Wearable devices with physiological parameter monitoring

Wearable devices with integrated physiological sensors and convex protrusions provide reliable pulse oximetry monitoring on the wrist, addressing the inconvenience of traditional sensors and enhancing exercise monitoring reliability.

JP7733660B2Active Publication Date: 2025-09-03MASIMO CORP
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Patent Information

Application Number
JP2022542744
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-05-11
Filing Date
2021-01-13
Publication Date
2025-09-03
Estimated Expiration
2041-01-13

AI Technical Summary

Technical Problem

Current pulse oximetry sensors require positioning near key capillary beds, which is inconvenient for monitoring during normal activities outside healthcare facilities, and existing exercise monitoring technologies are not reliable for daily routines including sports activities.

Method used

Integrating physiological monitoring sensors into a wearable device like a wristwatch with convex protrusions and light barriers to improve optical coupling, allowing pulse oximetry measurement at sparse capillary bed locations and enabling algorithms for higher-effort daily exercise.

Benefits of technology

Enables reliable and convenient pulse oximetry monitoring on the wrist, supporting continuous measurement of physiological parameters such as oxygen saturation and pulse rate during daily activities.

✦ Generated by Eureka AI based on patent content.

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Abstract

The wearable health monitoring device may include a physiological parameter measurement sensor or module configured to contact the wearer's skin when the device is worn by the wearer on the wrist. The physiological parameter measurement sensor may noninvasively and optionally continuously measure one or more physiological parameters of the wearer, such as oxygen saturation. The sensor may include a convex curvature to improve pressure and, therefore, optical coupling between the wearer's skin and the physiological parameter measurement sensor while balancing pressure and wearer comfort. The sensor may include an optical barrier and other optical barriers between the emitter and detector to improve signal strength and reduce noise.
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Description

[Technical Field]

[0001] The present disclosure relates to a wearable health monitoring device that incorporates multiple sensors worn on the wrist. [Background technology]

[0002] Spectroscopy is a common technique for measuring the concentration of organic and some inorganic components of solutions. The theoretical basis of this technique is the Beer-Lambert law, which states that the concentration of an absorber in a solution, c i is the path length d at a particular wavelength λ λ , the intensity of the incident light I 0,λ , and the extinction coefficient ε i,λ is known and can be determined by the intensity of light transmitted through the solution.

[0003] In generalized form, the Beer-Lambert law can be expressed as:

[0004]

number

[0005] where μ α,λ is the bulk absorption coefficient, which represents the probability of absorption per unit length. The minimum number of discrete wavelengths required to solve Equation 1 and Equation 2 is the number of significant absorbers present in the solution.

[0006] A practical application of this technique is pulse oximetry or plethysmography, which utilizes noninvasive sensors to measure oxygen saturation and pulse rate, among other physiological parameters. Pulse oximetry or plethysmography relies on a sensor that is attached externally to the patient (typically, for example, at a fingertip, toe, ear, forehead, or other measurement site) and outputs signals indicative of various physiological parameters (e.g., the patient's blood constituents and / or analytes (including, for example, a percentage value for arterial oxygen saturation), among other physiological parameters). The sensor has at least one emitter that transmits optical radiation of one or more wavelengths into a tissue site and at least one detector that responds to the intensity of the optical radiation (which may be reflected from or transmitted through the tissue site) after absorption by pulsatile arterial blood flowing through the tissue site. Based on this response, the processor determines the relative concentrations of oxygenated hemoglobin (HbC) and deoxygenated hemoglobin (Hb) in the blood and derives oxygen saturation (which can provide early detection of potentially dangerous decreases in the patient's oxygen supply) and other physiological parameters.

[0007] The patient monitoring device can include a plethysmograph sensor that can calculate oxygen saturation (SpC), pulse rate, plethysmographic waveform, perfusion index (PI), pleth variability index (PVI), methemoglobin (MetHb), carboxyhemoglobin (CoHb), total hemoglobin (tHb), respiratory rate, glucose, and / or other parameters measured by the plethysmograph sensor. The parameters measured by the plethysmograph sensor can be displayed individually, in groups, as trends, in combination, or as an overall wellness index or other index on one or more monitors.

[0008] Pulse oximetry sensors are described in U.S. Pat. No. 6,088,607, entitled "Low Noise Optical Probe," pulse oximetry signal processing is described in U.S. Pat. No. 6,650,917 and U.S. Pat. No. 6,699,194, entitled "Signal Processing Apparatus" and "Signal Processing Apparatus and Method," respectively, and pulse oximeter monitors are described in U.S. Pat. No. 6,584,336, entitled "Universal / Upgrading Pulse Oximeter," all of which are assigned to Masimo Corporation, Irvine, Calif., and each is incorporated herein by reference in its entirety. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Patent No. 6,088,607 [Patent Document 2] U.S. Patent No. 6,650,917 [Patent Document 3] U.S. Patent No. 6,699,194 [Patent Document 4] U.S. Patent No. 6,584,336 [Patent Document 5] U.S. Provisional Application No. 63 / 068256 [Patent Document 6] U.S. Patent Application Publication No. 2020 / 0138288 [Patent Document 7] U.S. Patent Application Publication No. 2020 / 0329993 [Patent Document 8] U.S. Patent No. 10,448,871 [Patent Document 9] U.S. Patent Application Publication No. 20190374173 Summary of the Invention [Problem to be solved by the invention]

[0010] A drawback of current pulse oximetry sensors is that they must be positioned near key capillary beds on the body (including fingers, ears, toes, nose, and forehead). Such locations are often inconvenient for monitoring users during normal activities outside of a healthcare facility. Furthermore, while technology exists for measuring oxygen saturation throughout exercise, it is geared toward the healthcare facility context and is not reliable for normal routines, including sports activities or other significant daily movements. Therefore, the present disclosure provides sensors that enable pulse oximetry to be measured in sparse capillary bed locations (including the wrist). The present disclosure also provides algorithms for measuring pulse oximetry despite higher-effort daily exercise. [Means for solving the problem]

[0011] Physiological monitoring sensors or modules (also referred to herein as physiological parameter measurement sensors or modules, or modules) can be integrated into a wearable device (e.g., a wristwatch or watch) that is fastened to a person's (the "wearer's") wrist. The sensors on the watch can be used to monitor the wearer's physiological parameters. The sensors can detect the wearer's pulse rate, oxygen saturation, hydration status, respiratory rate, and / or other parameters (e.g., parameters disclosed herein). The sensors can include convex protrusions to improve pressure and contact, and thus optical coupling, between the wearer's skin and the physiological parameter measurement sensor. The curvature of the sensor can be designed to balance the desired pressure by the watch on the wearer's wrist and the wearer's comfort. The sensors can include a light barrier between the module's emitter and detector and / or light-diffusing material surrounding the emitter and detector, among other features, to improve signal strength and reduce noise. The sensor or watch can include a connection port for accepting another sensor, which may be configured to be coupled to the wearer at a measurement location on the wearer's body other than the wrist. The sensor may be configured to measure one or more of the physiological parameters continuously, at specific time intervals, and / or upon request of the wearer. For example, the sensor may be configured to continuously measure the wearer's oxygen saturation and / or pulse rate when the watch is worn on the wearer's wrist.

[0012] An exemplary optical physiological sensor of the present disclosure may be integrated into a watch configured to monitor the health of a wearer. The optical physiological sensor may be configured to face the wearer's tissue when the watch is worn by the wearer, and may be configured to measure physiological parameters of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a first emitter grouping including a first plurality of light-emitting diodes (LEDs) at a first location; a second emitter grouping including a second plurality of LEDs at a second location different from the first location, where the second emitter grouping may include the same number and type of LEDs as the first emitter grouping; one or more light blocks separating the first emitter grouping from the second emitter grouping; a light diffusing material configured to diffuse light emitted by each of the first and second plurality of LEDs; a plurality of detectors including four or more photodiodes; and (ii) a convex surface configured to be positioned between (i) the first and second emitter groupings and the four or more photodiodes and (ii) tissue of the wearer, where the convex surface includes one or more surface materials.

[0013] In some configurations, the one or more surface materials may include at least a portion of one or more light blocking and light transmissive materials.

[0014] In some configurations, the emitters in the first or second emitter groupings may not be electrically connected to each other.

[0015] In some configurations, the first or second emitter grouping may define a group of emitters that are positioned in close proximity.

[0016] In some configurations, the multiple detectors can be both near and far detectors individually for each emitter grouping.

[0017] In some configurations, the first and second emitter groups may be positioned at non-central locations on the sensor's printed circuit board (PCB).

[0018] In some configurations, the one or more light blocks can extend from a surface of the sensor that positions the first and second plurality of LEDs toward the wearer's tissue when the watch is worn.

[0019] In some configurations, each of the first or second emitter groupings may be surrounded by its own diffusing material.

[0020] In some configurations, the light diffusing material surrounding the first emitter grouping can be different from the light diffusing material surrounding the second emitter grouping.

[0021] In some configurations, at least some of the multiple detectors may extend around the periphery of the sensor.

[0022] In some configurations, multiple detectors may be positioned in a grid pattern and / or across from one another.

[0023] In some configurations, the locations of the emitter groupings may be interleaved with multiple detectors.

[0024] In some configurations, at least one of the plurality of detectors may be positioned between the first plurality of LEDs and the second plurality of LEDs, and at least one of the plurality of detectors may be positioned on each of at least two sides of each of the first plurality of LEDs and the second plurality of LEDs.

[0025] In some configurations, the sensor may further include a processor configured to determine an oxygen saturation measurement based on a signal from the optical physiological sensor.

[0026] An exemplary optical physiological sensor of the present disclosure may be integrated into a watch configured to monitor a wearer's health. The optical physiological sensor may be configured to face the wearer's tissue when the watch is worn by the wearer and to measure the wearer's physiological parameters using information from the optical physiological sensor. The optical physiological sensor may include a plurality of emitters configured to emit light at a plurality of different wavelengths, the plurality of different wavelengths including at least three different wavelengths; a plurality of detectors configured to detect light emitted by the plurality of emitters and attenuated by the user's tissue when the watch is worn on the wearer's wrist, and configured to output a signal to a sensor processor for determining the wearer's physiological parameters; and a sensor housing in which the plurality of emitters and the plurality of detectors are enclosed, the sensor housing including a convex, skin-facing, optically transparent cover extending over the plurality of emitters and the plurality of detectors, the cover positioned on a first side of the sensor housing. The sensor housing may include a transparent cover and a printed circuit board (PCB) positioned on a second side of the sensor housing opposite the first side, with the plurality of emitters and detectors positioned on the skin-facing side of the PCB; and a plurality of light barriers extending from the PCB to the cover, the plurality of light barriers forming walls of chambers and configured to block light between the chambers or substantially all light, each chamber enclosing one or more emitters without a detector or enclosing one or more detectors without an emitter, wherein at least one of the skin-facing surface of the cover and the light barriers may define a skin-facing surface of the sensor, and wherein a surface area of ​​the cover extending above the chambers enclosing the one or more detectors is at least 50% of the surface area of ​​the skin-facing surface of the sensor.

[0027] In some configurations, the surface area of ​​the cover extending above the chamber surrounding the one or more detectors is at least 100 mm 2 It is possible that:

[0028] In some configurations, the surface area of ​​the cover extending above the chamber surrounding the one or more detectors is at least 150 mm 2 It is possible that:

[0029] In some configurations, the surface area of ​​the cover extending above the chamber surrounding the one or more detectors is at least 165 mm 2 It is possible that:

[0030] In some configurations, the surface area of ​​the optically transparent cover extending above the chamber surrounding the one or more emitters is at least 25 mm 2 It is possible that:

[0031] In some configurations, the surface area of ​​the optically transparent cover extending above the chamber surrounding the one or more detectors is at least 35 mm 2 It is possible that:

[0032] In some configurations, the skin-facing surface of the sensor can have a longer side and a shorter side, the longer side being configured to fit the width of the wearer's wrist when the watch is being worn.

[0033] In some configurations, more of the detectors may be positioned along the longer sides than along the shorter sides.

[0034] In some configurations, the plurality of emitters can include a first group of emitters and a second group of emitters, and the chamber includes a first emitter chamber surrounding the first group and a second emitter chamber surrounding the second group.

[0035] In some configurations, the plurality of detectors may include a first ring of detectors and a second ring of detectors, where the first ring of detectors surrounds a first group of emitters and the second ring of detectors surrounds a second group of emitters.

[0036] In some configurations, at least one of the plurality of detectors may be positioned between the first group of emitters and the second group of emitters and may be shared by the first and second rings of detectors.

[0037] In some configurations, some of the multiple detectors may be closer to the emitters of the first group than the rest of the multiple detectors, and some of the multiple detectors may be closer to the emitters of the second group than the rest of the multiple detectors.

[0038] In some configurations, the multiple light barriers may extend to the skin-facing surface of the cover.

[0039] An exemplary optical physiological sensor of the present disclosure may be integrated into a watch configured to monitor the health of a wearer. The optical physiological sensor may be configured to face the wearer's tissue when the watch is worn by the wearer and to measure the wearer's physiological parameters using information from the optical physiological sensor. The optical physiological sensor may include a plurality of emitters configured to emit light at a plurality of different wavelengths, the plurality of different wavelengths including at least three different wavelengths; a plurality of detectors configured to detect light emitted by the plurality of emitters and attenuated by the user's tissue when the watch is worn on the wearer's wrist, and configured to output a signal to a sensor processor for determining the wearer's physiological parameters; and a sensor housing in which the plurality of emitters and the plurality of detectors are enclosed, the sensor housing having a convex, skin-facing, light-transmitting cover extending over the plurality of emitters and the plurality of detectors. The cover may include: a light-transmitting cover positioned on a first side of the sensor housing; a printed circuit board (PCB) positioned on a second side of the sensor housing opposite the first side, with the plurality of emitters and detectors positioned on a skin-facing side of the PCB; and a plurality of light barriers extending from the PCB to the cover, the plurality of light barriers forming walls of chambers and configured to block light between or substantially all light, each chamber enclosing one or more emitters without a detector or enclosing one or more detectors without an emitter, and at least one of the plurality of light barriers may extend to the skin-facing surface of the cover.

[0040] In some configurations, all of the light barriers may extend to the skin-facing surface of the cover.

[0041] In some configurations, at least one of the skin-facing surface of the cover and the light barrier may define the skin-facing surface of the sensor.

[0042] In some configurations, the skin-facing surface of the sensor may include a continuous curvature.

[0043] In some configurations, the cover can be a single lens or cover.

[0044] In some configurations, the cover can include individual lenses, with each lens or cover covering a single chamber.

[0045] In some configurations, the cover can include a lens or cover that covers all of the chambers that extend above the detector or detectors.

[0046] In some configurations, a lens or cover that covers all chambers extending above one or more detectors may not cover chambers extending above one or more emitters.

[0047] In some configurations, the light barriers may include tinted sapphire glass.

[0048] An exemplary optical physiological sensor of the present disclosure can be integrated into a watch configured to monitor a wearer's health. The optical physiological sensor can be configured to face the wearer's tissue when the watch is worn by the wearer and can be configured to measure the wearer's physiological parameters using information from the optical physiological sensor. The optical physiological sensor can include: a first emitter including a first plurality of light-emitting diodes (LEDs) positioned on a surface of a substrate; a first photodiode positioned on the surface of the substrate; a curved surface extending above all of the first plurality of LEDs and the first photodiode; and a first light barrier positioned between the first emitter and the first photodiode, the first light barrier extending from the surface of the substrate to the curved surface.

[0049] In some configurations, the first light barrier may include one or more portions that together extend from the surface of the substrate to the curved surface.

[0050] In some configurations, the sensor may further include a second emitter including a second plurality of LEDs positioned above the surface of the substrate; a second photodiode positioned above the surface of the substrate; and a second light barrier positioned between (i) both the first and second emitters and (ii) the second photodiode, the second light barrier extending from the surface of the substrate to a curved surface, and the curved surface may extend above all of the second plurality of LEDs and the second photodiode.

[0051] In some configurations, the second light barrier may include one or more portions that together extend from the surface of the substrate to the curved surface.

[0052] In some configurations, the portions of the curved surface positioned above the first and second emitters can include at least a first material, the portions of the curved surface positioned above the first and second photodiodes can include at least a second material, and the portions of the first and second barriers extending to the curved surface can include at least a third material different from the first and second materials.

[0053] In some configurations, at least the first, second, and third materials can together define a curved surface.

[0054] In some configurations, the first and second materials may comprise the same material.

[0055] An exemplary optical physiological sensor of the present disclosure may be integrated into a watch configured to monitor a wearer's health. The optical physiological sensor may be configured to face the wearer's tissue when the watch is worn by the wearer and to measure the wearer's physiological parameters using information from the optical physiological sensor. The optical physiological sensor may include: a plurality of light-emitting diodes (LEDs) configured to emit light to the wearer's tissue; a wall dividing the plurality of LEDs into at least a first group of LEDs and a second group of LEDs, the wall preventing at least some of the light emitted from the first group of LEDs from contacting the second group of LEDs; four or more photodiodes configured to detect light emitted by the plurality of LEDs after attenuation by the tissue; and one or more covers covering the plurality of LEDs and the four or more photodiodes, the one or more covers together forming a portion of a convex surface configured to contact the tissue.

[0056] An exemplary optical physiological sensor of the present disclosure may be integrated into a watch configured to monitor the health of a wearer. The optical physiological sensor may be configured to face the wearer's tissue when the watch is worn by the wearer and to measure the wearer's physiological parameters using information from the optical physiological sensor. The optical physiological sensor may include a plurality of emitters configured to emit light at a plurality of different wavelengths, the plurality of different wavelengths including at least three different wavelengths; a plurality of detectors configured to detect light emitted by the plurality of emitters and attenuated by the user's tissue when the watch is worn on the wearer's wrist, and configured to output a signal to a sensor processor for determining the wearer's physiological parameters; and a sensor housing in which the plurality of emitters and the plurality of detectors are enclosed, the sensor housing having a convex, skin-facing, light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover configured to transmit the signal to a sensor processor for determining the wearer's physiological parameters. the sensor housing may include a light-transmitting cover positioned on a first side thereof; a printed circuit board (PCB) positioned on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being positioned on a skin-facing side of the PCB; and a plurality of light barriers extending from the PCB to the cover, the plurality of light barriers forming walls of chambers and configured to block light between the chambers or substantially all light, each chamber surrounding one or more emitters without a detector or surrounding one or more detectors without an emitter, the plurality of detectors may include a plurality of far detectors, the plurality of far detectors being farther from at least some of the plurality of emitters than the remainder of the plurality of detectors.

[0057] In some configurations, the plurality of emitters can include a first group of emitters and a second group of emitters, and the chamber includes a first emitter chamber surrounding the first group and a second emitter chamber surrounding the second group.

[0058] In some configurations, the plurality of detectors may include a first ring of detectors and a second ring of detectors, where the first ring of detectors surrounds a first group of emitters and the second ring of detectors surrounds a second group of emitters.

[0059] In some configurations, at least one of the plurality of detectors may be positioned between the first group of emitters and the second group of emitters and is shared by the first and second rings of detectors.

[0060] In some configurations, some of the plurality of detectors can be closer to the emitters of the first group than the rest of the plurality of detectors, and some of the plurality of detectors are closer to the emitters of the second group than the rest of the plurality of detectors.

[0061] In some configurations, the sensor may further include a sensor processor, the sensor processor configured to determine a hydration state of the user based on signals from the plurality of remote detectors.

[0062] In some configurations, at least one of the emitters may be configured to emit light at a wavelength that is more sensitive to water than the rest of the different wavelengths.

[0063] In some configurations, the wavelength that is more sensitive to water can be about 970 nm.

[0064] In some configurations, the sensor processor may be configured to compare reflected light signals at wavelengths that are more sensitive to water with other wavelengths that are less sensitive to water from multiple distant detectors.

[0065] In some configurations, the sensor processor may be configured to selectively activate some of the plurality of emitters and / or activate or deactivate some of the plurality of detectors.

[0066] An exemplary optical physiological sensor of the present disclosure may be integrated into a watch configured to monitor the health of a wearer. The optical physiological sensor may be configured to face the wearer's tissue when the watch is worn by the wearer and may be configured to measure the wearer's physiological parameters using information from the optical physiological sensor. The optical physiological sensor includes: a plurality of emitters configured to emit light at a plurality of different wavelengths, at least one of the emitters may be configured to emit light at a reference wavelength; a plurality of detectors configured to detect light emitted by the plurality of emitters and attenuated by the user's tissue when the watch is worn on the wearer's wrist; a sensor processor configured to output signals to the sensor processor to determine at least some of the wearer's physiological parameters based in part on the reflected light signal of the reference wavelength; and a sensor housing in which the plurality of emitters and the plurality of detectors are enclosed within the housing. the sensor housing can include a skin-facing, convex, light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover being positioned on a first side of the sensor housing; a printed circuit board (PCB) positioned on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being positioned on the skin-facing side of the PCB; and a plurality of light barriers extending from the printed circuit board to the cover, the plurality of light barriers forming walls of chambers and configured to block light between the chambers or substantially all light, each chamber enclosing one or more emitters without a detector or enclosing one or more detectors without an emitter.

[0067] In some configurations, the reference wavelength can be about 525 nm.

[0068] In some configurations, the reference wavelength of light can be green or yellow.

[0069] In some configurations, the sensor processor may be configured to extract features from the signals of the other wavelengths based on the reflected light signal of the reference wavelength, and may be configured to calculate at least some of the physiological parameters based on the extracted features.

[0070] In some configurations, at least one of the emitters may be configured to emit light at a wavelength that is more sensitive to oxygen saturation.

[0071] In some configurations, at least one of the emitters may be configured to emit light at a wavelength that is more sensitive to water.

[0072] In some configurations, at least one of the emitters may be configured to emit light at a normalized wavelength.

[0073] In some configurations, the sensor processor may be configured to determine the hydration state of the user based on the reflected light signal at the wavelength more sensitive to water and the normalized wavelength.

[0074] In some configurations, the one or more physiological parameters may include pulse rate, respiratory rate, SpO2, PVI, PI, RRP, hydration, or a combination thereof.

[0075] In some configurations, the sensor may further include a thermistor positioned near the plurality of emitters.

[0076] In some configurations, the sensors may further include an accelerometer and / or a gyroscope.

[0077] In some configurations, the sensor processor may be configured to selectively activate some of the plurality of emitters and / or activate or deactivate some of the plurality of detectors.

