Systems and methods for multivariate stroke detection

Abstract

A system for detecting an abnormal event in a human includes a body in contact with a skin surface of the human, a heat source for heating the skin surface to a target temperature, a skin temperature sensor for measuring the temperature of the skin surface in contact with the heat source, a blood content sensor for measuring blood content at the skin surface, and a hardware processor communicatively coupled to the heat source, the blood content sensor, the skin temperature sensor, and the environmental temperature sensor, wherein the hardware processor is configured to receive a baseline blood content signal, initiate a heating cycle by outputting a heating signal to the heat source, receive a second blood content signal from the blood content sensor, compare the second blood content signal to the baseline blood content signal, and determine whether an abnormal biological event is occurring.

Description

[Technical field]

[0001] Incorporation by Reference This application claims priority to U.S. Provisional Patent Application No. 62 / 915,269, filed October 15, 2019, and U.S. Provisional Patent Application No. 63 / 053,265, filed July 17, 2020, each of which is incorporated herein by reference in its entirety and forms a part of this disclosure. Any features, structures, materials, methods, or steps described and / or illustrated with respect to any embodiment in the above provisional patent application may be used in conjunction with or in place of any features, structures, materials, methods, or steps described in the following paragraphs of this specification and / or illustrated in the accompanying drawings.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of disease detection, and more specifically to the field of stroke detection. [Background technology]

[0003] A stroke occurs when blood flow to the brain is cut off, causing brain tissue to die. An ischemic stroke occurs when blood flow to the brain is blocked, usually as a result of a blood clot. A hemorrhagic stroke occurs when a blood vessel in the brain ruptures and bleeds into brain tissue and the surrounding space.

[0004] When a stroke occurs, the physiological symptoms vary depending on the location of the affected tissue. Early symptoms of stroke progression may be alleviated or even eliminated if the interruption in blood flow is resolved quickly before tissue dies. One category of symptoms is vision loss, including blurred vision, often likened to a falling curtain, or even complete loss of vision. Stroke patients also often experience eye deviations and difficulty with eye tracking.

[0005] A stroke can affect the parts of the brain involved in vision, and can also affect the parts of the brain involved in speech, understanding, and communication. A stroke patient may have slurred or stammering speech that is hard to understand.

[0006] Another common symptom of a stroke is muscle weakness on one side of the body. This can cause partial or total paralysis of the side of the face, one arm, one leg, or the entire side of the body.

[0007] Ischemic strokes are the most common type of stroke and are often experienced without pain, whereas hemorrhagic strokes can be extremely painful and are often described as the sudden onset of the "worst headache of one's life." Many people also experience dizziness, nausea, and vomiting along with the headache. The sense of smell and taste may also be affected during a stroke.

[0008] Anything that affects the brain, from trauma to stroke, has the potential to cause cognitive impairment. Feelings of confusion or constantly thinking about your actions can sometimes occur a few days before a stroke occurs.

[0009] Another common symptom of a stroke is sudden fatigue.

[0010] Stroke detection can be difficult because stroke symptoms vary in duration and can occur with or without pain. Additionally, strokes can occur during sleep, making detection even more difficult. Even if a stroke occurs during sleep, the person may not immediately wake up. As a result, when a patient wakes up with symptoms, it is unclear whether the stroke has just begun or has already occurred during sleep.

[0011] There are many evidence-based interventions that could dramatically reduce death and disability from this disease if stroke is detected and patients seek treatment promptly. In severe ischemic stroke, each minute of delay in restoring blood flow results in one week of Disability Adjusted Life Years (DALYs) lost. Despite the availability of such treatments, less than 20% of patients receive such treatments. Even for patients who receive interventions, outcomes are often suboptimal due to delays to intervention. Detecting strokes is difficult because they are often painless, mimic other health events, and because their symptoms are diverse. Improving the detection of stroke onset and treatment seeking could dramatically reduce death and disability associated with this disease.

[0012] Like stroke, COVID-19 has been found to have a variety of symptoms, many of which resemble those of neurological disorders. Recent publications have shown early evidence of encephalopathy, inflammatory CNS syndromes, ischemic stroke, and peripheral neuropathy in patients being treated for COVID-19. (Zubair, JAMA Neurology, 2020) As most COVID-19 patients are managed remotely and a significant proportion of hospitalized patients require invasive ventilation, monitoring for overt symptoms of neurological disorders can be challenging. Therefore, improving remote monitoring and treatment of COVID-19 patients could dramatically reduce the deaths and disability associated with the disease. Summary of the Invention

[0013] One aspect of the disclosure relates to a wearable system for detecting abnormal biological events in a human, the system including a body having a second surface in contact with a skin surface of the human and a first surface opposite the second surface, a thermal stimulus source in communication with the skin surface, such as a heat source configured to heat the skin surface to a target temperature or such as a Peltier cooler, a skin temperature sensor disposed on the second surface and configured to measure a temperature of the skin surface in contact with the heat source, a blood content sensor disposed on the second surface and configured to measure a blood volume at the skin surface, and a hardware processor communicatively coupled to the heat source, the blood content sensor, the skin temperature sensor, and to an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system. The hardware processor is configured to receive a baseline blood volume signal, initiate a heating cycle to heat the skin surface to a target temperature by outputting a heating signal to a heating source, receive a second blood volume signal from the blood volume sensor in response to the skin surface reaching the target temperature, compare the second blood volume signal to the baseline blood volume signal, and determine whether an abnormal biological event is occurring based on the comparison.

[0014] In some embodiments, the second blood volume signal includes a set of blood volume signals such that the blood volume at the skin surface is repeatedly measured before, during, and after a heating cycle by the heating source, hi some embodiments, the second blood volume signal includes a plurality of blood volume signals such that the blood volume at the skin surface is continuously measured before, during, and after a heating cycle by the heating source.

[0015] In some embodiments, the hardware processor is further configured to receive a second blood volume signal after the target temperature is reached, or after a predetermined amount of time has elapsed, or after one or more heating cycles have been completed.

[0016] In some embodiments, comparing the second blood volume signal to the baseline blood volume signal includes calculating a baseline ratio of alternating current (AC) to direct current (DC) for the baseline blood volume signal and a second ratio of AC to DC for the second blood volume signal, and comparing the baseline ratio to the second ratio.

[0017] In some embodiments, the environmental temperature sensor is located on a first surface of the body of the wearable system.

[0018] In some embodiments, the system further includes a remote computing device communicatively coupled to the wearable system, the remote computing device including the environmental temperature sensor, In some embodiments, the remote computing device includes one of a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.

[0019] In some embodiments, the heat source is disposed on the second surface of the body.

[0020] In some embodiments, the hardware processor is further configured to receive baseline temperature signals from the skin temperature sensor and from the environmental temperature sensor, to determine a target temperature based on the baseline temperature signals, and to determine whether the target temperature is less than a maximum temperature value.

[0021] In some embodiments, the hardware processor is further configured to maintain the target temperature by periodically operating the heating source.

[0022] In some embodiments, the system further includes one or more electrodermal activity sensors disposed on the second surface.

[0023] In some embodiments, the one or more electrodermal activity sensors are spaced from the heating member by about 0.25 inches to about 4 inches (about 6.35 mm to about 101.6 mm).

[0024] In some embodiments, the system further includes one or more motion sensors configured to measure movement of a body part to which the wearable system is coupled.

[0025] In some embodiments, the first surface and the second surface define a cavity therebetween to provide air flow between the first surface and the second surface.

[0026] In some embodiments, the hardware processor is located on or in the first surface.

[0027] In some embodiments, the cavity formed by the first and second sides physically separates the heating source from a hardware processor on or within the first side.

[0028] In some embodiments, the cavity formed by the first and second surfaces has a volume sufficient to facilitate cooling of the heat source between heating cycles.

[0029] In some embodiments, the abnormal biological event comprises a stroke event.

[0030] In some embodiments, the wearable system is positioned on the user's left limb and a second wearable system is positioned on the user's right limb, the second wearable system including a second heating member, a second skin temperature sensor, and a second blood volume sensor, and the hardware processor is further configured to determine whether an abnormal biological event is occurring by comparing the right side blood volume signal with the left side blood volume signal.

[0031] In some embodiments, the hardware processor is further configured to time-synchronize the signals received from the left and right limbs and to determine whether an abnormal biological event is occurring by comparing the synchronized signals from the left and right limbs, in some embodiments the comparison taking into account baseline differences between the left and right limbs.

[0032] In some embodiments, the system further includes a tightenable band coupled to the body. In some embodiments, the tightenable band further includes a visual indicator to indicate that one or more of the heating element, skin temperature sensor, blood content sensor, or combination thereof are sufficiently coupled to the skin surface to enable an accurate sensor reading. In some embodiments, one or more ends of the tightenable band are coupled to the body in a position centered relative to the one or more sensors disposed on the second surface.

[0033] In some embodiments, the heating source is arranged concentrically around one or both of the blood content sensor and the skin temperature sensor.

[0034] In some embodiments, the blood content sensor includes a photoplethysmography sensor or an impedance-based pulse sensor.

[0035] In some embodiments, the skin temperature sensor includes a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.

[0036] In some embodiments, the system further includes a support structure coupled to the heat source, the support structure configured to couple the heat source to the second surface and further configured to at least partially expose the heat source to the cavity.

[0037] In some embodiments, the blood content sensor is further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[0038] In some embodiments, the target temperature is personalized for the user. In some embodiments, personalizing the target temperature includes receiving a user input related to a temperature sensed at the skin surface. In some embodiments, personalizing the target temperature is based on a signal received from a blood content sensor.

[0039] In some embodiments, the heat source comprises one of a heating element or an environmental temperature.

[0040] Another aspect of the invention relates to a wearable system for detecting abnormal biological events in a human, the system including a body having a first side opposite a second side in contact with a skin surface of the human, the first side and the second side forming a cavity therebetween to provide airflow between the first side and the second side, a heating member disposed on the second side configured to heat the skin surface for a predetermined period of time, a skin temperature sensor disposed on the second side configured to measure a temperature of the skin surface in contact with the heating member, a blood content sensor disposed on the second side configured to measure a blood content at the skin surface, and a hardware processor communicatively coupled to the heating member, the blood content sensor, the skin temperature sensor, and to an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system.

[0041] The hardware processor is configured to receive a baseline blood content signal from the blood content sensor, initiate a heating cycle to heat the skin surface to a target temperature by outputting a heating signal to the heating member, receive a second blood content signal from the blood content sensor in response to the skin surface reaching the target temperature, compare the second blood content signal to the baseline blood content signal, and determine whether an abnormal biological event is occurring based on the comparison.

[0042] Another aspect of the invention relates to a wearable system for detecting abnormal biological events in a human, the system including a body having a second surface in contact with a skin surface of the human and a first surface opposite the second surface, a heating source in communication with the skin surface, the heating source configured to heat the skin surface to a target temperature, a skin temperature sensor disposed on the second surface, the skin temperature sensor configured to measure a temperature of the skin surface in contact with the heating source, a sensor disposed on the second surface, the sensor configured to measure a parameter of interest in the human, and a hardware processor communicatively coupled to the heating source, the sensor, the skin temperature sensor, and to an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system.

[0043] The hardware processor is configured to receive a baseline sensor signal from the sensor, initiate a heating cycle to heat the skin surface to a target temperature by outputting a heating signal to a heating source, receive a second sensor signal from the sensor in response to the skin surface reaching the target temperature, compare the second sensor signal to the baseline sensor signal, and determine whether an abnormal biological event is occurring based on the comparison.

[0044] In some embodiments, the sensor is selected from the group consisting of a stretch sensor, an electrodermal activity sensor, an electrocardiogram sensor, a camera, or a blood content sensor.

[0045] In some embodiments, the parameters of interest include one or more of blood pressure, heart rate, heart rate variability, gaze, facial expression, skin conductance response, vasodilator response, or dilator response.

[0046] The foregoing is a summary and is necessarily limited in detail. These and other aspects, features and advantages of the present technology are described below in connection with various embodiments and with reference to the accompanying drawings. [Brief description of the drawings]

[0047] [Figure 1A] FIG. 1A illustrates one embodiment of a multivariate system for detecting stroke. [Figure 1B] FIG. 1B illustrates another embodiment of a multivariate system for detecting stroke. [Diagram 2] FIG. 2 shows blood pressure pulses at various parts of the body. [Diagram 3] FIG. 3 shows one embodiment of a wearable device for detecting stroke. [Figure 4] FIG. 4 shows another embodiment of a wearable device for detecting stroke. [Diagram 5] Figure 5 shows that when the wearable device is moved, the plane of motion moves and the accelerometer tracks the change in the plane of motion and adjusts the movement in three dimensions accordingly. [Figure 6] FIG. 6 shows the measurement of heading, roll and pitch by the acceleration sensors. [Figure 7] FIG. 7 illustrates one embodiment of a data capture workflow that includes motion data measurements (eg, acceleration). [Figure 8] FIG. 8 illustrates one embodiment of a workflow for calculating tremor measurements from captured acceleration data. [Figure 9] FIG. 9 shows a graphical representation of acceleration data analyzed using an application on a computing device. [Figure 10] FIG. 10 shows a graphical representation of distance data analyzed using an application on a computing device. [Figure 11] FIG. 11 shows a graphical representation of movement data analyzed using an application on a computing device. [Figure 12] FIG. 12 illustrates one embodiment of a system for detecting symmetric limb movement. [Figure 13]FIG. 13 illustrates one embodiment of a system for detecting asymmetric limb movement. [Figure 14] FIG. 14 shows another embodiment of a system for detecting asymmetric limb movement. [Figure 15] FIG. 15 shows another embodiment of a system for detecting symmetric limb movement. [Figure 16] FIG. 16 shows another embodiment of a system for detecting asymmetric limb movement. [Figure 17] FIG. 17 illustrates another embodiment of a system for detecting asymmetric limb movement. [Figure 18] FIG. 18 shows another embodiment of a system for detecting symmetric limb movement. [Figure 19] FIG. 19 shows another embodiment of a system for detecting asymmetric limb movement. [Figure 20] FIG. 20 shows another embodiment of a system for detecting symmetric limb movement. [Figure 21] FIG. 21 shows another embodiment of a system for detecting asymmetric limb movement. [Figure 22] FIG. 22 shows another embodiment of a system for detecting symmetric limb movement. [Figure 23] FIG. 23 shows another embodiment of a system for detecting asymmetric limb movement. [Figure 24] FIG. 24 shows another embodiment of a system for detecting symmetric limb movement. [Diagram 25] FIG. 25 shows another embodiment of a system for detecting asymmetric limb movement. [Figure 26] FIG. 26 illustrates one embodiment of an application on a computing device for comparing two sets of data from two limbs. [Figure 27] FIG. 27 shows a graphical representation of acceleration data from two wrists. [Figure 28] FIG. 28 shows a graphical representation of the distance data from the two wrists. [Figure 29] FIG. 29 shows a graphical representation of movement data from two wrists. [Diagram 30] FIG. 30 shows a graphical display of movement data from two wrists while using the zoom feature of an application on a computing device. [Diagram 31] FIG. 31 shows a graphical representation of the distance data from the two wrists. [Diagram 32] FIG. 32 shows a graphical representation of acceleration data from two wrists. [Diagram 33] FIG. 33 illustrates one embodiment of the architecture of the data processing module. [Diagram 34] FIG. 34 illustrates one embodiment of a machine learning model used to model a person's movement patterns, for example while sleeping. [Diagram 35] FIG. 35 illustrates another embodiment of a machine learning model used to model human mobility patterns. [Diagram 36] FIG. 36 illustrates another embodiment of a machine learning model used to model human mobility patterns. [Figure 37] FIG. 37 illustrates one embodiment of a system for detecting stroke. [Figure 38] FIG. 38 illustrates one embodiment of a digital "FAST" test. [Figure 39] FIG. 39 illustrates one embodiment of a system for detecting stroke configured to determine whether a response is symmetric or asymmetric by stimulating the response symmetrically and measuring the output of the response. [Diagram 40] FIG. 40 illustrates one embodiment of a wearable system for detecting abnormal biological events. [Diagram 41] FIG. 41 shows another embodiment of a wearable system for detecting abnormal biological events. [Diagram 42] FIG. 42 shows a support structure coupled to a heat source for one embodiment of a wearable system for detecting abnormal biological events. [Diagram 43] FIG. 43 shows a cross-sectional view of a wearable system for detecting abnormal biological events. [Diagram 44] FIG. 44 shows one embodiment of a tightenable band for coupling the wearable system to a skin surface. [Diagram 45] FIG. 45 shows a first wearable system and a second wearable system for measuring response asymmetry across the right and left limbs, respectively. [Figure 46A] FIG. 46A graphically illustrates a method for processing a signal received from a blood content sensor. [Figure 46B] FIG. 46B graphically illustrates a method for monitoring the heating cycles and the corresponding vasodilatory response over time. [Figure 47] FIG. 47 graphically illustrates the vasodilatory response of the skin surface over time and in response to the application of heat. [Figure 48] FIG. 48 illustrates a method for detecting abnormal biological events by measuring the vasodilatory response of the skin surface over time in response to the application of heat. [Figure 49] FIG. 49 illustrates one embodiment of a thermal stimulation member that can be incorporated into a wearable system. [Figure 50] FIG. 50 shows another embodiment of a thermal stimulation member incorporated into a wearable system. [Figure 51] FIG. 51 shows an in-ear wearable system for measuring one or more vital signs. [Figure 52] FIG. 52 illustrates a method for detecting an abnormal biological event. [Diagram 53] FIG. 53 illustrates a method for measuring a user's heart rate variability. [Figure 54]FIG. 54 shows a graph including electrocardiogram data for detecting abnormal biological events. [Figure 55] FIG. 55 shows a graph including electrocardiogram data for detecting abnormal biological events. [Figure 56] FIG. 56 shows a graph containing asymmetric electrodermal activity data for detecting abnormal biological events. [Figure 57] FIG. 57 shows a graph containing various parameters of interest within the electrodermal activity data. [Figure 58] FIG. 58 illustrates a method for measuring a user's heart rate variability and various characteristic analyses. [Figure 59] FIG. 59 shows a time domain analysis of heart rate variability data. [Figure 60] FIG. 60 shows a geometric analysis of the heart rate variability data. [Figure 61] FIG. 61 shows a frequency domain analysis of heart rate variability data. [Figure 62] FIG. 62 shows a non-linear analysis of heart rate variability data. [Figure 63] FIG. 63 shows a method for measuring skin conductance response. [Figure 64] FIG. 64 shows a graph containing asymmetric skin conductance responses over time. [Figure 65] FIG. 65 shows a graph containing the amplitude of the asymmetric skin conductance response over time. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] The depicted embodiments are merely exemplary and are not intended to limit the present disclosure. The schematic diagrams are shown to illustrate features and concepts and are not necessarily drawn to scale.

