Non-invasive wearable device for physiological assessment of physical and cognitive preparations for military tasks

Abstract

Disclosed is a device wearable by a user, comprising: a strap configured to be worn in substantially complete cross-sectional contact with a biological compartment of the user; a tensioning mechanism connected to the strap, the tensioning mechanism configured to allow a perimeter of the strap to (i) expand to accommodate fluid entry into the biological compartment and (ii) contract to accommodate fluid exit from the biological compartment such that the strap maintains substantially complete cross-sectional contact with the biological compartment of the user; and a sensor connected to the strap, the sensor configured to collect a plurality of patient data. The apparatus is adapted for use in military preparation for evaluating an individual or a queue of individuals.

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 systems, organisms, or, for example, humans, or non-biological 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 adjustable or manually adjustable straps. Background Art

[0002] A historical perspective illustrates a number of advantages of the disclosed technology. Known devices and methods for monitoring biological systems and known systems for maintaining or improving health are insufficient. For example, known wearable devices are often available in an off-the-shelf market; however, many patients and users are excluded from that market. Furthermore, and as another example, known wearable devices are often "one-size-fits-all"; however, many patients and users cannot be adapted to such devices. Additionally, wearable devices often only accomplish the intended function of the wearable device when worn as intended, and do little or no work if not worn substantially continuously. There are often critical moments when a wearable device should be worn, but off-the-shelf and one-size-fits-all devices may not be worn at those moments and have the characteristic of often motivating patients and users to remove the wearable device. Summary of the invention

[0003] Disclosed are designs for adjustable wearable devices, methods for making adjustable wearable devices, methods for adjusting adjustable wearable devices, and methods for improving compliant and extended use of adjustable wearable devices. The disclosed technology provides a device that can be worn by a user, the device comprising: a band configured to be worn in substantially full cross-sectional contact with a biological compartment of the user; a tensioning mechanism connected to the band, the tensioning mechanism configured to allow the circumference of the band to (i) expand to accommodate fluid entering the biological compartment, and (ii) contract to accommodate fluid flowing out of the biological compartment, so 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 multiple patient data. Also disclosed are methods for collecting and distributing data collected via the device. In certain embodiments of the disclosed devices and methods, the data is related to the health capabilities of the user. In certain embodiments of the disclosed devices and methods, the data is related to the heat flux of the user. In certain embodiments of the disclosed devices and methods, the data is related to the heat flux of the user over multiple circadian cycles.

[0004] The present disclosure provides designs and methods for manufacturing devices for continuously and contextually characterizing the metabolic state of an individual by measuring the individual's thermal signature to assess the so-called thermoregulatory phenotype. Changes associated with this phenotype are sensitive indicators of changes in health state. The device is designed and configured so that it delivers a general correlation between an individual's thermal signature and physiological reserve in human use. Additional information can be obtained within the thermal signature to operationally assess readiness. Clinical studies are designed to collect data that will serve as novel vital signs and overall health characteristics of steady state, which are suitable for early detection of many disease states, management of personal physical and mental health, and readiness.

[0005] In certain embodiments, the disclosed technology provides an apparatus wherein the tensioning mechanism is directly connected to the sensor.

[0006] In certain embodiments, the disclosed technology provides devices wherein the tensioning mechanism is directly connected to the strap.

[0007] In certain embodiments, the disclosed technology provides a device wherein the tensioning mechanism is located within a buckle that is directly connected to the strap.

[0008] In certain embodiments, the disclosed technology provides an apparatus wherein the tensioning mechanism includes a first mechanism and a second mechanism, the first mechanism and the second mechanism being positioned in parallel when the strap is in the closed position.

[0009] In certain embodiments, the disclosed technology provides a device wherein the buckle is positioned parallel to the sensor when the strap is in the closed position.

[0010] In certain embodiments, the disclosed technology provides a device wherein a first end of a strap is configured to be wound into a first strap adapter, the first strap adapter being positioned within a tensioning mechanism, and a second end of the strap is configured to be wound into a second strap adapter, the second strap adapter being positioned within the tensioning mechanism, wherein the first strap adapter and the second strap adapter are configured to stabilize the first end of the strap and the second end of the strap.

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

[0012] In certain embodiments, the disclosed technology provides a device wherein a spring is embedded within a strap.

[0013] In certain embodiments, the disclosed technology provides an apparatus wherein the tensioning mechanism includes a slide.

[0014] In certain embodiments, the disclosed technology provides a device wherein a first end of the strap overlaps a second end of the strap.

[0015] In certain embodiments, the disclosed technology provides an apparatus wherein the tensioning mechanism is circular.

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

[0017] In certain embodiments, the disclosed technology provides an apparatus wherein a tensioning mechanism is configured to bring a first end of a strap and a second end of the strap together or apart.

[0018] In certain embodiments, the disclosed technology provides an apparatus wherein the buckle further comprises at least two pulleys configured to transfer tension from the strap.

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

[0020] In certain embodiments, the disclosed technology provides an apparatus wherein a second connector is placed on a second pulley of at least two pulleys and includes a first connector end and a second connector end, wherein the first connector end is fixed, the second connector end is connected to a tensioning mechanism, and the second connector is 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 wherein 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 a device wherein the biological compartment is at least one of a lower leg and a forearm.

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

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

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

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

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

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

[0032] In certain embodiments, the disclosed technology provides an apparatus comprising an additional sensor, wherein the additional sensor is configured to dynamically measure tension of the strap.

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

[0034] In certain embodiments, the sensor is configured to remain flush with the user's biological compartment due to a tensioning mechanism that allows the circumference of the band to expand and contract.

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

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

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

[0038] In certain embodiments, the disclosed technology provides methods wherein winding and tensioning 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 device that can be worn by a user, the method comprising: dynamically adjusting a tensioning mechanism based on a circumference of a biological compartment of the user, the tensioning mechanism being connected to the wearable device; dynamically sensing at least one emergent factor of the user's biological system; and, generating a plurality of data, the plurality of data being related to the at least one emergent factor.

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

[0041] In certain embodiments, the disclosed technology provides a method, which also includes: estimating heat removal of the biological system over time based on surface temperature differences; estimating heat generation of the biological system over time based on physical activity; and estimating the basal metabolic state of the biological system based on the temporal alignment of heat removal and heat generation.