[0078] An exemplary optical physiological sensor of the present disclosure may be integrated into a watch configured to monitor the health of a wearer. The optical physiological sensor may be configured to face the wearer's tissue when the watch is worn by the wearer and to measure the wearer's physiological parameters using information from the optical physiological sensor. The optical physiological sensor may include a plurality of emitters configured to emit light at a plurality of different wavelengths, the plurality of different wavelengths including at least three different wavelengths; a plurality of detectors configured to detect light emitted by the plurality of emitters and attenuated by the user's tissue when the watch is worn on the wearer's wrist, the detectors configured to output signals to a sensor processor to determine the wearer's physiological parameters; and a sensor housing in which the plurality of emitters and the plurality of detectors are enclosed, the sensor housing comprising a convex, skin-facing, light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover configured to cover the sensor housing. the sensor housing may include a light-transmitting cover positioned on a first side of the sensor housing, a printed circuit board (PCB) positioned on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors positioned on a skin-facing side of the PCB; and a plurality of light barriers extending from the PCB to the cover, the plurality of light barriers forming walls of chambers and configured to block light between the chambers or substantially all light, each chamber surrounding one or more emitters without a detector or surrounding one or more detectors without an emitter, wherein each chamber surrounding the one or more emitters may be filled with a diffusing material such that no air gaps exist between the plurality of emitters and the cover.

[0079] In some configurations, the light diffusing material can include glass microspheres.

[0080] In some configurations, the cover may include glass microspheres.

[0081] In some configurations, the sensor housing can include one or more openings configured to receive a flow of light diffusing solution.

[0082] In some configurations, the light diffusing solution may be UV cured after being injected into each chamber surrounding one or more emitters.

[0083] In some configurations, the sensor housing can include one or more air vent openings configured to receive air displaced from the chamber by the flow of the light diffusing solution.

[0084] In some configurations, each chamber surrounding one or more detectors may be filled with a diffusing material such that no air gaps exist between the detectors and the cover.

[0085] In some configurations, the diffusing material in each chamber surrounding one or more emitters can be configured to improve light mixing, such that light emitted by one of the emitters in the same chamber appears to be emitted from the same entire chamber.

[0086] An exemplary watch of the present disclosure may be configured to monitor physiological parameters of a wearer. The watch may include any of the optical sensors or physiological parameter measurement sensor arrangements disclosed above; a watch processor separate from and in electrical communication with the sensor processor; a power supply configured to power the watch and the sensor; and a display in communication with the processor, the display configured to display a plurality of physiological parameters monitored by the sensors.

[0087] In some configurations, the display may be configured to display the wearer's SpO2 and pulse rate as monitored by the sensors.

[0088] In some configurations, the sensor may be configured to continuously monitor the wearer's SpO2 and pulse rate.

[0089] In some configurations, the display may be configured to continuously display the wearer's SpO2 and pulse rate.

[0090] In some configurations, the watch may further include an ECG sensor.

[0091] In some configurations, the ECG sensor may include a reference electrode, a negative electrode, and a positive electrode.

[0092] In some configurations, the reference electrode and the negative electrode may be positioned on the sensor.

[0093] In some configurations, a portion of the watch housing may form the positive electrode.

[0094] In some configurations, the ECG sensor may be in electrical communication with the sensor processor.

[0095] In some configurations, the watch may further include a wireless transmitter such that the watch is configured to wirelessly connect to external devices and / or external sensors.

[0096] In some configurations, the wireless transmitter may be a Bluetooth chip.

[0097] In some configurations, the external device and / or external sensor may include a bedside monitor, a mobile communication device, a tablet, a nurse's station system, or a different medical device.

[0098] The health monitoring watch of the present disclosure may include a strap and a housing. The housing may include a first chamber, a second chamber, and four or more light sensors, the first chamber including a first well having a first depth below a first surface configured to contact a user's skin; and a first plurality of light emitting diodes positioned at the first depth inside the first well, the first plurality of light emitting diodes including a first light emitting diode configured to emit light at a first wavelength, a second light emitting diode configured to emit light at a second wavelength different from the first wavelength, and a third light emitting diode configured to emit light at a third wavelength different from the first wavelength and the second wavelength. a second well having a second depth below a second surface configured to contact the skin of a user; and a first wall surrounding the first well, the second chamber comprising: a second plurality of light emitting diodes positioned at the second depth inside the second well, the second plurality of light emitting diodes including a fourth light emitting diode configured to emit light at a first wavelength, a fifth light emitting diode configured to emit light at a second wavelength different from the first wavelength, and a sixth light emitting diode configured to emit light at a third wavelength different from the first wavelength and the second wavelength; and a second wall surrounding the second well.

[0099] The wearable health monitoring device may be configured to be worn on a user's wrist and to monitor one or more physiological parameters indicative of the user's health. The wearable health monitoring device may include: a first emitter grouping including a first plurality of light emitting diodes (LEDs) configured to emit light of one or more wavelengths, the first emitter grouping may be disposed at a first location, the first location spaced apart from an axis extending through a center of the wearable health monitoring device; a second emitter grouping including a second plurality of LEDs configured to emit light of one or more wavelengths, the second emitter grouping may be disposed at a second location, the second location spaced apart from the first location and spaced apart from an axis extending through a center of the wearable health monitoring device; one or more light blocks separating the first emitter grouping from the emitter grouping; a first light diffusing material configured to be positioned between the first emitter grouping and tissue of the user when the wearable health monitoring device is in use, the first light diffusing material being configured to spread light emitted from one or more of the first plurality of LEDs before the emitted light reaches the tissue; and a second light diffusing material configured to be positioned between the second emitter grouping and tissue of the user when the wearable health monitoring device is in use, the second light diffusing material being configured to spread light emitted from one or more of the second plurality of LEDs before the emitted light reaches the tissue;The imaging system may include a plurality of photodiodes configured to detect at least a portion of light emitted from one or more of the first plurality of LEDs or one or more of the second plurality of LEDs after attenuation through tissue of the user, the plurality of photodiodes configured to output one or more signals in response to the detected light; and a processor configured to receive and process one or more signals in response to the one or more signals output by the plurality of photodiodes, the processor further configured to determine a physiological parameter of the user based on the received and processed one or more signals;

[0100] It is noted that "plethysmograph" (commonly referred to as "photoplethysmograph") as used herein encompasses its broad ordinary meaning known to those skilled in the art, which at least includes data representative of changes in absorption of particular wavelengths of light as a function of changes in body tissue resulting from pulsating blood. Moreover, "oximetry" as used herein encompasses its broad ordinary meaning known to those skilled in the art, which at least includes those non-invasive procedures for measuring parameters of circulating blood through spectroscopy.

[0101] For purposes of summary, certain aspects, advantages, and novel features have been described herein. It should, of course, be understood that not necessarily all such aspects, advantages, or features need be present in any particular embodiment.

[0102] The drawings and associated description are provided to illustrate embodiments of the present disclosure, not to limit the scope of the claims. In this disclosure, "bottom" refers to the side that faces the wearer's wrist when an example wearable device disclosed herein is worn on the wearer's wrist, and "top" refers to the side that faces away from the wearer's wrist. [Brief explanation of the drawings]

[0103] [Figure 1A] FIG. 1 is a first diagram of an exemplary wearable device including a physiological parameter measurement sensor or module worn on the wrist using a strap. [Figure 1B] FIG. 1B is a second view of the exemplary wearable device of FIG. 1A worn on the wrist. [Figure 1C] FIG. 1 illustrates an exemplary fingertip sensor that may be coupled to a wearable device of the present disclosure. [Figure 1D] FIG. 1C is a top perspective view of the exemplary wearable device of FIGS. 1A-1C with a partial view of the strap. [Figure 1E] FIG. 1E is a bottom perspective view of the exemplary wearable device of FIG. 1D. [Figure 1F] FIG. 1 is a side view of an exemplary wearable device without straps when the device is interfacing with the wearer's skin. [Figure 1G] FIG. 1F is a top perspective view of the exemplary wearable device of FIG. [Figure 1H] FIG. 1 is a bottom perspective view of an exemplary wearable device. [Figure 1I] FIG. 1 is a perspective view of an exemplary strap configured to secure a wearable device disclosed herein to a wearer's wrist. [Figure 2] 1 is a diagram that schematically illustrates a non-limiting example network of devices that can communicate with a wearable device as disclosed herein. [Figure 3]10A-10C illustrate exemplary displays of physiological parameter measurements on a wearable device disclosed herein. [Figure 4] FIG. 1 illustrates an exemplary physiological parameter measurement module of a wearable device. [Figure 5A] FIG. 1 is a side view of an exemplary wearable device incorporating an exemplary physiological parameter measurement module. [Figure 5B] FIG. 5B illustrates a cross-sectional view of the example wearable device of FIG. 5A. [Figure 5C] FIG. 5B is a perspective view of the wearable device of FIG. 5A. [Figure 5D] FIG. 5B is a bottom view of the wearable device of FIG. 5A. [Figure 6] FIG. 1 is a diagram illustrating schematically the arteries and capillaries of the human hand and the proximal portion of the human forearm. [Figure 7A] 1 is a schematic system diagram of a wearable device including a physiological parameter measurement module. [Figure 7B] FIG. 1 is a partially exploded view of an exemplary wearable device. [Figure 7C] FIG. 7C illustrates an exemplary light-transmitting cover of the physiological parameter measurement module of FIG. 7B. [Figure 7D] 7C is an exploded view of the ECG electrodes, light-transmitting cover, and opaque frame of the physiological parameter measurement module of FIG. 7B. [Figure 7E] 7C or 7D incorporating the ECG electrodes, light-transmitting cover, and opaque frame of a physiological parameter measurement module. FIG. [Figure 7F] FIG. 7F is a top perspective view of the exemplary physiological parameter measurement module of FIG. 7E. [Figure 7G] FIG. 2 is a diagram schematically illustrating a top view of an exemplary device processor board of a wearable device disclosed herein. [Figure 7H]FIG. 2A is a diagram schematically illustrating a bottom view of an exemplary device processor board of a wearable device disclosed herein. [Figure 8A] FIG. 2 is a diagram schematically illustrating a top view of an exemplary sensor or module processor board of an exemplary physiological parameter measurement module. [Figure 8B] FIG. 10 is a diagram schematically illustrating a bottom view of an exemplary sensor or module processor board of an exemplary physiological parameter measurement module. [Figure 8C] 10A-10C show various views of the bonding of the detector to the PCB substrate of the physiological parameter measurement module. [Figure 8D] 10A-10C show various views of the bonding of the detector to the PCB substrate of the physiological parameter measurement module. [Figure 8E] 10A-10C show various views of the bonding of the detector to the PCB substrate of the physiological parameter measurement module. [Figure 8F] 8C-8E illustrate perspective views of PCB substrates of physiological parameter measurement modules having wire bonding arrangements different from those shown in FIGS. 8C-8E. [Figure 9A] A diagram illustrating light diffusing material filled channels and air venting channels in the opaque frame of an exemplary physiological parameter measurement module. [Figure 9B] A diagram illustrating light diffusing material filled channels and air venting channels in the opaque frame of an exemplary physiological parameter measurement module. [Figure 10] FIG. 2 is a longitudinal cross-sectional view of an exemplary physiological parameter measurement module and illustrates an exemplary light path between an emitter and a detector of the module. [Figure 11A] 1 is a schematic system diagram of an exemplary wearable device including a physiological parameter measurement module. [Figure 11B] 11B is a schematic diagram of the exemplary device processor shown in FIG. 11A. [Figure 11C] 11B is a schematic system diagram of the exemplary sensor or module processor shown in FIG. 11A. [Figure 11D] FIG. 11D is a block diagram of an exemplary front-end circuit of the sensor or module processor of FIG. 11C. [Figure 12A] FIG. 1 is a bottom view of an exemplary physiological parameter measurement module with first and second ECG electrodes. [Figure 12B] FIG. 10 is a top perspective view of an exemplary wearable device including a third ECG electrode. [Figure 12C] FIG. 12C is a partial top perspective view of the exemplary wearable device of FIG. 12B, with the third ECG electrode shown as transparent to illustrate the contact spring underneath the third ECG electrode. [Figure 13A] FIG. 2 is an example block diagram of an LED drive circuit of the physiological parameter measurement module disclosed herein. [Figure 13B] FIG. 1 is an exemplary block diagram of an emitter circuit of a physiological parameter measurement module disclosed herein. [Figure 13C] FIG. 2 is an exemplary block diagram of a detector circuit of a physiological parameter measurement module disclosed herein. [Figure 13D] FIG. 2 is an exemplary block diagram of a temperature sensor circuit of a physiological parameter measurement module disclosed herein. [Figure 14A] FIG. 1 is an exemplary block diagram illustrating signal processing in a conventional plethysmograph sensor. [Figure 14B] FIG. 1 is an exemplary block diagram illustrating signal processing in a conventional plethysmograph sensor. [Figure 15A] 1 is an exemplary schematic input and output flow diagram of a physiological parameter measurement module disclosed herein. [Figure 15B] 1 is an exemplary schematic input and output flow diagram of a physiological parameter measurement module disclosed herein. [Figure 15C] 1 is an exemplary schematic input and output flow diagram of the gyroscope and accelerometer of the physiological parameter measurement module disclosed herein. [Figure 15D] FIG. 1 is an exemplary schematic block diagram for determining pulse rate using a physiological parameter measurement module disclosed herein. [Figure 15E] FIG. 10 illustrates exemplary decision logic for determining pulse rate using the physiological parameter measurement module disclosed herein. [Figure 15F] 1 is an exemplary schematic input and output flow diagram for determining oxygen saturation using a physiological parameter measurement module disclosed herein. [Figure 15G] FIG. 1 illustrates an exemplary decision logic for determining oxygen saturation using the physiological parameter measurement module disclosed herein. [Figure 16A] FIG. 10 is a diagram illustrating a schematic diagram of an exemplary plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device. [Figure 16B] FIG. 16B is a bottom view of an exemplary physiological parameter measurement module incorporating the plethysmograph sensor arrangement of FIG. 16A. [Figure 16C] FIG. 16C is a side view of the exemplary physiological parameter measurement module of FIG. 16B. [Figure 16D] FIG. 16C is a bottom perspective view of the exemplary physiological parameter measurement module of FIG. 16B. [Figure 16E] FIG. 16C is a bottom view of a variation of the exemplary physiological parameter measurement module of FIG. 16B including ECG electrodes. [Figure 16F] FIG. 16F is a side view of the exemplary physiological parameter measurement module of FIG. 16E. [Figure 16G]16F is a bottom perspective view of the exemplary physiological parameter measurement module of FIG. 16E with the opaque frame and light-transmitting cover hidden to show the ECG electrodes assembled with the sensor or module processor board. [Figure 17A] FIG. 16B is a bottom perspective view of an exemplary physiological parameter measurement module incorporating the plethysmograph sensor arrangement of FIG. 16A. [Figure 17B] FIG. 17B is a bottom view of the exemplary physiological parameter measurement module of FIG. 17A. [Figure 17C] FIG. 17B is a side view of the exemplary physiological parameter measurement module of FIG. 17A. [Figure 18A] FIG. 10 is a diagram illustrating a schematic diagram of an exemplary plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device. [Figure 18B] FIG. 10 is a diagram illustrating a schematic diagram of an exemplary plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device. [Figure 19A] FIG. 10 is a diagram illustrating a schematic diagram of an exemplary plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device. [Figure 19B] FIG. 19B is a bottom view of an exemplary physiological parameter measurement module incorporating the plethysmograph sensor arrangement of FIG. 19A. [Figure 19C] FIG. 19C is a side view of the physiological parameter measurement module of FIG. 19B. [Figure 20A] FIG. 1 is a bottom view of an exemplary physiological parameter measurement module of a wearable device when worn on a schematic representation of a wearer's wrist. [Figure 20B] FIG. 20B is a side view of the physiological parameter measurement module of FIG. 20A. [Figure 20C] FIG. 20B is an exploded view of the physiological parameter measurement module of FIG. 20A. [Figure 20D]FIG. 20B is an exploded view of the physiological parameter measurement module of FIG. 20A. [Figure 20E] FIG. 20B is a first side view of an exemplary wearable device incorporating the physiological parameter measurement module of FIGS. 20A-20D. [Figure 20F] FIG. 20F is a bottom view of the wearable device of FIG. 20E. [Figure 20G] FIG. 20F is a second side view of the wearable device of FIG. 20E. [Figure 20H] FIG. 20F is a third side view of the wearable device of FIG. 20E. [Figure 20I] FIG. 20F is a bottom perspective view of the wearable device of FIG. 20E. [Figure 20J] FIG. 20F is a top perspective view of the wearable device of FIG. 20E. [Figure 21A] 20B is a perspective view of an exemplary physiological parameter measurement module having an alternative light-transmitting cover curvature from the module of FIG. 20A. [Figure 21B] 20B is a perspective view of an exemplary physiological parameter measurement module having an alternative light-transmitting cover curvature from the module of FIG. 20A. [Figure 21C] FIG. 21C is a longitudinal cross-sectional view of the physiological parameter measurement module of FIGS. 21A and 21B. [Figure 22A] 20B is a perspective view of an exemplary physiological parameter measurement module having an alternative light-transmitting cover curvature different from the module of FIG. 20A. [Figure 22B] 20B is a perspective view of an exemplary physiological parameter measurement module having an alternative light-transmitting cover curvature different from the module of FIG. 20A. [Figure 22C] FIG. 22C is a longitudinal cross-sectional view of the physiological parameter measurement module of FIGS. 22A and 22B. [Figure 23A] FIG. 20B is a bottom perspective view of an exemplary wearable device incorporating the physiological parameter measurement module of FIGS. 20A-20D. [Figure 23B] FIG. 23B is a side view of the wearable device of FIG. 23A. [Figure 23C]FIG. 23B is a top perspective view of the wearable device of FIG. 23A. [Figure 23D] FIG. 23B is a top view of the wearable device of FIG. 23A. [Figure 23E] FIG. 23B is a bottom view of the wearable device of FIG. 23A. [Figure 24A] FIG. 10 is a bottom view of another exemplary physiological parameter measurement module of a wearable device. [Figure 24B] FIG. 24B is a side view of the physiological parameter measurement module of FIG. 24A. [Figure 25A] FIG. 10 is a bottom view of another exemplary physiological parameter measurement module of a wearable device. [Figure 25B] FIG. 25B is a side view of the physiological parameter measurement module of FIG. 25A. [Figure 25C] FIG. 25C is a first side view of another exemplary wearable device incorporating the physiological parameter measurement module of FIGS. 25A-25B. [Figure 25D] FIG. 25D is a bottom view of the wearable device of FIG. 25C. [Figure 25E] FIG. 25D is a second side view of the wearable device of FIG. 25C. [Figure 25F] FIG. 25D is a top perspective view of the wearable device of FIG. 25C. [Figure 25G] FIG. 25D is a third side view of the wearable device of FIG. 25C. [Figure 25H] FIG. 25D is a bottom perspective view of the wearable device of FIG. 25C. [Figure 26A] FIG. 1 is a diagram illustrating a microneedle inserted into the skin of a wearer. [Figure 26B] A diagram schematically illustrating a microneedle patch connected to the main body of a wearable device disclosed herein. [Figure 26C] FIG. 10 is a diagram illustrating a schematic diagram of a microneedle patch coupled to a strap of a wearable device disclosed herein. [Figure 26D]FIG. 10 schematically illustrates a simplified system diagram of a microneedle patch and wearable device. DETAILED DESCRIPTION OF THE INVENTION

[0104] Although specific embodiments and examples are described below, those skilled in the art will understand that the disclosure extends beyond the specifically disclosed embodiments and / or uses, and obvious modifications and equivalents thereof, based on the disclosure herein. Accordingly, it is not intended that the scope of the disclosure disclosed herein should be limited by any specific embodiments described below.

[0105] Overview of wearable devices containing physiological parameter measurement sensors or modules Daily use of a wearable healthcare monitoring device can include oximetry-based or plethysmograph-based parameters and / or ECG physiological parameters, which may be beneficial to the wearer. The device (e.g., device 10 as shown in FIGS. 1A-1H) can be a wristwatch incorporating a physiological parameter measurement sensor 100 or a wrist-worn physiological parameter measurement sensor with a built-in clock or time-telling function. Device 10 can include an adjustable strap 30. Thus, the wearer does not need to wear additional sensors when performing daily activities, and the device's appearance is less likely to attract attention from the general public and make the wearer feel less self-conscious about wearing a pulse oximeter sensor on their body. Additionally, the wearer can connect additional sensors (e.g., a fingertip plethysmograph sensor shown in FIG. 1C) and / or other physiological monitoring devices to the wearable device to expand its functionality.

[0106] The wearer can be informed of physiological parameters such as vital signs (including, but not limited to, heart rate (or pulse rate) and oxygen saturation) by the wearable device 10. The device 10 can display one or more of the measured physiological parameters on its display 12. The information can be useful for providing feedback to the wearer and / or a third-party user (e.g., a healthcare professional or a member of the wearer's family) when the wearer is exercising or otherwise to alert the wearer to possible health-related conditions (including, but not limited to, changes in the wearer's physiological parameters in response to medication being administered to the wearer).

[0107] As shown in FIGS. 1A-1H , the wearable device 10 can be a watch, which can include a physiological parameter measurement sensor or module 100 configured to measure indications of the wearer's physiological parameters, such as pulse rate, respiratory rate, oxygen saturation (SpO2), pleth variability index (PVI), perfusion index (PI), respiration from pulse (RRp), hydration, glucose, blood pressure, and / or other parameters. The physiological parameter measurement sensor or module 100 can be an optical sensor. Additionally, the sensor or module 100 can optionally calculate a wellness index based on two or more individual physiological parameters measured by the module and / or received by the sensor or module 100 based on externally connected sensors and / or patient monitoring devices. The sensor or module 100 can perform intermittent and / or continuous monitoring of the measured parameters. The sensor or module 100 may additionally and / or alternatively perform spot checks of the measured parameters, for example, upon request of the wearer.

[0108] As shown in FIGS. 1E and 1H , the bottom side of the device (or watch) housing 101 can include an opening sized to hold the physiological parameter measurement module 100 while still allowing the tissue-facing surface of the sensor or module 100 to be exposed. Retaining the sensor or module 100 within the device housing 101 can be assisted by any suitable retention mechanism. As shown in FIGS. 1F and 1H , the physiological parameter measurement module 100 can include a light-transmitting cover 102 that interfaces with the skin, enclosing multiple light emitters 104 (e.g., LEDs, etc.) and one or more light detectors (also referred to as “detectors”) 106. Additionally, the sensor or module 100 can optionally include an electrocardiogram (ECG) sensor, which can include multiple ECG electrodes 124, 125. As shown in FIGS. 1G and 1H, some of the ECG electrodes 125 may be positioned away from the sensor or module 100, and some of the ECG electrodes 124 may be positioned on the sensor or module 100. The cover 102 may include multiple lenses or covers or a single lens or cover assembly. The physiological parameter measurement module 100 is designed to reduce noise in the signal detected by the detector 106 by reducing the mixing of emitted and reflected light, for example, using a substantially opaque light barrier. As shown in FIG. 1F, the light barrier 120 may include a first light barrier, which may be located between the emitter and detector of the sensor or module 100. The first light barrier may extend along (e.g., extend entirely around) an inner portion of the cover 102. The first light barrier may also constrain the light emitted by the emitter to a predetermined angle.The sensor or module 100 may include additional light barriers (e.g., including side perimeter walls and additional light barriers) to separate the detectors from the emitters and / or to separate different detector groups from each other.

