Patent Grant
11504020
This disclosure relates generally to the field of disease detection and, more specifically, to stroke detection.
A stroke results from the death of brain tissue due to disruptions of blood flow to the brain. An ischemic stroke happens when there is a blockage of blood flow to the brain, usually as the result of a blood clot. Hemorrhagic stroke happens when there is a rupture of a blood vessel in the brain, resulting in bleeding into the brain tissue and surrounding space.
There are many physiologic symptoms of stroke onset that vary depending on the location of the affected tissue. Early symptoms of an evolving stroke may be able to reduce or even resolve if the interruption of blood flow is resolved quickly, before the tissue has died. One category of symptoms is disrupted vision, including blurred, dimming often likened to a curtain falling) or even complete loss of vision. Stroke patients often also experience eye deviation or difficult with eye tracking.
Just as a stroke can affect the part of the brain that is associated with sight, it can also affect the parts of the brain that have to do with speech, comprehension and communication. Patients suffering from a stroke may exhibit slurred speech or garbled speech that renders them incomprehensible.
Another common symptom of stroke is weakness on one side of the body. This can manifest or partial or total paralysis of the side of the face, one arm, one leg, or the entire side of one's body.
Ischemic stroke is the most common type of stroke and is often painless when experienced, but hemorrhagic strokes are very painful, often being described as sudden onset of “the worst headache of one's life”. Often, many people's headaches are accompanied with a feeling of dizziness, nausea, and vomiting. Smell and taste can also be impacted during the onset of a stroke.
Anything that affects the brain, from trauma to stroke, has the potential for cognitive disablement. A feeling of confusion, or a constant second-guessing of ones' actions, can sometimes appear days before a stroke occurs.
Another common symptom of a stroke is the sudden onset of fatigue.
Stroke symptoms can vary in duration and occur with or without pain, which can make stroke detection difficult. Further, strokes can occur during sleep, making detection even more difficult. If a stroke does occur while the person is sleeping, it may not wake a person up right away. As a result, when patients wake up symptomatic, it is unclear whether the stroke just started or whether it has already been occurring during sleep.
If a stroke is detected and patients seek care quickly, there are many evidence-based interventions that can dramatically reduce the death and disability resultant from the disease. In severe ischemic strokes, every minute of delay to flow restoration is equated to the loss of a week of Disability Adjusted Life Years (DALYs). Despite these treatments being available, fewer than 20% of patients receive them. Even among patients that do receive intervention, outcomes are often suboptimal because of the delays to intervention. Stroke detection is difficult because stroke frequently doesn't hurt, mimics other health events, and is heterogeneous in its presentation. Improvements in detection of and care-seeking for stroke onset could dramatically reduce the death and disability associated with the disease.
Like stroke, COVID-19 is proving to have heterogeneous symptoms, many of which resemble those of neurologic disorders. Recent publications have shown early evidence of encephalopathies, inflammatory CNS syndromes, ischemic strokes, and peripheral neurological disorders in patients being treated for COVID-19. (Zubair, JAMA Neurology, 2020) With most COVID-19 patients being managed remotely, and a significant percentage of inpatients requiring invasive ventilation, monitoring for the obvious symptoms of neurological disruption may be difficult. As such, improvements in remote monitoring and care for COVID-19 patients could dramatically reduce the death and disability associated with the disease.
One aspect of the present disclosure is directed to a wearable system for detecting an anomalous biologic event in a person. The system includes a body having a first surface opposite a second surface in contact with a skin surface of a person; a thermal stimulus source such as a heat source or a Peltier cooler in communication with the skin surface, such that the heat source is configured to heat the skin surface to a target temperature; a skin temperature sensor positioned on the second surface and configured to measure a temperature of the skin surface in contact with the heat source; a blood volume sensor positioned on the second surface and configured to measure a blood volume of the skin surface; and a hardware processor communicatively coupled to the heat source, the blood volume sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure a temperature of the environment around the wearable system. The hardware processor is configured to: receive a baseline blood volume signal from the blood volume sensor, output a heating signal to the heat source to initiate a heating cycle, such that the heating cycle comprises heating the skin surface to the target temperature, 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 anomalous biologic event has occurred based on the comparison.
In some embodiments, the second blood volume signal includes a set of blood volume signals, such that the blood volume of the skin surface is measured repeatedly before, during, and after a heating cycle of the heat source. In some embodiments, the second blood volume signal includes a plurality of blood volume signals, such that the blood volume of the skin surface is measured continuously before, during, and after a heating cycle of the heat source.
In some embodiments, hardware processor is further configured to receive the second blood volume signal after the target temperature is reached, after a predetermined length of time has expired, or after one or more heating cycles have concluded.
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.
In some embodiments, the environmental temperature sensor is positioned on the first side of the body of the wearable system.
In some embodiments, the system further includes a remote computing device communicative coupled to the wearable system and comprising the environmental temperature sensor. In some embodiments, the remote computing device includes one of: a laptop, cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.
In some embodiments, the heat source is positioned on the second surface of the body.
In some embodiments, the hardware processor is further configured to receive baseline temperature signals from the skin temperature sensor and the environmental temperature sensor, determine the target temperature based on the baseline temperature signals, and determine whether the target temperature is below a maximum temperature value.
In some embodiments, the hardware processor is further configured to cycle the heat source to maintain the target temperature.
In some embodiments, the system further includes one or more electrodermal activity sensors positioned on the second surface.
In some embodiments, the one or more electrodermal activity sensors are spaced apart from the heating element by about 0.25 inches to about 4 inches.
In some embodiments, the system further includes one or more motion sensors configured to measure a motion of a body portion to which the wearable system is coupled.
In some embodiments, the first and second surfaces define a cavity therebetween to provide airflow between the first and second surfaces.
In some embodiments, the hardware processor resides on or within the first surface.
In some embodiments, the cavity defined by the first and second surfaces physically separates the heat source from the hardware processor on or within the first surface.
In some embodiments, the cavity defined by the first and second surfaces has sufficient volume to facilitate cooling of the heat source in between heating cycles.
In some embodiments, the anomalous biologic event comprises a stroke event.
In some embodiments, the wearable system is positioned on a left limb of a user and a second wearable system is positioned on a right limb of the user, wherein the second wearable system comprises a second heating element, a second skin temperature sensor, and a second blood volume sensor, wherein the hardware processor is further configured to compare right side blood volume signals to left side blood volume signals to determine whether the anomalous biologic event has occurred.
In some embodiments, the hardware processor is further configured to synchronize the signals received from the left limb and the right limb in time; and compare the synchronized signals from the left limb and the right limb to determine whether the anomalous biologic event occurred. In some embodiments, the comparison takes into account a baseline difference between the left limb and the right limb.
In some embodiments, the system further includes a tensionable band coupled to the body. In some embodiments, the tensionable band further includes a visual indicator to indicate when one or more of: the heating element, the skin temperature sensor, the blood volume sensor, or a combination thereof is sufficiently coupled to the skin surface to enable accurate sensor readings. In some embodiments, one or more ends of the tensionable band are coupled to the body at a position that is centered with respect to one or more sensors positioned on the second surface.
In some embodiments, the heat source is positioned concentrically about one or both of the blood volume sensor and the skin temperature sensor.
In some embodiments, the blood volume sensor comprises a photoplethysmography sensor or an impedance plethysmographic sensor.
In some embodiments, the skin temperature sensor comprises a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor.
In some embodiments, the system further includes a support structure coupled to the heat source and configured to couple the heat source to the second surface and at least partially expose the heat source to the cavity.
In some embodiments, the blood volume sensor is further configured to measure one or more of: heart rate, heart rate variability, or oxygen saturation.
In some embodiments, the target temperature is individualized to the user. In some embodiments, individualization of the target temperature includes receiving a user input related to perceived temperature of the skin surface. In some embodiments, individualization of the target temperature is based on signals received from the blood volume sensor.