[0049] The above is a summary and is necessarily limited in detail. The above aspects, as well as other aspects, features, and advantages of the present technology, are described below in connection with various embodiments. The inclusion of the following embodiments is not intended to limit the disclosure to those embodiments, but rather to enable any person skilled in the art to make and use the contemplated invention or inventions. Other embodiments may be utilized, and modifications may be made without departing from the spirit or scope of the subject matter presented herein. The aspects of the present disclosure as described and illustrated herein can be configured, combined, modified, or designed in a variety of different combinations, all of which are expressly contemplated and form part of the present disclosure.

[0050] Described herein are systems, devices, and methods for multivariate detection of stroke. Multivariate may include using more than one, or at least two, or multiple, factors, markers, or other parameters to detect stroke. In some embodiments, multivariate may include using a parameter measured at multiple sites or locations, or measured at multiple time points (e.g., at random or fixed intervals, on-demand, automatically, etc.). In various embodiments, multivariate may include detecting measured parameters symmetrically or asymmetrically. The measured parameters may include functional parameters (e.g., gait, speech, facial changes, etc.), biological parameters or markers (e.g., blood proteins, metabolites, etc.), quantitative parameters (e.g., limb asymmetry, heart rate variability, etc.), spatial (e.g., between neck and chest, between arms and legs, etc.) differences in one or more (e.g., 2, 3, 4, 5, 10, 15, 20, etc.) measured parameters, and / or time differences in one or more measured parameters.

[0051] In some embodiments, there may be an overlay of multivariate signals including two measurement data types, physiological or quantitative signals (e.g., skin electromagnetic potential, Doppler flow signal abnormalities, hyperhidrosis, skin blood flow, cerebral perfusion, heart rate variability, etc.), and / or clinical symptoms or functional parameters (e.g., limb asymmetry, slurred speech, facial ptosis, retinal abnormalities, etc.). Although clinical symptoms occur after the onset of a stroke, weak signals from clinical symptom measurements combined with physiological signal measurements may detect or predict the possibility of a stroke before the onset of a stroke. Parameters that may be measured before, during, or after the onset of a stroke include quantitative parameters, functional parameters, and / or blood / body fluid parameters. Any parameter shown / described herein may be measured asymmetrically as described elsewhere herein. Illustrative, non-limiting examples of quantitative parameters include volume impedance spectroscopy, EEG asymmetry, cerebral perfusion, skin temperature / body temperature (e.g., paretic limbs are up to 6° C. colder or 16% colder compared to non-paretic limbs), hyperhidrosis (e.g., increased by 40%-60% in paretic limbs), limb asymmetry, drift and pronation tests, skin blood flow, muscle tone, heart rate variability (e.g., spectral content decreases by more than 10-fold after stroke onset and persists for 3-7 days), facial EMG, cerebral blood flow (CBF), carotid artery stenosis, salivary cortisol, nerve specific enolase (NSE), saliva (NSE), etc. Illustrative, non-limiting examples of functional parameters include speech changes, speech comprehension, written comprehension, consciousness, coordination / orientation, facial weakness, arm weakness, body weakness (e.g., grip strength), leg weakness, foot weakness, unilateral weakness, difficulty walking, dizziness, sudden loss of vision, restricted field of vision, gaze shift, thunderclap headache, neck stiffness (nape of neck), respiration, blood pressure (e.g., up to 60% increase in both systolic (200 mmHg) and diastolic (140 mmHg)), etc. Illustrative, non-limiting examples of blood / fluid parameters include CoaguCheck (Roche), HemoChron (ITC), iSTAT (Abbott), Cornell University, ReST (Valtari Bio Inc.), SMARTChip (sarissa Biomedical), etc.

[0052] In some embodiments, multiple measurement sites (e.g., radial, brachial, etc., vascular) are used to measure differences in signal or data patterns between the sites by comparing them to measurements of nominally healthy sites or by comparing them to individual baselines as input to the data processing module. For example, an individual's baseline may be recorded over time, and when an adverse event occurs, changes (e.g., absolute or relative) from the baseline are determined, unilaterally or bilaterally. In some embodiments, a new baseline may be established after an adverse event occurs. Furthermore, as shown, for example, in FIG. 2, blood pressure pulses vary at different sites in the body, indicating that slightly different signals are measured at different sites. For example, when only one site is measured, changes over time are observed. When multiple sites are monitored and / or measured, changes over time and changes relative to each other and / or to the baseline can be used to identify patterns or the occurrence of asymmetric signals. In some embodiments, an individualized baseline is further calculated based on the patient's health history (e.g., diabetes, cardiac pacing, history of stroke, etc.), demographics, lifestyle (e.g., smoker, active exerciser, alcohol drinker, etc.), etc.

[0053] In some embodiments, as shown in FIGS. 1A-1B, a system 100 for multivariate stroke detection includes hardware components (e.g., wearable devices, sensors, computing devices, remote sensing devices, etc.) and a data processing module stored in or in communication with the hardware. The hardware components, e.g., one or more sensors, may be located on a user of the system, on both sides of the user of the system, or throughout a location occupied by the user. Optionally (shown in dashed lines), the system for multivariate stroke detection may further include a third party device, such as a device including, e.g., an Amazon® Alexa® or Amazon® Echo® device, as described in more detail elsewhere herein. For example, there may be bidirectional communication (e.g., via a wired connection or via wireless communication) between the hardware components and the data processing module, and / or between the data processing module and the third party device, and / or between the third party device and the hardware components.

[0054] In one exemplary, non-limiting embodiment of the system of FIG. 1, a digital FAST (i.e., face droop, arm weakness, speech difficulties, time to call for help) test may be performed by the system of FIG. 1. For example, the hardware components may include one or more cameras placed throughout the location occupied by the user and configured to detect (e.g., using computer vision techniques) changes in facial expression (e.g., droop) as a result of a stroke, as shown in FIG. 38 (i.e., the "F" portion of the FAST test). Additionally, one or more sensors or other hardware components (e.g., cameras, microphones, etc.) may be placed throughout the location occupied by the user. The one or more sensors are communicatively coupled to the data processing module such that parameters sensed by the sensors may be transmitted to the data processing module for digitization, filtering, processing, and / or analysis. In the case of the digital FAST test, asymmetric arm weakness may be sensed by the one or more sensors. A third party device configured to receive and evaluate speech quality to identify speech difficulties may be communicatively coupled to the data processing module and / or to the hardware components. As such, the user may be prompted to speak by the third party device, and the user's response may be sensed by the hardware components (e.g., one or more microphones), thereby determining the user's speech quality. One or more of these detected parameters may be analyzed and, optionally, transmitted to a caregiver, authorized family and / or friends, a medical provider, a physician, and / or an emergency response team.

[0055] In some embodiments, the system for multivariate stroke detection may further include an application downloaded and / or stored onto the hardware components or onto a computing device (e.g., a mobile computing device) communicatively coupled to the hardware components. The application may be configured to process sensor data, camera data, audio data, etc., and / or may be configured to display the sensed or acquired data in real time, for example in a graphical display, and / or may be configured to zoom in order to find various characteristics of the data.

[0056] In some embodiments, data may be transmitted to or from the device for detecting stroke to a central hub, mobile computing device, server, or other storage and / or computing device. Data transmission may include wireless communication (e.g., Near Field Communication (NFC) protocol, Low Energy Bluetooth® protocol, other radio frequency (RF) communication protocol, etc.) between the sensor locations on the body and / or between the sensor locations on the body and the central hub. In other embodiments, data transmission may include wired communication between the sensor locations on the body and / or between the sensor locations on the body and the central hub. In some embodiments, the central hub may be a monitor in a medical facility, a home monitor, the patient's mobile computing device, or other wireless device. Alternatively, one or more sensors on the body may function as the central hub. The hub device may wirelessly transmit a signal to activate a medical pathway and / or notify one or more individuals (e.g., family, friends, physicians, EMS, etc.).

[0057] In some embodiments, transmission of data to a central hub followed by multivariate analysis may alert the patient, next of kin, and / or third parties to identify possible false positives or false negatives.

[0058] In some embodiments, devices for detecting stroke may be worn on the patient's exterior or on the skin surface or may be implanted as hardware prior to and / or during a stroke, including days prior to and during the event, to provide continuous and variable monitoring of various physiological parameters. Various embodiments described herein may be either wearable or implantable devices.

[0059] In some embodiments, the device for detecting stroke may be, for example, a patch, a headband or sweatband, a ring, a watch (e.g., to measure locomotion, as shown in FIG. 7 ), an adhesive strip, a helmet, a bracelet, an anklet, a sock (e.g., to measure heart rate, heart rate variability, temperature, gait, etc.), a shoe insole (e.g., to measure heart rate, heart rate variability, temperature, gait, etc.), clothing, a belt, a necklace, an earring (e.g., on or in the ear to measure heart rate, heart rate variability, EEG asymmetry, etc.), a hearing aid, an earphone, a pair of glasses or sunglasses or smart glasses (e.g., to measure EOG, EMG, EEG, gaze, facial muscles, etc.), a headband, a wristwatch (e.g., to measure locomotion, as shown in FIG. 7 ), an adhesive strip, a helmet, a bracelet, an anklet, a sock (e.g., to measure heart rate, heart rate variability, temperature, gait, etc.), a shoe insole (e.g., to measure heart rate, heart rate variability, temperature, gait, etc.), a The wearable devices may include, for example, a smart tattoo (e.g., to measure EEG, ECG, etc.), a bra, a bra clip, a chest strap, contacts (e.g., to measure tear content, etc.), a mouth guard or bite splint (e.g., to measure salivary nerve specific enolase, cortisol, temperature, movement, etc.), a hat or cap (e.g., to measure various signals using ultrasound), a wearable speaker (e.g., to measure heart rate, heart rate variability, movement, etc.), or sensors otherwise incorporated into any wearable garment or accessory or device. For example, a patch (e.g., wearable on the neck) may be used to estimate cerebral blood flow using Doppler ultrasound or blood oxygen content or other blood characteristics as an indication of blood being introduced into the brain (carotid artery) or being withdrawn from the brain (jugular vein), and a patch or strip (e.g., wearable on the head) may be used to detect EEG or sEMG. Additionally, for example, a wearable device for detecting stroke may include one or more transcutaneous sensors configured to measure changes in one or more gases that enter through the skin (e.g., nitric oxide (NO) can be measured directly or through measurement of specific by-products), and one or more biomarkers present in the blood that diffuses into the subcutaneous region or into the epidermis can be measured externally.In some embodiments, a wearable device for detecting stroke may include a wristband or patch combined with microneedles configured to measure subcutaneous or interstitial fluid (e.g., similar to a continuous glucose monitor).

[0060] In some embodiments, a wearable device for detecting stroke may include a wearable array of indicators (e.g., chromogenic indicators) configured to measure chemicals, analytes, proteins, etc., in an individual's bodily fluids (e.g., blood, interstitial fluid, etc.). For example, the array may include a membrane having an array printed thereon where a subset of indicator spots respond by changing color or characteristics when exposed to one or more analytes. The color response of the indicators may be read optically, for example, using a camera or other image sensor on a computing device, and compared to a baseline reading or a reference or standard value. A color difference map may be generated by overlaying and / or subtracting two images (baseline and experimental, or experimental and reference / standard). As exemplary, non-limiting analytes, an increase in nitric oxide may be detected in the blood or interstitial fluid of an individual after a stroke event, and / or modifications of one or more proteins by nitric oxide may be detected in the blood or interstitial fluid of an individual after a stroke event, and / or one or more intermediates or by-products of nitric oxide may be detected in the blood or interstitial fluid of an individual after a stroke event. For example, nitric oxide has been shown to modify proteins 1) by binding to metal centers, 2) by nitrosylation of thiol and amine groups, 3) by nitration of tyrosine, tryptophan, amine, carboxylic acid, and phenylalanine groups, and 4) by oxidation of thiols (both cysteine ​​and methionine residues) and tyrosine. Such methods may avoid the need to measure asymmetric changes in one or more parameters, as described elsewhere herein.

[0061] In some embodiments, a system for detecting stroke may include one or more Doppler radar sensors, microphones, and cameras equivalent to a "FAST" test using computer vision or similar techniques throughout the home to detect visual signs of stroke, as shown in FIG. 38. For example, a machine learning model may be trained with a training dataset of images of stroke patients to identify asymmetric facial characteristics such as facial ptosis. As can be seen from FIG. 38, the system can identify ptosis with respect to the position of the patient's mouth, nose, and eyes. Through high frame rate Euler video processing techniques, facial capillary asymmetry may also be detected by the system described herein. The system may further employ confirmatory biometrics such as HR / HRV, respiration rate (e.g., via Doppler radar), and / or bilateral temperature via infrared camera (i.e., FLIR).

[0062] In some embodiments, the device for detecting stroke may include a device that can be placed in a room, office, home, vehicle, or other location, or in or on a bed or other furniture (e.g., bedside monitor, monitor in mattress or bedding, etc.). For example, smart speakers (e.g., to prompt the user to respond to questions to analyze speech quality), microphones, cameras, and / or mirrors may be placed in positions to detect changes in the user's speech, activity, movement, gait, facial appearance, heart rate, and / or heart rate variability. The device may include a data processing module to distinguish changes in the measured parameters compared to those from healthy trained patient data or compared to those from individualized baseline data, which may also be referred to as reference data. The healthy trained patient data may be specific to a particular user or may be pre-determined aggregate values ​​from past studies. The healthy trained patient data or the individualized patient data may be stored as one or more parameters or as a signature.

[0063] In some embodiments, as shown in FIG. 3, the device may be a finger ring or a pair of finger rings to be worn, one on each hand or foot, for measuring temperature, volume impedance spectroscopy, hyperhidrosis, heart rate or heart rate variability, e.g., by a PPG sensor to monitor blood flow velocity, and / or locomotion (e.g., by including an acceleration sensor and / or gyroscope therein), e.g., to measure limb asymmetry or gait changes. Temperature measuring devices may include, but are not limited to, infrared sensors, thermometers, thermistors, or heat flow transducers. Hyperhidrosis measuring devices may include, but are not limited to, detection of analytes, including ions, metabolites, acids, hormones, and small proteins, based on potentiometry, chronoamperometry, cyclic voltammetry, square wave stripping voltammetry, or detection of conductivity changes. Sensor measurement devices may include, but are not limited to, photoplethysmography (PPG) devices, skin conductance sensors measuring skin conductance / galvanic skin response (GSR) or electrodermal activity (EDA), or skin temperature measurement devices (e.g., contact devices and non-contact devices such as IR imaging cameras).

[0064] In some embodiments, the ring may incorporate an expandable component or an expandable sensor to allow the ring to expand or stretch when the finger is expanded. This component may include, but is not limited to, an elastomeric film polymer with varying degrees of bonding to allow for different flexible components, or to measure the reflectance of polarized light. This component may include plastic segments of the ring that can be loosened / tightened, or may build slidable components that can be moved apart. Non-limiting examples of expandable sensors include, but are not limited to, strain gauges, or electrical components configured to change inductance, resistance, or capacitance when stretched.

[0065] In some embodiments, the device may be a strip to measure brain waves by electroencephalography (EEG) and / or muscle contractions by surface electromyography (sEMG). EEG measurements may be compared to baseline values ​​to detect EEG changes or asymmetries. In some embodiments, EMG measures changes in facial muscles compared to baseline measurements, thereby identifying muscle weakness and tightness.

[0066] In some embodiments, the device may be a wearable eyewear device that measures electrooculogram (EOG), EMG, EEG, gaze, and facial muscle symmetry, as shown in Figure 4. EOG measurements identify changes in corneal retinal orienting potentials between the front and back of the eye, which can be compared to either the other eye or a previous baseline value, so that changes in gaze and visual field size can be detected.

[0067] In some embodiments, as shown in Figures 5-6, a device for detecting stroke may include a wearable device for measuring changes in movement (e.g., in three axes), such as asymmetrical movement, to detect tremors. In some embodiments, a device for detecting stroke may include a wearable device for measuring changes in movement (e.g., in three axes), such as asymmetrical movement, to detect tremors. Such devices may include accelerometers, gyroscopes, inclinometers, compasses, or other devices for measuring acceleration, distance, and / or movement. For example, as shown in Figure 5, as the wearable device undergoes movement, the plane of motion also moves. The accelerometer may track the change in plane and adjust the movement in the three dimensions accordingly. Additionally, as shown in Figure 6, the accelerometer may track heading, roll, and pitch.

[0068] In some embodiments, a device for detecting stroke may be configured to detect asymmetric responses, asymmetric outputs, or asymmetric signals. For example, one or more devices (e.g., rings, watches, etc.) described herein may be used to measure symmetric and asymmetric limb movements. Figures 12-25 illustrate various symmetric and asymmetric movements that may be measured by one or more embodiments described herein. For example, Figures 12, 15, 18, 20, 22, and 24 illustrate various embodiments of symmetric movements (e.g., up-down, left-right, rotational, etc.) between two limbs that may be measured by various devices described herein. Figures 13-14, 16-17, 19, 21, 23, and 25 illustrate various embodiments of asymmetric limb movements (e.g., up-down, left-right, rotational, etc.) that may be measured by various devices described herein.

