Wearable earpiece oxygen monitor

Abstract

To provide a device for monitoring the oxygen saturation level of a wearer.SOLUTION: The apparatus includes a processor, a memory operably coupled to the processor, a first housing portion, a second housing portion, and a connection member. The first housing portion includes at least one light emitting diode (LED) and the second housing portion includes a light detector. The connecting member is mechanically coupled to each of the first housing portion and the second housing portion. The apparatus is sized and shaped to be worn about a portion of an ear of a wearer of the apparatus. In operation, the at least one LED emits light in a direction towards the photodetector. A portion of the emitted light passes through the portion of the ear before reaching the light detector. The photodetector detects a signal in response to the portion of the emitted light, and the memory stores instructions that cause the processor to calculate an oxygen saturation level of the wearer based on the detected signal.SELECTED DRAWING: Figure 7

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 862,316, entitled "Wearable Earpiece Oxygen Monitor," filed June 17, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0002] Field

[0002] The present disclosure relates to physiological monitoring technology, and more particularly to monitoring oxygen levels of a wearer of a device. [Background technology]

[0003] background

[0003] Medical conditions such as pulmonary hypertension can be treated by providing a patient with supplemental oxygen therapy, which may involve delivering oxygen to a patient continuously or during predetermined events such as exercise or sleep. Summary of the Invention [Means for solving the problem]

[0004] overview

[0004] A device for monitoring a blood oxygen saturation level of a wearer of the device includes a processor, a memory operably coupled to the processor, a first housing portion, a second housing portion, and a connecting member. The first housing portion includes at least one light emitting diode (LED), and the second housing portion includes a photodetector. The connecting member is mechanically coupled to each of the first and second housing portions. The device is sized and shaped to be worn about a portion of the ear of a wearer of the device. In operation, the at least one LED emits light in a direction toward the photodetector. A portion of the emitted light passes through the portion of the ear before reaching the photodetector. The photodetector detects a signal in response to the portion of the emitted light, and the memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the detected signal.

[0005] In some embodiments, a device includes a processor, a memory operably coupled to the processor, at least one light-emitting diode, a photodetector, and a plurality of sensors. The device can be sized and shaped to mechanically attach to a portion of the ear of a wearer of the device. The at least one light-emitting diode is configured, in operation, to emit light in a direction toward the photodetector, a portion of the emitted light passing through the portion of the ear before reaching the photodetector. The photodetector is configured to detect a signal responsive to the portion of the emitted light. The memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the detected signal portion, and store a representation of the calculated blood oxygen saturation level and at least one measurement collected by the plurality of sensors in the memory.

[0006] In some embodiments, the device includes a processor, a memory operably coupled to the processor, a light-emitting diode, and a photodetector. The device is sized and shaped to mechanically attach to a portion of the ear of a wearer of the device. The memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on a signal detected at the photodetector, the signal resulting from the emission of the at least one light-emitting diode. The memory also stores instructions that cause the processor to compare the calculated blood oxygen saturation level with a predetermined threshold blood oxygen saturation level and, in response to detecting that the calculated blood oxygen saturation level is lower than the predetermined blood oxygen saturation level, generate an alert. [Brief explanation of the drawings]

[0007] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1A]

[0007] FIG. 1 is a diagram of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 1B]

[0007] FIG. 1 is a diagram of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 1C]

[0007] FIG. 1 is a diagram of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 1D]

[0007] FIG. 1 is a diagram of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 2A]

[0008] 1 is a rendering of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 2B] 8 is a rendering of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 2C]8 is a rendering of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 2D] 8 is a rendering of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 3]

[0009] FIG. 1 is a schematic diagram illustrating components of a wearable oxygen monitor, according to some embodiments. [Figure 4]

[0010] FIG. 1 is a schematic diagram of a charger for a wearable oxygen monitor, according to some embodiments. [Figure 5]

[0011] 1 is a rendering of a charging case for a wearable oxygen monitor with the wearable oxygen monitor disposed therein, according to some embodiments. [Figure 6]

[0012] FIG. 1 is a schematic diagram of a wearable oxygen monitor showing its internal components, according to some embodiments. [Figure 7]

[0013] 1 is a rendering of a wearable oxygen monitor configured to be worn around the upper portion of a user's ear, according to one embodiment. [Figure 8A]

[0014] 1 is a diagrammatic rendering of a wearable oxygen monitor within a charging case, according to one embodiment. [Figure 8B]

[0014] FIG. 1 is a diagrammatic rendering of a wearable oxygen monitor within a charging case, according to one embodiment. [Figure 8C]

[0015] 1 is a diagrammatic rendering of a wearable oxygen monitor with example dimensions shown, according to one embodiment. [Figure 8D]

[0015] FIG. 1 is a diagrammatic rendering of a wearable oxygen monitor, with example dimensions shown, according to one embodiment. [Figure 9]

[0016] 10 is a wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 10]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 11]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 12]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 13]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 14]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 15]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 16]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 17]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 18]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 19]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 20]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 21]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 22]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 23]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 24]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 25]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 26]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 27]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 28]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 29]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 30]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 31]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 32]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 33]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 34]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 35]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 36]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 37]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 38]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 39]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 40]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 41]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 42]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 43]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 44]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 45]

[0016] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0008] Detailed Description

[0017] Some medical conditions, such as pulmonary hypertension (PH), pulmonary arterial hypertension (PAH), and idiopathic PAH (IPAH), are managed through the administration of oxygen and, in conjunction with this, the monitoring of oxygen levels. However, known devices for monitoring oxygen levels (such as pulse oximeters) are typically worn on a patient's finger for a discontinuous period of time to measure and then removed, for example, because they are not designed for continuous wear or are uncomfortable. Furthermore, when a patient is asleep, they typically do not wear the pulse oximeter and are unable to see the pulse oximeter's digital reading. Therefore, known pulse oximeters may be ineffective in notifying a patient of a critical drop in the patient's oxygen level, for example, when the patient is asleep, which may result in worsening of symptoms or even death. Furthermore, known pulse oximeters do not include automated emergency detection and response capabilities. In other words, if a user takes the initiative to measure their oxygen level and determines that the level is too low, they may take another initiative to address it if they are able to do so themselves (e.g., call a doctor or emergency services using another device such as a phone), potentially wasting valuable time.

[0009]

[0018] Embodiments of the present disclosure include a wearable oxygen monitor that can be worn continuously and that can perform continuous oxygen monitoring, and that alerts the wearer / user when a detected oxygen level detected during oxygen monitoring is below a predetermined or predefined threshold. The wearable oxygen monitor can include an alert mechanism, such as a button or touch screen, that, when interacted with by the user, initiates / activates one or more processes (e.g., stored in the memory of the wearable oxygen monitor and executable via a processor (e.g., microprocessor) of the wearable oxygen monitor). The one or more processes can include an emergency plan. The emergency plan may include, but is not limited to, one or more of contacting emergency services (e.g., initiating a call to 911), sending a short message service (SMS) message (i.e., text message) alert to a pre-programmed phone number (e.g., to the mobile device of the user or other designated person), emitting a sound from a sound generating portion of the wearable oxygen monitor (e.g., an electronic beep effect emitted through a speaker), sending a signal to the mobile device (e.g., via a transceiver mounted on the wearable oxygen monitor) to cause an alert such as a vibration, sound effect, and / or vibration generated by a haptic feedback element (e.g., a piezoelectric transducer) of the wearable oxygen monitor, etc.

[0010]

[0019] In some embodiments, the wearable oxygen monitor is configured to call 911 (or other emergency services) in response to a button press (or other interaction with an alert mechanism) made by the wearer / user, e.g., as part of a defined emergency plan. The wearable oxygen monitor may also include a speaker and microphone so that the oxygen monitor functions as a headset. For example, the wearer / user can hear an emergency dispatcher through the wearable oxygen monitor's speaker and can speak to the emergency dispatcher through the wearable oxygen monitor's microphone. In some implementations, in response to a button press, in addition to calling 911, the wearable oxygen monitor may be configured to simultaneously trigger the generation and transmission (e.g., via a wireless communication channel) of an alert text message to one or more emergency contacts (e.g., three separate emergency contacts) stored in the wearable oxygen monitor's memory and / or accessible by the wearable oxygen monitor via its mobile software application. The alert text message may include one or more of the alert message, the wearer / user's vital signs / biometrics, and an indication that 911 has been called.

[0011]

[0020] In some embodiments, the wearable oxygen monitor is in the form of a wearable, hardware-based earpiece that is sized and shaped to fit and be worn around a portion of the wearer's ear (e.g., the helix, scapha, pinna, or any other portion of the outer ear). The earpiece can clip onto, mechanically attach to, or otherwise grip the portion of the ear. For example, the earpiece includes a gap or recess defined therein that is sized and shaped to receive the portion of the ear. When the ear portion is inserted into or received by the gap or recess, the earpiece can be configured to exert a biasing or spring force that provides a squeezing action around the ear portion so as to be held securely over the wearer's ear. The wearable oxygen monitor may include one or more of: one or more light-emitting diodes (LEDs), one or more light sensors / photodetectors, one or more lightweight, power-efficient wireless sensors (e.g., temperature sensors, pressure sensors, accelerometers, GPS sensors, etc.), a speaker, a microphone, a processor, and memory operatively coupled to the processor. The memory stores instructions executable by the processor during operation. During operation, the one or more LEDs (e.g., red and / or green LEDs) may emit light through the portion of the ear, and the light transmitted through the portion of the ear may be detected at the one or more light sensors / photodetectors. One or more biometric characteristics or vital signs (e.g., blood oxygen level, blood oxygen saturation (SpO2), heart rate, body temperature, pulse rate, respiratory rate, blood pressure, hydration, etc.) may then be calculated based on the amount of light detected at the one or more light sensors / photodetectors and / or based on the amount of light absorbed by the ear (and therefore not reaching the one or more light sensors / photodetectors). For example, blood oxygen saturation (SpO2) can be calculated based on the amount of light absorbed by the ear using Beer's Law (also known as the Beer-Lambert Law, which states that absorbance is proportional to the concentration of one or more attenuating species in a sample of material). In some embodiments, the accuracy of blood oxygen saturation determination increases with the thickness of the ear in which the wearable oxygen monitor is positioned during operation.

[0012]

[0021] In some embodiments, the one or more LEDs include two LEDs, where the first LED is a red (650 nm) LED and the second LED is an infrared (950 nm) LED. During operation, when light from each of the two LEDs passes through adjacent portions of the ear, the light emitted from the first (red) LED is partially absorbed by deoxyhemoglobin in that portion of the ear, and the light emitted from the second (infrared) LED is partially absorbed by oxyhemoglobin in that portion of the ear (the amounts of which can be determined based on the detected light in the photodetector / photosensor). Then, for example, oxygen concentration can be calculated / detected based on the ratio of the amount of light absorbed by deoxyhemoglobin to the amount of light absorbed by oxyhemoglobin. In some embodiments, the one or more LEDs include at least one red and / or infrared LED for detecting the wearer's blood oxygen level and at least one green LED for detecting the wearer's pulse. In some implementations, the determination of blood oxygen level includes an adjustment to the detected signal (e.g., in a photodetector / light sensor) to compensate for ambient or environmental light, such as sunlight. The adjustment can be based, for example, on an additional light sensor positioned on the exterior surface of the wearable oxygen monitor. Such an adjustment can be made, for example, when the wearable oxygen monitor is worn outdoors.

[0013]

[0022] The memory may communicate with / via and / or store software applications compatible with one or more mobile devices (e.g., Windows, iOS, Android). The wearable oxygen monitor may be lightweight, power efficient, and configured to communicate with one or more mobile devices and / or software applications using one or more wireless communication protocols (e.g., Bluetooth, 4G, 5G, etc.). The wearable oxygen monitor earpiece may include a power source that is rechargeable by a wired or wireless charging pod. Charging of the earpiece may occur when the earpiece is at least partially contained within, and optionally in electrical contact with, the charging pod.

[0014]

[0023] In some embodiments, the emergency plan is activated in response to the wearer interacting (e.g., pressing, tapping, manually operating, etc.) with the alert mechanism a predetermined number of times (e.g., 1, 2, 3, 4, etc.) and / or a predetermined frequency (e.g., 3 rapid taps within 1-5 seconds of each other). For example, the wearer can trigger the implementation / deployment of the emergency plan by pressing a button on the wearable oxygen monitor three times.