In some embodiments, the heat source comprises one of: a heating element or an environmental temperature.
Another aspect of the present invention is directed to a wearable system for detecting an anomalous biologic event in a person. The system includes a body having a first surface opposite a second surface in contact with a skin surface of a person, the first and second surfaces defining a cavity therebetween to provide airflow between the first and second surfaces; a heating element positioned on the second surface and configured to heat the skin surface for a predetermined length of time; a skin temperature sensor positioned on the second surface and configured to measure a temperature of the skin surface in contact with the heating element; a blood volume sensor positioned on the second surface and configured to measure a blood volume of the skin surface; and a hardware processor communicatively coupled to the heating element, the blood volume sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure a temperature of the environment around the wearable system.
The hardware processor is configured to receive a baseline blood volume signal from the blood volume sensor, output a heating signal to the heating element to initiate a heating cycle, such that the heating cycle comprises heating the skin surface to a target temperature, 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 anomalous biologic event has occurred based on the comparison.
Another aspect of the present invention is directed to a wearable system for detecting an anomalous biologic event in a person. The system includes a body having a first surface opposite a second surface in contact with a skin surface of a person; a heat source in communication with the skin surface, such that the heat source is configured to heat the skin surface to a target temperature; a skin temperature sensor positioned on the second surface and configured to measure a temperature of the skin surface in contact with the heat source; a sensor positioned on the second surface and configured to measure a parameter of interest of the person; and a hardware processor communicatively coupled to the heat source, the sensor, the skin temperature sensor, and an environmental temperature sensor configured to measure a temperature of the environment around the wearable system.
The hardware processor is configured to receive a baseline sensor signal from the sensor, output a heating signal to the heat source to initiate a heating cycle, wherein the heating cycle comprises heating the skin surface to the target temperature, 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 anomalous biologic event has occurred based on the comparison.
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 volume sensor.
In some embodiments, the parameter of interest includes one or more of a blood pressure, a heart rate, a heart rate variability, a gaze, a facial expression, a skin conductance response, a vasodilation response, or a dilation response.
The foregoing is a summary, and thus, necessarily limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology are described below in connection with various embodiments, with reference made to the accompanying drawings.
The illustrated embodiments are merely examples and are not intended to limit the disclosure. The schematics are drawn to illustrate features and concepts and are not necessarily drawn to scale.
The foregoing is a summary, and thus, necessarily limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology will now be described in connection with various embodiments. The inclusion of the following embodiments is not intended to limit the disclosure to these embodiments, but rather to enable any person skilled in the art to make and use the contemplated invention(s). Other embodiments may be utilized, and modifications may be made without departing from the spirit or scope of the subject matter presented herein. Aspects of the disclosure, as described and illustrated herein, can be arranged, combined, modified, and designed in a variety of different formulations, all of which are explicitly contemplated and form part of this disclosure.
Described herein are systems, devices, and methods for multivariate detection of stroke. Multivariate may include using more than one, at least two, or a plurality of factors, markers, or other parameters to detect stroke. In some embodiments, multivariate may include using one parameter measured at multiple locations or positions or at multiple times (e.g., random or fixed intervals, on demand, automatically, etc.). In various embodiments, multivariate may include detecting a measured parameter symmetrically or asymmetrically. The measured parameter may include a functional parameter (e.g., gait, speech, facial changes, etc.); a biological parameter or marker (e.g., blood proteins, metabolites, etc.); a quantitative parameter (e.g., limb asymmetry, heart rate variability, etc.); a spatial (e.g., neck vs. chest; arm vs. leg; etc.) difference in one or multiple (e.g., 2, 3, 4, 5, 10, 15, 20, etc.) measured parameters; and/or a temporal difference in one or multiple measured parameters.
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 anomaly, hyperhydrosis, cutaneous blood flow, brain perfusion, heartrate variability, etc.), and/or clinical manifestations or functional parameters (e.g., limb asymmetry, speech slur, facial droop, retinal abnormality, etc.). Clinical manifestations occur following stroke onset, but a faint signal from a clinical manifestation measurement combined with a physiological signal measurement may detect or predict stroke likelihood prior to stroke onset. Parameters that may be measured before, during, or after a stroke include quantitative parameters, functional parameters, and/or blood/fluid parameters. Any of the parameters shown/described herein may be measured asymmetrically, as described elsewhere herein. Exemplary, non-limiting examples of quantitative parameters include: volumetric impedance spectroscopy, EEG asymmetry, brain perfusion, skin/body temperature (e.g., cold paretic limb, up to 6° C. colder or 16% colder than non-paretic limb), hyperhidrosis (e.g., greater than 40-60% increase on paretic limb), limb asymmetry, drift and pronation test, cutaneous blood flow, muscle tone, heartrate variability (e.g., decrease in spectral components by greater than 10×, lasting 3-7 days after stroke onset), facial surface EMG, cerebral blood flow (CBF), carotid artery stenosis, salivary cortisol, neuron specific enolase (NSE), salivary (NSE), etc. Exemplary, non-limiting examples of functional parameters include: speech changes, speech comprehension, text comprehension, consciousness, coordination/directions, facial muscle weakness, arm weakness, body weakness (e.g., grip), leg weakness, foot weakness, unilateral weakness, difficulty walking, vertigo, sudden vision problems, limited visual field, altered gaze, thunderclap headache, nuchal rigidity (nape of neck), respiration, blood pressure (e.g., increase up to 60% in both systole (200 mHg) and diastole (140 mmHg)), etc. Exemplary, non-limiting examples of blood/fluid parameters include: CoaguCheck (Roche), HemoChron (ITC), iSTAT (Abbott), Cornell University, ReST (Valtari Bio Inc.), SMARTChip (sarissa Biomedical), etc.
In some embodiments, multiple measurement locations (e.g., radial, brachial, etc. vessels) may be used to measure a difference in signal or data pattern among those locations compared to nominal, healthy location measurements or compared to an individual baseline as an input into a data processing module. For example, an individual baseline may be recorded overtime and, when an adverse event occurs, a change (e.g., absolute or relative value) from baseline is determined unilaterally or bilaterally. In some embodiments, after the adverse event occurs, a new baseline may be established. Further for example, as shown in
In some embodiments, as shown in
In one exemplary, non-limiting embodiment of the system of
In some embodiments, a system for multivariate stroke detection may further include an application downloaded and/or stored on a hardware component or downloaded and/or stored on a computing device (e.g., mobile computing device) communicatively coupled to the hardware component. The application may be configured to process sensor data, camera data, speech data, etc. and/or display data sensed or captured in real time, for example in a graphical representation, and/or allow zooming to view various features of the data.
In some embodiments, data may be transmitted to and/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., a nearfield communications (NFC) protocol, a low energy Bluetooth® protocol, other radiofrequency (RF) communication protocol, etc.) between sensor locations on the body and/or a central hub. In other embodiments, data transmission may include wire communication between sensor locations on the body and/or a central hub. In some embodiments, the central hub may be a monitor in a medical facility, home monitor, patients' mobile computing device, or other wireless device. Alternatively, one or more of the sensors on the body may act as the central hub. The hub device may wirelessly send signals to activate a medical care pathway and/or notify one or more individuals (e.g., family, friends, physician, EMS, etc.).
In some embodiments, data transmission, following multivariate analysis, to the central hub may alert the patient, the next of kin, and/or a third party to identify possible false positives or negatives.
In some embodiments, a device for stroke detection may be worn on an exterior or skin surface of the patient or implanted as hardware prior to and/or during stroke, including up to days before the event and during the event to provide continuous variable monitoring of various physiological parameters. The various embodiments described herein may either be a wearable device or an implantable device.
