Ear-worn oxygen monitoring system

Abstract

A device for monitoring an oxygen saturation level of a wearer includes a first body portion, a second body portion, and a connecting member. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode, and at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a grommet, and the connecting member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions that cause the processor to emit light from the at least one light emitting diode when the device is positioned over the wearer's ear and during operation of the device, and to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light.

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. 63 / 342,100, filed May 14, 2022, entitled "Ear-Wearable Oxygen Monitoring System," the disclosure of which is incorporated by reference in its entirety into this specification.

[0002] Field

[0002] The present disclosure relates to physiological monitoring technology, and more specifically, 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 predefined events, such as exercise or sleep. Summary of the Invention [Means for solving the problem]

[0004] overview

[0004] In some embodiments, a device for monitoring an oxygen saturation level of a wearer of the device includes a first body portion, a second body portion, and a connecting member. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode operably coupled to the processor, and at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a grommet, and the connecting member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions that cause the processor to emit light from the at least one light emitting diode when the device is positioned over the wearer's ear and during operation of the device, and to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light.

[0005]

[0005] In some embodiments, the kit includes a device for monitoring an oxygen saturation level of the device, a charger case, and a plurality of flexible ear pads. The device is configured to be positioned over a wearer's ear and includes a first body portion, a second body portion, and a connecting member mechanically coupled to each of the first body portion and the second body portion. The first body portion has a processor, a memory operably coupled to the processor, at least one light emitting diode (LED), and at least one optical sensor. The at least one optical sensor is configured to detect, during operation, a reflected portion of light emitted from the at least one light emitting diode, the reflected portion of light can include light reflected from a surface of the wearer's ear. The memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the reflected portion of light. The charger case is configured to house and power the device. Each flexible ear pad from the plurality of flexible ear pads is configured to be mechanically coupled to the second body portion, for example, via a grommet / annular region of the second body portion.

[0006]

[0006] In some embodiments, a method of manufacturing an oxygen saturation level monitoring device includes bonding an electronic board to an ear pad using at least one of silicone or epoxy such that the electronic board is affixed to the ear pad within a cavity defined in a surface of the ear pad, and attaching the ear pad to a chassis. The chassis can include a first body portion, a second body portion, and a connecting member as described herein. [Brief description of the drawings]

[0007] Detailed Description of the Drawings [Figure 1A] 7 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 1B] 7 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 1C] 7 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 1D]

[0008] FIG. 2 is a rendering of an exploded view of the wearable oxygen monitor of FIGS. 1A-1C, showing its components. [Figure 1E] FIG. 1 is a rendering of an exploded view of the wearable oxygen monitor of FIGS. 1A-1C, showing its components. [Figure 1F]

[0009] 1A-1C and a rendering of a charger case for the wearable oxygen monitor of FIGS. 1A-1C. [Figure 1G] 1A-1C and a rendering of a charger case for the wearable oxygen monitor of FIGS. 1A-1C. [Figure 1H]Renderings of the wearable oxygen monitor of FIGS. 1A-1C and a charger case for the wearable oxygen monitor of FIGS. 1A-1C. [Figure 1I] Renderings of the wearable oxygen monitor of FIGS. 1A-1C and a charger case for the wearable oxygen monitor of FIGS. 1A-1C. [Figure 1J] Renderings of the wearable oxygen monitor of FIGS. 1A-1C and a charger case for the wearable oxygen monitor of FIGS. 1A-1C. [Figure 2A]

[0010] FIG. 1 illustrates a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments. [Figure 2B]

[0010] 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 2C]

[0010] 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 2D]

[0010] 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 2E]

[0010] 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 2F]

[0010] 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 2G]

[0010] 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 2H]

[0010] 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 2I]

[0010] 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 2J]

[0010] 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 2K]

[0010] 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 2L]

[0010] 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 2M]

[0010] 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 2N]

[0010] 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 2O]

[0011] FIG. 2C is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2P] FIG. 2 is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2Q] FIG. 2 is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2R] FIG. 2 is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2S]FIG. 2 is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2T] FIG. 2 is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2U] FIG. 2 is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2V] FIG. 2 is a diagram of a charger case in a closed configuration, according to some embodiments, the charger case configured to house and power the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2W]

[0012] 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. FIG. [Figure 2X] FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2Y] FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2Z] FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2AA] FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2AB]FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2AC] FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2A-D] FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration, the charger case housing the wearable oxygen monitor of FIGS. 2A-2N. [Figure 2AE]

[0013] FIG. 2C is a view of the charger case of FIGS. 2O-2V in an open configuration and without a wearable oxygen monitor contained therein. [Figure 2AF] FIG. 2O-2V is a view of the charger case of FIGS. 2O-2V in an open configuration and without a wearable oxygen monitor contained therein. [Figure 2A-G]

[0014] 13 is a rendering of a charger case with a panel removed to show the underlying shape of a recess / pocket configured to house a wearable oxygen monitor, according to some embodiments. [Diagram 3]

[0015] FIG. 1 is a schematic diagram illustrating components of a wearable oxygen monitor, according to some embodiments. [Figure 4]

[0016] FIG. 1 is a block diagram illustrating components of a wearable oxygen monitor, according to some embodiments. [Diagram 5]

[0017] FIG. 2 is a block diagram illustrating components of a charger case according to some embodiments. [Figure 6]

[0018] FIG. 2 illustrates a wearable oxygen monitor when worn above the ear of a user / wearer, according to one embodiment. [Figure 7A]

[0019] 1A-1C are renderings showing components of a wearable oxygen monitor configured to be worn about a portion of a user's ear, in various stages of assembly, according to some embodiments. [Figure 7B] 3A-3C are renderings showing components of a wearable oxygen monitor configured to be worn around a portion of a user's ear, in various stages of assembly, according to some embodiments. [Figure 7C] 3A-3C are renderings showing components of a wearable oxygen monitor configured to be worn around a portion of a user's ear, in various stages of assembly, according to some embodiments. [Figure 8A]

[0020] 1 is a rendering of a flexible electronics assembly for a wearable oxygen monitor, according to some embodiments. [Figure 8B] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8C] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8D] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8E] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8F] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8G] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8H] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8I] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8J] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8K] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8L] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8M] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8N] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8O] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8P] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8Q] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8R] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8S] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8T] Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 8U]Rendering of a flexible electronic circuit assembly for a wearable oxygen monitor according to some embodiments. [Figure 9A]

[0021] 1 is a rendering of an ear pad having an optical sensor circuit positioned within a recess in the ear pad, according to some embodiments. [Figure 9B]

[0021] A rendering of an ear pad having an optical sensor circuit positioned within a recess in the ear pad, according to some embodiments. [Figure 9C]

[0022] 1 is a photographic image showing a bottom view of an assembled ear pad with optical sensor circuitry according to one embodiment. [Figure 10A]

[0023] FIG. 1 illustrates a grommet without ear pads for a wearable oxygen monitor, according to some embodiments. [Figure 10B]

[0023] FIG. 1 illustrates a grommet with thin ear pads for a wearable oxygen monitor according to some embodiments. [Figure 10C]

[0023] FIG. 1 illustrates a grommet with thick ear pads for a wearable oxygen monitor according to some embodiments. [Figure 11]

[0024] FIG. 1 is a flow diagram illustrating a method of manufacturing a wearable oxygen monitor, according to some embodiments. [Figure 12]

[0025] 13 is a wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 13]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 14]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 15]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 16]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 17]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 18]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 19]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 20]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 21]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 22]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 23]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 24]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 25]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 26]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 27]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 28]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 29]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 30]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 31]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 32]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 33]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 34]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 35]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 36]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 37]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 38]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 39]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 40]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 41]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 42]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 43]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 44]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 45]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 46]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 47]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 48]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 49]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 50]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 51]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 52]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Diagram 53]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 54]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 55]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 56]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 57]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 58]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 59]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 60]

[0025] A wireframe of a user interface screen of a mobile app that interacts with a wearable oxygen monitor, according to some embodiments. [Figure 61A]

[0026] 1 is a rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor, according to some embodiments. [Figure 61B]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61C]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61D]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61E]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Fig.61F]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61G]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Fig.61H]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Fig.61I]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Fig.61J]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61K]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61L]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61M]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. [Figure 61N]

[0026] A rendering of a flexible electronic circuit assembly and components therein for a wearable oxygen monitor according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Detailed Description

[0027] 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, 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 discrete period of time for measurement and then removed, for example, because they are not designed for continuous wear or are uncomfortable. Furthermore, when a patient is asleep, the patient typically does not wear the pulse oximeter and is unable to see the pulse oximeter's digital reading. Thus, known pulse oximeters may not be effective 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, a user may take the voluntary action of measuring their own oxygen level and, if they determine that the level is too low, may take another voluntary action 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]

[0028] An embodiment of the present disclosure includes a wearable oxygen monitor that can be worn continuously and can perform continuous oxygen monitoring, and that alerts a wearer / user when a detected oxygen level detected during oxygen monitoring is below a predetermined or predefined threshold. In some embodiments, the wearable oxygen monitor includes a first body portion, a second body portion, and a connecting member or portion disposed or positioned between the first body portion and the second body portion. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode (LED), and at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a grommet, and the connecting member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions that cause the processor to emit light from the at least one light emitting diode when the device is positioned over the wearer's ear and during operation of the device, and to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light. Additional details regarding certain aspects of the wearable oxygen monitor described herein can be found, by way of example, in U.S. Patent No. 10,987,067, entitled “Wearable Earpiece Oxygen Monitor,” issued on April 27, 2021, the entire contents of which are incorporated by reference into this specification for all purposes.