[0015]

[0024] In some embodiments, the wearable oxygen monitor is configured to connect to and communicate (e.g., via wireless network communication) with a software application running on a mobile device (e.g., a smartphone, tablet, laptop computer, etc.) of the wearable oxygen monitor user / user or another person. The software application can include code that causes storage of all vital signs records (e.g., blood oxygen level, heart rate / pulse, body temperature, hydration level, etc.) detected by one or more sensors on the wearable oxygen monitor, e.g., so that such records can be transmitted to or presented to a healthcare provider. Alternatively or additionally, the software application can facilitate definition / setting / customization of one or more set points or thresholds, e.g., by the wearer / user of the wearable oxygen monitor or other authorized person. The one or more set points or thresholds can include oxygen levels that trigger alerts or alarms. Alternatively or additionally, the software application may facilitate the definition / setting / customization, e.g., by the wearer / user of the wearable oxygen monitor or other authorized person, of one or more emergency contacts to which SMS messages are sent and / or phone calls are made when an alert / alarm is triggered.

[0016]

[0025] In some embodiments, a wearable oxygen monitor includes a processor and a memory operably coupled to the processor. The memory stores instructions executable by the processor during operation. The instructions can include, for example, instructions to calculate oxygen concentration continuously and / or at predetermined intervals (e.g., every 1 second, every 2 seconds, every 3 seconds, every 4 seconds, every 5 seconds, every 6 seconds, every 7 seconds, every 8 seconds, every 9 seconds, every 10 seconds, every 11 seconds, every 12 seconds, every 13 seconds, every 14 seconds, every 15 seconds, every 16 seconds, every 17 seconds, every 18 seconds, every 19 seconds, every 20 seconds, every 21 seconds, every 22 seconds, every 23 seconds, every 24 seconds, every 25 seconds, every 26 seconds, every 27 seconds, every 28 seconds, every 29 seconds, every 30 seconds, every 45 seconds, every 5 minutes, every 10 minutes, every 15 minutes, every 30 minutes, etc.).

[0017]

[0026] The time interval may be configurable by the wearer / user of the wearable oxygen monitor and / or another authorized user, for example, via a software application running on the person's mobile device and via wireless communication with the wearable oxygen monitor. In some embodiments, the instructions include instructions for comparing the measured oxygen concentration level (measured by the wearable oxygen monitor) to a predetermined threshold value stored in the memory of the wearable oxygen monitor. The predetermined threshold value may be configurable by the wearer / user of the wearable oxygen monitor and / or another authorized user, for example, via a software application.

[0018]

[0027] In some embodiments, the wearable oxygen monitor is configured to emit an audible alarm and / or vibration in response to detecting that the wearer / user's oxygen level is below a defined threshold (e.g., indicative of an "alarm condition"). The intensity, volume / volume, and / or frequency of the audible alarm and / or vibration may increase over time until the alarm is acknowledged by the wearer / user (e.g., via the wearer's / user's interaction with an alert mechanism on the wearable oxygen monitor or via a graphical user interface (GUI) rendered by a software application on the wearer's / user's mobile device). Alternatively or additionally, the intensity, volume / volume, and / or frequency of the audible alarm and / or vibration may increase in response to and / or proportion to an increase in the calculated difference between the detected oxygen level and the defined threshold, such that an increase in the intensity, volume / volume, and / or frequency of the audible alarm and / or vibration represents an increase in the severity of the alarm condition. Similarly, the intensity, volume / volume and / or frequency of the audible alarm and / or vibration may be reduced in response to and / or proportionate to a reduction in the calculated difference between the detected oxygen level and the specified threshold, such that an increase in the intensity, volume / volume and / or frequency of the audible alarm and / or vibration represents a reduction in the severity of the alarm condition. The wearable oxygen monitor may terminate the audible alarm and / or vibration when it detects that the current oxygen level is at or above the specified threshold.

[0019]

[0028] In some embodiments, the oxygen level detected by the wearable oxygen monitor (and optionally other sensor data collected by / detected at the wearable oxygen monitor) is stored locally (e.g., within the memory of the wearable oxygen monitor) and / or transmitted (e.g., via the transceiver of the wearable oxygen monitor) to a cloud-based server or other storage repository, e.g., using a software application. The wearable oxygen monitor, the cloud-based server, and / or a software application associated with the wearable oxygen monitor can be configured to analyze the sensor data collected / detected at the wearable oxygen monitor, e.g., to determine one or more condition or biometric parameters based on the sensor data, detect data related to the sensor data over time, etc. The locally stored and / or transmitted data can include, in addition to the detected oxygen level and optional other sensor data, information such as the time and date of a detection event associated with such data, an earpiece identifier, an identifier associated with the wearer, etc. Data stored on the cloud-based server can be downloaded from the cloud-based server by the wearer / user and / or other authorized persons and presented to a physician, e.g., for purposes of diagnosis, investigation of abnormal events, etc. The wearer / user's ability to download data from the cloud-based server can be limited to daily or weekly, for example. Alternatively or additionally, the user can send a request to the cloud-based server, the request including a query specifying a date range for which the user would like to retrieve data. Although described herein as relating to oxygen levels, the systems and methods of the present disclosure can alternatively or additionally be used to detect other biometric characteristics or vital signs, such as heart rate / pulse, body temperature, hydration levels, salinity, etc.

[0020]

[0029] In some embodiments, a mobile software application is configured for use with one or more wearable oxygen monitors of the present disclosure. The mobile software application may be compatible with one or more of Android, iOS, and Windows and may facilitate continuous communication between one or more mobile devices running the mobile software application and the wearable oxygen monitor (e.g., via one or more wireless sensors of the wearable oxygen monitor). The mobile software application may be configured to record / store detected vital signs / biometric characteristics information (e.g., continuously, periodically, intermittently, and / or upon request or user interaction with the mobile software application) and, optionally, upload the detected data to cloud-based storage for future reference. The mobile software application may be configured to transmit and / or receive signals that result in the display, e.g., in the GUI of the wearer / user's mobile device, of one or more of the detected data values ​​(and / or graphical representations thereof, e.g., over time), including, e.g., oxygen level, heart rate, etc. The mobile software application can be configured to identify and / or cause storage (e.g., in a database or other repository) of geometrics (e.g., geographic data such as GPS data) and / or barometrics (e.g., environmental data such as atmospheric pressure) in addition to biometric information detected by the wearable oxygen monitor, and / or track the occurrence of serious / emergency events over time (e.g., as indicated by the triggering of an emergency plan). Data received and / or stored by the software application can include crowd-sourced data (e.g., from multiple different wearable oxygen monitors associated with multiple different wearers, optionally without including identifying information associated with each individual wearer).

[0021]

[0030] In some embodiments, data detected by one or more wearable oxygen monitors and information derived from such data are stored in a common repository and used to train machine learning (ML) or artificial intelligence (AI) algorithms. The trained ML / AI algorithms can be used, for example, to predict future serious / urgent events (i.e., perform predictive analysis) based on current (latest) sensor readings detected on a particular wearer's wearable oxygen monitor. When a future serious / urgent event is predicted, an "early warning" alert can be generated and presented to the wearer / user (e.g., via a GUI on the wearer's mobile device, via a software application running thereon) so that the wearer / user can take remedial or preventative measures (e.g., increase oxygen intake).

[0022]

[0031] 1A-1D are diagrams of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. As shown in FIG. 1B, the wearable oxygen monitor 100 includes a first housing portion 102, a second housing portion 104, a first light-emitting diode (LED) 108A, a second LED 108B, an alert mechanism (e.g., a button) 112, and a connecting member 106 mechanically coupled to each of the first housing portion 102 and the second housing portion 104. Each of the first housing portion 102 and the second housing portion 104, or portions thereof, may be removable and interchangeable with replacement housing "skins" having different appearances (e.g., colors, textures, patterns), for example, to customize the appearance of the wearable oxygen monitor 100. Alternatively or additionally, the wearable oxygen monitor 100 may be compatible with one or more housing portion covers (“shells”) that can fit over one or both of the first housing portion 102 and the second housing portion 104. In other words, separate shell covers can be configured to mechanically accommodate (or fit over) all or a portion of the first housing portion 102 or the second housing portion 104 for customization of the appearance of the wearable oxygen monitor 100.

[0023]

[0032] 2A-2D are renderings of a wearable oxygen monitor 200 configured to be worn around a portion of a user's ear, according to some embodiments. As shown in FIG. 2A , the wearable oxygen monitor 200 includes a first body portion 200A (e.g., having a substantially hemispherical shape) and a second body portion 200B (e.g., having a substantially hemispherical shape) that are mechanically (and optionally electrically) connected to one another via a connecting member 210 (e.g., a "hook"). The first body portion 200A and the second body portion 200B are in an unworn state (e.g., when charging), such that there is a gap between the first body portion 200A and the second body portion 200B (the "first configuration"). The gap can be, for example, about 1 millimeter (mm), about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or between any two of the aforementioned values. The connecting member 210 can include metal, and the gap is expandable to position the wearable oxygen monitor about the portion of the user's ear.

[0024]

[0033] In some embodiments, during placement or "donning" of the wearable oxygen monitor 200, the gap can be expanded by moving the first body portion 200A and the second body portion 200B away from each other, increasing the radius of curvature of the connecting member 210, and / or deforming the connecting member 210. Once positioned at the portion of the user's ear (the "second configuration") and an external force is removed from the wearable oxygen monitor 200, the first body portion 200A and the second body portion 200B can naturally move toward each other a distance equal to the gap, for example, due to the shape memory or inherent spring force of the connecting member 210, to ensure that the wearable oxygen monitor 200 remains securely positioned at the portion of the user's ear during use (e.g., while the user is moving).

[0025]

[0034] 3 is a cross-sectional schematic diagram illustrating internal components of a wearable oxygen monitor, according to some embodiments. As shown in FIG. 3, the wearable oxygen monitor 300 includes a first housing portion 320A (having a substantially hemispherical shape), a second housing portion 320B (having a substantially hemispherical shape), and a connecting member 320C mechanically coupled to each of the first and second housing portions 320A, 320B. The wearable oxygen monitor 300 optionally includes a power (“on” / “off”) button (not shown). The first housing portion 320A includes one or more LEDs 322 (optionally in a row or array), a speaker 334, and a microphone 336, each optionally electrically coupled to a battery 332B or other power source and / or optionally electrically coupled to a battery 332A of the second housing portion 320B via an electrical conduit extending from the first housing portion 320A through the connecting member 320C. The first housing 320A also includes an alert mechanism (e.g., an actuatable button) 327 electrically connected to one of the batteries 332A or 332B and operably coupled to at least one of the processor 326 and the transceiver 330. The second housing portion 320B includes one or more photodetectors 324, a processor 326 operably coupled to a memory 328, and the transceiver 330, the transceiver 330 operably coupled to the processor 326 and configured to send and / or receive communications (e.g., to and from a remote computing device, such as a mobile device of the wearer / user of the wearable oxygen monitor 300 or other authorized person), including, for example, data collected by the one or more photodetectors 324 and / or processor 326 and / or stored in the memory 328.The processor 326 is operatively coupled to and configured to control (e.g., based on processor-executable instructions stored in memory 328 and / or received via transceiver 330) at least one of the one or more LEDs 322, microphone 336, speaker 334, or battery 332B via an electrical conduit (not shown) extending from the first housing portion 320A through connecting member 320C to the second housing portion 320B and / or battery 332B. Each of the photodetector 324, processor 326, and transceiver 330 is optionally electrically coupled to the battery 332A or other power source and / or is optionally electrically coupled to the battery 332B of the first housing portion 320A via an electrical conduit (not shown) extending from the second housing portion 320B through connecting member 320C. In operation, when worn about a portion of a wearer / user's ear, the one or more LEDs 322 emit light through one or more passages / orifices "M," and the emitted light partially passes through (i.e., is transmitted through) and partially absorbed within the portion of the ear in a direction toward one or more photodetectors 324. The one or more photodetectors 324 detect signals in response to the emitted light. In some embodiments, the processor 326 determines the wearer's oxygen level based on the detected signals and, optionally, stores the determined oxygen level in memory 328, optionally along with date information, time information, and / or other sensor data detected based on one or more other sensors (not shown) included in the wearable oxygen monitor 300. Alternatively or additionally, the raw data including the detection signal (optionally along with data detected using one or other sensors) can be transmitted via processor 326 and using transceiver 330 to a remote computing device, such as a cloud-based server, a remote mobile device, etc., for determining oxygen levels based on the raw data.While shown and described with respect to FIG. 3 as being in a particular portion of the wearable oxygen monitor 300 (first housing portion 320A or second housing portion 320B), any component or combination of components of the wearable oxygen monitor 300 (i.e., LED 322, microphone 336, speaker 334, battery 332A, battery 332B, photodetector 324, processor 326, transceiver 330, and / or memory 328) may alternatively be positioned in the first housing portion 320A, the second housing portion 320B, or both, depending on the particular embodiment.