[0109] 1F illustrates the device 10 being worn on a wearer's wrist 2 with the physiological parameter measurement module 100 facing the wrist 2. The physiological parameter measurement module 100 on the device 10 is designed to reduce and / or eliminate a gap between the surface of the physiological parameter measurement module 100 and the wearer's skin at the measurement site where the device 10 is worn. If the device 10 is worn too loosely on the wrist (which may be the case if the device 10 is able to slide over the skin when moved), the gap between the tissue-facing surface of the physiological parameter measurement module 100 and the wearer's skin may cause inaccurate measurements. This is because the gap may result in light-piping and may cause the emitted light to not penetrate deep enough into the wearer's tissue, for example, by not penetrating deeper than the upper skin layers (e.g., the epidermis) of the wearer's tissue, which typically do not have blood vessels. Thus, the light cannot reach and / or interact with tissue located below the upper skin layer (e.g., arterial blood in the dermis, etc.) The gap can also result in a loss of attenuated and reflected light through the gap, allowing a smaller portion of the attenuated and reflected light to reach the detector 106.

[0110] The tightness of the device 10 on the wearer's body (e.g., wrist) can be adjusted by adjusting any suitable strap 30 used to secure the device to the wearer's body. The strap can be connected to the device 10 using any suitable strap connection 22. For example, the strap connection 22 can be compatible with third-party watch bands and / or wearable blood pressure monitors, etc. As shown in FIG. 1I, the exemplary strap 30 can be stretchable to evenly distribute the pressure of the device 10 around the wrist and provide better contact between the sensor or module 100 and the wrist 2, while not compromising the wearer's comfort and / or reducing blood flow across the wrist 2 in a manner that reduces the accuracy of measurements by the sensor or module 100. As shown in FIG. 1I, a rubber base 302 can be molded through multiple metal loops 304 disposed along the length of the strap 30 to form the strap 30. The metal loop 304 may include a thin (e.g., less than about 1 mm) wall of metal forming a closed loop with perforations generally transverse to the length (i.e., along the width) of the strap 30 and perpendicular to the thickness of the strap 30. During the overmolding process, the rubber material may fill or substantially fill the spaces within the perforations. The metal loops 304 may be arranged in two rows along the length of the strap 30. Alternatively, the metal loops may include partial loops with openings, or the strap may include two or more partial metal loops snapped onto each other around a rubber base. Additional details of the strap 30 are described in U.S. Provisional Application No. 63 / 068,256, entitled "WEARABLE PHYSIOLOGICAL MONITORING DEVICE WITH ADJUSTABLE STRAPS," filed August 20, 2020, the entire contents of which are incorporated herein by reference.

[0111] Additionally, the gap between the surface of the physiological parameter measurement module 100 and the wearer's skin at the measurement site can be reduced by the design of the optically transparent cover 102. As shown in FIG. 1F , the cover 102 of the physiological parameter measurement module 100 can include a convex curvature or convex protrusion on the cover 102 that interfaces with the skin. As will be explained in more detail below, the curvature of the cover 102 of the sensor or module 100 can include multiple lenses or covers or a single lens or cover and can be discontinuous or continuous.

[0112] As shown in FIG. 1F , when the device 10 is worn by a wearer, the convex cover 102 can be pressed onto the skin, and the wearer's tissue 2 can conform around the convex curve. The contact between the convex cover 102 and the wearer's tissue 2 can leave no air gap between the tissue 2 and the convex cover 102. And, because the emitter and / or detector can be surrounded by a light-diffusing material (as will be described below), the physiological parameter measurement module 100 can leave no air gap between the tissue 2 and either the emitter and / or detector. Optionally, certain portions of the cover 102 can protrude more into the skin than the rest of the cover. The pressure exerted on the skin by the curved portion of the cover 102 and / or the absence of an air gap can increase the illuminated light and / or detection area, improve optical coupling of the emitted light and blood vessels and / or optical coupling of the reflected light and detector, reduce light piping, and / or reduce blood stagnation. The cover curves can be configured to balance the pressure needed to improve contact between the cover 102 and the skin with the comfort of the wearer.

[0113] Wearable device 10 can be used in a standalone manner and / or in combination with other devices and / or sensors. As shown in FIG. 2 , device 10 can connect (e.g., wirelessly) with multiple devices, including, but not limited to, a patient monitor 202 (e.g., a bedside monitor, e.g., Masimo's Radical-7®, Rad-97® (optionally with noninvasive blood pressure or NomoLine capnography), and Rad-8® bedside monitor; a patient monitoring and connectivity hub, e.g., Masimo's Root® Platform; any handheld patient monitoring device; and any other wearable patient monitoring device), a mobile communication device 204 (e.g., a smartphone), a computer 206 (which can be a laptop computer or a desktop), a tablet 208, and / or a nurse's station system 210. The wireless connection can be based on Bluetooth technology and / or near-field communication (NFC) technology. Additionally, the wearable device 10 may connect (e.g., via any of the connected devices disclosed herein or directly) to a computing network 212. The wearable device 10 may establish connections via the network 212 to one or more electronic medical record systems 214 and / or remote servers 216 with databases.

[0114] Optionally, device 10 may be integrated with more sensors and / or configured to connect to multiple external sensors wirelessly or via a connecting cable. The connecting cable may be a universal connector configured to connect to any of the medical devices and / or sensors disclosed herein and provide communication between wearable device 10 and the connected medical device and / or sensor. The cable may optionally include a board-in cable device that includes its own processor but may not include its own display.

[0115] Device 10 can act as a hub for external sensors (e.g., sensors described in U.S. Patent Application Publication No. 2020 / 0138288, published May 7, 2020, which is incorporated herein by reference in its entirety). The sensors described in U.S. Patent Application Publication No. 2020 / 0138288 can collect patient physiological data and provide power for a reusable pairing device. The reusable pairing device can establish wireless communication with a patient monitoring device. Wearable device 10 can replace the patient monitoring device in U.S. Patent Application Publication No. 2020 / 0138288. As another example, device 10 can replace the patient monitor device described in U.S. Patent Application Publication No. 2020 / 0329993, published October 22, 2020, which is incorporated herein by reference in its entirety. By replacing the patient monitor device in U.S. Patent Application Publication No. 2020 / 0329993, the wearable device 10 performs all computer calculations based on sensor data, eliminating the need for heavy computing power for connected external sensors (e.g., the ECG sensor disclosed in U.S. Patent Application Publication No. 2020 / 0329993).

[0116] Device 10 may include an open architecture and may allow for the connection of third-party wireless sensors and / or third-party access to sensors on or connected to wearable device 10. The sensors may include, for example, temperature sensors, altimeters, gyroscopes, accelerometers, emitters, LEDs, etc. Third-party applications may be installed on wearable device 10 and may use data from one or more of the sensors on wearable device 10 and / or in electrical communication with the wearable device.

[0117] Optionally, wearable device 10 may communicate with any other suitable non-invasive sensors (e.g., acoustic sensors, blood pressure sensors, temperature sensors, movement sensors, ECG sensors, etc.). Some examples of these devices include Masimo's Radius PPG™ sensors, Radius T™ sensors, and Centroid™ sensors, or others. One or more of these sensors (e.g., the Centroid™ sensor) may be used for stroke detection. Wearable device 10 may output an alert of stroke detection in the wearer and / or automatically initiate communication with first responders and / or the wearer's guardian or next of kin upon stroke detection.

[0118] Wearable device 10 may optionally be in communication with a chemical sensor, which may detect, for example, chemicals on the wearer's skin, and / or sweat, and / or the odor of certain chemicals in the air. The chemical sensor may include an electrochemical sensor or any other suitable type of chemical sensor. A chemical sensor configured to analyze the composition of sweat may output measurements that assist wearable device 10 in detecting stress and / or the wearer's hydration state. Wearable device 10 may optionally be in communication with a skin impedance sensor, which may be used to monitor the wearer's hydration state.

[0119] Another exemplary sensor that may be integrated into or connected to device 10 and / or sensor or module 100 may include a toxin and / or radiation detector configured to detect toxins in the air (e.g., airborne pollutant or contaminant particles, carbon monoxide, smoke, etc.). The toxin detection may assist a medical provider and / or firefighter wearing device 10. Alternatively, device 10 may be wirelessly connected to an external toxin and / or radiation detector. The toxin and / or radiation detector may be used with a smart mask. For example, the external toxin and / or radiation detector may be positioned on the mask, which may enable the mask to output a warning to the mask wearer when the mask filter or cartridge needs replacement.

[0120] Optionally, the wearable device 10 can communicate with a glucose monitor, which can be invasive or minimally invasive, such as a finger-prick glucose monitor or a continuous non-invasive glucose monitor. The wearable device 10 can receive and display the wearer's glucose level from the glucose monitor. Optionally, the wearable device 10 can also communicate with an insulin pump. The wearable device 10 can send a control signal to cause the insulin pump to dispense insulin to the wearer based on the wearer's monitored glucose level.

[0121] As shown in FIG. 3 , device 10 may include a display screen 12 positioned on the top side of device housing 101. In addition to a time and date indicator, one display layout (e.g., a default display layout) of display screen 12 may display the wearer's SpO2 measurement, pulse rate (PR) measurement, respiration rate (RR) measurement, and / or hydration status (HO). The format of the displayed measurements is not limiting. For example, some measurements (e.g., SpO2 measurement and PR measurement) may be displayed as numeric values. As another example, some measurements (e.g., RR measurement and hydration status) may be displayed as a sliding scale. In the illustrated example, hydration status may be displayed as having three levels, from low (L) to high (H). In the illustrated example, respiration rate may be displayed as ranging from 5 bpm to 25 bpm. The wearer can optionally view individual display layouts for each measurement or group of measurements by tapping the display screen 12 (which can be a touchscreen) and / or by pressing a button on the device 10. Each measurement can be displayed constantly, at specific intervals, and / or upon receiving display instructions (e.g., by the wearer tapping on the display screen 12 and / or pressing a button on the device 10). Each measurement can be configured to be displayed at a different frequency or the same frequency. Time and certain physiological parameters (e.g., SpO2 and pulse rate) can be available instantly and / or intermittently and / or measured continuously (e.g., at least 5 to 10 or more measurements per minute), and the displayed values ​​can be constantly updated. Optionally, the display can further show trendlines for some parameters (e.g., SpO2 and pulse rate).In one example, the display of the wearable device may be configured to display only the time, SpO2, and pulse rate.

[0122] As shown in FIG. 4 , the physiological parameter measurement module 100 may be pre-assembled before being integrated into the device 10. The physiological parameter measurement module 100 may be characterized before being assembled with the rest of the device 10. The pre-assembled physiological parameter measurement module 100 may be secured within the device housing 101 using various mechanical assembly mechanisms (e.g., one or more screws or other fasteners). The sensors or modules 100 of the wearable device 10 may be interchangeable and may be replaced without replacing the memory within the device 10. For example, the sensor or module 100 may include quick-connect (and / or quick-release) features for attaching the sensor or module 100 to the rest of the device 10 (e.g., magnetically attachable to the device 10). An electrical connection may be established between the physiological parameter measurement sensor or module processor board and the circuitry of the rest of the device 10 (e.g., including the device processor and display 12). Optionally, the electrical connection may include a connector 32 on the sensor or module 100. Connector 32 is configured to be electrically connected to the flex circuit. Wearable device 10 and sensor or module 100 are portable and can be moved from location to location. As described above, the functionality of wearable device 10 can be integrated with and / or interchangeable with various other patient monitoring devices, displays, etc.

[0123] The sensor or module 100 may be applied to a location on the body other than the wrist. Alternatively or additionally, multiple modules 100 may be applied to different locations on the wearer's body. Other types of straps or fastening mechanisms may be used to attach multiple modules 100 to other parts of the body. Other types of straps or fastening mechanisms may optionally include a power supply (e.g., a battery) to power the module 100, which may not be integrated into the wearable device 10 but may not have its own display. For example, an optical sensor may be placed on the wearer's neck to measure arterial and venous oxygen saturation, which may be transmitted to and displayed on the wearable device 10. The wearer may view their oxygen consumption information on the wearable device 10 based on signals from the optical sensor on the neck and / or signals from sensors or modules 100 positioned on the wearable device 10.

[0124] 5A-5D, exemplary wearable device 500 can include a watch housing 501. Features of device 500 can be incorporated into features of device 10, and features of device 10 can be incorporated into features of device 500. Watch housing 501 can have a length of, for example, between about 40 mm and 50 mm, or between about 42 mm and 46 mm. Watch housing 501 can have a width of, for example, between about 32 mm and about 40 mm, or between about 35 mm and about 38 mm. When fully assembled, watch 500 can have a thickness or height of, for example, between 10 mm and about 15 mm, or between 12 mm and about 14 mm.

[0125] As described above, the physiological parameter measurement module can include multiple emitters and multiple detectors. The emitters can transmit optical radiation of multiple wavelengths into a tissue site (near the wearer's wrist), and the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsating arterial blood flowing through the tissue site. In addition to light being attenuated by blood in the arteries, light interaction also occurs at the capillary level. Arteries are located deeper below the skin surface than capillaries, requiring LED emitters with greater light intensity and, therefore, greater power consumption to ensure that the emitted light reaches the arteries. Furthermore, measuring the light intensity signal of light after attenuation by blood in the arteries requires more selective placement of emitters and detectors directly above the arteries to capture the blood pulsation. The physiological parameter measurement module disclosed herein is designed to utilize attenuation by blood in capillaries and does not rely on blood flow in the arteries. The patient parameter measurements made by the modules disclosed herein can be sufficiently accurate for clinical use. The modules disclosed herein can provide plethysmograph-based patient parameter measurements with an accuracy within about 4% error, or within about 2% error. As shown in FIG. 6 , the wrist 62 has fewer capillaries per volume than the fingertip 64. Therefore, the module is designed to have a width to provide a larger coverage area of ​​the wearer's wrist, which can boost the signal from sensors positioned on the module (which will be described in more detail below).

[0126] When measuring oxygen saturation based on attenuation by blood in capillaries, it is desirable to avoid veins. Because venous blood contains less oxygen, light intensity signals attenuated by venous blood can cause erroneous readings of oxygen saturation measurements. Optionally, the sensor or module processor of the physiological parameter measurement module disclosed herein can reduce the influence of pulsating veins on the signal by comparing signals from multiple detectors to determine which detector receives a better and / or clearer signal, and by deactivating detectors that are more likely to cover and / or be around pulsating veins. The sensor or module processor can dynamically adjust which detectors to deactivate. Deactivating a detector can include deactivating the operation of that detector and / or ignoring the signal from that detector.

[0127] Optionally, the sensors of the physiological parameter measurement module or the module processor can map physiological parameter measurements calculated from signals received at detectors and / or clusters of detectors located in different regions of the module. Variations in the mapped measurements (e.g., if outside a specific range) can be an indication that the pressure distribution of the wearable device on the wearer's body is unbalanced, and thus the pressure of the device on the wearer is either too high or too low and / or the wearable device is tilted on the wrist. The wearable device can output instructions to the wearer to readjust the tightness of the straps and / or to re-center the wearable device on the wrist. Variations in the mapped measurements (e.g., if outside a specific range) can additionally or alternatively provide an indication that a particular detector or cluster of detectors is positioned over a large, pulsating vein, as described above. The readings from that particular detector or cluster of detectors may be ignored, or the detector suspected of covering a pulsating vein may be deactivated. When two or more physiological parameter measurements (e.g., oxygen saturation measurements, etc.) disagree between two or more detectors (e.g., have variability beyond a certain range), the sensor or module processor may use the higher or highest measurement, or alternatively, may use a combination of measurements from two or more detectors (e.g., use one of two measurements at different times, or so forth).

[0128] Alternatively or additionally, the mapped measurements may be compared with experimentally determined data at the same detector or detector cluster locations. The experimentally determined data may be obtained, for example, using a conventional reflectance pulse oximeter taped over the corresponding detector location, or may be obtained using any other suitable known method for making the same measurements, including the same wrist-based sensor configurations described herein. The comparison between the mapped measurements and the experimentally determined data may provide an indication of whether the device achieved the desired pressure on the wearer's body, whether a particular detector and / or detector cluster is placed over or near a pulsating vein (which may interfere with physiological parameter measurements), or other indications. For example, if the difference between the mapped measurements and the experimental data at a particular location falls outside a predetermined range, the sensor or module processor may determine that the pressure at that location is too high or too low, and / or that the pressure distribution across the body is not sufficiently balanced to provide an accurate measurement, and / or that the detector or detector cluster is placed over the wearer's pulsating vein. The experimental data may be stored in a memory device of the sensor or module processor.

[0129] Comparisons between mapped measurements and / or comparisons between mapped measurements and empirical data can be performed when the wearer first puts on the device and / or can be performed at specific time intervals over the duration the device is worn on the wearer. Additionally, performing comparison-based diagnostics can enable the sensor or module processor to determine which detector provides the most accurate and / or reliable measurements at the start of measurements and / or dynamically during use of the device.

[0130] Various exemplary components of a wearable device The components of the wearable device will now be described. As shown in FIGS. 7A and 7B, the device 10 can include its own device processor 14, which can be a digital / analog chip or other processor (e.g., a digital watch processor or a smartwatch processor, etc.). As shown in FIGS. 7B, 7G, and 7H, the device processor 14 can be located on a PCB. FIGS. 7G and 7H illustrate exemplary PCB layouts for the device processor 14. As shown in FIGS. 7A and 7B, the device 10 can include a power supply 16 for powering the device processor 14, the display screen 12, and / or the physiological parameter measurement module 100, which can be a battery. The battery 16 can last for at least 10 hours, or at least 12 hours, or at least 14 hours, or at least about 16 hours after each charge with continuous measurement and / or display of certain physiological parameters (e.g., SpO2 and pulse rate, etc.).

[0131] The device 10 may be configured to display the time after the battery 16 is depleted, even if other features (e.g., measuring physiological parameters using a module) are unavailable when the battery 16 is depleted. Additionally, when the device 10 is used clinically, the display 12 may continue to display important patient information (e.g., the patient's name, admission date, etc.) after the battery 16 is depleted. The device 10 may include non-volatile memory for storing important patient information. The device 10 may include a dual-battery configuration with a main battery and a backup battery. The power management of the device 10 may automatically switch so that the device 10 is powered by the backup battery when the main battery is depleted. The device may additionally or alternatively be configured to be solar-powered, for example, by including a solar panel on the dial or elsewhere on the wearable device 10. The display 12 of the device 10 may use e-ink or ULP (ultra-low power screen) technology, which draws a small amount of current to display information. The display 12 can automatically adjust brightness, being brighter outdoors and dimmer indoors, further extending battery life.

[0132] As shown in FIGS. 7A and 7B , the sensor or module 100 of the wearable device 10 can include a sensor or module processor 108 (which can include memory and / or other electronics, such as that shown in FIG. 11C ). The sensor or module processor 108 can process signals from one or more of the sensors in the sensor or module 100 (or, optionally, other sensors in communication with the device 10) to determine multiple physiological parameters. All processing of raw sensor data from sensors in communication with the sensor or module processor 108 (via wired and / or wireless connections) is performed by the sensor or module processor 108. The sensor or module processor 108 can be configured to drive the emitters 104 to emit light of different wavelengths and / or process attenuated light signals from the detector 106 after absorption by the wearer's body tissue. The sensor or module processor 108 can determine physiological parameters based on the detected signals and output them for display on the device display screen 12. Optionally, the sensor or module 100 can send a signal (e.g., a preprocessed signal) from the detector 106 to the device processor 14, which can determine a physiological parameter based on the detected signal and output it for display. Absorption of light can be via transreflectance by the wearer's body tissue, for example, by pulsating arterial blood flowing through capillaries (and, optionally, arteries) in the tissue site (e.g., wrist) where the device 10 is worn. The sensor or module processor 108 can be located on a PCB 116 (e.g., such as that shown in FIG. 7B ).

[0133] The sensor or module 100 may include two or more groups or clusters of light emitters (e.g., LEDs, etc.) 104 and two or more groups of light detectors (also referred to as "detectors") 106. Each group of emitters 104 may be configured to emit four (or three) different wavelengths as described herein. The sensor or module 100 may include one or more thermistors 110 or other types of temperature sensors. The thermistors 110 may be located near one or more groups of emitters 104. There may be at least one thermistor 110 near each group of emitters 104. The thermistors 110 may provide wavelength correction for the light emitted by the emitters 104. Optionally, the thermistors 110 may additionally measure the temperature of the wearer of the device 10. Optionally, there may be one or more thermistors 110 positioned elsewhere in the sensor or module 100. The emitter 104, thermistor 110, and / or detector 106 may be positioned on a PCB 116.

[0134] 7A , the device 100 may include a gyroscope 112, an accelerometer 114, and / or other position and / or orientation detection sensors. The gyroscope 112 and / or accelerometer 114 may be in electrical communication with the sensor or module processor 108. The sensor or module processor 108 may determine motion information from signals from the gyroscope 112 and / or accelerometer 114. The motion information may provide a noise measure for analysis of pulse wave information and other signal processing (e.g., processing of ECG signals) performed by the sensor or module processor 108. The gyroscope 112 and / or accelerometer 114 may be located on the PCB 116.

[0135] FIG. 8A illustrates an example layout of the top side of the PCB 116. FIG. 8B illustrates an example layout of the bottom side of the PCB 116. The first or bottom side of the PCB 116 includes the emitter 104, the detector 106, the temperature sensor 110, and any other sensors, such as a gyroscope and / or an accelerometer. FIGS. 8C-8E illustrate that the detector 106 is electrically connected to the PCB 116 via wire bonds 107. The module may include wires 105 extending above the detector 106 for shielding purposes. The number of wires 105 extending above the detector 106 may vary. The manner in which the wires 105 extend above the detector 106 may vary. The wires 105 do not have to extend all the way above the detector 106 across the width or length of the detector. For example, as shown in FIG. 8F , the detectors of the detector groups 106 a, 106 b, and 106 a / b may each be electrically connected to a first side of the PCB 816 via wire bonds 107. Wires 105 may extend along each side of the detector for noise shielding. In the illustrated example, the wires 105 may extend along each long side of the detector. The wires 105 may extend parallel to the length of the detector. The wires 105 may not extend above the body of the detectors 106 a, 106 b, and 106 a / b. The emitters in the emitter groups 104 a, 104 b may each be electrically connected to a first side of the PCB 816 via wire bonds 107. The thermistors 110 in each of the emitter groups 104 a, 104 b may each be electrically connected to the first side of the PCB 816 via wire bonds 107. The detectors, emitters, and / or thermistors may alternatively be electrically connected to the PCB 116 via other suitable types of electrical connectors.