In some embodiments, a device for detecting stroke may include a wearable device, for example a patch, headband or sweatband, ring, watch (e.g., to measure movement as shown in
In some embodiments, a wearable device for detecting stroke may comprise a wearable array of indicators (e.g., chromogenic indicators) configured to measure a chemical, analyte, protein, etc. in a bodily fluid of an individual (e.g., blood, interstitial fluid, etc.). For example, the array may comprise a membrane with a printed array thereon that when exposed to one or more analytes, a subset of the indicator spots responds by changing color or properties. The color response of the indicators may be optically read, for example using a camera on a computing device or other image sensor and compared to a baseline reading or a reference or standard. A color difference map may be generated by superimposing and/or subtracting the two images (baseline and experimental or experimental and reference/standard). As an exemplary, non-limiting analyte, an increase in nitric oxide may be detected in blood or interstitial fluid of an individual after a stroke event and/or modification of one or more proteins by nitric oxide may be detected in blood or interstitial fluid of an individual after a stroke event and/or one or more intermediates or byproducts of nitric oxide may be detected in blood or interstitial fluid of an individual after a stroke event. For example, nitric oxide has been shown to modify proteins via: 1) binding to metal centers; 2) nitrosylation of thiol and amine groups; 3) nitration of tyrosine, tryptophan, amine, carboxylic acid, and phenylalanine groups; and 4) oxidation of thiols (both cysteine and methionine residues) and tyrosine. Such methods may bypass the need to measure an asymmetrical change in one or more parameters, as described elsewhere herein.
In some embodiments, a system for stroke detection may include one or more Doppler radar sensors, microphones, and cameras throughout a home to detect visual signs of stroke, equivalent to a “FAST” test using computer vision or similar techniques, as shown in
In some embodiments, a device for detecting stroke may include a device positionable in a room, office, home, vehicle, or other location; or in or on a bed or other furniture (e.g., bedside monitors; monitors within mattresses, bedding, etc.). For example, a smart speaker (e.g., to prompt a user to respond to a question to analyze speech quality), microphone, camera, and/or mirror may be positionable in a location to detect changes in a user's speech, activities, movement, gait, facial appearance, heart rate, and/or heart rate variability. The device may comprise a data processing module to differentiate changes in the measured parameters as compared to that from healthy learned patient data or individualized baseline data. This can be also be referred to as reference data. The healthy learned patient data may be unique to a particular user or an aggregate value that is predetermined from previous studies. The healthy learned patient data or individualized patient data can be stored as a one or more parameters or a signature.
In some embodiments, as shown in
In some embodiments, the ring may incorporate a stretchable or expandable element or stretch sensor to allow the ring to expand or stretch when the finger swells. This element may include, but is not limited to, elastomer film polymers of various degree of bonding to allow for different pliable elements or measuring the reflectivity of polarized light. This element may comprise a plastic segment of the ring that can be loosened/tightened, or by building a slidable element that can be pulled apart. Non-limiting examples of a stretch sensor include, but are not limited to, a strain gauge or an electrical component configured to change inductance, resistance, or capacitance when stretched.
In some embodiments, the device may be a strip that measures brain waves through electroencephalogram (EEG) and/or muscle contractions through surface electromyography (sEMG). The measurement of EEG may be compared to a baseline value to detect a change or asymmetry of the EEG. In some embodiments, EMG measures facial muscle changes compared to a baseline measurement to identify muscle weakness and tone.
In some embodiments, as shown in
In some embodiments, as shown in
In some embodiments, a device for detecting stroke may be configured to detect asymmetrical responses, outputs, or signals. For example, one or more devices (e.g., ring, watch, etc.) described herein may be used to measure symmetrical and asymmetrical limb movement.
In some embodiments, as shown in
As discussed above, if a stroke is detected and patients seek care quickly, it can dramatically reduce death and disability. Continuous monitoring for a stroke event may improve the response time. However, continuous monitoring of anomalous biologic events such as stroke events using existing monitors can be challenging. These monitors are cumbersome and may be difficult for users to wear over an extended period of time. In contrast, the inventors realized that wearable devices, such as watches with integrated sensors and electronics may improve continuous monitoring of stroke events. An impaired vasodilation response may be indicative of a stroke, heart failure, hypertension, diabetes, menopause, or other conditions.
Applying heat stress to a portion of the skin may enable detection of vasodilation response. Accordingly, systems and methods described below enable detection of impaired vasodilation in a form factor that improves continuous anomalous cardiac event monitoring. In some embodiments, as shown in
In one example, a system or device 400 for detecting an anomalous biologic event may include a body 416 having a first surface 404 opposite a second surface 404 in contact with a skin surface of a person. The first 404 and second 404 surfaces may be coupled via one or more or a plurality of sidewalls 405. For example, one or more sidewalls 405 may extend from a perimeter of the first surface 404 and couple to a perimeter of the second surface 402. The first 404 and/or second 402 surface may include one or more sensors positioned thereon. For example, one or more sensors on the first surface 404 may measure an environment of the user wearing or using the wearable system, and one or more sensors on the second surface 402 may measure one or more properties, features, or characteristics of the skin surface of the user and thus the user itself. Alternatively, the first surface 404 may include one or more sensors or imagers or cameras for assessing a facial region of a user, for example, via a FAST test.
A wearable device 400 may be secured to a user, for example a limb of a user or a skin surface of a user, via a coupling element 408, for example a tensionable band, which will be described in greater detail elsewhere herein. The coupling element 408 may be adjustable such that the wearable device may be cinched or tensioned to promote greater contact and thus coupling between the wearable device and the skin surface or tension released to reduce contact or coupling between the wearable device and the skin surface. As shown in
A wearable device 400 may include a heat source 410 in communication with the skin surface. The heat source 410 is configured to heat the skin surface to a target temperature or a pre-determined temperature. The heat source 410 may be a heating element; an environmental heat source, for example a warm room, warm environment (e.g., under the covers, hot day, etc.); thin film resistance flexible heater; polyimide heater; etc. In some embodiments, a heat source 410 is positioned on a second surface 402 of the body 416, so that there is coupling or contact between the heat source 410 and a skin surface. Alternatively, a heat source 610 or one or more sensors 612, 626 may be positioned on a coupling element 608 of the system 600, as shown in
In some embodiments, as shown in
In a still further embodiment, the sensor module 809 may be positionable in an in-ear device (e.g., ear lobe clip, ear bud, hearing aid, etc.), as shown in
Further, the heat source 410 may be communicatively coupled to a hardware processor such that the hardware processor outputs a heating signal to the heat source 410 to activate the heat source to initiate a heating cycle. For example, a heating cycle may include receiving baseline temperature signals from a skin temperature sensor and an environmental temperature sensor, determining the target temperature based on the baseline temperature signals, and determining whether the target temperature is below a maximum temperature value.
In some embodiments, a target temperature may be equal to a baseline skin temperature as measured by the skin temperature sensor plus about 1 to about 20 degrees, for example about 1 to about 5 degrees, about 1 to about 10 degrees, about 5 to about 10 degrees, about 5 to about 15 degrees, about 8 to about 12 degrees, etc. In one embodiment, the target temperature is equal to the baseline skin temperature as measured by the skin temperature sensor plus about 5 to about 15 degrees. In another embodiment, the target temperature is equal to the baseline skin temperature as measured by the skin temperature sensor plus about 7 to about 13 degrees. In another embodiment, the target temperature is equal to the baseline skin temperature as measured by the skin temperature sensor plus about 10 degrees. If the target temperature is greater than a maximum temperature value, the system pauses or delays until the baseline skin temperature drops below a minimum threshold or recalculates the target temperature so that it is less than the maximum temperature value. If the target temperature is less than a maximum temperature sensor, the system proceeds to activate the heat source to heat the skin surface to the target temperature.
In some embodiments, the heat source cycles between the target temperature and a deactivated or off state or between the target temperature and a temperature that is lower than the target temperature but greater than the skin baseline temperature, for example to maintain the target temperature, hereinafter referred to as a dwell time.
In some embodiments, a duration of a heating cycle and a target temperature are interconnected and based on user preference or user perception of heat on the skin surface or a vasodilation response of the user. For example, a higher target temperature may be used for a shorter time period or a lower target temperature may be used for a longer time period.