[0042] In certain embodiments, the disclosed technology provides a method, which also includes: obtaining a quasi-periodic rhythm of a biological system based on multiple data, wherein the quasi-periodic rhythm includes a second time scale, a minute time scale, a sub-diurnal time scale, a diurnal time scale, a lunar phase cycle, or a year time scale.

[0043] In certain embodiments, the disclosed technology provides a method further comprising: obtaining a variability of a quasi-periodic rhythm over a predetermined amount of time; and determining a fitness capacity based on the variability of the quasi-periodic rhythm.

[0044] In certain embodiments, the disclosed technology provides a method, which also includes: estimating heat removal of a biological system over time based on surface temperature differences; estimating heat generation of the biological system over time based on physical activity; estimating a basal metabolic state of the biological system based on the time alignment of heat removal and heat generation; and determining health capacity by applying a time-dependent function to the estimated basal metabolic state, wherein the time-dependent function is derived from a quasi-periodic rhythm of the biological system.

[0045] In certain embodiments, the disclosed technology provides methods wherein the plurality of data includes heat flux data.

[0046] In certain embodiments, the disclosed technology provides methods wherein at least one health capability is a basal metabolic condition and at least one emergent factor is the temporal alignment of heat production and heat elimination.

[0047] In certain embodiments, the disclosed technology provides methods wherein the time alignment is associated with at least one quasi-periodic rhythm of a biological system.

[0048] In certain embodiments, the disclosed technology provides methods wherein at least one quasi-periodic rhythm is a circadian rhythm. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1A , Figure 1B , Figure 1C , Figure 2A , Figure 2B and Figure 2C Some wearable devices known in the art are shown.

[0050] Figure 3A and Figure 3B An example embodiment of a tensioning mechanism is shown.

[0051] Figure 4 An example embodiment of a tensioning mechanism is shown.

[0052] Figure 5A and Figure 5B An example embodiment of a tensioning mechanism within a retainer is shown.

[0053] Fig. 6A and Figure 6B An example embodiment of an internal compartment of a tensioning mechanism is shown.

[0054] Figure 7 An example embodiment of a tensioning mechanism is shown.

[0055] Figure 8 An example embodiment of a strap with a buckle is shown.

[0056] Fig.9A and Fig. 9B An example embodiment of a tensioning mechanism is shown.

[0057] Figures 10 to 17 An example embodiment of a wearable device is shown.

[0058] Fig.18 An example embodiment of a sensor is shown.

[0059] Fig.19 An example embodiment of a sensor is shown.

[0060] Fig. 20 An example embodiment of a sensor is shown.

[0061] Fig.21 An example embodiment of a sensor is shown.

[0062] Figure 22 to Figure 23 An example embodiment of a battery is shown.

[0063] Figure 24 to Figure 25 An example embodiment of a hot plate is shown. DETAILED DESCRIPTION

[0064] All patents, patent applications and other publications mentioned herein, including all sequences disclosed in these references, are expressly incorporated herein by reference to the same extent as each individual publication, patent or patent application is specifically and individually indicated as being incorporated by reference. All documents cited are fully incorporated herein by reference in relevant parts, for the purposes indicated by the context of the citation of all documents cited in this article. However, the citation of any file should not be interpreted as admitting that it is prior art about the present disclosure.

[0065] The generation, analysis, and use of data related to the health capacity of biological systems have been explored. More specifically, the use of sensors and combinations of sensors to capture data related to the health capacity of biological systems has also been explored. Health capacity can refer to the resilience (adaptability) of a system, which is primarily expressed by its ability to sustain or achieve some core functions. In order to assess the health capacity of a system, one can interpret the emergent factors of the system. Emergent factors can refer to properties of water or water systems or biological systems or complex adaptive systems that can be related to the health capacity of the system or form the basis for assessing the health capacity of the system. Emergent factors can also refer to events, deviations from standards, or other time-dependent patterns in some measurable parameters of a system that can be observed directly or indirectly. Emergent factors or characteristics can also refer to characteristics of a biological system that cannot be easily predicted from the functions of the components of the system. Examples of emergent properties can include amphiphilicity, conductivity, solvation ability, ion mobility, oxidation-reduction potential, ligand association, hydration, electrolysis, thermal conductivity, heat capacity, heat absorptivity, adhesion, cohesion, transparency, turbidity, incompressibility, polarity, dipole, dipole motion, diamagnetism, voltage range of liquid phase, temperature range of liquid phase, abundance and speciation, energy flux, momentum, particles or other matter, heat removal, heat removal as an absolute static value of heat removal or as a periodic function, such as diurnal periodicity of heat removal.

[0066] Since water is critical to the function of every chemical or physical process at all scales in all biological systems (e.g., whole body, cells, tissues, organs, etc.), and thus the availability of well-connected water and any of the aforementioned entities associated with water (alone or in combination) is important to the function of biological systems, it is useful to select and utilize sensors that directly and / or indirectly measure properties of water and any of the aforementioned entities associated with water (alone or in combination) to quantify and learn at least the following operational characteristics of biological systems. For example:

[0067] High heat capacity: The relatively high heat capacity of water and water systems provides thermal stability to the internal environment of biological systems. In contrast, the heat capacity of other typical or abundant solvents is substantially less than half that of water.

[0068] Incompressibility: The relative incompressibility of water and aqueous systems has an unusually high thermal diffusivity that is comparable to that of solids. In contrast, other typical or abundant solvents are substantially more compressible and therefore susceptible to structural damage.

[0069] Large thermal diffusivity: Water and aqueous systems have an exceptionally high thermal diffusivity that is comparable to that of solids. This minimizes harmful internal temperature changes around active organelles. In contrast, other typical or abundant solvents are substantially less efficient at distributing energy and will have larger temperature gradients around metabolic centers, potentially leading to structural degradation.

[0070] Large infrared absorption band: Metabolism makes and breaks carbon bonds in a specific way to build organic structures. Waste heat from these processes is efficiently captured by water's infrared absorption band. In contrast, other typical or abundant solvents are substantially less efficient at capturing heat. Efficient capture of heat is also critical for fast enzyme kinetics.