[0069] In some embodiments, as shown in FIG. 39, a device or system for detecting stroke may be configured to stimulate a response and measure the response of each side of a user's body (e.g., to detect an asymmetric response) and to determine whether the response between the two sides, or the difference in the response between the two sides, is indicative of a stroke event. For example, a thermal (i.e., hot or cold) stimulus may be applied to a skin portion of the user's body (as shown in the top diagram), and the body's response to the thermal stimulus may be monitored over time (as shown in the bottom diagram) to determine whether homeostasis has been reached and / or whether a difference in response or return rate exists between the two sides of the body (in other words, whether an asymmetric response exists). Further examples include stimulating the muscular or nervous system using electrical signals and monitoring the response over time and / or between the two sides using electromyography (EMG), bioimpedance, or electroneurogram (ENG), respectively. These "stimulating / transmitting" and "receiving / detecting" members may be located in the same area, or may be spaced apart from one another to take measurements across different areas of the body.

[0070] As mentioned above, if a stroke is detected and the patient seeks treatment promptly, death and disability can be dramatically reduced. Continuous monitoring for stroke events can improve response times. However, it can be difficult to continuously monitor abnormal biological events such as stroke events using existing monitors. These monitors can be cumbersome and difficult for users to wear for extended periods of time. In contrast, the inventors have realized that a wearable device, such as a wristwatch with embedded sensors and electronics, can improve continuous monitoring of stroke events. A reduced vasodilator response may be indicative of stroke, heart failure, hypertension, diabetes, menopause, or other conditions.

[0071] Applying thermal stress to a portion of the skin may enable detection of a vasodilation response. Thus, the systems and methods described below enable detection of reduced vasodilation in a form factor that improves continuous abnormal cardiac event monitoring. In some embodiments, as shown in FIG. 40, a system or device 400 for detecting abnormal biological events may function to heat a skin surface and measure a vasodilation response of the skin surface. The system or device 400 may further function to measure one or more additional parameters, such as biological signals, as described in more detail elsewhere herein.

[0072] In one example, a system or device 400 for detecting abnormal biological events may include a body 416 having a first surface 404 opposite a second surface 404 that contacts a human skin surface. The first surface 404 and the second surface 404 may be coupled via one or more side walls 405. For example, the one or more side walls 405 may extend from a periphery of the first surface 404 and couple to a periphery of the second surface 402. The first surface 404 and / or the second surface 402 may include one or more sensors disposed on an upper surface. For example, the one or more sensors on the first surface 404 may measure the environment of a user wearing or using the wearable system, and the one or more sensors on the second surface 402 may measure one or more characteristics, features, or features of the user's skin surface, and thus the user himself. Alternatively, the first surface 404 may include one or more sensors or image sensors or cameras for assessing the user's facial areas, for example by means of a FAST test.

[0073] The wearable device 400 may be secured to a user, e.g., to a user's limb or skin surface, via a coupling member 408, e.g., a tightenable band, described in more detail elsewhere herein. The coupling member 408 may be adjustable such that the wearable device may be tightened or tensioned to promote stronger contact between the wearable device and the skin surface, and thus coupling, or tension may be released to reduce contact or coupling between the wearable device and the skin surface. As shown in FIG. 41 , the coupling member 408 may be coupled to the body 416 of the wearable device via one or more connectors 422a, 422b, 422c, 422d. For example, the coupling member 408 may be coupled to the body 416 of the wearable device via a connector 422 that includes one or more pin joints, a snap-fit ​​connection to the coupling member 408, a slide-fit connection to the coupling member 408, or the like. When the tightenable band 408 is coupled to the body 416 via the connector 422, the tightenable band is centered over the one or more sensors disposed on the second surface such that there is sufficient coupling between the sensors and the skin surface.

[0074] The wearable device 400 may include a heating source 410 in communication with the skin surface. The heating source 410 is configured to heat the skin surface to a target or predetermined temperature. The heating source 410 may be a heating member, such as an environmental heating source such as a warm room or warm environment (e.g., under the covers, on a hot day, etc.), a thin film resistive flexible heater, a polyimide heater, etc. In some embodiments, the heating source 410 is disposed on the second surface 402 of the body 416 such that there is a bond or contact between the heating source 410 and the skin surface. Alternatively, the heating source 610 or one or more sensors 612, 626 may be disposed on the coupling member 608 of the system 600 such that the body 616 is spaced apart from a sensor module 609 including the heating source 610 and the one or more sensors 612, 626, as shown in FIG. 50. Alternatively, the heating source and / or one or more sensors may be distributed among the coupling member, body, and sensor module depending on which sensors are incorporated into the system and the particular requirements or parameters of those sensors.

[0075] In some embodiments, as shown in Figure 49, the heat source 710 may include a thermal stimulation member including a single printed layer of resistive ink on a polyimide film 702. Heat traces 704, as well as traces for one or more sensors 706 (e.g., blood content sensors, infrared sensors, temperature sensors, etc.), may also be printed onto the polyimide film 702 as well, as shown in Figure 49.

[0076] In still further embodiments, the sensor module 809 may be placed in an in-ear device (e.g., an earlobe clip, an earbud, a hearing aid, etc.), as shown in Fig. 51. The sensor module may be configured to measure one or more parameters, such as, for example, blood pressure, temperature, and / or oxygen saturation, depending on which sensors are present.

[0077] Further, the heating source 410 may be communicatively coupled to the hardware processor such that the hardware processor activates the heating source to begin a heating cycle by outputting a heating signal to the heating source 410. For example, the heating cycle may include receiving baseline temperature signals from the skin temperature sensor and from the environmental temperature sensor, determining a target temperature based on the baseline temperature signals, and determining whether the target temperature is less than a maximum temperature value.

[0078] In some embodiments, the target temperature may be equal to the baseline skin temperature measured by the skin temperature sensor plus about 1 degree to about 20 degrees, such as about 1 degree to about 5 degrees, about 1 degree to about 10 degrees, about 5 degrees to about 10 degrees, about 5 degrees to about 15 degrees, about 8 degrees to about 12 degrees, etc. In one embodiment, the target temperature is equal to the baseline skin temperature measured by the skin temperature sensor plus about 5 degrees to about 15 degrees. In another embodiment, the target temperature is equal to the baseline skin temperature measured by the skin temperature sensor plus about 7 degrees to about 13 degrees. In another embodiment, the target temperature is equal to the baseline skin temperature measured by the skin temperature sensor plus about 10 degrees. If the target temperature is greater than the maximum temperature value, the system pauses or delays until the baseline skin temperature is below a minimum threshold, or recalculates the target temperature to be less than the maximum temperature value. If the target temperature is less than the maximum temperature sensor, the system prompts activating the heating source, thereby heating the skin surface to the target temperature.

[0079] In some embodiments, the heating source cycles between the target temperature and a deactivated or off state, or between the target temperature and a temperature lower than the target temperature but higher than the skin baseline temperature, e.g., to maintain the target temperature, hereinafter referred to as a dwell time.

[0080] In some embodiments, the duration of the heating cycle and the target temperature are interrelated and based on the user's preference, or based on the user's perception of heat on the skin surface, or based on the user's vasodilation response, for example, a higher target temperature may be used for a shorter period of time, or a lower target temperature may be used for a longer period of time.

[0081] Additionally, the system or device 400 may be configured to receive one or more user inputs related to thermal sensations sensed on the skin surface and / or related to the sensitivity of the user's vasodilatory response. For example, the user may input, for example, via a user input member (e.g., a button), that the target temperature feels too hot or too cold, whereupon the system responds by lowering the target temperature but extending the amount of time the skin is heated. Additionally or alternatively, based on user preferences, or based on a preset configuration (e.g., at the time of manufacture), or as a result of sensed data (e.g., based on sensor data), the heating source may reach the target temperature via one of a number of ramp functions, e.g., a slow ramp, a large step function, etc. Alternatively, the heating source may reach the target temperature through a number of microstimuli. Additionally, for example, the target temperature may be individualized for the user based on the sensitivity of the user's vasodilatory response.

[0082] In some embodiments, the device or system 400 for detecting abnormal biological events includes a support structure 428 coupled to the heat source 410 and configured to couple the heat source 410 to the second surface 402. For example, as shown in FIG. 42, the support structure 428 includes an arm 432 extending toward or to the center of the heat source 410 to support the heat source 410, and one or more spokes 430 extending from the arm 432 to the periphery of the heat source 410. The spokes 430 may be substantially equally spaced from adjacent spokes 430. The spokes 430 may also be circumferentially arranged around the pin or joint 434. The spokes 430 of the support structure 428 further define airflow openings 442 that may allow air to interact with the heat source 410 to cool the heat source 410. The spokes 430 further define airflow openings 422 for at least partially exposing the heat source to the cavity formed by the first and second sides, as described elsewhere herein. Alternatively, or additionally, the heat source 410 may be cooled by one or more vents, by a blower for passing an air flow over the heat source 410, by a coolant, or by other mechanisms known to those skilled in the art.

[0083] In some embodiments, the support structure 428 applies pressure onto the heat source 410 to enhance contact or coupling between the heat source 410 and the skin surface. In one embodiment, the tightenable band includes a strain gauge that determines the tensile stress the band is under. The output or signal of the strain gauge can then be visualized or displayed to the user so that the user knows if the band is tensioned to an appropriate level relative to the heat source and / or one or more sensors. Alternatively, the spring constant (k) of the material may be used to calculate the force (F=kx) and depending on how much the material is stretched (put under tension), the band can exhibit a force based on the displacement. Thus, the support structure 428 may include a flexible material, for example a flexible plastic. In other embodiments, the support structure 428 includes a rigid material.

[0084] Further, as shown in FIG. 40-FIG. 41, the device or system 400 for detecting abnormal biological events further includes a skin temperature sensor 414 and a blood content sensor 412. The blood content sensor 412 can be incorporated into a form factor such as the device or system 400, which improves continuous monitoring of abnormal cardiac events. The blood content sensor 412 can measure a parameter that can provide a vasodilatory response. Furthermore, a skin temperature sensor 414 can also be incorporated into the device or system 400. The skin temperature sensor 414 is disposed on the second surface 402 and configured to measure a temperature of a skin surface in contact with the heating source 410. The blood content sensor 412 is disposed on the second surface 402 and configured to measure a blood volume at the skin surface. The blood content sensor can be a photoelectric pulse wave sensor or an impedance pulse wave sensor. The blood content sensor can employ light of wavelengths of 530 nm (green), 645 nm (red), 470 nm (blue), or a combination thereof. Different wavelengths may be more appropriate for different applications, for example, green (530 nm) light may be more accurate for heart rate measurements (e.g., heart rate variability, heart rate, etc.). Additionally or alternatively, the blood content sensor may be further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[0085] The system or device 400 for detecting abnormal biological events may include an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system 400. For example, the environmental temperature sensor may be located on a first side 404 of the body 416 of the wearable system opposite the second side 402 that includes the heating source 410. Alternatively, the system or device 400 may be communicatively coupled to an environmental temperature sensor on or in a remote computing device. For example, the remote computing device may include a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, a netbook, or the like.

[0086] The skin temperature sensor and / or the environmental temperature sensor may include a thermocouple, a resistive temperature detector, a thermistor, or an infrared temperature sensor. The type of temperature sensor selected may depend on the error rate, coupling efficiency with respect to the skin surface, among other characteristics.

[0087] In some embodiments, the heat source 410 is concentrically positioned around one or both of the blood content sensor 412 and the skin temperature sensor 414, as shown in Figures 40-41. However, any location or arrangement in which the blood content sensor 412 and the skin temperature sensor 414 may be coupled to the skin surface is envisioned.

[0088] A hardware processor (located in or communicatively coupled to the wearable system) communicatively coupled to the skin temperature sensor 414 and the environmental temperature sensor can be configured to execute a method including receiving a first temperature signal using the skin temperature sensor, receiving a second temperature signal using the environmental temperature sensor, and calculating a temperature difference between the skin temperature and the environmental temperature. For example, if the temperature difference is less than a set threshold, the difference between the target temperature and the maximum temperature value may be increased. In contrast, if the temperature difference is greater than a set threshold, the difference between the target temperature and the maximum temperature value may be decreased. The environmental temperature sensor may also be used in an analysis to determine erroneous results, such as false positives of anomalies. By comparing pre- and post-stimulation signals and / or comparing left and right limbs, extrinsics, such as environmental temperature responses, may be reduced in the analysis of anomalies.

[0089] Additionally, a hardware processor may be coupled to the heating source 410 and the blood content sensor 412. In some instances, the system 400 described above may enable non-invasive monitoring of vasodilatory and / or vasoconstrictory activity. The human body regulates a stable equilibrium through homeostatic processes. For example, when a stimulus is applied to the patient's body, one or more homeostatic processes attempt to counteract the effect of the stimulus. For example, with respect to an induced thermal stimulus that increases or decreases the temperature of a tissue site, the body attempts to reverse the temperature change through blood flow (vasodilation or vasoconstriction). Thus, the system 400 may induce and measure a vasodilatory response. As described above, stroke and other abnormalities may decrease the vasodilatory response. Thus, in some instances, it may be advantageous to monitor changes in the vasodilatory response to determine abnormalities such as stroke. A blood content sensor, such as an optical sensor, may enable monitoring of blood flow and the corresponding vasodilatory response. In some instances, one or more temperature sensors (via thermistors or optical radiation-based detectors) can also allow for the determination of the vasodilatory response by monitoring how quickly the skin temperature returns to equilibrium after stimulation. In some instances, the vasodilatory response is correlated with the rate or slope of change of a measured parameter, such as blood volume parameters, temperature, and others described herein. In additional instances, the vasodilatory response can be correlated with the steepness of the rate of change. This can be calculated using the second derivative.

[0090] In some instances, it may be advantageous to use a combination of a heating source 410 and a blood content sensor 412 to improve cardiac monitoring. The heating source 410 and the blood content sensor 412 may be incorporated into a form factor that may be worn by a user for continuous monitoring. The measurements may be repeated non-invasively without significant discomfort to the patient. Furthermore, as shown in FIGS. 46A-46B and 47, the response time from application of heat to changes in blood volume is relatively short. This allows for a relatively fast determination of abnormal biological events. Therefore, it may be advantageous to integrate a heating source with a blood content sensor in any of the wearable systems disclosed herein to improve continuous cardiac monitoring. In some instances, a Peltier cooler may be used as a heat source instead of or in addition to the heating source 410.

[0091] Further, in some instances, the stimulation can be electrical stimulation in addition to or instead of thermal stimulation. For example, the system 400 can include multiple electrodes for inducing and / or measuring electrical activity across the tissue site. The electrical activity can include bioimpedance to detect high or low muscle tone, which can occur with hemiplegia. The system 400 can include at least two electrodes. In some instances, the system 400 can include at least four electrodes. For example, the system 400 can include two pairs of electrodes for measuring bioimpedance. These four electrodes can be disposed on the second surface 402. The electrodes can also be disposed on the strap 408 or on an external accessory to which the system 400 can be attached. Bioimpedance can measure both intercellular and intracellular muscle, which can be used to detect hemiplegia, and can be used for both detection and rehabilitation. EDA electrodes can also be attached to the strap 408 at any location along the second surface facing the skin. Further, the system 400 can also include six or more electrodes. Electrodes may be incorporated onto the system 400 such that the electrodes are in contact with the skin tissue of the user.

[0092] As described above, optical sensors such as blood volume sensor 412 can probe the target tissue to determine parameters that correlate with the vasodilatory response. Other sensors can also be used to extract parameters for determining the vasodilatory response. For example, system 400 can provide an indication of the vasodilatory response by determining hemodynamic parameters such as cardiac output using minimally invasive and / or invasive sensors. System 400 can also include one or more electrical-based sensors such as bioimpedance sensors, EDA sensors, ECG sensors, EEG sensors, EMG sensors, and the like. Electrical sensors may enable measurement of hydration, skin conductance, bioimpedance, and other electrical parameters related to hemodynamic function, or may measure electrical signaling of neural activity and its effects. Additionally, system 400 can include one or more ultrasound sensors to obtain hemodynamic parameters. Temperature sensors can also enable determination of the vasodilatory response. Thus, the system 400 may include a combination of some or all of the sensors described above to extract one or more parameters that correlate with hemodynamic function or homeostasis.

[0093] The table below provides examples of physiological phenomena and corresponding parameters that may be monitored. [Table 1]

[0094] Patients after stroke are often monitored in a neuro-ICU. This can be costly as nurses need to check on the patient regularly. Thus, system 400 can enable improved monitoring without requiring the patient to enter a neuro-ICU and / or without requiring a caregiver to check regularly. Although system 400 is described as a wearable system, in some examples, some or all of the components of system 400 may be placed in proximity to a user without being directly attached to or worn by the user. For example, when a user needs to be monitored in a hospital environment, some or all of the components of system 400 can be placed in proximity to the user's hospital bed. For example, the thermal stimulation source may include a laser.

[0095] Thus, the hardware processor may be configured to perform a method including receiving a baseline blood content signal from the blood content sensor S5202, initiating a heating cycle by outputting a heating signal to a heating source S5204, receiving a second blood content signal from the blood content sensor S5206, comparing the second blood content signal to the baseline blood content signal S5208, and determining whether an abnormal biological event is occurring based on the comparison S5210, as shown in Figure 52. Each step in the method may be repeated at least once, one or more times, multiple times, on a loop, or in other manners according to a physician or caregiver or user preference.