Further, the system or device 400 may be configured to receive one or more user inputs related to a perceived heat sensation on the skin surface and/or to a sensitivity of a vasodilation response of the user. For example, a user may input that the target temperature felt too hot or too cold, for example via a user input element (e.g., button), such that the system responds by reducing the target temperature but elongating an amount of time that the skin is heated. Additionally, or alternatively, based on user preference, preset configurations (e.g., during manufacturing), or as a result of sensed data (e.g., based on sensor data), the heat source may reach the target temperature via one of a plurality of ramping functions, for example slow ramping, larger step functions, etc. Alternatively, the heat source may reach the target temperature through a plurality of micro-stimulations. Further, for example, a target temperature may be individualized for the user based on the sensitivity of the vasodilation response of the user.
In some embodiments, a device or system 400 for detecting an anomalous biologic event 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
In some embodiments, support structure 428 exerts pressure on the heat source 410 to increase contact or coupling between the heat source 410 and the skin surface. In one embodiment, the tensionable band includes a strain gauge that determines the tensile stress the band is subjected to. The strain gauge output or signal could then be visualized or displayed to a user so the user knows if the band is tensioned to an appropriate level for the heat source and/or sensor(s). Alternatively, a spring constant (k) of the material may be used to calculate the force (F=kx), so depending on how much the material is stretched (put in tension), the band could indicate that force based on the displacement. As such, the support structure 428 may comprise a flexible material, for example a flexible plastic. In other embodiments, the support structure 428 comprises a rigid material.
Further, as shown in
A system or device 400 for detection of an anomalous biologic event may include an environmental temperature sensor configured to measure a temperature of the environment around the wearable system 400. For example, the environmental temperature sensor may be positioned on the first side 404 of the body 416 of the wearable system, opposite the second side 402 that includes the heat 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.
The skin temperature sensor and/or environmental temperature sensor may include a thermocouple, a resistance temperature detector, a thermistor, or an infrared temperature sensor. The type of temperature sensor selected may depend on error rate, coupling to skin surface efficiency, among other features.
In some embodiments, the heat source 410 is positioned concentrically about one or both of the blood volume sensor 412 and the skin temperature sensor 414, as shown in
A hardware processor (within the wearable system or communicatively coupled to the wearable system) communicatively coupled to the skin temperature sensor 414 and the environmental temperature sensor may be configured to perform a method comprising: receiving a first temperature signal using the skin temperature sensor and a second temperature signal using the environmental temperature sensor; and calculating a temperature differential between the skin temperature and the environment temperature. For example, if the temperature differential is below a set threshold, a difference between the target temperature and the maximum temperature value may be increased. In contrast, if the temperature differential is above a set threshold, a difference between the target temperature and the maximum temperature value may be reduced. The environmental temperature sensor may also be used in analysis of determining erroneous results, such as false positive indications of abnormalities. By comparing signals before and after stimulus and/or by comparing left versus right limb, externalities such ambient temperature response may be reduced in the analysis of abnormalities.
Further, the hardware processor may be coupled to the heat source 410 and the blood volume sensor 412. In some instances, the system 400 describe above can enable non-invasive monitoring of vasodilation and/or vasoconstriction. Human body regulates stable equilibrium through the process of homeostasis. For example, if a stimulus is applied to a body of patient, one or more homeostatic processes will attempt to counteract the effect of stimulus. For example, with respect to an induced thermal stimulus that increases or decreases temperature at a tissue site, the body will attempt to reverse the temperature change through blood flow (vasodilation or vasocontraction). Accordingly, the system 400 can induce and measure the vasodilatory response. As discussed above, stroke and other abnormalities can impair the vasodilatory response. Therefore, in some instances, it may be advantageous to monitor the change in the vasodilatory response to determine abnormalities, such as stroke. A blood volume sensor, such as optical sensors, can enable monitoring of the blood flow and correspondingly the vasodilatory response. In some instances, one or more temperature sensors (through a thermistor or optical radiation-based detectors) can also enable determination of the vasodilatory response by monitoring how quickly the temperature of the skin returns to equilibrium following the stimulus. In some examples, the vasodilatory response is correlated with a rate of change or slope in the measured parameter, such as blood volume parameters, temperature, and others discussed herein. In additional examples, the vasodilatory response can be correlated with a steepness of the rate of change. This can be calculated using a second derivative.
In some instances, it can be advantageous to use a combination of a heat source 410 and the blood volume sensor 412 to improve cardiac monitoring. The heat source 410 and the blood volume sensors 412 can be integrated into a form factor that a user can wear for continuous monitoring. The measurements can be repeated non-invasively without significant discomfort to the patients. Furthermore, as shown in
Furthermore, in some instances, the stimulus can be an electrical stimulus in addition to or instead of the thermal stimulus. For example, the system 400 may include a plurality of electrodes for inducing and/or measuring electrical activity across a tissue site. Electrical activity can include bioimpedance for detecting 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 measurement of bioimpedance. These four electrodes may positioned on the second surface 402. The electrodes may also be positioned on the strap 408 or an external accessory that can attach the system 400. Bioimpedance can measure muscles both inter and trans cellularly which could be used to detect hemiparesis and could be used for both detection as well as rehabilitation. The EDA electrodes can also be mounted anywhere along the second surface facing the skin to the strap 408. Furthermore, the system 400 can also include six or more electrodes. The electrodes can be integrated on the system 400 such that they are in contact with the skin tissue of the user.
As discussed above, an optical sensors, such as the blood volume sensor 412, can interrogate a target tissue to determine parameters that correlate with the vasodilatory response. Other sensors can also be used to extract parameters for determination of the vasodilatory response. For example, the system 400 can use minimally invasive and/or invasive sensors to determine hemodynamic parameters, such as cardiac output, to provide an indication of the vasodilation response. The system 400 can also include on 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 that relate to hemodynamic function or measure electrical signaling of neural activity and its effect. Furthermore, the system 400 can include one or more ultrasound sensors to obtain hemodynamic parameters. Temperature sensors can also enable determination of the vasodilation response. Accordingly, the system 400 can include a combination of some or all of the sensors discussed above to extract one or more parameters that correlate with hemodynamic function or maintenance of homeostasis.
The following table illustrates example physiological phenomena and corresponding parameters that can be monitored:
Patients are often monitored in neuro ICU after a stroke. This can be expensive as a nurse needs to conduct periodic checks on the patient. Accordingly, the system 400 can enable improved monitoring without requiring the patient to be in the neuro ICU and/or without requiring a caregiver to conduct periodic checks. While the system 400 is described as a wearable system, in some examples, some or all of the components of the system 400 may be positioned in proximity to the user but not directly attached 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 the system 400 can be positioned in proximity to the user's hospital bed. For example, the thermal stimulus source can include a laser.
As such, the hardware processor may be configured to perform the method, as shown in
In some embodiments, the second blood volume signal is a set of blood volume signals, such that the blood volume of the skin surface is measured repeatedly before, during, and/or after a heating cycle of the heat source. The blood volume of the skin surface may be measured at a pre-set interval, for example every about 10 ms to about 1 sec, about 1 sec to about 5 sec, about 5 sec to about 10 sec, etc. Alternatively, the blood volume of the skin surface is measured randomly or only upon detection of a change in temperature of the skin surface or upon detection of a change in vasodilation by the blood volume sensor. A measurement frequency may be individualized for a user, for example if a vasodilation response of a user in response to heat is very sensitive, a reduced frequency of blood volume measurements may be needed. In contrast, if a vasodilation response of a user in response to heat is less sensitive, an increased frequency of blood volume measurements may be needed.
In some embodiments, the second blood volume signal is a plurality of blood volume signals, such that the blood volume of the skin surface is measured continuously before, during, and/or after a heating cycle of the heat source.