[0071] There is currently no widely accepted measure of health. Health is often defined as the absence of disease (symptoms). Disease measures are lagging indicators of health deterioration and therefore do not reflect health in a positive sense, and are not inherently optimizable relative to actual health outcomes rather than disease outcomes. Advances in the understanding of disease have revealed that early changes in inflammation may be predictors of disease and that inflammation is also a late sign of pathogenesis.

[0072] Inflammation is a common pathway that can affect every organ system in the body. The inflammatory response can be triggered by a range of stimuli or stressors, ranging from normal responses to exercise and training to mechanisms now associated with tumor formation and neurodegeneration. Clinical signs of inflammation have traditionally been defined as the following five: increased heat, pain, redness, swelling and loss of function, and now early inflammation - the so-called pre-inflammatory phase - is a risk factor for disease. We note an association between changes in water and emergence parameters and inflammation, such as temperature and swelling.

[0073] Edema is an example of inflammation. Edema may occur when fluid accumulates in the patient's tissue and may affect anyone by increasing the size of a part of the patient's body. For example, the size of the circumference of the patient's biological compartment may increase. As explained above, edema may be a symptom of an underlying health condition. The underlying health condition can be monitored or evaluated by using a wearable device that can collect and / or monitor the health capabilities of a biological system. The wearable device may include at least one wearable thermodynamic sensor, and at least one wearable thermodynamic sensor may be configured to: measure an emergent factor of a human, wherein the emergent factor is the time alignment of heat generation and heat removal of a human, and the time alignment is related to the circadian rhythm of the human; and, based on the emergent factor, generate measurement data, the measurement data including heat flux data over time. The wearable device may also capture heat flux data, wherein at least one health capability is a basal metabolic condition, and at least one emergent factor is the time alignment of heat generation and heat removal of a biological system. The wearable device may include an array of sensors that record health metrics and capture data. The wearable device may continuously record a "energy signature" metric or indicator of the subject's selected health. In some embodiments, the wearable device needs to be low-cost and low-power, thereby enabling accessibility and real-time continuous data capture. In some embodiments, the wearable device includes a multimodal sensor system that measures electrochemical, mechanical, structural, thermal and / or energy properties that reflect homeostasis and cell physiology. The wearable device can include any number of sensors.

[0074] Mild or severe cases of edema may prevent the patient from wearing a wearable device that would be able to monitor and / or assess the health capacity of the patient's biological compartments. The patient may remove the wearable device because the wearable device is too tight because the wearable device may restrict the patient's biological compartments. In some cases, severe cases of edema may not allow the patient to use any wearable device that has been available because it is not feasible to accommodate the size of the patient's edema. Unless the patient is continuously wearing a wearable device that allows for the capture and assessment of data, data related to the health capacity of the biological system cannot be captured or assessed. In other words, when the user removes the wearable device, the data stream collected by the wearable device is terminated.

[0075] As in Figure 1A , Figure 1B , Figure 1C , Figure 2A , Figure 2B and Figure 2CAs depicted in , certain wearable devices known in the art include various passive and actively adjustable wearable devices that provide "off-the-shelf" solutions. Actively adjustable wearable devices include strap styles that require the user to manually adjust the size of the strap. These adjustments can be macro or micro adjustments. For example, the strap can be made of a flexible material in different sizes. For example, the size of the strap can be "small" or "large", with "small" being able to fit a user's wrist circumference of 5.5 inches-7 inches and "large" being able to fit a user's wrist circumference of 7.1 inches-8.7 inches. The limited range of adjustability may result in discomfort to the user, which may cause the user to remove the device, thereby terminating any data flow.

[0076] Therefore, there is a need for a device that allows optimal monitoring of health capacity and heat flux. Such a device is disclosed herein. In some embodiments, the wearable device may include a strap, a tensioning mechanism, and a sensor. The wearable device can be worn around a biological compartment to measure emergent factors. As used herein, a biological compartment may refer to a wrist, ankle, finger, toe, calf, forearm, thigh, upper arm, and / or abdomen. A biological compartment may undergo a change in steady state, which may cause the size or shape of the biological compartment to change or vary. A biological compartment may undergo a change in steady state, in which the flow of water is by no means normal. For example, a patient with any disease element may experience or experience a huge change in the diameter of the biological compartment. During the change in the steady state of the biological compartment, the monitoring of the patient's health capacity may not be optimal. In some embodiments, the wearable device can be applicable to the change in steady state exhibited by the biological compartment measured by the wearable device.

[0077] In some embodiments, the strap can be adapted to the user. For example, the size of the strap can vary (e.g., small, medium, large) to allow the strap to be worn by users with various sizes of biological compartments. In some embodiments, the strap is adjustable and can include a flexible material. Such flexible materials can include nylon, rubber, silicone, fabric, etc. In some embodiments, the adjustability of the strap can allow the patient to continue wearing the wearable device while the biological compartment is undergoing or experiencing a change in homeostasis. For example, the circumference or length of the strap can be increased or decreased. In other words, the circumference or length of the strap can be adjusted to adapt to or adapt the circumference of the biological compartment. This can allow the patient to remain comfortable (e.g., not feel restricted) while wearing the device and experiencing a change in homeostasis. Similarly, this can allow the patient to continue wearing the wearable device at all times, which can allow the wearable device to collect a continuous stream of data. The adjustable strap can allow patients susceptible to irregular biological compartment homeostasis to wear the wearable device and monitor the patient's health capabilities. Additionally, in some embodiments, the adjustability of the strap allows sensors that measure or evaluate various emergent factors to maintain substantially complete connection with the biological compartment that is intended to be measured or evaluated. This can allow the sensor to maintain a continuous and uninterrupted stream of data collection, since without substantially complete connection of the sensor to the biological compartment being measured, the sensor cannot evaluate or monitor the biological compartment.

[0078] Military applications, including assessment of military readiness.

[0079] Physicists have encountered the problem of emergent order before (e.g., magnetism), and have concluded that it may be advantageous to identify thermodynamic parameters that summarize the order, rather than trying to measure the molecular details of the order directly. Virtually all order is associated with missing 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 bellwether for hidden organization. Landau defined the order parameter (see, e.g., https: / / en.wikipedia.org / wiki / Landau_theory): a useful mathematical device that quantifies the thermodynamic properties and robustness of the underlying order.

