Multimodal physiological monitoring system
A wearable multimodal monitoring system combining NIRS, ECG, and ICG sensors addresses the challenge of continuously monitoring DO2, enabling real-time, non-invasive assessment for improved resuscitation and resource management in critical care.
Patent Information
- Application Number
- PCT/US2025/013812
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-01-31
- Filing Date
- 2025-01-30
- Publication Date
- 2025-08-07
AI Technical Summary
Current systems lack a clinically acceptable method for continuously monitoring critical physiological parameters like Delivery of Oxygen (DO2) without invasive procedures, especially in resource-limited environments such as military operations or damage control surgery.
A wearable multimodal physiological monitoring system integrating optical and non-optical biometric sensors, including near-infrared spectroscopy (NIRS), electrocardiography (ECG), and impedance cardiography (ICG), to provide continuous monitoring of DO2 through a combination of sensors and algorithms.
Enables real-time, non-invasive monitoring of DO2, facilitating effective resuscitation endpoints and resource management in critical care scenarios, such as hypotensive resuscitation and damage control surgery.
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Figure US2025013812_07082025_PF_FP_ABST
Abstract
Description
MULTIMODAL PHYSIOLOGICAL MONITORING SYSTEMCROSS REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to US Provisional Patent Application No. 63 / 627,741 filed lanuary 31, 2024. The entire contents of which are hereby incorporated by reference.TECHNICAL FIELD
[0002] The present disclosure relates generally to systems and methods for measuring physiological parameters. In particular, the present disclosure relates to systems and methods for aggregating and processing physiological signals from a user.BACKGROUND
[0003] Near-infrared spectroscopy (NIRS) devices can non-invasivcly interrogate biological tissue using a selection of light wavelengths in the red and near- infrared (NIR) region of the electromagnetic spectrum. These wavelengths are particularly well suited for deep light penetration through tissue, versus lower wavelengths of light that are scattered or absorbed by confounding factors in the body and thus cannot reach the tissue depth of these red and NIR wavelengths. NIRS devices generally feature at least two wavelengths of light output in this range and at least one detector, and including additional optical elements can allow different depths of sensing. Red and near-infrared wavelengths are particularly effective for non-invasively sensing different molecular states of hemoglobin in various body tissues. Another similar technology that assesses the pulsatile component of tissue optical absorption is photoplethysmography (PPG), from which are derived measures of pulse oximetry (SpO2), pulse rate (PR), respiratory rate (RR), perfusion index (Pi), and other valuable optical measures of physiological parameters.
[0004] Coupling of NIRS systems and methods, PPG systems and methods, and additional electrophysiological sensing capabilities in an integrated and / or wearable package would be desirable. For example, combining electrocardiography (ECG) in addition to cardiopulmonary function monitoring with NIRS could enable continuous heart rhythm monitoring of cardiac biopotentials. The biopotential signal collected by a wearable ECG can provide information about the electrical functioning of the heart and can be used to derive heartrate (HR) and heart rate variability (HRV) among other metrics. Impedance cardiography (ICG), the time derivative of thoracic electrical bioimpcdancc (BioZ), which changes according to contractions of the heart may also be desirable in a multimodal sensing system. ICG is a well-established and FDA-cleared technique for non-invasive examination of deep tissue hemodynamics. The pulsatile BioZ change measured by ICG can be used to measure stroke volume (SV), which can then be utilized to obtain a measurement of cardiac output (CO). ICG can also measure other hemodynamic parameters of cardiac function and blood flow including stroke index (SI), cardiac index (CI), systemic vascular resistance (SVR), total arterial compliance (TAC), thoracic fluid content (TFC), pre-ejection period (PEP), and left ventricular ejection time (LVET). By using a combination of physiological sensing capabilities, it may be possible to continuously monitor the Delivery of Oxygen (DO2), a critical measure of cardiopulmonary function. However, there are currently no clinically acceptable systems or methods for monitoring DO2 without continuous access to vessels to perform blood gas analysis or related hemoglobin analysis procedures.
[0005] Therefore, it would be desirable to provide portable, wearable sensing systems and methods to continuously monitor critical physiological conditions, such as DO2, in a noninvasive manner.SUMMARY
[0006] In some examples, a system for multimodal physiological monitoring may include a wearable physiological monitoring system including sensors capable of detecting one or more optical biometric properties of the user, sensors capable of detecting one or more non- optical biometric properties of the user, and a processor to receive signals from the sensors, process the signals based on predefined algorithms, and determine physiological parameters of the wearer.
[0007] The sensors may include a light source capable of emitting a set of wavelengths of red or near-infrared light, and detectors capable of detecting the set of wavelengths. The optical biometric properties can include tissue oxygenation, pulse oximetry, pulse rate, respiratory rate, blood oxygen saturation, and blood pressure. The non-optical biometric properties may include electrocardiography (ECG), impedance cardiography (ICG), bioimpedance circuitry, thermal properties, and mechanical properties. The system can further include a screen, wherein the representations of the determined physiological parameters aredisplayed on the screen. The determined physiological parameters can include a calculated Delivery of Oxygen (DO2).
[0008] In some examples, a system for multimodal physiological monitoring can include a monitoring device comprising with sensors capable of detecting optical biometric properties of the user, a flexible substrate for fixing the monitoring device to a user, and including sensors capable of detecting non-optical biometric properties of the user, and a processor which receives signals from the sensors, processes the received signals based on predefined algorithms, and determines one or more physiological parameters.
[0009] The sensors capable of detecting optical biometric properties can include a light source to emit a first set of wavelengths of blue, green, yellow, orange, red, near-infrared light, or short wave infrared light. The sensors capable of detecting optical biometric properties can further include detectors capable of detecting the set of wavelengths. The optical biometric properties detected by the sensors can include tissue oxygenation, pulse rate, respiratory rate, oxygen saturation, blood pressure, or combinations thereof. The non-optical biometric properties detected by the sensors can include electrocardiography (ECG), impedance cardiography (ICG), bioimpedance circuitry, thermal properties, and mechanical properties. The sensors for detecting non-optical biometric properties may include an ECG electrode and an ICG electrode. The monitoring device may include the processor and further include an interface for electrical communication of the signals from the non-optical sensors to the processor. The system may also include an external device in wireless communication with the monitoring device, and the external device can include the processor. The external device can include a screen, and the screen can display a representation of the physiological parameters determined by the system. The representation of the determined physiological parameters can be a graph. The determined physiological parameters can include a calculated Delivery of Oxygen (DO2) value. The flexible substrate can be an adhesive patch. The monitoring device further can include additional sensors such as a core temperature, ambient temperature, and / or skin temperature sensor, an accelerometer, ambient light sensor, ambient pressure sensor, and an acoustic sensor.