[0010]

[0029] In some embodiments, the connection member includes or is made of nylon and is therefore only slightly flexible (essentially rigid), and the adjustability of the wearable oxygen monitor and / or the conformity of the wearable oxygen monitor to the shape of the wearer / user's ear is achieved via a pair of ear pads, one or both of which may be flexible (e.g., silicone pads), at least one of which is replaceable with different sizes. In other words, at least one of the flexible ear pads from the pair of flexible ear pads can be removed from the wearable oxygen monitor and replaced with an ear pad having a different dimension. In some such embodiments, only one of the flexible ear pads from the pair of flexible ear pads is configured to be easily removable and replaceable by the user. The removable ear pad can be coupled to the second body portion, for example, via its ring-like structure (also referred to herein as a "grommet" or "annular opening"), as described further below.

[0011]

[0030] In some implementations, the at least one optical sensor is positioned within and secured to a cavity defined in a surface of one of the ear pads (e.g., a flexible ear pad coupled to the first body portion and optionally configured to not be easily removed / replaced by a user, or a non-flexible ear pad, optionally configured to not be easily removed / replaced by a user). The at least one optical sensor may be "potted" with a material such as epoxy (e.g., an optically transparent epoxy such that the optical signal is not interfered with / altered or is minimally interfered with / altered).

[0012]

[0031] In some implementations, the wearable oxygen monitor of the present disclosure includes a flexible conductor (e.g., a conductor having a substantially S-shaped or curved / serpentine "ribbon" shape) so that at least a subassembly of the wearable oxygen monitor can "flex" to accommodate the process of positioning the wearable oxygen monitor over the ear of a user / wearer. Alternatively or additionally, the wearable oxygen monitor of the present disclosure can include a DC power line communication transceiver chipset (e.g., Maxim MAX20340).

[0013]

[0032] In some embodiments, a wearable oxygen monitoring kit includes an ear-worn device ("wearable oxygen monitor") as shown and described herein, a charger case, and optionally a set of flexible ear pads configured to be interchangeably attached to the ear-worn device via grommets. Each flexible ear pad from the set of flexible ear pads can have a different set of associated dimensions so that the "fit" of the ear-worn device can be adjusted / customized to different user (ear) sizes / geometry. Improving the fit of the ear-worn device to the user / wearer can result in improved user comfort and ergonomics as well as improved optical signal quality during operation of the ear-worn device. In some such implementations, the charger case and the ear-worn device are configured to exchange data and power (e.g., simultaneously) via one or more (e.g., two) charging contacts. Although described above as "flexible" for purposes of conforming to a user's ear, the ear pads may alternatively be formed from inflexible or substantially inflexible materials, for example for applications requiring greater durability / ruggedization (e.g., underwater use, military use, etc.).

[0014]

[0033] In some embodiments, during manufacture / assembly of the wearable oxygen monitor, the optical substrate (i.e., the circuit board containing the at least one optical sensor and / or at least one optical detector) is bonded to the ear pads using another material such as silicone (e.g., optically clear silicone) or epoxy, thereby producing a subassembly (i.e., the optical substrate and the ear pads) that is at least waterproof and provides sufficient optical transparency for acceptable performance of the at least one optical sensor and / or at least one optical detector.

[0015]

[0034] In some embodiments, the wearable oxygen monitor of the present disclosure may include an alert mechanism, such as a button or touch screen, which when interacted with by a 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 may 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), issuing a sound from a sound generating portion of the wearable oxygen monitor (e.g., an electronic beep effect issued via a speaker), sending a signal (e.g., via a transceiver mounted on the wearable oxygen monitor) to a mobile device 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.

[0016]

[0035] 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 may hear an emergency dispatcher through the wearable oxygen monitor's speaker and may 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.

[0017]

[0036] 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 to hold it 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 / detectors, 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 a 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 / detectors. Then, based on the amount of light detected at the one or more light sensors / detectors and / or based on the amount of light absorbed by the ear (and thus does not reach the one or more light sensors / detectors), 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 be calculated. 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 implementations, the accuracy of blood oxygen saturation determination increases with the thickness of the portion of the ear in which the wearable oxygen monitor is positioned during operation.

[0018]

[0037] In some embodiments, the one or more LEDs include two LEDs, the first being a red (650 nm) LED and the second being an infrared (950 nm) LED. In 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 at the photodetector / photosensor). Then, the oxygen concentration can be calculated / detected, for example, 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 concentration 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, in low light environments, and / or in environments with direct or indirect lighting sources.

[0019]

[0038] The memory can communicate with / through and / or store software applications compatible with one or more mobile devices (e.g., Windows, iOS, Android). The wearable oxygen monitor can be configured to be lightweight, power efficient, and 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 can include a power source that is rechargeable by a wired or wireless charging pod. Charging of the earpiece can occur when the earpiece is at least partially housed within the charging pod and, optionally, in electrical contact with the charging pod.

[0020]

[0039] In some embodiments, the emergency plan is activated in response to the wearer interacting (e.g., pressing, tapping, manually, 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.

[0021]

[0040] In some embodiments, the wearable oxygen monitor is configured to connect 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 other person. The software application may include code that provides for 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 board the wearable oxygen monitor, such that such records may be transmitted or presented to a healthcare provider. Alternatively or additionally, the software application may facilitate the 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 may include oxygen levels that trigger an alert or alarm. 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 calls are made when an alert / alarm is triggered.

[0022]

[0041] 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.).

[0023]

[0042] 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 (as measured by the wearable oxygen monitor) to a predefined threshold stored in a memory of the wearable oxygen monitor. The predefined threshold may be configurable by the wearer / user of the wearable oxygen monitor and / or another authorized user, for example, via a software application.

[0024]

[0043] In some embodiments, the wearable oxygen monitor is configured to emit an alarm sound 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 alarm sound 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 of 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 alarm sound 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 alarm sound and / or vibration represents an increase in the severity of the alarm condition. Similarly, the intensity, volume / volume and / or frequency of the alarm sound 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 alarm sound and / or vibration represents a reduction in the severity of the alarm condition. The wearable oxygen monitor may terminate the alarm sound and / or vibration upon detecting that the current oxygen level is at or above the specified threshold.

[0025]

[0044] 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 a 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 may be configured to analyze the sensor data collected / detected at the wearable oxygen monitor, e.g., to determine one or more status or biometric parameters based on the sensor data, to detect data related to the sensor data over time, etc. The locally stored and / or transmitted data may include information such as the time and date of a detection event associated with such data, an identifier for the earpiece, an identifier associated with the wearer, etc. Data stored on the cloud-based server may 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 may be limited to downloading data from the cloud-based server on a daily or weekly basis, for example. Alternatively or additionally, the user may 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 may alternatively or additionally be used to detect other biometric characteristics or vital signs, such as heart rate / pulse, body temperature, hydration levels, salinity, etc.

[0026]

[0045] 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 (e.g., continuously, periodically, intermittently, and / or upon request or user interaction with the mobile software application) the detected vital signs / biometric information and, optionally, upload the detected data to a cloud-based storage for future reference. The mobile software application may be configured to transmit and / or receive signals that result in a display, e.g., in a 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 may 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 may 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).

[0027]

[0046] 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 to predict (i.e., perform predictive analysis) future serious / urgent events, for example, based on current (latest) sensor readings detected on a particular wearer's wearable oxygen monitor. Once 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).

[0028]

[0047] 1A-1C are renderings of a wearable oxygen monitor 100 configured to be worn about a portion of a user's ear, according to some embodiments. As shown in FIG. 1A-1C, the wearable oxygen monitor 100 includes a first body portion 100A and a second body portion 100B, which are mechanically coupled by a connecting member 110. At least a portion of the first body portion 100A and the second body portion 100B may be integrally or monolithically formed with one another, for example, from nylon, plastic, or other suitable material.