[0026]

[0035] FIG. 4 is a schematic diagram of a charger for wearable oxygen monitor 400 in an open configuration, according to some embodiments. FIG. 5 is a rendering of a charger similar to that of FIG. 4 , with a wearable monitor earpiece disposed therein (500), according to some embodiments. Charging of the earpiece can occur when the earpiece is at least partially contained within, and optionally in electrical contact with, a charging pod. As shown in FIGS. 4 and 5 , the charger can include a divider around which the earpiece is positioned when in the charging configuration. In some embodiments, the charger for wearable oxygen monitor 300 and / or wearable oxygen monitor 400 includes an outer “shell” or “housing” that is removable so that a replacement shell or housing (e.g., having a different appearance, such as color, texture, pattern, etc.) can be substituted for the original shell or housing.

[0027]

[0036] A wearable oxygen monitor of the present disclosure, according to some embodiments, can include one or more (eg, any combination) of the following features: Continuous oxygen monitoring, Heart rate monitoring, · Generate and send alerts; · Activation of predefined emergency plans; Interaction with a mobile software application; and / or · Predictive analytics.

[0028]

[0037] In some embodiments, a wearable monitoring system includes a wearable oxygen monitor and a mobile software application ("mobile app") executing on a computing device of a user or wearer of the wearable oxygen monitor. During operation of the wearable oxygen monitor (i.e., when the wearable oxygen monitor is powered on and worn by the wearer), the wearable oxygen monitor can continuously monitor the wearer's oxygen level, for example, by comparing the measured oxygen level to a predefined oxygen level threshold. Based on the monitoring and in response to detecting that the measured oxygen level is below the predefined oxygen level threshold, the wearable oxygen monitor can generate an alert including a representation of the hypoxic condition and send a signal representative of the alert to the mobile app, causing the alert (including one or more of text, graphics, video instructions, and audio instructions) to be displayed and / or played by the mobile app and the computing device (e.g., via a graphical user interface (GUI) of the computing device and / or one or more speakers of the computing device).

[0029]

[0038] In some embodiments, during operation, the wearable oxygen monitor detects data related to one or more physiological conditions of the wearer (collectively referred to herein as “vital signs”), e.g., at multiple stages over time, including but not limited to oxygen level, heart rate, etc. In response to detecting a vital sign, the wearable oxygen monitor can store the vital sign in the wearable oxygen monitor's memory. Alternatively, or in combination, the wearable oxygen monitor can transmit signals representing the vital signs to one or more remote computing devices (e.g., the user's / wearer's mobile computing device, optionally running a mobile app) for storage and / or display (e.g., via a GUI). The vital signs may be substantially accessible and searchable by the wearer or user. Additionally, the wearer can provide a physician with access to the vital signs, for example, by providing the physician with access credentials (for the wearable oxygen monitor and / or mobile app) and / or by generating and sending an email or other message containing a representation of the vital signs to the physician (via the mobile app).

[0030]

[0039] In some embodiments, a wearable monitoring system includes a wearable oxygen monitor and a mobile app running on a computing device of a user or wearer of the wearable oxygen monitor. The wearable monitoring system is configured to generate and send one or more alerts when vital signs are determined to not meet a predetermined condition (optionally customizable by the wearer / user). For example, the wearable monitoring system (e.g., the wearable oxygen monitor and / or the mobile app) can be configured to generate and send one or more alerts when the oxygen level measured by the wearable oxygen monitor falls below a predefined (optionally customizable) level (also referred to herein as a "trigger" or "threshold"). Additionally, the wearable monitoring system can be configured to generate and transmit one or more alerts in response to a user / wearer pressing an alert mechanism (e.g., an activation button) of the wearable oxygen monitor or otherwise interacting with the wearable oxygen monitor (examples of which include, but are not limited to, a voice command, rotating a component of the wearable oxygen monitor, sliding a component of the wearable oxygen monitor, pressing or squeezing a component of the wearable oxygen monitor (e.g., for a predefined time, with a predefined amount of force, a predefined number of consecutive times (e.g., three times), in a predefined pattern, etc.), removing a component of the wearable oxygen monitor, removing the wearable oxygen monitor entirely from the wearer's ear, etc.).

[0031]

[0040] The one or more alerts may include a representation of a "hypoxic" condition and / or associated instructions to perform one or more commands, such as initiating a call or otherwise contacting emergency services (e.g., 911) (e.g., via a mobile device running a mobile app), sending an SMS, email, or other message to one or more emergency contacts, emitting a sound from a sound output portion of the wearable oxygen monitor (e.g., an electronic beep effect emitted through a speaker), causing a vibration to be generated by a haptic feedback element (e.g., a piezoelectric transducer) of the wearable oxygen monitor, sending a signal to a mobile device (e.g., via a transceiver carried by the wearable oxygen monitor) to cause an alert, such as a sound effect and / or vibration. The user or wearer, via the mobile app, can determine customized values ​​for one or more of the following: threshold oxygen level; detection interval (e.g., for oxygen level, blood oxygen saturation level, or other vital sign); frequency of vital sign calculation (e.g., to calculate oxygen concentration at 1-30 second intervals); thresholds for other vital signs and / or biometric characteristics; emergency contact information (e.g., phone number, email address, name, etc.); emergency planning data; vital sign priority; emergency contact priority; access permissions for healthcare providers;

[0032]

[0041] In some embodiments, the wearable monitoring system includes predictive analytics functionality and / or interacts with a predictive analytics system to provide advance warning (“pre-warning”) to the wearer or user before a serious health episode occurs, for example, by identifying / detecting patterns based on the wearer's / user's previous serious health episodes. The predictive analytics functionality may be implemented using software (e.g., artificial intelligence (AI), machine learning, or other algorithms) and / or hardware. Pattern identification / detection may be performed by analyzing biometric feature data (including vital signs and / or other data detected and / or collected by the wearable monitoring system), optionally in combination with geographic feature data and / or barometric feature data collected using the wearable monitoring system. For example, the collected geographic feature data and / or barometric feature data may be compared with historical data relating to the occurrence of hypoxia alerts / warnings and / or the occurrence of emergency services calls (e.g., 911 calls) to identify one or more patterns or correlations that can be used to predict the wearer's next alert, predict a set of conditions under which the wearer is likely to experience an alert event, generate one or more advance warnings for display via the GUI of the wearer's mobile computing device, etc.

[0033]

[0042] In some embodiments, the wearable monitoring system includes a wearable hardware-based earpiece and a mobile app compatible with Windows®, iOS®, and Android® computing devices. The earpiece may be, for example, Bluetooth®, BLE®, ZigBee®, Z-Wave®, 6LoWPAN®, Thread®, WiFi-ah® (HaLow®), 2G® (GSM), 3G®, 4G®, LTE® Cat 0®, Cat 1®, Cat 3®, LTE-M1®, Narrowband IoT® (NB-IoT®), 5G®, NFC®, RFID, SigFox®, LoRaWAN®, Ingenu®, Weightless-N®, Weightless-P®, Weightless-W®, ANT®, ANT+®, DigiMesh®, MiWi®, EnOcean®, Dash7® or The earpiece is configured to communicate with a computing device running a mobile app using a power-efficient, lightweight wireless protocol such as WirelessHART®. The earpiece includes one or more of the following components: one or more light-emitting diodes (LEDs), one or more light sensors / photodetectors, one or more lightweight, power-efficient wireless sensors, a speaker, a microphone, one or more air quality monitoring sensors, and one or more body temperature sensors. During operation of the earpiece, the one or more LEDs can transmit light generated by the one or more LEDs to a portion of the ear of a wearer of the earpiece such that the transmitted light is detected by the one or more light sensors / photodetectors, the one or more light sensors / photodetectors being positioned on an opposite side of the ear portion compared to the one or more LEDs.The amount of light absorbed by the ear can be determined / calculated based on the amount of transmitted light detected by one or more optical sensors / detectors. Then, based on the amount of light absorbed by the ear, a blood oxygen saturation (SpO2) level can be calculated using, for example, the Beer-Lambert Law ("Beer's Law"). Calculating the amount of light absorbed by the ear and / or calculating the SpO2 level can be performed by a processor in the earpiece, by a mobile app, and / or via a processor in a remote computing device in communication with the earpiece.

[0034]

[0043] In some embodiments, the wearable monitoring system includes a wearable hardware-based earpiece (wearable oxygen monitor), a charger (e.g., a charging “pod,” as shown in FIG. 4 ), and a mobile app. The wearable oxygen monitor can be in continuous communication via the mobile app, for example, using one or more wireless antennas or sensors. The charger can be a wireless charger configured to wirelessly charge the earpiece when the earpiece is at least partially housed within the charger (and optionally, when the charger cover or lid is closed). The earpiece can be configured to generate and / or transmit an alert in response to detecting that the wearer's oxygen level is below a predefined threshold. Additionally, the earpiece can be configured to generate and / or transmit multiple alerts in response to detecting that the wearer's oxygen level is below a predefined threshold multiple times over time. In response to detecting an increasing difference between the wearer's measured / detected / calculated oxygen levels and the predefined thresholds over time (i.e., the wearer's measured / detected / calculated oxygen levels are decreasing over time and are all below the predefined thresholds), the frequency with which alerts are generated and / or transmitted can be increased. Similarly, in response to detecting a decreasing difference between the wearer's measured / detected / calculated oxygen levels and the predefined thresholds over time (i.e., the wearer's measured / detected / calculated oxygen levels are increasing over time and are all below the predefined thresholds), the frequency with which alerts are generated and / or transmitted can be decreased. Additionally, in response to detecting an increasing difference between the wearer's measured / detected / calculated oxygen levels and the predefined thresholds over time, the strength or severity of the alert can be increased over time and / or the type of alert generated / sent can be changed over time.For example, the volume of the sound emitted (from the wearable oxygen monitor and / or from the computing device running the mobile app) may be increased, the rate of a blinking light (in the wearable oxygen monitor and / or on the computing device running the mobile app) may be increased, the text description of the alert (e.g., presented to the wearer / user via the GUI of the mobile device running the mobile app) may be changed from "low" to "medium" or from "medium" to "high", etc. Similarly, the intensity of the alert may be reduced over time and / or the alert generated / transmitted may be increased in response to detecting a decreasing difference over time between the wearer's measured / detected / calculated oxygen level and the predefined threshold. The type of alert can be changed over time. For example, the sound emitted (from the wearable oxygen monitor and / or from the computing device running the mobile app) can be quieted / softened, the rate of a flashing light (on the wearable oxygen monitor and / or on the computing device running the mobile app) can be reduced, the text description of the alert (e.g., presented to the wearer / user via the GUI of the mobile device running the mobile app) can change from "high" to "medium" or from "medium" to "low," etc. The alert can be terminated when the wearer's most recently measured / detected / calculated oxygen level reaches a "normal" level (e.g., at or above a predefined threshold).

[0035]

[0044] The embodiments described herein can be used to monitor the symptoms of, predict the progression of, and / or be part of a treatment plan for one or more medical conditions, such as pulmonary hypertension (PH), pulmonary arterial hypertension (PAH), idiopathic PAH (IPAH), pulmonary fibrosis, scleroderma, cystic fibrosis, lupus, sickle cell anemia, asthma, chronic obstructive pulmonary disease (COPD), heart disease, and Eisenmenger's syndrome.

[0036]

[0045] In some embodiments, the wearable oxygen monitor is configured to continuously or intermittently monitor vital signs such as oxygen level and heart rate and transmit data associated with the vital signs (e.g., via a mobile app) for storage in records in memory or other storage repository. In some such cases, when storing the vital signs, the mobile app may also provide for the storage of some or all of the following additional information: the wearer's GPS location information, the wearer's altitude (e.g., retrieved using a Google Application Programming Interface (API)), a room air quality index (e.g., detected by the wearable oxygen monitor's onboard sensors), environmental temperature, and environmental humidity level.