[0096] In some embodiments, the second blood volume signal is a set of blood volume signals for repeatedly measuring the blood volume at the skin surface before, during, and / or after a heating cycle by the heating source. The blood volume at the skin surface may be measured at preset intervals, such as, for example, every about 10 ms to about 1 second, every about 1 second to about 5 seconds, every about 5 seconds to about 10 seconds, etc. Alternatively, the blood volume at the skin surface may be measured randomly, or only when a change in temperature at the skin surface is detected, or when a change in vasodilation is detected by the blood volume sensor. The measurement frequency may be individualized to the user, for example, if the user's vasodilation response to heat is very sensitive, it may be necessary to reduce the frequency of blood volume measurements. In contrast, if the user's vasodilation response to heat is less sensitive, it may be necessary to increase the frequency of blood volume measurements.

[0097] In some embodiments, the second blood volume signal is a plurality of blood volume signals such that blood volume at the skin surface is continuously measured before, during, and / or after a heating cycle by the heating source.

[0098] In some embodiments, block S5206 includes receiving a second blood volume signal after the target temperature is reached, or after a predetermined amount of time has elapsed, or after a dwell time (i.e., cycling the heat source on and off during a heating cycle, or cycling the heat source between the target temperature and a lower temperature during a heating cycle), or after one or more heating cycles have been completed. The frequency of sampling and / or sampling relative to a heating cycle (before, during, or after a heating cycle) may be based on the user's biology so that sampling is individualized.

[0099] In some embodiments, block S5208 includes calculating a baseline ratio of alternating current (AC) to direct current (DC) for the baseline blood volume signal and a second ratio of AC to DC for the second blood volume signal, as shown in FIG. 46A, and comparing the baseline ratio to the second ratio. The methodology and rationale for the AC to DC ratio are described in Tusman et al. "Advanced uses of pulse oximetry for monitoring mechanically ventilated patients," Anesth Analg 2017; 124: 62-71, which is incorporated by reference in its entirety. The top left diagram of FIG. 46A shows raw PPG amplitude data, as well as the DC and AC components of the signal. Taking the AC to DC ratio on the raw signal results in the top right diagram. The PPG data shown in the bottom left diagram was collected during two heating cycle experiments. The AC and DC components of the signal are represented in separate, side-by-side graphs. When the ratio of AC to DC is calculated for the two heat cycle experiments, the normalized PPG signal is obtained as shown in the lower right figure. The same PPG data is shown in FIG. 46B, overlaid with the heat cycle data. As shown, the temperature at the skin surface reaches the target temperature (i.e., about 42° C.) during each heat cycle, as indicated by the shaded area of ​​the graph. The perfusion index or normalized PPG signal similarly spikes in response to the application of heat during each heat cycle. FIG. 47 illustrates the same data as FIG. 46A-B, with the additional definition of a baseline window, a vasodilation window, and a post-vasodilation window. The heat cycle was 5 minutes off, 5 minutes on, 15 minutes off, 5 minutes on, and 10 minutes off. The time windows selected for comparison were the baseline time window (e.g., a minimum of 2 minutes before the "heat source is turned on for the first time"), the vasodilatation time window (e.g., a maximum of 2 minutes of "heat source on"), the post-first vasodilatation time window (e.g., a minimum of 2 minutes after the "heat source is turned on for the first time"), and the post-second vasodilatation time window (e.g., a minimum of 2 minutes after the "heat source is turned on for the second time").As shown in Figures 46A-47, the application of heat induces a reproducible vasodilatory response over multiple cycles.

[0100] As mentioned above, tracking of vasodilation response can be used to monitor abnormalities such as stroke. However, vasodilation response in a user can be affected by several causes that are not related to stroke or the abnormality being monitored. Therefore, using the system 400 at only one tissue site can result in false positives. The inventors have observed that by monitoring multiple tissue sites, the monitoring results can track the abnormality more closely and reduce false results. FIG. 45 shows the first system 400 and the second system 500 arranged approximately symmetrically on the right limb and on the left limb. Thus, if stimulation is applied approximately synchronously across the first system 400 and the second system 500, the degree of symmetry or asymmetry of the measurements in response to the approximately simultaneous stimulation can be used to reduce false results in determining stroke. Although the disclosure herein provides stroke as an example of an abnormality, the system 400 and method described herein can also be used to monitor other abnormalities. For example, other abnormalities or physiological deviations can include menopause, diabetes, and peripheral blood circulation disorders that can affect peripheral blood circulation. In some instances, menopause, diabetes, and other disorders can affect all parts of the body or can affect certain parameters uniformly. For example, vasodilatory responses may be uniformly impaired in conditions such as menopause compared to stroke, which is more likely to be asymmetric. Thus, stroke can be differentiated from these other abnormalities based on the asymmetry observed in vasodilatory responses and other multifaceted measurements, and vice versa. In another example, even if vasodilatory responses are affected, the electrical measurements described herein using EDA and bioimpedance may remain the same. Thus, asymmetries in measurements can also be used to form abnormalities.

[0101] In some embodiments, as shown in FIG. 48, a method 4800 for detecting abnormal biological events includes applying a hyperthermic stimulus (e.g., as shown in FIG. 46B-FIG. 47) S4810, receiving one or more signals indicative of blood volume, blood flow, or blood perfusion in the tissue of the user in response to the hyperthermic stimulus S4820, extracting one or more characteristics for the one or more signals S4830, comparing the one or more characteristics for the right and left sides of the user (e.g., the right and left limbs as shown in FIG. 45) S4840, and calculating an acute stroke classification score S4850. Additionally, the method 4800 can optionally compare baseline measurements before and after application of the stimulus, as described in more detail with respect to FIG. 52 for both the left and right limbs. When monitoring multiple tissue sites, such as monitoring left and right limbs as shown in FIG. 45, the system 500 may include all of the same components as the system 400 described above. In other cases, system 500 may include fewer components than system 400. For example, both systems may not require a display. In addition, one of the systems may include computing capabilities, while the other may collect and transmit data to the mated system for computation. Thus, one of systems 400 and 500 may not include a hardware processor. Thus, systems 400 and 500 may operate in a master-slave configuration. Systems 400 and 500 may be paired wirelessly via Bluetooth or other wireless protocols. In some instances, systems 400 and 500 may be paired with an external computing system, such as a patient monitor, a hub, or a smartphone.

[0102] In some embodiments of block S4830, the one or more characteristics include, but are not limited to, amplitude or systolic or diastolic wave, waveform shape, waveform complexity, perfusion index (i.e., relationship between pulsatile (AC) and non-pulsatile (DC) components of the PPG signal), DC offset, stiffness index (i.e., h / ΔT in terms of the time between the peaks of the forward and backward waves along the vascular tree, where h is the patient's height), reflection index (i.e., ratio of the height of the forward wave to the backward wave, B / A×100), notch location (i.e., location of the bifurcated notch, e.g., with vasoconstriction the location moves leftward within the systolic wave), peak-to-peak phase shift, slope onset of the temperature and / or blood volume signal, slope decay of the temperature and / or blood volume signal, midpoint of the upward slope of the temperature and / or blood volume signal, vasodilation response as an indicator of collateral status of the brain and / or heart, etc.

[0103] In any embodiment described herein, a wearable system or device for detecting abnormal biological events may include one or more electrodermal activity sensors disposed on a second side of the system and / or on a fastenable band. For example, as shown in FIG. 41, electrodermal sensors 424, 426 are disposed on a second side 402 of a wearable system 400. The electrodermal sensors 424, 426 may be spaced apart from each other by a distance 444 equal to about 5 mm to about 10 mm, about 10 mm to about 20 mm, about 20 mm to about 30 mm, about 30 mm to about 40 mm, about 40 mm to about 50 mm, about 50 mm to about 60 mm, about 60 mm to about 70 mm, about 70 mm to about 80 mm, about 80 mm to about 90 mm, or about 90 mm to about 100 mm, measured from a center point of each sensor. Additionally, the electrodermal sensors 424, 426 may be spaced from the heat source by a distance equal to about 10 mm to about 20 mm, about 20 mm to about 30 mm, about 30 mm to about 40 mm, about 40 mm to about 50 mm, about 50 mm to about 60 mm, about 60 mm to about 70 mm, about 70 mm to about 80 mm, about 80 mm to about 90 mm, or about 90 mm to about 100 mm, measured from the center of the sensor and from the center of the heat source.

[0104] As an example, as shown in FIG. 56, the electrodermal activity (EDA) of the user's skin surface may be measured over time. The electrodermal activity of the left and right sides may be measured over time and compared. FIG. 56 shows the electrodermal activity of the left and right sides, including events (shown as triangles) that may indicate abnormal biological events. The signal collected by the electrodermal activity sensor may be processed to extract one or more characteristics. For example, as shown in FIG. 57, the one or more characteristics may include rise time (i.e., from the start of the SCR to the apex), amplitude (i.e., EDA at the apex minus EDA at the start of the SCR), skin conductance response (SCR) width (i.e., between 50% amplitude on the rising side and 50% amplitude on the falling side), decay time (i.e., time from the apex to 50% amplitude), area under the curve (i.e., SCR width multiplied by amplitude), maximum derivative of the SCR, and / or apex value.

[0105] FIG. 63 illustrates a method 6300 for analyzing EDA data, and FIG. 64-65 illustrate representative EDA data. The method 6300 for analyzing EDA data includes receiving a signal from one or more EDA sensors (e.g., as shown in FIG. 56), detecting and / or removing one or more artifacts (e.g., as shown in FIG. 56), calculating or extracting one or more skin conductance response (SCR) characteristics (e.g., as shown in FIG. 57), calculating an average or mean value of the one or more characteristics (e.g., as shown in FIG. 58), and calculating the SCR per time period (e.g., as shown in FIG. 69). For example, the SCR amplitude is shown graphically in FIG. 65 for a one-minute interval. As shown, for this individual, the SCR amplitude changes asymmetrically over time (i.e., right side response compared to left side response). Furthermore, as shown in FIG. 64, when SCRs per minute are compared for left and right responses, the SCRs per minute vary asymmetrically over time.

[0106] In any embodiment described herein, the wearable system or device for detecting abnormal biological events may include one or more motion sensors 436 configured to measure movement of a body part to which the wearable system is coupled, as shown in FIG. 43. For example, the one or more motion sensors may measure acceleration in six or nine degrees of freedom. As described elsewhere herein, the wearable system or device for detecting stroke may measure asymmetric movement or trembling for right and left limbs in combination with measuring vasodilation response in response to application of heat. The one or more motion sensors may be located anywhere on the wearable device. For example, in one embodiment, the motion sensor is located in or on the first surface. In another embodiment, the motion sensor is located in or on the second surface. In another embodiment, the motion sensor is located between the first surface and the second surface. In another embodiment, the motion sensor is located on a sidewall of the body of the wearable device. In another embodiment, the motion sensor is positioned in the system, for example adjacent to a vasodilatation sensor or temperature sensor, concentrically surrounded by a heating source, as shown in FIG.

[0107] The heat source of the wearable device or system 400 may be cooled between heating cycles to ensure that the vasodilatory response of the skin surface returns to or substantially to the baseline between heating cycles. In this case, the heat source may be cooled by an airflow system (e.g., a fan), a vacuum mechanism or a vibration mechanism (e.g., a solenoid and diaphragm, an oscillating piezoelectric element) configured to displace or pull or move ambient air across the heat source, or the like. In one embodiment, as shown in FIGS. 40-43, a wearable system or device for detecting abnormal biological events includes a first surface 404 and a second surface 402 that form a cavity 406 therebetween to provide airflow between the first surface 404 and the second surface 402. The cavity 406 formed by the first surface 404 and the second surface 402 physically separates the heat source 410 from a hardware processor 409 located on or within the first surface 404. The hardware processor 409 may include a microcontroller, a digital signal processor, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. The cavity 406 functions to cool the heating source 410 to a temperature approaching, substantially equal to, or equal to the air temperature or ambient temperature in the environment by exposing the heating source 410 to the surroundings or to the environment or to the ambient air. The cavity 406 may be an empty space, an interstitial space, a space containing one or more components, or the like. In some embodiments, the cavity 406 formed by the first surface 404 and the second surface 402 is open to ambient or environmental air such that the side walls 405 joining the first surface 404 and the second surface 402 together are located on opposite sides, as shown in Figures 40-41, thereby making the cavity 406 open to ambient air on both sides.Alternatively, the side walls 405 are connected to one another and adjacent, such that the cavity is open to ambient air on adjacent or connected sides.

[0108] For example, in some embodiments, the cavity 406 formed by the first side 404 and the second side 402 has a sufficient volume to facilitate cooling of the heat source 410 between heating cycles. Alternatively, or in addition, the cavity 406 may further include an air flow system, or a vacuum mechanism, or a vibration mechanism, or other air flow mechanism to facilitate air flow through the cavity 406 to reduce the temperature or cool the heat source 410.

[0109] In some embodiments of a wearable system or device, the device includes a port 420 for electrically coupling the device to a power source, for example to charge a battery 407 within the device. Additionally or alternatively, the port 420 electrically couples the wearable device to an external or remote computing device (e.g., laptop, desktop, server, workstation, etc.) for downloading data from the device, uploading system parameters, installing updates to the wearable device, etc. The wearable device may further include one or more user input members 418 for powering the device on and off, for inputting user specific responses or features or characteristics, for customizing the user device interface or functionality, etc.

[0110] In some embodiments, as shown in FIG. 45, a wearable system for detecting abnormal biological events includes a first system or device 400 placed on a user's left limb and a second system or device 500 placed on a user's right limb. The first device 400 and the second device 500 may measure similar parameters or characteristics such that the parameters or characteristics are comparable over time and / or on an event-by-event basis to detect asymmetric biological responses. For example, a hardware processor as part of the system or communicatively coupled to a device (e.g., laptop 450 or mobile computing device 46) may be configured to determine whether an abnormal biological event is occurring by comparing a right side blood volume signal (e.g., in response to application of heat) to a left side blood volume signal (e.g., in response to application of heat). The right side blood volume signal and the left side blood volume signal may be compared to a baseline right side blood volume signal and a baseline left side blood volume signal, respectively, to account for any asymmetric baseline differences that may exist between the left and right sides. Additionally, the method performed by the hardware processor may include synchronizing in time the signals received from the left and right limbs and determining whether an abnormal biological event is occurring by comparing the synchronized signals from the left and right limbs.

[0111] 44, a coupling member 408 configured to couple a wearable system for detecting abnormal events to a limb or body part of a user is illustrated. For example, the coupling member may be a tightenable band for coupling a detection system or device to a limb or body part of a user. The tightenable band is formed from or includes a stretchable material (e.g., silicone, rubber, Lycra, spandex, elastane, neoprene, leather, cloth, etc.). Alternatively, a portion or section 440 of the coupling member may be stretchable such that applying different degrees of tension to the coupling member may cause the stretchable portion or section 400 to stretch or contract. Thus, the coupling member may be adjustable such that the coupling member conforms to different shapes and sizes of body parts. For example, the coupling member may have an adjustable circumference. The coupling member may further include a visual indicator 438 to indicate that one or more of the heating member, skin temperature sensor, blood content sensor, or combinations thereof, are sufficiently coupled to the skin surface to allow for an accurate sensor reading.

[0112] Referring to FIG. 37, a system for detecting stroke may include collecting data from one or more sources, such as, for example, contact-based sources, non-contact-based sources, and sources that stimulate a response and then measure a response output. As shown in FIG. 37, the system may include a main station or docking station and / or a measurement station for one or more measurement devices. For example, heart rate monitors, devices for measuring asymmetric responses or effects (e.g., watches worn on each wrist), etc. may be included in the system. The system may be portable, such that the system may be located in a mobile stroke detection unit for rapid detection of stroke, or may be located in the home of a high-risk patient.

[0113] For example, as shown in FIG. 8, a method for detecting tremor (i.e., asymmetric wrist movement) includes measuring acceleration in the x-, y-, and / or z-planes for two limbs (e.g., two arms or two legs) of an individual, measuring distance in the x-, y-, and / or z-planes for two limbs of the individual, and calculating the movement of each limb relative to the other limbs of the individual. In some embodiments, symmetrical movement indicates healthy, non-stroke movement, and asymmetrical movement indicates tremor or stroke events. Exemplary acceleration data (XYZ) is shown in FIG. 9, distance data (XYZ) is shown in FIG. 10, and distance (MM / S, movement) data is shown in FIG. 11. In some embodiments, a particular pattern of movement over time is unique to an individual and is classified as tremor based on data collected over time. For example, tremor data may be collected over several hours, including wake and sleep cycles. Statistical modeling of tremor then becomes a signature for each patient. The signature also allows a baseline to be established for each patient, and again, this baseline behavior may be specific to the individual and even to the individual's "wake cycle" and "sleep cycle."

[0114] As shown in FIG. 26, an application downloaded and / or stored on a hardware component of a system or computing device for detecting stroke collates and analyzes acceleration data and distance data sensed by a sensor, such as an accelerometer. A comparison of two data sets (i.e., Test Run 1 and Test Run 2) obtained from devices placed on two limbs (e.g., wrists) of a user is shown in FIG. 26. For example, the application on the computing device may be configured to compare two acceleration data sets (FIGS. 27, 32), two distance data sets (FIGS. 28, 31), and two movement data sets (FIGS. 29, 30) from devices placed on two wrists of a user. As shown in FIGS. 29-30, the application on the computing device may further include a zoom function to display a subset of the total data collected, for example, at a given time (e.g., overnight, during a tremor instance, etc.).

[0115] In some embodiments of a device for detecting tremors or asymmetric movements, the device may include a feedback mechanism (e.g., visual, tactile, or audio) when a threshold is reached or exceeded, or when various comparison criteria are met, such as when a current movement pattern matches a previously identified tremor pattern for an individual. In some embodiments, a motion sensor or a mobile computing device communicatively coupled to the wearable device generates a vibration signal in the wearable device, in the sensor, and / or in the computing device when a comparison between the two signals exceeds a predefined threshold.