[0029]

[0048] 1D and 1E are exploded view renderings of the wearable oxygen monitor 100 of FIGS. 1A-1C, showing its components. For example, as shown in FIG. 1D, the wearable oxygen monitor 100 includes a battery 102, an antenna 104, a vibration motor 108, charging contacts 112, a back cap 105, and a cosmetic surface 106. Each of the battery 102, the antenna 104, the vibration motor 108, the charging contacts 112, the back cap 105, and the cosmetic surface 106 can be included within and / or attached to a first body portion (i.e., 100A of FIGS. 1A-1C). FIG. 1E is a different perspective view relative to FIG. 1D, showing additional components of the first body portion, namely, a processor 114, an accelerometer 116, a flash memory 118, a biosensor 120, and flexible ear pads 124. FIG. 1E also shows that the second body portion includes a grommet 121 and a removable ear pad 122 positioned within the grommet 121 .

[0030]

[0049] 1F-1J are renderings of the wearable oxygen monitor of FIGS. 1A-1C and a charger case 150 for the wearable oxygen monitor of FIGS. 1A-1C. The charger case 150 has a lower / base portion and a lid portion, with the base and lid portions coupled together by a hinge. As shown in FIG. 1F, the wearable oxygen monitor 100 fits within and is partially contained within a complementary shaped recess in the charger case 150. In other words, when positioned within the charger case 150, a first portion of the wearable oxygen monitor 100 is located within the recess and a second portion of the wearable oxygen monitor 100 is positioned within a recess defined by the lid of the charger case 150.

[0031]

[0050] 2A-2N are diagrams of a wearable oxygen monitor 200 configured to be worn about a portion of a user's ear, according to some embodiments. FIGs. 2O-2V are diagrams of a charger case in a closed configuration, according to some embodiments, where the charger case is configured to house and power the wearable oxygen monitor of FIGs. 2A-2N. FIGs. 2W-2AD are diagrams of the charger case of FIGs. 2O-2V in an open configuration, where the charger case houses the wearable oxygen monitor of FIGs. 2A-2N. FIGs. 2AE and 2AF are diagrams of the charger case of FIGs. 2O-2V in an open configuration and not housing a wearable oxygen monitor. FIG. 2AG is a rendering of the charger case with a panel removed to show the underlying shape of a recess / pocket configured to house a wearable oxygen monitor, according to some embodiments.

[0032]

[0051] 3 is a schematic diagram illustrating components of a wearable oxygen monitor 300, according to some embodiments. As shown in FIG. 3, the wearable oxygen monitor 300 includes a memory 328, a processor 326, a transceiver 330, one or more batteries or other power sources 332, one or more LEDs 322 (optionally in a row or array), one or more optical sensors 324, and optionally one or more speakers 334 and / or microphones 336. The one or more batteries 332 are electrically coupled to and configured to power each of the processor 326, the transceiver 330, the LEDs 322, the optical sensor 324, the optional speaker 334, the optional microphone 336, and optionally the memory 328. The processor 326 is operably coupled to each of the memory 328, the LEDs 322, the optical sensor 324, the transceiver 330, and the optional microphone 336.

[0033]

[0052] The wearable oxygen monitor 300 optionally includes an alert mechanism (e.g., an actuatable button) electrically connected to the one or more batteries 332 and operably coupled to at least one of the processor 326 and the transceiver 330. The transceiver 330 may be configured to transmit and / or receive communications (e.g., to or from a remote computing device, such as a mobile device of a wearer / user of the wearable oxygen monitor 300 or other authorized person), including, for example, data collected / detected by the one or more optical sensors 324 and / or the processor 326 and / or stored in the memory 328. The processor 326 may be configured to control at least one of the one or more LEDs 322, the microphone 336, the speaker 334, or the one or more batteries 332 (e.g., based on processor-executable instructions stored in the memory 328 and / or received via the transceiver 330) via electrical conduits (not shown). In operation, and when worn about a portion of a wearer / user's ear, the one or more LEDs 322 emit light such that the emitted light is reflected by a portion of the ear (e.g., a surface or surface layer) in a direction toward one or more optical sensors 324. The one or more optical sensors 324 detect a signal in response to the reflected light. In some implementations, the processor 326 determines an oxygen level of the wearer based on the detection signal, and optionally stores the determined oxygen level in memory 328 along with date information, time information, and / or other sensor data detected based on one or more other sensors (not shown) mounted on the wearable oxygen monitor 300. Alternatively or additionally, raw data including the detection signal (optionally along with data detected using one or more other sensors) can be transmitted via the processor 326 and using the transceiver 330 to a remote computing device, such as a cloud-based server, a remote mobile device, etc., for determining an oxygen level based on the raw data.

[0034]

[0053] FIG. 4 is a block diagram illustrating components of a wearable oxygen monitor 400 (such as the wearable oxygen monitors shown in FIGS. 1A-1E and / or 2A-2N) according to some embodiments. As shown in FIG. 4, the wearable oxygen monitor 400 includes a vibration motor 440 operatively coupled to a motor drive circuit 442, a battery (e.g., lithium polymer ("LiPo")) 432 operatively coupled to a battery monitoring circuit 446, a system voltage regulator (e.g., 1.8V) 448, and a battery charging power management integrated circuit ("PMIC") 450. The battery charging PMIC 450 is operatively coupled to a direct current ("DC") power line communications ("PLC") transceiver (e.g., MAX20340) 452. Each of the DC PLC transceiver 452, battery monitoring circuit 446, and motor drive circuit 442 are operatively coupled to a system on chip ("SoC") (e.g., Nordic nRF52 series) 444, which is further operatively coupled to an antenna 446 (e.g., a Bluetooth® ("BLE") antenna circuit). The DC PLC transceiver 452 is also operatively coupled to a "charge in" external charging contact from a pair of external charging contacts 438, which also include a ground contact. The SOC 444 is operatively coupled to one or more optical sensors 424, an accelerometer 454, a serial peripheral interface ("SPI") flash memory 456, and a serial wire output ("SWO") programming connection (e.g., a pogo pin) 458.

[0035]

[0054] FIG. 5 is a block diagram illustrating components of a charger case 500 (such as the charger case shown in FIGS. 2O-2AF), according to some embodiments. As shown in FIG. 5, the charger case 500 includes a battery 502 (e.g., a LiPo battery) operatively coupled to each of a battery monitoring circuit 504, a regulator 516 (e.g., 3.3V), a DC-DC converter 518, and a battery charging PMIC 520. The battery monitoring circuit 504 is operatively coupled to a microcontroller 506 (e.g., an STM32G0 series microcontroller), which is further operatively coupled to each of a DC PLC transceiver 526 (e.g., a MAX20340), a SWO programming connection 522 (e.g., TagConnect), an LED driver 508, and a button 512 or other actuator 512 (e.g., for triggering a "wake-up" of the charger case and / or for checking the battery power level). The LED driver 508 is operatively coupled to one or more LED indicators 510 (e.g., for indicating battery level based on, e.g., lighting color and / or lighting status). The battery charging PMIC 520 is operatively coupled to a Universal Serial Bus (USB) 524 (e.g., Type C), and the DC PLC 526 is operatively coupled to a "charging output" contact from a pair of contacts 530 that also includes a ground contact. The pair of contacts 530 may be configured to mechanically mate with and electrically couple to the external charging contacts 438 of the wearable oxygen monitor 400 of FIG. 4.

[0036]

[0055] FIG. 6 is a diagram of the wearable oxygen monitor 600 when worn on the upper portion of a user / wearer's ear with the first body portion 600A and the connecting member 610 visible, according to one embodiment. The connecting member 610 can be made of nylon, plastic, or any other suitable material. Although shown positioned on the upper portion of the ear in FIG. 6, the wearable oxygen monitor 610 may alternatively be positioned on the earlobe or any other portion of the ear. For example, the wearable oxygen monitor 600 may be positioned on the helix, scapha, pinna, or earlobe of the ear. During placement or "donning" of the wearable oxygen monitor 600, the gap between the first body portion 600A and the second body portion of the wearable oxygen monitor 600 may be enlarged, for example, by moving the first and second body portions away from each other, enlarging the radius of curvature of the connecting member 610, and / or deforming the connecting member 610. When positioned at the above-mentioned portion of the user's ear ("second form") and external force is removed from the wearable oxygen monitor 600, the first body portion 600A and the second body portion can naturally move toward each other a distance equal to a portion of the gap, for example, due to the shape memory or inherent spring force (or biasing force) of the connecting member 610, so as to ensure that the wearable oxygen monitor 600 remains securely positioned at the above-mentioned portion of the user's ear during use (e.g., while the user is moving).