[0037]

[0046] The wearer or user of the wearable oxygen monitor can later retrieve / download the records (e.g., based on a specified date or date range) and present them to their physician, for example, for purposes of diagnosis and / or investigation of the causes behind undesirable fluctuations. Alternatively or additionally, the records can be automatically downloaded and emailed to the wearer and / or other users, healthcare providers, etc., for example, according to a predefined, customizable schedule (e.g., daily, weekly, monthly).

[0038]

[0047] In some embodiments, the wearable oxygen monitor is configured to initiate a call to emergency services (e.g., 911) in response to the wearer or user pressing an alert mechanism (e.g., an enable button on the wearable oxygen monitor) or otherwise interacting with the wearable oxygen monitor's interface. The button press (or other interaction) can trigger activation of an onboard speaker and microphone to facilitate the call so that the wearer or user can speak into the microphone and listen to the other party on the call via the speaker. This allows the wearer / user to notify emergency services of the situation and call for appropriate assistance. Optionally, the button press (or other interaction) can also (e.g., simultaneously) trigger the generation of an alert and wireless transmission via SMS text message to one or more user-defined emergency contact telephone numbers (e.g., as defined in a mobile app).

[0039]

[0048] Alternatively or additionally, in some embodiments, the wearable oxygen monitor is configured to generate and send an SMS text message to one or more (e.g., three) emergency contacts predefined by the wearer (e.g., as part of a predefined emergency plan) in response to the wearer or user (e.g., a bystander) pressing a button on the wearable oxygen monitor (or otherwise interacting with the wearable oxygen monitor's interface). The SMS text message may include one or more of the following: an alert message, the wearer's vital signs data, the wearer's current GPS location, and an indication of whether emergency services (e.g., 911) have already been called.

[0040]

[0049] In some embodiments, during operation, the wearable oxygen monitor is positioned over a portion of the wearer's ear and can be in continuous communication (e.g., via one or more wireless antennas, such as Bluetooth, 4G, or 5G antennas) with a mobile app simultaneously running on the wearer's mobile computing device. The wearable oxygen monitor detects the wearer's oxygen level and heart rate, either continuously or intermittently over time, and transmits signals that result in a display of the wearer's detected oxygen level and heart rate via a GUI on the wearer's mobile computing device. The display of the detected oxygen level and heart rate can be in the form of, for example, a graph, plot, or chart. The display can be dynamically updated in real time or substantially in real time in response to new measurements of oxygen level and heart rate. When triggered, an alert can be displayed in the GUI along with or instead of the displayed data.

[0041]

[0050] In some embodiments, the wearable oxygen monitor is an internet-of-things (IoT) device and includes an on-board Long Term Evolution (LTE) module / chip for 5G connectivity to other computing devices in the IoT.

[0042]

[0051] Figure 6 is a schematic diagram of a wearable oxygen monitor 600 in cross section and showing its internal components, according to some embodiments. As shown in Figure 6, and similar to the wearable oxygen monitor 300 of Figure 3, the wearable oxygen monitor 600 includes a first housing portion 600A (a left side having a substantially hemispherical shape), a second housing portion 600B (a right side having a substantially hemispherical shape), and a connecting member 610 mechanically coupled to each of the first housing portion 600A and the second housing portion 600B. The first housing portion 600A includes one or more air quality sensors 640, a speaker 642, an alert mechanism (e.g., an actuatable button) 615, and a microphone 644. In some such embodiments, two or more of the microphone 644, speaker 642, and one or more air quality sensors 640 “share” a common opening in the outer shell / wall of the first housing portion 600A (i.e., open to the outside air through a common opening), while the remainder of the outer shell / wall of the first housing portion 600A, along with the entire outer shell / wall of the second housing portion 600B, are sealed and waterproofed. The one or more air quality sensors 640 may be configured to detect one or more of biogenic volatile compounds (BVOCs), temperature, humidity, carbon monoxide, carbon dioxide, sulfur dioxide, nitrous oxide, particulate matter, ozone, and / or other gases. For example, in some embodiments, the one or more air quality sensors 640 are configured to detect temperature, humidity, and one or more BVOCs and output a relative “score” of the ambient air quality. Alternatively or additionally, the first housing portion 600A and / or the second housing portion 600B may include Bluetooth® 5.1 Direction Finding functionality, for example, to determine the relative locations of multiple users (e.g., patients in a hospital).

[0043]

[0052] The first housing portion 600A also includes one or more of one or more photodetectors 646A (e.g., photodiodes), one or more light emitting diodes (LEDs) 648 (e.g., two LEDs), one or more body temperature sensors 650, and an optional battery 652A. The battery 652A may be a rechargeable battery or a non-rechargeable battery. The body temperature sensor 650 may include one or more thermal conductivity probes and / or one or more non-contact temperature sensors, such as a thermopile infrared (IR) sensor.

[0044]

[0053] The second housing portion 600B includes a processor 660, an analog processing circuit 654, one or more internal measurement sensors 656, one or more wireless transceivers 658, and a memory 662. The one or more internal measurement sensors 656 may include, for example, one or more of an altimeter, a gyroscope, an accelerometer, a GPS sensor, a magnetic sensor, a galvanic skin response (GSR) sensor, or a humidity sensor. The processor 660 is operably coupled to each of the analog processing circuit 654, the one or more internal measurement sensors 656, the one or more wireless transceivers 658, and the memory 662. The second housing portion 600B also includes one or more photodetectors 646B electrically coupled / connected to the analog processing circuit 654, an alert mechanism (e.g., an actuatable button) 616, and / or an optional battery 652B electrically coupled / connected to the processor 660. The battery 652B may be a rechargeable battery or a non-rechargeable battery. As shown by dashed lines in FIG. 6 , electrical connections can exist between components in either or both of the first housing portion 600A and the second housing portion 600B (i.e., some or all of one or more air quality sensors 640, speaker 642, microphone 644, one or more photodetectors 646A, one or more light-emitting diodes (LEDs) 648, one or more body temperature sensors 650, processor 660, one or more photodetectors 646B, analog processing circuit 654, one or more internal measurement sensors 656, or one or more wireless transceivers 658, alert mechanism 615, alert mechanism 616, processor 600) and one or both of battery 652A and battery 652B via connecting member 610 of the wearable oxygen monitor 600. The alert mechanism 615 and / or the alert mechanism 616 may be electrically connected and / or operatively / communicatively coupled to one or more of the battery 652A, the battery 652B, the processor 660, the analog processing circuitry 654, or the wireless transceiver 658.

[0045]

[0054] The processor 660 may be configured to control (e.g., turn on and off) one or more of the air quality sensors 640, the speaker 642, the microphone 644, the one or more photodetectors 646A, the one or more photodetectors 646B, the one or more light-emitting diodes 648, the one or more body temperature sensors 650, the battery 652A, the battery 652B, the analog processing circuit 654, the internal measurement sensor 656, and / or the wireless transceiver 658. Alternatively or additionally, the processor may be configured to receive signals, measurements, and / or data from one or more of the air quality sensors 640, the microphone 644, the one or more photodetectors 646A, the one or more photodetectors 646B, or the one or more body temperature sensors 650. Memory 662 may store instructions that cause processor 660 to perform analyses or calculate one or more measurements based on measurements and / or data detected / generated by sensors and other components included in wearable oxygen monitor 600. For example, memory 662 may store instructions that cause processor 660 to predict or evaluate whether an alert event (e.g., a detected episode of hypoxia) was caused by a physical reason or an environmental factor. Processor 660 may store measurements and / or data in memory 662 and retrieve the stored data, for example, for inclusion in a mobile app and / or a signal transmitted to one or more remote computing devices via wireless transceiver 658, and optionally for presentation via a GUI of one or more remote computing devices. In addition to measurements and / or data generated by sensors and other components included in wearable oxygen monitor 600, memory 662 may also store processor-executable instructions (software) that cause the processor to operate as well as implement one or more user-customizable emergency plans, as discussed herein.

[0046]

[0055] In some embodiments, memory 662 stores instructions that cause processor 660 to detect when alert mechanism 615 and / or alert mechanism 616 have been interacted with (e.g., pressed) by the wearer (i.e., a manual alert), and, in response to detecting that alert mechanism 615 and / or alert mechanism 616 have been interacted with, generate and transmit (via a wireless transceiver) a message to one or more emergency contacts stored in memory 662 (e.g., as part of an emergency plan stored in memory 662). The memory 662 may also store instructions that cause the processor 660, in response to detecting that the alert mechanism 615 and / or the alert mechanism 616 have been interacted with, to initiate a call to emergency services (911), activate the speaker 642, activate the microphone 644, emit an audio sound indicating an alert, emit a light indicating an alert, generate and send an alert message to a mobile app (via the wireless transceiver) for presentation to a user via a GUI of the user's computing device, and store in memory an alert record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor 600 (e.g., air quality sensor 640, photodetectors 646A, 646B, body temperature sensor 650, internal measurement sensor 656) at the time of the alert.

[0047]

[0056] Alternatively or additionally, memory 662 may store instructions that cause processor 660 to compare one or more measurements collected by one or more components of wearable oxygen monitor 600 with predetermined thresholds stored in memory 662. The processor may detect that an alarm condition exists when it determines that one or more measurements are undesirably below or undesirably above the predetermined threshold. Memory 662 may also store instructions that cause processor 660, in response to detecting an alarm condition, to generate and send a message to one or more emergency contacts stored in memory 662 (e.g., as part of an emergency plan stored in memory 662). The memory 662 may also store instructions that cause the processor 660, in response to detecting an alarm condition, to initiate a call to emergency services (911), activate the speaker 642, activate the microphone 644, emit an audio signal indicating an alarm, emit a light indicating an alarm, generate and transmit an alert message to a mobile app (via the wireless transceiver) for presentation to a user via a GUI of the user's computing device, and store in memory an alert record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor 600 (e.g., air quality sensor 640, photodetectors 646A, 646B, body temperature sensor 650, internal measurement sensor 656) at the time of the alert.

[0048]

[0057] In some embodiments, the first housing portion 600A of the wearable oxygen monitor 600 includes a battery 652A, and the second housing portion 600B of the wearable oxygen monitor 600 does not include a battery 652B. In such embodiments, a single battery 652A can power the components in each of the first housing portion 600A and the second housing portion 600B (i.e., one or more air quality sensors 640, a speaker 642, a microphone 644, one or more photodetectors 646A, one or more light-emitting diodes (LEDs) 648, one or more body temperature sensors 650, a processor 660, an analog processing circuit 654, one or more internal measurement sensors 656, or one or more wireless transceivers 658). In other embodiments, the second housing portion 600B of the wearable oxygen monitor 600 includes a battery 652B, and the first housing portion 600A of the wearable oxygen monitor 600 does not include a battery 652A. In such an embodiment, a single battery 652B can provide power to the components in each of the first housing portion 600A and the second housing portion 600B (i.e., one or more air quality sensors 640, a speaker 642, a microphone 644, one or more photodetectors 646A, one or more light-emitting diodes (LEDs) 648, one or more body temperature sensors 650, a processor 660, an analog processing circuit 654, one or more internal measurement sensors 656, or one or more wireless transceivers 658).In yet another embodiment, the first housing portion 600A of the wearable oxygen monitor 600 includes a battery 652A, and the second housing portion 600B of the wearable oxygen monitor 600 includes a battery 652B, for example, the battery 652A powers the components within the first housing portion 600A of the wearable oxygen monitor 600 (i.e., one or more air quality sensors 640, a speaker 642, a microphone 644, one or more photodetectors 646A, one or more light-emitting diodes (LEDs) 648, and / or one or more body temperature sensors 650), and the battery 652B powers the components within the second housing portion 600B of the wearable oxygen monitor 600 (i.e., a processor 660, an analog processing circuit 654, one or more internal measurement sensors 656, and / or one or more wireless transceivers 658).

[0049]

[0058] Alternatively or additionally, in some embodiments, the first housing portion 600A of the wearable oxygen monitor 600 includes one or more photodetectors 646A, and the second housing portion 600B of the wearable oxygen monitor 600 does not include one or more photodetectors 646B. In other embodiments, the second housing portion 600B of the wearable oxygen monitor 600 includes one or more photodetectors 646B, and the first housing portion 600A of the wearable oxygen monitor 600 does not include one or more photodetectors 646A. In yet other embodiments, the first housing portion 600A of the wearable oxygen monitor 600 includes one or more photodetectors 646A, and the second housing portion 600B of the wearable oxygen monitor 600 includes one or more photodetectors 646B.