[0080] Our insights are based in part on the notion that the organization of living systems has associated thermodynamic signatures that resemble order parameters. Moreover, only these biological order parameters can be learned with high accuracy using small sample sizes. Furthermore, this thermal signature can inform us about the robustness of biological order—the physiological reserve and readiness.

[0081] Can be called Enerji TMThe wearable device is designed and configured to quantify physiological energy output (e.g., peripheral heat and physical activity). The device was benchmarked against gold standard physiological endpoints in multiple IRB-approved human studies. The metrics used for this benchmarking involved signals with high accuracy with training sets as small as 25 samples.

[0082] Robust structures are identified in the human thermal signature and serve as direct measurements of autonomous processes that underlie homeostasis (i.e., biological tissues). Specifically, the device provides a means for non-invasively detecting the thermal signature of the inflammatory cascade prior to any alteration in core temperature. This observation has implications from the perspective of thermal physics and transformational biology applications.

[0083] Despite fundamental differences in the hypothalamic-adrenal-pituitary axis between men and women, there is a lack of readily available metrics that characterize the functional capacity of neuroendocrine responses, which are critical to the prevention and survival of traumatic injury (references). Instead, it is often assumed that the physiological response to trauma is similar between men and women, and standard metrics default to men's metrics, potentially leading to suboptimal treatment of female traumatic injuries. The wearable device described in this article uses a physical model of temperature homeostasis inspired by the function of the hypothalamus to explain the health importance of an individual's thermal signature (see references 1-5). By measuring the main data streams integrated by the hypothalamus (heat and body temperature), the device allows the basis of homeostasis and physiological reserves to be characterized - including differences between sexes (see references 4, 5) - and allows the definition of sex-specific metrics related to the treatment of traumatic injuries (see reference 6). The wearable device continuously and contextually measures these main data streams modulated by the hypothalamus, and provides a means for characterizing both individuals and sex groups by measuring their thermal signatures to assess what we call the thermoregulatory phenotype.

[0084] The disclosed technology is based in part on the utilization of a novel physical model of temperature homeostasis, thereby providing a means for understanding and / or interpreting the health significance of an individual's thermal signature (thermal phenotype) and for acting on that interpretation in a variety of ways. Unlike and superior to simple skin thermometry, this non-invasive wearable device continuously senses the thermal signature of body heat and does not require charging or battery replacement over a period of up to several months.

[0085] The disclosed technology relates to a non-invasive wearable device for physiological assessment of physical and cognitive readiness for military missions. The present disclosure provides designs and methods for manufacturing devices for continuously and contextually characterizing the metabolic state of an individual by measuring the individual's thermal signature to assess the so-called thermoregulatory phenotype. Changes associated with this phenotype are sensitive indicators of changes in health state. The device is designed and configured so that the device delivers a general correlation between an individual's thermal signature and physiological reserve in human use. Additional information can be obtained within the thermal signature to operationally assess readiness. The clinical study is designed to collect data that will serve as a novel vital sign of steady state and an overall health signature that is suitable for early detection of many disease states, management of personal physical and mental health, and readiness.

[0086] Warfighter readiness is determined by the warfighter's physiological reserve, or the warfighter's ability to adapt and perform (e.g., maintain homeostasis) under stress. This "reserve" can be assessed clinically through various stress tests, but has never been reduced to a precise physical measurement that can be passively performed by a wearable device. Our goal is to automate the measurement of physiological reserve using wearable devices so that readiness can be assessed continuously for individuals as well as at a population scale.

[0087] Currently, when stress testing is not possible, medical professionals quantify readiness by manually assessing vital signs and other physiological markers / tests. Because the currently available panel of physiological data only weakly correlates with physiological reserve in young, healthy subjects, medical professionals must exercise difficult clinical judgment when assessing each patient. As a result, this approach has a large subjective component, limiting both accuracy and scalability. Our approach assumes that readiness and physiological reserve are determined by the organization of bioenergetic resources that underlie homeostasis. While some consumer wearables measure skin temperature, none measure actual energy. Using a novel sensor configuration, Enerji TM The device estimates peripheral heat elimination, a rich and novel physiological energy measure fundamentally related to homeostasis and hypothalamic regulation. By continuously compiling this signature, we have identified and quantified previously unobserved patterns, which we call thermoregulatory phenotypes. We propose that these structures are directly determined by autonomic control of thermoregulation and therefore reveal homeostatic stress in real time, enabling prediction of readiness.

[0088] Enerji TMDevices can deliver on the hardware requirements of this BAA. Our first IRB-approved human trial has shown general associations between our signals and physiological reserve. The remaining challenge is to distill the general information of our data stream into actionable assessments of readiness. Current trials are collecting data toward this goal. If successful, we will discover new vital signs of steady state that serve as global health signatures of individuals that are suitable for assessment of readiness as well as early detection of many disease states and management of individual physical and mental health.

[0089] In certain embodiments, the innovation leverages a physical model of temperature homeostasis inspired by the function of the hypothalamus to explain the health importance of an individual's thermal signature (references 1-4). By measuring the primary data streams integrated by the hypothalamus (heat and body temperature), we reveal the logical basis of homeostasis and physiological reserve. Therefore, instead of using "molecular biomarkers" to determine health, our approach uses thermal energy markers of homeostasis. Our prototype wearable device continuously senses this signature and does not require charging or battery replacement for several months. In a military environment, we envision a closed, secure wireless ecosystem to enable timely data collection and analysis, resulting in readiness results within a few hours of deployment (Figure A). Since we have physiological sensors and prototypes that have already been partially developed, our main technical challenge lies in collecting relevant data that will allow us to establish robust thresholds that connect metrics of an individual warfighter's thermoregulatory phenotype to the individual warfighter's level of physical and cognitive readiness.

[0090]

[0091] Figure A: Using Enerji TM Schematic diagram of the proposed solution for wearable devices

[0092] Due to both (1) the physical connection to homeostasis and hypothalamic function and (2) the human research data that has been collected, a robust preparation model was developed, as discussed below.