[0037]

[0056] 7A-7C are renderings showing components of a wearable oxygen monitor 700 configured to be worn about a portion of a user's ear at various stages of assembly, according to some embodiments. As shown in FIG. 7A, the wearable oxygen monitor 700 includes a first body portion 700A and a second body portion 700B that are mechanically coupled by a connecting member 710. FIGS. 7B and 7C show that the wearable oxygen monitor 700 includes a cosmetic surface 706, a back cap 705, a connecting member 710 connecting the first body portion 700A and the second body portion 700B, electronic circuitry 760 (e.g., including some or all of the electronic components shown in FIGS. 3 and 4), flexible ear pads 724, grommets 721, and adjustable ear pads 722.

[0038]

[0057] 8A-8U are renderings of a flexible electronics assembly (e.g., electronics 760 of FIGS. 7A-7C) for a wearable oxygen monitor, according to some embodiments. FIGS. 9A and 9B are renderings of an ear pad (e.g., an ear pad of a first body portion) with an optical sensor circuit positioned within a recess of the ear pad, according to some embodiments. FIG. 9C is a photographic image showing a bottom view of an assembled ear pad with an optical sensor circuit, according to one embodiment. FIGS. 10A-10C are views of a wearable oxygen monitor showing a grommet without an ear pad, with a thin ear pad, and with a thick ear pad, respectively, according to some embodiments.

[0039]

[0058] 11 is a flow diagram illustrating a method of manufacturing a wearable oxygen monitor according to some embodiments. As shown in FIG. 11, method 1100 includes bonding an electronic board to an ear pad (e.g., flexible ear pad 724 of FIG. 7C) using at least one of silicone or epoxy such that the electronic board is affixed to the ear pad within a cavity defined in a surface of the ear pad at 1102, and attaching the ear pad to a chassis at 1104.

[0040]

[0059] In some embodiments, a device for monitoring an oxygen saturation level of a wearer of the device includes a first body portion, a second body portion, and a connecting member. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode, and at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a grommet, and the connecting member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions that cause the processor to emit light from the at least one light emitting diode when the device is positioned over the wearer's ear and during operation of the device, and to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light.

[0041]

[0060] In some implementations, the second body portion further comprises a flexible ear pad. Alternatively or additionally, the first body portion may comprise a flexible ear pad. Alternatively or additionally, the device further comprises a vibration motor, and the memory further stores instructions for operating the vibration motor in response to detecting an event. The event may include at least one of detecting an alarm condition, detecting a low battery condition, or detecting successful positioning of the device on the wearer's ear.

[0042]

[0061] In some embodiments, the connecting member can include nylon. Alternatively or additionally, the first body portion can include a flexible ear pad, and the at least one optical sensor can be positioned (potted) within a cavity defined in the flexible ear pad. For example, the at least one optical sensor can be secured within the cavity by epoxy.

[0043]

[0062] The processor and memory can be positioned on a circuit board, and the at least one optical sensor can be electrically coupled to the circuit board via a flexible conductor. The flexible conductor can be substantially S-shaped.

[0044]

[0063] In some embodiments, the apparatus also includes 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 at least one of the microphone or the speaker in response to detecting the alarm condition.

[0045]

[0064] 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 further storing instructions that cause the processor to transmit a signal representing the measurement data to the mobile software application via the wireless transceiver.

[0046]

[0065] In some embodiments, the memory further stores instructions that cause the processor to transmit a signal to the mobile software application according to a predetermined schedule, the signal representing the measurement data.

[0047]

[0066] 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 further storing instructions that cause the processor to store data collected by the at least one sensor in the memory.

[0048]

[0067] 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 further stores instructions that cause the processor to send a signal to the mobile software application according to a predetermined schedule, the signal representing data collected by the at least one sensor.

[0049]

[0068] In some embodiments, the reflected portion of the light is a first reflected portion of the light, and the instructions to cause the processor to calculate a blood oxygen saturation level of the wearer include instructions to cause the processor to calculate a blood oxygen saturation level of the wearer based on the first reflected portion of the light and the second reflected portion of the light.

[0050]

[0069] In some embodiments, the device also includes an alert mechanism (e.g., a button) operatively coupled to the processor, and the memory further stores 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. In some embodiments, the device is waterproof. In some embodiments, the second body portion does not include any electronic components.

[0051]

[0070] In some embodiments, the kit includes an ear-worn device, a charger case, and a plurality of flexible ear pads. The ear-worn device is configured to be positioned over a wearer's ear, the device including a first body portion, a second body portion, and a connecting member mechanically coupled to each of the first body portion and the second body portion. The first body portion has a processor, a memory operably coupled to the processor, at least one light emitting diode, and at least one optical sensor configured to detect, during operation, a reflected portion of light emitted from the at least one light emitting diode, the reflected portion of light being reflected from a surface of the wearer's ear. The memory stores instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the reflected portion of light. The charger case is configured to house and power the device. The plurality of flexible ear pads, each flexible ear pad from the plurality of flexible ear pads configured to be mechanically coupled to the second body portion. The second body portion can include an annular opening, and each flexible ear pad from the plurality of flexible ear pads can be configured to be mechanically coupled to the second body portion through the annular opening. Alternatively or additionally, the device and the charger case can be configured such that data can be exchanged between the device and the charger case (e.g., via a pair of electrical contacts).

[0052]

[0071] A wearable oxygen monitor of the present disclosure, according to some embodiments, may 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; Interacting with a mobile software application; and / or · Predictive analytics.

[0053]

[0072] In some embodiments, the wearable monitoring system includes a wearable oxygen monitor and a mobile software application ("mobile app") running 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 transmit a signal representative of the alert to the mobile app such that the alert (including one or more of text, graphics, video instructions, and audio instructions) is 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).

[0054]

[0073] In some embodiments, during operation, the wearable oxygen monitor detects data related to one or more physiological conditions (collectively referred to herein as "vital signs") of the wearer, 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 may store the vital sign in a memory of the wearable oxygen monitor. Alternatively or in combination, the wearable oxygen monitor may transmit a signal representative of the vital sign to one or more remote computing devices (e.g., a mobile computing device of the user / wearer, 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 may provide access to the vital signs to a physician, e.g., by providing access credentials (for the wearable oxygen monitor and / or the mobile app) to the physician and / or by generating and sending an email or other message (via the mobile app) containing a representation of the vital signs to the physician.

[0055]

[0074] 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 conform to a predefined 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 an 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 enable button) of the wearable oxygen monitor or otherwise interacting with the wearable oxygen monitor (examples 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 times in a row (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.).

[0056]

[0075] The one or more alerts may include a representation of a "low oxygen" 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, issuing 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 (e.g., via a transceiver carried by the wearable oxygen monitor) to a mobile device 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 levels, detection intervals (e.g., for oxygen levels, blood oxygen saturation levels, or other vital signs), frequency of vital signs 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 numbers, email addresses, names, etc.), emergency planning data, vital signs priority, emergency contact priority, access permissions for healthcare providers, etc.

[0057]

[0076] In some embodiments, the wearable monitoring system includes predictive analytics capabilities and / or interacts with a predictive analytics system to provide advance warning ("pre-warning") to the wearer or user before a serious health condition episode occurs, for example, by identifying / detecting patterns based on the wearer's / user's previous serious health condition episodes. The predictive analytics capabilities 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 to 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.

[0058]

[0077] 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 / detectors, 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 / detectors, the one or more light sensors / detectors being positioned on an opposite side of said portion of the ear 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 light sensors / detectors. Based on the amount of light absorbed by the ear, a blood oxygen saturation (SpO2) level can then be calculated, for example, using the Beer-Lambert Law ("Beer's Law"). The calculation of the amount of light absorbed by the ear and / or the calculation of 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.

[0059]

[0078] 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 FIGS. 1F-1J), 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 an alarm is generated and / or transmitted can be increased. Similarly, 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 increasing over time and are all below the predefined thresholds), the frequency with which an alarm is 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 intensity or severity of the alarm can be increased over time and / or the type of alarm generated / sent can be changed over time.For example, a sound emitted (from the wearable oxygen monitor and / or from a computing device running the mobile app) may be increased in volume, a blinking light rate (in the wearable oxygen monitor and / or from a computing device running the mobile app) may be increased, a text description of an alert (e.g., presented to the wearer / user via a 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 an alert may be reduced over time and / or an alert generated / transmitted may be increased or decreased in response to detecting a decreasing difference over time between the wearer's measured / detected / calculated oxygen level and a 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 blinking light (in the wearable oxygen monitor and / or from the computing device running the mobile app) can be slowed down, the text description of the alert (e.g., presented to the wearer / user via a GUI of the mobile device running the mobile app) can be changed from "high" to "medium" or from "medium" to "low", etc. The alert can be terminated when the wearer's recently measured / detected / calculated oxygen level reaches a "normal" level (e.g., at or above a predefined threshold).

[0060]

[0079] The embodiments described herein may be used to monitor 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.