[0010] In some examples, method for multimodal physiological monitoring and calculating biometric properties includes fixing sensors capable of detecting optical biometric properties to a user, fixing sensors capable of detecting non-optical biometric properties of theuser, transmitting signals acquired by the sensors to a processor, executing instructions to process the transmitted signals based on the one or more predefined algorithms; and outputting determined physiological parameters of the user. The determined physiological parameters can include a calculated Deliver of Oxygen (DO2) value. Algorithms used for calculating biometrics may use signals and outputs from a measurement modality (e.g., non-optical) to improve the accuracy of outputs from another measurement modality (e.g., optical), or vice versa, or with a combination of interactions.BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The accompanying drawings, which are incorporated in and form a pail of the specification, illustrate the embodiments of the invention and together with the written description serve to explain the principles, characteristics, and features of the invention. In the drawings:
[0012] FIG. 1 is a schematic representation of a system for multimodal monitoring of physiological parameters, in accordance with some examples of the present disclosure.
[0013] FIG. 2 A depicts an example of a monitoring device of a system for multimodal monitoring of physiological parameters, in accordance with some examples of the present disclosure.
[0014] FIG. 2B depicts an example of a monitoring device of a system for multimodal monitoring of physiological parameters, in accordance with some examples of the present disclosure.
[0015] FIG. 2C depicts an example of a monitoring device of a system for multimodal monitoring of physiological parameters applied to a user, in accordance with some examples of the present disclosure.
[0016] FIG. 3 depicts an example of a monitoring device of a system for multimodal monitoring of physiological parameters applied to a user, in accordance with some examples of the present disclosure.
[0017] FIG. 4 depicts an example of a visual representation of data acquired and / or calculated by a system for multimodal monitoring of physiological parameters, in accordance with some examples of the present disclosure.DETAILED DESCRIPTION
[0018] This disclosure is not limited to the particular systems, devices, and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions, examples, or embodiments only, and is not intended to limit the scope of the disclosure.
[0019] The following terms shall have, for the purposes of this application, the respective meanings set forth below. Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the ait. Nothing in this disclosure is to be construed as an admission that the embodiments or examples described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention.
[0020] As used herein, the singular forms “a,” “an,” and “the” include plural references, unless the context clearly dictates otherwise. Thus, for example, reference to a “fiber” is a reference to one or more fibers and equivalents thereof known to those skilled in the art, and so forth.
[0021] As used herein, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. For example, about 50 mm means in the range of 45 mm to 55 mm.
[0022] As used herein, the term “consists of’ or “consisting of’ means that the device or method includes only the elements, steps, or ingredients specifically recited in the particular claimed embodiment or claim.
[0023] In embodiments or claims where the term “comprising” is used as the transition phrase, such embodiments can also be envisioned with replacement of the term “comprising” with the terms “consisting of’ or “consisting essentially of.”
[0024] It is to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. It is also to be understood that the listing of one or more method steps in any order does not preclude the performance of such one or more methods steps in alternative orders, nor does it preclude the simultaneous performance of any such one or more method steps. Similarly, it is also to be understood that the mention of one or more componentsin a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.
[0025] It will be understood by those within the art that, in general, terms used herein are generally intended as “open” terms (for example, the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” et cetera). While various compositions, methods, and devices are described in terms of “comprising” various components or steps (interpreted as meaning “including, but not limited to”), the compositions, methods, and devices can also “consist essentially of’ or “consist of’ the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups.
[0026] In addition, even if a specific number is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of "two components," without other modifiers, means at least two components, or two or more components). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, et cetera” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, et cetera). In those instances where a convention analogous to “at least one of A, B, or C, et cetera” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, et cetera). It will be further understood by those within the ait that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, sample embodiments, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”
[0027] Furthermore, where features of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.
[0028] As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, et cetera. As will also be understood by one skilled in the art all language such as “up to,” “at least,” and the like include the number recited and refer to ranges that can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 components refers to groups having 1, 2, or 3 components. Similarly, a group having 1-5 components refers to groups having 1, 2, 3, 4, or 5 components, and so forth.
[0029] With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity.
[0030] The resuscitative capacity of fresh whole blood (FWB) is unmatched in austere damage control surgery (DCS), however, FWB supply can be limited. In a forward operational military environment, FWB can be one of the most limited medical materiel solutions available to military care providers. Limited availability of this critical resource, and the fact that blood loss from massive hemorrhage is the leading cause of potentially survivable deaths in battlefield casualties, has resulted in a tremendous effort to improve hemostatics and deliver real-time guidance of life-saving interventions (LSIs).
[0031] Hypotensive resuscitation is a method used in resource-limited emergency medicine to maintain a tolerable (but permissively suboptimal) hypotensive state in casualties by delivering just enough fluids to maintain life and temporarily stabilize the patient until definitive medical care can be provided. However, the enormous complexity of compensatory responses to massive blood loss results makes it difficult setting objective resuscitationendpoints for each casualty’s physiology at the time of need. Compensatory mechanisms are driven by the body’s ability to maintain end-organ perfusion and offset hypovolemic shock, and a real-time measure of Delivery of Oxygen (DO2) could provide a suitable resuscitation endpoint. Currently, no solution exists for continuously monitoring DO2 or change in DO2 as a resuscitation endpoint.
[0032] Near-infrared spectroscopy devices interrogate biological tissue using a selection of light wavelengths in the red and NIR region of the electromagnetic spectrum. These wavelengths are particularly well suited for deep light penetration through tissue, versus lower wavelengths of light that are scattered or absorbed by confounding factors in the body and thus cannot reach the tissue depth of these red and NIR wavelengths. NIRS devices generally feature at minimum two wavelengths of light output in this range and at least one detector, and including additional optical elements can allow different depths of sensing, while adding wavelengths can increase signal accuracy and compensation for confounding factors in the body, including variations in skin pigmentation due to melanin, the presence of tattoos, or variations in tissue composition under the skin itself.
