is a basal metabolic state; At least one emergent factor is the temporal alignment of heat production and heat removal.

44. 44. The method of claim 43, The temporal alignment relates to at least one quasi-periodic rhythm of the biological system.

45. 45. The method of claim 44, The at least one quasi-periodic rhythm is a circadian rhythm.

46. A method for assessing military readiness by utilizing a device according to any one of claims 1 to 31.

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