In some embodiments, block S5206 includes receiving the second blood volume signal after the target temperature is reached, after a predetermined length of time has expired, after a dwell time (i.e., cycling heat source on and off during a heat cycle or cycling heat source between target temperature and lower temperature during a heat cycle) has expired, or after one or more heating cycles have concluded. A frequency of sampling and/or sampling relative to a heat cycle (before, during, or after the heat cycle) may be based on a user's biology, such that the sampling is individualized.
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 and comparing the baseline ratio to the second ratio, as shown in
As discussed above, tracking a vasodilation response can be used in monitoring abnormalities, such as stroke. However, the vasodilation response in a user can be affected by several sources that are unrelated to the stroke or the abnormality that is being monitored. Accordingly, using the system 400 in only one tissue site may result in false positives. It was observed by the inventors that by monitoring multiple tissue sites, the monitoring results may more closely track the abnormalities and reduce erroneous results.
In some embodiments, as shown in
In some embodiments of block S4830, the one or more features include, but are not limited to, an amplitude or a systolic or diastolic wave, a waveform shape, a waveform complexity, a perfusion index (i.e., a relationship between the pulsatile (AC) and the non-pulsatile (DC) components of PPG signal), DC offset, a stiffness index (i.e., time between peaks of forward and backward waves along the vascular tree; h/ΔT, where h is a patient's height), a reflection index (i.e., a ratio between the heights of the backward and the forward waves; B/A×100), a notch position (i.e., position of the dichrotic notch; e.g., with vasoconstriction, the position moves toward the left into the systolic wave), a peak to peak phase shift, slope onset of temperature signal and/or blood volume signal, slope decay of temperature signal and/or blood volume signal, midpoint of rising slop of temperature signal and/or blood volume signal, a vasodilation response as an indicator of a collateral state of the brain and/or heart, etc.
In any of the embodiments described herein, a wearable system or device for detecting anomalous biologic events may include one or more electrodermal activity sensors positioned on the second surface and/or a tensionable band of the system. For example, as shown in
As shown in
In any of the embodiments described herein, a wearable system or device for detecting anomalous biologic events may include one or more motion sensors 436 configured to measure a motion of a body portion to which the wearable system is coupled, as shown in
The heat source of the wearable device or system 400 may be cooled in between heating cycles to ensure a return to baseline or substantially baseline of the vasodilation response of the skin surface in between heating cycles. As such, the heat source may be cooled by an airflow system (e.g., fan), a vacuum or vibrating mechanism configured to displace or pull or move environmental air across the heat source (e.g., solenoid and diaphragm, oscillating piezo element), etc. In one embodiment, as shown in
For example, in some embodiments, the cavity 406 defined by the first 404 and second 402 surfaces has sufficient volume to facilitate cooling of the heat source 410 in between heating cycles. Alternatively, or additionally, the cavity 406 may further include an airflow system, vacuum or vibrating mechanism, or other airflow mechanism to promote airflow through the cavity 406 to reduce a temperature or cool the heat source 410.
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 in the device. Additionally, or alternatively, port 420 electrically couples the wearable device to an external or remote computing device (e.g., laptop, desktop, server, workstation, etc.) to download data from the device or upload system parameters or install updates to the wearable device. The wearable device may further include one or more user input elements 418 to power on and off the device; to input user specific reactions, features, or characteristics, to customize an interface or functionality of the user device, etc.
In some embodiments, as shown in
Turning now to
Referring to
For example, as shown in
As shown in
In some embodiments of a device for detecting tremors or asymmetrical motion, the device may include a feedback mechanism (e.g., visual, haptic, or audio) when a threshold has been reached or surpassed or various comparison criteria have been met, for example when a current movement pattern matches a previously identified tremor pattern for the individual. In some embodiments, a mobile computing device communicatively coupled to a movement sensor or wearable device generates a vibration signal in the wearable device, sensor, and/or computing device if the comparison between the two signals exceeds a predefined threshold.
To determine which embodiments would be best for stroke detection, several factors may be considered: alert 911 capability; passive monitoring; detection when patient is alone; and detection when patient is sleeping. Additional factors may include, but not be limited to: fully mobile; patient specific algorithm; active patient engagement after a passive alert; detection for the cognitively impaired patient; detection for prior stroke patient; detection of all strokes including posterior; diagnose type of stroke; passive monitor that wakes the patient up; and commence stroke treatment. For example, if a possible stroke event is detected, a wearable system may initiate a tactile, auditory, and/or visual alert to determine whether the user is conscious, unconscious, experiencing other stroke symptoms, etc. If the patient does not respond in a predetermined time window, a caregiver, emergency services, physician, etc. may be alerted to the stroke event. The wearable system can be linked to a clinician computing system. The alert can be transmitted directly to the clinician computing system that may prompt a telemedicine assessments. The clinician may work up an NIH Stroke Score assessment in response to the alert and/or data received from the wearable system. In some instances, the wearable system can by itself or in conjunction with a personal computing system enable self-assessment by walking the person and/or available witnesses through a FAST (Facial drooping, Arm weakness, Speech difficulties and Time) assessment.
In some instances, the wearable system can transmit a signal to the user's home automation system or to at least one electronically enabled door lock to unlock at least one door and/or disable the user's home alarm system in response to an alert for the stroke event. The wearable system can also initiate transmission of a floor plan access pathway leading from an access point of entry to the location of the patient, in the home or facility where the user has had indicium of a potential stroke. The location of the patient can be determined based on a local area network or differential GPS. In some embodiments, a stroke detection device or system may trigger an audible alarm to alert a patient or caretaker, for example while sleeping, that a stroke event has occurred. The audible alarm can also enable emergency services to locate patient when they enter home. All of these measures can help to reduce the time it takes for the emergency services or caregivers to reach the patient.
The home automation system can also include smart displays and smart speakers. These smart displays and speakers can be used to convey information to emergency medical response personnel, such as the identification of which medications the patient should be taking and, if available, information about whether they are compliant with prescribed regimens. Information such as the identity of physicians, medical history, allergies, and the existence of medical care power of attorney or advance directives associated with the patient may also be conveyed.
Furthermore, when alerting emergency services or physicians, data including medical history may be transmitted directly to emergency services or physician computing systems, either directly from the wearable system or from a remote memory, initiated by a signal from the wearable system. In addition to alerts, the wearable system can also instruct a user to undertake or automatically activate certain stroke treatments. Stroke treatments can include inducing hypothermia to provide a neuro-protectant for the patient. The wearable system can trigger inhalation of cooling gases, activation of a cooling helmet, activation of an ultrasonic helmet to break up cloths, or ingestion or triggering administration of a drug patch or pill. The trigger can be instructions to the patient or medical responder, or automatic activation. In some instances, for Ischemic strokes, the wearable system can trigger mechanisms to increasing blood pressure and vasodilate blood vessels (through some of the mechanisms discussed above).
Treatments responsive to the detection of a potential stroke can be initiated by the patient if they are conscious and able, or by the medical response personnel via the home automation system. Patients in a particular high risk category may have previously been fitted with a wearable treatment device which can be activated automatically in response to a signal indicating the detection of a potential stroke, or activated by medical personnel following clinical examination which was initiated by an alert from the wearable system.
In some embodiments, a stroke detection device or system may trigger an audible alarm to alert a patient or caretaker, for example while sleeping, that a stroke event has occurred. The audible alarm can also enable emergency services to locate patient when they enter home.
In any of the embodiments described herein, a stroke detection device or system may record an onset of a stroke event and/or provide a “last known well” indicator to help inform treatment decisions.