[0050]

[0059] To begin using the wearable oxygen monitor 600, the wearer positions the wearable oxygen monitor 600 in the wearing configuration around a portion of the wearer's ear (e.g., the helix, scapha, or upper portion of the ear, such as the pinna). In a first example wearing configuration, the first housing portion 600A of the wearable oxygen monitor 600 contacts or is adjacent to the front or anterior surface of the ear, and the second housing portion 600B of the wearable oxygen monitor 600 contacts or is adjacent to the posterior or posterior / back surface of the ear. In a second example wearing configuration, the second housing portion 600B of the wearable oxygen monitor 600 contacts or is adjacent to the front or anterior surface of the ear, and the first housing portion 600A of the wearable oxygen monitor 600 contacts or is adjacent to the posterior or posterior / back surface of the ear. In other words, when the wearable oxygen monitor 600 is worn, the first housing portion 600A and the second housing portion 600B are positioned on opposite sides of the wearer's ears.

[0051]

[0060] In some embodiments, the first housing portion 600A of the wearable oxygen monitor 600 includes one or more photodetectors 646A, and the second housing portion 600B of the wearable oxygen monitor 600 includes one or more photodetectors 646B. During use and operation of the wearable oxygen monitor 600, the one or more light emitting diodes 648 can emit light along the direction of the arrow labeled "T" in FIG. 6, with at least a portion of the emitted light being transmitted or propagated through a portion of the wearer's ear and detected at the photodetector 646B in the second housing portion 600B (referred to herein as "transmission detection"). Also as shown in FIG. 6, at least a portion of the emitted light is reflected (e.g., along the direction of the arrow labeled "R" in FIG. 6) and detected at the photodetector 646A in the first housing portion 600A (referred to herein as "reflection detection"). In some such embodiments, the one or more light emitting diodes 648 include two light emitting diodes 648, i.e., one for transmission sensing and one for reflection sensing. A first light emitting diode 648 from the two light emitting diodes 648 can be configured to emit light having a first wavelength, and a second light emitting diode 648 from the two light emitting diodes 648 can be configured to emit light having a second wavelength that is different from the first wavelength.

[0052]

[0061] With respect to FIG. 6 , while shown and described as being in a particular portion of the wearable oxygen monitor 600 (first housing portion 600A or second housing portion 600B), any component or combination of components of the wearable oxygen monitor 600 (i.e., air quality sensor 340, speaker 642, microphone 644, photodetector 646A, LED 648, body temperature sensor 650, battery 652A, battery 652B, photodetector 646B, analog processing circuitry 654, internal measurement sensor 656, processor 660, wireless transceiver 658, and / or memory 662) may alternatively be positioned in the first housing portion 600A, the second housing portion 600B, or both, depending on the particular embodiment.

[0053]

[0062] In some embodiments, memory 662 stores instructions that cause processor 660 to calculate one or more scores based on readings / measurements from one or more of air quality sensor 640, photodetectors 646A, 646B, body temperature sensor 650, or internal measurement sensor 656. Memory 662 may also store instructions that cause processor 660 to perform an alert-related action in response to determining that one or more of the calculated scores is below a predefined minimum threshold or above a predefined maximum threshold. The alert-related actions may include one or more of initiating a call to emergency services (911), activating the speaker 642, activating the microphone 644, emitting an audio signal indicating an alert, emitting a light indicating an alert, generating and transmitting an alert message to a mobile app (via a wireless transceiver) for presentation to a user via a GUI of the user's computing device, and causing storage in memory of an alert record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor 600 (e.g., air quality sensor 640, photodetectors 646A, 646B, body temperature sensor 650, internal measurement sensor 656) at the time of the alert.

[0054]

[0063] Alternatively or additionally, memory 662 may store instructions that cause processor 660 to compare one or more scores, ranges, or thresholds stored in memory 662 with one or more readings / measurements from one or more of air quality sensor 640, photodetectors 646A, 646B, body temperature sensor 650, or internal measurement sensor 656 to determine whether an out-of-tolerance condition exists. Memory 662 may also store instructions that cause processor 660 to perform an alert-related action in response to determining that an out-of-tolerance condition exists. The alert-related actions may include one or more of initiating a call to emergency services (911), activating the speaker 642, activating the microphone 644, emitting an audio signal indicating an alert, emitting a light indicating an alert, generating and transmitting an alert message to a mobile app (via a wireless transceiver) for presentation to a user via a GUI of the user's computing device, and causing storage in memory of an alert record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor 600 (e.g., air quality sensor 640, photodetectors 646A, 646B, body temperature sensor 650, internal measurement sensor 656) at the time of the alert.

[0055]

[0064] 7 is a rendering of a wearable oxygen monitor 700 configured to be worn around the upper portion of a user's ear, according to one embodiment. As shown in FIG. 7, when worn by a wearer, the wearable oxygen monitor 700 can be positioned around the helix, scapha, pinna, or earlobe of the ear, with a connecting member 710 of the wearable oxygen monitor 700 (joining the first and second housing portions of the wearable oxygen monitor) crossing the upper edge of the ear and mechanically supporting the wearable oxygen monitor 700 in place.

[0056]

[0065] 8A and 8B are diagrammatic renderings of a wearable oxygen monitor 800 within a portable charging case 850, according to one embodiment. As shown in FIG. 8A , the portable charging case 850 includes a charging port 852 for electrically connecting to a power source. The portable charging case 850 includes a plurality of pockets, receptacles, chambers, or recesses defined therein that can at least partially accommodate and position / stabilize the wearable oxygen monitor 800. When the wearable oxygen monitor 800 is at least partially accommodated within the pocket or recess, the wearable oxygen monitor 800 can be wirelessly charged by the portable charging case 850 when the portable charging case 850 is connected to a power source via the charging port 852, and optionally, when a rechargeable battery (not shown) within the portable charging case 850 is at least partially charged and is no longer connected to a power source via the charging port 852.

[0057]

[0066] 8C and 8D are diagrammatic renderings of a wearable oxygen monitor (such as wearable oxygen monitor 800 of FIGS. 8A and 8B) with example dimensions, according to one embodiment. As shown in FIG. 8C, the wearable oxygen monitor has a maximum width of 18.9 mm and a maximum height of 28.1 mm. As shown in FIG. 8D, the wearable oxygen monitor has a clearance of 1 mm to 4 mm, a maximum depth of 27.3 mm, and a connecting member radius of curvature of 7.3 mm.

[0058]

[0067] 9-45 are wireframes of user interface screens (for GUI display) of a mobile app (e.g., running on a mobile computing device) that interacts with a wearable oxygen monitor, according to some embodiments. As shown in FIG. 9 , a user of the mobile app (and optionally a wearer of an associated wearable oxygen monitor, as shown and described herein) can create a user profile in the mobile app. Creating a user profile can include specifying one or more medications the user is currently taking or has taken in the past. The user interface can include a search bar in which the user can enter search criteria related to one or more medications and, by pressing the Enter key, cause a search to be performed for matches to the search criteria. Results identified via the search can then be displayed for selection via the user interface. The user can “add” a medication to their user profile by clicking the “+” sign next to the associated medication. Also shown in FIG. 9 are the available / navigable screens: “Dashboard,” “Reports,” “Medical ID,” “Progress,” and “Diary.”

[0059]

[0068] FIG. 10 illustrates that creating a user profile can also include specifying one or more symptoms the user is currently experiencing or has experienced in the past. The user interface can include a search bar where the user can enter search criteria related to one or more symptoms and, by pressing the Enter key, cause a search to be performed for matches to the search criteria. Results identified via the search can then be displayed for selection via the user interface. The user can "add" a symptom to their user profile by clicking the "+" sign next to the associated symptom. The user interface also includes an "emergency" button that the user can select to trigger one or more alerts to be generated and / or sent. For example, selecting an "emergency" button, similar to pressing an alert mechanism of a wearable oxygen monitor described herein, can trigger one or more of the following: generating and sending a message to one or more emergency contacts (e.g., stored as part of an emergency plan), initiating a call to emergency services (911), activating the speakerphone of the mobile computing device, emitting a sound indicating an alert, emitting a light (e.g., of a predetermined color and / or pattern) indicating an alert, displaying an alert message via a user interface, and causing storage in memory of an alert record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor. Figure 11 shows the alerts and notifications user interface, through which a user can turn alerts and notifications on or off using a slider.

[0060]

[0069] FIGS. 12-16 show welcome screens describing the functionality of the mobile app, through which a user can sign up for the service (see FIG. 13), log in to the mobile app, and set up and personalize the mobile app. The mobile app can be personalized, for example, to include a representation of one or more safe blood oxygen saturation (SpO2) thresholds, and to generate a warning or alert when the wearer's SpO2 is detected as too low by the wearable oxygen monitor. FIG. 17 shows a synchronization request, in which the mobile app requests user input ("OK") to allow the mobile app to establish a Bluetooth® connection and synchronize the mobile app with the wearable oxygen monitor via the Bluetooth® connection. FIG. 18 shows the user interface appearance during synchronization. FIG. 19 shows a login screen, and FIG. 20 shows a user's "Get Started" option, for example, after the user's initial login event. 21-33 show user interfaces for questionnaires (e.g., presented sequentially) requesting input from the user regarding whether the user is from the United States, desired emergency thresholds for oxygen level, heart rate, altitude, and air quality, settings (alerts and notifications, location services, unit selection, language selection, app syncing, and other personalization settings), profile data (name, age, gender, weight, pulmonary hypertension (PH) classification (e.g., pulmonary arterial hypertension (PAH), pulmonary hypertension due to left heart disease, chronic obstructive pulmonary disease, chronic thromboembolic pulmonary hypertension (CTEPH), or pulmonary hypertension of unknown multifactorial mechanism), safety thresholds, medications, and allergies / reactions), diary personalization, emergency information (emergency contacts, physician records, records for EMS), gender, year and month of birth, weight, whether or not the user has cardiovascular disease, and whether or not the user has pulmonary hypertension (and, if so, its World Health Organization (WHO) classification).

[0061]

[0070] FIG. 34 shows a developer test module screen, including a battery level display and current oxygen level (percentage) and heart rate (beats per minute, BPM) readings. FIG. 35 shows the current blood oxygen saturation level (percentage) and heart rate (beats per minute, BPM) readings, along with the current altitude (feet), humidity (percentage), air quality index (e.g., good, fair, poor), and barometric pressure (inches of mercury (Hg)). FIG. 36 shows a user interface that allows a user to select the measurements they want to display on their dashboard page. FIG. 37 shows an example of today's diary entry, including date, time, SpO2, heart rate, altitude, air quality index, barometric pressure, and humidity values ​​(e.g., average, high, etc.), along with medications taken today (if any), symptoms experienced today (if any), and user-entered notes (if any). FIG. 38 illustrates a location-based services user interface, through which a user can turn location-based services (e.g., GPS location) on or off using a slider. FIG. 39 illustrates a user interface accessible to users with a premium account, or that provides users with the option to sign up for a premium account, for example. A premium account can provide users access to features such as predictive analytics, detailed report generation, and weekly and monthly vital signs presentation via a mobile app dashboard. FIG. 40 illustrates a user interface showing a Medical ID tab with data entered. FIG. 41 illustrates a user interface showing current oxygen level (percentage) and heart rate (BPM) readings along with a resettable timer. FIG. 42 illustrates a user interface showing user-selectable options for report generation, including time period, subject vital signs, and report format (e.g., Microsoft® Excel® or Adobe® PDF®). FIG. 43 shows the safety threshold user interface, through which the user can use the slider to set a threshold percentage SpO2 value and select "Done" when finished.Figure 44 is a user interface showing the configuration after the safety threshold has been set and a premium account has been established (as opposed to the configuration shown in Figure 23, which does not include the safety threshold or OxiWear Premium line items). Figure 45 is a user interface showing an example landing screen (i.e., the first screen a first-time user sees, through which the user can register an account) that may be displayed when the mobile app is first launched / opened.

[0062]

[0071] In some embodiments, a device for monitoring a blood oxygen saturation level of a wearer of the device includes a processor, a memory operably coupled to the processor, a first housing portion, a second housing portion, and a connecting member. The first housing portion includes at least one light emitting diode (LED), and the second housing portion includes a photodetector. The connecting member is mechanically coupled to each of the first and second housing portions. The device can be sized and shaped to be worn about a portion of the ear of a wearer of the device. In operation, the at least one LED emits light in a direction toward the photodetector. A portion of the emitted light passes through the portion of the ear before reaching the photodetector. The photodetector detects the portion of the emitted light (e.g., by generating and detecting a voltage or current signal in response to the portion of the emitted light striking a surface of the photodetector), and the memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the detected signal.