[0116] In determining which embodiment is best for stroke detection, several factors may be considered, such as alert 911 functionality, passive monitoring, detection of patient alone, and detection of patient asleep. Additional factors may include, but are not limited to, full mobility, patient specific algorithms, active patient engagement after active alert, detection for patients with cognitive impairment, detection for patients with stroke history, detection of all strokes including sequelae, diagnosis of stroke type, passive monitoring to wake the patient, and initiation of stroke treatment. For example, if a possible stroke event is detected, the wearable system may initiate tactile, audio, and / or visual alerts, determine if the user is conscious, unconscious, experiencing other stroke symptoms, etc. If the patient does not respond within a predefined time window, an alert of the stroke event may be issued to a caregiver, emergency services, physician, etc. The wearable system may be linked to a clinician computing system. The alert may be sent directly to a clinician computing system that may facilitate a remote medical evaluation. The clinician may generate an NIH Stroke Score assessment in response to the alert and / or in response to data received from the wearable system. In some instances, the wearable system, by itself or in conjunction with a personal computing system, may enable self-assessment by walking the individual through the FAST (Facial Droop, Arm Weakness, Speech Difficulty, Time) assessment and / or by available witnesses.

[0117] In some implementations, the wearable system may transmit a signal to the user's home automation system or to at least one electronically enabled door lock in response to an alert regarding a stroke event, thereby unlocking at least one door lock and / or disabling the user's home alarm system. The wearable system may also initiate transmission of a floor plan access route from an entrance access point to the patient's location within the home or facility where the user has received an indication of a possible stroke. The patient's location may be determined based on a local area network or differential GPS. In some embodiments, the device or system for detecting stroke may activate an audible alarm, for example during sleep, to alert the patient or a caregiver that a stroke event has occurred. The audible alarm may also enable emergency services to locate the patient when they enter the residence. All these measures may help to reduce the time it takes emergency services or caregivers to reach the patient.

[0118] The home automation system may also include smart displays and smart speakers that can be used to communicate information to emergency medical responders, such as identification of which medications the patient should be taking, and possibly information regarding compliance with the prescribed medication regimen. Information such as physician identity, medical history, allergies, and the presence of a health care proxy or advance directive associated with the patient may also be communicated.

[0119] Furthermore, when an alert is issued to an emergency service or physician, data including medical history may be transmitted directly from the wearable system or from a remote memory initiated by a signal from the wearable system to the computing system of the emergency service or physician. In addition to alerting, the wearable system may also instruct the user to perform or automatically activate a specific stroke treatment. Stroke treatment may include inducing hypothermia to provide neuroprotective agents to the patient. The wearable system may trigger the inhalation of cooling gas, activation of a cooling helmet, activation of an ultrasonic helmet to dissolve clothing, or ingestion or administration of a drug patch or tablet. Triggering may be an instruction to the patient or medical responder, or may be automatic activation. In some instances, for an ischemic stroke, the wearable system may trigger mechanisms to increase blood pressure and dilate blood vessels (via some of the mechanisms described above).

[0120] Treatment responsive to detection of a potential stroke can be initiated by the patient, if the patient is conscious and competent, or by medical responders via a home automation system. Patients in certain high-risk categories may already be wearing wearable treatment devices that can be activated automatically in response to a signal indicative of detection of a potential stroke, or by medical personnel following clinical testing initiated by an alert from the wearable system.

[0121] In some embodiments, the device or system for detecting stroke may activate an audible alarm, for example during sleep, to alert the patient or a caregiver that a stroke event has occurred. The audible alarm may also enable emergency services to locate the patient when they enter the residence.

[0122] In any of the embodiments described herein, a device or system for detecting stroke may record the onset of a stroke event and / or provide a "last known good" indication to help inform treatment decisions.

[0123] In some embodiments, the system for detecting stroke includes a data processing module. The data processing module may be configured to extract patterns. The patterns may suggest any ischemic or hemorrhagic episodes very early, possibly immediately before, the actual stroke event. In some embodiments, the patterns may be determined empirically, for example, based on population-wide analysis, based on cohort analysis, and / or based on individual analysis of the signals analyzed for parameters and / or patterns indicative of stroke onset. In some embodiments, the signal processing may employ signal processing tools, such as filtering, extraction, digitization, data deconvolution, machine learning, and / or other techniques known in the art. In particular, the signal processing may use higher order statistics to see hidden patterns in the data. The use of higher order statistics, known as cumulants, and the use of its Fourier spectrum, often referred to as polyspectrum, may reveal not only higher order amplitude information (such as that carried by the power spectrum or autocorrelation), but also phase information. Phase information may reveal salient features of the data that are not available through simple harmonic analysis. Another important feature of polyspectra is that they are independent of Gaussian processes, which can then be processed automatically, improving the signal-to-noise ratio and enabling novel detections. In some embodiments, multiple spectra and their manipulations may be selected to identify hidden patterns in the sensed signal, e.g., BP(t), ECG(t), etc.

[0124] For example, as shown in Figs. 53-55, a wearable system may collect electrocardiogram (ECG) data, pre-process the data, identify peaks in the data, and apply decision logic to the data. Fig. 54 shows electrocardiogram data collected over time. Fig. 55 shows RR intervals (i.e., the time between beats in milliseconds) extracted from the electrocardiogram data. The method 5300 shown in Fig. 53 may be used to calculate an individual's heart beats and / or heart rate variability (i.e., the specific changes in the time between successive beats). As shown in Fig. 53, ECG data is input into a method 5300 for detecting QRS complexes in an electrocardiogram signal (i.e., the ventricular depolarization and main spikes in an ECG signal). Pre-processing in block S5310 includes applying signal processing techniques for QRS feature extraction. For example, pre-processing may be applied to reduce the effects of muscle noise, power line interference, baseline wander, and / or T-wave interference. Peak detection in block S5320 includes, for example, QRS peak detection using an adaptive threshold. Each potential peak is compared to a baseline value. A baseline skin temperature is established by measuring unstimulated skin for a period of time. After the baseline is determined, the stimulus (e.g., application of heat) can reach either a time limit or a temperature limit. The temperature limit can be absolute or relative to the baseline skin temperature. The baseline value is updated according to the amplitude of the detected peak. The decision logic in block S5330 classifies the current peak as a QRS, T wave, or an error beat using the peak slope and / or the peak-to-peak interval.

[0125] As shown in Figures 58-62, the electrocardiogram data may be processed via a number of techniques, such as to extract various features and / or calculate one or more features (e.g., heart rate variability, heart rate, total power, etc.). For example, time domain analysis (Figure 58), geometric analysis (Figure 59), frequency domain analysis (Figure 60), and / or non-linear analysis (Figure 61) may be used.

[0126] As shown in Fig. 58, ECG data (e.g., Fig. 54) is provided into method 5800. The method includes receiving ECG data of a user using an ECG, detecting beats in the ECG data (e.g., detecting R-peaks in the ECG data) S5810, identifying and correcting irregular beats (e.g., identifying missed beats, extra beats, and ectopic beats and correcting each beat using adjacent beats) S5820, identifying intervals between normal R-peaks (i.e., NN interval time series (NNIs)), pre-processing the data (e.g., correcting outliers in the NNIs) S5840, and performing one or more analyses S5850. For example, time domain analysis may be used to calculate heart rate (e.g., 60 divided by the average value of NNIs), standard deviation of NNIs (SDNN), root mean square of consecutive differences (RMSSD), and percentage of adjacent NNIs that differ from each other by more than 50 ms (pNN50), as shown in Figure 59. Furthermore, for example, frequency domain analysis may be used to calculate relative power (e.g., relative power of each frequency band (VLF / total, LF / total, HF / total)), normalized power (e.g., normalized power of LF and HF frequency bands (LF / (LF+HF), HF / (LF+HF)), LF / HF ratio (e.g., LF power / HF power), and total power (e.g., total power over all frequency bands), as shown in Figure 61. Furthermore, for example, geometric analysis may be used to calculate baseline width of the interpolated triangle (TINN), and / or may be used to calculate the ratio between the total number of NNIs and the maximum value of the NNI histogram distribution (i.e., the triangular index).Furthermore, for example, the nonlinear analysis may be used to perform Poincaré analysis (i.e., analyzing the Poincaré plot of NNIs-SD1, SD2, SD ratio, ellipse area), DFA (detrended fluctuation analysis (i.e., short-term and long-term fluctuations of NNIs)), and / or entropy analysis (i.e., calculating approximate entropy, sample entropy, and fuzzy entropy of NNIs), as shown in FIG.

[0127] In some embodiments, the data processing module may distinguish changes from healthy "learned" or individualized baseline data by using continuously or intermittently monitored physiological signals. For example, the module may continuously learn signals from individual patients rather than using statistical averages taken from a large number of patients. Custom reference signals may significantly improve subtle changes in physiological signals for individual patients. In some embodiments, physiological parameters may be processed as a function of time, including the shape of the curve changes, including hidden harmonics, changes in higher order derivatives, etc.

[0128] An embodiment of various components of the data processing module is shown in Figure 33. The core engine of an embodiment of the data processing module may include one or more of the following parameters: high speed processing, support for advanced analytics, real-time stream processing, integration with both NoSQL and RDBMS, and integration with Hadoop.

[0129] The data processing module may employ various machine learning techniques to identify patterns, extract patterns, identify parameters indicative of stroke onset, etc. Machine learning may be broadly defined as the application of any computer-enabled algorithm that can be applied to a data set to find patterns in the data. Using machine learning algorithms, relationships between inputs and outputs of a system are determined using a training data set representative of all behaviors found in the system. This training may be supervised or unsupervised. For example, as shown in FIG. 34, a simple neural network called a multi-layer perceptron (MLP) may be used to model various parameters or patterns of an individual, for example, during sleep. Each node is a neuron that uses a non-linear activation function. Such a simple neural network may be used to distinguish data that is not linearly separable. In some embodiments, a deep learning network may be used, as shown in FIG. 35. The deep learning network may include a leveraged recurrent neural network (RNN) implementation, as shown in FIG. 36. The system generates layers of interconnected networks, each layer corresponding to a time slice. RNNs have proven to be very effective at processing time series data, and assuming the training input is time-dependent, they can accurately model / predict changes through time, generating actual output values ​​with respect to data points rather than simply being given a range, with each time slice having its own user-specified feedforward network.

[0130] In some embodiments, the system that provides comprehensive stroke care includes: educational resources tailored to the patient based on demographics, stroke type, comorbidities, medications, etc.; reminders (e.g., medications, rehabilitation appointments, etc.); collaborative care resources (e.g., spouse, doctor, physical therapist, caregiver, etc.); management tools to support dynamic lifestyle changes such as activity tracking with continuous data collection via wearables, fitness tracking and guided meditation, stroke risk level assessment; and communication tools to connect stroke survivors with others in groups, connecting both patients and caregivers to give and receive support and encouragement. This may include one or more of the following: community with others as part of the first national stroke survivor network, such as "checking in" to ensure they are progressing towards goals and are doing well mentally, sharing stories and relating to others, and receiving telehealth / rehabilitation resources from a speech therapist or mental health counselor; patient rehabilitation and monitoring or other enabling technologies; tools such as setting recovery goals and tracking progress and assessing cognition; stroke detection and alerting caregivers via phone / message, communication tools for patients with aphasia, etc.

[0131] Example 1 Various functional symptoms, quantitative markers, and blood / body fluid products were scored for their ability to detect stroke. The scoring criteria were: evidence-based, high sensitivity (>90%), very few false positives (<10%), and passive (automatic) stroke detection. Each of these parameters was scored on a scale of 0 to 5, except for passive detection, which was scored on a scale of 0 (active detection) to 1 (passive detection). This score was then multiplied by the weighting factors shown in Table 1 below, and a total score was obtained by summing all the weighting factors.

[0132] As shown in Tables 2 and 5 below, the functional symptoms with the highest total scores were facial weakness, unilateral weakness, visual field restriction, gaze change, and speech change. Of these functional symptoms, only facial weakness, unilateral weakness, and speech change can be passively detected. [Table 2] [Table 3]

[0133] The quantitative markers with the highest total scores were cerebral blood flow, EEG asymmetry, carotid artery stenosis, volume impedance spectroscopy, and limb asymmetry, as shown in Tables 3 and 5. Of these quantitative markers, all are considered passively detectable. [Table 4]

[0134] As shown in Tables 4 and 5, the products with the highest total scores were Cornell University's products, SMARTChip and ReST. None of these were considered passive detection. [Table 5] [Table 6]

[0135] In summary, a multivariate system for detecting stroke may include detecting one or more of cerebral blood flow, EEG asymmetry, carotid artery stenosis, volumetric impedance spectroscopy, limb asymmetry, facial weakness, unilateral weakness, and speech changes. In some embodiments, these various parameters may be measured at different locations and / or at different times to determine the onset, occurrence, or impact of a stroke.

[0136] Example 2 Symmetric and asymmetric acceleration and distance were measured using an Apple® watch and displayed by a graphical display within an application on the computing device (Figures 9-11, 27-32). In this example, the implementation also measures the resolution of the Apple® watch's acceleration sensor and existing API functions.

[0137] In this example, the device was worn on the user's wrist. Any acceleration of the wrist, including x-axis, y-axis, and z-axis acceleration, was recorded and stored in an on-board database. The computing device has a "sync" feature that can transfer data to the computing device for analysis. Tables 6-8 show the acceleration data, distance data, and calculated movement data (i.e., distance traveled), respectively, obtained using an Apple® watch worn on each of the user's wrists. Data values ​​were recorded at various time points, as shown in Figures 9-11 and 27-32. [Table 7] [Table 8] [Table 9]

[0138] In summary, a system for detecting stroke may include one or more of detecting x-axis, y-axis, and / or z-axis acceleration and / or x-axis, y-axis, and / or z-axis distance, and in some embodiments, calculating distance of movement (i.e., displacement) to determine asymmetric limb movements, gait, etc. that may be indicative of a stroke event.

[0139] The system and method in the preferred embodiment and its variants can be embodied and / or implemented at least in part as a machine configured to receive a computer-readable medium having computer-readable instructions stored thereon. The instructions are preferably executed by computer-executable components preferably integrated with the system and by one or more portions of a hardware processor on the device for detecting stroke and / or on the computing device. The computer-readable medium can be stored on any suitable computer-readable medium, such as RAMs, ROMs, flash memories, EEPROMs, optical devices (e.g., CD or DVD), hard drives, floppy drives, or any suitable device. The computer-executable components are preferably general-purpose or application-specific hardware processors, although any suitable dedicated hardware or hardware / firmware combination can alternatively or additionally execute the instructions.

[0140] As used in the specification and claims, the singular forms "a," "an," and "the" include both singular and plural references unless the context clearly dictates otherwise. For example, the term "signal" may include and is intended to include a plurality of signals. Although the claims and disclosures may at times include terms such as "plural," "one or more," or "at least one," the absence of such terms is not intended to mean that a plurality is not intended, and should not be interpreted as meaning that a plurality is not intended.

[0141] The terms "approximately" or "about," when used before a numerical designation or range (e.g., to define a length or pressure), indicate approximations that may vary by (+) or (-) 5%, (+) or (-) 1%, or (+) or (-) 0.1%. All numerical ranges provided herein are inclusive of the beginning and ending numerical values ​​recited. The term "substantially" indicates a majority (i.e., greater than 50%) or essentially all of a device, material, or composition.

[0142] As used herein, the terms "comprise" or "comprising" are intended to mean that the devices, systems, and methods include the recited elements and may additionally include any other elements. "Consisting essentially of" shall mean that the devices, systems, and methods include the recited elements and exclude other elements that are essential to the combination for the described purpose. Thus, as defined herein, a system or method that consists essentially of elements does not exclude other materials, features, or steps that do not materially affect the basic and novel feature or features of the claimed disclosure. "Consisting of" shall mean that the devices, systems, and methods include the recited elements and exclude more than trivial or inconsequential elements or steps. Embodiments defined by each of these transitional terms are within the scope of this disclosure.

[0143] The examples and illustrations contained within are for purposes of illustration and not limitation, but rather depict specific embodiments in which the subject matter may be practiced. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to herein, individually or collectively, by the term "invention" for convenience only, and are not intended to spontaneously limit the scope of the present application to any single invention or inventive concept when multiple inventions are in fact disclosed. Thus, although specific embodiments are shown and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific embodiment presented. The present disclosure is intended to cover any and all adaptations or modifications of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

[0144] Exemplary embodiments 1. A wearable system for detecting abnormal biological events in a human, comprising:

[0145] a main body having a second surface that contacts a surface of human skin and a first surface located on the opposite side to the second surface;

[0146] a heat source in communication with the skin surface, the heat source configured to heat the skin surface to a target temperature;

[0147] a skin temperature sensor disposed on the second surface, the skin temperature sensor configured to measure a temperature of a skin surface in contact with the heating source;

[0148] a blood content sensor disposed on the second surface, the blood content sensor configured to measure blood content at the skin surface;

[0149] a hardware processor communicatively coupled to the heating source, the blood content sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system;

[0150] receiving a baseline blood content signal from the blood content sensor;

[0151] outputting a heating signal to a heat source to initiate a heating cycle for heating the skin surface to a target temperature;

[0152] receiving a second blood content signal from the blood content sensor in response to the skin surface reaching the target temperature;

[0153] comparing the second blood volume signal to a baseline blood volume signal;

[0154] and a hardware processor configured to determine, based on the comparison, whether an abnormal biological event is occurring.

[0155] The wearable system of any embodiment disclosed herein, wherein the second blood volume signal includes a set of multiple blood volume signals for repeatedly measuring blood volume at the skin surface before, during, and after a heating cycle by the heating source.

[0156] The wearable system of any embodiment disclosed herein, wherein the second blood volume signal includes a plurality of blood volume signals for continuously measuring blood volume at the skin surface before, during, and after a heating cycle by the heating source.

[0157] In any embodiment of the wearable system disclosed herein, the hardware processor is further configured to receive a second blood volume signal after the target temperature is reached, or after a predetermined amount of time has elapsed, or after one or more heating cycles have been completed.

[0158] The wearable system of any embodiment disclosed herein, wherein the comparison includes calculating a baseline ratio of alternating current (AC) to direct current (DC) for the baseline blood volume signal and a second ratio of AC to DC for the second blood volume signal, and comparing the baseline ratio to the second ratio.