[0033] However, many existing NIRS systems and methods are unable to be coupled with electrophysiological sensing capabilities in an integrated and / or wearable package. Most portable, wearable electrophysiological sensing systems, such as those used in electroencephalography (EEG), use a very small number of electrodes for cognitive sensing and do not have the additional benefit of optical hemodynamic sensing for additional contextual awareness.
[0034] Accordingly, the systems and methods disclosed herein may provide integrated and wearable optical and non-optical biometric sensing capabilities, such as a combination of electrophysiological, functional NIRS (fNIRS), impedance cardiography (ICG), and photoplethysmography (PPG)-based sensing, providing additional physiological metrics such as pulse rate, respiratory rate, oxygen saturation (SpO2), and blood pressure-related data streams in a single wearable system. The combination of sensing capabilities can enable realtime measure of Delivery of Oxygen (DO2). An exemplary DO2 calculation is provided below.Equation 1 : The D 2 Equation with denoted cardiac output (CO) and arterial oxygenation ( CaO2) components. 1.34 and 0.003 are constants representing the oxygen binding and the oxygen-carrying capacity of hemoglobin, respectively.
[0035] Although DO2 is a critical measure of cardiopulmonary function, it is tissuespecific and varies rapidly based on local oxygen demand, and there is no clinically accepted way to monitor DO2 without continuous access to vessels to perform blood gas analysis or related hemoglobin analysis procedures. However, correlating noninvasive measurement techniques exist and combining them into a single patient monitoring platform may allow for a real-time DO2 estimate sufficient to guide hypotensive resuscitation and other life-saving interventions (LSIs), for example in damage control surgery (DCS) to optimize the use of limited resources such as fresh whole blood (FWB). Such estimates may be extremely valuable in austere military settings.
[0036] The CaC>2 component of DO2 in Equation 1 requires measurement of hemoglobin [Hb], arterial blood oxygen saturation (SaCh), and the partial pressure of oxygen in the arterial blood (PaCh). NIRS can be used to measure A[Hb] as well as deep tissue oximetry (StCh). SaO2 can be estimated from the SpCh measurements derived from the pulsatile component of the optical signal and is related to PaCh via the oxygen-hemoglobin dissociation curve. PaCh is driven exclusively by alveolar partial pressure and the alveolar-capillary interface and is therefore not expected to change significantly under physiologic conditions except for ventilation-perfusion imbalance or other lung dysfunction. PaCb is thus expected to have a minimal contribution to trending CaCh in comparison to [Hb] and SaC>2, as seen in Equation 1.
[0037] A combined NIRS and electrocardiography (ECG) wearable patch may enable continuous heart rhythm monitoring of cardiac biopotentials via ECG in addition to cardiopulmonary function monitoring with NIRS. The biopotential signal collected by wearable ECG contains information about the electrical functioning of the heart and can be used to derive heart rate (HR) and heart rate variability (HRV) among other metrics. ECG can be combined with impedance cardiography (ICG), the time derivative of thoracic electrical bioimpedance (BioZ), which changes according to contractions of the heart. ICG is a well- established and FDA-cleared technique for non-invasive examination of deep tissue hemodynamics. The pulsatile BioZ change measured by ICG can be used to measure strokevolume (SV), which can then be multiplied by the heart rate (HR) to obtain the cardiac output CO term in Equation 1. ICG can also measure other hemodynamic parameters of cardiac function and blood flow including stroke index (SI), cardiac index (CI), systemic vascular resistance (SVR), total arterial compliance (TAC), thoracic fluid content (TFC), pre-ejection period (PEP), and left ventricular ejection time (LVET). SV by itself has also been shown to be a useful metric of fluid responsiveness, which is vital to improving outcomes in resuscitation and treatment for trauma patients. Furthermore, the transthoracic BioZ measurement on which ICG is based can provide additional insight into the assessment of thoracic fluid status, as the overall BioZ of the thorax will decrease with increased thoracic fluid.
[0038] FIG. 1 depicts a wearable multimodal physiological monitoring system 100, according to some examples. The system 100 can comprise monitoring device 110. Monitoring device 110 can be attached to a body of a user or wearer 101 to be monitored using a substrate 122 configured as an adhesive patch. In some examples, monitoring device 110 comprises optical emitters and detectors for NIRS sensing. The monitoring device 110 may further include acoustic sensors for phonocardiography (PCG). The monitoring device 110 may also include one or more accelerometers, gyroscopes, or both, for seismocardiography (SCG), detecting chest motion, and / or detecting motion of the wearer 101. The motion sensors may also be utilized to reduce noise caused by motion of the wearer 101 or the wearer’s environment. The monitoring device 110 may further include one or more optical sensors for photoplethysmography (PPG). The monitoring device 110 may further include one or more temperature sensors or shortwave infrared (SWIR) optical emitters and detectors performing shortwave infrared spectroscopy (SWIRS) or both for sensing an ambient temperature, skin temperature, and / or a core body temperature of the wearer 101. The monitoring device 110 may further comprise a display or screen for providing information, such as measured or aggregated data, to a user. This display may be integrated, wired, or wirelessly connected to the monitoring device 110.
[0039] In some examples, the substrate 122 comprises electrodes 124 for receiving ECG and ICG signals. In some examples, the monitoring device 110 comprises an input / output (VO) interface 116 to provide a front-end and establish a connection to the electrodes 124. In some examples, the monitoring device 110 may be reusable and sterilizable, and the substrate 122 may single use. In some examples, the substrate 122 may be a single use adhesive patch. Insome examples, the substrate 122 may be attached to a wearer 101 without adhesion. For example, the flexible substrate 122 can be strapped to or otherwise attached to a wearer 101.