[0136] The second or top side of the PCB 116 may include sensors or the module processor 108 and other circuit hardware. The second side of the PCB 116 may be electrically noisy and is isolated from the sensors on the first side of the PCB 116 by a board. The electronics on the same side of the PCB 116 are substantially completely overmolded to reduce or prevent components from becoming displaced or damaged during use. On the second side of the PCB 116 (which faces away from the light-transmitting cover 102), the PCB 116 may be covered with a molten plastic or other suitable electronics protective material 130 (e.g., such as those shown in FIGS. 7B and 7F). As shown in FIG. 7F, the electronic components on the second side of the PCB 116 may generally be sealed by the protective material 130, except that a connector 132 may extend from the second side of the PCB 116 and be exposed. The connector 132 may electronically connect the sensor or module 100 to the circuitry of the wearable device 10.

[0137] Optionally, as shown in Figures 7A, 7B, and 7D, device 10 can include an electrocardiogram (ECG) sensor including multiple electrodes 124, 125 configured to contact the wearer's skin. One or more ECG electrodes 124 can be positioned on sensor or module 100 (e.g., such as those shown in Figures 7B and 7E). One or more ECG electrodes 125 can be positioned elsewhere on the device (e.g., ECG electrodes 125 can form part of the housing of wearable device 10, as shown in Figure 7B). The ECG sensor can be in electrical communication with sensor or module processor 108 via an ECG connector.

[0138] 7B-7E, the physiological parameter measurement module 100 can include a light-transmitting cover 102 that interfaces with the skin, the light-transmitting cover 102 enclosing a first side of a PCB 116 that positions a plurality of light emitters 104 and detectors 106. The sensor or module 100 can include a light barrier construction 120 configured to separate the emitters 104 and detectors 106 into different chambers such that light cannot, or substantially cannot, travel between the chambers. The light-transmitting cover 102 can extend over the various emitter and detector chambers formed by the light barrier construction 120 and the PCB 116. The light-transmitting cover 102 can include individual lenses or covers (e.g., as shown in FIG. 7D ), a single lens or cover (e.g., as shown in FIGS. 17A-17C ), or a combination of individual emitter-chamber-covering lenses or covers and a single lens or cover covering multiple detector chambers (e.g., as shown in FIG. 7C ). In the exemplary lens or cover 102b shown in FIG. 7C , individual lenses or covers configured to cover detector chambers (e.g., as shown in FIG. 7D ) can be interconnected by bridging portions 103 between the detector chambers to form a single-piece lens or cover. The lens or cover 102b can be combined with the lens or cover 102a covering the emitter chambers to cover all openings in the light barrier construction 120 to form sealed emitter and detector chambers. The light barrier construction 120 can be overmolded onto the lens or cover 102b and the lens or cover 120a. The lens or cover 102b may not be configured to cover the emitter chamber, which may be covered by a separate lens to prevent any light from traveling between the emitter chamber and the detector chamber.

[0139] As shown in FIG. 7B , the physiological parameter measurement module 100 may include an opaque frame 126. The opaque frame 126 may house the light barrier construction 120. Alternatively, the opaque frame 126 and the light barrier construction 120 may form an integral piece (e.g., as shown in FIG. 7D ). The opaque frame 126 may include recesses having a shape and size for housing ECG electrodes 124 or other components having an appropriate shape and size. The front side of the electrodes 124 may have one or more posts 137 that extend beyond the openings in the opaque frame 126 into corresponding openings on the PCB 116. The posts 137 of the electrodes 124 may establish electrical connections with corresponding openings in the PCB 116. A number of screws (or other types of fasteners) may extend from the front side of the PCB 116 into corresponding openings in the PCB 116 and threadably engage with the posts 137 or otherwise secure the electrodes 124 to the sensor or module 100. When a wearer wears a wearable device incorporating the sensor or module 100 on their wrist, the electrodes 124 may come into contact with the wearer's skin.

[0140] The physiological parameter measurement module 100 can include a diffusing material or encapsulant, which can include, for example, microspheres or glass microspheres. As described above, the encapsulant can eliminate air gaps between the surface of the optically transparent cover 102 and the emitter 104 and / or detector 106. The encapsulant can be included around the emitter 104 to spread the emitted light more evenly, making it appear to be emitted from the entire emitter chamber rather than from a point source (i.e., a single LED emitter) in the absence of the encapsulant. The encapsulant can allow the emitted light to travel through a larger volume of tissue at the tissue site. The diffusing material can act as a beam shaper, which can homogenize the input light beam from the emitter, shape the output intensity profile of the received light, and define the manner (e.g., shape or pattern) in which the emitted light is distributed at the tissue measurement site. Such diffuser materials can, for example, deliver substantially uniform illumination over a specific target area in an energy-efficient manner. According to the Beer-Lambert law, the amount of light absorbed by a substance is proportional to the concentration of the light-absorbing substance in the irradiated solution (e.g., arterial blood). Therefore, by irradiating a larger volume of tissue and / or increasing the amount of detected light, a larger sample size of light attenuated by the wearer's tissue can be measured. A larger sample size provides a data set that is more representative of the complete interaction of the emitted light as it passes through the patient's blood, compared to a smaller sample size.

[0141] The diffusing material can be any suitable material, such as glass, frosted glass, glass beads, opal glass, grayed glass, polytetrafluoroethylene, or a microlens-based, band-limited, engineered diffuser capable of delivering efficient and uniform irradiation. UV-cured flow glass microspheres are injected into one or more openings on the sensor or module 100 (e.g., after the sensor or module 100 is assembled). An example of an engineered diffuser can include molded plastic with a specific shape, pattern, and / or texture designed to diffuse emitter light across the tissue surface. The diffusing material can be made of frosted glass, which spreads the emitted light with a Gaussian intensity profile. The diffusing material can include glass beads. The diffusing material can be constructed to diffuse the emitted light in a Lambertian pattern. A Lambertian pattern is one in which the radiant intensity is substantially constant throughout the area of ​​distribution. One such diffusing material can be made of opal glass. Opal glass is similar to frosted glass, but has one surface coated with an opalescent coating to diffuse light evenly. The diffusing material may be capable of distributing the emitted light over a planar surface (e.g., the surface of a tissue measurement site) in a predetermined geometric shape (e.g., rectangular, square, circular, or other) and with a substantially uniform intensity profile and energy distribution. The efficiency (or amount of light transmitted by the diffusing material) may be greater than 70% of the light emitted by the emitter. The efficiency may be greater than 90% of the emitted light. Additional examples of diffusing materials are described in U.S. Pat. No. 10,448,871, the entire contents of which are incorporated herein by reference and should be considered part of this disclosure.

[0142] Additionally or alternatively, the physiological parameter measurement module 100 can include an encapsulant or light-diffusing material within the detector chamber to spread the reflected light more evenly, increasing the amount of reflected light that reaches the detector. The module can include a light-diffusing material positioned around the detector to scatter and / or deflect the reflected light so that more of it can be detected by the detector. For example, reflected light can continue to bounce off the diffusing material until it reaches the detector. Thus, the light-detecting surface area within the module can be larger than the surface area of ​​the detector. Having a light-diffusing material can reduce the power required to drive the emitter LEDs and / or the number of detectors in a particular location on the module, which can reduce the power consumption of the module.

[0143] As shown in FIG. 9A , the opaque frame 126 of the sensor or module 100 can include multiple light-diffusing material (or encapsulant) fill holes 144. The light-diffusing material or encapsulant (e.g., a flow of glass microspheres) can be injected into the multiple chambers through the fill holes 144 and directed along multiple fill channels 446 (see FIG. 9B ) interconnected with the fill holes 144 to the respective emitter or detector chambers, as illustrated by the arrows in FIG. 9A . The fill channels 146 can be positioned on a side of the opaque frame 126 facing away from the wearer's tissue. As shown in FIG. 9B , the side of the opaque frame 126 facing away from the wearer's tissue can further include multiple air vent channels 145. Air can escape into the vent channels 145 when the diffusing material solution or encapsulant is injected into the respective chambers through the fill holes 144, making it easier for the injected solution to flow into the respective chambers. As shown in Figure 9B, module 401 may not have air vent or fill channels between the emitter and detector chambers to avoid light piping along such channels. The encapsulant may be UV cured after being injected into each chamber.

[0144] The opaque frame 126 can be configured such that the fill holes 144 and channels 146 allow the light-diffusing material to fill only the emitter chamber, only the detector chamber, or both the emitter and detector chambers. Optionally, in addition to or as an alternative to the light-diffusing material, the detector chamber can include a light-transmitting lens or cover over the surface of the PCB not occupied by the detector. The light-transmitting lens or cover inside the detector chamber can help focus reflected light onto the detector inside the detector chamber.

[0145] 10, a cross-sectional view of the sensor or module 100 illustrates some of the emitter and detector chambers. The chambers illustrated in FIG. 10 include a first emitter chamber 136a surrounding the first emitter group 104a, a second emitter chamber 136b surrounding the second emitter group 104b, a first detector chamber 140 surrounding one of the detectors 106a of the first group surrounding the first emitter group 104a, a second detector chamber 142 surrounding one of the detectors 106b of the second group surrounding the second emitter group 104b, and a third detector chamber 138 opposite the third detector chamber 138 surrounding one of the detectors 106a / b of the shared group surrounding both the first and second emitter groups 104a, 104b.

[0146] 10 , light from a first emitter group 104a may travel a shorter path to the first group detector 106a or the shared group detector 106a / b, as indicated by the shorter arrows, and light from the first emitter group 104a may travel a longer path to the second group detector 106b, as indicated by the longer arrows. The opposite is true for light from the second emitter group 104b, which may travel a shorter path to the second group detector 106b or the shared group detector 106a / b and a longer path to the first group detector 106a. As described herein, the emitters 104a, 104b and / or detectors 106a, 106b, 106a / b of different groups may be operated independently and / or simultaneously. The signals output by the different groups of detectors 106a, 106b, 106a / b based on light emitted from the first emitter group 104a and / or the second emitter group 104b can provide different information due to the different light paths that can travel through different areas of tissue. Longer paths penetrate deeper into the tissue than shorter paths, passing through a larger volume of tissue to reach the detectors of the “distant” group, while shorter paths penetrate less deeply into the tissue, traveling through a smaller volume of tissue to reach the detectors of the “near” group. The different information can be separated and / or combined to calculate multiple physiological parameters of the wearer of the sensor or module 100 (e.g., an indication of the wearer's hydration status), as will be described in more detail below.

[0147] 11A schematically illustrates an exemplary wearable device 10 disclosed herein. As described above, the device processor 14 may be connected to the module sensors 108 of the physiological parameter measurement module 100, which may include emitters, detectors, thermistors, and other sensors disclosed herein. Electrical connections between the device processor 14 and the sensors or module processor 108 may optionally be established via a flex connector 32. The sensors or module processor 108 may be coupled to ECG electrodes 124, 125, optionally via an ECG flex connector 123.

[0148] The device processor 14 may be connected to a display 12, which may include a display screen and touch input from the wearer. The device processor 14 may include a battery 16 and, optionally, one or more wireless charging coils 17 to enable wireless charging of the battery 16. The device processor 14 may be connected to an antenna 19 for extending a wirelessly transmitted signal to an external device, for example, as described with reference to FIG. 2. The device processor 14 may include connections to a first user interface (UI 1) 13a and a second user interface (UI 2) 13b on the device 10 to receive input from the wearer. As shown in FIG. 1F, exemplary first and second user interfaces 13a, 13b may be in the form of buttons 13. Additionally or alternatively, the device 10 may include a microphone. The device 10 may receive user input via a user interface, which may be a button, a microphone, and / or a touchscreen. User input can instruct device 10 to turn on and / or off certain measurements and / or to control externally connected devices (e.g., insulin pumps, therapeutic drug delivery devices, or the like). Device processor 14 is connected to a user feedback output 15, which can provide feedback to the wearer, for example, in the form of vibrations, audio signals, and / or other forms. Device processor 14 can optionally be connected to an accelerometer and / or gyroscope 42 located on device 10 that is different from the accelerometer 114 and gyroscope 112 on physiological parameter measurement module 100.The accelerometer and / or gyroscope 42 may measure the position and / or orientation of the wearer for non-physiological parameter measurement functions, such as to sense when the wearer is awake and / or to rotate the display 12.

[0149] FIG. 11B illustrates exemplary components of the device processor 14 PCB board. As shown in FIG. 11B, the device processor 14 may include a Bluetooth coprocessor 1400 and a system processor 1402. The system processor 1402 may perform peripheral functions for the device 10, receive user (i.e., wearer) input, and communicate with the sensor or module processor 108. The Bluetooth coprocessor 1400 may focus on managing Bluetooth communications, allowing the system processor 1402 to focus on memory-intensive tasks (e.g., managing the display screen 12). The Bluetooth coprocessor 1400 may be activated when there is incoming and / or outgoing Bluetooth communication. Alternatively, the Bluetooth coprocessor 1400 may be replaced by a different wireless coprocessor configured to manage wireless communications using a different wireless communication protocol.

[0150] FIG. 11C illustrates exemplary components of the module processor PCB board 116. As shown in FIG. 11C, the sensor or module processor 108 can include a calculation processor 1080 and a system processor 1082. The calculation processor 1080 can manage host communication with the device processor 14 via a host connector 1084. The calculation processor 1080 can perform algorithmic computations to calculate physiological parameters based on signals received from the ECG electrodes 124 / 125 and optical sensors (including the emitter 104, detector 106, and temperature sensor 110), and optionally, signals received from other sensors in communication with the sensor or module processor 108. The calculation processor 1080 can have a relatively large memory suitable for performing the algorithmic computations. The system processor 1082 can communicate with a power management integrated circuit (PMIC) 1090. The system processor 1082 may run the physical systems of the sensor or module 100 (including, for example, turning on and off emitter LEDs, changing gain, setting currents, reading the accelerometer 114 and / or gyroscope 112, etc.) and may thin out data to a lower sampling rate. The system processor 1082 may focus on data processing, measurements, and diagnostics, as well as the basic functions of the sensor or module processor 108. The system processor 1082 may allow the calculation processor 1082 to sleep (be inactive) most of the time, waking up only when there is enough measurement data to perform calculations.

[0151] Figure 11D illustrates an example front-end analog signal conditioning circuit 1088 of the module PCB 116 shown in Figure 11C. The entire front-end circuit 1088 can be located on a single application specific integrated circuit (ASIC).

[0152] The front-end circuitry 1088 may include a transimpedance amplifier 1092 configured to receive analog signals from the optical sensors (including the emitters 104, the detectors 106, and the temperature sensors 110), which may be preprocessed (e.g., via a low-pass filter 1094 and a high-pass filter 1096) before being sent to an analog-to-digital converter 1098. The analog-to-digital converter 1098 may output digital signals based on the analog signals from the optical sensors (including the emitters 104, the detectors 106, and the temperature sensors 110) to the system processor 1082 and the calculation processor 1080. The front-end circuitry 1088 may include a detector cathode switch matrix 1083 configured to activate the cathodes of the detectors selected to be activated. In configurations in which the detectors share a common cathode and have different cathodes, the matrix 1083 may be further configured to deactivate (e.g., by shorting) the anodes of the detectors selected to be deactivated.

[0153] The front-end circuitry 1088 may include an ECG amplifier 1091 configured to receive analog signals from the ECG electrodes 124 / 125, which may output an amplified analog signal to an analog-to-digital converter 1096. The amplified analog signal may include an ECG difference between the positive and negative electrodes. The analog-to-digital converter 1098 may output a digital signal based on the analog signal from the ECG electrodes 124 / 125 to the system processor 1082 and the calculation processor 1080.

[0154] The ECG electrodes 124 can include a negative electrode, a positive electrode, and a reference electrode. As shown in FIG. 12A , two electrodes 124 positioned on the sensor or module 100 can act as a reference electrode and a negative (or positive) electrode, respectively. As shown in FIGS. 12B and 12C , a portion of the device housing 101 surrounding the display screen 12 can function as another ECG electrode 125. An electrically insulating material 127 can separate the ECG electrode 125 from the rest of the housing 101, such that current between the ECG electrodes 125 and the ECG electrodes 124 travels through the wearer's body. When a wearer desires to take a measurement using an ECG sensor including the ECG electrodes 124, 125, the wearer can press or touch the electrode 125 with their finger or another part of their body, so that the wearer's skin comes into contact with the electrode 125.

[0155] In the illustrated example, the ECG electrode 125 can be a positive electrode (or a negative electrode if one of the electrodes 124 serves as a positive electrode). As shown in FIG. 12C , the electrode 125 is illustrated as being transparent to reveal one or more spring contacts 131 positioned underneath the electrode 125. The shape, size, and / or number of the spring contacts 131 can vary from the example shown in FIG. 12C . The spring contacts 131 can establish an electrical connection between the electrode 125 and the sensor or module processor 108 of the sensor or module 100. For example, the spring contacts 131 can establish an electrical connection between the electrode 125 and a connector 132. The spring contacts 131 can be biased toward the electrode 125 to ensure a tight electrical connection between the spring contacts 131 and the electrode 125. Readings from the electrodes 124, 125 can enable the sensor or module processor 108 to acquire the wearer's ECG signal and, optionally, make physiological measurements (e.g., heart rate, respiration rate, and / or other) based on the acquired ECG. The sensor or module processor 108 can communicate the ECG signal and / or ECG-related measurements to the wearable device processor 14. The wearer's ECG waveform and / or measurements made from the ECG can be displayed on the display screen 12.

[0156] FIG. 13A illustrates an example LED driver circuit 1086 of the module PCB 116 shown in FIG. 11C. The entire LED driver circuit 1086 may be located on a single ASIC with front-end circuitry 1088. As described above, the system processor 1802 can output control signals to turn on and off the emitter LEDs. As shown in FIG. 13A, the LED driver circuit 1086 may include an emitter switch matrix 1085 configured to drive any of the emitters (or emitter groups) selected to be turned on, or to turn off any of the emitters (or emitter groups) selected to be turned off.

[0157] FIG. 13B illustrates an exemplary emitter circuit including eight different emitter LEDs 104. The number of LEDs can vary and can be greater than eight. The emitters of the physiological parameter measurement module can be configured to emit multiple (e.g., three, four, or more) wavelengths. Each of the emitters can be configured to emit light at a different wavelength than the other emitters. Alternatively, one or more of the emitters can emit light at two or more wavelengths. In the illustrated example, the emitter circuit can include four drivers for driving the eight emitter LEDs. Alternatively, the module can include more than four LEDs per emitter group. Each LED driver can drive the LEDs to emit light at a different wavelength. The device or module can allow access to some of the LEDs to a third-party device, for example, for measurement purposes. The LED driver can selectively drive some, but not all, of the LEDs.

[0158] The emitter may be configured to emit light at a first wavelength that provides an intensity signal that can act as a reference signal. The first wavelength may be more absorbed by the human body than other wavelengths of light emitted by the emitter. The reference signal may be stronger and less susceptible to noise than signals from other wavelengths emitted by the emitter. The reference signal may be used by the physiological parameter measurement sensor or module processor to extract information from other signals (e.g., information related to and / or indicative of pulse rate, harmonics, or otherwise). The physiological parameter measurement sensor or module processor may focus analysis on the extracted information to calculate the wearer's physiological parameters. Including a reference signal may reduce power consumption and conserve the device's battery life. The first wavelength can be about 525 nm to about 650 nm, or about 580 nm to about 585 nm, or about 645 nm to about 650 nm, or about 525 nm, or about 580 nm, or about 645 nm. The light providing the reference signal can have an orange or yellow color. Alternatively, the light providing the reference signal can have a green color.

[0159] The emitter may be configured to emit light having a second wavelength having a red color. The second wavelength may be from about 620 nm to about 660 nm. The second wavelength may be more sensitive to changes in oxygen saturation (SpO2) than other wavelengths of light emitted by the emitter. The second wavelength is preferably closer to 620 nm (e.g., about 625 nm), which results in greater absorption by the wearer's body tissue and therefore a stronger signal and / or a sharper curve in the signal than wavelengths closer to 660 nm. The physiological parameter measurement sensor or module processor 108 may extract information, such as a pulse waveform, from the second wavelength signal.

[0160] The emitter can be configured to emit light having a third wavelength of about 900 nm to about 910 nm, or about 905 nm, or about 907 nm. The third wavelength can be in the infrared range. The sensor or module processor can use the third wavelength as a normalizing wavelength when calculating the ratio of intensity signals of other wavelengths, for example, the ratio of the intensity signal of the second wavelength (red) to the third wavelength (infrared).

[0161] Additionally or optionally, the emitter may be configured to emit light having a fourth wavelength that is more sensitive to changes in water than the remaining emitted wavelengths. The fourth wavelength may be in the infrared range and approximately 970 nm. The physiological parameter measurement sensor or module processor may determine physiological parameters, such as the wearer's hydration status, based at least in part on a comparison of the intensity signals of the fourth wavelength and the different wavelengths detected by a specific detector. The detectors used for hydration monitoring may be positioned a predetermined distance from the emitter (i.e., "distant" detectors as disclosed herein), allowing the light to travel through a specific depth of tissue before being detected by the detector.

[0162] The emitters in the physiological parameter measurement sensor or module may be arranged in two emitter groups. Each emitter group may include four emitter LEDs configured to emit the first, second, third, and fourth wavelengths described above. The emitters in the same emitter group may be positioned in the same emitter chamber as disclosed herein. Each of the four drivers is configured to drive the emitter to emit one of the four wavelengths described above.

[0163] FIG. 13C illustrates an exemplary detector circuit including 14 detectors 106. The total number of detectors on the module can vary. The 14 detectors can form seven detector groups, with each group including two detectors. The number of detectors in each group can vary. Detectors in the same detector group can be positioned in the same detector chamber as disclosed herein. Each detector group can output one signal, which can be the combined signal of two detectors in the same group. As shown in FIG. 13C, the detectors can share a common anode but have seven different cathodes corresponding to the seven detector groups.

[0164] 13D illustrates an exemplary thermistor circuit. In the illustrated example, the physiological parameter measurement module can include two thermistors 110. The two thermistors can be positioned in two emitter chambers near two emitter groups, respectively.