[0159] The wearable system of any embodiment disclosed herein, wherein the environmental temperature sensor is disposed on a first surface of the body of the wearable system.

[0160] The wearable system of any embodiment disclosed herein further comprising a remote computing device communicatively coupled to the wearable system, the remote computing device including an environmental temperature sensor.

[0161] The wearable system of any embodiment disclosed herein, wherein the remote computing device is one of a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.

[0162] The wearable system of any embodiment disclosed herein, wherein the heating source is disposed on the second surface of the body.

[0163] The hardware processor is

[0164] receiving a baseline temperature signal from the skin temperature sensor and from the environmental temperature sensor;

[0165] determining a target temperature based on the baseline temperature signal;

[0166] In any embodiment the wearable system disclosed herein further configured to determine if the target temperature is less than a maximum temperature value.

[0167]

[0023] In any embodiment disclosed herein, the wearable system further comprises a hardware processor configured to maintain the target temperature by periodically operating the heating source.

[0168] The wearable system of any embodiment disclosed herein, further comprising one or more electrodermal activity sensors disposed on the second surface.

[0169] The wearable system of any embodiment disclosed herein, wherein the one or more electrodermal activity sensors are spaced from the heating member by about 0.25 inches to about 4 inches (about 6.35 mm to about 101.6 mm).

[0170] The wearable system of any embodiment disclosed herein further comprising one or more motion sensors configured to measure movement of a body part to which the wearable system is coupled.

[0171] The wearable system of any embodiment disclosed herein, wherein the first surface and the second surface form a cavity therebetween to provide airflow between the first surface and the second surface.

[0172] The wearable system of any embodiment disclosed herein, wherein the hardware processor is located on or within the first surface.

[0173] The wearable system of any embodiment disclosed herein, wherein the cavity formed by the first and second surfaces physically separates the heating source from a hardware processor on or within the first surface.

[0174] The wearable system of any embodiment disclosed herein, wherein the cavity formed by the first and second surfaces has a volume sufficient to facilitate cooling of the heat source between heating cycles.

[0175] The wearable system of any embodiment disclosed herein, wherein the abnormal biological event comprises a stroke event.

[0176] The wearable system of any embodiment disclosed herein, wherein the wearable system is positioned on the user's left limb and a second wearable system is positioned on the user's right limb, the second wearable system including a second heating member, a second skin temperature sensor, and a second blood volume sensor, and the hardware processor is further configured to determine whether an abnormal biological event is occurring by comparing the right side blood volume signal with the left side blood volume signal.

[0177] The hardware processor is

[0178] The signals received from the left and right limbs are synchronized in time.

[0179] The wearable system of any embodiment disclosed herein, further configured to determine whether an abnormal biological event is occurring by comparing the synchronized signals from the left and right limbs.

[0180] The wearable system of any embodiment disclosed herein, wherein the comparison takes into account baseline differences between the left and right limbs.

[0181] The wearable system of any embodiment disclosed herein, further comprising a tightenable band coupled to the body.

[0182] In any embodiment of the wearable system disclosed herein, the tightenable band further includes a visual indicator to indicate that one or more of the heating element, skin temperature sensor, blood content sensor, or combination thereof are sufficiently coupled to the skin surface to allow an accurate sensor reading.

[0183] The wearable system of any embodiment disclosed herein, wherein one or more ends of the tightenable band are coupled to the body in a position centered relative to one or more sensors disposed on the second surface.

[0184] The wearable system of any embodiment disclosed herein, wherein the heating source is concentrically disposed around one or both of the blood content sensor and the skin temperature sensor.

[0185] The wearable system of any embodiment disclosed herein, wherein the blood content sensor includes a photoplethysmography sensor or an impedance-based pulse wave sensor.

[0186] The wearable system of any embodiment disclosed herein, wherein the skin temperature sensor comprises a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.

[0187] The wearable system of any embodiment disclosed herein further comprising a support structure coupled to the heating source, the support structure configured to couple the heating source to the second surface and further configured to at least partially expose the heating source to the cavity.

[0188]

[0023] In any embodiment the wearable system disclosed herein, wherein the blood content sensor is further configured to measure one or more of: heart rate, heart rate variability, or oxygen saturation.

[0189] The wearable system of any embodiment disclosed herein, wherein the target temperature is personalized to the user.

[0190] The wearable system of any embodiment disclosed herein, wherein the individualization of the target temperature includes receiving user input related to a temperature sensed at the skin surface.

[0191] The wearable system of any embodiment disclosed herein, wherein the individualization of the target temperature is based on a signal received from the blood content sensor.

[0192] The wearable system of any embodiment disclosed herein, wherein the heat source comprises one of a heating element or an environmental temperature.

[0193] The wearable system of any embodiment disclosed herein, wherein the hardware processor is configured to send an electronic message to a first electronic system configured to electronically manage the home automation system in response to determining the abnormal biological event.

[0194] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a door lock, and the electronic message is configured to instruct the first electronic system to unlock the door lock.

[0195] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a home alarm system, and the electronic message is configured to instruct the first electronic system to disable the home alarm system.

[0196] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a display, and the electronic message is configured to instruct the first electronic system to display the user's medical information.

[0197] The wearable system of any embodiment disclosed herein, wherein the medical information includes medication information and / or adherence to a medication regimen.

[0198] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a display, and the electronic message is configured to instruct the first electronic system to display a stroke treatment user interface.

[0199] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a speaker system, and the electronic message is configured to instruct the first electronic system to activate an audible alarm using the speaker system.

[0200] The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to issue an alert to a third party computing system in response to determining the abnormal biological event.

[0201] The wearable system of any embodiment disclosed herein, wherein the third party computing system includes an emergency services system.

[0202] The wearable system in any embodiment disclosed herein, wherein the third party computing system includes a clinician computing system.

[0203] The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to initiate a treatment protocol in response to detecting the abnormal biological event.

[0204] The wearable system of any embodiment disclosed herein, further comprising a wearable treatment system, wherein the treatment protocol is configured to activate the wearable treatment system.

[0205] The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises an ultrasound helmet.

[0206] 47. The wearable system of claim 46, wherein the wearable treatment system includes a cooling gas supply system.

[0207] The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises a cooling helmet.

[0208] 1. A wearable system for detecting abnormal biological events in a human, comprising:

[0209] a body having a second surface in contact with a human skin surface and a first surface opposite the second surface, the first surface and the second surface defining a cavity therebetween to provide airflow between the first surface and the second surface;

[0210] a heating member disposed on the second surface, the heating member configured to heat the skin surface for a predetermined period of time;

[0211] a skin temperature sensor disposed on the second surface, the skin temperature sensor configured to measure a temperature of a skin surface in contact with the heating member;

[0212] a blood content sensor disposed on the second surface, the blood content sensor configured to measure blood content at the skin surface;

[0213] a hardware processor communicatively coupled to the heating member, the blood content sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system;

[0214] receiving a baseline blood content signal from the blood content sensor;

[0215] outputting a heating signal to a heat source to initiate a heating cycle for heating the skin surface to a target temperature;

[0216] receiving a second blood content signal from the blood content sensor in response to the skin surface reaching the target temperature;

[0217] comparing the second blood volume signal to a baseline blood volume signal;

[0218] and a hardware processor configured to determine, based on the comparison, whether an abnormal biological event is occurring.

[0219] 1. A wearable system for detecting abnormal biological events in a human, comprising:

[0220] a main body having a second surface that contacts a surface of human skin and a first surface located on the opposite side to the second surface;

[0221] a heat source in communication with the skin surface, the heat source configured to heat the skin surface to a target temperature;

[0222] a skin temperature sensor disposed on the second surface, the skin temperature sensor configured to measure a temperature of a skin surface in contact with the heating source;

[0223] a sensor disposed on the second surface, the sensor configured to measure a parameter of interest in the person; and

[0224] a hardware processor communicatively coupled to the heating source, the sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system;

[0225] receiving a baseline sensor signal from the sensor;

[0226] outputting a heating signal to a heat source to initiate a heating cycle for heating the skin surface to a target temperature;

[0227] receiving a second sensor signal from the sensor in response to the skin surface reaching the target temperature;

[0228] comparing the second sensor signal to a baseline sensor signal;

[0229] and a hardware processor configured to determine, based on the comparison, whether an abnormal biological event is occurring.

[0230] The wearable system of any embodiment disclosed herein, wherein the sensor is selected from the group consisting of a stretch sensor, an electrodermal activity sensor, an electrocardiogram sensor, a camera, or a blood content sensor.

[0231] The wearable system of any embodiment disclosed herein, wherein the parameter of interest includes one or more of blood pressure, heart rate, heart rate variability, gaze, facial expression, skin conductance response, vasodilation response, or dilation response.

[0232] 1. A wearable system for detecting abnormal biological events in a human, comprising:

[0233] a main body having a second surface that contacts a surface of human skin and a first surface located on the opposite side to the second surface;

[0234] a stimulus source in communication with the skin surface, the stimulus source configured to apply a stimulus to the skin surface;

[0235] a blood content sensor disposed on the second surface, the blood content sensor configured to measure blood content at the skin surface;

[0236] a hardware processor communicatively coupled to the stimulus source and to the blood content sensor;

[0237] receiving a baseline blood content signal from the blood content sensor;

[0238] Initiating a stimulation cycle by outputting a stimulation signal to a stimulation source;

[0239] receiving a second blood content signal from the blood content sensor in response to initiation of the stimulation cycle;

[0240] comparing the second blood volume signal to a baseline blood volume signal;

[0241] and a hardware processor configured to determine, based on the comparison, whether an abnormal biological event is occurring.

[0242] The wearable system of any embodiment disclosed herein, wherein the stimulation source comprises a heating source.

[0243] The wearable system of any embodiment disclosed herein, wherein the stimulation source includes a power source.

[0244] The wearable system of any embodiment disclosed herein, wherein the comparison comprises determining a change in vasodilatory response.

[0245] The wearable system of any embodiment disclosed herein, wherein the stimulation source comprises a Peltier cooler.

[0246] The wearable system of any embodiment disclosed herein, wherein the second blood volume signal includes a set of multiple blood volume signals for repeatedly measuring blood volume at the skin surface before, during, and after a stimulation cycle.

[0247] The wearable system of any embodiment disclosed herein, wherein the second blood volume signal includes a plurality of blood volume signals for continuously measuring blood volume at the skin surface before, during, and after a stimulation cycle.

[0248] In any embodiment of the wearable system disclosed herein, the hardware processor is further configured to receive a second blood volume signal after the target stimulation is reached, or after a predetermined amount of time has elapsed, or after one or more stimulation cycles have been completed.

[0249] The wearable system of any embodiment disclosed herein, wherein the comparison includes calculating a baseline ratio of alternating current (AC) to direct current (DC) for the baseline blood volume signal and a second ratio of AC to DC for the second blood volume signal, and comparing the baseline ratio to the second ratio.

[0250] The wearable system of any embodiment disclosed herein, wherein the blood content sensor is disposed on a first surface of a body of the wearable system.

[0251] The wearable system of any embodiment disclosed herein further comprising a remote computing device communicatively coupled to the wearable system, the remote computing device including a blood content sensor.

[0252] The wearable system of any embodiment disclosed herein, wherein the remote computing device includes one of a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.

[0253]

[0023] In any embodiment herein disclosed, the wearable system further comprises a stimulation source disposed on the second surface of the body.

[0254] The hardware processor is

[0255] receiving a baseline blood content signal from the blood content sensor;

[0256] determining a target blood volume based on the baseline blood volume signal;

[0257] In any embodiment the wearable system disclosed herein further configured to determine if the target blood volume is less than a maximum blood volume value.

[0258]

[0023] In any embodiment disclosed herein, the wearable system further comprises a hardware processor configured to maintain a target blood volume by periodically operating the stimulation source.

[0259] The wearable system of any embodiment disclosed herein, further comprising one or more electrodermal activity sensors disposed on the second surface.

[0260] The wearable system of any embodiment disclosed herein, wherein the one or more electrodermal activity sensors are spaced from the stimulation source by about 0.25 inches to about 4 inches (about 6.35 mm to about 101.6 mm).

[0261] The wearable system of any embodiment disclosed herein further comprising one or more motion sensors configured to measure movement of a body part to which the wearable system is coupled.

[0262] The wearable system of any embodiment disclosed herein, wherein the first surface and the second surface form a cavity therebetween to provide airflow between the first surface and the second surface.

[0263] The wearable system of any embodiment disclosed herein, wherein the hardware processor is located on or within the first surface.

[0264] The wearable system of any embodiment disclosed herein, wherein the cavity formed by the first and second surfaces physically separates the stimulation source from the hardware processor on or within the first surface.

[0265] The wearable system of any embodiment disclosed herein, wherein the cavity formed by the first and second surfaces has a volume sufficient to facilitate cooling of the stimulation source between stimulation cycles.

[0266] The wearable system of any embodiment disclosed herein, wherein the abnormal biological event comprises a stroke event.

[0267] The wearable system of any embodiment disclosed herein, wherein the wearable system is positioned on the user's left limb and a second wearable system is positioned on the user's right limb, the second wearable system including a second stimulation source and a second blood volume sensor, and the hardware processor is further configured to determine whether an abnormal biological event is occurring by comparing the right side blood volume signal with the left side blood volume signal.

[0268] The hardware processor is

[0269] The signals received from the left and right limbs are synchronized in time.

[0270] The wearable system of any embodiment disclosed herein, further configured to determine if an abnormal biological event is occurring by comparing the synchronized signals from the left and right limbs.

[0271] The wearable system of any embodiment disclosed herein, wherein the comparison takes into account baseline differences between the left and right limbs.

[0272] The wearable system of any embodiment disclosed herein, further comprising a tightenable band coupled to the body.

[0273] In any embodiment of the wearable system disclosed herein, the tightenable band further includes a visual indicator to indicate that one or more of the stimulation source, blood content sensor, or a combination thereof are sufficiently coupled to the skin surface to enable an accurate sensor reading.

[0274] The wearable system of any embodiment disclosed herein, wherein one or more ends of the tightenable band are coupled to the body in a position centered relative to one or more sensors disposed on the second surface.

[0275] The wearable system of any embodiment disclosed herein, wherein the stimulation sources are arranged concentrically around the blood content sensor.

[0276] The wearable system of any embodiment disclosed herein, wherein the blood content sensor includes a photoplethysmography sensor or an impedance-based pulse wave sensor.

[0277] The wearable system of any embodiment disclosed herein further comprising a support structure coupled to the stimulation source, the support structure configured to couple the stimulation source to the second surface and further configured to at least partially expose the stimulation source to the cavity.

[0278]

[0023] In any embodiment the wearable system disclosed herein, wherein the blood content sensor is further configured to measure one or more of: heart rate, heart rate variability, or oxygen saturation.

[0279] The wearable system of any embodiment disclosed herein, wherein the stimulation cycle is personalized for the user.

[0280] The wearable system of any embodiment disclosed herein, wherein the individualization of the stimulation cycle includes receiving user input related to the stimulation sensed at the skin surface.

[0281] The wearable system of any embodiment disclosed herein, wherein the stimulation cycle is individualized based on a signal received from the blood content sensor.

[0282] The wearable system of any embodiment disclosed herein, wherein the stimulus source comprises one of a heating element or an environmental temperature.

[0283] The wearable system of any embodiment disclosed herein, wherein the hardware processor is configured to send an electronic message to a first electronic system configured to electronically manage the home automation system in response to determining the abnormal biological event.

[0284] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a door lock, and the electronic message is configured to instruct the first electronic system to unlock the door lock.

[0285] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a home alarm system, and the electronic message is configured to instruct the first electronic system to disable the home alarm system.

[0286] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a display, and the electronic message is configured to instruct the first electronic system to display the user's medical information.

[0287] The wearable system of any embodiment disclosed herein, wherein the medical information includes medication information and / or adherence to a medication regimen.

[0288] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a display, and the electronic message is configured to instruct the first electronic system to display a stroke treatment user interface.

[0289] The wearable system of any embodiment disclosed herein, wherein the home automation system includes a speaker system, and the electronic message is configured to instruct the first electronic system to activate an audible alarm using the speaker system.

[0290] The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to issue an alert to a third party computing system in response to determining the abnormal biological event.

[0291] The wearable system of any embodiment disclosed herein, wherein the third party computing system includes an emergency services system.

[0292] The wearable system in any embodiment disclosed herein, wherein the third party computing system includes a clinician computing system.

[0293] The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to initiate a treatment protocol in response to detecting the abnormal biological event.

[0294] The wearable system of any embodiment disclosed herein, further comprising a wearable treatment system, wherein the treatment protocol is configured to activate the wearable treatment system.

[0295] The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises an ultrasound helmet.

[0296] The wearable system of any embodiment disclosed herein, wherein the wearable treatment system includes a cooling gas supply system.

[0297] The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises a cooling helmet.

[0298] 1. A system for detecting an abnormal biological event in a human, comprising:

[0299] a first stimulation source configured to stimulate a first tissue site located on a right side of the person's body at a first time;

[0300] a second stimulation source configured to stimulate a second tissue site located on a left side of the person's body at a second time;

[0301] one or more hardware processors;

[0302] determining a first vasodilator response based on the stimulation of the first tissue site;

[0303] determining a second vasodilator response based on stimulation of the second tissue site.

[0304] determining one or more differences relating to the first vasodilator response and the second vasodilator response;

[0305] and one or more hardware processors configured to detect an abnormal biological event based on one or more differences determined regarding the first vasodilator response and the second vasodilator response.

[0306]

[0023] The system of any embodiment disclosed herein, wherein the first stimulus source comprises at least one or more of a heating source, a cooling source, or a power source.

[0307] The system of any embodiment disclosed herein, wherein the second stimulus source comprises at least one or more of a heating source, a cooling source, or a power source.

[0308] 4. The system of any embodiment disclosed herein, wherein the first time is synchronized with the second time.