[0063]

[0072] In some embodiments, the light detector is a first light detector, the portion of the emitted light is a first portion of the emitted light, and the first housing also includes a second light detector configured to detect a reflected second portion of the emitted light. The memory also stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the detection of the first portion of the emitted light and the detection of the second portion of the emitted light.

[0064]

[0073] In some embodiments, the device also includes at least one of a microphone or a speaker operatively coupled to the processor, and the memory also stores instructions for causing the processor to activate at least one of the microphone or the speaker in response to detecting the alarm condition.

[0065]

[0074] In some embodiments, the apparatus also includes a wireless transceiver operatively coupled to the processor and configured to communicate with the mobile software application, the memory also storing instructions that cause the processor to transmit signals representing the measurement data to the mobile software application via the wireless transceiver.

[0066]

[0075] In some embodiments, the memory also stores instructions that cause the processor to send signals to the mobile software application according to a predetermined schedule, the signals representing the measurement data.

[0067]

[0076] In some embodiments, the device also includes at least one sensor operatively coupled to the processor, the at least one sensor including at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or a barometric pressure sensor, and the memory also stores instructions that cause the processor to store data collected by the at least one sensor in the memory.

[0068]

[0077] In some embodiments, the device also includes at least one sensor operatively coupled to the processor, the at least one sensor including at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or a barometric pressure sensor. The memory also stores instructions that cause the processor to send signals to the mobile software application according to a predetermined schedule, the signals representing data collected by the at least one sensor.

[0069]

[0078] In some embodiments, a device includes a processor, a memory operatively coupled to the processor, at least one light-emitting diode operatively coupled to the processor, a photodetector operatively coupled to the processor, and a plurality of sensors operatively coupled to the processor. The device may be sized and shaped to mechanically attach to a portion of an ear of a wearer of the device. In operation, the at least one light-emitting diode is configured to emit light in a direction toward the photodetector, such that a portion of the emitted light passes through the portion of the ear before reaching the photodetector. The photodetector is configured to detect the portion of the emitted light. The memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the detected portion of the emitted light, and store a representation of the calculated blood oxygen saturation level and at least one measurement collected by the plurality of sensors in the memory.

[0070]

[0079] In some embodiments, the plurality of sensors includes at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or a barometric pressure sensor.

[0071]

[0080] In some embodiments, the light detector is a first light detector, the portion of the emitted light is a first portion of the emitted light, and the device also includes a second light detector configured to detect a reflected second portion of the emitted light. The memory also stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the emission of the first portion of the emitted light and the detection of the second portion of the emitted light.

[0072]

[0081] In some embodiments, the device also includes at least one of a microphone or a speaker operatively coupled to the processor, and the memory also stores instructions for the processor to activate the at least one of the microphone or the speaker in response to detecting the alarm condition.

[0073]

[0082] In some embodiments, the apparatus also includes a wireless transceiver operatively coupled to the processor and configured to communicate with the mobile software application, the memory also storing instructions that cause the processor to transmit signals representing the measurement data to the mobile software application via the wireless transceiver.

[0074]

[0083] In some embodiments, the memory also stores instructions that cause the processor to transmit a signal to the mobile software application according to a predetermined schedule, the signal representing at least one measurement collected by the plurality of sensors.

[0075]

[0084] In some embodiments, the apparatus also includes an alert mechanism operatively coupled to the processor, the memory further storing instructions that cause the processor to generate and transmit a signal representative of an alert in response to detecting user interaction with the alert mechanism.

[0076]

[0085] In some embodiments, the device includes a processor, memory operatively coupled to the processor, a light-emitting diode, and a photodetector. The device is sized and shaped to mechanically attach to a portion of the ear of a wearer of the device. The memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on a detected portion of the emitted light at the photodetector, the signal resulting from the emission of the at least one light-emitting diode. The memory also stores instructions that cause the processor to compare the calculated blood oxygen saturation level with a predetermined threshold blood oxygen saturation level and, in response to detecting that the calculated blood oxygen saturation level is lower than the predetermined blood oxygen saturation level, generate an alert.

[0077]

[0086] In some embodiments, the memory also stores instructions that cause the processor to perform at least one of the following in response to detecting that the calculated blood oxygen saturation level is lower than a predetermined threshold blood oxygen saturation level: (1) initiate contact with an emergency services entity; (2) send one of a short message service (SMS) text or an email message to at least one emergency contact based on the emergency contact information stored in the memory; (3) cause the device to emit a sound; (4) cause the device to vibrate using a haptic feedback element; (5) send a signal to a mobile software application to cause a display on the wearer's computing device of a representation of an alert; (6) send a signal to the mobile software application to vibrate the wearer's computing device; or (7) send a signal to the mobile device to cause the wearer's computing device to emit a sound.

[0078]

[0087] In some embodiments, the instructions to cause the processor to compare the calculated blood oxygen saturation level with a predetermined threshold blood oxygen saturation level include instructions to perform multiple such comparisons over time according to a predefined schedule.

[0079]

[0088] In some embodiments, the light detector is a first light detector, the portion of the emitted light is a first portion of the emitted light, and the device also includes a second light detector configured to detect a reflected second portion of the emitted light. The memory also stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the detection of the first portion of the emitted light and the detection of the second portion of the emitted light.

[0080]

[0089] In some embodiments, the device also includes at least one of a microphone or a speaker operatively coupled to the processor, and the memory also stores instructions for causing the processor to activate the at least one of the microphone or the speaker in response to detecting that the calculated blood oxygen saturation level is below a predetermined threshold blood oxygen saturation level.

[0081]

[0090] In some embodiments, the memory also stores instructions that cause the processor to send signals to the mobile software application according to a predefined schedule, the signals representing the measurement data.

[0082] Wearable Oxygen Monitor Applications - COVID-19

[0091] The novel coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that has paralyzed many organ systems and resulted in hundreds of thousands of deaths to date. COVID-19 adversely affects the respiratory system, ranging from mild upper respiratory tract symptoms to pneumonia and acute respiratory distress syndrome. One possible COVID-19-induced symptom is silent hypoxia, in which patients experience below-average (i.e., "low") tissue and blood oxygen saturations but do not exhibit respiratory distress. Although the mechanism by which silent hypoxia occurs is unknown, this phenomenon merits significant clinical and public health attention. Silent hypoxia presents at least two public health challenges. Two key challenges exist: 1) infected individuals may progress to more severe disease states but may not realize they are COVID-positive, and 2) infected, asymptomatic hypoxic patients may act as vectors for infecting those around them ("silent transmission"). For hypoxic patients, continuous blood oxygen saturation monitoring is critical. Therefore, there is a need for a small, portable, and wearable device that provides real-time SpO2 monitoring and alerts the user when their SpO2 level drops below acceptable levels.

[0083]

[0092] One or more embodiments of the wearable oxygen monitor described herein can provide robust blood oxygen saturation level monitoring for a variety of applications, including identifying patients with asymptomatic hypoxia, helping alert healthcare providers to patients at risk for serious disease progression, enhancing existing COVID-19 diagnostic platforms such as nasopharyngeal swabs, preventing the spread of COVID-19, assisting healthcare providers in care coordination, and monitoring one or more of the various medical conditions described below. A normal blood oxygen saturation level is approximately 95 percent. When a patient exhibits blood oxygen saturation below this threshold, the patient's organ systems, particularly the brain, may not receive an adequate oxygen supply, which can lead to confusion or lethargy. When oxygen levels fall below 80 percent, there is a risk of serious damage to vital organs, potentially resulting in death.

[0084]

[0093] COVID-19 has been reported to induce asymptomatic hypoxia in patients. According to Dr. Richard Levitan, an emergency physician at Bellevue Hospital in New York, people with COVID-induced asymptomatic hypoxia do not experience respiratory distress until the day they arrive at the hospital. Therefore, some COVID-19 patients may be completely asymptomatic despite having COVID-induced hypoxia for a period of time, suggesting that patients with asymptomatic hypoxia may be able to spread the infection to others, potentially leading to more severe stages of COVID-19.

[0085]

[0094] Continuous blood oxygen saturation monitors are desirable to protect vulnerable populations and facilitate the earliest possible detection of low blood oxygen saturation. Highly sensitive monitoring can help ensure patients receive medical assistance before their condition worsens, thereby improving patient outcomes and helping healthcare systems manage the current burden of the pandemic.

[0086] COVID-19 Symptoms and Risk Factors

[0095] Fever, designated by the Centers for Disease Control and Prevention as a temperature above 100.4°C, is the symptom most commonly associated with COVID-19 in the civilian population. However, a clinical observational analysis at Northwell Health, the largest medical institution in New York, showed that only 30.7% of patients diagnosed with COVID-19 were febrile in clinical presentation. The weak correlation between fever and infection suggests that COVID-19 symptoms are highly variable and that institutions should screen patients for multiple parameters when assessing the presence or severity of infection.

[0087]

[0096] While the association between fever and infection is unclear, clinical studies have distinguished certain risk factors that may predispose patient populations to severe infection. Observations of COVID-19 positive patients at Northwell Health showed that 56.6% had a history of hypertension, 41.7% had a history of obesity, and 33.8% had diabetes. The strong correlation between pre-existing chronic conditions and COVID-19 hospitalization clearly highlights the need for robust monitoring, especially in high-risk populations.

[0088]

[0097] Clinical observations also suggest the desirability of prognostic markers for COVID-19 that could help ensure patients are treated earlier and more aggressively, as well as prevent progression to mechanical ventilation, which is associated with significantly higher mortality rates. In connection with the planned reopening of workplaces and schools, some organizations are planning the use of thermal scanners to notify individuals with fevers. However, individuals with fevers may act as vectors for the spread of infection despite not exhibiting this benchmark symptom of COVID-19. More extensive symptom tracking could help prevent the spread of COVID-19.

[0089] Risk of COVID-19 and the Significance of Hypertension in the Elderly

[0098] People over 65 years of age are disproportionately affected by COVID-19 infections, hospitalizations, ICU admissions, and deaths. The higher risk of COVID-19 for older adults has significantly impacted the implementation of social distancing and other public health measures designed to slow the spread of the disease. The strong correlation between hypertension and COVID-19 is likely central to the high proportion of elderly patients infected. 63.1% of adults over 60 years of age have hypertension, and many in this patient population use angiotensin-converting enzyme (ACE) inhibitors to lower their blood pressure. The sustained use of ACE inhibitors may play a role in increasing the expression of ACE-2 receptors in the cardiovascular, renal, gastrointestinal, and pulmonary organ systems. Because SARS-CoV-2 is thought to enter cells through the ACE-2 receptor, increased ACE-2 expression in hypertensive patients, which are commonly found in the elderly, may play a role in increasing their disease burden.

[0090] COVID-19 and Hospital-Acquired Infections in High-Risk Patients

[0099] Dr. Shu-Yuan Xiao, a gastroenterologist affiliated with the University of Chicago School of Medicine, investigated two patients at Zhongnan Hospital in Wuhan, China. These patients underwent lobectomy for adenocarcinoma and were found to have COVID-19 during surgery. Pathology reports revealed that both patients had pulmonary edema and alveolar inflammation, both characteristic of pneumonia. Neither patient exhibited symptoms of pneumonia at the time of surgery, suggesting that they remained in the early stages of disease progression. Unexpected cases of pneumonia in patient populations presenting for surgical procedures for non-COVID symptoms present a risk that asymptomatic patients could serve as vectors for healthcare providers and other patients in the hospital. To prevent the spread of COVID-19 within healthcare settings, active symptom monitoring is advisable to isolate patients suspected of being positive.

[0091] Silent hypoxia: a clinical challenge

[0100] Hypoxemia refers to below-average blood oxygenation, and hypoxia is a clinical condition characterized by decreased tissue oxygen tension. Clinically, normal arterial blood oxygen saturation is designated as 94% to 100%. Reduced blood and tissue oxygenation can impair cellular metabolism, growth, and development. Healthcare professionals have traditionally understood hypoxia to be consistent with symptoms of respiratory distress, such as shortness of breath. However, the clinical manifestations of COVID-19 partially contradict this understanding. Dr. Richard Levitan, a volunteer paramedic at Bellevue Hospital in New Norwegian, reported cases in which patients did not complain of respiratory distress for several days before being seen at a hospital, despite imaging confirming viral pneumonia and below-average blood oxygen saturation. These cases document a phenomenon referred to as "silent hypoxia." The above-mentioned classification levels for hypoxemia are shown in the table below.