[0165] Exemplary Signal Processing of Physiological Parameter Measurement Module Figures 14A and 14B show functional block diagrams of the operation of a conventional pulse oximeter performed by a digital signal processing system. The signal processing functions described below are performed by a digital signal processor (DSP) with a microcontroller providing system management. As shown in Figure 14A, the analog signal from the detector of a conventional pulse oximeter is digitized, filtered, and normalized, and further processed using conventional pulse oximetry signal processing algorithms. Parallel signal processing engines (DST®, FST®, SST™, and MST™) are used to separate the arterial signal from sources of noise (including venous signals) and accurately measure SpO2 and pulse rate, even during exercise. Figure 14B shows a generalized functional block diagram for the operations performed on 20 Khz sample data entering the digital signal processing system from the analog-to-digital converter (ADC). As shown in Figure 14B, the DSP first performs demodulation, as represented in demodulation module 400. The processor performs decimation on the data resulting from the demodulation, as represented by decimation module 402. The processor calculates certain statistics, as represented by statistics module 404, and performs a saturation transform on the data resulting from the decimation operation, as represented by saturation transform module 406. The processor forwards the data that has undergone the statistical operation and the saturation transform operation to a saturation operation as represented by saturation calculation module 408 for outputting an oxygen saturation measurement value and a pulse rate operation as represented by pulse rate calculation module 410 for outputting a pulse rate value.

[0166] 15A-15G illustrate exemplary signal processing for a physiological parameter measurement sensor or module disclosed herein. As shown in FIG. 15A, the sensor or module processor can receive intensity signals from detectors responsive to detected reflected light of the first (reference signal or green or yellow light signal), second (red light signal), third (infrared light signal), and fourth (infrared light signal having a wavelength of 970 nm) wavelengths described above, as well as signals from the gyroscope and accelerometer. The sensor or module processor can output multiple physiological parameters based on the input signals from the sensors described above. The multiple physiological parameters can include, for example, SpO2 (Sat), pulse rate (PR), perfusion index (PI), pleth variability index (PVI), respiration rate from pulse wave (RRp), and hydration index.

[0167] As shown in more detail in FIG. 15B , the sensor or module processor can process the intensity signals in response to the detected light of the first, second, and third wavelengths in non-normalized and normalized forms (in normalization modules “Norm” 1500, “Norm 1” 1502, and “Norm 2” 1504). As explained above, the signal of the third wavelength can be used as a normalization signal. The sensor or module processor can extract various information in a pulse rate determination module 1506 from the intensity signals in response to the detected light of the first, second, and third wavelengths, as well as from signals from the accelerometer and gyroscope (e.g., PR (which can be output as a PR measurement), time domain (TD) saturation information, frequency domain (FD) saturation information, PI information, and PVI information, etc.).

[0168] FIG. 15C illustrates exemplary processing of raw signals from the accelerometer and gyroscope to output gyroscope and accelerometer signals. The sensor or module processor can combine the raw gyroscope and accelerometer signals, respectively (which can be raw signals from any axis of the gyroscope and / or accelerometer), with the gyroscope / accelerometer time instant and pulse time instant signals, respectively, in an interpolation module 1518 or an interpolation 1 module 1520. The sensor or module processor can further process the output from the interpolation module 1518 or the interpolation 1 module 1520, respectively, in a low-pass filter and decimation module 1522 or a low-pass filter and decimation 1 module 1524, to output gyro 1 and accelerometer 1 signals. The output gyro 1 and accelerometer 1 signals can be sent to the ASIC described above.

[0169] As shown in Figure 15D, the sensor or module processor can extract motion information from the gyroscope and accelerometer inputs and the normalized signals of the first, second, and third wavelengths in an interference mitigation (IM) and motion analysis module 1526. Also shown in Figure 15D, the sensor or module processor can obtain time domain pulse rate (TDPR) information, TD saturation information, PI information, and PVI information from the intensity signals of the first, second, and third wavelengths in a time domain pulse rate determination module 1528. The sensor or module processor can obtain frequency domain pulse rate (FDPR) information and FD saturation information in a frequency domain pulse rate determination module 1530 based on the normalized signals of the first, second, and third wavelengths. The sensor or module processor may determine and output a pulse rate in pulse rate determination logic 1532 based on the TDPR information, FDPR information, interference mitigation (IM)PR information (output by interference mitigation and motion analysis module 1526), ​​and motion information.

[0170] FIG. 15E illustrates exemplary pulse rate determination logic. In this example, the decision logic stage 2 module 1534 may receive as input raw pulse rate calculations from individual pulse rate determination engines (e.g., the time-domain pulse rate determination module 1528, the frequency-domain pulse rate determination module 1530, and the interference mitigation and motion analysis module 1526, as shown in FIG. 15D), pulse wave features including the time and frequency domains from N channels (e.g., N=4 or more) of the pulse wave signal, and motion features obtained from the motion analysis module 1536. The motion analysis module 1536 may assess the amount of motion, define the type of motion, and / or calculate the motion rate (e.g., per minute) if the motion is determined to be periodic, based on motion information from a 6-DOF (degrees of freedom) inertial measurement unit (IMU). The IMU may include an accelerometer and a gyroscope on top of the physiological parameter measurement module.

[0171] Continuing with reference to FIG. 15B , the sensor or module processor can determine an oxygen saturation measurement based on the normalized signal at the third wavelength, the normalized signal at the second wavelength, the TD saturation information, the FD saturation information, the PR, and the motion information in an oxygen saturation determination module 1508. FIG. 15F illustrates an oxygen saturation determination module including multiple parallel signal processing engines (e.g., a Seed saturation module 1538, an SST saturation module 1540, a DST saturation module 1542, an interference mitigation (IM) saturation module 1544, and a signal / noise criterion saturation module 1546) configured to feed individual raw oxygen saturation (SpO2) values ​​to decision logic 1548. The decision logic 1548 can further receive motion information as an input and output a final oxygen saturation measurement based on the motion information and the raw oxygen saturation values ​​determined by the parallel engines.

[0172] FIG. 15E illustrates exemplary oxygen saturation determination logic. In this example, saturation determination logic stage 2 module 1550 may receive as input raw oxygen saturation calculations from the parallel engine described above, pulse wave features, pulse rate, and motion features obtained by motion analysis module 1552. The pulse wave features received by module 1550 may include features in the pulse rate determination logic shown in FIG. 15E. Additionally, the pulse wave features received by module 1550 may include saturation-related features, such as the DC ratio of the second and third wavelengths. Motion analysis module 1552 may receive the same features as the pulse rate determination logic shown in FIG. 15E.

[0173] Continuing to refer to FIG. 15B, the sensor or module processor can determine a PI measurement based on the normalized signal at the third wavelength and the PI information in a perfusion index determination module 1510. The sensor or module processor can determine a PVI measurement based on the PVI information in a pleth variability index determination module 1512. The sensor or module processor can determine an RRp measurement based on the intensity signals at the first and second wavelengths in a respiration rate determination module 1514. The sensor or module processor can determine a hydration value index based on the intensity signal at a fourth wavelength (e.g., from a "distant detector" disclosed herein) (which is more sensitive to water changes at the measurement site) and an intensity signal at another wavelength (e.g., a third wavelength or approximately 905 nm) that is less sensitive to water changes in a hydration value determination module 1516. The sensor or module processor can focus on the DC component of the signal for hydration status monitoring.

[0174] Various exemplary physiological parameter measurement modules and wearable devices incorporating the same will be described below. Each of the exemplary modules and devices can incorporate any of the features of the physiological parameter measurement module 100 and device 10 described above, all of which will not be repeated for the sake of brevity. Features of the exemplary modules and devices disclosed herein can be incorporated into one another.

[0175] Example of a physiological parameter measurement module with a double emitter group FIG. 16A schematically illustrates an example arrangement of optical sensors (including emitters, detectors, and thermistors) on a sensor or module processor PCB 116. As shown in FIG. 16A, the PCB 116 may include a first group of emitters 104a and a second group of emitters 104b. Each group of emitters may include four emitters. The emitters 404a, 404b in each group may emit at least first, second, third, and fourth wavelengths, as described above. The first and second groups of emitters 404a, 404b may be positioned a predetermined distance from each other on a first side of the PCB 116. The PCB 116 may include a temperature sensor (e.g., a thermistor, etc.) 110, as described above, positioned on a first side of the PCB 116. One temperature sensor 110 may be near the first group of emitters 404a, and another temperature sensor 110 may be near the second group of emitters 404b.

[0176] The PCB 116 may be elliptical in shape, but the shape of the PCB is not limiting. The two groups of emitters 104 a, 104 b may be located on different parts of a first side of the PCB 116 that is separated along the minor axis of the ellipse. Each of the two groups of emitters 104 a, 104 b may be surrounded by a first light barrier to form an emitter chamber.

[0177] The first and second groups of emitters 104a, 104b may be surrounded by two rings of detectors 106a, 106b, with the detectors 106a, 106b separated from the first and second groups of emitters 104a, 104b, respectively, by a predetermined distance. The two rings of detectors 106a, 106b may share multiple (e.g., two or more) detectors 106a / b common to both rings. The detectors 106a / b common to both rings may be positioned along the minor axis of an ellipse. In the illustrated example, the PCB 116 may include 14 detectors coupled to the PCB 116, although the total number of detectors may vary.

[0178] Detector 106b can be a far detector with respect to the first group of emitters 104a, and detectors 106a, 106a / b can be near detectors with respect to the first group of emitters 104a. Detector 106a can be a far detector with respect to the second group of emitters 104b, and detectors 106b, 106a / b can be near detectors with respect to the second group of emitters 104b. Thus, each detector 106a, 106b, 106a / b can receive two signals for each wavelength emitted by the first and second groups of emitters 104a, 104b, respectively. As described above, the signals output by the far and near detectors can provide different information due to different optical paths, which can travel through different areas of the tissue. Additionally, a remote detector for each group of emitters 104a, 104b can detect light emitted by each group of emitters 104a, 104b, e.g., light at the fourth wavelength and other wavelengths, and light attenuated by tissue, to provide an indication of the wearer's hydration status as described herein.

[0179] The detectors 106a, 106b, 106a / b may be separated or partitioned into seven detector regions. Each detector region may include two detectors or any other number of detectors. Each detector region may form a detector chamber surrounded by a light barrier. As described above, the sensor or module processor may process signals received from a particular emitter and at a detector in the same detector region as the signal source. Thus, for each wavelength, the sensor or module processor may receive data from a total of 14 signal sources, with two from each detector region acting as far and near detectors for different groups of emitters.

[0180] 16B-16D illustrate an exemplary physiological parameter measurement module 400 of a wearable device. Module 400 may incorporate any of the features of the example modules described herein.

[0181] As shown in FIG. 16B, the physiological parameter measurement module 400 can include a first group of emitters 404a and a second group of emitters 404b incorporating the arrangement shown in FIG. 16A. Each group of emitters can include four emitters (or, optionally, a different number of emitters, such as six or eight emitters). The emitters 404a, 404b in each group can emit at least a first, second, third, and fourth wavelength, as described above. Each of the two groups of emitters 404a, 404b can be surrounded by a first light barrier 420 to form an emitter chamber.

[0182] The first and second groups of emitters 404a, 404b in the module 400 may be surrounded by two rings of detectors 406a, 406b, which are separated from the first and second groups of emitters 404a, 404b by a first light barrier 420. The two rings of detectors 406a, 406b may share multiple (e.g., two or more) detectors 406a / b common to both rings. The detectors 406a, 406b, 406a / b may have the same arrangement as the detectors shown in FIG. 16A. In the illustrated example, the module 400 may include 14 detectors, although the module 400 may include a different total number of detectors.

[0183] 16B and 16D, detectors 406a, 406b, 406a / b may be separated or partitioned into seven detector chambers by portions of first light barrier 420 and second light barrier 422. Each detector region may include two detectors or any other number of detectors. Along the outer periphery of module 400, detectors 406a, 406b, 406a / b may be enclosed within module sidewall 424. The sensor or module processor of module 400 may process signals received from a particular emitter and at the detectors within the same detector region as one signal source as described above. The placement of emitters 104a, 104b and detectors 106a, 106b, 106a / b, and light-diffusing material encapsulating emitters 104a, 104b and / or detectors 106a, 106b, 106a / b, can improve sensing coverage on the wearer's wrist, which, as explained above, has fewer capillaries per volume than a fingertip. The aggregate light-detecting area of ​​106a, 106b, 106a / b in FIG. 16B, i.e., the aggregate surface area of ​​all detector chambers, can occupy about 50% or more of the tissue-facing surface of the physiological parameter measurement module. The aggregate light-detecting area in FIG. 16B can be, for example, about 100 mm 2 or approximately 125mm 2 , or approximately 150 mm 2 , or approximately 165 mm 2 The aggregate light emitting area in FIG. 16B, i.e., the aggregate surface area of ​​both emitter chambers, can be, for example, about 25 mm 2 , or about 30 mm 2 , or approximately 35 mm 2 Any other example physiological parameter measurement module disclosed herein may have the same or substantially similar aggregate light detection and / or light emission area as module 400 shown in FIG.

[0184] At a first side of the PCB 416, the module 400 may be surrounded by a curved, light-transmitting cover 402 with a convex protrusion. As shown in FIG. 16C , the cover 402 may have a continuous curvature. The first and second light barriers 420, 422 are configured to contact the first side of the PCB 416 at one end. At the other end, the heights of the first and second light barriers 420, 422 and the sidewall 424 may generally follow the curvature of the cover 402. The sidewall 424 may be shorter than the second light barrier 422. The height of the second light barrier 422 may increase from the periphery of the module 400 toward the center of the module 400 until the second light barrier 422 merges with the first light barrier 420, with the first light barrier 420 being the tallest of the light barriers. The light barriers 420, 422 can extend to the tissue-facing surface of the cover 402 such that when the module 400 is pressed into the skin of a wearer of a device incorporating the module 400, the tissue-facing surfaces of the first and second light barriers 420, 422 and the side wall 424 can be configured to contact the skin of a wearer. The cover 402 can include individual lenses or covers (such as that shown in FIG. 7D ) or a combination of lenses or covers covering individual emitter chambers and lenses or covers covering multiple detector chambers (such as that shown in FIG. 7C ). The tissue-facing surface of the module 400 can include a continuous convex curvature.

[0185] The first and second light barriers 420, 422 and the sidewall 424 can optionally form a single light barrier construction. The single light barrier construction can be formed by any suitable manufacturing technique and any suitable material (e.g., plastic, colored or opaque sapphire glass, or others). The single light barrier construction can include a recess at one end, the recess shaped and sized to receive the PCB 416 (including the electronics thereon). A first side of the PCB 416 can include the emitters 404a, 404b, the detectors 406a, 406b, 406a / b, the temperature sensor 410, and any other sensors, such as a gyroscope and / or an accelerometer. A second side of the PCB 416 can include a sensor or module processor and other circuit hardware.

[0186] As described above, the module 400 can include multiple chambers, and various light barriers, as described herein, extend from the PCB 416 to the tissue-facing surface of the cover 402 to prevent light from traveling between the chambers. The light-diffusing material described above can be added above and around the emitters 404a, 404b (e.g., via fill holes as described herein) and / or, optionally, above and around the detectors 406a, 406b, 406a / b to improve the distribution of emitted and / or detected light after attenuation by tissue. The light-diffusing material can include a flow of glass microsphere solution, which can be injected into the chambers after the module 400 is assembled. After being injected into each chamber, the solution can be UV-cured. When the diffusion material solution is injected into each chamber through the injection opening, air can escape through the vent openings disclosed herein, making it easier for the glass microsphere solution to flow into each chamber. The cover 402 can also contain glass microspheres. Light-diffusing materials within the cover 402 and inside the emitter chamber and / or first light barrier 420 can cause emitted light to leave the emitter chamber surrounding the emitters 404a, 404b in a direction generally parallel to the height of the first light barrier 420. The light-diffusing materials within the cover 402 and detector chamber can increase the amount of reflected light directed toward and detected by the detectors 406a, 406b, 406a / b.

[0187] 16E-16G illustrate an exemplary physiological parameter measurement module 401 for a wearable device. Module 401 includes the same optical sensor arrangement as shown in FIGS. 16A-16D and may have any of the features of module 400 in FIGS. 16B-16D, with the differences noted in the description of FIGS. 16E-16G. Module 401 may have any of the features of the other exemplary physiological parameter measurement modules described herein.

[0188] The module 401 may include a generally circular exterior shape. The generally circular exterior shape may be defined by an opaque frame 426 extending above the PCB 416 from a first side of the PCB 416. The opaque frame 426 may have a predetermined height such that a top side of the opaque frame 426 may be generally level with (or slightly recessed or protruding from) a second side of the PCB 416. As shown in FIG. 16G, the PCB 416 may be generally circular in shape. The opaque frame 426 may be generally concentric with the PCB 416. The opaque frame 426 and the PCB 416 are not transparent to light. The opaque frame 426 in FIGS. 16E and 16F may include a first light barrier 420 and a second light barrier 422 as a unitary piece.

[0189] The module 401 may include one or more (e.g., two or more) ECG electrodes 424. In the illustrated example of FIGS. 16E-16G, one of the ECG electrodes 424 may be a reference electrode, and the other of the ECG electrodes 424 may be a negative or positive electrode. The opaque frame 426 may have a recess having a shape and size to accommodate the electrode 424, similar to the recess on the opaque frame 126 shown in FIG. 7D. As shown in FIG. 16F, the bottom surface of the electrode 424 may have a curvature that is generally continuous with the curvature of the opaque frame 426 and the optically transparent cover 402. As shown in FIG. 16G, the top side of the electrode 424 may have one or more posts 437 that extend beyond the opening in the opaque frame 426 and into corresponding openings on the PCB 416. The posts 437 of the electrode 424 may establish electrical connection with corresponding openings in the PCB 416. A plurality of screws (or other types of fasteners) may extend from the front side of the PCB 416 into corresponding openings in the PCB 416 and secure the electrodes 424 to the module 401 by threadably engaging with the posts. When a wearer wears a wearable device incorporating the module 401 on their wrist, the electrodes 424 may contact the wearer's skin. The electrodes 424 may have the same polarity as the electrodes 124 disclosed herein. As disclosed herein, a wearable device incorporating the module 401 may include another ECG electrode 125 positioned on the housing of the wearable device configured to contact the wearer's skin.

[0190] On a second side of PCB 416 (which faces away from cover 402), PCB 416 may be covered with molten plastic or other suitable electronics protective material 430 (similar to protective material 130 disclosed herein), except that flex connector 432 may remain exposed. Flex connector 432 may be configured to electrically connect module 401 to a wearable device incorporating module 401.

[0191] 17A-17C illustrate an exemplary physiological parameter measurement module 403 of a wearable device. Module 403 includes the same optical sensor arrangement as shown in FIGS. 16A-16G and may have any of the features of module 400 in FIGS. 16B-16D and any of the features of module 401 in FIGS. 16E-16G, with the differences noted in the description of FIGS. 17A-17C. Module 401 may have any of the features of the other example physiological parameter measurement modules described herein.

[0192] As shown in FIGS. 17A-17C, the opaque frame 426 can include an opening that fits over the light-transmitting cover 402. The cover 402, which extends over the emitter or detector chamber formed by the light barriers 420, 422, and 423 and the PCB 415, can include a single lens or cover. The cover 402 can be elliptical in shape. The cover 402 can have a continuous convex curvature. As shown in FIG. 17C, the light barriers 420, 422, and 423 do not need to extend to the tissue-facing surface of the cover 402 but can extend below the cover 402 so that when a wearer wears a wearable device incorporating the module 402, the wearer's tissue comes into contact with the cover 402 and the electrodes 424 but does not come into contact with any of the light barriers 420, 422, and 423.

[0193] 18A-19C illustrate other non-limiting examples of physiological parameter measurement modules with two emitter groups in two separate emitter chambers formed by a light barrier. In these configurations, the perimeter of the module can have different shapes. For example, FIG. 19A schematically illustrates a module 300 having two overlapping circular outer shapes. The circles within the module 300 can have a radius of, for example, between about 6 mm and about 12 mm, or between about 8 mm and about 10 mm. The module 300 can have any of the features of other modules disclosed herein. The module 300 can include emitters 300a, 300b and detectors 306a, 306b, 306a / b arranged in substantially the same manner as the modules 400, 401, and 403 described above, except that each emitter group 304a, 304b includes three emitters. The module 300 can include a thermistor near each emitter group 304 a, 304 b. The module 300 can have a length of, for example, between about 22 mm and about 28 mm, or between about 24 mm and about 26 mm.

[0194] 18B illustrates a physiological parameter measurement module 301 including a variation of the emitter and detector arrangement of module 300 of FIG. 18A and may include any of the features of module 300, except for the differences described herein. Module 301 differs from module 300 by not sharing a detector positioned between the two groups of emitters 304a, 304b. The first group of emitters 304a may be surrounded by a first ring of detectors 306a on a first side of the minor axis A2, and the second group of emitters 304b may be surrounded by a second ring of detectors 306b on a second side of the minor axis A2.

[0195] FIG. 19A illustrates a physiological parameter measurement module 201 that includes a variation of the emitter and detector arrangement of module 300 of FIG. 18A. The physiological parameter measurement module 201 can have any of the features of module 300, with the differences noted in the description of FIG. 19A. Module 201 can have any of the features of other modules disclosed herein. In module 201, the two overlapping circles of detectors 206a, 206b are closer to each other than in module 300. Detectors 206a / b can be farther apart than in module 300 and may not be positioned between or separate the two emitter groups 204a, 204b. Module 201 can include two groups of emitters separated from each other by a single light barrier. Each detector in module 201 can form its own detector chamber with one or more light barriers. The circular shape can have, for example, a radius between about 6 mm and about 12 mm, or between about 8 mm and about 10 mm. Module 300 can have, for example, a length between about 18 mm and about 24 mm, or between about 20 mm and about 22 mm.

[0196] 19B and 19C illustrate variations of the module 201 in FIG. 19A , with differences noted in the descriptions of FIGS. 19B and 19C . The module 200 in FIGS. 19B and 19C can have any of the features of the example modules described herein. In FIGS. 19B and 19C , the physiological parameter measurement module 200 can include two groups of emitters 204 a, 204 b surrounded by a ring of detectors 206. The module 200 can have a width of, for example, between about 16 mm and about 22 mm, or between about 18 mm and about 20 mm. The module 200 can have a length of, for example, between about 20 mm and about 28 mm, or between about 22 mm and about 25 mm.

[0197] Each group of emitters 204a, 204b may include three of the emitters. Each group of emitters 204a, 204b may emit at least the first, second, and third wavelengths described above. Optionally, each emitter group 204a, 204b may include a fourth emitter configured to emit a fourth wavelength that is more sensitive to water. The emitters may be positioned at or near a central portion of the PCB 216 of the module 200. The module 200 may include a temperature sensor positioned on the PCB 216 near each group of emitters 204a, 204b.