[0309] The system of any embodiment disclosed herein, wherein the first vasodilatory response is determined based on a parameter responsive to the measurement from the first blood content sensor.

[0310] The system of any embodiment disclosed herein, wherein the second vasodilatory response is determined based on a parameter responsive to the measurement from the second blood content sensor.

[0311] The system of any embodiment disclosed herein, wherein the first vasodilator response is determined based on a parameter responsive to a measurement from the electrical activity sensor.

[0312] The system of any embodiment disclosed herein, wherein the second vasodilatory response is determined based on a parameter responsive to a measurement from the electrical activity sensor.

[0313] In any embodiment of the system disclosed herein, the one or more hardware processors are further configured to determine a first baseline vasodilation response prior to stimulation at the first tissue site and to determine a second baseline vasodilation response prior to stimulation at the second tissue site.

[0314] 1. A wearable system for detecting a stroke event in a human, comprising:

[0315] a first wearable device configured to contact a first skin surface of the person and further configured to be secured to a left limb of the person;

[0316] a first heating source in communication with the first skin surface, the first heating source configured to heat the first skin surface to a first target temperature;

[0317] a first skin temperature sensor configured to measure a first temperature of a first skin surface;

[0318] a first wearable device including a first blood content sensor configured to measure a first blood content at a first tissue site proximate to a first skin surface;

[0319] a second wearable device configured to contact a second skin surface of the person and further configured to be secured to a right limb of the person;

[0320] a second heating source in communication with the second skin surface, the second heating source configured to heat the second skin surface to a second target temperature;

[0321] a second skin temperature sensor configured to measure a second temperature of a second skin surface;

[0322] a second blood content sensor configured to measure a second blood content at a second tissue site proximate to the second skin surface; and

[0323] one or more hardware processors;

[0324] receiving a first baseline blood content signal from a first blood content sensor;

[0325] receiving a second baseline blood content signal from a second blood content sensor;

[0326] outputting a first heating signal to a first heating source to initiate a first heating cycle for heating the first skin surface to a first target temperature;

[0327] receiving a first post-stimulus blood content signal from a first blood content sensor in response to the first skin surface reaching a first target temperature;

[0328] outputting a second heating signal to a second heating source to initiate a second heating cycle for heating the second skin surface to a second target temperature;

[0329] receiving a second post-stimulus blood volume signal from a second blood volume sensor in response to the second skin surface reaching a second target temperature;

[0330] and one or more hardware processors configured to determine a stroke event based on the first baseline blood volume signal, the second baseline blood volume signal, the first post-stimulation blood volume signal, and the second post-stimulation blood volume signal.

[0331] The wearable system of any embodiment disclosed herein, wherein the second post-stimulus blood volume signal includes a set of multiple blood volume signals for repeatedly measuring the second blood volume at the second skin surface before, during, and after a heating cycle by the second heating source.

[0332] The wearable system of any embodiment disclosed herein, wherein the second post-stimulus blood volume signal includes a plurality of blood volume signals for continuously measuring the second blood volume at the second skin surface before, during, and after a heating cycle by the second heating source.

[0333] In any embodiment of the wearable system disclosed herein, the one or more hardware processors are further configured to calculate a first baseline ratio of alternating current (AC) to direct current (DC) for the first baseline blood volume signal, calculate a second baseline ratio of AC to DC for the second blood volume signal, and compare the first baseline ratio to the second baseline ratio.

[0334] The wearable system of any embodiment disclosed herein, wherein the first wearable device further includes an environmental temperature sensor.

[0335] The wearable system of any embodiment disclosed herein further includes a remote computing device communicatively coupled to the first wearable device and the second wearable device.

[0336] The wearable system of any embodiment disclosed herein, wherein the remote computing device includes one of a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.

[0337] The wearable system of any embodiment disclosed herein, further comprising one or more electrodermal activity sensors.

[0338] The wearable system of any embodiment disclosed herein, wherein the one or more electrodermal activity sensors are spaced from at least one of the first heating source or the second heating source by about 0.25 inches to about 4 inches (about 6.35 mm to about 101.6 mm).

[0339] The wearable system of any embodiment disclosed herein further includes one or more motion sensors configured to measure movement of a body part to which at least one of the first wearable device or the second wearable device is coupled.

[0340] The wearable system of any embodiment disclosed herein, further comprising at least one tightenable band coupled to the body.

[0341] The wearable system of any embodiment disclosed herein, wherein the first heating source is concentrically disposed around one or both of the first blood content sensor and the first skin temperature sensor.

[0342] The wearable system of any embodiment disclosed herein, wherein the second heating source is concentrically disposed around one or both of the second blood content sensor and the second skin temperature sensor.

[0343] The wearable system of any embodiment disclosed herein, wherein the first blood content sensor includes a photoelectric pulse sensor or an impedance pulse sensor.

[0344] The wearable system of any embodiment disclosed herein, wherein the second blood content sensor includes a photoplethysmography sensor or an impedance-based pulse wave sensor.

[0345] The wearable system of any embodiment disclosed herein, wherein the first skin temperature sensor comprises a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.

[0346] The wearable system of any embodiment disclosed herein, wherein the second skin temperature sensor comprises a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.

[0347] In any embodiment the wearable system disclosed herein, the first blood content sensor is further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[0348] In any embodiment the wearable system disclosed herein, wherein the second blood content sensor is further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[0349] At least one of the first target temperature or the second target temperature is personalized to the user. , a wearable system in any embodiment disclosed herein. [1] A wearable system for detecting abnormal biological events in a human, comprising: a main body having a second surface that contacts a surface of human skin and a first surface located on the opposite side to the second surface; a heat source in communication with the skin surface, the heat source configured to heat the skin surface to a target temperature; a skin temperature sensor disposed on the second surface and configured to measure a temperature of the skin surface in contact with the heating source; a blood content sensor disposed on the second surface and configured to measure blood content at the skin surface; a hardware processor communicatively coupled to the heating source, the blood content sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system, receiving a baseline blood content signal from the blood content sensor; initiating a heating cycle including heating the skin surface to the target temperature by outputting a heating signal to the heat source; receiving a second blood content signal from the blood content sensor in response to the skin surface reaching the target temperature. comparing the second blood volume signal to the baseline blood volume signal; and a hardware processor configured to determine whether an abnormal biological event is occurring based on the comparison. [2] The wearable system of [1] above, wherein the second blood volume signal includes a set of blood volume signals in which the blood volume at the skin surface is repeatedly measured before, during, and after a heating cycle by the heating source. [3] The wearable system of [1] above, wherein the second blood volume signal includes a plurality of blood volume signals in which the blood volume at the skin surface is continuously measured before, during, and after a heating cycle by the heating source. [4] The wearable system of [1] above, wherein the hardware processor is further configured to receive the second blood volume signal after the target temperature is reached, a predetermined amount of time has elapsed, or after one or more heating cycles have been completed. [5] The wearable system of [1] above, wherein the comparison includes calculating a baseline ratio of alternating current (AC) to direct current (DC) for the baseline blood volume signal and a second ratio of AC to DC for the second blood volume signal, and comparing the baseline ratio to the second ratio. [6] The wearable system described in [1] above, wherein the environmental temperature sensor is arranged on the first surface of the main body of the wearable system. [7] The wearable system described in [1] above, further comprising a remote computing device communicatively coupled to the wearable system and including the environmental temperature sensor. [8] The wearable system of [7] above, wherein the remote computing device includes one of a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook. [9] The wearable system described in [1] above, wherein the heating source is arranged on the second surface of the body.

[10] The hardware processor, receiving a baseline temperature signal from the skin temperature sensor and from the environmental temperature sensor; determining the target temperature based on the baseline temperature signal; The wearable system of [9] above, further configured to determine whether the target temperature is less than a maximum temperature value.

[11] The wearable system described in

[10] above, wherein the hardware processor is further configured to maintain the target temperature by periodically operating the heating source.

[12] The wearable system described in [1] above, further comprising one or more electrodermal activity sensors disposed on the second surface.

[13] The wearable system of

[12] above, wherein the one or more electrodermal activity sensors are spaced from the heating member by about 0.25 inches to about 4 inches (about 6.35 mm to about 101.6 mm).

[14] The wearable system of [1] above, further comprising one or more motion sensors configured to measure movement of a body part to which the wearable system is coupled.

[15] The wearable system described in [1] above, wherein the first surface and the second surface define a cavity therebetween to provide air flow between the first surface and the second surface.

[16] The wearable system described in

[15] above, wherein the hardware processor is located on or within the first surface.

[17] The wearable system described in

[16] above, wherein the cavity defined by the first surface and the second surface physically separates the heating source from the hardware processor on or within the first surface.

[18] The wearable system described in

[16] above, wherein the cavity defined by the first surface and the second surface has a volume sufficient to facilitate cooling of the heat source between heating cycles.

[19] The wearable system of [1] above, wherein the abnormal biological event includes a stroke event.

[20] The wearable system of [1] above, wherein the wearable system is positioned on a user's left limb and a second wearable system is positioned on the user's right limb, the second wearable system including a second heating member, a second skin temperature sensor, and a second blood volume sensor, and the hardware processor is further configured to determine whether the abnormal biological event is occurring by comparing the right side blood volume signal with the left side blood volume signal.

[21] The hardware processor, to synchronize the signals received from the left and right limbs in time; The wearable system of

[20] above, further configured to determine whether the abnormal biological event is occurring by comparing the synchronized signals from the left limb and the right limb.

[22] The wearable system described in

[21] above, wherein the comparison takes into account a baseline difference between the left limb and the right limb.

[23] The wearable system described in [1] above, further comprising a tightenable band coupled to the body.

[24] The wearable system of

[23] above, wherein the tightenable band further comprises a visual indicator that indicates that one or more of the heating element, the skin temperature sensor, the blood content sensor, or a combination thereof are sufficiently coupled to the skin surface to enable an accurate sensor reading.

[25] The wearable system described in

[24] above, wherein one or more ends of the tightenable band are coupled to the body in a position centered relative to one or more sensors disposed on the second surface.

[26] The wearable system described in [1] above, wherein the heating source is arranged concentrically on one or both of the blood volume sensor and the skin temperature sensor.

[27] The wearable system described in [1] above, wherein the blood volume sensor includes a photoelectric pulse wave sensor or an impedance pulse wave sensor.

[28] The wearable system of [1] above, wherein the skin temperature sensor includes a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.

[29] The wearable system of [1] above, further comprising a support structure coupled to the heating source and configured to couple the heating source to the second surface and at least partially expose the heating source to the cavity.

[30] The wearable system of [1] above, wherein the blood volume sensor is further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[31] The wearable system described in [1] above, wherein the target temperature is individualized for the user.

[32] The wearable system of

[31] above, wherein the individualization of the target temperature includes receiving user input related to a temperature sensed at the skin surface.

[33] The wearable system described in

[31] above, wherein the individualization of the target temperature is based on a signal received from the blood content sensor.

[34] The wearable system described in [1] above, wherein the heating source includes one of a heating element or an ambient temperature.

[35] The wearable system of [1] above, wherein the hardware processor is configured to send an electronic message to a first electronic system configured to electronically manage a home automation system in response to the determination of the abnormal biological event.

[36] The wearable system described in

[35] above, wherein the home automation system includes a door lock, and the electronic message is configured to instruct the first electronic system to unlock the door lock.

[37] The wearable system described in

[35] or

[36] above, wherein the home automation system includes a home alarm system, and the electronic message is configured to instruct the first electronic system to disable the home alarm system.

[38] The wearable system described in any one of

[35] to

[37] above, wherein the home automation system includes a display and the electronic message is configured to instruct the first electronic system to display medical information of the user.

[39] The wearable system of

[38] above, wherein the medical information includes medication information and / or compliance with medication prescriptions.

[40] The wearable system of

[35] above, wherein the home automation system includes a display and the electronic message is configured to instruct the first electronic system to display a stroke treatment user interface.

[41] The wearable system of any one of claims

[35] to

[40] above, wherein the home automation system includes a speaker system, and the electronic message is configured to instruct the first electronic system to activate an audible alarm using the speaker system.

[42] The wearable system of [1] above, wherein the hardware processor is further configured to issue an alert to a third party computing system in response to the determination of the abnormal biological event.

[43] The wearable system described in

[42] above, wherein the third party computing system includes an emergency services system.

[44] The wearable system of

[42] above, wherein the third party computing system includes a clinician computing system.

[45] The wearable system of [1] above, wherein the hardware processor is further configured to initiate a treatment protocol in response to the detection of the abnormal biological event.

[46] The wearable system described in

[45] above, further comprising a wearable treatment system, wherein the treatment protocol is configured to activate the wearable treatment system.

[47] The wearable system described in

[46] above, wherein the wearable treatment system includes an ultrasonic helmet.

[48] ​​The wearable system described in

[46] above, wherein the wearable treatment system includes a cooling gas supply system.

[49] The wearable system described in

[46] above, wherein the wearable treatment system includes a cooling helmet.

[50] A wearable system for detecting abnormal biological events in a human, comprising: a body having a second surface in contact with a human skin surface and a first surface opposite the second surface, the first surface and the second surface defining a cavity therebetween for providing airflow between the first surface and the second surface; a heating member disposed on the second surface and configured to heat the skin surface for a predetermined period of time; a skin temperature sensor disposed on the second surface and configured to measure a temperature of the skin surface in contact with the heating member; a blood content sensor disposed on the second surface and configured to measure blood content at the skin surface; a hardware processor communicatively coupled to the heating member, the blood content sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system, receiving a baseline blood content signal from the blood content sensor; outputting a heating signal to the heating element to initiate a heating cycle for heating the skin surface to a target temperature; receiving a second blood content signal from the blood content sensor in response to the skin surface reaching the target temperature. comparing the second blood volume signal to the baseline blood volume signal; and a hardware processor configured to determine whether an abnormal biological event is occurring based on the comparison.

[51] A wearable system for detecting abnormal biological events in a human, comprising: a main body having a second surface that contacts a surface of human skin and a first surface located on the opposite side to the second surface; a heat source in communication with the skin surface, the heat source configured to heat the skin surface to a target temperature; a skin temperature sensor disposed on the second surface and configured to measure a temperature of the skin surface in contact with the heating source; a sensor disposed on the second surface and configured to measure a parameter of interest in the person; a hardware processor communicatively coupled to the heat source, the sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system, receiving a baseline sensor signal from the sensor; outputting a heating signal to the heat source to initiate a heating cycle for heating the skin surface to the target temperature; receiving a second sensor signal from the sensor in response to the skin surface reaching the target temperature. comparing the second sensor signal to the baseline sensor signal; and a hardware processor configured to determine whether an abnormal biological event is occurring based on the comparison.

[52] The wearable system described in

[51] above, wherein the sensor is selected from the group consisting of a stretch sensor, a skin electrodermal activity sensor, an electrocardiogram sensor, a camera, or a blood volume sensor.

[53] The wearable system of

[51] above, wherein the parameters of interest include one or more of blood pressure, heart rate, heart rate variability, gaze, facial expression, skin conductance response, vasodilation response, or dilation response.

[54] A wearable system for detecting abnormal biological events in a human, comprising: a main body having a second surface that contacts a surface of human skin and a first surface located on the opposite side to the second surface; a stimulation source in communication with the skin surface and configured to apply a stimulation to the skin surface; a blood content sensor disposed on the second surface and configured to measure blood content at the skin surface; a hardware processor communicatively coupled to the stimulus source and the blood content sensor, receiving a baseline blood content signal from the blood content sensor; initiating a stimulation cycle by outputting a stimulation signal to the stimulation source; receiving a second blood content signal from the blood content sensor in response to the initiation of the stimulation cycle; comparing the second blood volume signal to the baseline blood volume signal; and a hardware processor configured to determine whether an abnormal biological event is occurring based on the comparison.

[55] The wearable system described in

[54] above, wherein the stimulation source includes a heating source.

[56] The wearable system described in

[54] above, wherein the stimulation source includes a power source.

[57] The wearable system of

[54] above, wherein the comparison includes determining a change in vasodilation response.

[58] The wearable system described in

[54] above, wherein the stimulation source includes a Peltier cooler.

[59] The wearable system of

[54] above, wherein the second blood volume signal includes a set of blood volume signals in which the blood volume at the skin surface is repeatedly measured before, during, and after the stimulation cycle.

[60] The wearable system of

[54] above, wherein the second blood volume signal includes a plurality of blood volume signals such that the blood volume at the skin surface is continuously measured before, during, and after the stimulation cycle.

[61] The wearable system of

[54] above, wherein the hardware processor is further configured to receive the second blood volume signal after a target stimulation is reached, or after a predetermined amount of time has elapsed, or after one or more stimulation cycles have ended.

[62] The wearable system of

[54] above, wherein the comparison includes calculating a baseline ratio of alternating current (AC) to direct current (DC) for the baseline blood volume signal and a second ratio of AC to DC for the second blood volume signal, and comparing the baseline ratio to the second ratio.

[63] The wearable system described in

[54] above, wherein the blood content sensor is disposed on the first surface of the body of the wearable system.

[64] The wearable system described in

[54] above, further comprising a remote computing device communicatively coupled to the wearable system, the remote computing device including the blood content sensor.

[65] The wearable system of

[64] above, wherein the remote computing device comprises one of a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.

[66] The wearable system described in

[54] above, wherein the stimulation source is disposed on the second surface of the body.

[67] The hardware processor, receiving a baseline blood content signal from the blood content sensor; determining a target blood volume based on the baseline blood volume signal; The wearable system of

[66] above, further configured to determine whether the target blood volume is less than a maximum blood volume value.

[68] The wearable system described in

[67] above, wherein the hardware processor is further configured to maintain the target blood volume by periodically operating the stimulation source.

[69] The wearable system described in

[54] above, further comprising one or more electrodermal activity sensors disposed on the second surface.

[70] The wearable system of

[69] above, wherein the one or more electrodermal activity sensors are spaced from the stimulation source by about 0.25 inches to about 4 inches (about 6.35 mm to about 101.6 mm).