[0093] The disclosed technology has the ability to detect inflammation non-invasively, which is a common pathogenic pathway. Specifically, in an unpublished IRB-approved study of human subjects, healthy volunteers were injected with lipopolysaccharide (LPS) to stimulate inflammation, and a series of biomarkers of inflammation were measured (see reference 5). In parallel, the thermoregulatory characteristics of the subjects were recorded non-invasively. The chart in the figure shown below depicts the baseline (in blue) joint distribution of heat and skin temperature over approximately 30 days for three individuals (one individual per row) from a recent study. A triangular frame is included to highlight inter-subject variability. The study protocol includes two injections of LPS one week apart. Sensor records taken within a few hours after the first LPS injection and the second LPS injection are indicated in red and green, respectively, as a time course within a 4-hour period after the injection. The depicted data are raw measurement data without any preprocessing, and the raw measurement data are intended only to show the structured relationship between skin temperature and body heat regulated by the hypothalamus.

[0094]

[0095] Figure 2: Thermal responses to two LPS injections over a 4-hour period in three subjects

[0096] Although there was variability between subjects, the results showed a common pattern of febrile responses preceding the onset of fever and a febrile response that was readily observed after symptoms. The results are consistent with known physiology - hypothalamic control of core temperature (Ref. 6). The pre-febrile response involves an abnormal point in the lower left quadrant (low fever, low skin temperature), which is a vasoconstrictive state that precedes and promotes the increase in core body temperature. Later, we see an abnormal point in the upper right (high fever, high skin temperature), which corresponds to the state of defervescence.

[0097] The data show that presymptomatic signals of inflammatory stress can be mediated by Enerji TM Equipment detection. By measuring warfighters under typical stress conditions, the technology can map thermal responses to levels of readiness. By measuring central parameters of the hypothalamic core logic of heat - the disclosed technology can identify stress patterns from a single subject. In fact, the inflammatory response seen in Figure 2 is independently visible in each individual. Capturing inter-subject variability is not strictly necessary for the signal to be useful, although capturing inter-subject variability provides the potential for statistical optimization.

[0098] Models were developed to construct a representative cohort of warfighters and subject them to typical stressors so that we could observe and set thresholds around characteristic stress responses in warfighters. This type of study was similar in structure and complexity to studies we had already run. Basic statistical methods and visualizations similar to those in Figure 2 were used to isolate and rank anomalous records associated with stressful conditions in preparation for an internal V&V presentation at the end of Phase I.

[0099] Similar experiments were performed using a test of cognitive readiness. These experiments showed how to determine how the stress thermoregulatory phenotype is related to cognitive performance. A strong relationship between cognitive function and thermoregulation was shown (see references 7-10). The device is also suitable for assessing cognitive readiness.

[0100] The challenge of molecular biomarkers is to establish the significance of the molecular biomarker relative to known physiology and homeostasis. Because the disclosed technology measures body heat which is fundamentally related to temperature homeostasis, the challenges of typical molecular biomarkers are avoided.

[0101] Develop appropriate computing and readout capabilities. Wearable devices can be ruggedized. The above data analysis platform can be deployed on the public cloud and can use commodity computers, network and storage services. The architecture can be redesigned to meet SWaP requirements for in-theater military use.

[0102] Clinical research: Such research is conducted to develop models to stratify the readiness of “healthy” individuals under various stress loads.

[0103] Data Analytics: Enhance data analytics to develop military-specific readiness models based on our sensor data and clinical research findings.

[0104] Hardware: The equipment is ruggedized to meet military specification requirements and data collection and display hardware is selected and / or developed that meets operational and SWaP requirements.

[0105] Software: Enhance software to integrate: wearable sensor devices; portable computers and readout capabilities; and centralized capabilities specific to DoD operational requirements (e.g., data storage, remote upgrade capabilities, etc.).

[0106] In some embodiments, the strap may include at least one strip. In some embodiments, the strap may include two strips, which may be parallel to each other. In some embodiments, the strap may include an enclosure. In some embodiments, the strap or enclosure may be textured. In some embodiments, when the strap is in a closed position, a patient may insert a portion of the biological compartment through an opening formed by the strap. In some embodiments, the strap may include a first portion and a second portion. In some embodiments, the first portion may include a receiving member that may receive the second portion of the strap.

[0107] In some embodiments, a strap may be connected to a tensioning mechanism. In some embodiments, the tensioning mechanism may receive a strap. The tensioning mechanism may include a first slot and a second slot, the first slot may receive a first portion of the strap, and the second slot may receive a second portion of the strap. In some embodiments, the tensioning mechanism may implement a winding function to adjust the strap. For example, the tensioning mechanism may be rotated to wrap the strap around the tensioning mechanism, thereby tightening the strap or reducing the length of the strap. Similarly, the tensioning mechanism may be rotated in the opposite direction to untie the strap from the tensioning mechanism, thereby loosening the strap or increasing the length of the strap. In some embodiments, the tensioning mechanism may be automatically or manually controlled. In some embodiments, the tensioning mechanism may be circular. In some embodiments, the tensioning mechanism may have a convex edge to allow the patient to better grip the tensioning mechanism.

[0108] In some embodiments, the tensioning mechanism may include a spring. In some embodiments, the spring may be embedded within the strap to allow the strap to expand. For example, the patient may pull on the strap, thereby lengthening the spring, which in turn may adjust the length of the strap. When the spring is at its shortest length, the strap may be at its minimum length or circumference.

[0109] In some embodiments, a portion of the tensioning mechanism may be positioned within a buckle that may be directly connected to the strap. The buckle may allow the strap to remain in a closed position when the patient is wearing the wearable device. In some embodiments, the buckle may include at least one pulley. The pulley may include a channel that receives a middle portion of the strap. For example, a first pulley may include a first channel that receives a first middle portion of a first portion of the strap. Similarly, a second pulley may include a second channel that receives a second middle portion of a second portion of the strap. The first middle portion and the second middle portion of the strap may be positioned within the first channel and the second channel of the pulley, respectively. The second portion of the tensioning mechanism may be positioned parallel to the first portion of the tensioning mechanism. The parallel configuration may form an opening for the patient to insert the biological compartment into the opening. The second portion of the tensioning mechanism may include a first connection point and a second connection point. The first connection point may be positioned on a first side of the tensioning mechanism, and the second connection point may be positioned on a second side of the tensioning mechanism. The connection point may be used to connect the strap to the tensioning mechanism. The tensioning mechanism may also include an anchor point to stabilize the strap within the tensioning mechanism. For example, a first end of a first portion of the strap may be connected to a first connection point, and a second end of the first portion of the strap may be connected to a first anchor point, the first anchor point being on an opposite side of the first connection point of the tensioning mechanism. Similarly, a first end of a second portion of the strap may be connected to a second connection point, and a second end of the second portion of the strap may be connected to a second anchor point, the second anchor point being on an opposite side of the second connection point of the tensioning mechanism. The tensioning mechanism may also include a knob that may be rotated to tighten or loosen the strap. This may cause the circumference of the strap to increase or decrease.