[0198] The emitters may be covered by an inner lens or cover 202a. In the illustrated example, the inner lens or cover 202a may be generally elliptical. In other examples, the inner lens or cover may have any other shape. The two groups of emitters 204a, 204b may be positioned on two parts of a central portion of a PCB that is divided along the minor diameter of the ellipse. The two groups of emitters 204a, 204b may be separated by an opaque divider barrier 228, which may reduce mixing of the light emitted by the two groups of emitters 204a, 204b. As shown in FIG. 19C , the divider barrier 228 may have the same or substantially the same height as the highest point of the inner lens or cover 202a when assembled into the module 200. The inner lens or cover 202a may include two components separated by the divider barrier 228.

[0199] The module 200 can include multiple detectors 206 (e.g., about six, eight, ten, or more), which can be arranged on a PCB such that the detectors 206 are spaced apart around the emitters 204a, 204b. The emitter groups 204a, 204b and the detectors 206 can be separated by a first light barrier 220. The first light barrier 220 can extend along and surround the inner lens or cover 202a. The divider barrier 228 and the first light barrier 220 can form two emitter chambers 234a, 234b, each surrounding one of the two emitter groups 204a, 204b. Additionally, the first light barrier 220 and the divider barrier 228 may constrain the light emitted by the emitters 204a, 204b to a predetermined angle, such that the light emitted by each group of emitters 204a, 204b may exit the inner lens or cover 202a in a direction generally parallel to the height of the first light barrier 220. The detectors 206 may be enclosed within the module sidewalls 224. The module sidewalls 224 may define the perimeter of the module 200. As shown in FIG. 19B , the perimeter of the module 200 may have a generally elliptical outer shape. The detectors 206 may be further separated from one another by multiple divider barriers 226, which form detector chambers 236, each containing one detector 206.

[0200] As shown in FIG. 19C, the first light barrier 220 can slightly protrude from the edges of the inner lens or cover 202a and other lenses or covers described below, i.e., it projects from them. The detector 206 can be covered by an outer lens or cover 202b. The outer lens or cover 202b can be generally concentric with the inner lens or cover 202a. In the illustrated example, the outer lens or cover 202b can be an elliptical disk, as shown in FIG. 19B. In other examples, such as those disclosed herein, the outer lens or cover can have other shapes. As shown in FIG. 19C, the outer lens or cover 202b can have a smaller curvature than the inner lens or cover 202a, causing the inner lens or cover 202a to protrude more than if the inner lens or cover had the same curvature as the outer lens or cover 202b.

[0201] 19C, the sidewalls 224 can be shorter than the first light barrier 220. The height of the sidewalls 224 can be configured such that the tissue-facing ends of the sidewalls 224 are generally continuous with the curvature of the outer lens or cover 202b. The divider barrier 226 can have a height that is shorter than the first light barrier 220. The height of the divider barrier 226 can be configured to accommodate the outer lens or cover 202b such that, when assembled, the outer lens or cover 202b forms a substantially smooth surface with the module sidewalls 224. The tissue-facing ends of the first light barrier 220 and the sidewalls 224 and the tissue-facing surfaces of the inner lens or cover 202a and the outer lens or cover 202b can form the tissue-facing surface of the module 200. The slightly protruding first light barrier 220 and / or inner lens or cover 202a may be pressed into the wearer's skin with more pressure than the rest of the lens or cover or light barrier.

[0202] The light diffusing material described above can be included in one or more of the chambers 234a, 234b, 236 of the module 200 to improve the distribution of emitted and / or detected light. As shown in FIG. 19B , one or more of the lenses or covers 202a, 202b can include an injection opening 244 so that the light diffusing material (which can include a flow of glass microsphere solution) can be injected into the respective chambers 234a, 234b, 236 after the module 200 is assembled. After injection, the solution can be UV-cured. The lenses or covers 202a, 202b can include one or more venting openings that are smaller than the injection openings 244. Air can optionally escape through a separate vent opening when the diffusing material solution is injected into the respective chambers 234a, 234b, 236 through the injection openings 244. Additionally, the inner lens or cover 202a and outer lens or cover 202b may contain glass microspheres to act as light diffusers.

[0203] Example of a physiological parameter measurement module with inner and outer detector groups and an example of a wearable device incorporating the same 20A-20D illustrate an exemplary physiological parameter measurement module 600 for a wearable device. The module 600 can have any of the features of the example modules described herein, with differences noted in the descriptions of FIGS. 20A-20D. The physiological parameter measurement module 600 can include a single emitter group having multiple emitters 604 (e.g., four emitters as shown in FIG. 20A, six emitters, or eight emitters). The emitters 604 of the module 600 can emit at least first, second, third, and fourth wavelengths, as described above. The emitters 604 can be positioned at or near a central portion of the PCB 616 of the module 600. The module 600 can include a temperature sensor 610 positioned on the PCB 616 near the emitters 604.

[0204] The module 600 may include multiple detectors 606, which may be arranged on the PCB 616 as an inner group of detectors 606 and an outer group of detectors 606. The detectors 606 of the inner group 606c (which may include, for example, about 10 (or a different number) of detectors 606) may surround the emitter 604 and be spaced apart from one another.

[0205] The detectors 606 in the outer groups may be positioned farther from the emitter 604 than the detectors 606 in the inner groups. The detectors 606 in the outer groups may be separated into a first outer group 606a and a second outer group 606b. As shown in FIG. 20A , the module 600 may have a first axis A1 and a second axis A2. The detectors 606 in the outer groups 606a, 606b may be positioned farther from the emitter 204 generally along the first axis A1 than the detectors 606 in the inner group. The detectors 606 in the two outer groups 606a, 606b are opposite the detectors 606 in the inner group along the first axis A1. The detectors 606 in the first and second outer groups 606a, 606b may be generally symmetrical about the first axis A1 and the second axis A2. Each of the first or second outer groups 606a, 606b of detectors 606 can include about five (or a different number) detectors 606, which are spaced apart from one another generally along the second axis A2. The detectors 606 of the outer groups 606a, 606b can be arranged generally concentrically with the detectors 606 of the inner group 606c.

[0206] The module 600 may be longer along the first axis A1 than along the second axis A2. The module 600 may have a dimension of approximately 25.4 mm (1 inch) along the first axis A1. The module may have a dimension of approximately 19.1 mm (0.75 inches) along the second axis A2. As shown in FIG. 20A , when a watch incorporating the module 600 is worn on a wearer's wrist, the first axis A1 may be generally parallel to the width of the wrist and perpendicular to the direction of blood flow along the wrist (i.e., along the direction between the hand and forearm), and the second axis A2 may be generally perpendicular to the width of the wrist and generally parallel to the direction of blood flow along the wrist. The distribution of the detectors 606 along the first axis A1 may improve detection of light attenuated by pulsating arterial blood in the capillaries, as the detectors 606 are positioned to cover a larger cross-section of blood flow through the wrist. Similarly, in other exemplary modules described herein (e.g., sensors or modules 100, 400, 401, 403, 300, 301, 200, 201, etc.), the physiological parameter measurement module is integrated into the wearable device such that when the wearable device is worn on the wrist, the longer side of the module is generally perpendicular to the direction of blood flow along the wrist (see, e.g., FIG. 1B).

[0207] As shown in FIG. 20A , the emitter 604 may be covered by an inner lens or cover 602a. In the illustrated example, the inner lens or cover 602a may be generally circular. In other examples, such as those disclosed herein, the inner lens or cover may not be generally circular, but may have other shapes, such as oval, rectangular, square, diamond, or others. The detectors 606 of the inner group 606c may be covered by a first outer lens or cover 602b. The first outer lens or cover 602b may be generally concentric with the inner lens or cover 602a. In the illustrated example, the first outer lens or cover 602b may be disk-shaped. The detectors 606 of the first and second outer groups 606a, 606b may be covered by a second outer lens or cover 606c and a third outer lens or cover 606d, respectively. The second and third outer lenses or covers 606c, 606d can be symmetrical about the second axis A2. As shown in FIG. 20B, the first, second, and third outer lenses or covers 602b, 602c, 602d can have substantially the same curvature. The inner lens or cover 602a can be more curved than the outer lenses or covers 602b, 602c, 602d, such that the inner lens or cover 602a protrudes more than if the inner lens or cover 602a had the same curvature as the outer lenses or covers 602b, 602c, 602d.

[0208] The detectors 606 and emitters 604 of the inner group 606c may be separated by a first light barrier 620. The first light barrier 620 may extend along and surround the inner lens or cover 602a, forming an emitter chamber. The detectors 606 of the first and second outer groups 606a, 606b may be separated from the detectors 606 of the inner group 606c by a second light barrier 622. The second light barrier 622 may be shorter than the first light barrier 620. The detectors 606 of the first and second outer groups 606a, 606b may be enclosed within a module sidewall 624 that surrounds the periphery of the module 600. The periphery of the module 600 may be elliptical or any other shape. The sidewall 624 may be shorter than the second light barrier 622. The height of the first and second light barriers 620, 622 and the height of the sidewall 624 can generally follow or be substantially continuous with the curvature of the first, second, and third outer lenses or covers 602b, 602c, 602d. The first and second light barriers 620, 622 and the sidewall 624 can have a predetermined height and are configured to contact the wearer's skin. Thus, the tissue-facing surface of the module 600 can be defined by the tissue-facing sides of the first and second light barriers 620, 622 and the sidewall 624 and the tissue-facing surfaces of the inner lens or cover 602a and the first, second, and third outer lenses or covers 602b, 602c, 602d.

[0209] In the illustrated example, the detectors 606 of the inner group 606c may be separated by a third light barrier 626 and a fourth light barrier 628 (see FIGS. 20C and 20D). The third and fourth light barriers 626, 628 may have a height less than the first light barrier 620 or the second light barrier 622. The height of the third and fourth light barriers 626, 628 may be configured to accommodate the first outer lens or cover 602b such that, when assembled, the first outer lens or cover 602b forms a substantially smooth surface with the second and third outer lenses or covers 602c, 602d. The first outer lens or cover 602b may sit on top of the third and fourth light barriers 626, 628.

[0210] The first light barrier 620 can protrude slightly from, i.e., sit protruding from, the edges of the inner lens or cover 602a and outer lenses or covers 602b, 602c, 602d. The slightly protruding first light barrier 620 and / or inner lens or cover 602a can be pressed into the wearer's skin with more pressure than the rest of the lenses or covers or light barriers. The first light barrier 620 can also reduce the mixing of emitted and reflected light and / or constrain the light emitted by the emitter 604 to an angle such that the emitted light exits the inner lens or cover 602a in a direction generally parallel to the height of the first light barrier 620.

[0211] 20C and 20D, the first, second, third, and fourth light barriers 620, 622, 626, 628 and the sidewall 624 can optionally form a single light barrier construction 630. The single light barrier construction 630 can be formed by any suitable manufacturing technique. The single light barrier construction 630 can include a recess 632 (see FIG. 20C) at one end configured to receive the PCB 616 (and the emitter 604, the detector 606, the temperature sensor 610, and any other sensors, such as a gyroscope and / or accelerometer, and the sensor or module processor, which are positioned on the PCB 616). The single light barrier construction 630 is capable of receiving lenses (including an inner lens or cover 602a, and first, second, and third outer lenses or covers 602b, 602c, 602d) at another end opposite the end including the recess 632.

[0212] The module housing can include multiple chambers, with light unable to travel between them due to the various light barriers described herein. As described above, the first chamber can be surrounded by the inner lens or cover 602a, the first light barrier 620, and a portion of the PCB 616. The first chamber 634 surrounds the emitter 604. The second and third chambers can be surrounded by the first outer lens or cover 602b, the first light barrier 620, the second light barrier 622, the third light barrier 626, the fourth light barrier 628, and a portion of the PCB 616. The second and third chambers can surround the inner group 606c of detectors 606, with half of the detectors in the inner group 606c surrounded by each of the second and third chambers. The fourth chamber may be surrounded by the second outer lens or cover 602c, the second light barrier 622, the sidewall 624, and a portion of the PCB 616. The fifth chamber may be surrounded by the third outer lens or cover 602d, the second light barrier 622, the sidewall 624, and a portion of the PCB 616. The fourth and fifth chambers may surround the detectors 606 of the first and second outer groups 606a, 606b, respectively.

[0213] Light from the emitter 604 may travel a shorter path to the detectors 606 of the inner group 606c and a longer path to the detectors 606 of the first and second outer groups 606a, 606b. The detectors 606 of the inner group 606c and the detectors 606 of the first and second outer groups 606a, 606b may be operated independently and / or simultaneously. The signals output by the detectors 606 of the inner and outer groups 606a, 606b may provide different information due to the different light paths that may travel through different areas of tissue. A longer path penetrates deeper into the tissue than a shorter path and travels through a larger volume of tissue to reach one of the detectors 606 of the outer groups 606a, 606b, while a shorter path does not penetrate as deeply into the tissue and travels through a smaller volume of tissue to reach one of the detectors 606 of the inner group 606c. The different information can be separated and / or combined to calculate multiple physiological parameters of the wearer of module 600 (e.g., an indication of the wearer's hydration status), which will be described in more detail below.

[0214] The light diffusing material described above can be included in one or more chambers of module 600 to improve the distribution of emitted and / or detected light after attenuation by tissue. As shown in FIG. 20A , one or more of lenses or covers 602a, 602b, 602c, 602d can include an injection opening 644 so that the light diffusing material (which can include a flow of glass microsphere solution) can be injected into the respective chamber after module 600 is assembled. After injection into the respective chamber, the solution can be UV cured. Lenses or covers 602a, 602b, 602c, 602d can include one or more venting openings 645 that are smaller than the injection openings 644. Each of the lenses or covers can include at least one venting opening 645. Air can escape through vent openings 645 when the diffusion material solution is injected into each chamber through injection openings 644, making it easier for the glass microsphere solution to flow into each chamber. Additionally, inner lens or cover 602a and / or outer lenses or covers 602b, 602c, and 602d can contain glass microspheres. The light-diffusing material in inner lens or cover 602a and the UV-curing material in first chamber 634 and / or first light barrier 620 can cause emitted light to leave first chamber 634 in a direction generally parallel to the height of first light barrier 620. The light-diffusing material in outer lenses or covers 602b, 602c, and 602d and the UV-curing material in the other chambers 636, 638, 640, and 642 can increase the amount of reflected light directed toward detector 606.

[0215] The module 600 shown in FIGS. 20A-20D can be incorporated into a wearable device disclosed herein (such as, for example, the watch 900 shown in FIGS. 20E-20J). The watch processor 914 and power supply can be enclosed within a watch housing 901. The watch housing 901 can include a connection port opening 950 configured to allow access to a connection port 952, which is in electrical communication with the watch processor 914 and / or the power supply. The connection port opening 950 can be positioned at one end of the watch housing 901 transverse to the first axis A1 of the module 600. The connection port 952 can allow charging of the power supply and / or data transfer to and from the watch processor 914. Optionally, as shown in Figures 20F and 20I, watch 900 can include a cable connector 945 extending outwardly from watch housing 901. Cable connector 945 can be positioned adjacent or near connection port opening 950.

[0216] The watch 900 can include a display screen 912 positioned on a first side of a watch housing 901. The watch housing 901 has a second side opposite the first side. The second side of the watch housing 901 can include an opening sized to hold the physiological parameter measurement module 600 while still allowing the tissue-facing surface of the module 600 to be exposed. The second side of the watch housing 901 can be removably attached to the first side of the watch housing 901 without the use of external fasteners, or alternatively, via one or more fasteners. For example, an electrical connection can be established between the physiological parameter measurement module PCB and the watch circuitry using a flex connector as disclosed herein.

[0217] The watch housing 901 can include strap coupling extensions 948 on opposite sides of the watch 900 along the length of the housing 901 (i.e., along the first axis A1 of the module 600). The extensions 948 can include bars 946 for connecting to any suitable watch strap.

[0218] 21A-21C and 22A-22C illustrate alternative lens or cover curvatures for the physiological parameter measurement module 600 of FIGS. 20A-20D, which may incorporate any of the features of the module 600 of FIGS. 20A-20D, except for the differences described below. As shown in FIGS. 21A-21C, the first outer lens or cover 602b of the module 601 may be more convex (i.e., more protruding) than the inner lens or cover 602a and the second and third outer lenses or covers 602c, 602d. The tissue-facing side curvature of the second light barrier 622 and side wall 624 may be substantially continuous with the curvature of the second and third outer lenses or covers 602c, 602d. The second light barrier 622 may be shorter than the first light barrier 620. The first light barrier 620 can be higher than the outer edge of the inner lens or cover 602a, which can promote separation of light emitted by the emitter 604 from light detected by the detector 606 before it is attenuated by the wearer's body tissue. In FIGS. 22A-22C, the module 603 can differ from the module 601 of FIGS. 21A-21C in that the inner lens or cover 602a can have the same height as the first light barrier 620 and the first outer lens or cover 602b. The inner lens or cover 602a can have a generally flat surface or can have a slight curvature that can be substantially continuous from the curvature of the first outer lens or cover 602b. The modules 601, 603 of Figures 21A-22C can facilitate pressing the first outer lens or cover 602b, or the first outer lens or cover 602b and the inner lens or cover 602a, further into the wearer's skin than the remainder of the tissue-facing surface of the module 600.

[0219] 23A-23E illustrate a watch 700 that can incorporate the physiological parameter measurement module 600. The watch 700 can have any of the features of the watch 900, with the differences noted in the description of FIGS. 23A-23E. As shown in FIGS. 23A-23E, the watch housing 701 of the watch 700 can include a flap 750 on a side of the housing 701 along the length of the watch housing 701, which is along the first axis A1 of the physiological parameter measurement module (see FIG. 23E). The flap 750 can be opened to provide access to a connection port (e.g., a connection port in the watch 900) in electrical communication with the watch processor 714 and / or the power supply 716. The connection port can allow charging of the power supply 716 and / or data transfer to and from the watch processor 714. The flap 750 can be closed when the connection port 752 is not in use.

[0220] The watch 700 can include a display screen positioned on a first side of a watch housing 701. The watch housing 701 has a second side opposite the first side. The second side of the watch housing 701 can include an opening sized to hold the physiological parameter measurement module 600 while still allowing the tissue-facing surface of the module 600 to be exposed. The second side of the watch housing 701 can be removably attached to the first side of the watch housing 701 via one or more screws 718 or other fasteners. When fully assembled, the watch 700 can have a thickness or height of, for example, between 10 mm and approximately 15 mm, or between 12 mm and approximately 14 mm.

[0221] The watch housing 701 can include a suitable strap connection configured to couple to a watch strap. The strap connection in the watch housing 701 can be different from the strap connection shown in watch 900. In an example, multiple strap openings can be at opposite ends of the watch, and the watch housing can additionally and / or alternatively include a strap slot at the same opposite end of the watch as the strap opening. In this example, the strap slot can be configured to slidably receive an end of a watch strap that includes a shape corresponding to the shape of the strap slot. The strap opening can be configured to receive a spring-loaded button near the end of the watch strap to releasably retain the strap after the end of the watch strap is received in the strap slot. Alternatively, the watch may not include a strap opening. The straps coupled to the example watches disclosed herein can be configured to allow adjustment of tightness around the wearer's wrist, for example, using a buckle connector and / or a Velcro connector.

[0222] Hydration monitoring using a wearable device incorporating an exemplary physiological parameter measurement module with a "near" and "far" detector or detector group An example physiological parameter measurement module disclosed herein can monitor a wearer's hydration status because water in bodily tissue can allow a larger portion of light at the third (or first or second) wavelength disclosed herein to pass through (i.e., act as a light pipe), but can bulk absorb light at the fourth wavelength disclosed herein. The physiological parameter measurement processor can compare the intensity signals of the fourth wavelength and another wavelength that is less sensitive to water changes from the same detector. When the wearer's hydration status is within the normal range and the wearer is not considered medically dehydrated, the signals of the fourth wavelength and the other wavelengths can show opposite trends, i.e., one increasing while the other decreases. When the wearer becomes medically dehydrated, the opposite trends may become less apparent, for example, by falling below a threshold.

[0223] Hydration monitoring can be performed when a physiological parameter measurement module (such as a sensor or module 100) is configured such that at least some of the detectors 106 are positioned farther (far detectors) from one of the emitters 104 (or emitter groups) than other detectors 106 (near detectors) (such as that illustrated in FIG. 10 ). In a configuration where two emitter groups are present, each detector 106 or detector region (which may include two or more detectors 106 enclosed within the same detector chamber) can act as a near (or shallow) detector or detector region for the group of emitters closer to that detector 106 or detector region, and as a far (or deeper) detector or detector region for the group of emitters farther away from the detector 106 or detector region.

[0224] Physiological parameter measurement modules 400, 401, 403 illustrate an exemplary configuration for monitoring a wearer's hydration levels. Detector 406a can be a far detector for a second group of emitters 404b, and detectors 406b, 406a / b can be near detectors for the second group of emitters 404b. Detector 406b can be a far detector for a first group of emitters 404a, and detectors 406a, 406a / b can be near detectors for the first group of emitters 404a. Physiological parameter measurement modules 300, 301 illustrate a similar detector arrangement in a configuration in which modules 300, 301 include a fourth emitter in at least one of the emitter groups configured to emit four wavelengths of light (except that in module 301, there is no shared detector between the two groups of emitters 304a, 304b).

[0225] The physiological parameter measurement modules 200, 201 illustrate additional exemplary detector configurations that may include a "near" detector for one group of emitters and a "far" detector for another group of emitters in a configuration in which the modules 200, 201 include a fourth emitter configured to emit light at a fourth wavelength. For example, a detector 206 on the far side of each group of emitters 204a, 204b may act as a "far" detector to detect light emitted by the emitters 204a, 204b of the respective group, e.g., light at the fourth wavelength and another wavelength, as well as light attenuated by tissue, to provide an indication of the wearer's hydration status.

[0226] The physiological parameter measurement module 600 illustrates an exemplary configuration for monitoring a wearer's hydration levels, with the detectors 606 in the inner group 606c acting as "near" detectors and the detectors in the outer groups 606a, 606b acting as "far" detectors.

[0227] In the configuration described above, each detector or detector region can provide two measurements calculated from the signals received from the closer and more distant emitter groups, respectively. The signal detected at the distant detector can provide an indication of the wearer's hydration status because light travels deeper through the wearer's tissue to reach the distant detector than it does to reach the closer detector. The signal detected at the near detector can optionally be used as a reference or for comparison with the signal detected at the distant detector when the physiological parameter measurement sensor or module processor determines the wearer's hydration status. The sensor or module processor of the physiological parameter measurement module disclosed herein can compare intensity signals at a fourth wavelength and another wavelength (e.g., a third wavelength or about 905 nm) that is less sensitive to water changes from one of the "distant" detectors. The module processor can focus on the DC component or DC bulk absorption measurement of the signal detected by the "distant" detector for hydration status monitoring. At DC levels, water can act as a light blocker (i.e., less light transmissive) for the fourth wavelength and as a lens or cover (i.e., more light transmissive) for the other wavelengths.