[0040] The monitoring device 110 may further comprise a communication interface for wirelessly communicating information, signals, and / or processed data from the monitoring device 110 to a network 200. Wireless communication may be established through Bluetooth or another suitable wireless communication means. The network may, for example, be a Bluetooth low energy (BLE) mesh network. The network may relay data from the monitoring device 110 to and external device 300 which may serve as a data aggregator. The external device 300 may be located remotely from the monitoring device 110. The external device 300 may be used for monitoring and aggregating data from multiple monitoring devices. In some examples, aggregated data may be remotely accessed by a physician or user. In some examples, a portal may include secure access to the data obtained, processed, aggregated, and / or calculated by the system. In some examples, the system may provide a network of connected data aggregation and analysis nodes that enable monitoring, analysis, and communication at the edge node with the patient, at a cloud-based analysis and storage node, and at least one medical provider node. In some examples, the system may provide a software for visualizing, analyzing, and communicating results between the patient and the different roles in their care team (including in-home care, remote monitoring services, specialty clinics and pharmacies, and the hospital).
[0041] In some examples, the external device 300 may comprise a display or screen for visualizing graphs, such as an electrocardiogram, photoplethysmogram, impedance cardiogram, phonocardiogram, seismocardiogram, temperature taken over time, and / or motion over time. The display or screen may provide a user interface, such as a touchscreen. FIG. 4 depicts an exemplary display 400 of an external device during a pressure chamber test conducted on a wearer. In the example, the external device may display a graph depicting stroke volume 404, a graph depicting change in oxyhemoglobin and deoxyhemoglobin 406, and tissue oxygenation 408 taken over a period of time. The display 400 may also provide a representation of ambient measurements or test variables, for example, a graphical of chamber pressure 402 in the provided scenario. A legend or key 410 may be provided to facilitate interpretation of the visualizations for the use.
[0042] It should be understood that the monitoring device 110 can be configured to perform some or all the functions of the external device 300, integrating communication processes between multiple other monitoring devices 110 or other physiological or environmental sensors attached to the user 101 or present within the user’s environment.
[0043] FIGs. 2A-2B depict an exemplary monitoring device 110. FIG. 2 A depicts a front perspective view of the monitoring device 110. As depicted, the monitoring device 110 may comprise one or more buttons 118 for interfacing with the monitoring device. Buttons 118 may be used to power on the device, change the functional mode of the device, or otherwise control the device. In some examples, a wireless charging adapter 115 can be used to recharge the battery of the monitoring device 110. FIG. 2B depicts a rear’ perspective view of the monitoring device 110. As depicted, the monitoring device 110 may comprise a sensor array 112. The sensor array 112 may comprise optical components for optical sensing such as NIRS, SWIRS, and / or PPG sensing. The monitoring device may further include additional sensors 114 for temperature sensing, phonocardiography, etc. In some examples, the monitoring device 110 further includes I / O interfaces 116 or frontends for coupling to ECG and / or ICG electrodes, which may be provided as part of the substrate 122. In some examples, the RO interfaces 116 of the monitoring device 110 and the electrodes 124 of the substrate 122 are electrically coupled, such that electrical signals can be passed through the electrodes 124 between skin of a wearer and the RO interfaces 116 of the monitoring device. In some examples, the substrate comprises apertures 126, 128 which correspond with the sensor arrays 112, 114 of the monitoring device 110. In some examples, a film covers the apertures 126, 128 to maintain sterility of the monitoring device without interfering with signals transmitted to or from the sensor arrays 112, 114. FIG. 2C depicts an exemplary monitoring device 110 adhered to a user / wearer 101 by a substrate 122 provided as an adhesive patch.
[0044] With reference to FIG. 3, the monitoring device 110 may include a processor 310, a light source 320, a detector 330, a RO device 340, an energy storage device 350 (e.g., a battery) configured to power the monitoring device 110 and / or the electronics module 104, a memory device 360, an environmental sensor 335, and a communication interface 365. Memory device 360 may include an operating system (OS) 370 and program 380, and a database 390. Operating system (OS) 370 may be a real-time operating system (RTOS) bare metal program instructions in system firmware operating on the processor 310. The RO devicemay include but is not limited to an analog to digital converter (ADC), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a combination thereof, or another subsystem for interfacing with the numerous sensors on the monitoring device 110.
[0045] Program 380 may include stored instructions that direct the processor 310 to perform one or more steps toward calculating biometric and / or environmental parameters of a patient. In some examples, processor 310 may detect external sensors provided on a corresponding flexible substrate or in wireless communication with the monitoring device 110. For example, the sensors external to the monitoring device 110 may include optical, thermal, mechanical, electrophysiological, and / or biochemical detectors. The processor 310 thus may be configured to detect what types of detectors are currently mounted proximal to the monitoring device or provided on a corresponding flexible substrate coupled to the monitoring device 110 such that it may later calculate the associated types of biometric parameters.
[0046] In some examples, the detector(s) 330 may include optical detectors configured to detect specific sets of wavelengths emitted from light source 320. The optical detectors may be configured to detect backscattered light from light source 320, as the backscattered light travels through tissue. In some examples, the optical detectors may comprise a single optical detector. In other examples, the optical detectors may comprise multiple optical detectors, such as 2 optical detectors, 3 optical detectors, 4 optical detectors, 5 optical detectors, and so on. In some examples, the optical detectors may be capable of detecting the first set of wavelengths, as described herein. In an example, the optical detectors may be capable of detecting the first set of wavelengths and the second set of wavelengths, as described herein.
[0047] In some examples, the processor 310 may be configured to select the emitted set(s) of wavelengths and the respective distance(s) of the light source 320 from the detector(s) 230, as discussed above. The input parameter may include, for example, a temperature, a lighting condition, a velocity, an acceleration, a change in acceleration, a pressure, a change in pressure, a volume, a change in volume, a measurement made, recorded, or calculated by the system, a communication from another device or system, or a combination thereof.
[0048] In some examples, the detector(s) 330 may include thermal detectors and / or SWIR optical detectors, for example, to measure a temperature of a patient. In some examples, the detector(s) 330 may include mechanical detectors, for example, to detect a patient’s fingerprint, patient’s vasomotor tone, or the movement of a limb or joint. In some examples,the detector(s) 330 may include electrophysiological detectors, for example, to take patient measurements associated with an ICG, a PPG, a PCG, a SCG, an electroencephalogram (EEG), an electrocardiogram (EKG), electromyography (EMG), electrodermal activity (EDA) and / or a galvanic skin response (GSR), bioelectrical impedance (BIA), and the like. In some examples, the detector(s) 330 may include biochemical detectors, for example, to take patient measurements associated with blood gas levels (e.g., peripheral oxygen, absolute oxygen, etc.), endocrine levels, cytokine levels, antibody or antigen levels, or a combination thereof.