In some embodiments, a system for detecting stroke includes a data processing module. The data processing module may be configured to extract a pattern. The pattern may suggest any ischemic or hemorrhagic episode very early, possibly imminently prior to an actual stroke event. In some embodiments, the pattern may be empirically determined, for example based on a population wide analysis, cohort analysis, and/or individual analysis of signals, which are analyzed for parameters and/or patterns indicative of stroke onset. In some embodiments, signal processing may employ signal processing tools, for example filtering, extracting, digitizing, data de-convolution, machine learning, and/or other methods known in the art. Specifically, the signal processing may use higher order statistics to ascertain hidden patterns in data. Use of higher order statistics, known as cumulants, and their Fourier spectra, often termed poly spectra, not only reveal the amplitude information in the higher order (such as those carried by power spectra or auto correlation) but may also include phase information. Phase information can reveal salient features of the data, otherwise unattainable from simple harmonic analysis. Another important feature of the polyspectra is the fact that they are blind to Gaussian processes. As a result, they can automatically handle Gaussians processes and thus improve signal to noise ratio, allowing novel detection. In some embodiments, a number of spectrums and their manipulations may be selected in order to identify hidden patterns in the sensed signals, for example BP(t), ECG(t) etc.
For example, as shown in
As shown in
As shown in
In some embodiments, the data processing module may use the continuously monitored or intermittently monitored physiological signals to differentiate changes from healthy “learned” or individualized baseline data. For example, the module may continuously learn the signals coming from an individual patient rather than using a statistical average taken from many patients. A custom reference signal may significantly improve minute changes in the physiological signals for an individual patient. In some embodiments, the physiological parameters may be processed as a function of time that includes the shape of the curve changes, including hidden harmonics, changes in higher order derivatives, etc.
The data processing module may employ various machine learning methods to identify patterns, extract patterns, identify parameters indicative of stroke onset, etc. Machine learning can be broadly defined as the application of any computer-enabled algorithm that can be applied against a data set to find a pattern in the data. A machine-learning algorithm is used to determine the relationship between a system's inputs and outputs using a learning data set that is representative of all the behavior found in the system. This learning can be supervised or unsupervised. For example, a simple neural network called a Multilayer Perceptron (MLP), as shown in
In some embodiments, a system for providing comprehensive stroke care comprises one or more of: educational resources tailored to the patient based on demographics, type of stroke, co-morbidities, medications, etc; management tools to assist with the dramatic changes in lifestyle, such as reminders (e.g., medications, rehabilitation appointments, etc.), collaborative care resources (e.g., for spouse, doctor, physical therapist, caretaker, etc.), activity tracking with continuous data collection via a wearable, fitness tracking and guided meditation, stroke risk level assessment, etc.; community with others as part of the first national stroke survivor network where stroke survivors can give and receive support and encouragement connecting both patients and caregivers, “check in” with others in your group to make sure they are making progress towards their goals and are doing well mentally, share stories and relate to others, receive telemedicine/rehab resources with a speech therapist or mental health counselor; patient rehab and monitoring, or other enabling technologies; set recovery goals and track progress, cognitive evaluation tools, etc.; stroke Detection to alert caretakers via call/message, communication tools for patients with aphasia, etc.
Various functional symptoms, quantitative markers, and blood/fluid products were scored for their ability to detect stroke. The scoring criteria were the following: should be grounded in scientific rationale, should be highly sensitive (>90%), should only have very few false positives (<10%), and stroke detection should be passive (automatic). Each of these parameters were scored from 0 to 5, except for passive detection which was scored on a scale of 0 (active detection) to 1 (passive detection). The score was then multiplied by a weight factor, shown in Table 1 below, and all the weighted factors summed to yield a total score.
As shown below in Tables 2 and 5, the functional symptoms with the highest total score were facial muscle weakness, unilateral weakness, limited visual field, gaze altered, and speech change. Of these functional symptoms, only facial muscle weakness, unilateral weakness, and speech change can be detected passively.
As shown in Tables 3 and 5, the quantitative markers with the highest total score were cerebral blood flow, EEG asymmetry, carotid artery stenosis, volumetric impedance spectroscopy, and limb asymmetry. Of these quantitative markers, all were considered to be detectable passively.
As shown in Tables 4 and 5, the products with the highest total score were Cornell University's products, SMARTChip, and ReST. Of these, none were considered to be passive detection.
Taken together, a multivariate system for stroke detection may include detecting one or more of cerebral blood flow, EEG asymmetry, carotid artery stenosis, volumetric impedance spectroscopy, limb asymmetry, facial muscle weakness, unilateral weakness, and speech change. In some embodiments, these various parameters may be measured at a variety of locations and/or times to determine stroke onset, occurrence, or after affects.
Symmetrical and asymmetrical acceleration and distance were measured using an Apple® Watch and displayed in a graphic representation (
For this example, the device was worn on a user's wrist. Any acceleration of the wrist was recoded and saved in the onboard database, including acceleration in x-, y- and z-axes. The computing device has a “sync” function that allows the data to be transferred to a computing device for analysis. Tables 6-8 show acceleration data, distance data, and calculated movement data (i.e., distance traveled), respectively, acquired using an Apple® Watch worn on each wrist of a user. Data values were recorded at various time points, as shown in
Taken together, a system for stroke detection may include detecting one or more of acceleration in x-, y- and/or z-axes; and/or distance in x-, y- and/or z-axes; and, in some embodiments, calculating a distance traveled (i.e., movement) to determine asymmetrical limb movement, gait, etc. possibly indicative of a stroke event.
The systems and methods of the preferred embodiment and variations thereof can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instruction. The instructions are preferably executed by computer-executable components preferably integrated with the system and one or more portions of the hardware processor on the device for detecting stroke and/or computing device. The computer-readable medium can be stored on any suitable computer-readable media such as RAMs, ROMs, flash memory, EEPROMs, optical devices (e.g., CD or DVD), hard drives, floppy drives, or any suitable device. The computer-executable component is preferably a general or application-specific hardware processor, but any suitable dedicated hardware or hardware/firmware combination can alternatively or additionally execute the instructions.
As used in the description and claims, the singular form “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 contemplated to include, a plurality of signals. At times, the claims and disclosure may include terms such as “a plurality,” “one or more,” or “at least one;” however, the absence of such terms is not intended to mean, and should not be interpreted to mean, that a plurality is not conceived.
The term “about” or “approximately,” when used before a numerical designation or range (e.g., to define a length or pressure), indicates approximations which may vary by (+) or (−) 5%, 1% or 0.1%. All numerical ranges provided herein are inclusive of the stated start and end numbers. The term “substantially” indicates mostly (i.e., greater than 50%) or essentially all of a device, substance, or composition.
As used herein, the term “comprising” or “comprises” is 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 of essential significance to the combination for the stated purpose. Thus, a system or method consisting essentially of the elements as defined herein would not exclude other materials, features, or steps that do not materially affect the basic and novel characteristic(s) of the claimed disclosure. “Consisting of” shall mean that the devices, systems, and methods include the recited elements and exclude anything more than a trivial or inconsequential element or step. Embodiments defined by each of these transitional terms are within the scope of this disclosure.
The examples and illustrations included herein show, by way of illustration and not of limitation, 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 this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
Example Embodiments
A wearable system for detecting an anomalous biologic event in a person, comprising one or more of the following:
The wearable system of any embodiment disclosed herein, wherein the second blood volume signal comprises a set of blood volume signals, such that the blood volume of the skin surface is measured repeatedly before, during, and after a heating cycle of the heat source.
The wearable system of any embodiment disclosed herein, wherein the second blood volume signal comprises a plurality of blood volume signals, such that the blood volume of the skin surface is measured continuously before, during, and after a heating cycle of the heat source.
The wearable system of any embodiment disclosed herein, wherein hardware processor is further configured to receive the second blood volume signal after the target temperature is reached, after a predetermined length of time has expired, or after one or more heating cycles have concluded.
The wearable system of any embodiment disclosed herein, wherein comparing comprises 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.
The wearable system of any embodiment disclosed herein, wherein the environmental temperature sensor is positioned on the first side of the body of the wearable system.
The wearable system of any embodiment disclosed herein, further comprising a remote computing device communicative coupled to the wearable system and comprising the environmental temperature sensor.
The wearable system of any embodiment disclosed herein, wherein the remote computing device comprises one of: a laptop, cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.