[0092] [Table 1]

[0093]

[0101] COVID-19 binds to receptors on alveolar cells that produce surfactant. Surfactant breaks the surface tension of water within the alveoli, thereby preventing the alveolar space from collapsing following exhalation. Infection causes a decrease in surfactant production and air space collapse. White blood cells, or leukocytes, initiate an inflammatory response within the alveoli. Leukocytes also release cytokines that promote fluid leakage from the lung's microvasculature into the spaces surrounding the alveoli. Fluid accumulation also contributes to alveolar collapse. Alveolar collapse reduces the surface area for oxygen to diffuse into the bloodstream, causing hypoxemia. At this stage in the disease progression, lung compliance may remain unchanged. Therefore, patients may still be able to exhale normal amounts of carbon dioxide, which prevents the development of respiratory distress and renders the patient "silent hypoxic." In some cases, fluid accumulation and inflammation can progress to a stage where overall lung volume is reduced, thereby preventing carbon dioxide removal and leading to respiratory distress. This transition can be rapid, requiring ventilatory support and placing a strain on the healthcare system as a whole.

[0094] COVID-19 and ARDS

[0102] Acute respiratory distress syndrome (ARDS) is characterized by the acute development of pulmonary edema and hypoxia, followed by dependence on mechanical ventilation. ARDS is a major cause of respiratory failure and was observed in 10% of ICU patients before the COVID-19 outbreak. Unlike silent hypoxia, ARDS is associated with reduced exhalation of carbon dioxide, which contributes to increased shortness of breath. Severe damage to the alveolar cells of the lungs causes ARDS. Alveolar damage leads to increased alveolar permeability to fluids, a process involving inflammatory signals known as cytokines. Disease progression can lead to widespread lung scarring and adverse changes in lung compliance.

[0095]

[0103] ARDS has particular relevance for COVID-19. A retrospective clinical study of 107 patients in Wuhan, China, showed that 26.2% of all COVID patients developed ARDS. Among COVID patients who died, 78.9% reported ARDS. Another Wuhan clinical study showed that patients developed ARDS 8 to 15 days after the onset of illness. Apparently benign hypoxia in "silent hypoxia" can progress to potentially fatal ARDS in COVID patients. Therefore, robust monitoring of blood oxygen saturation could alert patients to hypoxia before the onset of ARDS, potentially improving outcomes and helping healthcare providers arrange care.

[0096] Clinical Management of ARDS

[0104] Severe inflammation and fluid accumulation in the lungs of patients with ARDS can lead to progressive pulmonary fibrosis, which can lead to the collapse of the entire lung. According to the American Thoracic Society, ARDS is associated with a 30-40% mortality rate. Among recovered patients, lung function can gradually recover, a process that can take six months to a year. However, this recovery is only partial because surviving patients have sub-average lung volume and residual pulmonary fibrosis. According to Dr. Gregory Cosgrove, chief medical officer of the Pulmonary Fibrosis Foundation, patients who survive ARDS may experience a reduced quality of life, which can lead to anxiety, depression, and / or PTSD. Therefore, clinical workflows should include symptom monitoring to rapidly identify patients whose mild COVID-19 symptoms may progress to more severe conditions, such as ARDS.

[0097] Thrombus formation and silent hypoxia

[0105] Increased awareness of silent hypoxia in COVID-19 patients has led to the emergence of a theory about the cause of this phenomenon, which seems at odds with conventional medical practice. Dr. Elnara Marcia Negri, a pulmonologist in Sao Paulo, Brazil, has clearly demonstrated the role of blood clot formation in causing silent hypoxia in COVID-19 patients. According to Negri, an inflammatory response in the pulmonary blood vessels may result in a slight increase in blood clot formation in COVID-19 patients. Increased blood clot formation impedes the diffusion of oxygen from the alveoli into the bloodstream, leading to hypoxia. Negri administered heparin, a common anticoagulant, to patients with hypoxia, regardless of whether they had symptoms. According to Negri, 24 of 27 patients recovered, validating Negri's theory. Negri advises patients to routinely monitor their blood oxygen saturation levels and to seek medical attention if their blood oxygen saturation drops below 93%.

[0098] Hypoxic seizures in COVID-19

[0106] Large vessel stroke is a condition in which blood flow in one of the major arteries perfusing the brain is interrupted. The interrupted blood flow reduces the availability of oxygen in the brain. Physicians affiliated with the Mount Sinai Health System in New York reported five cases of stroke in COVID-19 positive patients under the age of 50. Furthermore, a retrospective study of data from Wuhan showed that the incidence of stroke among COVID-19 patients was approximately 5%.

[0099]

[0107] Furthermore, the average age of COVID-19 patients who suffered a stroke in Wuhan was 55 years old, suggesting that COVID-19-related stroke poses a unique risk to a slightly younger patient population. Physicians attribute the incidence of stroke in COVID-19 patients to the role that the infection plays in damaging the endothelial cells that line blood vessels. The association of COVID-19 with other serious pathologies, such as large-vessel stroke, clearly demonstrates the desirability of robust monitoring of blood oxygen saturation.

[0100] Shortcomings of known COVID-19 diagnostic techniques

[0108] Researchers at Cleveland Clinic investigated the efficacy of existing diagnostic technologies used to identify patients who tested positive for COVID-19. These diagnostic tests included Abbott's ID NOW machine, which is said to provide results in less than 15 minutes. The study found that the ID NOW had a 14.8% false-negative rate and an 85.2% true-positive rate. The study's results suggest that the ID NOW test falsely identifies approximately 15% of positive patients as not infected. The study also examined the DiaSorin Simplexa test, which had an 89.3% true-positive rate. According to Dr. Gary Procop, director of COVID-19 testing at Cleveland Clinic, diagnostic tests should have a true-positive rate of at least 95% to convince the public of the test's efficacy. While the diagnostic platforms created by Roche and Cepheid had accuracy rates above 95%, the accuracy of the DiaSorin Simplexa and ID NOW platforms was below threshold, suggesting that there are still gaps in the field of COVID-19 diagnostics. Challenges in COVID-19 testing make monitoring other clinical variables, such as blood oxygen saturation, even more important. Complementing traditional nasopharyngeal swab testing with robust oxygen monitoring could result in even higher accuracy in COVID-19 diagnostics and allow for the rapid identification of patients requiring medical assistance.

[0101] A known monitoring solution to combat silent hypoxia - pulse oximetry

[0109] Given the possibility that patients may experience severe hypoxemia before the onset of respiratory distress, some healthcare providers have required widespread pulse oximetry. Pulse oximetry provides patients with a noninvasive method of monitoring their blood oxygen saturation levels and can alert them to hypoxia even if they report no other symptoms. Pulse oximeters contain a light-emitting sensor that can be clipped onto the patient's finger. Patients using home pulse oximeters can consult with their healthcare provider to facilitate proper interpretation of their blood oxygen saturation levels. Dr. Levitan, an emergency physician at Bellevue Hospital who cited cases of asymptomatic hypoxia, has required all COVID-19-positive patients to routinely test their blood oxygen saturation levels within two weeks of diagnosis. Oxygenation monitoring for undiagnosed patients with symptoms of cough, fatigue, and / or fever may also be prudent.

[0102]

[0110] While known pulse oximeters, such as finger clips, can be useful for patient assessment, they are often difficult to transport and / or use. Some pulse oximeters, such as the Nonin Onyx, are bulky and may fall during patient transport or as a result of routine daily movements, such as standing, sitting, and shaking fingers. Additionally, some patients may have a weak pulse or tissue damage, which can bias measurement results. Other known wearable devices enable measurements only at the wrist, and these devices typically do not provide oxygen monitoring or related alerts. Rather, these devices measure pulse and fitness-related metrics, such as steps and sleep time.

[0103]

[0111] In the case of COVID-19, pulse oximeter finger cuffs typically do not provide and / or are not used for continuous monitoring. In the case of silent hypoxia, if the patient does not experience any respiratory distress, the patient may not think to check their blood oxygen saturation levels and may be unaware of their hypoxia for an extended period of time.

[0104]

[0112] As discussed above, blood oxygen saturation is a valuable biomarker of COVID-19 for both symptomatic and asymptomatic individuals. The wearable oxygen monitor embodiments described herein facilitate continuous monitoring of blood oxygen saturation levels via measurements taken at the patient's ear (e.g., helix, scapha, pinna, etc.), with associated measurement data displayed via a mobile software application. If the wearer's SpO2 level drops below an acceptable level, an alarm is generated and communicated to the wearer (via one or more of an audio indication, a light indication, a GUI display, etc.). Additionally, the wearer can trigger a call to emergency services by clicking a button on the wearable oxygen monitor.

[0105]

[0113] All combinations of the above concepts and additional concepts discussed herein (where such concepts are not mutually inconsistent) are contemplated as being part of the subject matter disclosed herein. Terms explicitly employed herein, which may also appear in any disclosures incorporated by reference, should be given the meaning most consistent with the particular concepts disclosed herein.

[0106]

[0114] The drawings are primarily for illustrative purposes and are not intended to limit the scope of the subject matter described herein. The drawings are not necessarily to scale, and in some cases, various aspects of the subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference numerals generally refer to like features (e.g., functionally similar and / or structurally similar elements).

[0107]

[0115] The entirety of this application (including the cover, title, headings, background, summary, brief description of drawings, detailed description, embodiments, abstract, figures, appendices, etc.) illustrates, by way of example, various embodiments in which embodiments may be practiced. The advantages and features of this application are merely a representative sample of embodiments and are not exhaustive and / or exclusive. Rather, they are presented to aid in understanding and teaching of embodiments and do not represent all embodiments. Accordingly, some aspects of the disclosure are not discussed herein. The fact that alternative embodiments may not be presented for certain portions of the innovation, or that additional, undescribed, alternative embodiments may be available for certain portions, should not be considered to exclude such alternative embodiments from the scope of the disclosure. It will be understood that many of these undescribed embodiments incorporate the same principles of the innovation, and others are equivalent. Accordingly, it is to be understood that other embodiments may be utilized, and that functional, logical, operational, organizational, structural, and / or topological changes may be made without departing from the scope and / or spirit of the disclosure. Accordingly, all examples and / or embodiments are considered non-limiting throughout this disclosure.

[0108]

[0116] Additionally, no inferences should be drawn with respect to embodiments discussed herein relative to embodiments not discussed herein, other than for the purposes of reducing space and repetition. For example, the logical and / or topological structure of any program component (collection of components), other components, and / or any combination of any present feature sets as depicted in the figures and / or described throughout is not limited to a fixed order of operations and / or placement; rather, any disclosed order is exemplary, and all equivalents regardless of order are contemplated by this disclosure.

[0109]

[0117] The term "automatically" is used herein to describe behavior that occurs without direct input or direction from an external source, such as a user. Automatically occurring behavior can occur periodically, sporadically, in response to a detected event (e.g., a user login), or according to a predetermined schedule.

[0110]

[0118] As used herein, the term "substantially" has the same meaning as "for the most part" or "to a significant extent." For example, the phrase "substantially uniform thickness" refers to a range of ±10% of the thickness value.

[0111]

[0119] The term "determining" encompasses a wide variety of actions, and thus "determining" can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, database, or another data structure), ascertaining, etc. "Determining" can also include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), etc., and "determining" can include resolving, selecting, choosing, establishing, etc.

[0112]

[0120] The phrase "based on" does not mean "based only on," unless expressly specified otherwise. In other words, the phrase "based on" describes both "based only on" and "based at least on."

[0113]

[0121] The term "processor" should be interpreted broadly to encompass a general purpose processor, a central processing unit (CPU), a microprocessor, a digital signal processor (DSP), a controller, a microcontroller, a state machine, etc. In some circumstances, a "processor" may refer to an application specific integrated circuit (ASIC), a programmable logic device (PLD), a field programmable gate array (FPGA), etc. The term "processor" may also refer to a combination of processing devices, e.g., a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0114]

[0122] The term "memory" should be interpreted broadly to encompass any electronic component capable of storing electronic information. The term memory may refer to various types of processor-readable media, such as random access memory (RAM), read-only memory (ROM), non-volatile random access memory (NVRAM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable PROM (EEPROM), flash memory, magnetic or optical data storage devices, registers, etc. Memory is said to be in electronic communication with a processor if the processor can read information from and / or write information to the memory. Memory that is integral to a processor is in electronic communication with the processor.