[0049] In some examples, processor 310 may perform one or more feedback actions based on calculating the biometric parameters. The feedback actions may include, for example, transmitting an alarm (e.g., such that a healthcare provider is alerted to a potential issue), activating a feedback device, or adjusting an environmental property.
[0050] In some examples, an external device in communication with the monitoring device may include a display, a switch, a sensor, an audible feedback device, a haptic feedback device, a color-based feedback device, a fragrance-based feedback device, and / or a tactile feedback device. In some examples, the monitoring device further comprises an environmental sensor 335. The environmental sensor 335 can measure parameters surrounding the patient and not the patient directly. Environmental properties may include, for example, temperature, humidity, pressure, motion, chemical composition, ambient light intensity, sound, etc., of the external environment in which the patient is positioned. As another example, environmental sensor 335 may include a microphone configured to receive spoken instructions informing the monitoring device 110 how to operate.
[0051] In some examples, the systems disclosed herein may provide electrical connections to a battery and an electronics module or modules that may process the electrophysiological signals and fNIRS signals separately or in tandem. The systems disclosed herein may be integrated into various types of equipment, uniforms, clothing, prosthetics, etc.
[0052] An exemplary light source used in the optical sensors of the system for NIRS sensing may include a single light source emitting one or more wavelengths of blue, green, yellow, orange, red, near-infrared, shortwave, or other light. In other examples, the light source 108 may include multiple light sources, such as 2 light sources, 3 light sources, 4 light sources, 5 light sources, and so on. In some examples, each light source may include one or more light emitting diodes (LEDs). In some examples, each light source may include a single tunable lightsource such as a broadband LED coupled with a miniature monochromator. In some examples, each light source may include one or more laser diodes. In an example, the light source may include a light source driver capable of selecting between the different light sources or selecting the wavelength from a tunable light source. In some examples, the light source may include one of more vertical-cavity surface-emitting lasers (VCSELs), edge emitting laser diodes (LDs), or other semiconductor laser sources.
[0053] In some examples, the light source may be capable of emitting a first set of wavelengths of red or near-infrared light. In some examples, each light source within the light source 108 may be capable of independently emitting a wavelength. The first set of wavelengths may comprise 1 wavelength, 2 wavelengths, 3 wavelengths, 4 wavelengths, 5 wavelengths, 6 wavelengths, 7 wavelengths, 8 wavelengths, 9 wavelengths, 10 wavelengths, or any other number of wavelengths known in the art. In some examples, each wavelength within the first set of wavelengths may independently be from about 450 nm to about 2000 nm. Each wavelength may be, for example, about 500nm, about 550 nm, about 600nm, 650 nm, about 655 nm, about 660 nm, about 665 nm, about 670 nm, about 675 nm, about 680 nm, about 685 nm, about 690 nm, about 695 nm, about 700 nm, about 705 nm, about 710 nm, about 715 nm, about 720 nm, about 725 nm, about 730 nm, about 735 nm, about 740 nm, about 745 nm, about 750 nm, about 755 nm, about 760 nm, about 765 nm, about 770 nm, about 775 nm, about 780 nm, about 785 nm, about 790 nm, about 795 nm, about 800 nm, about 805 nm, about 810 nm, about 815 nm, about 820 nm, about 825 nm, about 830 nm, about 835 nm, about 840 nm, about 845 nm, about 850 nm, about 855 nm, about 860 nm, about 865 nm, about 870 nm, about 875 nm, about 880 nm, about 885 nm, about 890 nm, about 895 nm, about 900 nm, about 905 nm, about 910 nm, about 915 nm, about 920 nm, about 925 nm, about 930 nm, about 935 nm, about 940 nm, about 945 nm, about 950 nm, or any range between any two of these values, including endpoints. In some examples, each wavelength within the first set of wavelengths may be greater than about 805 nm. In some examples, the average of the first set of wavelengths may be greater than about 805 nm. In some examples, the first set of wavelengths may include at least one wavelength of about 535 nm and at least one wavelength of about 980 nm. In some examples, the first set of wavelengths may include seven individual wavelengths to interrogate the targeted tissue: one in the green region at or above 500 nm, one in the red region below 730 nm, one in the NIR region below the 805 nm isosbestic point, one near or atthe 805 nm isosbestic point, two in the NIR region above the isosbestic point, and one or more in the SWIR region above 1000 nm.
[0054] As described herein, the multimodal physiological monitoring system, through use a monitoring device may acquire data from sensors to measure PPG, NIRS, ECG, temperature, motion, ICG, PCG, SCG, and / or BioZ signals. The signals may then be processed and / or aggregated to derive physiological parameters, such as AHb, StCh, SpCh, pulse rate, heart rate, respiratory rate, stroke volume, cardiac output, and delivery of oxygen. Metrics acquired and / or calculated by the system may further include, pulse rate variability, tissue perfusion at various depths, heart rate variability, heart sounds, chest motion, hemoglobin concentration, perfusion, ambient pressure, pulmonary metrics, end tidal volume, stroke index, cardiac index, systemic vascular resistance, total arterial compliance, thoracic fluid content, pre-ejection period, left ventricular ejection time, and other useful metrics. Comparisons can also be calculated between each of the above metrics, and the results of which may be used to dynamically adjust system behavior, for example, for managing battery lifetime, for adjusting sample frequency, for turning on or off other measurement modalities to confirm derange physiological measurements, to initiate or escalate alarms, or manage other changes.
[0055] In some examples, the multimodal physiological monitoring system is utilized to acquire a combination of multimodal physiological measures to assess real-time change in oxygen delivery and report DO2 measurements and / or changes in DO2 measurements of a user 101. The DO2 information may be critical in some applications, such as hypotensive resuscitation, where limited medical resources may be saved by determination of a resuscitation endpoint. For example, in military operations, fresh whole blood may be transferred from a military personnel who is not seriously injured (NSI) to critically injured personnel. In such a case, it would be desirable to monitor DO2 parameters of critically injured personnel to conserve fresh whole blood and prevent NSI personnel from having to remove themselves from a battle.