The wearable system of any embodiment disclosed herein, wherein the heat source is positioned on the second surface of the body.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to:
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to cycle the heat source to maintain the target temperature.
The wearable system of any embodiment disclosed herein, further comprising one or more electrodermal activity sensors positioned on the second surface.
The wearable system of any embodiment disclosed herein, wherein the one or more electrodermal activity sensors are spaced apart from the heating element by about 0.25 inches to about 4 inches.
The wearable system of any embodiment disclosed herein, further comprising one or more motion sensors configured to measure a motion of a body portion to which the wearable system is coupled.
The wearable system of any embodiment disclosed herein, wherein the first and second surfaces define a cavity therebetween to provide airflow between the first and second surfaces.
The wearable system of any embodiment disclosed herein, wherein the hardware processor resides on or within the first surface.
The wearable system of any embodiment disclosed herein, wherein the cavity defined by the first and second surfaces physically separates the heat source from the hardware processor on or within the first surface.
The wearable system of any embodiment disclosed herein, wherein the cavity defined by the first and second surfaces has sufficient volume to facilitate cooling of the heat source in between heating cycles.
The wearable system of any embodiment disclosed herein, wherein the anomalous biologic event comprises a stroke event.
The wearable system of any embodiment disclosed herein, wherein the wearable system is positioned on a left limb of a user and a second wearable system is positioned on a right limb of the user, wherein the second wearable system comprises a second heating element, a second skin temperature sensor, and a second blood volume sensor, wherein the hardware processor is further configured to compare right side blood volume signals to left side blood volume signals to determine whether the anomalous biologic event has occurred.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to:
The wearable system of any embodiment disclosed herein, wherein the comparison takes into account a baseline difference between the left limb and the right limb.
The wearable system of any embodiment disclosed herein, further comprising a tensionable band coupled to the body.
The wearable system of any embodiment disclosed herein, wherein the tensionable band further comprises a visual indicator to indicate when one or more of: the heating element, the skin temperature sensor, the blood volume sensor, or a combination thereof is sufficiently coupled to the skin surface to enable accurate sensor readings.
The wearable system of any embodiment disclosed herein, wherein one or more ends of the tensionable band are coupled to the body at a position that is centered with respect to one or more sensors positioned on the second surface.
The wearable system of any embodiment disclosed herein, wherein the heat source is positioned concentrically about one or both of the blood volume sensor and the skin temperature sensor.
The wearable system of any embodiment disclosed herein, wherein the blood volume sensor comprises a photoplethysmography sensor or an impedance plethysmographic sensor.
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.
The wearable system of any embodiment disclosed herein, further comprising a support structure coupled to the heat source and configured to couple the heat source to the second surface and at least partially expose the heat source to the cavity.
The wearable system of any embodiment disclosed herein, wherein the blood volume sensor is further configured to measure one or more of: heart rate, heart rate variability, or oxygen saturation.
The wearable system of any embodiment disclosed herein, wherein the target temperature is individualized to the user.
The wearable system of any embodiment disclosed herein, wherein individualization of the target temperature comprises receiving a user input related to perceived temperature of the skin surface.
The wearable system of any embodiment disclosed herein, wherein individualization of the target temperature is based on signals received from the blood volume sensor.
The wearable system of any embodiment disclosed herein, wherein the heat source comprises one of: a heating element or an environmental temperature.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is configured to transmit an electronic message to a first electronic system responsive to the determination of the anomalous biologic event, said first electronic system configured to electronically manage a home automation system.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a door lock and wherein said electronic message is configured to instruct the first electronic system to unlock the door lock.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a home alarm system and wherein said electronic message is configured to instruct the first electronic system to disable the home alarm system.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a display and wherein said electronic message is configured to instruct the first electronic system to display user's medical information.
The wearable system of any embodiment disclosed herein, wherein the medical information comprises medication information and/or medication regimen compliance.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a display and wherein said electronic message is configured to instruct the first electronic system to display stroke treatment user interface.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a speaker system and wherein said electronic message is configured to instruct the first electronic system to trigger an audible alarm with the speaker system.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to alert a third party computing system responsive to the determination of the anomalous biologic event.
The wearable system of any embodiment disclosed herein, wherein the third party computing system comprises an emergency service system.
The wearable system of any embodiment disclosed herein, wherein the third party computing system comprises a clinician computing system.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to initiate treatment protocol responsive to the detection of anomalous biologic event.
The wearable system of any embodiment disclosed herein, further comprising a wearable treatment system and said treatment protocol is configured to activate the wearable treatment system.
The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises an ultrasonic helmet.
The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises a cooling gas delivery system.
The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises a cooling helmet.
A wearable system for detecting an anomalous biologic event in a person, comprising one or more of the following:
A wearable system for detecting an anomalous biologic event in a person, comprising one or more of the following:
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 volume sensor.
The wearable system of any embodiment disclosed herein, wherein the parameter of interest includes one or more of: a blood pressure, a heart rate, a heart rate variability, a gaze, a facial expression, a skin conductance response, a vasodilation response, or a dilation response.
A wearable system for detecting an anomalous biologic event in a person, comprising one or more of the following:
The wearable system of any embodiment disclosed herein, wherein the stimulus source comprises a heat source.
The wearable system of any embodiment disclosed herein, wherein the stimulus source comprises an electrical source.
The wearable system of any embodiment disclosed herein, wherein the comparison comprises determining a change in vasodilation response.
The wearable system of any embodiment disclosed herein, wherein the stimulus source comprises a Peltier cooler.
The wearable system of any embodiment disclosed herein, wherein the second blood volume signal comprises a set of blood volume signals, such that the blood volume of the skin surface is measured repeatedly before, during, and after the stimulus cycle.
The wearable system of any embodiment disclosed herein, wherein the second blood volume signal comprises a plurality of blood volume signals, such that the blood volume of the skin surface is measured continuously before, during, and after the stimulus cycle.
The wearable system of any embodiment disclosed herein, wherein hardware processor is further configured to receive the second blood volume signal after a target stimulus is reached, after a predetermined length of time has expired, or after one or more stimulus cycles have concluded.
The wearable system of any embodiment disclosed herein, wherein comparing comprises 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.
The wearable system of any embodiment disclosed herein, wherein the blood volume sensor is positioned on the first side of the body of the wearable system.
The wearable system of any embodiment disclosed herein, further comprising a remote computing device communicative coupled to the wearable system and comprising the blood volume sensor.
The wearable system of any embodiment disclosed herein, wherein the remote computing device comprises one of: a laptop, cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.
The wearable system of any embodiment disclosed herein, wherein the stimulus source is positioned on the second surface of the body.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to:
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to cycle the stimulus source to maintain the target blood volume.
The wearable system of any embodiment disclosed herein, further comprising one or more electrodermal activity sensors positioned on the second surface.
The wearable system of any embodiment disclosed herein, wherein the one or more electrodermal activity sensors are spaced apart from the stimulus source by about 0.25 inches to about 4 inches.
The wearable system of any embodiment disclosed herein, further comprising one or more motion sensors configured to measure a motion of a body portion to which the wearable system is coupled.
The wearable system of any embodiment disclosed herein, wherein the first and second surfaces define a cavity therebetween to provide airflow between the first and second surfaces.
The wearable system of any embodiment disclosed herein, wherein the hardware processor resides on or within the first surface.
The wearable system of any embodiment disclosed herein, wherein the cavity defined by the first and second surfaces physically separates the stimulus source from the hardware processor on or within the first surface.
The wearable system of any embodiment disclosed herein, wherein the cavity defined by the first and second surfaces has sufficient volume to facilitate cooling of the stimulus source in between stimulus cycles.
The wearable system of any embodiment disclosed herein, wherein the anomalous biologic event comprises a stroke event.