[0110] In some embodiments, the wearable device may include an array of sensors. In some embodiments, the sensor may record health metrics. In some embodiments, the wearable device continuously records energy signature metrics or indicators of health selected by the user. In some embodiments, the wearable device captures the complexity of emergence-derived at the scale of cell physiology. In some embodiments, the wearable device requires low cost and low power consumption to achieve accessibility and real-time continuous data capture. In some embodiments, the wearable device includes a multimodal sensor system that measures electrochemical, mechanical, structural, thermal and / or energy properties that reflect steady state and cell physiology. In some embodiments, the wearable device includes a sensor that controls and / or measures tension in a tensioning mechanism. In some embodiments, the sensor may be connected to a strap and / or a tensioning mechanism. In some embodiments, the first sensor may be based on a circumferential measurement, in which the sensor may dynamically measure tension in the strap and / or tension in the tensioning mechanism. In some embodiments, the second sensor may dynamically measure various emergent factors of a biological compartment. For example, the second sensor may dynamically measure pressure, heat flux, volume, etc. of a biological compartment. In some embodiments, the sensor may measure various emergent factors non-invasively or micro-invasively. In some embodiments, the sensor can dynamically measure the tension in the band and dynamically equalize the tension to the internal pressure of the biological compartment. In some embodiments, the sensor can include embedded microneedles to dynamically measure interstitial pressure micro-invasively. In some embodiments, the sensor can include a controller that can dynamically modify the tensioning mechanism and / or the tension in the band based on measurements measured by the sensor.

[0111] like Figure 3A As shown, the wearable device 300 may include a band 310 , a tensioning mechanism 320 , a first sensor 330 , and a second sensor 340 . Figure 3B It is shown that the tensioning mechanism 320 can be square, round, or include a convex edge finish. The tensioning mechanism 320 can be controlled mechanically or automatically. The first sensor 330 can dynamically measure various emergence factors of the user. The second sensor 340 can measure and / or control the tension within the tensioning mechanism 320. The first sensor 330 can include a thermal disk that can be flush with the user's skin during wearing of the wearable device 300.

[0112] The tensioning mechanism 320 is designed to receive a strap and may include a first channel 350 and a second channel 360. Depending on whether the tensioning mechanism 320 is to be tightened or loosened, the amount of strap 310 received by the first channel 350 and the second channel 360 is designed so that the amount of strap 310 can be increased or decreased. The tensioning mechanism 320 may maintain the strap 310 and the tensioning mechanism 320 at a desired tension using click friction rotation feedback. Each click friction rotation may retract the strap 310 by further wrapping the strap 310 around the first channel 350 and the second channel 360, or release the strap 310 by untying the strap 310 from the channel. The strap 310 may be similar to a rope bracelet. The material of the strap 310 may be a biocompatible silicone spaghetti rope of different diameters to improve user comfort. The strap 310 may have a diameter of about 0.5 mm to about 2 mm.

[0113] like Figure 4 As shown, the diameter of the tensioning mechanism 420 can be about 10 mm to about 30 mm. The diameter of the tensioning mechanism 420 can be proportional to the length of the strap and the permitted adjustment range of the length of the strap. The height of the tensioning mechanism 420 can be about 8 mm to about 15 mm.

[0114] like FIG. 5A to FIG. 5B As shown, the tensioning mechanism 520 can be inserted into the annular groove 530. The width of the annular groove 530 can range from about 1 inch to about 2 inches. The height of the annular groove 530 can range from about .1 inches to about .4 inches. The diameter of the tensioning mechanism 520 can be about .5 inches-1.5 inches and is inserted into the opening of the annular groove 520. FIG. 5A to FIG. 5B As shown, the opening of the annular groove can extend from the top of the annular groove 520 to the bottom of the annular groove 520. The diameter of the opening at the top of the annular groove 520 can be greater than the diameter of the opening at the bottom of the annular groove 520. In other words, the diameter of the opening can decrease throughout the depth of the annular groove. The diameter of the opening of the annular groove can be consistent throughout a portion of the annular groove, and a shelf is formed when the diameter of the opening decreases. The shelf allows the tensioning mechanism 520 to sit on the annular groove. The opening at the bottom of the annular groove 520 allows the sensor to contact the user's skin.

[0115] As shown in FIG6 , the proportional fit study shows that the components of the tensioning mechanism fit within the internal compartment of the tensioning mechanism.

[0116] like Figure 7 As shown, strap 710 may include spring 720. Spring 720 may allow the length of strap 710 to increase to accommodate the biological compartment of the user.

[0117] like Figure 8As shown, the wearable device may include a strap 810 and a buckle 820. The buckle 820 may be connected to the strap 810. The buckle 820 may also connect the first end of the strap 810 to the second end of the strap 810, thereby forming a closed loop or bracelet for the user to wear. The tensioning mechanism may be located within the buckle.

[0118] like FIG. 9A to FIG. 9B As shown, the tensioning mechanism 920 includes at least two buckles 930, 940. The buckles 930, 940 can be a pulley system that assists in tightening or loosening the wearable device. The pulley can include a channel that receives the middle portion of the strap. FIG. 9A to FIG. 9B As shown, the first pulley 930 has a first channel that receives the first middle portion of the first portion of the strap 910. The second pulley 940 includes a second channel that receives the second middle portion of the second portion of the strap 915. The first middle portion and the second middle portion of the strap can be positioned in the first channel and the second channel of the pulley, respectively. The tensioning mechanism 920 can include a first connection point 950 and a second connection point 960. As shown in FIG. Fig.9A As shown. A first connection point 950 is positioned on a first side of the tensioning mechanism 920, and a second connection point 960 is positioned on a second side of the tensioning mechanism 920. The connection points are used to connect the strap to the tensioning mechanism 920. The tensioning mechanism 920 also includes anchor points 970a, 970b to stabilize the strap within the tensioning mechanism. Fig.9A As shown, a first end 972 of the first portion of the strap is connected to the first connection point 950, and a second end 974 of the first portion of the strap is connected to a first anchor point 970a, which is located on the opposite side of the first connection point 950 of the tensioning mechanism. Similarly, a first end 976 of the second portion of the strap is connected to a second connection point 960, and a second end 978 of the second portion of the strap is connected to a second anchor point 970b, which is located on the opposite side of the second connection point 960 of the tensioning mechanism. The tensioning mechanism also includes a knob 980, which is rotated to tighten or loosen the strap. This can increase or decrease the circumference of the strap. As shown in FIG. Fig. 9B As shown, fasteners 930, 940 are connected to secure the wearable device around the user's biological compartment.