[0061]

[0080] In some embodiments, the wearable oxygen monitor is configured to continuously or intermittently monitor vital signs such as oxygen levels and heart rate, and transmit data associated with the vital signs via a mobile app (e.g., implemented using a cloud-based server) for storage in a record in a memory or other storage repository. In some such cases, when storing the vital signs, the mobile app may also provide for storage of some or all of the following additional information: GPS location of the wearer, altitude of the wearer (e.g., retrieved using a Google Application Programming Interface (API)), an indication of room air quality (e.g., detected by an on-board sensor of the wearable oxygen monitor), environmental temperature, and environmental humidity level.

[0062]

[0081] 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).

[0063]

[0082] 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) may trigger activation of an on-board 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) may also trigger (e.g., simultaneously) 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 the mobile app).

[0064]

[0083] Alternatively or additionally, in some embodiments, the wearable oxygen monitor is configured to generate and send an SMS text message 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) to one or more (e.g., three) emergency contacts predefined by the wearer (e.g., as part of a predefined emergency plan). 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 as to whether a call has already been made to emergency services (e.g., 911).

[0065]

[0084] 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 of 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 the oxygen level and heart rate. "Substantially in real time" as used herein can refer to an event occurring shortly after the predicated event, adjusted for processing-related delays (e.g., computational delays, transmission delays, etc.). When triggered, an alert can be displayed in the GUI along with or in place of the displayed data.

[0066]

[0085] 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.

[0067]

[0086] In some embodiments, the first housing portion of the wearable oxygen monitor includes one or more air quality sensors, a speaker, an alert mechanism (e.g., an actuatable button), and a microphone. In some such embodiments, two or more of the microphone, speaker, and one or more air quality sensors "share" a common opening in the outer shell / wall of the first housing portion (i.e., open to the outside air through the common opening), while the remaining portion of the outer shell / wall of the first housing portion, along with the entire outer shell / wall of the second housing portion, is sealed and waterproofed. The one or more air quality sensors can 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 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 may include Bluetooth® 5.1 Direction Finding functionality, for example, to identify the relative positions of multiple users (e.g., patients in a hospital). The batteries described herein may be rechargeable or non-rechargeable. The body temperature sensors described herein may include one or more thermal conductivity probes and / or one or more non-contact temperature sensors, such as a thermopile infrared (IR) sensor.

[0068]

[0087] In some embodiments, the first housing portion of the wearable oxygen monitor includes an analog processing circuit and / or one or more internal measurement sensors. The one or more internal measurement sensors may include, for example, one or more of an altimeter, a gyroscope, an accelerometer, a GPS sensor, a magnetometer, a galvanic skin response (GSR) sensor, or a humidity sensor. A processor of the wearable oxygen monitor may be operatively coupled to each of the analog processing circuit and the one or more internal measurement sensors.

[0069]

[0088] Alternatively or additionally, in some embodiments, the memory of the wearable oxygen monitor stores instructions that cause the processor to detect when an alert mechanism of the wearable oxygen monitor has been interacted with (e.g., pressed) by the wearer (i.e., a manual alert) and, in response to detecting that the alert mechanism has been interacted with, generate and transmit (via the wireless transceiver) a message to one or more emergency contacts stored in the memory (e.g., as part of an emergency plan stored in the memory). The memory may also store instructions that, in response to detecting that the alert mechanism has been interacted with, cause the processor to initiate a call to emergency services (911), activate the speaker, activate the microphone, emit an audio sound indicating an alert, emit a light indicating an alert, 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 cause storage in the memory of an alert record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor (e.g., air quality sensor, photodetector, body temperature sensor, internal measurement sensor, etc.) at the time of the alert.

[0070]

[0089] Alternatively or additionally, the memory may store instructions that cause the processor to compare one or more measurements collected by one or more components of the wearable oxygen monitor with a predetermined threshold stored in the memory. The processor may detect that an alarm condition exists when it determines that one or more measurements are undesirably below or above the predetermined threshold. The memory may also store instructions that cause the processor to generate and send a message to one or more emergency contacts stored in the memory (e.g., as part of an emergency plan stored in the memory) in response to detecting the alarm condition. The memory may also store instructions that cause the processor, in response to detecting an alarm condition, to initiate a call to emergency services (911), activate the speaker, activate the microphone, emit an audio sound 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 cause storage in the memory of an alert record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor (e.g., air quality sensor, photodetector, body temperature sensor, internal measurement sensor) at the time of the alert.

[0071]

[0090] In some embodiments, to begin using the wearable oxygen monitor, the wearer positions the wearable oxygen monitor in a wearing configuration around a portion of the wearer's ear (e.g., the upper part of the ear, such as the helix, scapha, or pinna of the ear). In a first example wearing configuration, a first housing portion of the wearable oxygen monitor contacts or is adjacent to a front or anterior surface of the ear, and a second housing portion of the wearable oxygen monitor contacts or is adjacent to a posterior or posterior / back surface of the ear. In a second example wearing configuration, a second housing portion of the wearable oxygen monitor contacts or is adjacent to a front or anterior surface of the ear, and a first housing portion of the wearable oxygen monitor contacts or is adjacent to a posterior or posterior / back surface of the ear. In other words, when the wearable oxygen monitor is worn, the first housing portion and the second housing portion are positioned on opposite sides of the wearer's ear.

[0072]

[0091] In some embodiments, a first light emitting diode of the wearable oxygen monitor can be configured to emit light having a first wavelength, and a second light emitting diode of the wearable oxygen monitor can be configured to emit light having a second wavelength that is different from the first wavelength.

[0073]

[0092] 12-48 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 (e.g., any of the wearable oxygen monitors described herein), according to some embodiments. As shown in FIG. 12, 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 that 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, a search can 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 on the "+" sign next to the associated medication. Also shown in FIG. 12 are the available / navigable screens, namely "Dashboard", "Reports", "Medical ID", "Progress" and "Diary".

[0074]

[0093] FIG. 13 illustrates that creating a user profile can also include specifying one or more symptoms that 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 can cause a search to be performed for matches to the search criteria by pressing the enter key. 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 on 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 the wearable oxygen monitor described herein, may 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 14 illustrates an alert and notification user interface, through which a user may turn alerts and notifications on or off using a slider.

[0075]

[0094] 15-19 show welcome screens illustrating the functionality of the mobile app, through which a user can sign up for the service (see FIG. 16), 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, such that a warning or alert is generated when the wearer's SpO2 is detected as too low by the wearable oxygen monitor. FIG. 20 shows a synchronization request, in which the mobile app requests a user's 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. 21 shows the user interface appearance during synchronization. FIG. 22 shows a login screen, and FIG. 23 shows a user's "Get Started" option, for example, after an initial login event by the user. 24-36 show a user interface of a questionnaire requesting input from the user regarding whether the user is from the United States, what emergency thresholds should be for oxygen level, heart rate, altitude and air quality, settings (alerts and notifications, location services, unit selection, language selection, app sync and other personal settings), profile data (name, age, sex, 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 personal settings, emergency information (emergency contacts, physician records, records for EMS), sex, month and year of birth, weight, whether or not the user has cardiovascular disease, and whether or not the user has pulmonary hypertension (and its World Health Organization (WHO) classification, if any). FIG. 34 shows a login screen, which a user may complete prior to accessing any of FIGS. 24-33 and 35-36, or after setting up a user account or completing the "sign up" process referenced in FIG. 22 (e.g., by answering the survey questions shown in FIGS. 24-33 and 35-36).

[0076]

[0095] FIG. 37 shows a developer test module screen including a battery level indication and current oxygen level (percentage) and heart rate (beats per minute, BPM) readings. FIG. 38 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 air pressure (inches of mercury (Hg)). FIG. 39 shows a user interface that allows the user to select the measurements they want to display on their dashboard page. FIG. 40 shows an example of today's diary entry including date, time, SpO2, heart rate, altitude, air quality index, air pressure and humidity values ​​(e.g., average, high, etc.) along with medications taken today (if any), symptoms experienced today (if any) and notes entered by the user (if any). FIG. 41 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. 42 illustrates a user interface that is accessible to users with, for example, a premium account or that provides users with the option to sign up for a premium account. A premium account can provide a user access to features such as predictive analytics, detailed report generation, and weekly and monthly vital signs presentation via a mobile app dashboard. FIG. 43 illustrates a user interface showing a Medical ID tab with data entered. FIG. 44 illustrates a user interface showing current oxygen level (percentage) and heart rate (BPM) readings along with a resettable timer. FIG. 45 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. 46 shows a safety threshold user interface, through which a user can use a slider to set a threshold percentage SpO2 value and select "Done" when finished.Figure 47 is a user interface showing the configuration after the safety thresholds have been set and a premium account has been established (as opposed to the configuration shown in Figure 26, which does not include the safety thresholds or the OxiWear premium line item). Figure 48 is a user interface showing an example landing screen (i.e., the first screen a first-time user sees, via which the user can register an account) that may be displayed when the mobile app is first launched / opened.