[0056] In some examples, tailored feedback can be provided for the specific circumstance. For example, if the system is being utilized for delivery of whole fresh blood, once the system determines a resuscitation endpoint has been reached, an alert may be provided signaling that transfusion can be ceased. Alerts and / or feedback may be provided by a paired device, such as a smartphone, tablet, laptop, or other device.
[0057] Monitoring of DO2 also has various uses in civilian application. For example, noninvasivc DO2 monitoring provided by the system and methods described herein can enable remote medical interventions, such as pharmaceutical titration, hardware function, or others for cardiopulmonary performance degradations in patients by remotely monitoring changes in reperfusion following low risk interventions. The system may also be useful for measuring cardiotoxicity of drug candidates by monitoring the patient before, during, and after treatment. The system may also be utilized to monitor responses to medications and guide the remote adjustment of their dosages (i.e., medication monitoring and titration), provide physiological surveillance for medication compliance, provide patient telemetry for discharged or remote patients, provide early alert of decompensation prior to presentation for admission or readmission at the hospital, guide remotely delivered therapies, and / or provide remote monitoring of remotely delivered tests or interventions (e.g. cardiac rehabilitation therapy, physical therapy, cognitive behavioral therapy, etc.). Because the delivery of oxygen with the heart, lungs, and vascular is such a critical component a life, the system may have applications in guiding medical decision making of disease screening and diagnosis as well as therapeutic interventions in cardiovascular medicine, pulmonological medicine, neurological medicine, infectious disease, trauma medicine, diabetes, and other applications.
[0058] In some examples, the system may include connected devices for measuring additional physiological parameters such as blood pressure. In an example, connected systems may allow for implementation of an ankle brachial index test (ABI) allowing for a comparison of tissue oxygenation at the wrist and the ankle and monitoring of differences between them that relate to cardiopulmonary dysfunction. Additionally, multiple wearable devices can be connected within the system to assess and / or compare shallower vs the deeper tissue, a proximal location (e.g. sternal) vs distal location (e.g. foot), the head vs the body, right cerebral hemisphere vs left cerebral hemisphere, provide contralateral comparisons (e.g. left vs right side, front vs back side, top vs bottom side, etc.), muscle vs bone, injured vs uninjured limbs, contracted vs relaxed muscles, locations superior and inferior to a wound (deeper or superficial) or other intervention device or techniques (e.g., tourniquet, blood pressure cuff, AV fistula, etc.).
[0059] Similarly, the system may be employed for monitoring of diabetic patients, where monitoring perfusion as a function of depth at distal sites can facilitate determination of skinperfusion and assess necropsy risk. The system can include a series of algorithms (on the device and in the network) that record and continuously analyze data thresholds and trends in order to assess and interpret changes in patient physiology as well as make recommendations to the care team.
[0060] Although some of the processing systems described herein can be embodied in software or code executed by general purpose hardware as discussed above, as an alternative the same can also be embodied in dedicated hardware or a combination of software / general purpose hardware and dedicated hardware. If embodied in dedicated hardware, each can be implemented as a circuit or state machine that employs any one of or a combination of a number of technologies. These technologies can include, but are not limited to, discrete logic circuits having logic gates for implementing various logic functions upon an application of one or more data signals, application specific integrated circuits (ASICs) having appropriate logic gates, field-programmable gate arrays (FPGAs), or other components, etc.
[0061] In some examples, the systems and methods described herein include independent wireless devices communicating biometrics information about different areas of tissue simultaneously. In some examples, the systems and methods described herein include scanning a single device over different areas of the body and continuously imaging tissue, changing methods based on determined tissue state or changes in patient condition.
[0062] In some examples, the systems and methods described herein include two or more independent systems that can simultaneously interrogate multiple areas of cerebral and somatic tissue to interrelate physiological status (for example, tissue oxygenation) in each area. These areas may have significantly different oxygenation signatures at any given time and simultaneously sampling these is particularly important to understand situations of local or central fatigue or recovery onset by the user 101. Simultaneous imaging of different body systems can also elucidate generalized physiological condition, for instance indicating systemic response to exogenous conditions such as carbon monoxide poisoning or endogenous conditions such as hemorrhage. The independently sampled processed data from each area of the body may then send signals to a user interface if a specific tissue level, condition, or status is reached, or stream data to the external processing module for real-time interpretation, or both.
[0063] In some examples, the multimodal systems and methods described herein include independent wireless devices communicating multi-point physiological information (c.g., oxygenation) about the brain, heart, lungs, vasculature, and body simultaneously.
[0064] In some examples, the systems disclosed herein can be networked for concurrent monitoring of different physiological conditions of a user 101, the same or different physiological conditions at different locations on the body of a user 101, one or more physiological conditions of a group of wearers in a population, or a combination thereof.
[0065] In some examples, the systems and methods described herein include multiple systems that can be worn by multiple different individuals whose data is integrated to form a comprehensive image of a group of individuals’ health. This integration can be simultaneous for co-located users or asynchronous for disparate groups, or another combination. For example, comparing real-time physiological monitoring across multiple individuals can enable population monitoring and a more holistic image of group performance and wellness. Such continuous imaging can identify early threats or enhancements and increase risk or opportunity for better group performance and outcome.
[0066] In some examples, the systems and methods described herein include monitoring population health through a network of individual users’ biometric detection systems. In some examples, this can enable broader decision making and earlier insight into performance degradations or risks from proximity to decompensating near neighbors. For example, the monitored conditions can include pre-symptomatic detection of infection, fatigue, or environmental exposure and the implementation of remedial strategies to optimize outcomes.
[0067] Where any component discussed herein is implemented in the form of firmware and / or software, any one of a number of programming languages may be employed such as, for example, C, C++, C#, Objective C, Java®, JavaScript®, Perl, PHP, Visual Basic®, Python®, Ruby, Flash®, or other programming languages. A number of firmware and / or software components are stored in the memory and are executable by the processor. In this respect, the term “executable” means a program file that is in a form that can ultimately be run by the processor. Examples of executable programs can be, for example, a compiled program that can be translated into machine code in a format that can be loaded into a random access portion of the memory and run by the processor, source code that can be expressed in proper format such as object code that is capable of being loaded into a random access portion of thememory and executed by the processor, or source code that can be interpreted by another executable program to generate instructions in a random access portion of the memory to be executed by the processor, etc. An executable program can be stored in any portion or component of the memory including, for example, random access memory (RAM), read-only memory (ROM), hard drive, solid-state drive, USB flash drive, memory card, optical disc such as compact disc (CD) or digital versatile disc (DVD), floppy disk, magnetic tape, or other memory components.