[0119] like Fig.10 As shown, the tensioning mechanism includes a first portion 1020 and a second portion 1030 that are parallel to each other during use of the wearable device 1000. The first portion 1020 and the second portion 1030 are held connected by a strap 1050, the length of which varies based on the variable size of the user's biological compartment.

[0120] Figure 11 to Figure 12shows different ways in which a pulley system can be used within a tensioning mechanism. Fig.11 As shown, the tensioning mechanism has a single pulley 1110 to dynamically adjust the size of the wearable device 1100. The wearable device 1100 includes a strap 1120 having an embedded pulley 1110 to improve the comfort of the portion of the wearable device that contacts the user's skin. The strap can be a flexible material to further increase the ability of the wearable device to adjust to changes in the size of the user's biological compartment. The flexible material of the strap can increase or decrease the size of the wearable device by approximately 1 inch to approximately 4 inches. Fig.12 As shown, the tensioning mechanism includes two pulleys 1210 that are embedded within the strap 1220, which can increase or decrease the size of the wearable device by approximately 1 inch to about 6 inches.

[0121] Figures 13 to 17 Various wearable devices having the tensioning mechanism described above are shown. Fig.13 As shown, the tensioning mechanism is on the external surface of the wearable device. This embodiment provides the user with easy access to the tensioning mechanism. Fig.14 As shown, the tensioning mechanism is located within an internal compartment of the wearable device. This embodiment protects the tensioning mechanism from accidental adjustment.

[0122] like Fig.15 As shown, the tensioning mechanism is also inside the wearable device. This embodiment allows for macro and micro adjustment of the size of the wearable device. As described above, the macro adjustment can be controlled by the length of the first portion of the strip and the second portion of the strip at which the user connects. The micro adjustment can be controlled by the tensioning mechanism. The strap of the tensioning mechanism is connected to the strip to allow for macro and micro adjustment to increase or decrease 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 wear of the wearable device.

[0123] like Fig.16 As shown, the flexible material or hair loop fabric can be wrapped or folded around the straps of the tensioning mechanism. Fig.17 As shown, the straps of the tensioning mechanism can be exposed to reduce the overall weight of the wearable device.

[0124] Figures 18 to 25 The sensor used in the tensioning mechanism is shown. Figures 18 to 21 As shown, the sensor is used to convert a signal control of the tensioning mechanism. The sensor controls the tightening and loosening of the tensioning mechanism and the overall size of the wearable device. The sensor includes an embedded magnet, and the embedded magnet is used to generate a rotation signal from the magnetic field orientation. The magnet can be a ceramic or ferrite donut magnet with a cross-field orientation. Figures 19 to 20 Examples of magnets available on the market are shown. Figure 22 to Figure 23 As shown, a battery can be included within the tensioning mechanism to increase the use of the wearable device.

[0125] like Figure 24 to Figure 25 The sensor is used to measure any number of emergent factors of the user. The sensor includes a thermal disk, which can be mounted inside a ring magnet, as described above. When the user is wearing the wearable device, the thermal disk contacts the user's skin.

[0126] The described embodiments are examples. Various changes may be made in the above apparatus and methods without departing from the scope of the present invention. All subject matter described in this disclosure, including the accompanying drawings, is illustrative and not restrictive.

[0127] References

[0128] Reference 1: Osilla EV, Marsidi JL, Sharma S. Physiology, Temperature Regulation. [Updated May 8, 2022]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Press; January 2022. Available from: https: / / www.ncbi.nlm.nih.gov / books / NBK507838 / .

[0129] Reference 2: Schieber AM, Ayres JS. Thermoregulation as a diseasetolerance defense strategy. Pathog Dis. 2016 Dec;74(9):ftw106. doi:10.1093 / femspd / ftw106. Epub 2016 Nov 3. PMID:27815313; PMCID:PMC5975229.

[0130] 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;PMCID:PMC3906745.

[0131] Reference 4: Kenny GP, Sigal RJ, McGinn R. Body temperature regulation indiabetes. Temperature(Austin). 2016 Jan 4;3(1):119-45. doi:10.1080 / 23328940.2015.1131506. PMID: 27227101; PMCID: PMC4861190.

[0132] 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. Epub 2018 Jun 22. PMID: 29936295.

[0133] Reference 6: Romanovsky AA. Skin temperature: its role inthermoregulation. Acta Physiol(Oxf). 2014 Mar;210(3):498-507. doi:10.1111 / apha.12231. PMID:24716231;PMCID:PMC4159593.

[0134] Reference 7: Altered Experienced Thermoregulation in Depression-NoEvidence for an Effect of Early Life Stress-PubMed (nih.gov), Front Psychiatry. Jul 21, 2021;12:620656. doi:10.3389 / fpsyt.2021.620656. PMID: 34366905; PMCID: PMC8333702.

[0135] 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. Am J Psychiatry 2013;170:802–804.

[0136] 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. PMID: 32343372.

[0137] Reference 10: Hancock, Peter A. and Ioannis Vasmatzidis. "Effects of heatstress on cognitive performance: the current state of knowledge." International Journal of Hyperthermia 19 (2003): 355-372.

Claims

1. A device capable of being worn by a user, comprising: a band configured to be worn in substantially full cross-sectional contact with a biological compartment of a user; a tensioning mechanism connected to the strap, the tensioning mechanism configured to allow a circumference of the strap to (i) expand to accommodate fluid entering the biological compartment, and (ii) contract to accommodate fluid exiting the biological compartment, such that the strap maintains substantially full cross-sectional contact with the biological compartment of the user; as well as A sensor is coupled to the belt, the sensor being configured to collect a plurality of patient data.