[0228] Additionally and / or alternatively, any of the modules disclosed herein may monitor the hydration status of a wearer by monitoring the wearer's PVI value. The module may determine a baseline PVI value for the wearer and output a notification of whether the wearer is dehydrated or hydrated based on a variation in the PVI value from the baseline.

[0229] The module may further combine hydration status monitoring by optical detectors and other sensors (e.g., sweat sensors or skin impedance sensors) in outputting the wearer's final hydration status indication. The module may calculate an average, weighted average, or otherwise, of raw hydration index values ​​calculated based on signals from different sensors and / or may rely on different hydration monitoring sensors for redundancy.

[0230] Because a person's hydration status is not expected to change rapidly, the physiological parameter measurement module may optionally take hydration status measurements less frequently than it takes measurements related to the wearer's pulse rate or SpO2 or other parameters. For example, the physiological parameter measurement sensor or module processor may take hydration status measurements every five minutes or more, and / or upon (e.g., only upon) request by the wearer, such as when the wearer presses a button on the device (a physical button and / or a touch button on the display) or otherwise directs the device using voice commands and / or hand gestures, etc.

[0231] An example of a generally circular physiological parameter measurement module and an example of a wearable device incorporating the same. The physiological parameter measurement module may alternatively include an inner portion of emitters and an outer ring of detectors, as shown in FIGS. 24A-24B and 25A-25B. The sensor or module 1000 of FIGS. 24A-24B and the module 1100 of FIGS. 25A-25B may have any of the features of the example modules described herein, with the differences noted in the descriptions of FIGS. 24A-24B and 25A-25B. Such physiological parameter measurement modules may have a generally circular outer shape. The sensor or module 1000 of FIGS. 24A-24B may be smaller than the module 1100 of FIGS. 25A-25B. For example, the sensor or module 1000 may have an outer diameter between about 12 mm and about 16 mm, or between about 14 mm and about 15 mm. For example, the module 1100 can have an outer diameter of between about 16 mm and about 22 mm, or between about 18 mm and about 20 mm.

[0232] The physiological parameter measurement modules 1000, 1100 may each include a single emitter group having multiple emitters 1004, 1104 (e.g., three emitters, etc.). The emitters 1004, 1104 of the sensor or module 1000, 1100 may emit at least first, second, and third wavelengths as described above. The emitters 1004, 1104 may be positioned at or near a central portion of the PCB of the sensor or module 1000, 1100. The sensor or module 1000, 1100 may include a temperature sensor positioned on the PCB near the emitters 1004, 1104.

[0233] The sensor or module 1000, 1100 can include multiple detectors 1006, 1106 (e.g., about six, eight, or more), and the multiple detectors 1006, 1106 can be arranged on a PCB such that the detectors 1006, 1106 are spaced apart around the emitters 1004, 1006. The emitters 1004, 1104 and the detectors 1006, 1106 can be separated by a first light barrier 1020, 1120. The first light barrier 1020, 1120 can surround the emitters 1004, 1104. Additionally, the first light barrier 1020, 1120 is capable of constraining the light emitted by the emitter 1004, 1104 to a predetermined angle such that the emitted light exits the inner lens or cover 1002a, 1102a in a direction generally parallel to the height of the first light barrier 1020, 1120.

[0234] The emitters 1004, 1104 may be covered by inner lenses or covers 1002a, 1102a. In the illustrated example, the inner lenses or covers 1002a, 1102a may be generally circular. The detectors 1006, 1106 may be covered by outer lenses or covers 1002b, 1102b. The outer lenses or covers 1002b, 1102b may be generally concentric with the inner lenses or covers 1002a, 1102a. In the illustrated example, the outer lenses or covers 1002b, 1102b may be disk-shaped when viewed directly above the sensor or module 1000, 1100. In other examples, such as those disclosed herein, the outer lenses or covers may have other shapes, such as oval or otherwise. The outer lens or cover 1002b, 1102b may have a smaller curvature than the inner lens or cover 1002a, 1102a, such that the inner lens or cover 1002a, 1102a protrudes more than if the inner lens or cover had the same curvature as the outer lens or cover 1002b, 1102b. As shown in Figures 24B and 25B, the first light barrier 1020, 1120 may protrude slightly from, i.e., stick out from, the outer edge of the inner lens or cover 1002a, 1102a. The slightly protruding first light barrier 1020, 1120 and / or inner lens or cover 1002a, 1102a may press into the wearer's skin with more pressure than the rest of the light barrier or lens or cover of the sensor or module 1000, 1100.

[0235] The detectors 1006, 1106 may be enclosed within module sidewalls 1024, 1124, which define the perimeter of the sensor or module 1000, 1100. The perimeter may be generally circular or of any other shape. The sidewalls 1024, 1124 may be shorter than the first light barrier 1020, 1120. The height of the sidewalls 1024, 1124 may be such that the tissue-facing ends of the sidewalls 1024, 1124 are generally continuous with the curvature of the outer lens or cover 1002b, 1102b. In the illustrated example, the detectors 1006, 1106 may be separated from one another by multiple generally opaque divider barriers 1026, 1126. The divider barrier 1026, 1126 can have a height that is less than the first light barrier 1020, 1120. The height of the divider barrier 1026, 1126 can be configured to accommodate the outer lens or cover 1002b, 1102b such that, when assembled, the outer lens or cover 1002b, 1102b forms a substantially smooth surface with the module sidewalls 1024, 1124. The outer lens or cover 1002b, 1102b can sit on the divider barrier 1026, 1126. The tissue-facing ends of the first light barrier 1020, 1120 and side wall portions 1024, 1124, and the tissue-facing surfaces of the inner lens or cover 1002a, 1102a and outer lens or cover 1002b, 1102b may be configured to contact the wearer's skin and form the tissue-facing surface of the sensor or module 1000, 1100.

[0236] The first light barrier 1020, 1120, the side walls 1024, 1124, and the divider barrier 1026, 1126 can optionally form a single light barrier construction. The single light barrier construction can accommodate the PCB of the sensor or module 1000, 1100, as well as the emitters 1004, 1104, the detectors 1006, 1106, the temperature sensor, and any other sensors, such as gyroscopes and / or accelerometers, and the sensor or module processor positioned on the PCB. The single light barrier construction can accommodate lenses (including inner lenses or covers 1002a, 1102a and outer lenses or covers 1002b, 1102b) at another end opposite the end that accommodates the PCB. As shown in FIGS. 25A and 25B, the light barrier construction of the module 1100 or PCB can additionally include multiple (e.g., four or other) extension prongs 1152. The extension prongs 1152 may be generally equally spaced around the side wall 1124 .

[0237] The sensor or module 1000, 1100 can include multiple chambers, with light unable to travel between them due to various light barriers described herein. The first chamber 1034, 1134 can be surrounded by an inner lens or cover 1002a, 1102a, a first light barrier 1020, 1120, and a portion of the PCB. The first chamber 1034, 1134 can surround the emitter 1004, 1104. The multiple second chambers 1036, 1136 can be surrounded by an outer lens or cover 1002b, 1102b, a first light barrier 1020, 1120, a divider barrier 1026, 1126, a sidewall 1024, 1124, and a portion of the PCB. Each of the second chambers 1036, 1136 may enclose one detector 1006, 1106.

[0238] The light diffusing material described above can be included in one or more of the chambers 1034, 1134, 1036, 1136 of the module housing to improve the distribution of emitted and / or detected light. Also, the inner lens or cover 1002a, 1102a and outer lens or cover 1002b, 1102b can include glass microspheres, as described above.

[0239] The watch 1200 in FIGS. 25C-25H is illustrated as incorporating the module 1100 shown in FIGS. 25A-25B. However, any of the exemplary watches disclosed herein can incorporate the physiological parameter measurement modules 1000, 1100 shown in FIGS. 24A-24B or 25A-25B. The watch 1200 can have any of the features of the wearable devices disclosed herein (e.g., watches 700, 900, etc.), all of which will not be repeated for the sake of brevity. The watch processor 1214 and power supply can be enclosed within a watch housing 1201. The watch housing 1201 can include a connection port opening 1250 configured to allow access to a connection port 1252, which is in electrical communication with the watch processor 1214 and / or the power supply. Opening 1250 can be on one side of watch 1200 perpendicular to first axis A1 of module 1100, closer to the strap coupling mechanism. Connection port 1252 can allow for charging of the power supply and / or data transfer to and from watch processor 1214. Optionally, as shown in FIGS. 25D, 25F, and 25H, watch 1200 can include a cable connector 1254 extending outward from watch housing 1201. Cable connector 1254 can be positioned adjacent to or near connection port opening 1250.

[0240] The watch 1200 can include a display screen 1212 positioned on a first side of a watch housing 1201. The watch housing 1201 has a second side opposite the first side. The second side of the watch housing 1201 can include an opening sized to hold the physiological parameter measurement module 1100 while still allowing the tissue-facing surface of the module 1100 to be exposed. The extension prongs 1152 of the module 1100 can be received into corresponding structures (e.g., recesses) on the second side of the watch housing 1201, which can prevent rotation of the module 1100 when installed in the watch 1200. The second side of the watch housing 1201 can be removably attached to the first side of the watch housing 1201 without the use of external fasteners or via one or more fasteners, as described above. An electrical connection can be established between the physiological parameter measurement module circuitry and the watch circuitry. Optionally, the electrical connection may include a flex circuit.

[0241] The watch housing 1201 can include a strap coupling extension 1248 on the opposite side of the watch 1200 along the first axis A1 of the module 1100. The extension 1248 can include a bar 1246 for connecting to any suitable watch strap.

[0242] Exemplary second sensor connection on a physiological parameter measurement module for preventing opioid overdose Examples of physiological parameter measurement modules disclosed herein can include an optional connector 118 (see FIG. 7A ) for accepting a second sensor, which can be a plethysmograph sensor or other suitable sensor. The connector 118 can be oriented to allow the second sensor to extend from the housing of the device 10 with reduced or no tissue impingement at the device / tissue interface, resulting in connection of the second sensor to the connector 118 having less or no effect on blood flow through the device measurement site. The second plethysmograph sensor can include any suitable plethysmograph sensor, for example, a fingertip sensor configured to monitor opioid overdose, as described in U.S. Patent Application Publication No. 20190374173, the entire contents of which are incorporated herein by reference and considered part of this disclosure. FIG. 1C illustrates a non-limiting example of the second sensor 119, which is a fingertip sensor. The second sensor 119 can extend from a wearable device such as that shown in FIG. 1C or from any of the examples of wearable devices disclosed herein.

[0243] As an alternative to connecting to a wearable device as shown in FIG. 1C , a connector from a watch disclosed herein can extend from an opening on the tissue-facing side of the device housing, such as an opening on the raised platform 703, 903 ( FIGS. 20I and 23A ). The connector can be coupled to the PCB 616 via a cable, which can optionally have a length configured to extend around the raised platform 703, 903, for example, to extend into a groove in the raised platform 703, 903, or to extend in other ways. Having the cable extend around the raised platform 703, 903 can allow for adjustment of cable slack when the connector connects to a second sensor. Also, having the connector extend from an opening on the raised platform 703, 903 can avoid the connector and / or cable from impinging on the tissue at the watch / tissue interface, as described above. The connector may alternatively be positioned in any other suitable location on the watch 700, 900.

[0244] The second plethysmograph sensor can have higher measurement accuracy than the physiological parameter measurement module disclosed herein. The wearer can disconnect and / or deactivate the second sensor while the wearer is awake and / or moving around. The wearer can connect and activate the second sensor, for example, when sleeping or resting. The sensor or module processor can ignore the signal from the module's detector when the second sensor is activated, and the sensor or module processor can output the physiological parameter based on readings from the second sensor. Alternatively, the sensor or module processor can output the physiological parameter based on a combination of readings from the second sensor and the module's detector. The wearer can have the flexibility to choose to use the physiological parameter measurement module and / or the second sensor depending on the wearer's needs.

[0245] The second plethysmographic sensor can, among other things, aid in the detection of opioid overdose in a wearer who uses opioids (e.g., for medical reasons) by detecting low oxygen saturation in the wearer's blood. Depression of breathing is the most dangerous side effect of an opioid overdose. Lack of oxygen to the brain can result not only in permanent neurological damage, but also in widespread damage to other organ systems (including the heart and kidneys). If a person who has experienced an opioid overdose is left unchecked and falls asleep, they can easily die as respiratory depression worsens. The second plethysmographic sensor can be configured to detect depression of breathing by detecting a decrease in oxygen saturation in the wearer's blood. The wearable device can be configured to automatically notify first responders and / or the wearer's family or guardians in response to detecting an opioid overdose in the wearer.

[0246] Optionally, the device processor of the wearable device can be in communication (e.g., via Bluetooth or NFC communication or via a network) with a processor of a drug delivery device, which is wearable by a wearer and configured to deliver one or more doses of a therapeutic drug (e.g., an opioid). The drug delivery device can include a delivery device, which can include a dose of the therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device for dispensing the therapeutic drug from the reservoir through the drug delivery channel, and an activation circuit for activating the dispensing device. The processor of the drug delivery device can receive a parameter measured by a second plethysmographic sensor of the wearable device disclosed herein. The processor of the drug delivery device can store memory storing instructions and can be configured to execute the instructions for at least comparing the parameter received from the wearable device to a threshold value indicative of an opioid overdose. The processor of the drug delivery device can determine, based on the comparison, whether an overdose event has occurred or is likely to occur, and can send at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug based on the determination.

[0247] Alternatively, the sensor or module processor of the physiological parameter measurement module can perform a comparison between the parameter measured by the second plethysmograph sensor and a predetermined opioid overdose threshold. Optionally, a microneedle patch can be used to provide medication that can reverse an opioid overdose. When the wearable device outputs an alert that the wearer's physiological parameter (e.g., SpO2) has exceeded a threshold (which may indicate an opioid overdose), the wearer can apply a microneedle patch containing the medication to their skin.

[0248] Alternatively or additionally, the second sensor can be any other suitable non-invasive sensor disclosed herein. Alternatively or additionally, example physiological parameter measurement modules disclosed herein can connect to the second sensor via a wireless connection, for example, using Bluetooth technology. The module can receive measured parameters from the connected second sensor and / or process sensor data received from the second sensor to calculate additional physiological parameters.

[0249] Exemplary Microneedle Patch In addition to and / or as an alternative to delivering medications to prevent opioid overdose as described herein, microneedle patches can be used for other purposes in combination with wearable devices. Microneedles have recently been used as a painless alternative to hypodermic needles for delivering drugs to the body. Microneedles on a patch can be placed on an arm or leg or other part of the body, which then creates tiny holes in the outermost layer of the skin, allowing drugs coated on each needle to diffuse into the body. Microneedles can be made from silicon, metal, synthetic polymers, or natural biodegradable materials (e.g., silk and chitin).

[0250] Due to their small size, microneedles are minimally invasive and cause less pain than larger needles (e.g., hypodermic needles). Additionally, microneedle patches are easier for the wearer to apply than hypodermic needles. In comparison, larger needles may require the correct injection depth and angle to ensure the drug is injected in the correct location.

[0251] FIG. 26A schematically illustrates a microneedle 3100 of a microneedle patch penetrating a wearer's tissue surface 2. Depending on its height, the microneedle 3100 can have various injection depths. For example, the microneedle 3100 can pierce only the epidermis (including the stratum corneum, which is the outer layer of the epidermis) 42. In other examples, the microneedle 3100 can pierce the epidermis 42 and the dermis 44, with the tip of the microneedle 3102 terminating in the dermis 44. In other examples (such as that shown in FIG. 26A), the microneedle 3100 can pierce the epidermis 42 and the dermis 44, with the tip 3102 terminating in the subcutaneous tissue 46.

[0252] Depending on the use, microneedles 3100 having different heights can be used for delivery of medication and / or irrigation fluid 3104 into different parts of the wearer's tissue. The microneedles 3100 can be used to deliver a wide range of drugs, biological therapeutics, and vaccines. The microneedles 3100 can be hollow with an internal reservoir for storing and delivering the drug or irrigation fluid 3104. Alternatively, the microneedles 3100 can be solid and coated with the drug 3104 (and optionally other surfactants / thickeners). Optionally, the microneedles 3100 can encapsulate the drug in a non-toxic polymer that is dissolvable and can dissolve once inside the skin.

[0253] Alternatively or additionally, the microneedle 3100 may be used to extract a tissue fluid sample 3104 (e.g., interstitial fluid of the wearer) for detection and / or analysis of analytes in the sample 3104. Optionally, the microneedle 3100 may perfuse the wearer's tissue with fluid before extracting the fluid (which may, for example, be in equilibrium with the chemical composition of the wearer's bodily fluid sample) back into the microneedle 3100. The microneedle 3100 may be hollow and may extract the fluid sample via surface tension. The analyte detection and / or analysis may provide information such as hydration state, glucose concentration, hemoglobin concentration, and / or orthogonal information about the fluid. The analyte detection and / or analysis may provide additional information related to, for example, sodium, potassium, glucose, chloride, bicarbonate, blood urea nitrogen, magnesium, creatinine, LDL cholesterol, HDL cholesterol, triglycerides, and pH.

[0254] The microneedle patch may be positioned under one of the straps or body portions of the wearable device, or may be applied remotely from the wearable device (somewhere else on the wearer's body) without contacting the device. Multiple microneedle patches may be applied to the wearer at different locations on the wearer's body. As shown in FIGS. 26B and 26C , the microneedles 3100 may be connected to a patch body portion 3106 to form a microneedle patch 3108. The patch body portion 3106 may be circular, oval, rectangular, square, triangular, teardrop-shaped, or any other shape. The size of the patch body portion 3106 is not limited. The surface of the patch body portion 3106 that is not connected to the microneedles 3100 may include an adhesive layer for releasably attaching the patch 3108 to the wearable device. The adhesive layer may be covered by a backing layer, which may be peeled off before applying the patch 3108 to the wearable device.

[0255] 26B, a microneedle patch 3108 may be placed on the body of the device 10. The patch 3108 may be applied below the skin-facing surface of the physiological parameter measurement sensor or module 100. The microneedles 3100 of the microneedle patch 3108 may face the skin of a wearer of the device 10 when the device 10 is worn. Thus, for example, when the device 10 is worn on the wearer's wrist with the strap wrapped around the wrist, the microneedles 3100 may pierce the skin above the wrist.

[0256] Additionally or alternatively, the microneedle patch 3108 may be integrated into or releasably secured to the inside of an adjustable strap 30 of the wearable device 10 (such as that shown in FIG. 26C ). The microneedles 3100 may face the skin around the wearer's wrist when the device 10 is worn. When the strap 30 is wrapped around the wearer's wrist, the microneedle patch 3108 may contact the skin around the wearer's wrist and the microneedles 3100 may penetrate the wearer's skin.

[0257] As shown in FIG. 26D , the microneedle patch 3108 can use the wearable device 10 as a platform or hub to communicate with the wearable device 10 to detect and / or analyze analytes in a fluid sample collected in the microneedle patch 3108. The patch 3108 can optionally include a sensor 3110, such as an electrochemical sensor (electrodes built into the microneedles), a colorimetric sensor, or the like. Alternatively, the patch 3108 can be connected to an external sensor for analyte detection and analysis. The patch 3108 can include an antenna 3112, which can be an NFC antenna or the like. The sensor 3100 can output a signal via the antenna 3112. The wearable device can receive a signal from the sensor 3100 via the antenna 3112. The device processor 14 (or, optionally, a sensor or module processor of a physiological parameter measurement sensor or module on the device 10) can process the signal from the sensor 3100 and determine the presence and / or concentration of a particular analyte in the fluid sample.

[0258] Exemplary Device Tightness Monitoring System and Method The desired tightness and / or pressure of the device on the body can be indicated by the skin interfacing with the wearable device, which moves with the device as it is moved. If the tightness and / or pressure of the device on the wearer's body is insufficient, ambient light entering the device-skin interface can result in noise in the signal detected by the detector and, therefore, inaccurate measurements taken by the device. If the device is worn too tightly (and / or if the pressure exerted by the device on the body is too high), blood pulsation and circulation at the wrist can be restricted, which can lead to a decrease in the device wearer's oxygen saturation reading. Optionally, when the device determines that the wearer's oxygen saturation reading is decreasing by a certain percentage, at a certain rate, and / or at a certain rate within a predetermined amount of time, the device can output a warning that the device is being worn too tight (which can include a message displayed on the device to the wearer to loosen the straps).

[0259] The device 10 can include an optional strain gauge 20 (see FIG. 7A ) to measure the pressure of the device 10 on the wearer. The strain gauge 20 can be positioned within the device housing 101 between the physiological parameter measurement module 100 and other components of the device 10 (e.g., the power supply 16, the device processor 14, or others). For example, the strain gauge 20 can be flanged between the physiological parameter measurement module 100 and the device processor 14. When the device 10 is worn on the wearer (e.g., on the wrist), pressure exerted against tissue by the module (particularly by the convex protrusion of the cover 102) can be transmitted to and measured by the strain gauge 20. The strain gauge 20 can also be incorporated into other example wearable devices disclosed herein.

[0260] Readings from the strain gauges 20 may be communicated to the device processor 14, which may process the readings and output an indication of the pressure exerted by the device 10 on the wearer for display on the display 12. The indication may take a variety of suitable forms, such as using different colors to indicate whether the pressure is too low, appropriate, or too high to obtain accurate or reliable measurements using the physiological parameter measurement module 100. In one example, the device 10 may display a green light when the pressure on the wearer is appropriate for use with the physiological parameter measurement module 100, and a red or other colored light for pressures that are too high or too low compared to the desired pressure or pressure range. The physiological parameter measurement module 100 may not be activated unless readings from the strain gauges 20 indicate that the desired pressure or pressure range has been achieved. Optionally, the device processor may deactivate the physiological parameter measurement module 100 and / or any other sensors on or attached to the device 10 in response to not detecting any readings from the strain gauges 20 (indicating that the device 10 is not being worn by a wearer). Automatically turning on and / or turning off sensors on or attached to the device 10 may reduce power consumption and increase battery life of the device 10.

[0261] Optionally, the wearable device 10 may include a motor for adjusting the tightness of the straps based on the monitored tightness of the straps and / or the pressure exerted by the sensor or module 100 against the wearer's skin.