[0068] The memory is defined herein as including both volatile and nonvolatile memory and data storage components. Volatile components are those that do not retain data values upon loss of power. Nonvolatile components are those that retain data upon a loss of power. Thus, the memory can include, for example, random access memory (RAM), read-only memory (ROM), hard disk drives, solid-state drives, USB flash drives, memory cards accessed via a memory card reader, floppy disks accessed via an associated floppy disk drive, optical discs accessed via an optical disc drive, magnetic tapes accessed via an appropriate tape drive, and / or other memory components, or a combination of any two or more of these memory components. In addition, the RAM can include, for example, static random access memory (SRAM), dynamic random access memory (DRAM), or magnetic random access memory (MRAM) and other such devices. The ROM may comprise, for example, a programmable read-only memory (PROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), or other like memory device.
[0069] Also, the processor can represent multiple processors and / or multiple processor cores and the memory can represent multiple memories that operate in parallel processing circuits, respectively. In such a case, the local interface can be an appropriate network that facilitates communication between any two of the multiple processors, between any processor and any of the memories, or between any two of the memories, etc. The local interface can include additional systems designed to coordinate this communication, including, for example, performing load balancing. The processor can be of electrical or of some other available construction.
[0070] Although some of the processing systems described herein can be embodied in software or code executed by general purpose hardware as discussed above, as an alternative the same can also be embodied in dedicated hardware or a combination of software / generalpurpose hardware and dedicated hardware. Tf embodied in dedicated hardware, each can be implemented as a circuit or state machine that employs any one of or a combination of a number of technologies. These technologies can include, but are not limited to, discrete logic circuits having logic gates for implementing various logic functions upon an application of one or more data signals, application specific integrated circuits (ASICs) having appropriate logic gates, field-programmable gate arrays (FPGAs), or other components, etc.
[0071] It should be understood that any logic or application described herein that incorporates software or code can be embodied in any non-transitory computer-readable medium for use by or in connection with an instruction execution system such as, for example, a processor in a computer system or other system. In this sense, the logic can include, for example, statements including instructions and declarations that can be fetched from the computer-readable medium and executed by the instruction execution system. In the context of the present disclosure, a "computer-readable medium" can be any medium that can contain, store, or maintain the logic or application described herein for use by or in connection with the instruction execution system. The computer-readable medium can incorporate any one of many physical media such as, for example, magnetic, optical, or semiconductor media. More specific examples of a suitable computer-readable medium include, but are not limited to, magnetic tapes, magnetic floppy diskettes, magnetic hard drives, memory cards, solid-state drives, USB flash drives, or optical discs. Also, the computer-readable medium can be a random access memory (RAM) including, for example, static random access memory (SRAM) and dynamic random access memory (DRAM), or magnetic random access memory (MRAM). In addition, the computer-readable medium can be a read-only memory (ROM), a programmable read-only memory (PROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), or other type of memory device.
[0072] Further, any logic or application described herein can be implemented and structured in a variety of ways. For example, one or more applications described can be implemented as modules or components of a single application. Further, one or more applications described herein can be executed in shared or separate computing devices or a combination thereof. For example, a plurality of the applications described herein can execute in the same computing device, or in multiple computing devices in the same computing environment. Additionally, it is understood that terms such as “application,” “service,”“system,” “engine,” “module,” and so on may be interchangeable and are not intended to be limiting.
[0073] As used herein, the terms "about" or "approximately" for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, "about" or "approximately" may refer to the range of values ±20% of the recited value, e.g., "about 90%" may refer to the range of values from 71% to 99%.
[0074] The disclosed technology described herein can be further understood according to the following clauses:
[0075] Clause 1: A wearable physiological monitoring system comprising: one or more first sensors capable of detecting one or more optical biometric properties of a user; one or more second sensors capable of detecting one or more non-optical biometric properties of the user; and a processor configured to: receive signals from the first sensors and the second sensors; process the received signals based on predefined algorithms; and determine, based on the processed signals, one or more physiological parameters.
[0076] Clause 2: The system of Clause 1, wherein the one or more first sensors comprise a first light source capable of emitting a first set of wavelengths of blue, green, yellow, orange, red, near-infrared, or shortwave infrared light, and one or more detectors capable of detecting the first set of wavelengths.
[0077] Clause 3: The system of Clause 1 or 2, wherein the one or more optical biometric properties comprise one or more of tissue oxygenation, pulse rate, respiratory rate, oxygen saturation, blood pressure, or combinations thereof.
[0078] Clause 4: The system of any one of Clauses 1 to 3, wherein the one or more non- optical biometric properties comprise one or more of electrocardiography (ECG), impedance cardiography (ICG), bioimpedance circuitry, thermal properties, acoustic properties, mechanical properties, or combinations thereof.
[0079] Clause 5: The system of any one of Clauses 1 to 4, further comprising a screen for displaying a visual representation of the one or more physiological parameters.
[0080] Clause 6: The system of any one of Clauses 1 to 5, wherein the one or more physiological parameters comprise Delivery of Oxygen (DO2).
[0081] Clause 7: A system comprising: a monitoring device comprising one or more first sensors capable of detecting one or more optical biometric properties of the user; a flexible substrate for fixing the monitoring device to a user, the flexible substrate comprising one or more second sensors capable of detecting one or more non-optical biometric properties of the user; and a processor configured to: receive signals from the first sensors and the second sensors; process the received signals based on predefined algorithms; and determine, based on the processed signals, one or more physiological parameters.
[0082] Clause 8: The system of Clause 7, wherein the one or more first sensors comprise a first light source capable of emitting a first set of wavelengths of blue, green, yellow, orange, red, near-infrared, or shortwave infrared light, and one or more detectors capable of detecting the first set of wavelengths.
[0083] Clause 9: The system of Clause 7 or 8, wherein the one or more optical biometric properties comprise one or more of tissue oxygenation, pulse rate, respiratory rate, oxygen saturation, blood pressure, or combinations thereof.
[0084] Clause 10: The system of any one of Clauses 7 to 9, wherein the one or more non- optical biometric properties comprise one or more of electrocardiography (ECG cardiography (ICG), bioimpedance circuitry, thermal properties, acoustic properties, mechanical properties, or a combination thereof.