2. The device according to claim 1, wherein: The tensioning mechanism is directly connected to the sensor.

3. The device according to claim 1, wherein: The tensioning mechanism is directly connected to the belt.

4. The device according to claim 1, wherein: The tensioning mechanism is located within a buckle that is directly connected to the strap.

5. The device according to claim 1, wherein: The tensioning mechanism includes a first mechanism and a second mechanism, the first mechanism and the second mechanism being positioned in parallel when the strap is in a closed position.

6. The device according to claim 4, wherein: When the strap is in the closed position, the buckle is positioned parallel to the sensor.

7. The device according to claim 1, wherein: The first end of the strap is configured to be wound into a first strap adapter, which is located within the tensioning mechanism, and the second end of the strap is configured to be wound into a second strap adapter, which is located within the tensioning mechanism, wherein the first strap adapter and the second strap adapter are configured to stabilize the first end of the strap and the second end of the strap.

8. The device according to claim 1, wherein: The tensioning mechanism includes a spring.

9. The device according to claim 8, wherein: The spring is embedded in the strap.

10. The device according to claim 1, wherein: The tensioning mechanism includes a sliding member.

11. The device according to claim 10, wherein: The first end of the strap overlaps the second end of the strap.

12. The device according to claim 1, wherein: The tensioning mechanism is circular.

13. The apparatus according to claim 1, wherein: The tensioning mechanism is knurled.

14. The apparatus according to claim 7, wherein: The tensioning mechanism is configured to bring the first end of the strap and the second end of the strap together or apart.

15. The apparatus according to claim 4, wherein: The buckle also includes at least two pulleys configured to transfer tension from the strap.

16. The device according to claim 15, wherein: The first connector is placed on a first pulley of the at least two pulleys and includes a first connector end that is fixed and a second connector end that is connected to the tensioning mechanism, the first connector being parallel to the second connector.

17. The apparatus according to claim 15, wherein: The second connector is placed on a second pulley of the at least two pulleys and includes a first connector end that is fixed and a second connector end that is connected to the tensioning mechanism, the second connector being parallel to the first connector.

18. The apparatus according to claim 1, wherein: The tensioning mechanism is configured to be adjusted based on a circumference of the biological compartment of the user.

19. The apparatus according to claim 18, wherein: The tensioning mechanism is configured to automatically adjust based on the circumference of the biological compartment of the user.

20. The apparatus of claim 1, wherein: The biological compartment is at least one of a wrist and an ankle.

21. The apparatus of claim 1, wherein: The biological compartment is at least one of a finger and a toe.

22. The apparatus of claim 1, wherein: The biological compartment is at least one of a calf and a forearm.

23. The apparatus of claim 1, wherein: The biological compartment is at least one of a thigh and an upper arm.

24. The apparatus of claim 1, wherein: The biological compartment is the abdomen.

25. The apparatus of claim 1, wherein: The sensor is configured to dynamically measure the pressure of the biological compartment.

26. The apparatus of claim 1, wherein: The sensor is configured to dynamically measure the circumference of the band.

27. The apparatus of claim 1, wherein: The sensor is configured to dynamically measure heat flux of the biological compartment.

28. The apparatus of claim 1, wherein: The sensor is configured to dynamically measure the volume of the biological compartment.

29. The device according to claim 1, comprising an additional sensor, wherein: The additional sensor is configured to dynamically measure the tension of the strap.

30. The device of claim 1, comprising an additional sensor, wherein: The additional sensor is configured to dynamically measure the tension of the tensioning mechanism.

31. The apparatus of claim 1, wherein: The sensor is configured to remain flush with the biological compartment of the user as the tensioning mechanism allows the circumference of the band to expand and contract.

32. A method of adjusting a device, the device being wearable by a user, the method comprising: placing a band over a biological compartment of a user, the band being configured to be worn in substantially full cross-sectional contact with the biological compartment of the user; as well as A winding tensioning mechanism is configured to receive the first end of the strap and the second end of the strap, and the tensioning mechanism is configured to bring the first end of the strap and the second end of the strap together or apart.

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

34. The method of claim 32, wherein: Winding the tensioning mechanism presses a sensor connected to the band to the biological compartment of the user, the sensor being configured to collect a plurality of user data.

35. The method of claim 32, wherein: Winding the tensioning mechanism occurs automatically based on the circumference of the biological compartment.

36. A method for collecting data from a device capable of being worn by a user, the method comprising: dynamically adjusting a tensioning mechanism based on a circumference of a biological compartment of the user, the tensioning mechanism being connected to a wearable device; dynamically sensing at least one emergent factor of a biological system of the user; as well as A plurality of data is generated, the plurality of data being related to the at least one emergent factor.

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

38. The method of claim 37, further comprising: estimating heat removal from the biological system over time based on surface temperature differences; estimating heat generation of the biological system over time based on the physical activity; as well as The basal metabolic status of the biological system is estimated based on the temporal alignment of heat elimination and heat production.

39. The method of claim 37, further comprising: A quasi-periodic rhythm of the biological system is obtained based on the multiple data, wherein the quasi-periodic rhythm includes a time scale of seconds, minutes, sub-diurnal, diurnal, lunar phase cycle or year.

40. The method of claim 39, further comprising: obtaining a variability of the quasi-periodic rhythm over a predetermined amount of time; as well as Fitness capacity is determined based on the variability of the quasi-periodic rhythm.

41. The method of claim 39, further comprising: estimating heat removal from the biological system over time based on surface temperature differences; estimating heat generation of the biological system over time based on the physical activity; estimating a basal metabolic state of the biological system based on the temporal alignment of heat elimination and heat production; as well as Fitness capacity is determined by applying a time-dependent function to the estimated basal metabolic condition, wherein the time-dependent function is derived from the quasi-periodic rhythm of the biological system.

42. The method of claim 37, wherein: The plurality of data includes heat flux data.

43. The method of claim 42, wherein: At least one health capability is a basic metabolic condition, and At least one emergent factor is the temporal alignment of heat generation and heat removal.

44. The method of claim 43, wherein: The time alignment is associated with at least one quasi-periodic rhythm of the biological system.

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

46. ​​A method of assessing military preparedness by utilizing the apparatus according to any one of claims 1 to 31.

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