[0262] Exemplary Additional Features of Wearable Devices Examples of wearable devices disclosed herein can provide protection for the wearer's safety by sending an alert to first responders (e.g., a hospital emergency room, firefighters, 911, security at the facility where the wearer is located, or others) and / or the wearer's family or guardians when the wearer is in danger, for example, when the wearer is drowning. The wearable device can include a swim mode, which the wearer can activate when going for a swim. The physiological parameter measurement module of the wearable device can monitor one or more parameters and determine that the wearer is about to drown (e.g., a child drowning in water) by, for example, determining that the wearer's breathing rate has become irregular (e.g., exhibiting fluctuations greater than a predetermined number per minute), or that the wearer's SpO2 value has dropped by a predetermined amount, or the like. Alternatively, the module processor can determine that the wearer is about to drown based on gyroscope and / or accelerometer readings (which may be further combined with parameters monitored by other sensors). In response to determining that the wearer is near drowning, the module can send a notification to the processor of the wearable device, and the processor can send an alert to first responders and / or the wearer's family or guardians. Additionally or alternatively, the wearable device can include a distress button that the wearer can press in an emergency (e.g., when the wearer is drowning, when they fall while alone (which may alternatively or additionally be determined using gyroscope and / or accelerometer readings, which may further be combined with parameters monitored by other sensors), or otherwise).

[0263] Physiological parameters measured by the modules disclosed herein (e.g., but not limited to, SpO2, PR, PI, PVI, RR, hydration values, ECG-related parameters, etc.) may be sufficiently reliable for healthcare or medical purposes, for example, in a hospital. The module may be configured to perform measurements at the same time every day. The wearable device (or the device's physiological parameter measurement module) may further include a hospital patient ID tag on a near-field communication (NFC) or Bluetooth chip, or a watch strap or band. Essential patient information (e.g., patient name, admission date, reason for admission, blood type, drug allergies, etc.) may be stored in a memory device of the watch or physiological parameter measurement module. The patient ID tag may not be easily removed and / or may include special tools such as an anti-theft device, requiring the patient to detach the watch strap, for example. Alternatively, the wearable device may display patient information (e.g., name, admission date, etc.) on the screen when the patient is admitted to the hospital. The patient ID tag is either disposable after the patient is discharged or reusable after disinfection. The physiological parameter measurement module can be removed and replaced when the patient ID tag (e.g., watch band) is changed. When the wearable device is worn by a caregiver, the caregiver can use the wearable device to communicate with other caregivers (e.g., to share important real-time information about the patient and / or update changes in patient status), replacing the need for dedicated communication tools (e.g., Vocera®, Spok®, etc.).

[0264] Terminology Many variations beyond those described herein will be apparent from this disclosure. For example, certain acts, events, or functions of any of the algorithms described herein may be performed in a different sequence, added, combined, or omitted entirely (e.g., not all described acts or events are necessary to practice the algorithm). Moreover, acts or events may be performed simultaneously, for example, through multithreading, interrupt processing, or multiple processors or processor cores, or on other parallel rather than sequential architectures. In addition, different tasks or processes may be performed by different machines and / or computing systems that can function together.

[0265] It should be understood that not necessarily all such advantages may be achieved in accordance with any particular example of the examples disclosed herein. Thus, the examples disclosed herein may be embodied or implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0266] The various illustrative logical blocks, modules, and algorithm steps described in connection with the examples disclosed herein may be implemented as electronic hardware, computer software, or a combination of both. To clearly illustrate this interchangeability of hardware and software, the various illustrative components, blocks, modules, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends on the particular application and design constraints imposed on the overall system. The described functionality may be implemented in various ways for each particular application, and such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure.

[0267] The various illustrative logic blocks and modules described in connection with the examples disclosed herein may be implemented or performed by a machine, such as a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but in alternative examples, the processor may be a controller, microcontroller, or state machine, or a combination thereof. A processor may include electrical or digital logic circuitry configured to process computer-executable instructions. In another example, a processor may include an FPGA or other programmable device that performs logical operations without processing computer-executable instructions. A processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a combination of multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. The computing environment can include any type of computer system, including, but not limited to, a microprocessor-based computer system, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computer calculation engine in a consumer electronics device, to name a few examples.

[0268] The steps of a method, process, or algorithm described in connection with the examples disclosed herein may be embodied directly in hardware, in a software module stored in one or more memory devices and executed by one or more processors, or in a combination of the two. The software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable storage medium, media, or physical computer storage known in the art. An exemplary storage medium may be coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The storage medium may be volatile or non-volatile. The processor and the storage medium may reside in an ASIC.

[0269] Conditional language used herein (e.g., "can," "might," "may," and "for example," among others) is generally intended to convey that a particular example includes a particular feature, element, and / or state, while other examples do not, unless specifically stated otherwise or otherwise understood within the context as used. Thus, such conditional language is not generally intended to imply that a feature, element, and / or state is required in any way with respect to one or more examples, or that one or more examples necessarily include logic for determining whether those features, elements, and / or states will be included or implemented in any particular example, with or without author input or prompting. Terms such as "comprising," "including," and "having" are synonymous and used inclusively in an open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in its inclusive sense (and not its exclusive sense), such that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Further, the term "respective" as used herein, in addition to having its ordinary meaning, can refer to any subset of the set of elements to which the term "respective" applies.

[0270] Disjunctive language, such as the phrase "at least one of X, Y, or Z," unless specifically stated otherwise, is understood in conjunction with the context as generally used to indicate that an item, term, etc. may otherwise be either X, Y, or Z, or any combination thereof (e.g., X, Y, and / or Z). Thus, such disjunctive language is generally not intended to, and should not, imply that a particular instance requires the presence of at least one of X, at least one of Y, or at least one of Z, respectively.

[0271] Unless otherwise expressly stated, articles such as "a" or "an" should generally be construed to include one or more described items. Thus, phrases such as "a device configured to" are intended to include one or more described devices. Also, such one or more described devices may be collectively configured to perform the stated description. For example, "a processor configured to perform descriptions A, B, and C" may include a first processor configured to perform description A in conjunction with a second processor configured to perform descriptions B and C.

[0272] While the foregoing detailed description has illustrated, described, and pointed out novel features as applied to various examples, it will be understood that various omissions, substitutions, and changes in the form and details of the illustrated devices or algorithms may be made without departing from the spirit of the disclosure. It will be recognized that the invention described herein may be embodied in forms that do not provide all of the features and benefits described herein, because some features may be used or practiced separately from others.

[0273] Additionally, all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Explanation of symbols]

[0274] 2 Wrist 10 devices 12 Display 13 Buttons 13a First User Interface (UI 1) 13b Secondary User Interface (UI 2) 14 Device Processors 15 User Feedback Output 16 Power supply source 17 Wireless charging coil 19 Antenna 20 strain gauges 22 Strap connection 30 Straps 32 flex connector 42 Accelerometer and / or gyroscope, epidermis 44 Dermis 46 Subcutaneous tissue 62 Wrist 64 Fingertips 100 Physiological parameter measurement sensor, physiological parameter measurement module 101 Device Housing 102 Light-transmitting cover 102a Lens or cover 102b Lens or cover 103 Bridging part 104 Emitter 104a First emitter group 104b Second emitter group 105 Wire 106 detector 106a First group detector 106b Second group of detectors 106a / b Shared Group Detector 107 Wire Bond 108 Module Processor 110 Temperature sensor, thermistor 112 Gyroscope 114 Accelerometer 116 PCB 118 Connector 119 Second Sensor 120 Light Barrier Construct 124 ECG electrodes 125 ECG electrode 126 Opaque Frame 127 Electrical insulating materials 130 Electronic equipment protection materials 131 Spring contact 132 Connector 136a First emitter chamber 136b Second emitter chamber 137 posts 138 Third Detector Chamber 140 First detector chamber 142 Second detector chamber 144 Filling hole 145 Air Vent Channel 146 filling channel 200 Physiological Parameter Measurement Module 201 Physiological Parameter Measurement Module 202 Patient Monitor 202a Inner lens or cover 202b Outer lens or cover 204 Mobile Communication Devices 204a, 204b emitters 206 Computers, detectors 206a, 206b, 206a / b detectors 208 tablets 210 Nurse Station System 212 Network 214 Electronic Medical Record System Remote server with 216 databases 224 Module side wall 228 Divider Barrier 234a, 234b emitter chamber 236 Detector Chamber 244 Injection opening 300 Physiological Parameter Measurement Module 301 Physiological Parameter Measurement Module 302 Rubber Base 304 Metal Loop 304a First group emitters 304b Second group of emitters 306a, 306b, 306a / b detectors 400 Demodulation Module, Physiological Parameter Measurement Module 401 Physiological Parameter Measurement Module 402 Decimation Module, Light-Transmitting Cover 403 Physiological Parameter Measurement Module 404 Statistics Module 404a First group emitters 404b Second group of emitters 406 Saturation Conversion Module 406a, 406b, 406a / b detectors 408 Saturation Calculation Module 410 Pulse rate calculation module, temperature sensor 416 PCB 420 First Light Barrier 422 Second Light Barrier 423 Light Barrier 424 Module side wall 426 Opaque Frame 430 Electronic equipment protection materials 432 flex connector 437 posts 500 devices 501 Watch Housing 600 Physiological Parameter Measurement Module 601 Module 602a Inner lens or cover 602b First outer lens or cover 602c Second outer lens or cover 602d Third outer lens or cover 603 Module 604 Emitter 606 Detector 606a First Outer Group 606b Second Outer Group 606c Inner Group 610 Temperature Sensor 616 PCB 620 First Light Barrier 622 Second Light Barrier 624 Side wall 626 Third Light Barrier 628 Fourth Light Barrier 630 Single Light Barrier Construct 632 recess 644 Injection opening 645 vent opening 700 Watch 701 Watch Housing 703 Raised Platform 714 Watch Processor 716 Power supply source 718 Screw 750 flap 752 connection port 816 PCB 900 Watch 901 Watch Housing 903 Raised Platform 912 display screen 914 Watch Processor 945 Cable Connector 946 Bar 948 Strap Coupling Extension 950 Connection port opening 952 connection port 1000 physiological parameter measurement modules 1002a Inner lens or cover 1002b Outer lens or cover 1004 Emitter 1006 detector 1020 First light barrier 1024 Module side wall 1026 Divider Barrier 1034 First Chamber 1036 Second Chamber 1080 Calculation Processor 1081 ECG amplifier 1082 system processors 1083 Detector Cathode Switch Matrix 1084 Host Connector 1085 Emitter Switch Matrix 1086 LED driver circuit 1088 Front-end circuit 1090 Power Management Integrated Circuit (PMIC) 1092 Transimpedance Amplifier 1094 Low Pass Filter 1096 High Pass Filter 1098 Analog to Digital Converter 1100 Physiological Parameter Measurement Module 1102a Inner lens or cover 1102b Outer lens or cover 1104 Emitter 1106 Detector 1120 First Light Barrier 1124 Module side wall 1126 Divider Barrier 1134 First Chamber 1136 Second Chamber 1152 Extension Prong 1200 Watch 1201 Watch Housing 1212 display screen 1214 Watch Processor 1246 Bar 1248 Strap Coupling Extension 1250 Connection port opening 1252 connection port 1254 Cable Connector 1400 Bluetooth Coprocessor 1402 System Processor 1500 Normalization module "Norm" 1502 "Norm 1" 1504 "Norm 2" 1506 Pulse Rate Determination Module 1508 Oxygen Saturation Determination Module 1510 Perfusion Index Determination Module 1512 Pleth Variability Index Determination Module 1514 Respiration Rate Determination Module 1516 Hydration Value Determination Module 1518 Interpolation Module 1520 Interpolation 1 Module 1522 Low-pass filter and decimation module 1524 Low-pass filter and decimation 1 module 1526 Interference Mitigation (IM) and Motion Analysis Module 1528 Time Domain Pulse Rate Determination Module 1530 Frequency Domain Pulse Rate Determination Module 1532 Pulse rate determination logic 1534 Decision Logic Stage 2 Module 1536 Movement Analysis Module 1538 Seed Saturation Module 1540 SST Saturation Module 1542 DST Saturation Module 1544 Interference Mitigation (IM) Saturation Module 1546 Signal / Noise Reference Saturation Module 1548 Decision Logic 1550 Saturation Decision Logic Stage 2 Module 1552 Motion Analysis Module 3100 Microneedle 3102 Tip 3104 Drugs, irrigation fluids 3106 Patch body 3108 Microneedle Patch 3110 Sensor 3112 Antenna A1 First axis A2 Second axis

Claims

1. An optical physiological sensor integrated into a watch configured to monitor the health of a wearer, the optical physiological sensor configured to face tissue of the wearer when the watch is worn by the wearer, the optical physiological sensor configured to measure physiological parameters of the wearer using information from the optical physiological sensor, the optical physiological sensor comprising: a first emitter grouping including a first plurality of LEDs at a first location; a second emitter grouping including a second plurality of LEDs at a second location different from the first location, the second emitter grouping including the same number and type of LEDs as the first emitter grouping; one or more optical blocks separating the first emitter grouping from the second emitter grouping; a light diffusing material configured to diffuse light emitted by each of the first and second pluralities of LEDs; a plurality of detectors including four or more photodiodes; a convex surface configured to be positioned between (i) the first and second emitter groupings and the four or more photodiodes and (ii) the tissue of the wearer, the convex surface comprising one or more surface materials; Optical physiological sensors, including:

2. The sensor of claim 1 , wherein the one or more surface materials include at least a portion of the one or more light-blocking and light-transmitting materials.

3. 3. The sensor of claim 1, wherein the emitters in the first or second emitter groupings are not electrically connected to each other.

4. The sensor of claim 1 , wherein the plurality of detectors act as far and near detectors, respectively, for different groups of emitters.

5. The sensor of claim 1 , wherein the first and second emitter groups are positioned at non-central locations on a printed circuit board (PCB) of the sensor.

6. 6. The sensor of claim 1, wherein the one or more light blocks extend from a surface of the sensor that positions the first and second plurality of LEDs toward the wearer's tissue when the watch is worn.

7. 7. A sensor according to claim 1, wherein each of the first or second emitter groupings is surrounded by its own diffusing material.

8. 8. The sensor of claim 7, wherein the light diffusing material surrounding the first emitter grouping is different from the light diffusing material surrounding the second emitter grouping.

9. The sensor of claim 1 , wherein at least some of the plurality of detectors extend around a periphery of the sensor.

10. The sensor of claim 9 , wherein the plurality of detectors are positioned in a grid pattern and / or opposite each other.

11. 11. The sensor of claim 9 or 10, wherein at least one of the plurality of detectors is positioned between the first grouping of emitters and the second grouping of emitters.

12. 12. The sensor of claim 1, wherein at least one of the plurality of detectors is positioned between the first plurality of LEDs and the second plurality of LEDs, and at least one of the plurality of detectors is positioned on each of at least two sides of each of the first plurality of LEDs and the second plurality of LEDs.

13. 13. A watch including an optical physiological sensor according to any one of claims 1 to 12, the watch further including a processor configured to determine an oxygen saturation measurement based on a signal from the optical physiological sensor.

14. an optical physiological sensor configured to monitor the health of a wearer, the optical physiological sensor configured to face tissue of the wearer when the watch is worn by the wearer, the optical physiological sensor configured to measure a physiological parameter of the wearer using information from the optical physiological sensor, the sensor comprising: a first emitter including a first plurality of LEDs positioned over a surface of the substrate; a first photodiode positioned on the surface of the substrate; a curved surface extending above all of the first plurality of LEDs and the first photodiode; a first light barrier positioned between the first emitter and the first photodiode, the first light barrier extending from the surface of the substrate to the curved surface; a second emitter including a second plurality of LEDs positioned above the surface of the substrate; a second photodiode positioned above the surface of the substrate; a second light barrier positioned between (i) both the first and second emitters and (ii) the second photodiode, the second light barrier extending from the surface of the substrate to the curved surface; Including, the first light barrier includes one or more portions that together extend from the surface to the curved surface of the substrate; The optical physiological sensor, wherein the curved surface extends over all of the second plurality of LEDs and the second photodiode.

15. The optical physiological sensor of claim 14 , wherein the second light barrier includes one or more portions that together extend from the surface of the substrate to the curved surface.

16. the portions of the curved surface positioned above the first and second emitters include at least a first material; a portion of the curved surface positioned above the first and second photodiodes includes at least a second material; 16. The optical physiological sensor of claim 15, wherein the portions of the first and second barriers that extend to the curved surface include at least a third material that is different from the first and second materials.

17. 17. The optical physiological sensor of claim 16, wherein at least the first, second, and third materials together define the curved surface.

18. 18. The optical physiological sensor of claim 16 or 17, wherein the first and second materials comprise the same material.

19. an optical physiological sensor configured to monitor the health of a wearer, the optical physiological sensor configured to face tissue of the wearer when the watch is worn by the wearer, the optical physiological sensor configured to measure a physiological parameter of the wearer using information from the optical physiological sensor, the sensor comprising: a plurality of LEDs configured to emit light into tissue of the wearer; a wall dividing the plurality of LEDs into at least a first group of LEDs and a second group of LEDs, the first group of LEDs including a first plurality of LEDs and the second group of LEDs including a second plurality of LEDs, the wall being one or more light blocks; four or more photodiodes configured to detect light emitted by the plurality of LEDs after attenuation by the tissue; one or more covers covering the plurality of LEDs and the four or more photodiodes, the one or more covers together forming a portion of a convex surface configured to contact the tissue; Optical physiological sensors, including:

20. A physiological parameter measuring sensor configured to be integrated into a watch configured to monitor the health of a wearer, the physiological parameter measuring sensor configured to face tissue of the wearer when the watch is worn by the wearer, the physiological parameter measuring sensor configured to measure a physiological parameter of the wearer using information from the physiological parameter measuring sensor, the sensor comprising: a plurality of emitters configured to emit light at a plurality of different wavelengths, the plurality of different wavelengths including at least three different wavelengths; a plurality of detectors configured to detect light emitted by the plurality of emitters and attenuated by tissue of the wearer when the watch is worn on the wrist of the wearer, and configured to output signals to a sensor processor for determining the physiological parameters of the wearer; a sensor housing, wherein the plurality of emitters and the plurality of detectors are enclosed within the housing; and Including, The sensor housing includes: a skin-facing, convex, light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover being positioned on a first side of a sensor housing; and a printed circuit board (PCB) positioned on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being positioned on the skin-facing side of the PCB; a plurality of light barriers extending from the PCB to the cover, the plurality of light barriers forming walls of chambers and configured to block light or substantially all light between the chambers, each chamber enclosing one or more emitters without a detector or one or more detectors without an emitter; Including, the plurality of detectors includes a plurality of far detectors, the plurality of far detectors being farther from at least some of the plurality of emitters than the remainder of the plurality of detectors; A physiological parameter measurement sensor, wherein the plurality of emitters includes a first group of emitters and a second group of emitters, and the chamber includes a first emitter chamber surrounding the first group and a second emitter chamber surrounding the second group.

21. 21. The sensor of claim 20, wherein the plurality of detectors includes a first ring of detectors and a second ring of detectors, the first ring of detectors surrounding the first group of emitters and the second ring of detectors surrounding the second group of emitters.

22. 22. The sensor of claim 21 , wherein at least one of the plurality of detectors is positioned between the first group of emitters and the second group of emitters and is shared by the first and second rings of detectors.

23. 23. The sensor of claim 21 or 22, wherein some of the plurality of detectors are closer to the emitters of the first group than the remainder of the plurality of detectors, and some of the plurality of detectors are closer to the emitters of the second group than the remainder of the plurality of detectors.

24. 24. The sensor of any one of claims 20 to 23, wherein the sensor includes the sensor processor, the sensor processor configured to determine a hydration state of the wearer based on signals from the plurality of remote detectors.

25. 25. The sensor of claim 24, wherein at least one of the emitters is configured to emit light at a wavelength that is more sensitive to water than the remainder of the different wavelengths.

26. 26. The sensor of claim 25, wherein the wavelength more sensitive to water is 970 nm.

27. 27. The sensor of any one of claims 24 to 26, wherein the sensor processor is configured to compare signals of light reflected from the wearer's tissue at the wavelengths that are more sensitive to water with other wavelengths that are less sensitive to water from the plurality of remote detectors.

28. 28. The sensor of claim 20, wherein the sensor processor is configured to selectively activate some of the plurality of emitters and / or activate or deactivate some of the plurality of detectors.

29. 1. A health monitoring watch comprising a strap and a housing, the housing comprising: a first chamber; a second chamber; and Four or more light sensors Including, The first chamber comprises: a first well having a first depth below a first surface configured to contact the skin of a user; a first plurality of LEDs positioned inside the first well at the first depth, the first plurality of LEDs including a first LED configured to emit light at a first wavelength, a second LED configured to emit light at a second wavelength different from the first wavelength, and a third LED configured to emit light at a third wavelength different from the first wavelength and the second wavelength; a first wall portion surrounding the first well; Including, The second chamber comprises: a second well having a second depth below a second surface configured to contact the skin of the user; a second plurality of LEDs positioned inside the second well at the second depth, the second plurality of LEDs including a fourth LED configured to emit light at the first wavelength, a fifth LED configured to emit light at the second wavelength different from the first wavelength, and a sixth LED configured to emit light at the third wavelength different from the first wavelength and the second wavelength; a second wall portion surrounding the second well; and Health monitoring watch, including.

30. 1. A wearable health monitoring device, the wearable health monitoring device being configured to be worn on a wrist of a user and to monitor one or more physiological parameters indicative of the user's health, the wearable health monitoring device comprising: a first emitter grouping including a first plurality of LEDs configured to emit light of one or more wavelengths, the first emitter grouping being disposed at a first location, the first location being spaced apart from an axis extending through a center of the wearable health monitoring device; a second emitter grouping including a second plurality of LEDs configured to emit light of one or more wavelengths, the second emitter grouping disposed at a second location, the second location spaced apart from the first location and spaced apart from the axis extending through the center of the wearable health monitoring device; one or more optical blocks separating the first emitter grouping from the second emitter grouping; a first light diffusing material configured to be positioned between the first emitter grouping and tissue of the user when the wearable health monitoring device is in use, the first light diffusing material configured to spread light emitted from one or more of the first plurality of LEDs before the emitted light reaches the tissue; and a second light diffusing material configured to be positioned between the second emitter grouping and the tissue of the user when the wearable health monitoring device is in use, the second light diffusing material configured to spread light emitted from one or more of the second plurality of LEDs before the emitted light reaches the tissue; and a plurality of photodiodes configured to detect at least a portion of light emitted from one or more of the first plurality of LEDs or one or more of the second plurality of LEDs after attenuation through the user's tissue, the plurality of photodiodes configured to output one or more signals in response to the detected light; a processor configured to receive and process one or more signals in response to the one or more signals output by the plurality of photodiodes, the processor further configured to determine a physiological parameter of the user based on the received and processed one or more signals; wearable health monitoring devices, including

Citation Information

Patent Citations

  • Oxygen saturation measuring device

    JP2002303576A

  • Portable type electrocardiograph

    JP2006061445A

  • Biological information processing apparatus, biological information processing method and program

    JP2009101057A

  • Oximeter and depth of consciousness monitor

    JP2013541990A

  • Modular sensor platform device and system

    JP2015112488A