[0077]

[0096] FIG. 49 illustrates a user interface including an Alerts sub-window disposed above a Dashboard window, the Alerts sub-window displaying one or more SpO 2 The indicator is displayed in response to the indicator dropping below a predefined threshold. In at least some embodiments, the predefined threshold is specified by a user, as shown in FIG. 60. The alerts subwindow comprises a user interface including one or more buttons with which a user may interact. For example, a user may interact with a snooze button to suppress the alerts subwindow (e.g., for a predefined period of time, such as 5 minutes, 10 minutes, 30 minutes, etc.). A user may further interact with a "Call 911" button configured to initiate a call to an emergency dispatch office. FIG. 50 illustrates a dashboard depicting a plurality of measurements, including biometric characteristic measurements of a user, as well as factors related to or contributing to the user's oxygen level. For example, the plurality of measurements may include SpO 2 The measurements may include one or more live biometric readings for blood oxygen level and / or heart rate. The measurements may also include one or more environmental measurements for altitude, air quality index, humidity, or barometric pressure. The dashboard may also depict in graphical form a record of one or more previous measurements. For example, a number of SpO2 values ​​sampled within the last hour (or any other desired preceding time period) may be displayed. 2and heart rate measurements may be plotted on a graph, which may be updated in real time or substantially real time in response to new measurements of oxygen level and heart rate.

[0078]

[0097] FIG. 51 shows a user interface including a month / calendar view of a user's journal entries. A user can enter a journal entry for a particular day, for example using the interface shown in FIG. 40. The journal entry includes date, time, SpO 2 , heart rate, altitude, air quality index, barometric pressure and humidity values ​​(e.g., average, high, etc.), along with medications taken (if any) for the day, symptoms experienced (if any) for the day, exercise and / or physical activity completed (if any), and records entered by the user (if any). The user can interact with the calendar for a given month to view any journal entries entered on a day for that given month. The user can further use the calendar to select a day for entering a new journal entry by interacting with a "+" icon or similar interface / GUI element. The user can further use the calendar to search for previous journal entries (e.g., using a keyword search, interacting with a magnifying glass icon or similar interface / GUI element).

[0079]

[0098] FIG. 52 illustrates a user interface including views of detected oxygen levels and heart rate. The views may be in the form of graphs, plots or charts, for example. One view may depict live readings, which may be dynamically updated in real-time or substantially real-time in response to new measurements of oxygen levels and heart rate. A second view may depict multiple detected oxygen levels, heart rates and / or other measurements taken within a time period defined by a user via the GUI. The time period may include a previous period and / or previous dates / ranges for which measurements were recorded (i.e., historical data / readings).

[0080]

[0099] 53 illustrates a user interface for displaying and configuring reports. The reports may include measurements collected over a user-defined period of time. The reports may include at least one of a plurality of vital sign / vital characteristic measurements and / or a plurality of environmental measurements. For example, the reports may include a plurality of SpO2 measurements recorded or otherwise captured within a given period of time. 2 , heart rate, and altitude measurements. The time period may include a past date (or date range) and / or time (or time range) defined by the user via the GUI. The user may download the report (e.g., as a file for viewing and / or local storage) and / or generate and send an email containing the report via the user interface.

[0081]

[0100] FIG. 54 illustrates a user interface that allows a user to access multiple settings. The settings may include, for example, identity security settings, alert and notification toggles, location access settings, Bluetooth and similar device connection settings related to wireless communication protocols, threshold settings, and / or SOS / emergency notification settings. The user interface may be configured to provide the user with access to a GUI for editing the user's profile, as shown in FIG. 59. The user interface may also provide a button that the user can use to delete the user's account.

[0082]

[0101] FIG. 55 illustrates a user interface through which a user can configure one or more connections between two or more devices. The devices can include, for example, one or more wearable oxygen devices and a mobile device (e.g., a smartphone, tablet, laptop, smartwatch, or similar computing device). The mobile device can be the device on which the user interface of FIG. 55 is displayed. The one or more connections can include, for example, one or more network connections using one or more wireless communication protocols (e.g., Bluetooth, 4G, 5G, etc.). A user can access the user interface by, for example, interacting with the interface illustrated in FIG. 54.

[0083]

[0102] 56 illustrates a user interface for configuring an SOS / emergency notification alert. The SOS alert may include a text alert sent to one or more contacts defined by a user using the user interface. The text alert may include an SMS text message. A user may access the user interface using, for example, the interface illustrated in FIG.

[0084]

[0103] FIG. 57 illustrates a user interface for configuring ID security. A user can use the user interface to configure / specify an email address for the user, which can be used to contact and / or identify the user. A user can also use the user interface to update a password used for account access and / or update a subscription plan associated with the user's account. A user can access the user interface, for example, using the interface illustrated in FIG. 54.

[0085]

[0104] 58 illustrates a user interface for configuring access to location information in association with a mobile app configured for use with one or more wearable oxygen devices. A user can configure access to location information to provide data indicative of the user's geographic location to one or more programs associated with the wearable oxygen device. A user can access the user interface, for example, using the interface illustrated in FIG.

[0086]

[0105] 59 shows a user interface for configuring a user's profile. The user interface may include name, gender, date of birth, weight and / or height fields. The user interface may be used to further enter information about the primary user of one or more wearable oxygen devices. A user may access the user interface, for example, using the interface shown in FIG. 54.

[0087]

[0106] Figure 60 shows the SpO2 value for triggering an alert. 2 1 shows a user interface for configuring thresholds. 2 A threshold can be set, for example, between the range of 92%-97%, which can trigger, for example, an alert subwindow shown in FIG. 49. The user interface can include interactive elements, such as sliders, drop-down menus, radio buttons, or other graphical or text-based elements, with which the user can interact to adjust the SpO 2 The threshold can be set. A user can access the user interface, for example, using the interface shown in FIG.

[0088]

[0107] 61A-61N include renderings of a flexible electronics assembly for a wearable oxygen monitor (e.g., electronics 760 of FIGS. 7A-7C) in various configurations according to some embodiments, showing its components along with the foldability / flexibility of the assembly.

[0089]

[0108] In some embodiments, a method of manufacturing an ear-worn device includes bonding an electronic board to an ear pad using at least one of silicone or epoxy such that the electronic board is affixed to the ear pad within a cavity defined in a surface of the ear pad, and attaching the ear pad to a chassis.

[0090]

[0109] Additional details regarding the embodiments of the wearable oxygen monitor described herein can be found, by way of example, in Appendices A-D attached to this disclosure.

[0091] Wearable oxygen monitor application-COVID-19

[0110] 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 caused 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 saturation but do not exhibit respiratory distress. Although the mechanism by which silent hypoxia occurs is unknown, the phenomenon merits significant clinical and public health attention. Silent hypoxia presents at least two problems with public health. Two key challenges are: 1) infected individuals may progress to a more severe disease state but may not realize that they are COVID positive, and 2) infected, asymptomatic hypoxic patients may act as vectors to infect people around them ("silent transmission"). For hypoxic patients, continuous blood oxygen saturation monitoring is important. Therefore, a small, portable, and wearable device is desirable that provides real-time SpO2 monitoring and alerts the user when their SpO2 level drops below acceptable levels.

[0092]

[0111] 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 the coordination of care, 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 may lead to confusion or lethargy. If oxygen levels fall below 80 percent, there is a risk of serious damage to vital organs, which may result in death.

[0093]

[0112] 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 become short of breath until the day they arrive at the hospital. This means that 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 and advance them to more severe COVID-19 stages.

[0094]

[0113] To protect vulnerable populations and facilitate the detection of low blood oxygen saturation as early as possible, continuous blood oxygen saturation monitors are desirable. Highly sensitive monitoring can help ensure that patients receive medical assistance before their condition worsens, thereby improving patient outcomes and helping healthcare systems manage the ongoing burden of the pandemic.

[0095] COVID-19 Symptoms and Risk Factors

[0114] Fever, designated by the Centers for Disease Control and Prevention as a body 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 institutions should screen patients for multiple parameters when assessing the presence or severity of infection.

[0096]

[0115] Although 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 indicates the advisability of robust monitoring, especially of high-risk populations.

[0097]

[0116] Clinical observations also suggest that prognostic markers for COVID-19 are desirable, which could help ensure that patients are treated earlier and more aggressively, as well as help prevent progression to mechanical ventilation, which is associated with a significantly higher mortality rate. 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, even though they do not exhibit this benchmark symptom of COVID-19. More extensive symptom tracking could help prevent the spread of COVID-19.

[0098] Risk of COVID-19 and the Importance of Hypertension in the Elderly

[0117] People over 65 years of age are overrepresented in the picture of COVID-19 infections, hospitalizations, ICU admissions, and deaths. The higher risk of COVID-19 for the elderly has had a significant impact on 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 may be central to the high proportion of elderly people among infected patients. 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. 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 believed to enter cells through the ACE-2 receptor, increased expression of ACE-2 in hypertensive patients, which are more prevalent among the elderly, may play a role in increasing the disease burden of patients.