[0115]

[0123] The terms "instructions" and "code" should be interpreted broadly to include any type of computer-readable statement. For example, the terms "instructions" and "code" may refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" may include a single computer-readable statement or many computer-readable statements.

[0116]

[0124] Some embodiments described herein relate to computer storage products having a non-transitory computer-readable medium (which may also be referred to as a non-transitory processor-readable medium) having instructions or computer code for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include propagating signals that are inherently transitory (e.g., propagating electromagnetic waves that carry information in a transmission medium such as space or a cable). The medium and computer code (which may also be referred to as code) may be designed and configured for a given purpose or multiple purposes. Examples of non-transitory computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as compact disks / digital video disks (CDs / DVDs), compact disks-read-only memory (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices specially configured to store and execute program code, such as application-specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memory (ROM), and random access memory (RAM) devices. Other embodiments described herein relate to computer program products, which may include, for example, instructions and / or computer code discussed herein.

[0117]

[0125] Some embodiments and / or methods described herein may be performed by software (executed in hardware), hardware, or a combination thereof. Hardware modules may include, for example, general-purpose processors, field-programmable gate arrays (FPGAs), and / or application-specific integrated circuits (ASICs). Software modules (executed in hardware) may be expressed in various software languages ​​(e.g., computer code), including C, C++, Java™, Ruby, Visual Basic™, and / or other object-oriented, procedural, or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions such as those produced by a compiler, code used to create web services, and files containing high-level instructions executed by a computer using an interpreter. For example, embodiments may be implemented using an imperative programming language (e.g., C, Fortran, etc.), a functional programming language (Haskell, Erlang, etc.), a logic programming language (e.g., Prolog), an object-oriented programming language (e.g., Java, C++, etc.), or other suitable programming language and / or development tools. Further examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

[0118]

[0126] Various concepts may be embodied as one or more methods, at least one example of which has been provided. Acts performed as part of a method may be ordered in any suitable manner. Thus, in embodiments, acts shown as sequential acts in an exemplary embodiment may be configured to be performed in an order different from that illustrated, which may include performing some acts simultaneously. In other words, it should be understood that such features may not necessarily be limited to a particular order of execution; rather, there may be any number of threads, processes, services, servers, etc. that may execute sequentially, asynchronously, concurrently, in parallel, simultaneously, synchronously, etc., in a manner consistent with this disclosure. Thus, some of these features may be mutually inconsistent, in that they cannot coexist in a single embodiment. Similarly, some features may be applicable to one aspect of the innovation and not to other aspects.

[0119]

[0127] Additionally, the present disclosure may include other innovations not currently described. The applicants reserve all rights in such innovations, including, but not limited to, the right to embody such innovations and to file additional applications, continuations thereof, continuations-in-part, divisional applications, etc. Accordingly, it should be understood that the advantages, embodiments, examples, functional, characteristic, logical, operational, organizational, structural, topological, and / or other aspects of the present disclosure should not be considered limitations on the disclosure as defined by the embodiments, or limitations on equivalents to the embodiments. Depending on the particular needs and / or characteristics of individual and / or enterprise users, database organizations and / or relational models, data types, data transmission and / or network frameworks, syntax structures, etc., various embodiments of the technology disclosed herein can be implemented in a manner that allows for great adaptability and customization as described herein.

[0120]

[0128] All definitions and those used herein should be understood to take precedence over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0121]

[0129] As used herein, in certain embodiments, the term "about" or "approximately," when preceding a numerical value, indicates a range of ±10% of that value. When a range of values ​​is given, it is understood that each intervening value between the upper and lower limits of that range, to one-tenth of the unit of the lower limit unless the context clearly dictates otherwise, and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges, which may independently be included in the smaller ranges, are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. When a stated range includes one or both of those limits, ranges excluding either or both of those included limits are also included within the disclosure.

[0122]

[0130] The indefinite articles "a" and "an" used in this specification and embodiments should be understood to mean "at least one" unless a different meaning is clearly indicated.

[0123]

[0131] The phrase "and / or" as used in the specification and embodiments should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are present in some cases conjointly and in other cases disjunctly. Multiple elements listed with "and / or" should be construed in the same sense, i.e., "one or more" of the elements so conjoined. Optionally, other elements other than the elements specifically identified by the "and / or" clause may be present, whether or not associated with those elements specifically identified. Thus, as a non-limiting example, a reference to "A and / or B," when used with open-ended language such as "comprising," can refer in one embodiment to A only (optionally including elements other than B), in another embodiment to B only (optionally including elements other than A), in yet another embodiment to both A and B (optionally including other elements), etc.

[0124]

[0132] As used herein and in the embodiments, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be interpreted as inclusive, i.e., including at least one of a plurality of elements or a list of elements, and optionally including more than one of additional unlisted items. Only terms clearly indicated to be different, such as "only one of" or "exactly one of," or, when used in the embodiments, "consisting of," shall refer to the inclusion of exactly one element of a plurality of elements or a list of elements. Generally, the term "or" as used herein shall be interpreted as indicating exclusive alternatives (i.e., "one or the other, but not both") only when preceding exclusive terms, such as "either," "one of," "only one of," or "exactly one of." "Consisting essentially of," when used in the embodiments, shall have its ordinary meaning as used in the field of patent law.

[0125]

[0133] As used herein and in the embodiments, the phrase "at least one" in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combinations of elements in the list of elements. This definition also allows, optionally, for elements other than the specifically identified elements in the list of elements to which the phrase "at least one" refers, to be present, whether or not related to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") can refer to, in one embodiment, at least one, optionally more than one A, with no B (and optionally including elements other than B); in another embodiment, at least one, optionally more than one B, with no A (and optionally including elements other than A); in yet another embodiment, at least one, optionally more than one A, and at least one, optionally more than one B (and optionally including other elements); etc.

[0126]

[0134] As in the foregoing specification, in the embodiments, all transitional phrases such as "comprise," "include," "carry," "have," "include," "involve," "hold," "consisting of," and the like, shall be understood to mean open-ended, i.e., including but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in the U.S. Patent and Trademark Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

1. a processor and a memory operatively coupled to the processor; a first housing portion including at least one light emitting diode; a second housing portion separate from and spaced apart from the first housing portion, the second housing portion including a photodetector; a connecting member mechanically coupled to each of the first housing portion and the second housing portion; Equipped with the at least one light emitting diode is configured to emit light in a direction toward the photodetector during operation, and a portion of the emitted light passes through a portion of an ear of a wearer of the device when the device is worn about the portion of the ear before reaching the photodetector and during operation of the light emitting diode; the photodetector is configured to detect the portion of the emitted light; the memory storing instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the detection of the portion of the emitted light.

2. 10. The device of claim 1, wherein the light detector is a first light detector, the portion of the emitted light is a first portion of the emitted light, the first housing portion further includes a second light detector configured to detect a reflected second portion of the emitted light, and the memory further storing instructions that cause the processor to calculate the blood oxygen saturation level of the wearer based on the detection of the first portion of the emitted light and the detection of the second portion of the emitted light.

3. 10. The device of claim 1, further comprising at least one of a microphone or a speaker operatively coupled to the processor, the memory further storing instructions to cause the processor to activate the at least one of the microphone or the speaker in response to detecting an alarm condition.

4. 10. The apparatus of claim 1, further comprising a wireless transceiver operatively coupled to the processor and configured to communicate with a mobile software application, the memory further storing instructions that cause the processor to transmit signals representing measurement data to the mobile software application via the wireless transceiver.

5. The apparatus of claim 1 , wherein the memory further stores instructions that cause the processor to transmit signals to a mobile software application according to a predetermined schedule, the signals representing measurement data.

6. 10. The device of claim 1, further comprising at least one sensor operatively coupled to the processor, the at least one sensor including at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or a barometric pressure sensor, and the memory further storing instructions that cause the processor to store data collected by the at least one sensor in the memory.

7. 10. The device of claim 1, further comprising at least one sensor operatively coupled to the processor, the at least one sensor including at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or a barometric pressure sensor, and the memory further storing instructions that cause the processor to send signals to a mobile software application according to a predetermined schedule, the signals representing data collected by the at least one sensor.

8. a processor and a memory operatively coupled to the processor; at least one light emitting diode operably coupled to the processor; a photodetector operably coupled to the processor; a plurality of sensors operably coupled to the processor; Equipped with the at least one light emitting diode is configured, in operation, to emit light in a direction toward the photodetector, a portion of the emitted light passing through a portion of an ear of a wearer of the device before reaching the photodetector; the photodetector is configured to detect the portion of the emitted light; The memory may be configured to: instructions to calculate a blood oxygen saturation level of the wearer based on the detected portion of the emitted light; instructions to store in a memory a representation of the calculated blood oxygen saturation level and at least one measurement collected by the plurality of sensors; A device containing

9. The device of claim 8 , wherein the plurality of sensors includes at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or a barometric pressure sensor.

10. 9. The device of claim 8, wherein the photodetector is a first photodetector, the portion of the emitted light is the first portion of the emitted light, the device further comprising a second photodetector configured to detect a reflected second portion of the emitted light, and the memory further storing instructions that cause the processor to calculate the blood oxygen saturation level of the wearer based on the detection of the first portion of the emitted light and the detection of the second portion of the emitted light.

11. 10. The device of claim 8, further comprising at least one of a microphone or a speaker operatively coupled to the processor, the memory further storing instructions to cause the processor to activate the at least one of the microphone or the speaker in response to detecting an alarm condition.

12. 10. The apparatus of claim 8, further comprising a wireless transceiver operatively coupled to the processor and configured to communicate with a mobile software application, the memory further storing instructions that cause the processor to transmit signals representing measurement data to the mobile software application via the wireless transceiver.

13. 10. The apparatus of claim 8, wherein the memory further stores instructions that cause the processor to transmit, according to a predetermined schedule, a signal to a mobile software application, the signal representing the at least one measurement collected by the plurality of sensors.

14. 10. The device of claim 8, further comprising an alert mechanism operatively coupled to the processor, the memory further storing instructions that cause the processor to generate and transmit a signal representing an alert in response to detecting user interaction with the alert mechanism.

15. a processor and a memory operatively coupled to the processor; a light emitting diode operatively coupled to said processor; a photodetector operatively coupled to the processor; Equipped with The memory may be configured to: instructions for calculating a blood oxygen saturation level of the wearer of the device based on a detected portion of the emitted light at the photodetector, the signal resulting from an emission of the at least one light emitting diode, at least a portion of the emission of the at least one light emitting diode passing through a portion of the wearer's ear before reaching the photodetector; instructions for comparing the calculated blood oxygen saturation level to a predetermined threshold blood oxygen saturation level; instructions for generating an alert in response to detecting that the calculated blood oxygen saturation level is lower than the predetermined blood oxygen saturation level; A device containing

16. The memory may cause the processor to, in response to detecting that the calculated blood oxygen saturation level is lower than the predetermined threshold blood oxygen saturation level: Initiating contact with emergency services entities; sending one of a short message service (SMS) text or an email message to at least one emergency contact based on the emergency contact information stored in the memory; causing the device to emit a sound; vibrating said device using a haptic feedback element; sending a signal to a mobile software application to cause a display on the wearer's computing device of a representation of the alert; sending a signal to a mobile software application to vibrate the wearer's computing device; or sending a signal to a mobile software application to cause the computing device of the wearer to emit a sound; 16. The apparatus of claim 15, further storing instructions to cause at least one of:

17. 16. The apparatus of claim 15, wherein the instructions to cause the processor to compare the calculated blood oxygen saturation level to a predetermined threshold blood oxygen saturation level include instructions to perform multiple such comparisons over time according to a predefined schedule.

18. 16. The device of claim 15, wherein the photodetector is a first photodetector, the portion of the emitted light is the first portion of the emitted light, the device further comprising a second photodetector configured to detect a reflected second portion of the emitted light, and the memory further storing instructions that cause the processor to calculate the blood oxygen saturation level of the wearer based on the detection of the first portion of the emitted light and the detection of the second portion of the emitted light.

19. 16. The device of claim 15, further comprising at least one of a microphone or a speaker operatively coupled to the processor, the memory further storing instructions to cause the processor to activate the at least one of the microphone or the speaker in response to detecting that the calculated blood oxygen saturation level is lower than the predetermined threshold blood oxygen saturation level.

20. 16. The apparatus of claim 15, wherein the memory further stores instructions that cause the processor to send signals to a mobile software application according to a predefined schedule, the signals representing measurement data.

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