The wearable system of any embodiment disclosed herein, wherein the wearable system is positioned on a left limb of a user and a second wearable system is positioned on a right limb of the user, wherein the second wearable system comprises a second stimulus source and a second blood volume sensor, wherein the hardware processor is further configured to compare right side blood volume signals to left side blood volume signals to determine whether the anomalous biologic event has occurred.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to:
The wearable system of any embodiment disclosed herein, wherein the comparison takes into account a baseline difference between the left limb and the right limb.
The wearable system of any embodiment disclosed herein, further comprising a tensionable band coupled to the body.
The wearable system of any embodiment disclosed herein, wherein the tensionable band further comprises a visual indicator to indicate when one or more of: the stimulus source, the blood volume sensor, or a combination thereof is sufficiently coupled to the skin surface to enable accurate sensor readings.
The wearable system of any embodiment disclosed herein, wherein one or more ends of the tensionable band are coupled to the body at a position that is centered with respect to one or more sensors positioned on the second surface.
The wearable system of any embodiment disclosed herein, wherein the stimulus source is positioned concentrically about the blood volume sensor.
The wearable system of any embodiment disclosed herein, wherein the blood volume sensor comprises a photoplethysmography sensor or an impedance plethysmographic sensor.
The wearable system of any embodiment disclosed herein, further comprising a support structure coupled to the stimulus source and configured to couple the stimulus source to the second surface and at least partially expose the stimulus source to the cavity.
The wearable system of any embodiment disclosed herein, wherein the blood volume sensor is further configured to measure one or more of: heart rate, heart rate variability, or oxygen saturation.
The wearable system of any embodiment disclosed herein, wherein the stimulus cycle is individualized to the user.
The wearable system of any embodiment disclosed herein, wherein individualization of the stimulus cycle comprises receiving a user input related to perceived stimulus of the skin surface.
The wearable system of any embodiment disclosed herein, wherein individualization of the stimulus cycle is based on signals received from the blood volume sensor.
The wearable system of any embodiment disclosed herein, wherein the stimulus source comprises one of a heating element or an environmental temperature.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is configured to transmit an electronic message to a first electronic system responsive to the determination of the anomalous biologic event, said first electronic system configured to electronically manage a home automation system.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a door lock and wherein said electronic message is configured to instruct the first electronic system to unlock the door lock.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a home alarm system and wherein said electronic message is configured to instruct the first electronic system to disable the home alarm system.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a display and wherein said electronic message is configured to instruct the first electronic system to display user's medical information.
The wearable system of any embodiment disclosed herein, wherein the medical information comprises medication information and/or medication regimen compliance.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a display and wherein said electronic message is configured to instruct the first electronic system to display stroke treatment user interface.
The wearable system of any embodiment disclosed herein, wherein the home automation system comprises a speaker system and wherein said electronic message is configured to instruct the first electronic system to trigger an audible alarm with the speaker system.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to alert a third party computing system responsive to the determination of the anomalous biologic event.
The wearable system of any embodiment disclosed herein, wherein the third party computing system comprises an emergency service system.
The wearable system of any embodiment disclosed herein, wherein the third party computing system comprises a clinician computing system.
The wearable system of any embodiment disclosed herein, wherein the hardware processor is further configured to initiate treatment protocol responsive to the detection of anomalous biologic event.
The wearable system of any embodiment disclosed herein, further comprising a wearable treatment system and said treatment protocol is configured to activate the wearable treatment system.
The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises an ultrasonic helmet.
The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises a cooling gas delivery system.
The wearable system of any embodiment disclosed herein, wherein the wearable treatment system comprises a cooling helmet.
A system for detecting an anomalous biologic event in a person, the system comprising one or more of the following:
The system of any embodiment disclosed herein, wherein the first stimulus source comprises at least one or more of the following: a heat source, a cooling source, or an electrical source.
The system of any embodiment disclosed herein, wherein the second stimulus source comprises at least one or more of the following: a heat source, a cooling source, or an electrical source.
The system of any embodiment disclosed herein, wherein the first time is synchronized with the second time.
The system of any embodiment disclosed herein, wherein the first vasodilation response is determined based on a parameter responsive to a measurement from a first blood volume sensor.
The system of any embodiment disclosed herein, wherein the second vasodilation response is determined based on a parameter responsive to a measurement from a second blood volume sensor.
The system of any embodiment disclosed herein, wherein the first vasodilation response is determined based on a parameter responsive to a measurement from an electrical activity sensor.
The system of any embodiment disclosed herein, wherein the second vasodilation response is determined based on a parameter responsive to a measurement from an electrical activity sensor.
The system of any embodiment disclosed herein, wherein the one or more hardware processors are further configured to determine a first baseline vasodilation response before the stimulation at the first tissue site and determine a second baseline vasodilation response before the stimulation at the second tissue site.
A wearable system for detecting a stroke event in a person, the wearable system comprising one or more of the following:
The wearable system of any embodiment disclosed herein, wherein the second post stimulation blood volume signal comprises a set of blood volume signals, such that the second blood volume of the second skin surface is measured repeatedly before, during, and after a heating cycle of the second heat source.
The wearable system of any embodiment disclosed herein, wherein the second post stimulation blood volume signal comprises a plurality of blood volume signals, such that the second blood volume of the second skin surface is measured continuously before, during, and after a heating cycle of the second heat source.
The wearable system of any embodiment disclosed herein, wherein the one or more hardware processors is 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 to the second baseline ratio.
The wearable system of any embodiment disclosed herein, wherein the first wearable device further comprises an environmental temperature sensor.
The wearable system of any embodiment disclosed herein, further comprising a remote computing device communicative coupled to the first wearable device and the second wearable device.
The wearable system of any embodiment disclosed herein, wherein the remote computing device comprises one of: a laptop, cellular device, a workstation, a server, a desktop computer, a personal digital assistant, a second wearable system or device, or a netbook.
The wearable system of any embodiment disclosed herein, further comprising one or more electrodermal activity sensors.
The wearable system of any embodiment disclosed herein, wherein the one or more electrodermal activity sensors are spaced apart from at least one of the firest heat source or the second heat source by about 0.25 inches to about 4 inches.
The wearable system of any embodiment disclosed herein, further comprising one or more motion sensors configured to measure a motion of a body portion to which at least one of the first wearable device or the second wearable device is coupled.
The wearable system of any embodiment disclosed herein, further comprising at least one tensionable band coupled to the body.
The wearable system of any embodiment disclosed herein, wherein the first heat source is positioned concentrically about one or both of the first blood volume sensor and the first skin temperature sensor.
The wearable system of any embodiment disclosed herein, wherein the second heat source is positioned concentrically about one or both of the second blood volume sensor and the second skin temperature sensor.
The wearable system of any embodiment disclosed herein, wherein the first blood volume sensor comprises a photoplethysmography sensor or an impedance plethysmographic sensor.
The wearable system of any embodiment disclosed herein, wherein the second blood volume sensor comprises a photoplethysmography sensor or an impedance plethysmographic sensor.
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.
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.
The wearable system of any embodiment disclosed herein, wherein the first blood volume sensor is further configured to measure one or more of: heart rate, heart rate variability, or oxygen saturation.
The wearable system of any embodiment disclosed herein, wherein the second blood volume sensor is further configured to measure one or more of: heart rate, heart rate variability, or oxygen saturation.
The wearable system of any embodiment disclosed herein, wherein at least one of the first target temperature or the second target temperature is individualized to the user.
This application is a continuation of U.S. patent application Ser. No. 17/070,832, filed on Oct. 14, 2020, which claims priority to U.S. Provisional Patent Application No. 62/915,269, filed on Oct. 15, 2019, and to U.S. Provisional Patent Application No. 63/053,265, filed on Jul. 17, 2020. Each of the patent applications are hereby incorporated by reference herein in their entireties, forming part of the present disclosure. Any feature, structure, material, method, or step that is described and/or illustrated in any embodiment in the foregoing patent applications can be used with or instead of any feature, structure, material, method, or step that is described in the following paragraphs of this specification and/or illustrated in the accompanying drawings.
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