[0099] COVID-19 and hospital-acquired infections in high-risk patients

[0118] Dr. Shu-Yuan Xiao, a gastroenterologist affiliated with the University of Chicago School of Medicine, investigated two patients at Zhongnan Hospital in Wuhan, China. The patients underwent lobectomy for adenocarcinoma and were found to have COVID-19 during surgery. Pathology reports showed that both patients had pulmonary edema and alveolar inflammation, both characteristic of pneumonia. At the time of surgery, neither patient showed symptoms of pneumonia, suggesting that they remained in the early stages of disease progression. Unexpected cases of pneumonia in a patient population reporting for surgery for non-COVID symptoms present a risk of asymptomatic patients serving as vectors for healthcare providers and other patients in the hospital. To prevent the spread of COVID-19 within healthcare settings, active monitoring for symptoms is advisable to isolate patients suspected to be positive.

[0100] Silent hypoxia: A clinical challenge

[0119] Hypoxemia refers to below-average blood oxygenation, and hypoxia is a clinical condition in which tissue oxygen pressure is reduced. Clinically, normal arterial blood oxygen saturation is designated as 94%-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 contradict this understanding in part. Dr. Richard Levitan, a volunteer paramedic at Bellevue Hospital in New Nork, has reported cases in which patients did not complain of respiratory distress for several days before being seen at the hospital, despite imaging confirming viral pneumonia and below-average blood oxygen saturation. These cases document a phenomenon termed "silent hypoxia." The above-mentioned classification levels for hypoxemia are shown in the following table:

[0101] [Table 1]

[0102]

[0120] COVID-19 binds to receptors on alveolar cells that produce surfactant. Surfactant breaks the surface tension of water in the alveoli, thereby preventing the alveolar space from collapsing following exhalation. Infection causes a reduction in surfactant production and collapse of the air spaces. White blood cells or leukocytes create an inflammatory response in the alveoli. They also release cytokines that promote leakage of fluid from the lung's microvasculature into the spaces surrounding the alveoli. Fluid accumulation also causes 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. Thus, the patient may still be able to exhale normal amounts of carbon dioxide, which prevents the development of dyspnea and makes 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 can place a strain on the healthcare system as a whole.

[0103] COVID-19 and ARDS

[0121] Acute respiratory distress syndrome (ARDS) is characterized by the acute development of pulmonary edema, hypoxia, and later dependence on mechanical ventilation. ARDS is a major cause of respiratory failure and was present in 10% of patients in ICUs before the COVID-19 outbreak. Unlike silent hypoxia, ARDS is associated with reduced exhalation of carbon dioxide, which causes increased shortness of breath. Severe damage in the alveolar cells of the lungs causes ARDS. Alveolar damage leads to increased alveolar permeability to fluids, a process that involves inflammatory signals known as cytokines. Disease progression may lead to widespread lung scarring and adverse changes in lung compliance.

[0104]

[0122] ARDS has particular relevance with respect to COVID-19. A retrospective clinical study of 107 patients in Wuhan, China showed that 26.2% of all COVID patients developed ARDS. Of COVID patients who died, 78.9% reported ARDS. Another Wuhan clinical study showed that patients developed ARDS 8–15 days after the onset of the disease stage. Apparently benign hypoxia in “silent hypoxia” can progress to ARDS, which can be fatal in COVID patients. Therefore, robust monitoring of blood oxygen saturation could alert patients to hypoxia before the onset of ARDS, improving outcomes and helping healthcare providers arrange care.

[0105] Clinical Management of ARDS

[0123] Severe inflammation and fluid accumulation in the lungs of ARDS patients can lead to the collapse of the entire lung due to progressive pulmonary fibrosis. 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, such recovery is only partial, as surviving patients will have sub-average lung volumes 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, it is desirable for clinical workflows to include symptom monitoring to rapidly identify patients whose mild COVID-19 symptoms may progress to a more severe condition such as ARDS.

[0106] Thrombus formation and silent hypoxia

[0124] The growing awareness of silent hypoxia in COVID-19 patients has led to theories about the cause of the phenomenon that seems to contradict medical practice. Dr. Elnara Marcia Negri, a pulmonologist in Sao Paulo, Brazil, clearly points to the role of blood clot formation in causing silent hypoxic states 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 the body of COVID-19 patients. The increased blood clot formation impedes the diffusion of oxygen from the alveoli into the bloodstream, resulting in hypoxia. Negri administered heparin, a common anticoagulant, to patients with hypoxia, regardless of whether the patient had symptoms or not. According to Negri, 24 out of 27 patients recovered, proving Negri's theory. Negri advises patients to routinely monitor their blood oxygen saturation levels and to go to the hospital when the patient's blood oxygen saturation drops below 93%.

[0107] Hypoxic seizures in COVID-19

[0125] Large vessel stroke is a condition in which blood flow is interrupted in one of the major arteries perfusing the brain. 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%.

[0108]

[0126] Furthermore, the average age of COVID-19 patients who suffered strokes in Wuhan was 55 years old, suggesting that COVID-19-related strokes pose a unique risk to a slightly younger patient population. Physicians attribute the incidence of strokes in COVID-19 patients to the role that the infection plays in causing damage to the endothelial cells that line blood vessels. COVID-19's association with other severe pathologies, such as large vessel strokes, clearly indicates the desirability of robust monitoring of blood oxygen saturation.

[0109] Shortcomings of known COVID-19 diagnostic techniques

[0127] Researchers at the Cleveland Clinic investigated the efficacy of existing diagnostic technologies used to identify patients who are positive for COVID-19. These diagnostic tests included Abbott's ID NOW machine, which was said to deliver results in less than 15 minutes. According to the study, the ID NOW had a false negative rate of 14.8% and a true positive rate of 85.2%. The results of the study suggest that the ID NOW test falsely labels approximately 15% of positive patients as not infected. The study also looked at the DiaSorin Simplexa test, which had a true positive rate of 89.3%. According to Dr. Gary Procop, head of COVID-19 testing at the Cleveland Clinic, diagnostic tests should have a true positive rate of at least 95% to convince the public of the test's efficacy. The diagnostic platforms created by Roche and Cepheid had accuracy rates above 95%, while the accuracy of the DiaSorin Simplexa and ID NOW platforms was below the threshold, suggesting that there are still gaps in the field of COVID-19 diagnosis. Challenges in COVID-19 testing make monitoring of 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 of COVID-19 diagnosis and rapidly identify patients who require medical assistance.

[0110] A known monitoring solution to try to prevent silent hypoxia - pulse oximetry

[0128] Given the possibility that patients may be severely hypoxic prior to the onset of respiratory distress, some health care providers have required widespread pulse oximetry. Pulse oximetry provides patients with a non-invasive method of monitoring their blood oxygen saturation levels and can alert them to hypoxia even if they do not report other symptoms. Pulse oximeters contain a light-emitting sensor that can be clipped onto the patient's finger. Patients who use home pulse oximeters can consult with their health care provider to facilitate proper interpretation of blood oxygen saturation levels. Dr. Levitan, an emergency physician at Bellevue Hospital who mentioned cases of asymptomatic hypoxia, has required all COVID-19 positive patients to routinely test the patient's blood oxygen saturation levels within two weeks of diagnosis. Oxygenation monitoring for patients who are undiagnosed but have symptoms of cough, fatigue and / or fever may also be prudent.

[0111]

[0129] Known pulse oximeters, such as finger clips, can be useful for patient assessment, but are often difficult to transport and / or use. Some pulse oximeters, such as the Nonin Onyx, are bulky and can fall during patient transport or as a result of routine daily movements, such as standing, sitting, and shaking fingers. In addition, some patients may have a weak pulse or tissue damage, which can bias the measurement results. Other known wearable devices allow measurements only at the wrist, and such devices typically do not provide oxygen monitoring or related alerts. Rather, such devices measure pulse and fitness-related measurements, such as steps and sleep time.

[0112]

[0130] In the case of COVID-19, pulse oximeter finger cuffs do not typically 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.

[0113]

[0131] As discussed above, blood oxygen saturation is a valuable biomarker of COVID-19 for both symptomatic and asymptomatic individuals. The wearable oxygen monitor embodiments illustrated 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.

[0114]

[0132] 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. Terminology expressly 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.

[0115]

[0133] 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 numbers generally refer to like features (e.g., functionally similar and / or structurally similar elements).