[71] The wearable system of

[54] above, further comprising one or more motion sensors configured to measure movement of a body part to which the wearable system is coupled.

[72] The wearable system described in

[54] above, wherein the first surface and the second surface form a cavity therebetween to provide air flow between the first surface and the second surface.

[73] The wearable system described in

[72] above, wherein the hardware processor is located on or within the first surface.

[74] The wearable system described in

[73] above, wherein the cavity formed by the first surface and the second surface physically separates the stimulation source from the hardware processor on or within the first surface.

[75] The wearable system described in

[73] above, wherein the cavity formed by the first surface and the second surface has a volume sufficient to promote cooling of the stimulation source between stimulation cycles.

[76] The wearable system of

[54] above, wherein the abnormal biological event comprises a stroke event.

[77] The wearable system of

[54] above, wherein the wearable system is placed on the user's left limb and a second wearable system is placed on the user's right limb, the second wearable system including a second stimulation source and a second blood volume sensor, and the hardware processor is further configured to determine whether the abnormal biological event is occurring by comparing the right side blood volume signal with the left side blood volume signal.

[78] The hardware processor, to synchronize the signals received from the left and right limbs in time; The wearable system of

[77] above, further configured to determine whether the abnormal biological event is occurring by comparing the synchronized signals from the left limb and the right limb.

[79] The wearable system described in

[78] above, wherein the comparison takes into account baseline differences between the left limb and the right limb.

[80] The wearable system described in

[54] above, further comprising a tightenable band coupled to the body.

[81] The wearable system of

[80] above, wherein the tightenable band further comprises a visual indicator for indicating that one or more of the stimulus source, the blood content sensor, or a combination thereof, are sufficiently coupled to the skin surface to enable an accurate sensor reading.

[82] The wearable system described in

[81] above, wherein one or more ends of the tightenable band are coupled to the body in a position centered relative to one or more sensors disposed on the second surface.

[83] The wearable system described in

[54] above, wherein the stimulation sources are arranged concentrically on the blood volume sensor.

[84] The wearable system described in

[54] above, wherein the blood volume sensor includes a photoelectric pulse wave sensor or an impedance pulse wave sensor.

[85] The wearable system of

[54] above, further comprising a support structure coupled to the stimulation source, the support structure configured to couple the stimulation source to the second surface and further configured to at least partially expose the stimulation source to the cavity.

[86] The wearable system of

[54] above, wherein the blood volume sensor is further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[87] The wearable system described in

[54] above, wherein the stimulation cycle is individualized for the user.

[88] The wearable system described in

[87] above, wherein the individualization of the stimulation cycle includes receiving user input related to stimulation sensed at the skin surface.

[89] The wearable system described in

[87] above, wherein the individualization of the stimulation cycle is based on a signal received from the blood content sensor.

[90] The wearable system described in

[54] above, wherein the stimulus source includes one of a heating element or environmental temperature.

[91] The wearable system described in

[54] above, wherein the hardware processor is configured to send an electronic message to a first electronic system configured to electronically manage a home automation system in response to the determination of the abnormal biological event.

[92] The wearable system described in

[91] above, wherein the home automation system includes a door lock, and the electronic message is configured to instruct the first electronic system to unlock the door lock.

[93] The wearable system described in

[91] or

[92] above, wherein the home automation system includes a home alarm system, and the electronic message is configured to instruct the first electronic system to disable the home alarm system.

[94] The wearable system of any one of claims

[91] to

[93] above, wherein the home automation system includes a display and the electronic message is configured to instruct the first electronic system to display medical information of the user.

[95] The wearable system of

[94] above, wherein the medical information includes medication information and / or compliance with medication prescriptions.

[96] The wearable system described in

[91] above, wherein the home automation system includes a display and the electronic message is configured to instruct the first electronic system to display a stroke treatment user interface.

[97] The wearable system of any one of claims

[91] to

[96] above, wherein the home automation system includes a speaker system, and the electronic message is configured to instruct the first electronic system to activate an audible alarm using the speaker system.

[98] The wearable system of

[54] above, wherein the hardware processor is further configured to issue an alert to a third party computing system in response to the determination of the abnormal biological event.

[99] The wearable system described in

[98] above, wherein the third party computing system includes an emergency services system.

[0100] The wearable system described in

[98] above, wherein the third party computing system includes a clinician computing system.

[0101] The wearable system described in

[54] above, wherein the hardware processor is further configured to initiate a treatment protocol in response to the detection of the abnormal biological event.

[0102] The wearable system described in

[0101] above, further comprising a wearable treatment system, wherein the treatment protocol is configured to activate the wearable treatment system.

[0103] The wearable system described in

[0102] above, wherein the wearable treatment system includes an ultrasonic helmet.

[0104] The wearable system described in

[0102] above, wherein the wearable treatment system includes a cooling gas supply system.

[0105] The wearable system described in

[0102] above, wherein the wearable treatment system includes a cooling helmet. 1. A system for detecting an abnormal biological event in a human, comprising: a first stimulation source configured to stimulate a first tissue site located on a right side of the person's body at a first time; a second stimulation source configured to stimulate a second tissue site located on a left side of the person's body at a second time; One or more hardware processors, determining a first vasodilator response based on the stimulation of the first tissue site. determining a second vasodilator response based on the stimulation of the second tissue site. determining one or more differences relating to the first vasodilator response and the second vasodilator response; and one or more hardware processors configured to detect an abnormal biological event based on the one or more differences determined for the first vasodilation response and the second vasodilation response.

[0107] The system described in

[0106] above, wherein the first stimulus source includes at least one or more of a heating source, a cooling source, or a power source.

[0108] The system described in

[0106] above, wherein the second stimulus source includes at least one or more of a heating source, a cooling source, or a power source.

[0109] The system described in the above

[0106] , wherein the first time is synchronized with the second time.

[0110] The system described in

[0106] above, wherein the first vasodilation response is determined based on a parameter responsive to a measurement from a first blood volume sensor.

[0111] The system described in the above

[0106] , wherein the second vasodilator response is determined based on a parameter responsive to a measurement from a second blood volume sensor.

[0112] The system described in the above

[0106] , wherein the first vasodilator response is determined based on a parameter responsive to a measurement from an electrical activity sensor.

[0113] The system described in the above

[0106] , wherein the second vasodilator response is determined based on a parameter responsive to a measurement from an electrical activity sensor.

[0114] The system described in

[0106] above, wherein the one or more hardware processors are further configured to determine a first baseline vasodilation response prior to the stimulation at the first tissue site, and to determine a second baseline vasodilation response prior to the stimulation at the second tissue site.

[0115] A wearable system for detecting a stroke event in a human, comprising: A first wearable device configured to contact a first skin surface of the person and further configured to be secured to a left limb of the person, a first heating source in communication with the first skin surface, the first heating source configured to heat the first skin surface to a first target temperature; a first skin temperature sensor configured to measure a first temperature of the first skin surface; a first wearable device including a first blood content sensor configured to measure a first blood content at a first tissue site proximate to the first skin surface; a second wearable device configured to contact a second skin surface of the person and further configured to be secured to a right limb of the person; a second heating source in communication with the second skin surface, the second heating source configured to heat the second skin surface to a second target temperature; a second skin temperature sensor configured to measure a second temperature of the second skin surface; a second wearable device comprising: a second blood content sensor configured to measure a second blood content at a second tissue site proximate to the second skin surface; and One or more hardware processors, receiving a first baseline blood content signal from the first blood content sensor; receiving a second baseline blood content signal from the second blood content sensor; outputting a first heating signal to the first heating source to initiate a first heating cycle for heating the first skin surface to the first target temperature; receiving a first post-stimulus blood content signal from the first blood content sensor in response to the first skin surface reaching the first target temperature; outputting a second heating signal to the second heating source to initiate a second heating cycle for heating the second skin surface to the second target temperature; receiving a second post-stimulus blood content signal from the second blood content sensor in response to the second skin surface reaching the second target temperature. and one or more hardware processors configured to determine a stroke event based on the first baseline blood volume signal, the second baseline blood volume signal, the first post-stimulation blood volume signal, and the second post-stimulation blood volume signal.

[0116] The wearable system described in

[0115] above, wherein the second post-stimulus blood volume signal includes a set of multiple blood volume signals for repeatedly measuring the second blood volume at the second skin surface before, during, and after a heating cycle by the second heating source.

[0117] The wearable system described in

[0115] above, wherein the second post-stimulus blood volume signal includes a plurality of blood volume signals for continuously measuring the second blood volume at the second skin surface before, during, and after a heating cycle by the second heating source.

[0118] The wearable system described in

[0115] above, wherein the one or more hardware processors are further configured to calculate a first baseline ratio of alternating current (AC) to direct current (DC) for the first baseline blood volume signal and a second baseline ratio of AC to DC for the second blood volume signal, and to compare the first baseline ratio with the second baseline ratio.

[0119] The wearable system described in

[0115] above, wherein the first wearable device further includes an environmental temperature sensor.

[0120] The wearable system described in

[0115] above, further including a remote computing device communicatively coupled to the first wearable device and the second wearable device.

[0121] The wearable system described in

[0120] above, wherein the remote computing device includes one of a laptop, a cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.

[0122] The wearable system described in

[0115] above, further comprising one or more electrodermal activity sensors.

[0123] The wearable system described in

[0122] above, wherein the one or more skin electrodermal activity sensors are spaced from at least one of the first heating source or the second heating source by approximately 0.25 inches to approximately 4 inches (approximately 6.35 mm to approximately 101.6 mm).

[0124] The wearable system described in

[0115] above, further including one or more motion sensors configured to measure movement of a body part to which at least one of the first wearable device or the second wearable device is coupled.

[0125] The wearable system described in

[0115] above, further comprising at least one tightenable band coupled to the main body.

[0126] A wearable system as described in

[0115] above, wherein the first heating source is arranged concentrically around one or both of the first blood volume sensor and the first skin temperature sensor.

[0127] A wearable system as described in

[0115] above, wherein the second heating source is arranged concentrically around one or both of the second blood volume sensor and the second skin temperature sensor.

[0128] The wearable system described in

[0115] above, wherein the first blood volume sensor includes a photoelectric pulse wave sensor or an impedance pulse wave sensor.

[0129] The wearable system described in

[0115] above, wherein the second blood volume sensor includes a photoelectric pulse wave sensor or an impedance pulse wave sensor.

[0130] The wearable system described in

[0115] above, wherein the first skin temperature sensor includes a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.

[0131] The wearable system described in

[0115] above, wherein the second skin temperature sensor includes a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.

[0132] The wearable system described in

[0115] above, wherein the first blood volume sensor is further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[0133] The wearable system described in

[0115] above, wherein the second blood volume sensor is further configured to measure one or more of heart rate, heart rate variability, or oxygen saturation.

[0134] A wearable system as described in

[0115] above, wherein at least one of the first target temperature or the second target temperature is individualized for the user.

[0135] The wearable system described in

[0115] above, wherein the determination of the stroke event is further based on stored normative data corresponding to healthy individuals. 1. A wearable system for detecting a stroke event in a human, comprising: A first wearable device configured to contact a first skin surface of the person and further configured to be secured to a left limb of the person, a first stimulus source in communication with the first skin surface, the first stimulus source configured to apply a first stimulus to the first skin surface; a first wearable device comprising: a first sensor configured to measure a first response at a first tissue site proximate to the first skin surface; a second wearable device configured to contact a second skin surface of the person and further configured to be secured to a right limb of the person, a second stimulus source in communication with the second skin surface, the second stimulus source configured to apply a second stimulus to the second skin surface; a second sensor configured to measure a second response at a second tissue site proximate to the second skin surface; and One or more hardware processors, commencing the application of the first stimulus at a first time by outputting a first stimulus signal to the first stimulus source; receiving the first response following the application of the first stimulus; commencing the application of the second stimulus at a second time by outputting a second stimulus signal to the second stimulus source. receiving the second response following the application of the second stimulus. and one or more hardware processors configured to determine a stroke event based on the first response and the second response. 137. A method for detecting a stroke event in a human, comprising: fastening a first wearable device to a left limb of the person, the first wearable device being configured to contact a first skin surface of the person and including a first stimulus source and a first sensor; securing a second wearable device configured to contact a second skin surface of the person and including a second stimulus source and a second sensor to a right limb of the person; commencing the application of the first stimulus at a first time by outputting a first stimulus signal to the first stimulus source; receiving a first response measured by the first sensor after the application of the first stimulus; commencing the application of the second stimulus at a second time by outputting a second stimulus signal to the second stimulus source; receiving a second response measured by the second sensor after the application of the second stimulus; determining a stroke event based on the first response and the second response.

Claims

1. 1. A wearable system for detecting abnormal biological events in a human, comprising: a main body having a second surface that contacts a surface of human skin and a first surface located opposite the second surface; a heat source in communication with the skin surface, the heat source configured to heat the skin surface to a target temperature; a skin temperature sensor disposed on the second surface and configured to measure a temperature of the skin surface in contact with the heat source; a sensor disposed on the second surface and configured to measure a parameter of interest in the person; a hardware processor communicatively coupled to the heat source, the sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure an environmental temperature surrounding the wearable system, receiving a baseline sensor signal from the sensor; outputting a heating signal to the heat source to initiate a heating cycle for heating the skin surface to the target temperature; receiving a second sensor signal from the sensor in response to the skin surface reaching the target temperature; comparing the second sensor signal to the baseline sensor signal; and a hardware processor configured to determine whether an abnormal biological event is occurring based on the comparison.

2. The wearable system of claim 1 , wherein the sensor is selected from the group consisting of a stretch sensor, an electrodermal activity sensor, an electrocardiogram sensor, a camera, or a blood content sensor.

3. 10. The wearable system of claim 1, wherein the parameters of interest include one or more of blood pressure, heart rate, heart rate variability, gaze, facial expression, skin conductance response, vasodilation response, or dilation response.

4. 1. A wearable system for detecting abnormal biological events in a human, comprising: a main body having a second surface that contacts a surface of human skin and a first surface located opposite the second surface; a stimulation source in communication with the skin surface and configured to apply a stimulation to the skin surface; a blood content sensor disposed on the second surface and configured to measure blood content at the skin surface; a hardware processor communicatively coupled to the stimulus source and the blood content sensor, receiving a baseline blood content signal from the blood content sensor; initiating a stimulation cycle by outputting a stimulation signal to the stimulation source; receiving a second blood content signal from the blood content sensor in response to the initiation of the stimulation cycle; comparing the second blood volume signal to the baseline blood volume signal; and a hardware processor configured to determine whether an abnormal biological event is occurring based on the comparison.

5. The wearable system of claim 4 , wherein the stimulus source includes a heating source.

6. The wearable system of claim 4 , wherein the stimulus source includes a power source.

7. The wearable system of claim 4 , wherein the comparison comprises determining a change in a vasodilatory response.

8. The wearable system of claim 4 , wherein the stimulation source includes a Peltier cooler.

9. 5. The wearable system of claim 4, wherein the second blood volume signal comprises a set of blood volume signals such that the blood volume at the skin surface is repeatedly measured before, during, and after the stimulation cycle.

10. 5. The wearable system of claim 4, wherein the second blood volume signal comprises a plurality of blood volume signals such that the blood volume at the skin surface is continuously measured before, during, and after the stimulation cycle.

11. 5. The wearable system of claim 4, wherein the hardware processor is further configured to receive the second blood volume signal after a target stimulation is reached, or after a predetermined amount of time has elapsed, or after one or more stimulation cycles have ended.

12. 5. The wearable system of claim 4, wherein the comparison includes calculating a baseline ratio of alternating current (AC) to direct current (DC) for the baseline blood volume signal and a second ratio of AC to DC for the second blood volume signal, and comparing the baseline ratio to the second ratio.

13. 1. A system for detecting a stroke event in a human, comprising: A first device configured to monitor a first skin surface of the person and configured to track a left side of the person, a first thermal stimulus source in thermal communication with the first skin surface, the first thermal stimulus source including a first surface area extending over a first body surface of the first device, the first body surface configured to contact the first skin surface; a first device configured to measure a first temperature of the first skin surface and comprising: a first skin temperature sensor disposed within a first opening surrounded by the first surface area; a second device configured to monitor a second skin surface of the person and configured to track a right side of the person, a second thermal stimulus source in thermal communication with the second skin surface, the second thermal stimulus source including a second surface area extending over a second body surface of the second device, the second body surface configured to contact the second skin surface; a second device configured to measure a second temperature of the second skin surface and comprising: a second skin temperature sensor disposed within a second opening surrounded by the second surface area; communicatively coupled to the first and second devices; receiving a first baseline temperature signal from the first skin temperature sensor; receiving a second baseline temperature signal from the second skin temperature sensor; outputting a first thermal stimulus signal to the first thermal stimulus source to initiate a first cycle at a first time during a first period of time; receiving a first temperature response of the first skin surface in response to the first thermal stimulation signal, the first temperature response being measured by the first skin temperature sensor; outputting a second thermal stimulus signal to the second thermal stimulus source to initiate a second cycle at a second time in a second period, where the first time is synchronized with the second time. receiving a second temperature response of the second skin surface responsive to the second thermal stimulation signal, the second temperature response being measured by the second skin temperature sensor; comparing the first temperature response to the second temperature response to determine whether a difference between the first temperature response and the second temperature response indicates a temperature asymmetry between a left side of the person and a right side of the person; and one or more hardware processors configured to generate an alert indicative of a stroke event based on the determined indication of temperature asymmetry.

14. The system of claim 13 , wherein the first device further comprises a first electrodermal activity sensor and the second device further comprises a second electrodermal activity sensor.

15. 14. The system of claim 13, wherein the first device further comprises a first blood content sensor configured to measure a first blood content at a first tissue site proximate to the first skin surface, and the second device further comprises a second blood content sensor configured to measure a second blood content at a second tissue site proximate to the second skin surface.

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