[0085] Clause 11: The system of Clause 10, wherein the one or more second sensors comprise at least one ECG electrode and at least one ICG electrode.
[0086] Clause 12: The system of Clause 11, wherein the monitoring device comprises the processor and an interface for electrical communication of the signals from the second sensors to the processor.
[0087] Clause 13: The system of Clause 7, further comprising an external device in wireless communication with the monitoring device, wherein the external device comprises the processor.
[0088] Clause 14: The system of Clause 13, wherein the external device comprises a screen for displaying a visual representation of the one or more physiological parameters.
[0089] Clause 15: The system of Clause 14, wherein the visual representation of the one or more physiological parameters comprises a graph.
[0090] Clause 16: The system of any one of Clauses 7 to 15, wherein the one or more physiological parameters comprise Delivery of Oxygen (DO2).
[0091] Clause 17: The system of any one of Clauses 7 to 16, wherein the flexible substrate comprises an adhesive patch.
[0092] Clause 18: The system of any one of Clauses 7 to 15, wherein the monitoring device further comprises one or more third sensors comprising a temperature sensor, an accelerometer, an acoustic sensor, or a combination thereof.
[0093] Clause 19: A method of calculating one or more biometric properties of a user, the method comprising: fixing one or more first sensors to the user, the one or more first sensors capable of detecting one or more optical biometric properties of the user; fixing one or more second sensors to the user, the one or more second sensors capable of detecting one or more non-optical biometric properties of the user; transmitting signals acquired by the first sensors and the second sensors to a processor; executing instructions to process the transmitted signal based on one or more predefined algorithms; and outputting one or more physiological parameters of the user.
[0094] Clause 20: The method of Clause 19, wherein the one or more physiological parameters comprise Delivery of Oxygen (DO2).
[0095] While various illustrative embodiments incorporating the principles of the present teachings have been disclosed, the present teachings are not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present teachings and use its general principles. Further, this application is intended to cover such departures from the present disclosure that are within known or customary practice in the art to which these teachings pertain.
[0096] In the above detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the present disclosure are not meant to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that various features of the present disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted,combined, separated, and designed in a wide variety of different configurations, all of which arc explicitly contemplated herein.
[0097] The present disclosure is not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various features. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the ail from the foregoing descriptions. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular- embodiments only, and is not intended to be limiting.
[0098] Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.
Claims
CLAIMS1. A wearable physiological monitoring system comprising: one or more first sensors capable of detecting one or more optical biometric properties of a user; one or more second sensors capable of detecting one or more non-optical biometric properties of the user; and a processor configured to: receive signals from the first sensors and the second sensors; process the received signals based on predefined algorithms; and determine, based on the processed signals, one or more physiological parameters.
2. The system of claim 1, wherein the one or more first sensors comprise a first light source capable of emitting a first set of wavelengths of blue, green, yellow, orange, red, near-infrared, or shortwave infrared light, and one or more detectors capable of detecting the first set of wavelengths.
3. The system of claim 1, wherein the one or more optical biometric properties comprise one or more of tissue oxygenation, pulse rate, respiratory rate, oxygen saturation, blood pressure, or combinations thereof.
4. The system of claim 1, wherein the one or more non-optical biometric properties comprise one or more of electrocardiography (ECG), impedance cardiography (ICG), bioimpedance circuitry, thermal properties, acoustic properties, mechanical properties, or combinations thereof.
5. The system of claim 1, further comprising a screen for displaying a visual representation of the one or more physiological parameters.
6. The system of claim 1, wherein the one or more physiological parameters comprise Delivery of Oxygen (DO2).
7. A system comprising: a monitoring device comprising one or more first sensors capable of detecting one or more optical biometric properties of the user; a flexible substrate for fixing the monitoring device to a user, the flexible substrate comprising one or more second sensors capable of detecting one or more non-optical biometric properties of the user; and a processor configured to: receive signals from the first sensors and the second sensors; process the received signals based on predefined algorithms; and determine, based on the processed signals, one or more physiological parameters.
8. The system of claim 7, wherein the one or more first sensors comprise a first light source capable of emitting a first set of wavelengths of blue, green, yellow, orange, red, near-infrared , or shortwave infrared light, and one or more detectors capable of detecting the first set of wavelengths.
9. The system of claim 8, wherein the one or more optical biometric properties comprise one or more of tissue oxygenation, pulse rate, respiratory rate, oxygen saturation, blood pressure, or combinations thereof.
10. The system of claim 9, wherein the one or more non-optical biometric properties comprise one or more of electrocardiography (ECG), impedance cardiography (ICG), bioimpedance circuitry, thermal properties, acoustic properties, mechanical properties, or a combination thereof.
11. The system of claim 10, wherein the one or more second sensors comprise at least one ECG electrode and at least one ICG electrode.
12. The system of claim 11, wherein the monitoring device comprises the processor and an interface for electrical communication of the signals from the second sensors to the processor.
13. The system of claim 7, further comprising an external device in wireless communication with the monitoring device, wherein the external device comprises the processor.
14. The system of claim 13, wherein the external device comprises a screen for displaying a visual representation of the one or more physiological parameters.
15. The system of claim 14, wherein the visual representation of the one or more physiological parameters comprises a graph.
16. The system of any one of claims 7 to 15, wherein the one or more physiological parameters comprise Delivery of Oxygen (DO2).
17. The system of claim 7, wherein the flexible substrate comprises an adhesive patch.
18. The system of any one of claim 7, wherein the monitoring device further comprises one or more third sensors comprising a temperature sensor, an accelerometer, an acoustic sensor, or a combination thereof.
19. A method of calculating one or more biometric properties of a user, the method comprising : fixing one or more first sensors to the user, the one or more first sensors capable of detecting one or more optical biometric properties of the user; fixing one or more second sensors to the user, the one or more second sensors capable of detecting one or more non-optical biometric properties of the user; transmitting signals acquired by the first sensors and the second sensors to a processor; executing instructions to process the transmitted signal based on one or more predefined algorithms; and outputting one or more physiological parameters of the user.
20. The method of claim 19, wherein the one or more physiological parameters comprise Deliver of Oxygen (DO2).
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