[0116]

[0134] The entirety of this application (including the cover, title, headings, background, summary, brief description of drawings, detailed description, embodiments, abstract, figures, appendices, etc.) illustrates various embodiments in which the embodiments may be practiced. The advantages and features of this application are merely representative samples of embodiments and are not exhaustive and / or exclusive. Rather, they are presented to aid in understanding and teaching the embodiments and do not represent all embodiments. Thus, some aspects of the disclosure are not discussed herein. The fact that alternative embodiments may not be presented for a given portion of the innovation, or that additional undescribed alternative embodiments may be available for a portion, should not be considered to exclude such alternative embodiments from the scope of the disclosure. It will be understood that many of those undescribed embodiments incorporate the same principles of the innovation, and others are equivalent. Thus, it should 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. Thus, all examples and / or embodiments are considered non-limiting throughout this disclosure.

[0117]

[0135] Additionally, no inferences should be made with respect to embodiments discussed herein relative to embodiments not discussed herein, other than for purposes of reducing space and repetition. For example, the logical and / or topological structure of any program components (collections of components), other components and / or any combination of any present feature sets as illustrated and / or described throughout is not limited to a fixed order of operations and / or placement, but rather, any disclosed orders are exemplary, and all equivalents regardless of order are contemplated by this disclosure.

[0118]

[0136] The term "automatically" is used herein to modify actions that occur without direct input or direction from an external source such as a user. Actions that occur automatically may occur periodically, sporadically, in response to a detected event (e.g., a user login), or according to a predetermined schedule.

[0119]

[0137] As used herein, the term "substantially" has a similar meaning to "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.

[0120]

[0138] 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.

[0121]

[0139] 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."

[0122]

[0140] 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 environments, 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 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.

[0123]

[0141] 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. A 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.

[0124]

[0142] The terms "instructions" and "code" should be interpreted broadly to include any type of computer-readable statements. 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.

[0125]

[0143] 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 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 tapes, optical storage media such as compact disks / digital video disks (CD / DVD), compact disks-read only memory (CD-ROM) and holographic devices, magneto-optical storage media such as optical disks, carrier wave signal processing modules, and hardware devices that are specifically 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.

[0126]

[0144] 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 generate web services, and files containing high-level instructions executed by a computer using an interpreter. For example, embodiments may be implemented using imperative programming languages ​​(e.g., C, Fortran, etc.), functional programming languages ​​(Haskell, Erlang, etc.), logic programming languages ​​(e.g., Prolog), object-oriented programming languages ​​(e.g., Java, C++, etc.), or other suitable programming languages ​​and / or development tools. Further examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

[0127]

[0145] Various concepts may be embodied as one or more methods, at least one example of which has been provided. The acts performed as part of the method may be ordered in any suitable manner. Thus, in an embodiment, although acts are shown as sequential acts in an exemplary embodiment, embodiments may be constructed in which the acts are 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, but rather, there may be any number of threads, processes, services, servers, etc., that may be executed 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 exist simultaneously in a single embodiment. Similarly, some features may be applicable to one aspect of the innovation and not to other aspects.

[0128]

[0146] In addition, the present disclosure may include other innovations not currently described. The applicants reserve all rights in such innovations, including the right to embody such innovations and to file additional applications, continuations thereof, continuations-in-part, divisional applications, and the like. It should therefore 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 present 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 configurations and / or relational models, data types, data transmission and / or network frameworks, syntax structures, and the like, various embodiments of the technology disclosed herein can be implemented in a manner that allows for great adaptability and customization as described herein.

[0129]

[0147] 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.

[0130]

[0148] As used herein, in certain embodiments, the term "about" or "approximately" when preceding a numerical value indicates a range of that value ±10%. When a range of values ​​is given, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit unless otherwise expressly indicated by the context, 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 be independently included in the smaller range, 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 in the disclosure.

[0131]

[0149] The indefinite articles "a" and "an" used in this specification and the embodiments should be understood to mean "at least one" unless a different meaning is clearly indicated.

[0132]

[0150] The phrase "and / or" as used in the present 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 disjointly. Multiple elements listed with "and / or" should be interpreted in the same sense, i.e., "one or more" of the elements so conjoined. Optionally, other elements may be present other than the elements specifically identified by the "and / or" clause, 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", may refer in one embodiment to only A (optionally including elements other than B), in another embodiment to only B (optionally including elements other than A), in yet another embodiment to both A and B (optionally including other elements), etc.

[0133]

[0151] "Or" as used herein and in the embodiments shall 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 being inclusive, i.e., including at least one of a plurality of elements or a list of elements, and optionally including more than one of further 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. In general, 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 an exclusive term, 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.

[0134]

[0152] 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 combination of elements in the list of elements. This definition also allows, optionally, that elements other than the specifically identified elements in the list of elements to which the phrase "at least one" refers may 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.

[0135]

[0153] As in the specification above, in the embodiments, all transitional phrases such as "comprises," "includes," "carries," "has," "includes," "involves," "holds," "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 United States Patent and Trademark Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

1. An apparatus comprising: Processor, a memory operatively coupled to the processor; at least one light emitting diode operatively coupled to said processor; and at least one optical sensor configured to detect, during operation, a reflected portion of light emitted from the at least one light emitting diode; a first body portion including a second body portion including a grommet; a connecting portion disposed between the first body portion and the second body portion; Equipped with The memory may include: causing light to be emitted from the at least one light emitting diode when the device is positioned over the wearer's ear and during operation of the device; and storing instructions that cause the device to calculate a blood oxygen saturation level of the wearer based on the reflected portion of light.

2. The device of claim 1 , wherein the second body portion further comprises a flexible ear pad.

3. The device of claim 1 , wherein the first body portion comprises a flexible ear pad.

4. The apparatus of claim 1 , further comprising a vibration motor operatively coupled to the processor, the memory further storing instructions for operating the vibration motor in response to detecting an event.

5. The event is Detecting an alarm condition, Detecting a low battery condition, or Detecting correct positioning of the device on the wearer's ear The apparatus of claim 4 , comprising at least one of:

6. The device of claim 1 , wherein the connecting member comprises nylon.

7. The device of claim 1 , wherein the first body portion includes a flexible ear pad, and the at least one optical sensor is positioned within a cavity defined in the flexible ear pad.

8. The apparatus of claim 7 , wherein the at least one optical sensor is secured within the cavity by epoxy.

9. The apparatus of claim 1 , wherein the processor and the memory are positioned on a circuit board, and the at least one optical sensor is electrically coupled to the circuit board via a flexible conductor.

10. The apparatus of claim 9 , wherein the flexible conductor is substantially S-shaped.

11. 13. The apparatus 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 the processor to activate the at least one of the microphone or the speaker in response to detecting an alarm condition.

12. 13. 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 causing the processor to transmit a signal representative of the measurement data to the mobile software application via the wireless transceiver.

13. 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.

14. 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.

15. 2. 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, the memory further storing instructions that cause the processor to send a signal to a mobile software application according to a predetermined schedule, the signal representing data collected by the at least one sensor.

16. 2. The device of claim 1, wherein the reflected portion of light is a first reflected portion of light, and the instructions to cause the processor to calculate the blood oxygen saturation level of the wearer include instructions to cause the processor to calculate the blood oxygen saturation level of the wearer based on the first reflected portion of light and a second reflected portion of light.

17. 13. The apparatus of claim 1, further comprising an alert mechanism operatively coupled to the processor, the memory further storing instructions causing the processor to generate and transmit a signal representative of an alert in response to detecting a user interaction with the alert mechanism.

18. The device of claim 1 , wherein the device is waterproof.

19. The device of claim 1 , wherein the second body portion does not include any electronic components.

20. a device configured to be positioned on an ear of a wearer, the device including a first body portion, a second body portion, and a connecting member mechanically coupled to each of the first body portion and the second body portion, the first body portion having a processor, a memory operatively coupled to the processor, at least one light emitting diode, and at least one optical sensor configured, during operation, to detect a reflected portion of light emitted from the at least one light emitting diode, the reflected portion of light being reflected from a surface of the ear of the wearer, and the memory storing instructions that cause the processor to calculate a blood oxygen saturation level of the wearer based on the reflected portion of light; a charger case configured to house and power the device; a plurality of flexible ear pads, each ear pad from the plurality of flexible ear pads configured to be mechanically coupled to the second body portion; A kit comprising:

21. 21. The kit of claim 20, wherein the second body portion includes an annular opening, and each flexible ear pad from the plurality of flexible ear pads is configured to be mechanically coupled to the second body portion through the annular opening.

22. 21. The kit of claim 20, wherein the device and the charger case are configured to enable data exchange between the device and the charger case.

23. 21. The kit of claim 20, wherein the device and the charger case are configured to enable at least one of data or power to be exchanged between the device and the charger case via a pair of electrical contacts.

24. bonding an electronic board to an ear pad using at least one of silicone or epoxy such that the electronic board is affixed to the ear pad within a cavity defined in a surface of the ear pad; Attaching the ear pad to a chassis; The method includes:

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